Charged up the Many Challenges Of

Home , Charged Up

March/April 2014// Vol.48 // No.2 The Root of Better Care BIOMEDICAL INSTRUMENTATION & TECHNOLOGY BIOMEDICAL INSTRUMENTATION & TECHNOLOGY BI&TBiomedical Instrumentation & Technology Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 All Charged Up The Many Challenges of

Battery Maintenance

March/April 2014 March/April 2014 The Root™ patient monitoring platform is designed to transform patient care from the operating room to general care areas through a powerful combination of the following high-impact innovations:

® ® ® • Volume 48

> Radical-7 Instant interpretation of Masimo’s breakthrough rainbow and SET measurements via Root’s • Volume 48 intuitive navigation and high-visibility, touchscreen displays

> SedLine brain function monitoring via Masimo Open Connect™ (MOC-9™) featuring four simultaneous • Number 2 • EEG channels for continuous assessment of both sides of the brain Number 2

See for yourself how Root is destined to transform patient care at www.masimo.com/root

ALSO IN THIS ISSUE 800-257-3810 | www.masimo.com/root Making Sense of CMS Requirements © 2014 Masimo Corporation. All rights reserved. Caution: Federal law restricts this device to sale by or on the order of a physician. Two Perspectives on Effective Management © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited.

March/April 2014

Sterile Processing In 2nd Edition Healthcare Facilities: Sterile Processing In Healthcare Facilities: Preparing for Preparing for In This Issue Accreditation Surveys

113 BRIGHT IDEAS 139 OBSERVATIONS Accreditation Surveys, An Overhaul of Code AND INSIGHTS nd Cover Story Carts Translates into Is ‘Old School’ Time Saved Equipment Testing Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 2 Edition 86 All Charged Up: The Many Joseph Sheffer Rose Seavey The Way to Go in Challenges of Battery Maintenance Developing Countries? Martha Vockley 117 DATA MANAGEMENT Patrick K. Lynch Now in its second edition, this popular resource The Basics of CMMS Ted Cohen 142 RESEARCH is filled with valuable tools for preparing Features Columns and Building a 3D for accreditation surveys and maintaining Departments 122 HTM NEWS & VIEWS Computed 97 Stressing Less and Making Sense Tomography Scanner compliance with accreditation requirements. Striking a Healthy 74 FRONTLINES Of Revised CMS From Surplus Parts Work-Life Balance Medical Equipment Mark A. Haidekker Stephanie Stephens 75 LETTERS TO THE EDITOR Maintenance Nearly doubled in size, the book features: Requirements 152 FINAL WORD 100 Perspective 76 THE ROUNDUP Alan Lipschultz Healthcare Technology ► Information on accreditation organizations and requirements Which of the Seven Management Is Not Dwarfs Is Your 80 DID YOU SEE? 131 THE FUNDAMENTALS OF… An Island ► The current National Patient Safety Goals Manager? Defibrillators Mary Logan ► Information on CDC’s Guide to Infection Prevention for Outpatient Settings Pam Roberts 81 COMMUNITY CLOSEUPS Robert M. Dondelinger 85 ASK GEORGE ► CMS worksheets 101 Perspective 138 READING ROOM The Art and Science Health Care ► Audit tools for immediate-use steam sterilization best practices and high- 110 VIEW FROM THE TOP Engineering Of Managing Direct Infusion Nurse level disinfection best practices Reports Reviewed by Champion Talks Matthew F. Baretich Kenneth E. Maddock ‘High Touch’ in ‘High Sterile Processing in Healthcare Facilities also includes information on policies 106 Understanding Key Tech’ World Factors in Steam and procedures, the creation of audit sheets, root cause analysis, failure modes Sterilization and effects analysis, tracer methodology, and much more. Donna Swenson

Authored by Rose Seavey RN, MBA, BS, CNOR, CRCST, CSPDT.

Order Code: SPHC or SPHC-PDF Biomedical Instrumentation & Technology Single back issues (when available): $34 Instrumentation & Technology, Allen Photocopies: Authorization to (ISSN 0899-8205) is published bimonthly (US) and $38 (International). Subscriptions Press, Inc. 810 E. 10th Street, Lawrence, photocopy items for internal or personal List $195 / AAMI member $115 by the Association for the Advancement are available on a calendar year basis only. KS 66044-8897; (785) 843-1274; e-mail: use, or the internal or personal use of of Medical Instrumentation, 4301 North Send orders and remittances to Biomedical [email protected]. Advertising specific clients, is granted by Allen Fairfax Drive, Suite 301, Arlington, VA Instrumentation & Technology, 810 E. 10th manager Judy Riling, 800-627-0326 ext. Press, Inc. for libraries and other users 22203. © 2014, Association for the Street, P.O. Box 1897, Lawrence, KS 66044, 249, [email protected] registered with the Copyright Clearance Advancement of Medical Instrumenta- (785) 843-1235 ext. 210. Center (CCC) Transaction Reporting Index: Biomedical Instrumentation & tion. Publishing services provided by Service, 222 Rosewood Drive, Danvers, Order your Copy Today! Editorial: Visit www.aami.org/ Technology is indexed or listed by Allen Press, Inc. MA 01923. publications/BIT/guidelines.html to Bioengineering Abstracts/Engineering Call +1-877-249-8226 or Membership: AAMI members receive view the complete author guidelines. Index, BMEDSS (telecommunication Periodical postage is paid at Arlington, a complimentary subscription. Contact Send general correspondence to the service), CINAHL, EMBASE/Excerpta VA, and additional mailing offices. visit http://my.aami.org/store membership at AAMI: (800) 332-2264 Publications Department, AAMI, 4301 Medica, Index Medicus, Medline, ext. 1214. North Fairfax Drive, Suite 301, Arlington, PubMed, and Referativnyl Zhurnal Visit AAMI on the web at aami.org VA 22203; (703) 525-4890, ext. 1225. (Academy of Sciences of Russia). Subscription rates: Individuals, $204 per Printed on acid-free paper. year: $237 international. Institutional, Advertising and Business: Send SOURCE CODE: PB $246 per year; $282 international. correspondence to Biomedical © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Frontlines

Senior Director of Rick Hampton A Powerful Communications Partners Healthcare System Sean Loughlin Boston, MA

Managing Editor Gregory L. Herr Jena Passut The Christ Hospital Subject Cincinnati, OH Editorial Board Chair Larry W. Hertzler, BS, MBA, W. Glenn Scales, CBET PE, CCE Durham, NC ARAMARK Healthcare If you had told me, say, six months ago that I would be Charlotte, NC Publisher

intrigued by a cover story on batteries and medical devices, I Allen Press Publishing Services Jeff Kabachinski, MCNE, MS-T Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 probably would have been a bit dubious. Batteries, after all, ARAMARK Healthcare Advertising Manager Charlotte, NC lack the “wow” factor that subjects such as 3D printing or Jane Richardson Sue Klacik robotics offer, nor do they have the same kind of popular Graphic Designer IAHCSMM news hook you’d expect to find in an article on how hospitals Kristin Blair Canfield, OH Alan Lipschultz, CCE Copy Editors face natural disasters. Healthcare Technology Barbara Saxton Consulting LLC But after reading our cover story on battery maintenance Joseph Sheffer North Bethesda, MD and talking to biomeds on the frontlines of healthcare Patrick K. Lynch, CBET MBA CCE Editorial Board technology, I’d be hard-pressed to name a subject that cuts Global Medical Imaging (GMI) across as many medical device types and has more relevance Pat Baird Charlotte, NC Baxter Healthcare Corporation Kenneth E. Maddock, BSEET to the day-to-day responsibilities of healthcare technology Round Lake, IL Baylor Scott and White Health management (HTM) professionals. Matthew F. Baretich, CCE, Dallas, TX As the FDA’s William Maisel said: “It’s easier to generate a PhD, PE Royce “Glen” McQuien Baretich Engineering Inc. Crothall Healthcare list of devices that don’t rely on batteries.” Fort Collins, CO San Antonio, TX It is in that spirit that AAMI decided to tackle the issue of Michael J. Capuano, CBET, CCE Manny Roman, CRES Hamilton Health Sciences Salon, OH battery maintenance with a BI&T cover story. The article Corporation Hamilton, ON, Canada Rick Schrenker, MS details a host of challenges associated with the use of battery- Massachusetts General Hospital powered medical devices, including undercharging and J. Tobey Clark, CCE Department of Biomedical University of Vermont Engineering overcharging, confusing error messages, leakage, and loose Technical Service Program Boston, MA Burlington, VT connections. What I found especially interesting was that the Ed Snyder Ted Cohen, MS, CCE Thomas Jefferson University outcomes of these problems, if left unaddressed, range from University of California Davis Hospital Health System Philadelphia, PA relatively minor workflow nuisances to patient and/or staff Clinical Engineering Department harm. In short, the proper design, use, and maintenance of Sacramento, CA Dave Stiles, CBET Long Beach Memorial Medical batteries is fundamental to the safe delivery of healthcare. Robert E. Dondelinger, CBET-E Center U.S. Military Entrance Processing Long Beach, CA Consider the fact that more battery-powered medical Command devices (many of them life-sustaining) are making their way North Chicago, IL Mention of any commercial Larry Fennigkoh, PhD, PE, CCE product, process or service into homes and the hands of nonprofessionals, and you have Milwaukee School of Engineering by trade name, trademark, a new appreciation for how important the subject truly is. Milwaukee, WI manufacturer, or otherwise in BI&T does not constitute David E. Francoeur, CBET AAMI’s focus on batteries in medical devices won’t end or imply an endorsement or CREST Services with this cover story. There are other resources in develop- Crothall Healthcare recommendation by AAMI. The views and opinions of the ment, and we’d welcome your comments on what you would Russell Furst authors in BI&T do not state or Lakeland Regional Health System reflect the opinion of AAMI. find valuable. With your feedback, battery maintenance may Biomedical Engineering one day disappear from AAMI’s list of top 10 challenges for St. Joseph, MI POSTMASTER: Send address hospital HTM departments. n John Gagliardi changes to: BI&T, 810 E. 10th MidWest Process Innovation, LLC Street, P.O. Box 1897, Lawrence, Maineville, OH KS 66044-8897. AAMI Members send changes to AAMI; 4301 Izabella Gieras, MS, MBA, CCE N. Fairfax Drive, Suite 301, Huntington Memorial Hospital Arlington, VA 22203-1633; Pasadena, CA non-members send changes to Alan Gresch Kansas address above. Sean Loughlin Alpha Source Senior Director of Communications [email protected]

74 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited.

Letters to the Editor Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 Risk Management and 80001

Regarding the research paper “Assessing a Hospital’s Medical IT Network Risk Management Practice with 80001-1” (January/February 2014 BI&T): The thing that amazes me is that most people I talk with claim that only big institutions like Partners and Kaiser can implement 80001, that there is no way a small hospital can do it. It takes a 40-bed hospital in Ireland to show it’s going to work exactly opposite to this. I spent a few hours at the HIMSS conference in February, getting my ears bent by IS security types and a couple of CIOs. I’m beginning to think that only small hospitals can implement 80001. The larger institutions are either too arrogant to feel they need it (they already know everything) or too bureaucratic to pull it off—or possibly, both. I did talk with a couple of CIOs who “got” it. But, they confessed, only after their network had been badly compromised.

Rick Hampton Wireless Communications Manager Partners HealthCare, Boston

High Performers

“How to become a High-Performing HTM Department” (November/December 2013 BI&T) is the best and most useful article written so far about the changing role of healthcare technology management (HTM) professionals and HTM overall. The article was packed with plenty of advice and proposals for action, but it also managed to offer a big picture on the changes we’re seeing. Congratulations to the author on a great job! I am an imaging specialist at University of Chicago Medicine. I don’t have a management role in the Radiology Engineering Department, but I have been looking for ways to improve department efficiency— introducing metrics, changing the culture, elevating our visibility, and doing many of the other good things mentioned in the article. The advice about “not butting heads” with IT was especially wise. I will read the article again and try to extract points of improvement and implement them in my environment. I believe in the saying, “You don’t need a title to be a leader.”

Aleksandar Popivoda, CRES Radiology Engineer University of Chicago Medicine

Biomedical Instrumentation & Technology March/April 2014 75 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited.

The Roundup A compilation of items about healthcare technology news, regulations, and AAMI initiatives

Paper Examines death decision as it is in the Other stakeholders have according to the letter. warship.” raised concerns. The Patient, The mHealth Regulatory Military Alarms To access a free copy of the Consumer, and Public Health Coalition echoed these

Management Safety Innovations paper—one Coalition, whose members concerns. In a prepared Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 “Deep within the center of a of a series of such papers include Public Citizen, the statement, the alliance of naval warship is a military published by HTSI—go to National Physicians Alliance, medical device makers, combat information center …” www.aami.org/htsi/safety_ and the Union of Concerned healthcare providers, software Is that any way to start a innovation.html. The formal Scientists, sent a letter to Sen. developers, and others said paper about the effective title of the paper is “Healthcare Tom Harkin, D-IA, chairman the bill would deregulate a management of clinical Alarm Safety—What We Can of the Senate Health, Educa- number of life-critical apps, alarms in hospitals? You bet Learn From Military Alarm tion, Labor, and Pensions including those allowing it is. Management Strategies.” Committee, in opposition to patients to diagnose The new paper, which the bill. melanoma and potential relies on the expertise of a Health IT Bill Elicits “We are extremely con- concussion symptoms. Lockheed Martin researcher, Mixed Reactions cerned that this bill will The Senate bill has been describes how the military deregulate a broad swath of referred to the Committee on In what they call a move to learned to maximize a Navy medical devices that rely on Health, Education, Labor, and create a more defined warfighter’s performance as software and will create Pensions. To read the entire regulatory framework for the crew dealt with an array opportunities for rampant text of the bill, visit http://1. health information technol- of automated notification ‘gaming’ to avoid regulation. usa.gov/1iRRqeM. ogy (IT), Sens. Deb Fischer, systems. “The military For example, MRIs [magnetic R-NE, and Angus King, recognized years ago that resonance imaging] and CT AAMI/FDA Summit I-ME, have introduced the while automated notification [computerized tomography] Preventing Regulatory To Study Ventilator systems provide constant scanners, or heart monitoring Overreach To Enhance Care Technology warnings, they do not devices, might no longer be Technology (PROTECT) Act necessarily result in the regulated by the FDA,” Since 2010, AAMI and the of 2014. needed recognition by The PROTECT Act would operations personnel,” reads establish a risk-based frame- the paper, which was work governing health IT, released by the Healthcare reducing bureaucratic red Technology Safety Institute, tape while improving patient which operates under the safety, according to the bill. AAMI Foundation. Fischer said the act would The paper includes advice clarify the U.S. Food and on how healthcare Drug Administration’s professionals and medical oversight of health IT, adding device manufacturers can that it will help keep the apply defense logic to the agency’s resources focused on management of clinical high-risk devices. In addition, alarms. “In the healthcare she said it would shield setting,” notes the paper, low-risk clinical and health “alarm management can be software from the medical as crucial to making life and device tax. This life-sustaining technology will be the focus of a new summit.

76 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. The Roundup

U.S. Food and Drug event will mark the sixth dicted an increased demand the electronic submission to Administration (FDA) have summit for AAMI and the for medical staff services and FDA of manufacturer and joined forces to host sum- FDA. For more information technologists. It emphasized importer MDRs is an impor- mits delving into specific about past summits, please that as more complex technol- tant step toward improving healthcare technology visit www.aami.org/meet- ogy is introduced into the agency’s systems for challenges, such as infusion ings/summits. healthcare facilities, the need collecting and analyzing systems. This fall, the two for skilled professionals to fix postmarket MDRs,” accord- will tackle the issue of Magazine Names these machines as they break ing to the rule. ventilation technology used Healthcare Jobs to will grow. The area of medical The agency has said a num- in operating rooms, critical- Watch equipment repairers will add ber of benefits will result care units, and other 12,800 positions by 2022, from this change, including healthcare delivery settings. Increased demand for home according to U.S. News. time and cost savings for Scheduled for Sept. 16 and healthcare professionals and AAMI’s spring 2013 issue of industry. It estimated a cost Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 17 in Herndon, VA, the those who repair medical Horizons took a comprehen- savings to industry of about summit will bring together equipment have made these sive look at home healthcare $9.2 million each year as a government regulators; two areas noteworthy for technology. For information result of reduced postage and leaders from the medical potential job seekers in 2014, about the Horizons series, go delivery expenditures. device industry; healthcare according to the U.S. News & to www.aami.org/ In addition, the final rule technology professionals; World Report. publications/Horizons. can benefit public health by clinicians, including physi- In its look at home allowing the agency to cians, nurses, and respiratory healthcare jobs, the U.S. FDA to Require communicate more effec- News spoke with Deborah therapists; and other experts. Electronic Reporting tively about suspected Rowe, senior director of These participants will work For Adverse Events problems to industry, together to identify the Genesis HealthCare, a healthcare providers, and challenges, set priorities, and nursing and rehabilitation The U.S. Food and Drug patients. The text of the final discuss next steps to address- therapy provider. Rowe said Administration (FDA) has rule, which takes effect Aug. ing the issues related to there will be 21 million issued a final rule that 14, 2015, is available at ventilation technology, which Americans age 85 years or requires medical device http://1.usa.gov/1eJ8hfb. helps patients who are older in 2050, and many will manufacturers and importers unable to breathe sufficiently want to have care provided to electronically submit Importers Brace outside hospitals. “As people mandatory adverse event on their own. For Environmental are aging, it takes that level reports for their products. Ventilator technology has Directive become increasingly complex of care to help people reside The change comes more than over the years, incorporating in their homes, whether they five years after the agency Device manufacturers who monitors and alarms to alert need transportation to their allowed manufacturers to offer their products in the clinicians if there is a prob- medical appointments or submit these medical device European Union (EU) have lem. However, there have someone ... to go shopping reports (MDRs) electronically just four months before an been some challenges for them,” she added. on a voluntary basis. environmental directive kicks associated with the use of this The magazine also pre- “This final rule to require in for them, restricting the technology, including ventilator-associated pneumonia. Furthermore, the technology is not just used in healthcare delivery organizations, but also in nonclinical settings, such as the home. In such an environment, ventilators are placed in the hands of untrained professionals, posing additional challenges for both the user and the care provider. The ventilator technology Mercury is one of the elements on the import restriction list.

Biomedical Instrumentation & Technology March/April 2014 77 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. The Roundup import of six substances deemed dangerous by regulators. First adopted in 2003, the Restriction of Hazardous Substances (RoHS) regulation covers electronic assemblies and equipment. It restricts the use of lead, mercury, cadmium, hexava- lent chromium, polybrominated biphenyls, and polybrominated diphe- Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 nyls. The legislation is designed to prevent the release of hazardous substances into the environment at the device’s end of life. Medical products had enjoyed an exemption from Could this pWave radio base station soon be a common sight in hospitals? this regulation. However, as of July 22, 2014, the EU will require RoHS compliance for all medical devices that man, an entrepreneur and The technology obviously ties, rather than regions. The are not implantable or force behind QuickTime and holds great promise for memo builds on recommen- critical to an implantable the facial motion capture communications. What dations from a program device’s operation. In vitro technology Mova, led the about other applications? alignment group she tasked diagnostics have until July team that developed pCell Perlman names wearable last September with looking 22, 2016, to comply. through his Reardan Compa- devices as one possible area; into ways to refine certain Eucomed, the body that nies incubator. could the wireless devices FDA functions and processes. represents European device “The entire world could increasingly being used by Hamburg said that with makers, names several have a broadband connection healthcare delivery the overhaul, regulatory and products that will be affected all of the time; wherever you organizations be another? compliance activities will be by the legislation, including are, whatever you’re doing,” organized around “distinct blood bag warmers, infusion Perlman said. FDA to Overhaul commodity-based, vertically pumps, and baby incubators. The technology uses the Organization integrated regulatory interference generated by Of Inspection, programs”: devices and mobile devices, combining radiological health, pharma- CEO Shares Vision transmitted radio signals Compliance Activities ceutical quality, food and For Unlimited from multiple pCell base In a move intended to feeds, products regulated by Broadband stations to create these improve how the U.S. Food the agency’s Center for Imagine a world in which personal cells. Even if a user and Drug Administration Biologics Evaluation and every wireless mobile device is in a crowded location, such (FDA) functions, Research, tobacco, and has its own personal cell as a stadium, individual Commissioner Margaret bioresearch monitoring. The with full broadband spec- mobile devices can function Hamburg has unveiled big move toward a commodity trum capacity. That’s the at full speed. Artemis has changes to the organization or products-based dream of one San Francisco- partnered with PureWave of the agency’s inspection approach—drugs, devices, based company. Networks to develop pWave and compliance activities. biologics—marks a big Artemis Networks founder radios, which will serve as the The thrust of the unfolding change from the current and CEO Steve Perlman base stations. Unlike conven- changes, detailed in a memo inspection and compliance recently demonstrated his tional cell towers, these released by Hamburg’s office, system, which is based on pCell technology in videos stations can be placed indoors is that the agency will place a geography. posted on YouTube. Perl- or outdoors. new emphasis on a special- Inspectors and compliance

78 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. The Roundup officers will specialize in tion on these medical followed by the stethoscope’s business with companies commodity areas, for exam- instruments. It found that diaphragm. Indeed, the focused on software, data, ple, medical devices, so they stethoscopes have the diaphragm was more and analytics. No financial can bring special training and potential to spread bacteria, contaminated than the three details have been disclosed. knowledge to a specific area. including methicillin- other parts of the physicians’ Following the close of the Her memo singled out resistant Staphylococcus hands. Even the tubing was deal, API unveiled its Patient medical devices as posing aureus (MRSA). contaminated—more so Classification Clinical particular challenges. In the first part of the than the back of the physi- Information Interface “Indeed, some medical two-phase study, researchers cians’ hands. software. The staffing and devices are so complex, that at the University of Geneva “By considering that scheduling software inte- we may need sub-specialists Hospitals in Switzerland stethoscopes are used grates with patients’ trained in just a segment of measured the total amount of repeatedly over the course of a electronic health records, that industry in order to carry bacteria on four sections of day, come directly into contact allowing for better workload Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 out effective oversight of a the physicians’ hands, with patients’ skin, and may management, according to a manufacturer,” she wrote. comparing those numbers harbor several thousands of prepared statement. with those on the stetho- bacteria (including MRSA) Study: Stethoscopes scopes’ diaphragms—the part collected during a previous Hillary Clinton More Contaminated that touches the patient’s physical examination, we Talks Health IT Than Doctors’ Hands skin—and tubing. The consider them as potentially second phase focused on significant vectors of trans- Possible presidential con- Stethoscopes are ubiquitous MRSA transmission, with the mission,” said the study’s lead tender Hillary Clinton took to in the healthcare facilities— physician conducting the investigator, Didier Pittet, MD, the stage at a recent health- so common, in fact, patients patient exam without gloves. director of the Infection care technology conference, might not even think about Results from 71 patients were Control Program and WHO calling for “evidence-based them. included in the final analysis. Collaborating Centre on policy debates.” A study published in the According to the results Patient Safety, University of The former secretary of Mayo Clinic Proceedings, for both phases, physicians’ Geneva Hospitals. “From state and U.S. senator spoke however, revealed some fingertips were the most infection control and patient at this year’s Health Informa- surprising findings about the contaminated area studied, safety perspectives, the tion and Management level of bacterial contamina- stethoscope should be Systems Society’s annual regarded as an extension of conference in Orlando, FL. the physician’s hands and be She said that healthcare disinfected after every patient information technology is contact.” vitally important because it can provide the evidence both clinicians and policy GE Completes API makers need to make sound Healthcare Buy decisions. In a move it says will bolster “I’m a true believer that its Hospital Operations good data makes for good Management portfolio, GE decisions, and that’s true of Healthcare has wrapped up medicine, and true of its acquisition of Hartford, business, government and WI-based API Healthcare, life,” she said. “I think it’s which offers healthcare- important to be guided by specific staffing and evidence—by what works or scheduling, patient classifica- doesn’t—not ideology or a tion, human resources, and past-held belief.” n payroll solutions. First announced Jan. 21, 2014, the deal boosts GE’s so-called Industrial Internet This common piece of medical equipment could be harboring deadly bacteria. strategy, enhancing its

Biomedical Instrumentation & Technology March/April 2014 79 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Did You See?

Did You See? Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021

The Center for Devices and Radiological Health has unveiled its strategic priorities for 2014-15. They include a fresh look at the role of clinical trials in the development of medical devices. For details, go to www.aami.org/news/2014/020614_CDRH_2014_Priorities.html.

A high school junior in Kansas used a 3D printer to make a prosthetic hand for a 9-year-old disabled family friend. AAMI’s vigorous standards program plays a major role in Read about the heartwarming story at http://aamiblog. shaping how medical devices org/2014/02/13/sean-loughlin-the-so-cool-story-of-a-teen-a are designed and used. You -3d-printer-medical-technology-and-one-happy-boy/. could have a seat at the table. Find out how at www.aami.org/standards

There’s a new training program on risk management of integrated systems. The program is geared toward clinical engineering and information technology professionals. Learn more at www.aami.org/meetings/ courses/htf.html. AAMI Board Chair Ray Laxton had a frank and funny reply to the question of what AAMI would do if its CEO were to leave tomorrow. To read Laxton’s answer, go to www.aami.org/news/2014/022514_AAMI_ Board_Chair_Featured.html.

80 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Community Closeups Ten Questions With … Phil Raymond

What drew your interest in focusing on What is the best part of your job? wireless issues in healthcare? The opportunity to create and share best Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 As a technologist with an engineering practices and have a positive impact on degree, I’ve found wireless communications enterprise networks. More importantly, it is to include challenges in radio frequency as having the opportunity to bring about well as data communications. When you add positive outcomes for clinical users, patients, in the virtuous nature of healthcare delivery, and their families. you have not only an exciting challenge in the technology arena, but also the opportunity to And the most challenging? improve patient care. Staying abreast of evolving technology in terms of complexity and market/industry adoption. Are more hospitals comfortable connecting their devices to Wi-Fi? What is the best career advice you received? Slowly, yes. However, I have found that People telling me I can’t do something— Phil Raymond is a wireless professionals at healthcare delivery organiza- nothing like the motivation to prove architect and global network tions need more education about a number naysayers wrong! product manager in Philips of wireless topics—ranging from the Healthcare’s Connected Care technology behind wireless connectivity to What is your proudest career moment? Solutions. An expert in wireless the implications of operating medical devices connectivity in the healthcare I have many, from graduating from Georgia and systems on their networks. space, Raymond is chair of the Tech with my engineering degree, to the Wi-Fi Alliance Healthcare humbleness of being considered a subject Marketing Task Group and Are hospitals doing enough with risk matter expert in areas of wireless connectiv- co-chairs the AAMI Wireless management? ity in healthcare. Strategy Task Force. Not enough are approaching wireless connectivity from a risk management standpoint. What work do you foresee for AAMI’s While you don’t have to use risk management Wireless Strategy Task Force? as a means of enabling a safe and effective Generating actionable content to help health- wireless network, it provides a solid founda- care delivery organizations in creating wireless tion and a pathway. Many believe that the medical IT networks, including developing standard IEC 80001-1 is too costly to imple- best practices for wireless network design and ment, but the answer is to apply the concepts management, and benchmarking test plans that meet the needs of a specific healthcare for onboarding wireless devices onto the organization. One size does not fit all. hospital’s wireless local area network.

Why did you get involved in standards work? What do you like to do in your spare time? When you want to bring about change in My family loves the Boston Bruins, so I technologies used by a variety of stakehold- watch the games with my girls. I’m also a ers, you start with standards, as they look to geek who enjoys digital video and photogra- stay above competitive differences and allow phy. All of the technology in the house for interoperability. sometimes drives my family nuts! n

Biomedical Instrumentation & Technology March/April 2014 81 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Community Closeups

Association Roundtable

Insights and advice from leaders of local and state biomedical associations

How do you encourage students to become active with your Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 society and support their growth as future leaders?

“We have members engaged in different “We are very lucky in light of the fact that we mentorship programs. We are involved with have one of the premier BMET programs in the three different biomedical programs at local nation in our backyard: Schoolcraft College in colleges. I am involved with Chattahoochee Livonia, MI. … As an instructor at Schoolcraft and Technical College in Georgia on its advisory current president of the Michigan Society for board. We also discount membership for Clinical Engineering, I make it a point to be sure students. Very soon, we are rewriting our bylaws that students are aware of the MSCE and are to allow for free membership for individuals and students. My invited to our monthly meetings. This gets the students engaged belief is this will help us reach out to many of the third-party with local biomedical technicians, clinical engineering biomedical technicians who have little support to get involved management, and medical equipment vendors—both sales and in the profession.” service. We encourage the students to begin their relationships Greg Goll, CBET BS with potential employers early in their scholastic journey. This also President gives the membership of the MSCE a chance to get to know the East Tennessee Biomedical Association President students, so if there are any employment opportunities, a relationship is already established. … We make it clear that “I am on the ITT Electronics Advisory Committee everyone is welcome to our meetings.” in the St. Louis area. I have a manager who is on Tom Parnin, CBET, CHSP the Jefferson College BMET [biomedical President equipment technician] Advisory Committee. We Michigan Society for Clinical Engineering have done tours of Mercy Clinical Engineering at Mercy Hospital St. Louis for students from ITT, “The board of the Oklahoma Association of Linn Tech, and Jefferson College. I have Healthcare Engineers has worked to provide presented to students at ITT about the healthcare technology growth opportunities for upcoming healthcare management field. …I send notices about our society meetings engineers. We have developed a six-year plan for to several area colleges: Linn State, Jefferson Community advancement on the board. … Each year all College, and St. Louis Community College. The Gateway board members are sponsored to attend the Biomedical Society has often participated in the Engineer’s national ASHE [American Society for Healthcare Week at the St. Louis Science Center.” Engineering] convention. The board also promotes and sponsors Douglas Dreps, MBA board members in AHA [American Hospital Association] President certifications in facility management, safety, and healthcare Gateway Biomedical Society constructor. It is the goal of the board to offer board members the opportunity to achieve the status of senior with ASHE by the end of their terms, which will provide multiple opportunities within their careers.” Ron Thetford, CHFM, SASHE President Oklahoma Association of Healthcare Engineers

82 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Community Closeups

People Are Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 Saying A sampling of comments from AAMI’s social media sites.

“Many devices are literally life savers. But when it “Alarm inflation was the inevitable product of comes to the design of medical devices—and the outdated ‘fire alarm’ concepts of monitoring clarity of instructions—I’m hearing about more good education, oversimplified engineering, and continued things than I’m seeing as a caregiver.” use of simplistic 20th century design.” — Suzanne Steidl, founder of Your Daughter’s in Town, an — Lawrence Lynn, president of Lynteck Medical advocacy group for elderly patients. From the AAMIBlog. Technologies. From the Healthcare Technology Safety Institute’s discussion group on LinkedIn.

“Communication, in general, can be difficult. Factor in different generational preferences and styles, and “Competition for your business is the only way to the chances for misunderstandings mushroom.” drive the best price.” — Michele DeMeo, sterilization consultant and hospice — Terrence Baker, manager of information systems and patient. From the AAMIBlog. clinical engineering for the North Central Region at Indiana University Health. From AAMI’s LinkedIn discussion group.

“The absolute best way to learn what the problems are in using medical equipment is simply to be on ‘first call’ 24 hours a day.” — Frank Block Jr., MD, retired after 30 years of anesthesiology practices. From the AAMIBlog.

Join the Conversation. www.twitter.com/aami_connect www.facebook.com/aamiconnect Discussion Groups www.aami.org/communities/discussion Search for AAMI in groups http://aamiblog.org

Biomedical Instrumentation & Technology March/April 2014 83 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Benchmark It!

Select the web-based benchmarking resource to fit your needs... Benchmarking Solutions Designed for healthcare technology management departments, this features over 70 measurements: HTM • Staffing levels Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021

Order code: ABS • Cost of maintenance contracts

List $850 • Personnel qualifications and responsibilities

AAMI member $750 • Number of devices maintained

Benchmarking Solutions Designed for sterile processing departments, this features more than 175 benchmarking metrics: Sterile Processing • Budgeting and financial issues

Order code: SPB • Sterilization practices

List $850 • Volume and types of work performed

AAMI member $750 • Staffing, qualifications, and much more.

Benchmarking Solutions Helps device companies compare elements of their quality management systems with Quality Management System those of their peers. It features more than 100 for Medical Devices measurements covering: • RISK MANAGEMENT: Adherence to standards, management involvement, and documentation Order code: QMS • CORRECTIVE & PREVENTIVE ACTION (CAPA): List $1,450 Issue escalation, CAPA management, and AAMI member $1,100 preventive action statistics

Benchmarking data can be submitted at the corporate, division, or site level. Developed with input from FDA, AdvaMed, and leading Risk Management and CAPA experts.

Order Your Copy Today! Call +1-877-249-8226 Visit http://my.aami.org/store © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Ask George

Regarding a smoke-free dures to focus specifically on between taking patient campus, what is The Joint those components. readings or data. Commission’s position on If your maintenance Any item that is in the means Benchmark It! electronic cigarettes? Ask history reveals other types of of egress (i.e., patient hallway) The Joint Commission failures (such as improper that is not actively used for environment of care use of accessories or damage more than 30 minutes would standards prohibit smoking from abuse) that are not be considered stored and Select the web-based benchmarking resource to fit your needs... George addressed by your scheduled (EC.02.01.03), regardless of should be removed. Certain the type of smoking (tobacco, activities, you should adopt wheeled equipment, such as Benchmarking Solutions Designed for healthcare technology management electronic, etc.). There are strategies (such as user crash carts, may reside in the departments, this features over 70 measurements: In this column, training, frequent rounding) BI&T features provisions for allowing means of egress as they may that address those issues. HTM questions and smoking in specific circum- be needed at any time, so they • Staffing levels You could compare your answers between stances, which may include a are always considered “in Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 AAMI members designated smoking room organization’s history to the use.” Also, wheeled carts, • Cost of maintenance contracts Order code: ABS and George with appropriate exhaust and aggregate experience of others such as isolation and chemo Mills, director of fire safety features. These by looking at larger databases, carts, may be in the means of List $850 • Personnel qualifications and responsibilities the Department of Engineering at locations are to be physically such as the FDA’s MAUDE egress while serving the The Joint Commission. Become system. Such a comparison part of the discussion and ask separated from care, treat- patient’s needs, even if the AAMI member $750 • Number of devices maintained might assist you in making a questions about those subjects ment, and service areas. The patient is moved from the that matter to you the most. You goal is to manage the smoke decision before multiple patient room for testing or can submit your Joint Commission in the environment (regard- occurrences of a problem other reasons. But when the Benchmarking Solutions Designed for sterile processing departments, this question at: www.aami.org/ less of whether it is tobacco surface at your organization. patient is discharged or not tmcconnect/askgeorge.html. Or smoke or smoke from the The number of data points longer needs those supplies, features more than 175 benchmarking metrics: to join AAMI’s Joint Commission electronic cigarette). necessary to prompt a the cart is removed from the Sterile Processing e-forum, which is open to all • Budgeting and financial issues change in either schedule or means of egress. The status AAMI members, visit www.aami. strategy should be a function org/tmcconnect/discussiongroups. With regard to evidence- of the equipment being of the criticality, failure Order code: SPB • Sterilization practices html. The questions and answers based maintenance, what plugged in to maintain may have been edited for space, would The Joint Commission mode, and potential failure batteries does not impact the List $850 • Volume and types of work performed style, and clarity. consider sufficient history to effects of the device. For item’s storage status. For justify changing intervals? example, one failure of a example, a computer on AAMI member $750 • Staffing, qualifications, and much more. pump in a life support device If the maintenance history wheels that is actively being may warrant greater consid- used may also be plugged in reveals that a device is failing eration than several pump at a rate that is more frequent and charging. When the failures in a patient support computer on wheels is not Helps device companies compare elements than your planned mainte- device. If there is any Benchmarking Solutions nance or fault-finding used for more than 30 of their quality management systems with uncertainty in whether minutes, it would be those of their peers. It features more than 100 (inspection) activities, you changes should be made in Quality Management System should adjust your frequencies considered storage, and needs measurements covering: the maintenance program to be relocated, regardless of for Medical Devices to make them more frequent. that could affect clinical Conversely, if your scheduled charging condition. • RISK MANAGEMENT: Adherence to standards, operations, the Environment Some relief to the problem of management involvement, and documentation activities are not detecting of Care Committee is a Order code: QMS potential failures, perhaps the corridor clutter might be if multidisciplinary body that the unit has a dead-end • CORRECTIVE & PREVENTIVE ACTION (CAPA): interval could be extended—or should be consulted for List $1,450 you may be looking at the corridor. An organization Issue escalation, CAPA management, and guidance and direction. could store up to 50 square preventive action statistics wrong things. Both possibili- AAMI member $1,100 ties should be considered. feet of equipment in a What is considered “stored” dead-end corridor. Such If the corrective mainte- equipment in a patient Benchmarking data can be submitted at the corporate, division, or site level. Developed with input nance history indicates a items could include C-arms hallway? I have been to and computers on wheels. from FDA, AdvaMed, and leading Risk Management and CAPA experts. pattern of failures (for several facilities where example, persistent prob- The equipment may be portable equipment is plugged in while stored in lems with a door latch plugged temporarily in an spring or a sensor), you may this location. n Order Your Copy Today! outlet in the patient hallway need to adjust your proce- to maintain battery power Call +1-877-249-8226

Visit http://my.aami.org/store Biomedical Instrumentation & Technology March/April 2014 85 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021

All Charged Up The Many Challenges of Battery Maintenance

Martha Vockley

About the Author A day in the life of Cmdr. Mike Krumlauf, a ultrasound machines, and constant positive critical care nurse at the National Institutes airway pressure (CPAP) and bilevel positive Martha Vockley is principal of of Health (NIH) Clinical Center, is a micro- airway pressure (BIPAP) machines. VockleyLang, LLC, cosm of a surging challenge in healthcare: Like many healthcare providers in hospitals a communications managing battery-powered medical devices. and other clinical settings, Krumlauf and his and marketing For Krumlauf, patient care routinely colleagues also rely on point-of-care support firm based in requires the use of a diverse collection of systems. For them, these systems include: Reston, VA. E-mail: high-tech and low-tech medical devices and • Portable workstations [email protected] equipment. The long list of items includes: –– Laptop computer ambulatory infusion pumps, intravenous (IV) –– Bar code scanner infusion pumps, blood pressure machines, –– Bar code printer oxygen saturation monitors, thermometers, –– Portable data assistant (PDA) scanner glucometers, ventilators, suction machines, • Unit-based cellphones scales, portable telemetry, feeding pumps, • Medication dispenser or storage machines defibrillators, automated external • Supply cabinets for stock patient care items defibrillators (AEDs), sequential compression devices, portable electroencephalogram All of these wired and wireless medical (EEG) and electrocardiogram (ECG) devices, equipment, and support systems machines, patient transfer lifts, patient beds, feature a common component—batteries.

86 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Cover Story

But the challenges of battery-powered Issue/Challenge Reported/Potential Outcome medical devices are myriad and diverse. Failure to plug in device • Premature depletion • Loss of power What Could Go Wrong? Inaccessible plugs/outlets • Premature depletion “We rely heavily on battery-powered medical • Loss of power devices,” says Krumlauf, who is also a nurse Overcharging • Overheating consultant with the Research and Practice • Fire Development section of the Nursing • Explosion Department at the NIH Clinical Center. Undercharging • Premature depletion “Frequent use leads to undercharging, with • Loss of power potential battery loss and failure. It’s very Leakage • Fire much a challenge to figure out how much Swelling • Explosion

power is left in all of the devices. Not every Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 Loose connections • Premature depletion device has a battery indicator or an alarm. For • Loss of power patient safety during transport, by ambulance Incorrect replacement • Leakage or through the hospital, you often have to send • Increased heat patients with two devices because you’re • Fire worried that one is going to fail.” Confusion with on/off button • Premature depletion A small-sample qualitative survey of nine • Loss of power respondents from nine hospitals in a net- Table 1. Types of Battery-related Issues and Challenges. (Source: Hazlett A. Overview of work of 250 healthcare facilities that MedSun Survey. Presentation at the FDA Public Workshop, Battery-Powered Medical Devices: participate in the U.S. Food and Drug Challenges and Opportunities. July 30–31, 2013.) Administration (FDA) Medical Product Safety Network, known as MedSun, sheds more light on the challenges posed by batteries. Up to 50% of service calls in hospitals surveyed are related to battery ing batteries in medical devices. Moreover, issues, according to the FDA’s Antoinette Hazlett says, the devices cited most Hazlett, manager of surveys, special studies, frequently by survey respondents are widely and research at the Center for Devices and used for diagnostic, therapeutic, and, in Radiological Health (CDRH) Office of some cases, life-support functions. They Surveillance and Biometrics, Division of include large-volume infusion pumps, Patient Safety Partnerships. telemetry boxes, pulse oximeters, The small survey of hospital biomedical or thermometers, electric beds, monitors, and clinical engineers, risk managers, nurses, portable or mobile devices. and purchasing directors may not represent At one hospital, severe Up to 50% of service calls in all device users’ experiences, Hazlett weather caused a power loss. hospitals surveyed are related to cautions. Still, the range of issues cited by While an emergency genera- just nine respondents at geographically tor kicked in within five or six battery issues, according to the FDA. diverse hospitals, which are shown in Table 1, seconds, a memory battery on is telling: failure to plug in battery-powered an infant isolette did not back medical devices; inaccessible plugs or outlets; up the programmed tempera- battery overcharging, undercharging, ture setting. The temperature reverted to the leakage, swelling, and loose connections; manufacturer’s default setting, and the incorrect replacement; and confusion with isolette became too hot. the on/off button. One hospital reported that a temporary These issues can result—and have external pacemaker provides no indication resulted—in premature battery depletion, that the battery is low or depleting. But when loss of power, overheating, fire, and explo- the battery is depleted, the staff has just two sion. All of these outcomes are potentially to five seconds to replace it. “Insufficient serious hazards to patient care; some could charging of infusion pumps causes alarms,” cause injuries or even death to patients and Hazlett adds. The burden of too many alarms anyone else in the proximity of malfunction- and alerts is already a major challenge in

Biomedical Instrumentation & Technology March/April 2014 87 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Cover Story

most hospitals. “Some hospitals have stopped devices and processes with an eye on using some of these devices.” improving patient care. Even in a highly controlled acute care Challenges with battery-powered medical Batteries in Implantable Devices setting, Krumlauf considers “what happens devices extend beyond hospitals and other In December 2013, the FDA when the lights go out” during routine power clinical settings. “Many medical devices have announced a pilot program checks and in emergencies—when genera- migrated to homes, into environments for focusing on implantable medi- tors and batteries power medical devices for which they are not necessarily intended, with cal devices that use batteries. critically ill patients. “If you were me, a nurse harsher use by people who don’t have In collaboration with manufac- or a healthcare provider, and the power is healthcare training,” Maisel says. turers and other stakeholders, out,” he says, “you’d wonder, ‘How long will Battery issues are migrating to homes and the FDA will develop: the power be out? Can you plug in all other nonclinical settings along with the • A framework for determin- devices? Which devices should you plug in? devices. For example, the FDA’s Mary ing specific manufacturing

What do we do next?’” Weick-Brady, senior policy advisor at CDRH, Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 operations, design consider- cites a July 2013 case study of a home-use ations, and controls that im- An Escalating Challenge ECG machine with a lithium-ion battery pact the quality and safety Krumlauf, Hazlett, and others whose perspec- recharging on a home kitchen counter. The of implantable devices that family heard popping noises and found the use batteries tives are captured in this article spoke at a public workshop on battery-powered medical “jumping battery” on the floor—and in • An inspectional approach devices convened by the FDA in July 2013. flames. The patient’s son put the fire out by that focuses on these factors More than 700 people—including 400 who stomping on the battery. While no injuries participated online from all over the world— resulted, the incident exemplifies a potential • Outcome measures to evaluate the effectiveness of this attended the workshop, which was held at fire hazard in recharging batteries. approach FDA headquarters in Silver Spring, MD. Lithium-ion batteries offer much higher The FDA hosted the battery workshop to energy density than other alternatives, The pilot program is part of raise awareness about battery challenges, and providing long run times with less frequent the FDA’s Case for Quality initi- to engage many stakeholders—including recharging required. They also do not suffer ative, which focuses on quality, healthcare providers, healthcare technology from the so-called “memory effect,” which enhanced data transparency, and stakeholder engagement. management (HTM) professionals, manufac- means that a battery holds less charge after By looking at quality, the turers, regulators, and patient safety repeated recharging. Lithium-ion batteries FDA aims to build on its op- advocates—in developing solutions. can be charged, fully or partially, at any time, erational model of ensuring In AAMI surveys of HTM professionals in greatly simplifying battery maintenance. Still, regulatory compliance by also hundreds of hospitals in 2011, 2012, and 2013, if overheated or overcharged, lithium batter- promoting “critical-to-quality” battery management emerged as a top 10 ies can rupture and combust. practices that correlate to medical device challenge. In the 2013 survey, In nonclinical settings, Weick-Brady says, higher quality outcomes. 50% of respondents cited battery the environment of use, users, and devices management as a challenge, ranking it are even more highly variable than in clinical “higher than alarm management, infusion settings—and few patients or family caregiv- pumps, and cybersecurity,” as the FDA’s ers are prepared to head off or troubleshoot battery issues. “What may be innocuous to [healthcare technology experts] may be an In AAMI surveys of HTM professionals in hundreds of emergency to a user,” she says. To learn more hospitals in 2011, 2012, and 2013, battery management about issues related to the use of healthcare emerged as a top 10 medical device challenge. technology in nonclinical settings, including emergency considerations, see the AAMI William Maisel, deputy center director for publication, A Vision for Anywhere, Everywhere science at CDRH, points out. Healthcare, available for free at Over the past decade, reports to the FDA’s www.aami.org/summit2013/index.html. MAUDE (Manufacturing and User Facility Device Experience) database about battery- ‘Mixed Bag of Challenges’ related issues have trended upward as well, Dave Marlow, a certified biomedical equip- according to Chris Lavanchy, engineering ment technician with the University of director at ECRI Institute, an independent Michigan Health System, has been working nonprofit organization that studies medical with and testing medical device batteries in

88 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Cover Story hospitals for more than 35 years. He catego- rizes the “mixed bag of challenges” with batteries as follows: • Different battery technologies • Manufacturers with different approaches • Different applications • Different levels of criticality • Medical facilities with different capabilities • User training and experience differences

At the FDA workshop, several presenters expounded on these challenges. The sheer

number and variety of battery-powered Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 medical devices compound the challenges in both clinical and nonclinical settings. The evolution of miniaturized, low-powered electronics; the demand for portable, mobile, and wireless devices; and the convenience of avoiding software boot-up time are contributing to the surge in battery-powered medical devices, ECRI Institute’s Lavanchy says. The quest for smaller batteries comes at a cost. “The persistent demand to reduce A patient monitor that was damaged from a battery fire. There was no harm to the patient, but the monitor was totaled. An investigation pointed to a problem with the battery’s safety circuit. battery size, increase longevity, and add The information was taken from FDA’s website which features presentations from the agency’s device features continues to drive batteries July 30-31, 2013 workshop on battery-powered medical devices. with more power and energy in a smaller package, which inherently adds risk,” says Dominick Frustaci, vice president of R&D patient lifts, infusion pumps, surgical saws, and product development engineering at suction pumps, and mobile X-rays, they are Greatbatch Medical, a company that designs helpful. But he sees the use of batteries in A Mismatch between Battery and manufactures batteries and other other devices, such as patient scales, And Device Life Cycles? components for healthcare technology. sequential compression devices, stationary Why can’t batteries last as There are many types of batteries—for infant incubators, and operating room tables, long as the projected life example, lead acid, lithium-ion, nickel as questionable. Batteries can be a “blessing” cycles of the devices they cadmium, nickel–metal hydride—each with or a “burden,” he says. power? That question arose different chemistries, characteristics, and “There is a tradeoff between the repeatedly during the FDA charging and maintenance requirements, convenience of battery power and the burden workshop on battery-powered depending on the manufacturer. Some to maintain them,” he says. “Maybe it is a bit medical devices. batteries are built into medical devices and of a luxury factor in having all these devices Aligning battery and are hard to access, or require battery support with batteries. Maybe we’re putting batteries device life cycles will systems to manage and service them. in devices just because we can.” require innovation and Battery applications and levels of critical- The maintenance challenge is exacerbated multidisciplinary collaboration. ity in these applications vary considerably as by the reality that medical facilities and users Such open innovation efforts well. Some batteries are the primary source differ in their capacity for proper battery use, could be spurred by incentive of power, as with implantable devices. servicing, and supportability. Clinicians might prizes such as those offered on Challenge.gov, the federal Others provide secondary, redundant, or not know that the intended use for batteries in government’s platform for backup power or functionality for devices or some medical devices is for backup power open innovation, according device accessories. only. Operating a ventilator, for example, in to Cristin Dorgelo, assistant For some applications, such as battery mode might result in exceeding the director for grand challenges defibrillators, transport ventilators, heart- recommended battery backup time. at the White House Office of lung machines, ventricular assist devices, Medical facilities also are increasingly Science and Technology Policy. and intra-aortic balloon pumps, batteries are burdened with the service requirements of vital, Lavanchy says. For others, such as battery-powered medical devices and equip-

Biomedical Instrumentation & Technology March/April 2014 89 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Cover Story

ment that patients take home with them. wide variation in standard deviations on the “Many failures in home health equipment tested values, in three models of are battery related,” says David Bradley, defibrillators, two models of infusion pumps, director of biomedical engineering at one model of a patient-controlled analgesia Nationwide Children’s, a pediatric hospital in (PCA) pump, Doppler ultrasound, and Columbus, OH. “There is low compliance in ventilator, respectively (Lipschultz, 2013). But Tips for HTM Professionals getting equipment returned” for servicing. the data on these devices did not indicate any difference in failure rates between OEM and What can HTM professionals A Closer Look non-OEM batteries. do now to help with the effec- Experts say the many challenges with “The ARAMARK conclusion is that the tive maintenance of battery- primary cause of premature battery failure powered devices? battery-powered medical devices generally fall into these four areas: purchase and seems to be a mismatch between the OEM • Ask manufacturers and expectations and clinical users’ understand-

replacement; charging; testing; storage, Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 third-party battery vendors transportation, and disposal. ing and ability to care for the batteries,” says to supply manuals, instruc- Purchasing and replacing. As they do with Alan Lipschultz, president of Healthcare tions for use, and/or labels sourcing and replacing many components Technology Consulting, who presented the with recommendations on ARAMARK findings at the FDA workshop. how to manage batteries. and parts of medical devices and equipment, most HTM professionals rely on both Finances are a significant issue as well • Develop a repository of original equipment manufacturers (OEMs) when it comes to battery procurement and labels for battery-powered and third-party vendors for batteries. Most replacement. “The cost of changing batteries medical devices with simple also use one or more trusted vendors, is expensive,” Bradley says. “We probably battery instructions for clini- according to an AAMI survey of HTM profes- spend $100,000 a year changing batteries.” cians and/or patients (e.g., Healthcare technology managers need to “Plug In!”). sionals on battery issues. “Some hospitals say they use OEM weigh cost, value, quality, and reliability of • Develop and follow a bat- batteries in the highest-risk applications,” OEM vs. non-OEM batteries. tery management plan—and Lavanchy says. “Most are concerned about Charging. Like Goldilocks in the children’s adjust the plan as needed. risk and liability.” fairy tale, it can be difficult for healthcare • Ensure that workbenches That is certainly the case for Nationwide providers and other device users to find the have appropriate equip- Children’s. “When children are burned, that “just right” charging level for batteries. ment and tools for inspect- makes the news,” Bradley says. The hospital Batteries can be overcharged, which can lead ing, testing, charging, and used to change batteries only upon failure— to battery (and device) damage, loss of power, replacing batteries. until a scorched patient monitor led to swelling, leakage, or explosion. Undercharg- changes in that process. The monitor battery, ing batteries can result in premature depletion • Maintain an inventory of spare batteries and acces- which had failed 30 days prior to that event, and loss of power. Older batteries tend not to sories. had been replaced with a new, non-OEM hold a charge as long as newer ones. Some battery when an apparent safety circuit batteries require a full charge–discharge– • Provide consistent and ongo- failure occurred while the monitor was in use charge cycle periodically—and that process ing education and training in a patient room. The patient was not needs to be tracked and managed. to staff responsible for the harmed; the monitor was totaled. Not all batteries, or battery-powered use, maintenance, charging, and replacement of battery- Now, all batteries are replaced every two medical devices, provide an indicator of powered medical devices. years at Nationwide Children’s. Only OEM battery status—and those that do can be hard batteries are used for life-safety and critical to decipher or even wildly inaccurate, notes • Provide staff with informa- equipment. The hospital also has limited the Bruce Adams, vice president of sales, Cadex tion about the cost implica- number of vendors from which it procures Electronics Inc., a battery charger and tions for replacing batteries. batteries, and attends to evaluating battery analyzer manufacturer. Not all battery quality during preventive maintenance and indicators give users sufficient advance when batteries are removed. notice that the battery power is running low. It’s unclear, however, whether or how OEM Excessive heat, cold, dampness, and debris batteries differ from those of third-party in the environment of use can cause failures suppliers. An analysis by ARAMARK of OEM in batteries, wiring, and connections, such as vs. non-OEM batteries revealed wide early deterioration, overheating, short variability in battery-induced failure rates circuits, corrosion, swelling, leakage, or (from approximately 4% to 70% per year) and premature discharge.

90 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Cover Story

Any of these issues can delay treatment, or The one type of battery that should always be tested, result in inappropriate treatment or hazardous situations, in patient care. Marlow says, is the failed battery. Testing. Procurement, replacement, and charging challenges underscore the importance of testing batteries for reliability and Primary batteries used in implantable predicting device performance. “A battery test medical devices, such as pacemakers and is important,” Adams says. “It tells you where defibrillators, pose special testing challenges the battery is in its life cycle, removes a risk, for manufacturers and healthcare providers. provides a time and date stamp for quality Implantable medical devices can be designed assurance. It’s important to make testing part to last 10 years or more; testing to ensure that of best practice in the healthcare market.” their batteries will last that long is vital for What Would Help Hospitals? Testing should begin with manufacturers evaluating reliability and predicting device Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 Ken Maddock is vice president and third-party battery vendors—through the performance, according to Michael Root, of facility support services with processes of battery and device design, science fellow at Boston Scientific, a medical Baylor Scott & White Healthcare development, and production—and continue technology company. in Dallas, TX. He offered the with HTM professionals when battery-pow- “Extensive testing is done at all stages of following suggestions for how ered medical devices are in the field. As the product life cycle,” Root says, including battery performance could be batteries become smaller and more sophisti- discharge, electrical, and environmental improved. cated, the testing regimen has become a testing during design and manufacturing. “The reality is that we greater challenge for both. “Predicting the end of life of a battery is a waste a lot of money by At Cadex Electronics, “the battery gets challenge. It’s often impractical to test replacing batteries before it treated like a medical device,” Adams says, devices and batteries for 10 years. There’s an is absolutely necessary. Better with tagging and tracking of battery data and important role for battery bench testing.” diagnostic tools designed by serial numbers and supplier information. “Once in the marketplace,” Root adds, the manufacturer specifically Battery testing is essential even for new “patient follow-ups are important to monitor for their device that give you more accurate data on the batteries. “Not all new batteries perform,” he their condition and their device. Remote condition of the battery and says. Over time and with use, “smart” digital monitoring at home can be done more when it should be replaced, batteries drift away from optimum capacity frequently than clinic visits. Cardiac rhythm whether built into the device levels; routine testing and calibration during systems and other implantable systems have or available separately, would preventive maintenance can correct this home monitoring systems.” But patient be a huge value. issue, extend battery life, and reduce replace- compliance with monitoring can be a “Associated with that is better ment costs. challenge, Root says. error messages. The messages Battery testing is time consuming and Both Fay and Root cite battery component that come up when there are requires a dedicated workbench, testing and materials sourcing as a challenge for battery issues are often confus- tools, procedures, and trained personnel, implantable battery cell manufacturers. ing to the customer and lead says Marlow of the University of Michigan “Supply chain quality risks are real,” Fay says. to unnecessary calls to the Health System. Most clinical facilities cannot He points out that 90% of the world’s cell healthcare technology depart- test every battery; some prioritize testing of production is for consumer products, not for ment and time spent by HTM batteries used in life-critical applications and high-reliability, high-risk applications such as technicians that could be better spent elsewhere. Messages that of non-OEM batteries, and test samples of healthcare technology. “Many suppliers more clearly indicate the action other batteries. This is not a fail-safe refuse to supply in the medical device space that needs to be taken would approach, however: Even batteries from the due to concerns about litigation, small lead to much greater efficiency same supplier and lot can differ in their market opportunity, and unique materials,” and increased uptime.” readiness for use and in their performance, adds Frustaci of Greatbatch Medical. says Alex Fay, senior business development “Cell and material quality vary,” Fay says. manager, Quallion LLC, a manufacturer of “Variations in production lots of materials lithium-ion batteries for medical, aerospace, can be very difficult to identify,” which and military applications. underscores the need for strict oversight of The one type of battery that should always materials suppliers, full traceability of materi- be tested, Marlow says, is the failed battery. als and finished cells, sampling multiple lots “You learn more from failed batteries than of key materials, and long-term testing of from new ones,” he says. retained samples from each lot.

Biomedical Instrumentation & Technology March/April 2014 91 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Cover Story

This kind of vigilance comes at a cost, Fay medical devices also is problematic, for the says, but this cost is probably worth it for military and for everyone else—particularly batteries in life-critical devices. And it when large quantities are shipped. “Lithium might save money down the line, and batteries are regulated in transportation reduce the indirect cost and risk of surgery because they present chemical and electrical to replace batteries on implantable devices, hazards and have more power than batteries costs of replacement batteries, staff time with other chemistries,” says Kevin Leary, a lost when a battery dies unexpectedly, transportation regulations specialist with the maintaining an inventory of spare batteries U.S. Department of Transportation Pipeline and accessories, recharging equipment, and and Hazardous Materials Safety Administra- patient inconvenience. tion. Lithium batteries, and some other types Storage, transportation, and disposal. of batteries, must be carefully packed to Healthcare providers and HTM professionals protect against short circuits, damage, and Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 report that storage of batteries (and battery- excessive movement; labeled as potentially powered medical equipment) is a problem. hazardous; and handled safely. Backup batteries, and equipment that is not in In addition, “transportation test require- use, take up space, but they need to be readily ments are required for all lithium and available when they are needed. Some batter- lithium-ion cells and batteries,” says Rich ies and devices have special storage Byczek, the global technical lead for electric requirements, such as temperature-controlled vehicle and energy storage at Intertek, a areas, and they might need to be tested or testing and certification provider. reconditioned after prolonged storage. Individuals traveling with battery-powered That’s an enormous challenge for the mobility aids, personal electronics, and military, which stockpiles battery-powered medical devices must meet special transport medical devices all over the United States requirements as well. Mobility aids must be and the world. “We buy 1,000 infusion transported as checked baggage unless the pumps and store them for a couple of years,” battery is specifically designed to be removed says Master Sgt. Curt Straub, CBET, non- during transit, Leary says. Users must verify commissioned officer in charge, U.S. Army that there are no obvious defects in the Medical Materiel Agency, National equipment, battery terminals are protected Maintenance Program. “That’s what we do.” from short circuits, the battery is securely That equipment needs to be ready for attached, and electrical circuits are isolated. deployment anywhere in the world at a Personal medical devices are permitted in moment’s notice. “Batteries are essential in a checked or carry-on baggage; spare batteries deployed environment to enhance power are permitted in carry-on baggage only. reliability,” Straub says. Diesel generators Finally, safe, proper disposal of batteries is provide initial power until a stable electrical a concern. Again, different batteries have power grid can be erected. “Power reliability different disposal requirements; some is questionable, especially at first,” he adds. batteries can be tossed in the normal trash, Temperatures in deployed environments others cannot. “Disposal issues are signifi- can be brutal—well over 110°F in the sum- cant,” Lipschultz says. mer in Kuwait and Iraq, for example, and as low as 25°F in the winter in Afghanistan, he Potential Solutions says. Extreme environmental conditions Like many intractable challenges in health- impact battery charge capacity. For example, care technology, addressing multifaceted a sealed lead battery stored at 68°F takes 16 challenges with batteries and battery-powered months to reach 50% state of charge; stored medical devices will require multidisciplinary at 104°F, it takes only four to five months to collaboration and commitment to achieve reach that state of charge. Charging require- solutions. Participants at the FDA workshop ments during storage differ for different offered these starting points: battery types as well; specifications range Standardized practices. Multiple national and from fully charged to charged to discharged. international standards and regulations for Transporting batteries and battery-powered battery design, development, testing, certifica-

92 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Cover Story tion, and transport exist. But many standards Human factors and systems approaches to apply to specific battery types, and they are not design of battery-powered medical devices. necessarily harmonized internationally. Poorly designed user interfaces on battery- “Solutions exist, but they are highly powered medical devices contribute to use dependent on the type of device, the battery (not user) errors, says the FDA’s Ron Kaye, technology, and the intended use,” says Root leader of the human factors premarket of Boston Scientific. “It would be difficult to evaluation team with CDRH. Identified implement a single set of prescriptive issues—such as confusion with on/off standards or guidelines that could be applied buttons, difficulty determining battery charge to all devices.” levels, insufficient response time when However, “general guidelines related to batteries need to be recharged or replaced, expectations of certain ‘bodies of knowledge’ and battery reversion to default settings for the battery selection/design and verification during power outages—could be resolved Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 process may be useful,” says Craig Schmidt, with attention to human factors during senior director of energy systems research at device design. “Human” human factors, Kaye Medtronic, a medical technology company. says, include: Still, most workshop participants advocated • Perception (e.g., visual, auditory, tactile) for such standardized practices as incorporat- • Cognition (e.g., interpreting meaning, ing battery charge indicators on devices, with recalling information, decision making, actionable alerts that give clinicians, HTM training, motivation, expectations) “We need to know professionals, or caregivers adequate time to • Actions (e.g., physical interactions, what how these devices are change batteries without disruptions in users do and don’t do) used—not how the patient care or safety hazards. As one manufacturers want respondent to the AAMI survey of HTM “Nonhuman” human factors are at play in professionals on battery issues asked: “How healthcare settings as well, including noise, them to be used.” much time before the device fails?” workload, number and variety of devices in the — Ron Kaye, FDA Manufacturers also advocated for recogni- use environment, and the medical device user tion of modeling methods for designing and interface, Kaye says. Inadequate interfaces allow testing batteries, particularly for batteries users to make errors that could be prevented, used in implantable medical devices. “For fail to orient users to problems in time to implantable batteries, it is necessary to test a prevent them, and lead users to make errors. new battery technology for many years before “We need to know how these devices are it can be designed into devices,” Frustaci of used—not how the manufacturers want Greatbatch Medical says. “This results in them to be used,” Kaye says. Manufacturers slow adoption of new technologies.” need to understand user expectations for how “Battery models are often an important the device will work, how problems occur component of the design/selection and during use, and the critical tasks that users verification process,” Schmidt says. Models are perform. That understanding can be gained useful in translating device requirements to through user-centered techniques such as battery requirements, criticality, rationale, speci- focus groups and interviews with users, fications, and design or selection; verification of contextual inquiry, and simulated usability testing strategies, plans, and data; simulating testing. Iterative, formative usability testing use conditions and labeling; accelerated tests of with prototypes can be used to improve battery performance; and verification and interface design. Summative testing can validation of device performance. provide data that validate usability. “Adoption of these models by regulatory Ensuring the safety of battery-powered bodies in support of device submissions medical devices requires an understanding of would help improve confidence and reliabil- how the battery interacts not just with the ity, as it is not practical to have device, but with the rest of the system, says long-term—more than five years—of real- the FDA’s Hamed Ghods, electrical engineer time test data available at the time of with the Division of Electrical and Software submission,” Frustaci says. Engineering at the CDRH Office of Science and Engineering Laboratories.

Biomedical Instrumentation & Technology March/April 2014 93 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Cover Story

He shared the case of a defibrillator that, critical seconds immediately before the shock after analyzing patients’ ECG waveforms and was delivered. determining that a shock was needed, would “The systems engineering approach can sometimes shut down before delivering the deal with this complexity and understand shock. The device had a voltage monitoring how parts interact with each other and with circuit that was designed to shut the device the patient,” Ghods adds. “The battery is one down when the battery had insufficient component of a complex system. It needs to charge remaining to deliver a shock. The be chosen correctly to assure that the host manufacturer’s investigation revealed that device meets its specifications. The device this protective circuit would malfunction design needs to satisfy the operating require- under certain conditions and shut down the ments of the battery. The design engineer’s device, even though the battery actually had task is to know the failure modes of these enough charge to complete the operation. components and design the system to fail Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 “Our independent investigation uncovered safe if any of the components fail.” a second design issue that had been over- Figure 1 shows a battery-powered medical looked by the manufacturer,” Ghods says. device system, and some points at which “The power conditioning circuitry of this system protections can be incorporated. defibrillator included several integrated From a systems engineering perspective, circuits that converted the incoming battery each component of the system has character- voltage to different voltages needed by the istics that introduce risk. A structured risk system. By design, the voltage converter chip management process is used to identify the requires input voltages greater than 9 volts to salient risks and corresponding protective operate. However, the battery voltage could measures. For example, overcurrent protec- drop as low as 7.7 volts during the run-up to tion may protect the battery from a delivering a shock. As a result, all of the downstream short circuit. Over- or undervolt- downstream circuitry powered by this chip age protection may mitigate against a failure was likely to be adversely affected in the in the power conditioning circuitry, or shut down the system in an orderly way when the battery charge is no longer sufficient to assure that the system will perform correctly. In many real-world designs, these protective measures add quite a bit of complexity to the system, and some protective measures may introduce new risks that must be mitigated. A thorough understanding of how these components interact with one another, with the user and patient, and with the environment is essential. Battery management plan. Given all the challenges with battery-powered medical devices, Marlow of the University of Michigan Health System recommended that healthcare facilities develop a battery management plan. That plan should cover such topics as prepurchase considerations, testing and maintenance schedules for batteries, procedures during power outages and emergencies, replacement and disposal Figure 1. A Battery-Powered Medical Device System policies, training, and equipment. and Systems Protections. (Source: Ghods H. “Batteries Information, training, and education. in Medical Devices: A Systems Engineering Clinicians and patients need more useful and Perspective.” Presentation at the FDA Public Workshop, Battery-Powered Medical Devices: Challenges and consistent information to manage the battery- Opportunities. July 30–31, 2013.) powered medical devices in their lives.

94 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Cover Story Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021

This colorful guide reminds hospital staff to plug in medical devices, so that batteries do not lose their charge prematurely. Image courtesy of Kwikpoint.

Instructions for use and labels are not very technologies and testing methods. “Under- useful for people who are not device or battery standing maintenance, how to maintain the experts—and they often are not available. stated charge—the education piece can be For example, clinicians need training, and very complicated for all of us,” Frustaci says. reminders, to reinforce the need to plug in Innovation. Finally, manufacturers, HTM medical devices so battery power is not professionals, and regulators say that innova- depleted, says Ron Charnock, chief operating tions and new science will be needed to officer, Kwikpoint, a communications firm. improve batteries and battery-powered medical “New training material by itself will not devices. Could new materials or different change behavior,” he says. “How you package chemistries be used to increase battery and deliver training and materials is as longevity—or reduce or eliminate the need for Clinicians and patients important, or more important.” For example, battery charging altogether? Time will tell. need more useful and a short, colorful “Quick Start Guide” or “Plug Or, perhaps, a true breakthrough will consistent information In!” label on a device could be more useful remake the battery landscape. That’s the to manage the battery- and effective than lengthy, complex, and direction in which researchers are headed. A confusing instructions. In addition, he says, team at the Massachusetts Institute of powered medical usability testing of information and training Technology (MIT), for example, devices in their lives. materials is important. experimented with wireless energy to power New media could help with communica- a light bulb. Now, an MIT spinoff, WiTricity tion, training, and education as well. Corp., is advancing that technology, known Kwikpoint developed a social marketing as highly resonant wireless power transfer. campaign for the FDA to provide information Highly resonant devices are tuned to the to healthcare providers and individuals with same frequency and exchange energy via an diabetes on proper sharps disposal. “Battery oscillating magnetic field, according to Colin change fits this model in terms of content McCarthy, sales engineer for automotive, and packaging,” he says. industrial, medical, and military at WiTricity. Even HTM professionals who are comfort- Highly resonant coupling enables charging at able working with batteries need training and a significant distance. education to keep up with new battery Elsewhere, Michael McAlpine, assistant

Biomedical Instrumentation & Technology March/April 2014 95 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Cover Story

professor of mechanical and aerospace Resources and References engineering at Princeton University, and his • AAMI. A Vision of Anytime, Everywhere Healthcare: colleagues are investigating the possibility of Priority Issues from the 2013 AAMI/FDA Summit human-powered implantable or wearable on Healthcare Technology in Nonclinical Settings. medical devices. The idea is to harness and Arlington, VA: Association for the Advancement convert the mechanical energy that the of Medical Instrumentation; 2013. Available human body produces with normal breathing at: www.aami.org/publications/summits/ and motion into enough electrical energy to HomeHealthcare.pdf. Accessed March 19, 2014. power portable electronics. • Lipschultz A. Medical Device Batteries: The research—which is supported by the Ubiquitous and Problematic. BI&T: Army Research Office (ARO), Defense 2013;47(6):494-498. Advanced Research Projects Agency (DARPA), DuPont, and the Project X innova- • Food and Drug Administration. Case Study for Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 tion fund—relies on nanotechnology, July 2013: Jumping Battery. Available at: http://1. advanced materials, and plenty of advanced usa.gov/OBtwe9. Accessed March 19, 2014. STEM (science, technology, engineering, and • Food and Drug Administration. Case for Quality. mathematics) know-how. Available at: http://1.usa.gov/1r0Mp93. Accessed Such possibilities look promising. That’s March 19, 2014. good because the role batteries play in modern healthcare technology is omnipres- • Food and Drug Administration. Battery- ent and crucial. Says the FDA’s Maisel: “It’s Powered Medical Devices Workshop: Challenges and Opportunities. Available at: http://1.usa. hard to think of a medical device component gov/1d4FiJ4 . Accessed March 19, 2014. that is more important than a battery. It’s easier to generate a list of devices that don’t rely on batteries.” n

96 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Features

Stressing Less and Striking A Healthy Work-Life Balance Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021

Stephanie Stephens

If you’re feeling stressed—at work or in that can in turn frustrate clinicians.” About the Author life—you’re not alone. Healthcare is a critical After factoring in the modern need for Stephanie and responsible field and, by its very nature, constant continuing education as equipment Stephens, MA, is will always be a stressful environment, says J. crosses into the network environment, along a freelance writer, Michael Shepherd, a certified biomedical with the financial pressures that most hospi- producer, and equipment technician at Grande Ronde tals face, Shepherd says the importance of multimedia expert. Hospital in LaGrande, OR. setting boundaries becomes readily apparent. E-mail: stephanie@ stephaniestephens. Feeling “maxed out” is a common feeling “I work to live, and not vice versa, so I don’t com for many Americans. According to the 2013 want to sour my home life with work,” he Work Stress Survey, more than eight in 10 says. “Any activity that distracts the mind and employed Americans reported being stressed keeps us from dwelling on stressful situa- out on the job amid heavier workloads and tions is helpful, as long as it’s not low pay.1 Stressors cited in the report self-destructive in other ways.” included poor compensation, unreasonable workload, frustration with coworkers or commutes, performing a job that isn’t a career choice, lack of opportunity for advancement, fear of being fired or laid off, and poor work-life balance. Because stress at work can mean stress at home, achieving work-life balance is vitally important. Your colleagues recommend reaching into your personal antistress toolkit and being resourceful. “It will be the responsibility of any given generation to adapt to the stressors of their times,” says Shepherd. For healthcare technology management (HTM) professionals, one stress factor is likely what Shepherd describes as “an explosion in the number of devices that need to be maintained. Our job has become less about component-level troubleshooting and repair and more about symptom isolation Sooner or later, most professionals will feel stress at work. Experts say it’s important to have and board replacement, resulting in delays effective coping strategies so that you don’t get burned out.

Biomedical Instrumentation & Technology March/April 2014 97 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Features

For Yadin David, owner of Biomedical handle difficult situations and directing Engineering Consultants LLC in Houston, one’s focus on getting the job done, then TX, processing stress in a healthy manner, leaving it at work. rather than internalizing it, is key to one’s According to Ted Cohen, manager of well-being. David, whose clients include both clinical engineering at UC Davis Health individuals and large hospitals, says stress is System in Sacramento, CA, we must accept external, like when you feel compelled to do that today’s work environment is all about something you cannot or don’t want to do. information technology (IT). “Systems of Understandably, internal stress occurs when systems, device integration, networks, and you expect yourself to perform well, even other complexities have increased,” he says. when 20 e-mails need to be answered and “Although system reliability is still very high, you’re out of time to deal with everything on and higher than ten years ago in some cases, it your plate. seems that when a complex system goes down Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 When he has to admit that “No, I didn’t do hard, it is often more difficult to get it back up my best,” he reshuffles to-do items that once quickly when more external resources—like took precedence. “Then, my answer can be the vendor or IT—are needed.” ‘yes,’” he says, because rearranging priorities “A decade ago, it was extremely uncommon is a much better solution than becoming for medical device companies to go through a overwhelmed by frustration. downsizing as a result of changes in health- David isn’t the only one who’s seen care delivery,” says Charles “Phil” Cogdill, stressed colleagues give up. “I have known senior director of quality affairs in Steriliza- hundreds of biomeds in my 30-plus years in tion and Microbiology at Covidien in Boulder, this career. Stress ranges from total apathy or CO. Today, however, he says, these changes not caring at all to utter meltdowns,” says have brought a terrific amount of stress. In Donald Armstrong, a certified biomedical addition, as more countries add individual What Stress Does equipment technician and customer quality requirements to those already in place, Temporarily: Stress can manager at GE Healthcare in Houston, TX. regulatory oversight of the manufacturing increase heart rate, blood “Stress in the correct dose is not necessar- and distribution of medical devices also has pressure, and muscle tension ily a terrible thing,” he says. “It does keep me ramped up considerably. and result in fear, confusion, on my toes and eliminates complacency—I Don’t try to manage alone, says Cogdill. “It anger, and even sweating. It did mention ‘the correct dose,’ however.” comes back to having a strong network of may cause headaches, fatigue, insomnia, and heartburn. family, friends, and professional colleagues Change Is Inevitable to be able to communicate with and receive Long term: Chronic stress can Would you turn back the clock? Most would affirmation and counsel from during a lead to a variety of diseases. It agree that we’re more stressed in our jobs difficult time.” can cause high blood pressure today than we were a decade ago. As tech- On the front lines, Cogdill’s daughter and heart problems or heart nology surges ahead, it inevitably brings Katherine, a member of AAMI’s Alarm attacks, as well as migraine headaches, back pain, ulcers, growth and ensuing stress with it, says Standards Committee, is a nurse on the and a weakened immune Salah Alkhallagi, director of clinical engi- neurology stroke floor at a northeastern system. neering at King Abdulaziz Medical City in hospital. Nursing can tax a person on Jeddah, Saudi Arabia. multiple levels, she says, when trying to What You Can Do “Ten years ago, we had 250 beds with less balance both patient and technical demands Avoid controllable stressors, than 4,000 pieces of equipment,” he says. and responsibilities, including responding to plan major lifestyle changes, “We’ve increased to approximately 600 beds constant alarms. realize your limitations, prior- and more than 8,000 pieces of equipment. It’s important, she says, to know at day’s end itize, improve communication, This leads to more workload and problems that she did things right for her patients. “It’s share your thoughts, develop related to medical equipment support, which about my self-care, learning to say ‘no’ when I a positive attitude, reward leads to more stress.” need to, and trying not to feel I have to always yourself, exercise, eat and To cope, Alkhallagi recommends staying ‘give, give, give’—especially as a nurse.” sleep well, and ask for help— even professional help if you calm under pressure, assessing the situa- need it. tion, and prioritizing responsibilities. He Getting Away from It All also cites the importance of open discus- As a former vice president at a medical device sions with coworkers to determine ways to company, Bob Schiffman of Meriden, CT,

98 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Features agrees with Cogdill that implementing various Future Stress countries’ individual regulations can create New employees in the biomedical equipment stress at smaller companies, where employees technician (BMET) space are expected to must wear many hats, and that stresses from obtain traditional knowledge in electrical other departments can spill over. engineering technology (e.g., basic circuits, “I try to step back, let Now a quality assurance and regulatory anatomy, physiology), as well as synthesize things go, and then look consultant at his own Medical Device Industry an increasing amount of information about at them again later.” Specialist, LLC, he doesn’t feel so emotionally medical device systems integration, IT, and tied, but he’s been proactive by taking a communication, says Chad Kennedy, PhD, — Bob Schiffman, stress-management course. He also practices chair and professor of biomedical engineer- Medical Device Industry visualization—guided imagery to distract ing technology at the College of Engineering Specialist, LLC. from stress—to relax and then restart. Schiff- & Information Sciences in Phoenix, AZ. man also goes freshwater fishing to wind

“Healthcare technology management Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 down and connect with nature. (HTM) job variety has necessarily increased “I try to step back, let things go, and then due to so many complex and integrated look at them again later,” he says. “I’m products,” he says. “As a result, many HTM probably helped by having practiced level departments try to have employees become thinking that was required in the Navy on ‘jacks of all trades’ on one end or parsed into submarines. Plus, now that I’m older, I’m specialties such as traditional BMET jobs, IT just more mellow.” jobs, or imaging jobs, leading to HR confusion Accept what you can do something about and hiring people with mismatched skill sets.” so you act on it and accept what you can’t Before they ever get that first job, today’s change, says Robin N. Faut, a certified students wonder what stressors lie ahead, says biomedical equipment technician and CE/IT John Noblitt, CBET and BMET program at Olathe Medical Center in Olathe, KS. “For director at Caldwell Community College in example, say I must reconfigure 21 anesthe- Hudson, NC. For example, his second-year sia machines quickly—that’s high stress. But BMET students often ask how the current now I’m working on it—natural stress relief. political atmosphere and Affordable Care Act But parts have not been ordered on time and implementation may affect their career choice. are on back order—more high stress.” “I’ve told them we’re uncertain about many Away from work, Faut practices Tai Chi, a issues on the horizon, but that they can mind-body practice that originated in China control the level of service they’ll be provid- as a martial art and is now known to reduce ing, no matter what happens,” he says. “As an stress on both muscles and joints—and on entry level BMET, they’ll have very little input the mind. about the funding of healthcare in the future, Working out is just the ticket for Alex but they can make sure the technology is Jordan, biomedical equipment technician maintained at the highest level for proper specialist and lead technician in ISS Solu- patient outcomes. They should strive to tions at Geisinger Medical Center in Danville, always provide the very best support possible, PA. Plus, he’s in great shape at age 51 and which is within their control.” n credits exercise for clearing his mind and keeping him focused at work. Reference The buildup of stress, he says, is inevitable. 1. Corinthian Colleges, Inc. Workplace Stress on the “I work in a very large hospital that provides Rise With 83% of Americans Frazzled by Something a lot of special services. Requirements must at Work. Available at http://globenewswire.com/ be adhered to, and it’s important to be timely news-release/2013/04/09/536945/10027728/en/ about fulfilling customers’ expectations.” Workplace-Stress-on-the-Rise-With-83-of-Americans- As a result, says Jordan, occasionally it’s just Frazzled-by-Something-at-Work.html. Accessed “time to take a fresh breath of air. I need to March 7, 2014. physically step away and come back with a new angle and new approach. That really works.”

Biomedical Instrumentation & Technology March/April 2014 99 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Features

PERSPECTIVE Which of the Seven Dwarfs Is Your Manager? Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021

Pam Roberts

About the Author The lessons learned from children’s fairy outlining the various dwarfs and how their tales can be applied to the dynamics of personalities may be similar to your current Pam Roberts is the director of interacting with colleagues at work. We learn or previous manager. As you interact with the Technical life lessons from fairy tales: Cinderella your supervisor, his or her unique personality Service Center teaches us not to mistreat others, Beauty and traits can have a positive impact and present & Answering the Beast teaches us to look beyond people’s challenges—the outcome depends largely on Services at Baylor outward appearance, and Snow White how you manage the interactions. Scott & White teaches us to work as a team. The first dwarf I will discuss is Dopey. Health in Dallas, TX. Snow White provides the greatest parallels Dopey is clueless and does not communicate. with the workplace. After Snow White fled Dopey tends to be quiet and reserved and can for her life from her wicked stepmother, she be difficult to get to know. If your boss is like found refuge with the Seven Dwarfs. To be Dopey, your job is to ensure that he is never successful, she quickly ascertained the clueless about your area. The key here is various personalities of the team of mining communication. You will need to keep dwarfs and adjusted her communication flowing actions accordingly. to your boss so he can Just as the dwarfs had Just as the dwarfs had always be aware of diverse and unique traits, diverse and unique traits, pertinent information. your coworkers, direct your coworkers, direct Have a discussion with reports, and boss have reports, and boss have him to determine how to various personality types. various personality types. establish communication, I will take some liberty in (continued on page 104)

100 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Features

PERSPECTIVE The Art and Science of Managing Direct Reports Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021

Kenneth E. Maddock

The following article is based solely on the of opinions, I apologize to those eagerly About the Author opinions of the author. Any facts included are awaiting a fountain of facts and formulas. Kenneth E. present entirely by accident and aren’t the fault I wander down that path because no Maddock is vice of the author. formulas exist for managing your direct president of Facility There; I feel so much better making that reports. Managing is an art more than a Support Services disclaimer. For the many years, I’ve read the science. Every individual is unique, and how with Baylor Scott outstanding content in this journal, I’ve you manage them is different. In fact, one of & White Health in Dallas, TX. E-mail: always been a bit intimidated by the scientific my direct reports, Pam Roberts, wrote the [email protected] and/or logical focus of complementary article on most of the articles, while the opposite page on how Managing is an art more my articles largely have you can manage your been opinion pieces. Oh than a science. Every manager, using the Seven sure; I’ve dipped my toes individual is unique, and Dwarfs as an analogy to into the pool of science how you manage them illustrate the differences occasionally, usually is different. among types of managers. pulling them back quickly Although I love her analogy, out of fear of having them I’m not going to steal her nipped off by more scientific minds. I usually idea and compare direct reports to the Seven skirt that pool by taking the path of enlight- Dwarfs, as creative and accurate as that ened opinion. So now I’m asked to write an approach may be. I confess: It does make me article on how best to manage direct reports. curious as to which dwarf she thinks I am. And once again, as I venture down the path This article is written largely from my perspective as an executive. But I believe that most of what I say applies to all levels of management. I mentioned previously that managing is an art as much as a science, but certain basic practices need to be applied before you can add the art. The number one thing that any manager needs to do at any level is to be very clear on expectations. State them, repeat them, repeat them again, repeat them some more, and then repeat them again. Then repeat as needed.

Biomedical Instrumentation & Technology March/April 2014 101 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Features

But without other pieces of the puzzle, these pretty complicated, isn’t it? Are you sure you constantly stated expectations become just still want to do this? another annoying, repetitious series of Perhaps I should have started with the fact platitudes. You have to measure against your that before you bother learning how to best expectations, and you have to set standards for manage your direct reports, you better make those measures. If you keep talking about the sure you have the talent to manage staff and importance of something and don’t measure it the stomach to take it on. If you had the or don’t set standards, your staff won’t believe talent to be a leader—if you can communi- that you really think it’s important. Your cate effectively, understand challenges and actions speak louder than your words. figure out how to overcome them, and The last piece to that particular puzzle is possess all of the other skills needed to be a accountability. Without accountability, nothing leader—you still have to be able to take the else you do matters. Your direct reports, stress associated with the job. If you are Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 assuming they have a modicum of basic convinced you have those traits, read on. intelligence, are going to base their actions on One of the most important management the things for which they are held accountable. arts is learning and understanding your staff. If you choose not to hold your team account- Understanding your staff starts with an able, you can hope that every direct report you obvious but often overlooked tactic: talk to have is noble, intelligent, always on the them. That’s right; engage in actual conversa- lookout for small children they can save from tion. Share what’s on your mind and get your getting hit by a bus, and doesn’t require staff to share what’s on theirs. Learn some- guidance to perform at an exceptional level. thing about them. You don’t need to be their friend, but you do need to make them Understanding your staff starts with an obvious but understand that you realize that they are a often overlooked tactic: talk to them. That’s right; person, not a stat on a spreadsheet. When you know someone and establish trust that engage in actual conversation. you will be open and honest with them, it makes it easier to have the hard conversa- But on the very small chance that you haven’t tions. It makes it easier to communicate in a been able to hire all superstars, you had better way that they will understand. It also will hold people accountable. make it easier for them to let you know what So that’s it. Management is a pretty simple they are really thinking. That’s the single thing, right? most important factor for a relationship 1. Set expectations. between a manager and a direct report. If 2. Make sure your staff is very clear on your your direct reports aren’t willing to tell you expectations. what they are thinking or what is really going 3. Measure against those expectations. on with their team, you are in a hole you 4. Set standards for those measures. probably can’t get out of. 5. Hold your direct reports accountable for As a manager, you also need to know when meeting those standards. to help your direct reports and when to leave But taking those five steps isn’t easy. them alone. It is normal for a new manager Challenges abound for each step. However, to want to stay just as involved with the the artistic side of the equation is even details they used to handle in addition to harder. How do you communicate with each taking on expanded duties. Don’t fall into staff member so that they understand that trap. You have to look at your ability to expectations? If your direct reports aren’t handle your duties as if your responsibilities meeting standards, is it because they don’t are a piece of rubber. The wider you stretch care, because they don’t have the ability, your responsibilities, the thinner the rubber because they don’t have the resources, or gets. At times, you will need to dig deeply something else entirely? After you figure out into an issue and help out a direct report. Just why they aren’t meeting expectations, what keep in mind that when you pull the rubber corrective action should you take? Does one to make it deeper in one spot, you have to approach work for all? Not usually. This is narrow your focus or you’ll tear the piece of

102 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Features rubber. I think about this with my team all correctly and therefore could be contributing the time. As with most organizations, we are to patient falls. Because executives chimed in trying to get more efficient. In some cases, on the initial message and because of past that means giving my directors responsibility concerns at the site about the nurse call, I for more than one site. I told that they have thought it was good to get involved. But I to understand that I’m pulling on one hand didn’t jump in and try to fix the problem. I and the organization is pulling on the other responded to let them know I was aware, told to stretch them out. They need to let me them what we would be doing and who know if they feel something tearing. If so, it would be managing the situation, and gave probably means that we aren’t meeting our them a timeline for an update on the situa- responsibilities and we have to add resources tion. Then, I stepped back out. I like to use or narrow their scope. the analogy of a One of the most fishing bird. If I’m a Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 important factors in If I’m a fishing bird, I have to go fishing bird, I have to effectively managing down into the water to eat, but go down into the your direct reports is I don’t have gills. If I stay under water to eat, but I understanding the don’t have gills. If I stimulus to which you water too long, I’ll drown. Leave stay under water too should react. What the water to those with gills. long, I’ll drown. Leave information will you the water to those rely upon to help you with gills. I belong at to decide if you need to get involved? In my a higher level, being able to keep my eyes on case, I have sometimes been guilty of many things, just diving into the water when overreacting to e-mails. Sometimes, when I have to. you are copied on an e-mail, you feel com- I would like you to take away a few key pelled to get involved, when in fact your points from this article: direct report already had the situation under • Make sure you have the acumen and control and was just keeping you informed. I stomach to be a manager. have had a couple of recent situations that • Set expectations, communicate expecta- may help you to understand how to approach tions, measure against expectations, set various issues. I took on some new responsi- standards for those measures, and hold bilities and have a new director reporting to your direct reports accountable for meeting me. He made me aware of a situation they those expectations. were having with connectivity associated with • You can never communicate too much. Get their electroencephalography units. He to know your direct reports and let them described the issue, told me who was get to know you. involved, told me what they suspected, and • Set criteria for when you need to jump into described what they were doing about it. I the detail, but never lose track of all of the just thanked him for letting me know, told things for which you are responsible. him to let me know if he needed help, and Thanks for reading, and if we run into moved on. One reason is simply that he gave each other at the AAMI Annual Conference, me the level of detail to make me comfort- buy me a coffee and I’ll tell you which dwarf able that he was on top of the issue. The I think I am. n other reason is that as a new direct report, he needs to know that I trust him. That trust doesn’t extend infinitely. If I need to get involved, I will. I have to be like a spider on a web. I want to scurry to the edge of my web when a nice, juicy bug gets caught, but I can’t afford to waste my time chasing leaves. Another situation involving patient falls presented itself. The staff were concerned that the bed exit alarm was not working

Biomedical Instrumentation & Technology March/April 2014 103 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Features

(continued from page 100) expecting him to fix the issue. Doc will need such as when to copy him on e-mails, regular communication to reassure him that frequency of meetings, formats for weekly all objectives are being met. status reports, and factors for success. My Following Doc is Bashful. Bashful is a very goal is to keep my boss from being blind- diligent worker and usually is very detail sided, so I keep him informed of anything oriented. The group usually likes Bashful, that would involve human resource actions but also knows that he cannot speak up in with the team, critical impacts, communica- meetings or go against the mainstream, so tions between team members and their he keeps a very low profile. To have success Setting aside time superiors, and the success and failure of the with Bashful, you need to ensure that rules to discuss what your team. Setting aside time to discuss what your are followed and the team adheres with all supervisor considers supervisor considers important and how you instructions. You also will need to reassure can help her be more successful is important. the team that Bashful has their best interest Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 important and how you Regular checkpoint meetings are crucial to in mind and is totally supportive. When you can help her be more ensure that you are always communicating are communicating concerns to Bashful, successful is important. and on the same page. always bring a suggested solution to him Regular checkpoint The next dwarf is Grumpy. Grumpy is the along with the problem. He may change the know-it-all person and tends to say “no” to solution and even take a different approach meetings are crucial anything new. If you ask people to name the than what you suggested. By supplying to ensure that you are dwarfs, Grumpy usually is one of the first suggestions, you will provide him with the always communicating names they remember. Why is that? The thought process needed for the discussion. and on the same page. reason is unfortunate, as we have a tendency This also will show him that you have put a to remember and dwell on the negative lot of thought into all the angles and possible rather than the positive. For example, say you ways to approach the issue. take your family on a wonderful outing to the Next in our lineup is Sleepy. Sleepy is as zoo and experience all types of exciting sights hard working as the rest of the dwarfs in the and sounds. Then, on the way out, you stop mine, but maintaining his relaxed working to buy your child a snow cone and he drops it style is important to him. He is even tem- on the ground as you are walking to your car. pered, and it takes a lot to upset him—the The thing the child probably will remember downside is that he can seem disinterested or the most about that day is the disappoint- even complacent. Sleepy can appear to be ment he felt with the dropped treat. So the bored in meetings and quickly moves on to challenge with working with Grumpy as your the next subject. Details seem to bog down boss is not letting her negative attitude infect Sleepy, and he prefers the big picture. To you or the team. You must remain upbeat work well with Sleepy, you will need to keep and create a positive work culture. To work him engaged by having your thoughts with Grumpy, you must present her with organized. In meetings with Sleepy, you facts with an upbeat attitude. With factual should get straight to the point. He does not evidence, Grumpy usually can be swayed to like a lot of fluff in reports or conversations. rational thinking and be agreeable. So you will need to put key elements of Now we will discuss Doc. Doc is the information up front in both verbal and natural leader of the seven dwarfs. He was written communications so that Sleepy can the decision maker and set the course of quickly ascertain the situation and determine action for others to follow. He is a person the course of action. Sleepy will need all your whose mind works faster than his ability to communications with him to be concise and articulate his thoughts. He is great at seeing brief—he usually does not like casual the overall big picture. While you are talking, chitchat. You probably will want summary his mind is racing and moving quickly to the notes for each area you discuss with him. solution. Doc is usually even tempered, Next in our discussion is Sneezy. Sneezy is articulate, and an innate problem solver. If more cautious and always wants to be pre- you need to brainstorm with Doc, you will pared. He tends to be very responsible and need to set the expectations up front that you detail oriented. He will need you to know and only need to bounce ideas around and are not explain all the reasons behind a suggestion or

104 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Features

Asked and Answered

When should I tell my manager about a particular work issue? can contribute to those objectives. Then, communicate your continual progress toward those goals. I find that keeping my direct leader informed keeps them from being blindsided. I always confirm with the leader how What can my manager do to support me in my job? and when he wants to receive communications. The best way your manager can support you is by How do I make myself valuable to my supervisor? providing an environment where you can communicate freely. The communication should include clear direction Being a leader is very demanding and stressful. These and a discussion on areas that are going well and those individuals are juggling many priorities and facing many requiring intervention.

challenges. They will have tremendous appreciation for you Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 if you are eager to assist. One way to provide assistance What are effective communication strategies in working is to research issues that you bring to them and provide with your manager? possible solutions. This may take a lot of effort on your part to consider all aspects of what is the best solution for your Consistency in keeping your boss informed is the best area, the company as a whole, and your customers. communication strategy. Meet with her to establish your communication plan and determine when and in what How do I know what’s important to my boss? manner you should provide information. For example, does your supervisor prefer e-mail, status updates, or face-to-face Knowing what’s important to your boss comes through meetings? It may be a combination of several methods. Being communication. Ask to meet with your leader, detail the transparent as possible—both when your team is doing well objectives for your department and company and how you and when mistakes have been made—is important.

solution. All reports will be thoroughly ways to communicate. In the workplace, analyzed and must be accurate. Inaccuracy hidden agendas often exist that are similar to causes Sneezy to doubt your overall credibility. those of jealous queens, wicked stepmothers, He is known to be thorough and fully pre- trolls, and other obstacles that would cause pared, and he expects the same from you. He us to divert our path and forget the true is extremely uncomfortable with waiting until objective of having highly effective communi- the last minute for projects and assignments. cation with our boss and coworkers. I have In the workplace, To work with Sneezy, always make sure you worked with many leaders who had person- set clear expectations on all deliverables. alities similar to those of the dwarfs. One hidden agendas often Confirm the due dates and content so that you particular leader had the reputation of exist that are similar to both clearly understand what is expected and changing his mind frequently, somewhat like those of jealous queens, are on the same page. Happy. As a result of the apparent indecisive- wicked stepmothers, Our final dwarf is Happy. Happy is affable ness, many staff struggled to follow trolls, and other and energetic and wants everyone to like directions from this leader. After meeting him. The challenge is that he may change his with him, I realized that his approach was to obstacles that would mind regarding decisions depending on the think out loud. What had been perceived as cause us to divert audience before him, as he wants to be perpetual changing of direction was in our path and forget viewed as agreeable. One way to work with actuality working through his thoughts the true objective of Happy is after you have met, send a brief verbally. I found that the way to be successful e-mail thanking him for the meeting and with this leader was to send e-mails recap- having highly effective confirming that you will proceed with the ping the conversation and confirming next communication with agreed-upon actions. The e-mail will affirm steps. This communication method was very our boss and coworkers. that you and he are in agreement and that effective and ensured that we were always on you are taking action. the same page. This leader was very influen- Although our workplace may not always tial in my career, and I learned much by have a fairy tale ending, we can identify the working for him. n personality traits of our supervisors from one or more of the dwarfs and find successful

Biomedical Instrumentation & Technology March/April 2014 105 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Features

Understanding Key Factors In Steam Sterilization Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021

Donna Swenson

About the Author Many factors influence whether a steriliza- Conditioning tion process will, in fact, result in a sterile The conditioning phase of the sterilization Donna Swenson, BS, CRCST, CHL, medical device, starting with how the device cycle refers to the process of eliminating all CSPDM, works for is used and the level of contamination. It is air from the chamber, which houses the Synergy Health, important to understand that the cleaning of device or equipment to be sterilized. The PLC, as the onsite a device—removing as much bioburden as chamber must be cleared of all air to ensure clinical operations possible— is crucial to effective sterilization. that the steam contacts all of the device manager of the But even if a device has been adequately Sterile Processing Department at surfaces to be sterilized. The process for Mount Sinai Hospital in Chicago. She cleaned, it may not be sterile at the end of the conditioning depends on the type of steam is co-chair of AAMI’s committee for sterilization process. Why? There could be sterilizer being used. the ANSI/AAMI/ISO 17665 series and several reasons. The design and configura- As the name suggests, a gravity displace- PB70. E-mail: [email protected]. tion of a device could impede penetration by ment sterilizer relies on gravity to remove air the sterilant, the device could be loaded into from the chamber. Steam is injected into the the sterilizer in a way that hinders contact chamber. As it builds, the colder air, which is between all surfaces and the sterilant, the heavier, is pushed down and out through a concentration or exposure time of the drain. Device and load configuration can sterilant could be inadequate, or a wet pack at have a major impact on the ability of the the end of the cycle could result in recon- sterilizer to remove air from the chamber. tamination. This article examines crucial Dynamic processes are faster at removing factors in effective steam sterilization: air and allowing the steam to quickly come conditioning, steam penetration, “wet packs,” into contact with the device surfaces. and understanding the difference between Dynamic air removal involves either a steam verification and validation. flush pressure pulse (SFPP) or a pre-vacuum method. With SFPP, steam is injected into the chamber through a series of steam flushes, which also push air out. It is important to understand that the cleaning of a In the pre-vacuum method, air is removed device—removing as much bioburden as possible— is via a vacuum pump, followed by injecting crucial to effective sterilization. But even if a device has steam into the chamber, which helps to push been adequately cleaned, it may not be sterile at the end out any remaining small amounts of air. This is usually done three to four times. Once the of the sterilization process. final vacuum is pulled, steam is injected to fill the chamber. Since all of the air has been removed from the chamber, the dispersion

106 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Features contact of the steam is usually very rapid. indicator test sheet inside a pack that meets However, some device configurations can the criteria specified in the ANSI/AAMI/ require additional exposure time to allow the ISO 11140 series of standards. A specified steam to reach all surfaces. This has resulted cycle is run, and the test sheet must show a in extended cycles being approved for the uniform color change. Results that are not sterilization of some devices. The U.S. Food uniform are considered a failure. and Drug Administration (FDA) approves standard steam sterilization cycles for health- Extended Cycles care applications and does not allow the One solution to steam penetration issues conditioning phase of the cycle to be changed. might be an extended cycle. The time needed at the point of exposure does not change. But Steam Contact if it takes longer for the steam to reach a given

If the steam cannot reach all of the surfaces, point, then an extended sterilization exposure Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 sterilization of the device will fail. A variety of time might be needed. If that is not possible steam penetration tests are available to help (e.g., in healthcare facilities in the United with this challenge. Different tests are States), then the device needs to be redesigned designed for specific product families. or the exposure time needs to be increased to Steam penetration tests check the amount compensate for the extra time needed for the If the steam cannot of noncondensable gas (NCG) present in the steam to reach all contact points. reach all of the surfaces, sterilizer chamber. Too much NCG will sterilization of the prevent steam from contacting the surfaces Wet Packs to be sterilized. A wet pack refers to moisture remaining device will fail. Quality assurance testing is performed on after completion of the sterilization and products that are routinely sterilized to cooling cycles. Such packs may lose their ensure that there is adequate steam contact. barrier properties, which could allow bacteria Process challenge devices are designed to to migrate to the inside of the package and simulate a product to be sterilized, offering a contaminate the contents or shorten the shelf challenge to the sterilization process that is life of the package. When steam encounters equal to or greater than the actual device. an object with a lower temperature, the steam gives up energy to the object that it Leak Test condenses upon. For the condensation to be Many dynamic air removal steam sterilizers re-evaporated, the same amount of energy have a leak test built into the machine. This must be applied to the condensed water. At test measures the leakage of air into the the end of the sterilization cycle a vacuum is chamber. It is complementary to the air- used to remove the steam from the steriliza- removal test, known as Bowie-Dick or DART tion chamber. The condensed water (daily air removal test). The maximum rate of produced during the exposure phase must air leakage should be 1.0mm Hg/minute.1 either be drained away or re-evaporated. The presence of NCG in larger quantities Under ideal conditions this is not a problem could affect the ability of steam to contact all since the energy needed for revaporization is surfaces to be sterilized. According to ANSI/ exactly the same amount of energy that was AAMI/ISO TIR 17665-2:2009, the leak test produced during condensation! In a properly should be performed quarterly. Some experts working system, wet packs should never be a recommend running this test weekly, and problem. Unfortunately wet packs do occur. others prefer to run it daily. Individual facility For the condensate to be re-vaporized the preferences and manufacturer recommenda- condensate must be kept in contact with its tions influence test frequency. energy. This energy was given up to the product upon which the steam condensed. If Bowie-Dick Test the condensate gets separated from the product Intended to be run at the same time each then there is no energy to be used for day, the Bowie-Dick test is used to evaluate re-vaporization. This condensate must instead the efficacy of air removal and steam be drained away. If the condensate is not penetration. The test involves a chemical re-vaporized or drained away a wet pack occurs.

Biomedical Instrumentation & Technology March/April 2014 107 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Features

Additional Resources A number of things can cause the condensate to eliminate the conditions which will cause to become separated from its energy. the wet pack. • Association for the Poor steam quality may cause wet pack Most of these problems can be prevented Advancement of Medical Instrumentation. Sterilization problems. Steam might condense in the pipes by configuring the device and the load to of Health Care Products— leading to the sterilizer. Sometimes this minimize the accumulation of condensate Moist Heat—Part 1: condensate can find its way into the sterilizer and the separation of the condensate and its Requirements for the chamber. Since the energy that produced the energy. Textile and peel packs should be Development, Validation condensate is in the pipes and not the cham- placed above trays. Place wrapped trays above and Routine Control of a ber or product there is no energy available for sterilization containers. Provide adequate Sterilization Process for revaporizing the condensate. This condensate space between packs and trays. Do not stack Medical Devices. ANSI/AAMI/ ISO 17665-1:2006. must be drained away. Steam quality also can containers or packages. A water separator be affected if the demand for steam is higher will help to prevent carryover of water from • Association for the than the steam generator or boiler’s capacity. the steam pipes. Ensuring that the steam Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 Advancement of Medical In this situation the steam pressure will drop generator or boiler has enough capacity to Instrumentation. causing a boil, and some water will be carried accommodate peak load periods will help Comprehensive Guide along with the steam into the sterilizer prevent carryover of water. to Steam Sterilization and Sterility Assurance in chamber. This water never evaporated to Health Care Facilities. ANSI/ become steam and therefore did not con- Verification vs. Validation AAMI ST79:2010, A.1:2010, dense, and thus it does not have any energy to Verification is “the confirmation by examina- A.2:2011, A.3:2012, A.4:2013. use for re-evaporation at the end of the tion and provision of objective evidence that sterilizer cycle. specified requirements have been fulfilled.”2 • International Association of Anything that causes a large amount of Whereas, validation is “a documented Healthcare Central Service Materiel Management. condensation to occur might procedure for obtaining, Central Service Technical result in a wet pack. If a recording, and interpreting The best way to Manual Workbook. 7th ed. sterilizer door is allowed to the results required to stay open between cycles it eliminate wet packs establish that a process will • Lewis PE, and Raymond G. might cool off, which can is to eliminate the consistently yield product Practical Guide to Autoclave cause a large amount of complying with predeter- Validation. Pharmaceutical conditions which will condensation to occur at the mined specification.3 Engineering. July/August cause the wet pack. 2002. beginning of the sterilization Processes that can be cycle. This condensate can confirmed with objective • Pflug I, Holcomb R, be blown onto the load evidence only need to be Gómez M. Principles of during the turbulence which occurs in the verified each time that they are run. However, the Thermal Destruction of cycle. Again, the source of the energy and the processes that do not provide objective Microorganisms. In: Block SS, ed. Disinfection, Sterilization condensate has been separated. Large evidence that the process has been accom- and Preservation. 5th ed. amounts of metal in the load also can cause plished need to be validated. This is the case large amounts of condensation to occur. This with sterilization processes. For many • U. S. Food and Drug condensation will drip off the product and reasons, it is impossible to prove that an item Administration. Guidance for can cause revaporization problems for that has been sterilized is sterile. Once the Industry. Process Validation: products that the condensate drips upon. process used to sterilize a particular device General Principles and Practices. Revision 1. Products that absorb the condensate will not has been validated by the manufacturer, then dry at the end of the cycle because there is no verification is conducted by the user each • U.S. Food and Drug Admin- energy available to re-vaporize the conden- time that the process is run. Verification istration. Draft Guidance sate. The following conditions may also ensures that the parameters of the validated for Industry and FDA Staff separate the condensate from its energy process were achieved and provides a strong – Processing/Reprocessing source: support devices, multiple tray layers, probability that the process achieved its goal, Medical Devices in Health Care Settings: Validation stacking of trays, dented or deformed trays. i.e., a sterile device. Methods and Labeling. Most steam sterilizers dry the load under Product quality assurance testing as vacuum conditions. If no energy is available described in ANSI/AAMI ST79 is used to for revaporization the vacuum will insulate confirm that the manufacturer’s validated the load. For this reason, increasing the dry processes being used at a particular facility time will have little effect on eliminating wet works in the particular sterilizers and for the packs. The best way to eliminate wet packs is particular devices that the facility sterilizes.

108 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Features

This testing, like process validation, is specific References to a particular machine. Product quality 1. AAMI. Sterilization of Health Care Products— assurance testing is performed by developing Moist Heat—Part 2: Guidance on the application of product families and designating a master ANSI/AAMI/ISO 17665-1. ANSI/AAMI/ISO TIR product for each product family. The master 17665-2:2009. Arlington, VA: Association for the product which represents all members of the Advancement of Medical Instrumentation; 2009. product family is then used for all testing. 2. FDA. Quality System Regulation. Code of Federal Results of testing apply to all members of the Regulations, Title 21, Part 820, Section 820.3 (aa) product family which the master product Definitions. Silver Spring, MD: U.S. Food and represents. Facilities might need to develop Drug Administration. more than one product family. 3. AAMI. Sterilization of Health Care Products— Vocabulary. ANSI/AAMI/ISO 11139:2006.

Conclusion Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 Steam sterilization has a long history of use; Arlington, VA: Association for the Advancement the mechanism of kill is well understood of Medical Instrumentation; 2006. and the process seems straightforward. However, the process is more complicated than it seems at first. Many factors have an impact on whether a sterile product will actually be produced. n

Human Factors Guidance

Standards on CD – Human Factors Recently expanded, this CD is your single source for Human Factors standards and guidance documents.

Searchable and easy to use, the CD contains • ANSI/AAMI HE75:2009, Human factors engineering - Design of medical devices • ANSI/AAMI/IEC 62366:2007/(R)2013, Medical devices - Application of usability engineering to medical devices • AAMI TIR49:2013, Design of training and instructional materials for medical devices used in non-clinical environments • AAMI TIR50:2014, Post-market surveillance of use error management • Human Factors & IT Horizons articles • Human Factors articles from BI&T, AAMI’s peer reviewed journal • FDA guidance documents and much more

Order Code: HFCOL-CD List $390 / AAMI member $195 SOURCE CODE: PB

Order Your Copy Today! Call +1-877-249-8226 or visit http://my.aami.org/store

Biomedical Instrumentation & Technology March/April 2014 109 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments

VIEW FROM THE TOP Infusion Nurse Champion Talks ‘High Touch’ in ‘High-Tech’ World Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021

How does your own experience as a nurse color Is there an infusion challenge that’s been your approach to your job as CEO of the society? particularly troublesome? And why do you My role as CEO revolves around meeting INS think it has not been resolved? members’ needs and advancing the organiza- A major challenge I see is the lack of aware- tion’s mission. My clinical experience as an ness of the risks associated with infusion infusion nurse allows me to have an under- therapy. While often infusion-related compli- standing of the issues infusion nurses face cations are not serious, there are each day as they seek to make a positive complications that are life threatening. impact on patient care. Catheters and needles are placed directly into a patient’s vein for the administration of fluids and medications, so skilled, competent You’ve been with INS since 1997. What’s been clinicians need to be the ones performing the biggest change you have seen during that these procedures. Also, attention for the time as it relates to infusions? Mary Alexander, MA, device does not end when it’s inserted, but The biggest change I’ve seen for patients RN, CRNI, FAAN, is chief care and maintenance practices need to needing infusions is the transition of care out executive officer of the continue for the length of the patient’s of the hospital setting to home, and the Infusion Nurses Society (INS). treatment. The expectation of a new graduate involvement and participation necessary in She was on the frontlines as nurse, as he or she enters the workplace, is direct care by the patient and caregivers. an intravenous staff nurse that he or she is competent in inserting an IV There was a time when only licensed health- in hospitals and healthcare properly and safely. However, there is care professionals provided infusions. systems for almost two minimal infusion education in schools of However, today, the participatory role of the decades before joining INS. nursing addressing this broad, comprehen- patient and family is critical to the success of sive specialty. the patient’s prescribed treatment.

In describing infusion nurses, you’ve talked about their ability to strike a balance between The biggest change I’ve seen for patients needing infusions is “high tech and “high touch.” What do you the transition of care out of the hospital setting to home, and mean by that? the involvement and participation necessary in direct care by While infusion nurses are well versed in using the latest technology to provide the the patient and caregivers. best infusion experience for their patients, they still must interact face-to-face with their

110 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments patients. Infusion therapy can be frightening any roll-out of a new device, or seek input for some patients, children, or adults—those from the nurses at the bedside so an who have a one-time infusion or those who accurate assessment of the clinical environ- have chronic conditions requiring lifelong ment can be matched with the particular treatment. The human connection—whether features of a product. a warm hand on a patient’s arm or making meaningful eye connection—goes a long way What can the manufacturers of medical devices in easing fears and comforting them. do to make the lives of infusion nurses easier and further advance the cause of patient safety? Healthcare has become so highly technical, Seeking input and feedback from infusion so interconnected. What does that mean 1) nurses about medical devices and technology in terms of the kinds of skills infusion nurses as it relates to real-life clinical scenarios need to succeed on their jobs and 2) how they would be helpful. The environment in the Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 interact with other hospital departments? “lab” may be quite different from that of an With the variety of devices and equipment, ICU [intensive care unit] setting. infusion nurses must have the ability to assess patients to determine appropriate What do you like the most about healthcare device selection, be competent in device technology in the modern world? insertion and care and maintenance practices, and know how to use devices and I believe the ability to retrieve information equipment as intended by the manufacturer. quicker and have more access to information With today’s complex healthcare environ- is helping healthcare providers be more ment and increased patient acuity, it’s efficient in their practices. essential that collaboration with other departments occurs so that continuity of What frustrates you about healthcare patient care is achieved. For example, technology? infusion nurses consult our pharmacy The rapidly changing advancements in partners with questions related to medica- healthcare technology and the time needed to tions, risk managers when an become competent in using them and infusion-related adverse event prompts a root mastering the learning curve. cause analysis, or social workers and discharge planners when treatment continues Include infusion nurses at the beginning of any roll-out of a on an outpatient basis. new device or seek input from the nurses at the bedside so an accurate assessment of the clinical environment can be What is the ideal relationship between infusion matched with the particular features of a product. nurses and healthcare technology management (HTM) professionals who maintain medical devices and systems? You’ve written about the lack of true The ideal relationship highlights the collabo- interoperability in healthcare. How far do you ration between the two groups so that each think healthcare is from achieving that goal? understands the purpose and focus of their Due to the many variable impacting interop- individual responsibilities. Since infusion erability, such as available funding and nurses are frequent end-users of technology, organizational resources, it’s difficult to such as electronic infusion devices, two-way determine when this will be achieved. communication between them and the HTM professionals is helpful should guidance for troubleshooting problems be needed. What is the biggest obstacle to interoperability?

How can HTM professionals best support the I believe the biggest obstacle is the complex- work of nurses, particularly infusion nurses? ity of patient management across the healthcare continuum, bearing in mind the Include infusion nurses at the beginning of

Biomedical Instrumentation & Technology March/April 2014 111 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments

numerous patient-care settings and chal- How important is teamwork to the effective lenges associated with them. delivery of healthcare? Interdisciplinary teamwork is essential in Is it harder in a healthcare environment that’s today’s complex healthcare environment. increasingly technical for infusion nurses to There must be open lines of communication maintain the human touch? among team members and respect and For infusion nurses, I believe maintaining acknowledgment of each member’s contribu- the human touch is woven into our DNA. All tions as they relate to the patient’s plan of care. healthcare professionals will need to consciously ensure they don’t forget the human I read another of your articles in which you touch and maintain quality patient experi- wrote about older nurses being “entrenched in ences, especially when they are busier and

the old ways of doing their jobs” as opposed Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 time with patients is limited. to embracing evidence-based practices. Do you believe evidence-based practices are the way to go for all of healthcare professionals? Why?

All healthcare professionals will need to consciously I believe evidence-based practice is the right thing to do for all healthcare professionals. ensure they don’t forget the human touch and maintain The data, evidence, and research become the quality patient experiences, especially when they are basis for practice and validates what we do busier and time with patients is limited. and the impact it has on patient care.

What keeps you up at night about infusion nursing in the United States? The lack of standardization of infusion practices. I believe having competent, skilled infusion nurses and teams to address the patients’ needs is invaluable as we seek to ensure that quality patient care is safe, efficient, and cost effective.

You have a magic wand. What’s the one thing you would change about healthcare technology that you believe would benefit patients the most? Improving the dissemination of patient information between departments, institutions, and healthcare providers so a seamless and accurate exchange occurs whereby patients don’t have to rely on memory or constantly repeating information. Not only will patients benefit, but so will providers, as details won’t be missed or overlooked and continuity of care is maintained. n

112 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments

BRIGHT IDEAS An Overhaul of Code Carts Translates into Time Saved Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021

Joseph Sheffer

As Joanne Rhodes, a registered nurse and Accounting Department bills the patient for director of sterile processing in the Central any missing items from the cart. After CSD Service Department (CSD) at Aultman adds the missing supplies and equipment to Hospital in Canton, OH, can attest, creating a the cart, it is brought to the hospital phar- standardized process for the maintenance of macy, where staff resupply the medication hospital emergency carts is trickier than one drawers. Then, the cart is scanned again and might think. But having a streamlined brought back to the CSD, where it waits in process in place is critical to delivering the replacement bay for redeployment. optimal care in the primary setting. “It is not just a simple, ‘Here is your Challenge cart—go,’” said Rhodes. “A lot of things have “In March 2013, we had several carts that had to happen in the background to make it a expired medications and supplies. It was very At a Glance seamless process.” time consuming to go to every floor to locate Aultman has 59 carts, each with a full each cart and complete the exchange pro- SUBJECT complement of medications, supplies, and cess,” said Rhodes. Central Service Department, equipment, such as endotracheal tubes, The solution at Aultman was borne out of Aultman Hospital intravenous (IV) start kits, laryngoscope sheer frustration. The Pharmacy Department blades, defibrillators, nasal cannulas, and and CSD got together to complete an analysis LOCATION suction catheters. The main hub for the of the code cart exchange process, and as Canton, OH carts is CSD, where they are prepped, Rhodes described, “We had several of the checked, scanned into the hospital’s track- ‘Eight Deadly Wastes’ in our system.” SIZE ing system, and deployed to the floor to She also explained that it was taking too 806 beds which they are assigned. long—up to three hours—to check, fill, and “The cart sits on the floor all the time, and replace a cart. “There are times when we will STAFF if clinicians need it in an emergency, they have multiple codes going on in different Key team members in the pull their cart into that room,” explained areas and to exchange that cart, it backs them central service, pharmacy, Rhodes. “They utilize their cart, and at the up. And you always have to have a cart and nursing departments end of that emergency, they will call the CSD available on the floor at any given point in and say, ‘I need you to exchange my cart.’” time, because if patients code once and you CSD then replaces the cart with one of five bring them back, you always have the opportu- carts waiting on standby. nity for that to happen again, and then you At that point, CSD begins a check-and-fill have to have another cart,” Rhodes said. process for the used cart. The charging In addition, growth at Aultman had function also is initialized, whereby the resulted in carts becoming nonstandardized.

Biomedical Instrumentation & Technology March/April 2014 113 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments

About the Author “As we had grown and developed and macy Department in March 2013, Aultman matured as a hospital, made new areas, decided to implement a radiofrequency Joseph Sheffer is publications reconstructed, etc., new carts were pur- identification (RFID) tagging system for the specialist at AAMI. chased, and in those new carts, items were in carts. It is used track all medications, thereby E-mail: jsheffer@ different places,” said Rhodes. limiting manual handling and check-in. aami.org As a result of the new carts being config- Jim Toohey, MS, RPh, executive director of ured differently from the old, asymmetry pharmacy at Aultman, said that as inventory existed in drawer sizes, for example, making comes in, those items that will be tagged are it challenging to streamline the contents of segregated. “An RFID label tag is created and the carts. “That’s when we realized,” Rhodes the information on it is checked by a pharma- said, “that if we made it so these drawers cist,” he said. “Then, a pharmacy technician could be easily exchanged, it would be a affixes the tag to the drug itself, where a hundred times better. … We had to pull these pharmacist checks it again for accuracy.” Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 carts together and make it so that six items Each tray also is tagged with a unique ID that go in this cart are now going to be in this tag according to the tray (e.g., code cart–tray cart. If it is drawer four here, it is going to be 1, code cart–tray 2, anesthesia tray), drawer four over here.” explained Toohey. Jeffrey Fostyk, PharmD, drug conservation Solution pharmacist at Aultman, described the process According to Rhodes, there was also a desire from this point: “When pharmacy receives a to introduce new products into the code tray to be restocked, it is placed in a contain- carts. New items such as IV kits, IV tubing, ment device, or scanning station. Then, and syringes were added to all code carts, software is run and a report of missing or while new emergency tape was added to the expired items is displayed onscreen for that pediatric carts. particular tray type. Those items are replaced, The next domino to fall was revamping the the tray is placed back in the containment organization of the medication drawers. device, the software is run again, and a list Based on a recommendation by the Phar- verifying all items, lot numbers, and expiration dates is printed. The tray then is marked as complete, a pharmacist performs a final visual check, and the tray is set aside for subsequent dispensing.” Automating the medication tracking system was an essential first step to organiz- ing the drawer system of the code carts. The RFID tagging system “made a huge improvement to the medication aspect of the carts. Before, it would take the pharmacy an hour, maybe an hour and a half, to go through and make sure every drug was correct and that the amount in the cart was correct,” said Rhodes. She estimated that following implementation of the tagging system, the turnaround time in pharmacy was reduced by more than half—to about 20 to 30 minutes—a meaningful savings, especially during times when the CSD is inundated with carts that need to be replenished. Because all medications are uniquely tagged, tracking supply, expiration dates, and recalls is a cinch, explained Fostyk. “We have By standardizing how its code carts are organized and maintained, Aultman Hospital has seen a already had to exercise this function to reduction in the amount of time it takes to process a cart. determine if we had recalled items in our code

114 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments carts,” he said. “It was absurdly simple to dial in the lot numbers in question and run a report. Fortunately, we had not used any of the recalled product. Our previous process would have dictated that we break open every code cart to check lot numbers on vials.” Toohey said that the return on investment from the RFID system was a considerable labor savings. Before implementing it, the pharmacist and technician would spend about 15 to 20 minutes per tray, whereas now they spend around five minutes total. “So now we have a more efficient way of Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 exchanging the medication drawers in the carts,” added Rhodes . “Whenever a change comes in, pharmacy can pull the appropriate box and change out the medications in the drawer in a much timelier manner. Then, they are able to get that cart back out to [the Key players in revamping the code carts (from left to right): Joanne Rhodes, RN, BSN, CNOR, CSD] more quickly, so we can put it back into director of sterile processing; Karen DeJanerio, CBSPD, TECH 2, cart specialist; Suzanne M. the exchange system.” Polcin, CPhT, pharmacy technician; Jeffrey Fostyk, PharmD, drug conservation pharmacist; and Aultman further streamlined the carts by Jim Toohey, MS, RPh, executive director of pharmacy. ensuring symmetry of contents between the old and newly purchased carts. “We made every cart the same, meaning each drawer is the contents and function of the carts. A the same location, no matter if it’s new or major aspect of the training was to instruct old,” said Rhodes. “So if it’s a first medication staff on the subtle nuances that existed drawer of this cart, it doesn’t matter if it’s a between the old and new carts. new cart or an old cart. So we standardized all “Despite the slight differences in the old of our lists in disposable supplies on those and new carts, ‘top of cart,’ ‘drawer one,’ etc., carts. It made the process so much quicker.” is still consistent between them,” explained This process of streamlining the carts Rhodes. “The training gave staff the confi- required education and buy-in, particularly dence to know that if they are taking care of a from the key players—CSD, pharmacy, and patient, items are going to be found in the nursing—and was spearheaded by the same place, whether they are using an old or Aultman Hospital Critical Care Coordination new cart.” Committee. The committee served as a governing body to decide on the cart contents Toohey said that the return on investment from the RFID system and their location within carts, as well as to was a considerable labor savings. Before implementing it, the periodically (at least annually) review the contents to determine whether they were pharmacist and technician would spend about 15 to 20 minutes meeting the overall needs of the hospital. per tray, whereas now they spend around five minutes total. Rhodes said that when the cart-standardization initiative began, different views on what should and should not be included Results existed among the departments. The Critical Rhodes described the process of revamping Care Coordination Committee developed a the carts as “human factors engineering after policy regarding the contents and use of the the fact.” carts, to which all areas of the hospital were “What we’re doing is actually compensat- asked to comply. ing for manufacturer diversity, which actually The hospital also initiated code blue is a big issue,” she said. “We utilize one trainings, during which staff were drilled on company in particular, but many manufactur- quickly demonstrating their familiarity with ers make carts. The hardest part is—as an

Biomedical Instrumentation & Technology March/April 2014 115 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments

organization that is large like ours—we not wasting our time and productivity by simply don’t have the money to go out and redoing carts when they didn’t need to be purchase a whole new fleet of carts that cost done,” said Rhodes. $3,000 apiece.” Because of this financial For others interested in implementing a reality, Aultman is slowly transitioning to the change such as this, Rhodes said the most new cart style as the old carts expire. valuable lesson she learned was the impor- With different carts in play, having a tance of collaboration and consensus. standard policy in place is crucial. “Certain “You need to get the team of stakeholders areas of the hospital may want to tweak their together, so that everyone is on the same carts, like the critical care unit may want heart page of what your goal is and how you are drips on their cart, but specific, unique going to accomplish it. Without that, we From the CSD, to pharmacy, items like that don’t go on the cart,” would not have been successful in making said Rhodes. “Those supplies are kept these changes,” she said. n to the nurses and physicians, Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 on that floor, so they’re readily and finally to patients, available when needed.” everyone benefits from Rhodes said she witnessed a having a well-organized and cascade effect from implementing efficient process in place. cart standardization. From the CSD, to pharmacy, to the nurses and physicians, and finally to patients, everyone benefits from having a well-organized and efficient process in place. “The new process has helped us out tremendously, by not wasting supplies and

ANSI/AAMI ES60601-1:2005 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (includes Amendment 1:2012)

AAMI Standards and Recommended Practices ANSI/AAMI ES 60601-1:2005/(R)2012 & A1:2012 This is the consolidated text of 60601-1 and the 2012 Amendment. Done in track changes so you can easily see the nearly 500 changes made by the Amendment.

Available in multiple formats, including the popular travel-size.

Order Code: 606011, 606011-PDF, 606011-CD, or 606011-PE ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Association for the Advancement of Medical Instrumentation List $440 / AAMI member $220 www.aami.org Medical electrical equipment— Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD). ISBN 1-57020-246-XMeasuring Only need the Amendment? Only 5.4” x 7” Order Code: 606011-A or 606011-A-PDF Don’t Miss the List $140 / AAMI member $70 Travel-Size Format!

Order your Copy Today! Call 877-249-8226 or visit http://my.aami.org/store

116 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments

DATA MANAGEMENT The Basics of CMMS Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 Ted Cohen

Editor’s Note: This article marks the first of a Almost all HTM programs use a comput- About the Author planned series on data management. The series erized database to store and retrieve Ted Cohen is is expected to cover many aspects of clinical HTM-related data. These databases, often manager of clinical engineering data management, including how to called a computerized maintenance engineering obtain the data, entering the data into a management system (CMMS), often are at UC Davis computerized maintenance management system built specifically for HTM activities. Most Medical Center in (CMMS), getting the data out of a CMMS are from commercial software vendors, Sacramento, CA. E-mail: theodore. (with reports), device and work-order nomencla- although a relative few clinical engineering [email protected] ture standards, best practices as it relates to departments still use custom-made CMMSs. financial matters, how to effectively use the data Figure 1 shows the basic structure for a (for example, as it relates to benchmarking and generic CMMS. statistical data analysis/data mining,) and data This first article will review HTM and integrity. Other possible topics include data CMMS data basics and introduce some data management for systems of systems, clinical integrity methods and ideas. alarms-related data, mobile tools, and auto- Effective HTM data management starts with mated device management. If you are interested an up-to-date medical equipment inventory. in contributing to this series, please contact Sean The inventory is the foundation for a high- Loughlin at [email protected]. quality medical equipment management program and the core structure that the entire Healthcare technology management CMMS relies upon. Table 1 shows the basic (HTM) data are used in making important fields used by all CMMSs to track a medical decisions, such as when to device equipment inventory. replace a medical system. Such Making sound There are many ways to struc- data also help in determining if ture these data, but all CMMSs decisions hinges a product recall affects your should have the fields shown in inventory and understanding on having high- Table 1. trends in service costs. Making quality data. There are many other equip- sound decisions hinges on ment-related fields that can be having high-quality data. Data included such as vendor, integrity is defined for this series as the data purchase order number, system identifier, accuracy, consistency, and date item was last physically inventoried, and comprehensiveness over the data’s lifetime. end-of-support date. Some of the more Data integrity will be a theme throughout important additional fields that require this series. tracking for information technology (IT) and

Biomedical Instrumentation & Technology March/April 2014 117 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments

alarm-related issues will be discussed in a Most CMMSs include a maintenance future article. schedule and scheduler. The maintenance schedule indicates for each device if and Service History when routine preventive maintenance (PM) All maintenance and repair activities— is required and what needs to be done. PM whether in-house or through a vendor, from activities may be on a fixed schedule (e.g., the service request to the in-house technician PM due every six months in January and activities—parts purchased, invoicing, and July), a floating schedule (e.g., PM is due bill payment must be tracked for Joint twice a year in six-month intervals), based on Commission and cost-management pur- hours of use as determined by a meter on the poses. By reading the service history, you device (e.g., every 2,000 hours clean the should be able to tell the equipment’s filters, every 4,000 hours replace the battery), or it may follow another scheduling strategy.

maintenance and repair story, not unlike how Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 an electronic medical record reveals the Table 3 shows typical maintenance schedule health history of a patient. Table 2 shows the data fields. fields that are typically used to track these Nomenclature standardization is important service requests and service history activities. so that like devices are categorized using the Depending on institutional policies, the same manufacturer and device-type terminol- CMMS also may be used to manage vendor ogy (e.g., a portable battery-powered purchase orders and spare parts manage- defibrillator is always called: Defibrillator, ment. Regardless of whether the CMMS is Battery Powered). Table 4 lists some typical used to manage vendor repair and parts common table information. purchases, it needs to document all parts and labor costs, vendor and in-house, in order to Purchasing and Service Contracts maintain a comprehensive service history. HTM or clinical engineering departments, A variety of additional fields may be their CMMSs and institutions, manage included such as: travel time, overtime, work purchase orders and service contracts in a remaining to be completed, other comments, variety of ways often involving other depart- and notes. ments. Therefore, no attempt is made here to

Field Name Field Description Example Data Equipment ID A unique identifier for each piece of equipment sometime called Tag Number or 1234567890 Property Number Manufacturer ID Manufacturer identifier: The name of the company that manufactured the device 101883 (Philips Medical (and/or Name) (typically from the device nameplate or documentation). May be a standardized field Systems) from the ECRI Institute’s Health Devices International Sourcebase. Model The name or number of the model of the device (from the device nameplate MP50 and/or device documentation) Serial Number A unique (to the manufacturer) alphanumeric string identifying the specific device 12345A987654321 Equipment Type A description (or code) indicating the type of equipment. Sometimes standardized 12636 (Physiological from the ECRI Institute’s Universal Medical Device Nomenclature System (UMDNS). Monitors) Location The equipment’s location. Typically three separate fields: Facility, building, room. UC Davis Medical Center, Main Hospital, Suite 0630 Owner, Customer, Name of the department and/or customer that owns or is the custodian of the SICU or Department equipment Equipment Status Status (e.g. in service, out of service) Active, In Use Acquisition Cost Purchase price of the device $25,125.88 Warranty The date the warranty expires 01/15/2014 Expiration Date Table 1. Minimum Equipment Inventory Fields

118 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments

Field Name Field Description Example Request Management Section Requestor ID and Contact Multiple fields indicating who the requestor is and their Ted Cohen, 916-734-1234, Theodore. Information contact information (e.g. e-mail address, phone number) [email protected] Date and Time of Request Local date and time of request 9/15/2013, 20:17 Problem Description Problem as described by the requestor Equipment will not turn on Equipment ID and/or Preferably, the unique ID number of the equipment. Tag number: 1234567890 Description Alternatively, a detailed description of the equipment Assigned Tech ID Unique identification of the person (and company) Ted Cohen (Employee Id 10) assigned by the software or by the dispatcher to do this work Service History Section In-house or Vendor Indication as to whether this entry is in-house or vendor. Vendor: Philips Medical Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 If vendor, provide the vendor ID. Employee/Tech ID Unique identification of the person (and company/ Clinical Engineering/Ted Cohen organization) that performed the work Completion Date/Time Date and time that the work was completed 9/15/2013 Action Taken Description of the work performed Power supply repaired Labor Hours The amount of time it took to complete the job 4.3 hours Labor Cost The total cost of labor for the job. $430.00 Parts Used Description of stock parts used 1 amp fuse, 50 uFarad capacitor, power cord Parts Cost Cost of the parts used Purchase Order Reference to any purchases (labor and/or materials) PO A78654. Note: Cost information associated with this work may be included under Parts and Labor or as part of PO. Work/Device Status Indication of whether the work has been completed Complete Failure Code Root cause of reported problem Unexpected Electronic Failure

Table 2. Service History Management

list a sample of CMMS fields for these Tools and techniques for managing data integrity start features. What is important is that the HTM with the HTM staff taking responsibility, and being held department, preferably within the CMMS, obtains all of the cost and other relevant accountable, for their CMMS data. service data (e.g., vendor field service reports from service contract activities) so that a Data Integrity comprehensive service history is stored in the Tools and techniques for managing data CMMS. All costs (e.g., fee-for-service, prepaid) integrity start with the HTM staff taking also need to be included in the CMMS. responsibility, and being held accountable, The above CMMS table and field descrip- for their CMMS data. Most CMMS software tions are only a summary. Most CMMSs have has tools to assist the staff in providing evolved to be much more comprehensive and real-time, and after-the fact, data integrity and contain a variety of additional fields and data error checks. However, commercial features not described here. Advanced CMMSs, in their pursuit of flexibility, may reporting tools, import and export tools, not implement or configure systems to make interfaces and other features will be dis- optimal use of these tools. cussed in a future article. Depending on the sophistication of the CMMS and its underlying database engine, some basic data integrity tools exist at the

Biomedical Instrumentation & Technology March/April 2014 119 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments

Field Name Field Description Example Device ID or Manufacturer/Model ID or device manufacturer/model Philips MP 50 Maintenance Interval How often is maintenance required 12months Next Due Date Next date that maintenance is due 9/15/2013 Type of Maintenance Schedule Fixed: Due every interval based on an absolute start date or sync date, or Float Float: Due every interval based on the last time the PM was complete. Maintenance Procedure This description could be a reference to a procedure library that’s part See mfr manual of the CMMS, paper-based procedure library, or service manual library #4321, pages (electronic or paper-based). 123-178

Table 3. Scheduled Maintenance Fields

Table Name Table Description Example Data Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 Departments/ List of customer departments and their locations and contact SICU, Cost center: 9641, Contact: Mary Customers information Smith, phone 12345, e-mail: marysmith @ emailaddress.com Equipment List of equipment types. May include standards-based codes from Device type: Physiological monitor; Risk Types ECRI Institute’s UMDS system classification: Moderate Risk; Default maintenance interval: 12 months Manufacturer List of manufacturers and their contact information (sales Phillips Medical 1234 Minuteman Lane, Names contacts, service contacts). If encoded there are standards-based Andover Mass, 12345; Sales contact Jane Doe; encoding for manufacturers (e.g., ECRI Institute’s Health Devices Service contact John Brown International Sourcebase). Note This table, or a similar one, may also be used for vendors. Employee Employee name, specialty, contact information, position level and/ Bill Smith; pager 123-4567; BMET 2, $125 per Identifiers or cost information (e.g. recharge rate) hour Facility Facility name, address, phone number, key contacts UC Davis Medical Center, 1234 Sacramento Identifiers Blvd, Stockton CA; John Doe; 123-456-7899 Table 4. Common Tables

database management and application layers. Type of Error Example At the database layer, these include key fields Date Work done in the future and referential integrity. Primary keys Date Work completed before describe one field or a combination of fields work started in one table that is always unique and Equipment ID No equipment ID or required. For example, the equipment tag equipment ID not on file number is often the primary key to the Equipment ID Archived/retired equipment equipment table. From a data integrity ID standpoint, it is important to always make Workorder Inconsistent technician the equipment tag number a required field. response: (e.g., Equipment That concept works well for the equipment not located, but the table’s data integrity, but for work-order data workorder indicates that integrity, what happens when a customer parts were replaced) reports a broken device and does not know Purchase Order No line items on PO the equipment tag number? Therefore, the Purchase Order Cost of line items > Not- equipment tag number cannot be a required to-Exceed value field in the work-order table. Managing this Stock Parts Negative parts quantity is an example of the application and configu- Table 5. Sample Error Checking ration flexibility that the CMMS developers need to provide. One application and configuration level technique for managing this example problem is to allow work orders to

120 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments be opened without an equipment tag “outlier” reports and data audits will be number, but require that work orders include explored further later in this series. an equipment tag number upon closure. Of course, modern CMMSs have many Another data integrity tool at the database more features, including interfaces to real level is known as referential integrity, which time location or radio frequency identifica- For More Information ensures that the relationships between tables tion systems for wireless equipment remain consistent. When one table contains location tracking, mobile wireless devices To gain a broader understand- a field that is a key to another table (a for data viewing and entry, and customer ing of CMMS basics, consider so-called “foreign” key), the concept of database access. n the book Computerized Main- referential integrity means that you may not tenance Management Systems for Clinical Engineering (2003 add a record to the table that contains the edition). The book is available foreign key unless there is a corresponding in the AAMI Store at http:// record in the linked, primary table. For my.aami.org/store/. Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 example, you cannot add a new manufacturer to the equipment table until you enter that manufacturer into the manufacturer common table. At the application layer, error checking may include mandatory fields, user-defined default values and application “sanity” error checking. Table 5 shows a short sample of types of common application layer error checks. Other data integrity methods such as

AAMI’s Dialysis Collection (2013 Edition)

This 10 document collection now includes 60601-2-16:2012, 2013 Edition Essential performance of hemodialysis, hemodiafiltration and

hemofiltration equipment. AAMI Standards Dialysis

This collection of every AAMI hemodialysis standard and guidance Dialysis document, includes seven published since 2011. Recent updates

include 11663 and 23500 (revise RD52), 13958 (reviseswww.aami.org RD61), 26722 (revise RD62), 13959, and TIR43. Standards on CD Dialysis Fully searchable and easy to use, the CD version also includes

important FDA and CMS guidance documents. Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Dr, Suite 301 Arlington,2013 VA 22203-1633 ISBN 1-57020-467-5 www.aami.org

CD or Book Buy Both and SAVE! For more information or to order additional copies, call +1-877-249-8226 or +1-240-646-7031 Any use of materials contained in this product—including reproduction, modification, distribution, or republication—without the prior written consent of AAMI is strictly prohibited. Includes Adobe Acrobat® Reader. © 1987-2011 Adobe Systems Incorporated. All rights reserved. Order Code: DSBKCD or DSBK13 Order Code: DSBK13-S Adobe and Acrobat are trademarks of Adobe Systems Incorporated. 2013 List $440 / AAMI member $270 List $590 / AAMI member $390 Order Your Copy Today! Call +1-877-249-8226 or visit http://my.aami.org/store

SOURCE CODE: PB

Biomedical Instrumentation & Technology March/April 2014 121 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments

HTM NEWS & VIEWS Making Sense of Revised CMS Medical Equipment Maintenance Requirements Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021

Alan Lipschultz

About the Author On Dec. 20, 2013, the Centers for Medicare & response providing evidence that other Medicaid Services (CMS) released a docu- alternatives to manufacturer PM recommen- Alan Lipschultz, CCE, PE,CSP, ment that will affect nearly all healthcare dations have not caused harm to patients and 4 is president technology management (HTM) urging CMS to allow more flexibility. of HealthCare organizations in the United States.1 The Many hospitals rely on TJC standards as Technology guidance document, titled Hospital Equipment they pertain to management of medical Consulting LLC in Maintenance Requirements, is addressed to equipment. HTM managers in these hospi- North Bethesda, CMS state directors who survey hospitals for tals may not realize that TJC bases its MD. E-mail: [email protected] compliance with the agency’s regulations. standards on the CMS standards. As a result Other accrediting organizations, such as The of this CMS directive, TJC recently Joint Commission (TJC) and DNV Healthcare announced a new Element of Performance, (DNV), base their accreditation on CMS effective 7/1/2014, to bring its standard in standards. The new memo involves compliance. CMS may elect to inspect a considerable revisions compared with a Dec. healthcare organization independently of 2, 2011, CMS document on the same subject.2 TJC. Hospitals that do not rely on TJC are The guidance issued by CMS in 2011 most likely already following CMS standards. caused a major stir in the HTM community The objective of the current article is to because it specified that hospitals should discuss the 2013 CMS document from the follow manufacturer preventive maintenance standpoint of HTM. HTM professionals are (PM) requirements in caring for hospital encouraged to focus on Appendix A, which facilities and equipment.3 Many HTM begins on page 6 of the CMS guidance, groups, based on their experience and because it is easier to read and is the actual professional judgment, had not been follow- standard with which hospitals need to ing manufacturer PM recommendations. comply. Because the current article is meant AAMI and the American Society for Health- for those with responsibility for managing care Engineering jointly developed a healthcare technology, it will focus on medical equipment, which is defined by CMS as “devices intended to be used for The guidance issued by CMS in 2011 caused a major stir diagnostic, therapeutic, or monitoring care in the HTM community because it specified that hospitals provided to a patient by the hospital (e.g., IV should follow manufacturer preventive maintenance (PM) infusion equipment, ventilators, laboratory 1 requirements in caring for hospital facilities and equipment. equipment, surgical devices, etc.).” Excerpts from sections of the CMS guidance relevant to HTM professionals are

122 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments provided, followed by commentary from the should take responsibility for expanding this author. (Note: My commentary is just that; list and discussing within their organization others may have equally valid commentary whether each example meets the definition of that may conflict with mine. In the end, what a “medical device.” If the device under really counts is the actual CMS language and discussion meets the definition of medical how inspectors interpret that language.) equipment and the HTM group does not have responsibility (either directly or by supervising Equipment a contractor), then some other group in the Of note, in the following excerpt, the term organization needs to assume responsibility. If “equipment” includes both medical and the consensus is that the device under facility equipment. discussion does not meet the definition, the “All equipment must be inspected, tested, discussion should be documented and saved for future reference. If a potential for patient

and maintained to ensure their safety, Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 availability, and reliability. The hospital harm exists because the medical equipment in maintains records of hospital personnel question is not maintained properly, then I qualifications and is able to demonstrate how urge the organization to err on the side of it assures all personnel, including contracted patient safety by including the example under personnel, are qualified. the definition of “medical equipment.” “All equipment maintenance policies, CMS specifically included “surgical procedures and programs, as well as specific devices” for the first time in the CMS equipment maintenance inventories, example list of devices that are clearly activities and schedules, fall under the “medical devices.” This is important and purview of the hospital’s clinical mainte- should not be ignored. Many HTM groups do nance personnel, safety department not have any involvement in maintenance personnel or other personnel who have been programs for surgical devices. Typically, the assigned responsibility for equipment operating room has assumed responsibility maintenance by hospital leadership. for these devices. I agree with CMS that “Hospitals comply with this regulation surgical devices clearly are “medical equip- when they follow the manufacturer-recom- ment,” as well as “healthcare technology.” mended maintenance activities and schedule. HTM groups need not have direct responsi- Hospitals may choose to perform mainte- bility for surgical devices, but they should be nance more frequently than the fully aware of what is happening with these manufacturer recommends, but must use devices in their organizations, even if this the manufacturer-recommended mainte- involves going outside of their comfort zone. nance activities in such cases. When equipment is maintained in accordance with If a potential for patient harm exists because the medical the manufacturer’s recommendations, the hospital must maintain documentation of equipment in question is not maintained properly, then I urge those recommendations and the hospital’s the organization to err on the side of patient safety by including associated maintenance activity for the the example under the definition of “medical equipment.” affected equipment.”

Commentary The requirements for “equipment mainte- The term “all equipment” as it pertains to nance policies, procedures and programs, as medical equipment includes many types of well as specific equipment maintenance medical equipment used in hospitals that are inventories, activities and schedules” clearly not necessarily under the purview of the HTM fall under the traditional HTM responsibility. group but still are “intended to be used for Keep this in mind when evaluating existing diagnostic, therapeutic or monitoring care policies, procedures, and programs for provided to a patient by the hospital.” Examples medical equipment not under the purview of could include sterilizers, operating tables, HTM (e.g., surgical devices). patient beds, stretchers, endoscopes, nurse call Even when outside contractors, including systems, and surgical devices. The HTM group the original manufacturer, have been

contracted to perform the required mainte- AEM Program nance, the hospital still is responsible for “A hospital may, under certain conditions, overseeing and documenting that the use equipment maintenance activities and needed work was done. frequencies that differ from those recom- Of note, “manufacturer-recommended mended by the manufacturer. Hospitals that maintenance activities and schedule” are the choose to employ alternate maintenance gold standard according to the CMS guidance. activities and/or schedules must develop, Even if hospitals want to increase the fre- implement, and maintain a documented quency of scheduled maintenance, they “must AEM program to minimize risks to patients use the manufacturer-recommended mainte- and others in the hospital associated with the nance activities.” I disagree with CMS on this use of facility or medical equipment. The particular point. For example, I see no reason AEM program must be based on generally why hospitals should not be able to replace

accepted standards of practice for facility or Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 batteries more often than recommended by medical equipment maintenance. An the manufacturer independent of other example of guidelines for a medical equip- manufacturer-recommended activities. If this ment medical equipment maintenance type of situation arises in your organization, I program may be found in the American suggest using an alternate equipment man- National Standards Institute/Association for agement (AEM) program (discussed below) to the Advancement of Medical Instrumentation document an acceptable deviation. document: ANSI/AAMI EQ 56:1999/ (R) 2013, Recommended Practice for a Medical Even when outside contractors, including the original Equipment Management Program. manufacturer, have been contracted to perform the required “There may be similar documents issued by other nationally recognized organizations maintenance, the hospital still is responsible for overseeing and which hospitals might choose to reference.” documenting that the needed work was done. Commentary If following TJC standards, EC.02.04.01, EP As mentioned previously, the manufacturer- 4, states: “The hospital identifies the activities, recommended maintenance activities and in writing, for maintaining, inspecting, and schedule are the gold standard from a CMS testing for all medical equipment on the standpoint. Although that seems logical, inventory” (also see EC.02.04.03, EPs 2 and 3). many issues exist with the maintenance Hospitals may use different strategies for activities specified by manufacturers, as different items, as appropriate. For example, reported by Stiefel.3 strategies such as predictive maintenance, In my experience, many HTM groups have reliability-centered maintenance, interval- paid little or only passing attention to based inspections, corrective manufacturer recommendations. Many HTM maintenance, or metered mainte- HTM groups who deviate from groups have routinely used generic inspec- nance may be selected to ensure tion procedures to test for device manufacturer-recommended reliable performance.” The “manu- performance, assuming that this will detect maintenance activities and facturer-recommended maintenance actual problems. Some have read manufac- frequencies now are required activities and schedule” are a turer manuals when the device was first to document all of these perfectly valid methodology for implemented into their system and infor- fulfilling this requirement. I suggest mally decided on the manufacturer deviations, along with a well- that hospitals document the ration- procedures that seemed “reasonable” based thought-out rationale. ale for known deviation from on their experience with similar devices. “manufacturer-recommended Most HTM groups have not documented maintenance activities and sched- who read the manufacturer recommenda- ule” using a documented process. The AEM tions, when the recommendations were read, strategy described by CMS is one such and whether deviations were made. process, and the similar process recom- All of this must change. HTM groups who mended by TJC is equally satisfactory. Both deviate from manufacturer-recommended processes should be based on actual data. maintenance activities and frequencies now

124 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments are required to document all of these devia- Database Project (www.htmcommunitydb. tions, along with a well-thought-out rationale. org/wiki/index.php?title=Main_Page; note: In many cases, existing policies and proce- “view” can be used for both the username dures may not mention deviations from and password). Malcolm Ridgway started the manufacturer recommendations. These site in response to the initial CMS require- policies and procedures need to specify ment to use manufacturer recommendations. under what circumstances deviations are Both sites are valuable resources for develop- allowed, who has the authority to make ing an AEM and are useful for sharing deviations, and the necessary documentation. knowledge on this important topic. Not only When CMS published the 2011 version of is it wasteful for each individual HTM group this document, some HTM groups publically to “reinvent the wheel,” but it also is impor- stated that they always follow manufacturer tant that our industry start developing recommendations. I urge those groups to common best practices. Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 question their teams to determine whether that actually occurs in practice. I strongly Decision to Place Equipment suspect that all HTM groups will want the In an AEM Program flexibility and procedure for setting up an “The determination of whether it is safe to AEM for some types of equipment. perform facility or medical equipment I expect that the percentage of devices maintenance without following the covered by an AEM will vary greatly among equipment manufacturer recommendations HTM groups. I also expect that the scrutiny must be made by qualified personnel, caused by the CMS regardless of whether standards will increase The burden of an AEM is they are hospital the percentage of employees or not a trivial one; thus, some devices maintained contractors. across the industry organizations will conclude “In determining according to manufac- in many cases that the path whether or not to turer recommendations. of least resistance is to follow include equipment in The burden of an AEM what the manufacturer an AEM program, and is not a trivial one; thus, which maintenance some organizations will recommends, even if they have strategies to use in conclude in many cases not done so in the past. developing mainte- that the path of least nance activities and resistance is to follow frequencies for what the manufacturer recommends, even if particular equipment, the hospital must take they have not done so in the past. into account the typical health and safety Notice that the CMS refers to American risks associated with the equipment’s use. National Standards Institute/AAMI Note that the risk may vary for the same type EQ56:1999, as revised in 2013.5 If this of equipment, depending on the patient care document is not already in your library, it setting within the hospital where it is used. should be. EQ56 contains many relevant “A hospital is expected to identify any sections that pertain to an AEM. HTM equipment in its AEM program which is groups should ensure that their AEM “critical equipment,” i.e., biomedical or program conforms with EQ56. physical plant equipment for which there is a As HTM groups develop their AEM, both risk of serious injury or death to a patient or generally and for individual types of equip- staff person should the equipment fail. ment, consulting and/or contributing their Surveyors must focus their review of a efforts to the AAMI Healthcare Technology hospital’s AEM program on critical equip- Management Resources web page (www. ment in that program and the hospital’s aami.org/htmconnect/index.html) is strongly documentation of the factors and evidence it encouraged. Readers also are encouraged to considered in developing an AEM strategy check out, and hopefully participate in for that equipment. developing, the Healthcare Community “Factors for a hospital to consider when

evaluating the risks associated with a particu- hospital (or its third party contractor), or on lar type of equipment include, but are not evidence publicly reported by credible limited to: sources outside the hospital, which: • How the equipment is used and the likely –– Provides the number, frequency, and nature consequences of equipment failure or of previous failures and service requests? malfunction—would failure or –– Indicates use of an AEM strategy does malfunction of the equipment hospital- not result in degraded performance of wide or in a particular setting be likely to the equipment? cause harm to a patient or a staff person? –– How serious is the harm likely to be? For “Generally multiple factors must be example, a slightly miscalibrated scale in considered, since different types of equip- an adult internal medicine outpatient ment present different combinations of clinic might not present significant risk severity of potential harm and likelihood of Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 of harm. However, a miscalibrated scale failure. The hospital is expected to be able to in a neonatal intensive care unit could demonstrate to a surveyor the factors it have very serious consequences for considered in its risk assessment for equip- patient care. ment placed in its AEM program.” –– How widespread is the harm likely to be? For example, are many patients Commentary exposed to the equipment, resulting in This guidance is fairly detailed and straightfor- harm due to failure impacting more ward regarding what must be considered and patients or staff? If harm would be documented as part of an AEM program. I In addition to widespread, even if the harm to each deliberately included the bulk of the guidance circumventing the affected individual is not serious, this in this area because I believe the CMS did an wasted time of would be a cause for concern. excellent job of absorbing and summarizing • Information, if available, on the manufac- everyone trying to the material that was submitted in reaction to turer’s equipment maintenance the agency’s 2011 statement. develop their own recommendations, including the rationale Hospitals that already have TJC documenta- analysis for an AEM, for the manufacturer’s recommendations; tion on their existing medical equipment community resources • Maintenance requirements of the equipment: management program (MEMP) need not are vital to gaining the –– Are they simple or complex? change the structure. However, they should –– Are the manufacturer’s instructions and review their program to ensure that it also wisdom that comes from procedures available in the hospital, and meets the AEM requirement. The title of your a shared experience. if so can the hospital explain how and program does not matter to CMS or TJC; why it is modifying the manufacturer’s however, both care that you are meeting the instructions? essential elements of their respective require- –– If the manufacturer’s instructions are ments. Ensuring that your program meets not available in the hospital, how does both sets of requirements is recommended. the hospital assess whether the AEM Putting together an AEM justification will uses appropriate maintenance strategies? not be a trivial exercise. As mentioned earlier, –– How readily can the hospital validate the in addition to circumventing the wasted time effectiveness of AEM methods for particu- of everyone trying to develop their own lar equipment? For example, can the analysis for an AEM, community resources hospital explain how it ensures there is no are vital to gaining the wisdom that comes reduction in the quality of the perfor- from a shared experience. mance of biomedical equipment subjected Note the emphasis on “critical equipment” to alternate maintenance methods? for which “a risk of serious injury or death to • The timely availability of alternate devices a patient or staff person should the equip- or backup systems in the event of equipment fail” exists. Equipment in this category ment failure or malfunction; and will draw serious attention if part of an AEM. • Incident history of identical or very similar Some HTM groups have decided on a “rule” equipment—is there documented in their facility that critical equipment is not evidence, based on the experience of the eligible for an AEM, even if noncritical

126 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments medical equipment is eligible. When an HTM group discovers actual injuries or near- TJC currently has specific, more stringent miss events that could have been caused by deviating requirements for life-support equipment from manufacturer responsibilities, that group will be (LSE). CMS in turn defines critical equipment. Generally speaking, all LSE also is responsible for letting the manufacturer and other HTM critical equipment but not vice versa. LSE groups know of its discovery. only refers to equipment involving a risk of death to a patient, while critical equipment also involves risk of serious injury to a in and of themselves when justifying the patient and risk of serious injury/death to a need for an AEM. Patient safety needs to be staff person (e.g., electrosurgical units, the primary focus. If a real cost-benefit issue powered surgical devices, surgical tables, exists, then the HTM group needs to discuss hyperthermia units, infusion pumps, some the topic with senior management, risk Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 laboratory analyzers, tracheal suction pumps, management, and patient safety. radiotherapy units, sterilizers). For example, if more staff would be needed To determine what constitutes critical to comply with manufacturer recommenda- equipment, each hospital will need to tions and a considerable safety risk would consider their individual situation, as well as result from not doing the maintenance, then discussions within the overall HTM profes- clearly more resources (not necessarily more sion. The discussion on the definition of staff) would need to be devoted to the task. In critical equipment should include clinicians most cases, the risk decisions will not be this and should be documented. clear cut. Cost-benefit ratios are appropriate Over time, I believe that manufacturers factors in the discussion, as long as patient will begin to see the wisdom of designing safety remains the primary target. For their recommended maintenance procedures example, if the institution does not have to reflect what makes sense in the real world. enough spare devices, then the option of I also predict that manufacturers will begin obtaining additional equipment or doing the monitoring community websites for postings recommended maintenance during off hours that pertain to their products and will needs to be explored. For each deviation from comment if they have safety concerns about the manufacturer-recommended mainte- what is being posted. Manufacturers bear nance, all factors and options should be some responsibility for knowing how their considered and the rationale documented. medical equipment is really being main- Certain manufacturers do not provide tained in the field. That responsibility will adequate service manuals and/or training to become hard to ignore after it becomes HTM groups to allow them to perform “reasonable” for manufacturers to be aware manufacturer-recommended maintenance of the content on the sites. When an HTM activities on medical equipment. In particu- group discovers actual injuries or near-miss lar, if referring to critical equipment, I events that could have been caused by suspect that most risk management and deviating from manufacturer responsibilities, senior administration teams will be reluctant that group will be responsible for letting the to allow an AEM without very strong evi- manufacturer and other HTM groups know dence that safety to patients and/or staff can of its discovery. be maintained. Even if the justification is Since 2011, some HTM groups have strong, the hospital may have assumed a suggested that their primary reason for not considerable degree of liability in the event of following manufacturer recommendations is equipment failure that results in serious because of the expense. When asked to injury. The hospital or HTM group always explain, these groups said that they don’t has the option of trying to convince the have the staff, that the parts are too expen- manufacturer to change their ways or risk sive, or that an inadequate supply of spares loss of future sales. will result in unacceptable downtime during The CMS requirements allow the use of scheduled maintenance. My advice has been data from reputable outside sources in that reasons such as these are not adequate justifying an AEM. Taking advantage of those

resources is important. In addition, the other sources is acceptable. If a product is manufacturer should be contacted directly if new to the market, an AEM is not an option you feel that their existing maintenance until a sufficient amount of actual experience recommendations are excessive, and a record is acquired. of the communications should be kept. You Strategies used by maintenance organiza- may not get much satisfaction from the tions. The CMS document contains a brief manufacturer, but your record of notifying summary of various strategies that mainte- them can become valuable if you decide to nance organizations have used as the basis implement an AEM. for an AEM. HTM groups often use a variety Imaging/radiologic equipment. CMS of these approaches depending on the type of makes it clear that medical lasers and equipment. Wang et al.6 provide a detailed imaging/radiologic equipment are not description of the different strategies. eligible for an AEM program. Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 “Imaging/radiologic equipment, whether AEM Program Documentation used for diagnostic or therapeutic purposes” “For each type of equipment subject to the is not allowed to have an AEM because it is AEM program, there must be documentation governed by CFR-482.26(b)(2).* After the indicating: December 2013 CMS document was released, • The pertinent types and level of risks to the agency clarified that imaging equipment patient or staff health and safety; that does not use ionizing radiation (e.g., • Alternate maintenance activities, and the ultrasound, magnetic resonance imaging, maintenance strategy and any other thermography) is not subject to this restric- rationale used to determine those activities; tion; therefore, an AEM may be considered. the differences from the manufacturer’s For both medical lasers and ionizing recommended maintenance activities are radiographic equipment, some HTM groups made explicit, unless the hospital is unable may want to consider an AEM in spite of the to obtain the manufacturer’s maintenance CMS stance. That decision should not be recommendations, due to the age of the made without thorough discussion with equipment or the manufacturer’s restrict- both the risk management group and the ing the availability of its recommendations; group responsible for compliance with • Alternate maintenance frequencies to be CMS. The perceived benefits on the part of used, if any, and the maintenance strategy the HTM team may be vetoed by one of and any other rationale used to determine these groups because of the possibility of those frequencies. For equipment identi- major negative consequences. fied as presenting a very low risk to patient or staff safety, it could be acceptable to not For both medical lasers and ionizing radiographic equipment, set a particular frequency but instead indicate a less specific approach, for some HTM groups may want to consider an AEM in spite of example, an interval range, such as “every the CMS stance. That decision should not be made without 12–24 months.” It could also be acceptable thorough discussion with both the risk management group to employ periodic “departmental sweeps” and the group responsible for compliance with CMS. for such very low risk equipment, where equipment functioning is sampled and operators are polled about its functionality. CMS makes it very clear that the requisite • The date when AEM program maintenance maintenance history for making a decision activities were performed and, if applica- about an AEM need not come from each ble, further actions required/taken; and individual hospital organization. Even if a • Documentation of any equipment failures specific device type is new to a particular (not including failures due to operator hospital organization, prior history from error), including whether there was result-

* The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the department and agencies of the federal government.

ing harm to an individual. (Note: equipment within the CMMS. Flag each equipment failure that is due to operator error and type as “yes” for those that definitely are which results in an adverse event or near “critical” and as “?” for a much larger group miss must be documented in accordance of types that bear some discussion with with the QAPI CoP, as part of the hospital’s clinicians. Brainstorm with clinicians, required tracking of patient safety-related particularly from surgery, catheterization incidents. However, there is no requirement labs, and other invasive labs, to supplement to include operator failures in equipment your list of types with other equipment maintenance documentation.) types that are potentially critical. 2. Begin the process of identifying in your “When the hospital has multiple identical CMMS the types of equipment (hopefully equipment items, the documentation may at the manufacturer/model level) for be generic to that type of equipment, except which you know that you have deviated Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 that documentation of maintenance activi- from manufacturer recommendations. At ties performed must be specific to each item this point, don’t worry about the details of of equipment.” the deviation, just document that it occurred. If uncertainty exists whether Commentary deviation occurred, categorize these types The key phrase in the preceding excerpt is as “not sure” until someone can investi- “For each type of equipment subject to the gate. If the list of equipment types that AEM program, there must be documentation need to be researched for this part is indicating.” In my opinion, HTM groups overwhelming, start with “critical equip- setting up an AEM need to document each ment” types. manufacturer model combination deviation. 3. Understand how existing policies/proce- In particular, when multiple manufacturers dures (both within the HTM group and in are involved, their maintenance recommen- the overall organization) mention (or do dations are based on different risk not mention) the subject of manufacturer assessments and design strategies. maintenance recommendations and Within the same medical equipment type or deviations from those recommendations. category (e.g., infusion pumps, electrosurgical If existing policies/procedures are silent units), documentation may be very similar on the subject, decide which ones logically among manufacturers but still have specifics address the overall topic of periodic for an individual manufacturer’s model maintenance of medical equipment or if combination. In some cases, several model something new is needed. numbers from the same manufacturer may be 4. Have an overall discussion on the topic similar enough that the AEM documentation with administration, the environment of can be lumped together. Wherever possible, I care (or safety) committee, the patient recommend that HTM groups use their safety committee, and the risk manage- computerized maintenance management ment team about the philosophy and system (CMMS) as the logical repository of policies that your organization wants to this required AEM documentation. take regarding these issues. I strongly advocate that HTM groups lead the Where to Begin? discussion, as they are the ones most HTM groups that have many undocumented knowledgeable about the issues. Be deviations from manufacturer recommenda- prepared to answer some of the following tions are likely to be overwhelmed by the questions, but don’t worry too much if you implications of this ruling. I recommend the don’t know the answers without talking to following priorities. The order of these other stakeholders: priorities is not as important as beginning a. What has been the past practice regard- efforts on all of them as soon as possible. ing deviation from manufacturer 1. Categorize your CMMS inventory to recommendations? identify the critical medical equipment. b. Does documentation exist on deviations Start with your list of “types” or “categories” that have been done in the past?

c. How big is the gap between current prac- This CMS directive has the potential to tice and full compliance? motivate the HTM industry toward standard- d. Do existing policies/procedures need to izing our practices based on actual data. Let’s be modified or created? get started! n e. What should be the timeline for an action plan? References f. Who will be responsible for coming into 1. Centers for Medicare & Medicaid Services. Hospital compliance with this document? (Hint: it Equipment Maintenance Requirements. Available should be HTM.) at: www.cms.gov/Medicare/Provider-Enrollment- 5. Develop a methodology for setting up and and-Certification/SurveyCertificationGenInfo/ documenting AEMs in general. Downloads/Survey-and-Cert-Letter-14-07.pdf. 6. Develop an action plan for gaining Accessed February 28, 2014. compliance with these new requirements. 2. Centers for Medicare & Medicaid Services. Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 Start with the critical equipment, then Clarification of Hospital Equipment Maintenance proceed to equipment deemed important. Requirements. Available at: www.cms.gov/ 7. Review medical devices cared for by Medicare/Provider-Enrollment-and-Certification/ third-party vendors (not by the manufac- SurveyCertificationGenInfo/downloads/ turer) to determine whether they follow SCLetter12_07.pdf. Accessed February 28, 2014. manufacturer recommendations. 8. Review types of medical devices in the 3. Stiefel RH. CMS Maintenance Update Is a Giant organization where HTM has no current Step Backwards. BI&T. 2012;46(2):137–8. involvement. Either HTM needs to get 4. AAMI, American Society for Healthcare involved or the groups in the organization Engineering. Update on Equipment Maintenance who are responsible need to be part of the Issue: CMS Reviewing Data Supplied by assessment and action plan. AAMI, ASHE. Available at: www.aami.org/ news/2012/081512_CMS.html. Accessed February Conclusion 28, 2014. Considerable work will be needed by many 5. American National Standards Institute, AAMI. HTM groups to achieve compliance with this AAMI EQ56/Ed.2: Recommended Practice for CMS directive. This guidance from CMS a Medical Equipment Management Program. represents an opportunity for the HTM field Available at: https://standards.aami.org/kws/ to implement much-needed standardization. public/projects/project/details?project_id=34. Maintenance of medical devices has varied Accessed February 28, 2014. too greatly and often has been based on opinion with little or no real data. 6. Wang B, Furst E, Cohen T, et al. Medical The issues surrounding this CMS directive Equipment Management Strategies. BI&T. may be overwhelming for some HTM 2006;46(3):233–7. groups. If so, have a frank discussion with senior leadership as soon as possible. Senior leadership needs to have a full understanding of barriers to compliance and, if necessary, implement an action plan for overcoming these barriers.

This guidance from CMS represents an opportunity for the HTM field to implement much-needed standardization. Maintenance of medical devices has varied too greatly and often has been based on opinion with little or no real data.

THE FUNDAMENTALS OF ... Defibrillators Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021

Robert Dondelinger

The heart is the cell-nourishment pump of crash cart in the facility. One of the items About the Author the body. Moving blood oxygenates tissues, found in many modern police squad cars is Robert Dondelinger, pumps nutrients to virtually every cell in the an automated external defibrillator (AED), CBET-E, MS, is the body, and disposes of cell waste. As long as which is a close cousin of the external senior medical the muscle fibers of the heart operate in manual defibrillator. Selected patients have logistician at precise synchronization, everything is fine. an internal defibrillator surgically implanted the U.S. Military When this vital organ malfunctions, we risk to continuously monitor heart rhythm and Entrance Processing Command in death. One of the more common malfunc- deliver appropriate shocks as necessary. This North Chicago, IL. E-mail: robert. tions of the heart is ventricular fibrillation, article will delve a bit into each of the three [email protected] where the heart stops its powerful pumping types of defibrillators. action and just twitches and quivers instead. This quivering action does not move blood Current Technology throughout the body efficiently or effectively. All defibrillators have two things in com- Another malfunction is ventricular tachycar- mon—they contain circuitry to deliver the dia, where the heart is in a “run away”-like lifesaving electrical shock and circuitry to state, beating at more than 100 times a monitor the heart and determine when that minute and with three or more irregular shock is indicated. Of the three types, only beats in a row. These are the main heart the two external defibrillators are likely to malfunctions that a defibrillator can correct. reach the biomedical electronic technician’s The world of defibrillators consists of three bench. The external manual defibrillator is basic types—external manual, automated the one that comes to most peoples’ minds external, and implantable (or internal). All when one says “defibrillator.” It is the one three have the same goal—to deliver a found on hospital crash carts and ambu- life-saving electric shock that restores the lances. To overcome thoracic impedance normal electrical activity of the patients’ heart—but they do so in different ways and under different circumstances. Next to The world of defibrillators consists of three basic types— intravenous pumps and electronic external manual, automated external, and implantable thermometers, the external defibrillator is (or internal). All three have the same goal—to deliver a one of the most common pieces of medical life-saving electric shock that restores the normal electrical equipment found in a hospital or large clinic. One is usually located on each ward, in each activity of the patients’ heart—but they do so in different clinic, and even the operating room area ways and under different circumstances. because they are typically found on every

while delivering the lifesaving shock to the determining the appropriate treatment. The heart, both types of external defibrillators original models featured only a three-lead provide as much as 360 joules (J) of energy in electrocardiogram (ECG) capability, but most a single 20-millisecond impulse of between 2 modern units can perform full 12-lead ECGs, and 4 kilovolts (kV) to the patient. determining lead selections using a hard or soft switch. Likewise, all modern and most External Manual Defibrillator legacy units are powered either by internal The external manual defibrillator also batteries or line power from a convenience contains a monitor to display an electrocar- outlet. As a safety feature, these devices will diograph for the provider to use in operate on line power, regardless of the presence or condition of the internal battery. Likewise, early and legacy models delivered a

monophasic waveform, providing a single Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 positive pulse of energy, while the newest models now deliver a biphasic waveform, providing a positive pulse followed by a negative pulse. Studies have shown that patients receiving biphasic shocks correct both ventricular fibrillation and tachycardia more successfully than those receiving monophasic shocks. Additionally, some external manual defibrillators also incorporate a pacemaker for temporary treatment of asystole, bradycardia, sick sinus syndrome, certain types of tachycardia, or any other condition requiring an external pacemaker. External manual defibrillators normally connect their monitor to the patient with conventional ECG electrodes, lead wires, and patient cable. Defibrillation is accomplished Figure 1. Typical Monophasic Waveform from an External Defibrillator using two hand-held insulated paddles that usually also allow the user to view an ECG signal when there is insufficient time to “wire” the patient to the monitor. To deliver the stored energy to the patient, the user must simultaneously press the discharge buttons located on each paddle. Pacemaker- equipped external defibrillators also can use self-adhesive electrode pads for both defibrillation and pacing. After connecting the external manual defibrillator, based upon the providers’ impression and diagnosis, the patient may

External manual defibrillators normally connect their monitor to the patient with conventional ECG electrodes, lead wires, and patient cable. Figure 2. Typical Biphasic Waveform from an External Defibrillator

132 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments only require the administration of oxygen is required. AEDs acquire cardiac and/or other drugs, as well as continued information and deliver their shock through monitoring. In other cases, the provider large self-adhesive conductive pads applied to determines that a shock is required, the the thorax on either side of the heart, and correct energy level to deliver to the patient, they use an algorithm to determine if a and how often to deliver this level before victim will benefit from defibrillation. trying a higher level or some other action. If defibrillation is indicated, automatic Oftentimes, the administration of both drugs units alert first responders to stay clear of the and shocks is required to return the patient’s patient, and then automatically deliver the heart to sinus rhythm. Most external manual defibrillators also have an internal mode used to restart hearts Properly administered PAD programs place defibrillators in near the final stage of open-heart surgery. In areas where certain members of the public, such as security Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 this mode, their output is limited to 50 J by guards, flight attendants, police officers, nonparamedic design because it is used directly on the heart fire fighters, and other AED-certified individuals, can access in an open chest. Another mode found in these defibrillators is the synchronized them in an emergency. cardioversion (sync) mode. The sync mode is typically used to cardiovert patients in ventricular tachycardia, which requires the required shock. Semi-automated units make delivery of the shock precisely with the peak the same algorithm-based determination, but of the R-wave. In the sync mode, discharge is depend on the first responder to push a button inhibited until the defibrillator locks onto the to deliver the lifesaving shock. Both varieties R-wave and then discharges with the peak of provide some form of instruction to user the next R-wave. The sync mode prevents personnel, usually both audible and visual, discharge during cardiac repolarization, such as when to provide cardio-pulmonary represented by the T-wave, where the shock resuscitation (CPR), when to stop, when it is could cause the heart to fibrillate. analyzing, and before shocking the patient. Some models even produce a metronome-like Automated External Defibrillator ticking sound at the ideal tempo for Automated external defibrillators, or AEDs as performing CPR and have both event and they are more commonly known, oftentimes audio recording capabilities to document the are part of a public accessible defibrillator episode for legal reasons. (PAD) program. Properly administered PAD programs place defibrillators in areas where Implantable (or Internal Automatic) certain members of the public, such as Defibrillator security guards, flight attendants, police Because these hermetically sealed pulse officers, nonparamedic fire fighters, and generators are implanted in the patient other AED-certified individuals, can access during a surgical procedure and are regulated them in an emergency. AEDs are not, as like other implantable medical devices (such many believe, as easy to use as a fire as artificial joints and heart valves), they are extinguisher. Neither are they intended to be rarely seen by biomeds. Implantable defibril- used by untrained casual passers-by to an lators acquire their cardiac information apparent heart attack. through small wires implanted in appropri- These units come in one of two varieties— ate cardiac muscle tissue. Using a proprietary fully and semi-automated. Both varieties are algorithm, these devices constantly analyze powered by internal batteries (only) and the ECG for patterns of ventricular tachycar- contain essentially the same circuitry as the dia or ventricular fibrillation. When the external manual defibrillator to provide the patient exhibits either condition, it delivers 2- to 4,000-volt biphasic waveform to exter- an appropriate shock through the same nally cardiovert the patient. However, the implanted wires. Directly connecting wires to primary difference is that the AED—not a the heart overcomes thoracic impedance, healthcare provider—determines if the shock hence requiring much lower voltages to be

effective, and allows them to be powered by ming. There is no biomed involvement in an internal battery lasting up to 10 years. this process. These devices contain all the basic functionality of an AED—monitoring, a Regulations decision-making algorithm, and the circuitry No specific regulations cover defibrillators to shock the heart. However, due to their beyond the requirement to conform to the intimate electronic contact with the heart, they regulations promulgated by the U.S. Food and can contain these functionalities in a much Drug Administration (FDA) for sale and use smaller package. Implantable defibrillators are of these types of medical devices in the United totally automatic—they determine if the shock States. Other authorities, such as the is required and then administer it. European Community, have similar requirements. However, the U.S. Department of

How to Manage Defibrillators Health and Human Services (HHS) and the Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 External manual defibrillators should be General Services Administration (GSA) jointly considered as resuscitative devices and issued ‘‘Guidelines for Public Access managed accordingly. Periodic services, such Defibrillation Programs in Federal Facilities’’ as preventive maintenance, calibration, and in 66 FR 28495–28501. This document became electrical safety testing should be individually effective on Aug. 14, 2009, and provides scheduled, and a detailed maintenance information for establishing public access history should be maintained on each defibrillation (PAD) programs in Federal supported device. The history should include facilities. Many state, county, and other all scheduled services and both modification non-federal activities use this document as a and remediation work orders. Maintainers model for their own PAD programs. must perform and document all manufac- The International Electrotechnical Com- turer-recommended scheduled services. If mission (IEC) is a worldwide organization for not specified by the manufacturer, periodic standardization. IEC 60601-2-4:2002 is the output readings should be taken, since this is international standard for defibrillators. one of the more critical aspects of the Additionally, the Association for the Advance- external manual defibrillator’s functions. ment of Medical Instrumentation (AAMI) The location of AEDs should be docu- and the American National Standards mented, with scheduled services usually Institute (formerly the National Bureau of consisting of checking the on-board status Standards) developed and published ANSI/ indicator on a periodic basis. Many models AAMI DF80:2003/(R)2010, titled “Medical do not provide any scheduled maintenance or electrical equipment—Part 2-4: Particular periodic testing procedures and instead rely requirements for the safety of cardiac solely on internal self-testing. Typically, they defibrillators (including automated external use a green/red status indicator to indicate defibrillators).” This standard specifies “OK/ready/normal” or “malfunctioning.” requirements for the safety of medical Since implantable defibrillators are electrical equipment intended to defibrillate regulated as implants, like stents and the heart by an electrical pulse via electrodes applied either to the patient’s skin or to the exposed heart and covers some areas not The location of AEDs should be documented, with scheduled addressed by the IEC standard. These are the services usually consisting of checking the on-board status two virtually international defibrillator indicator on a periodic basis. standards followed by all manufacturers.

Risk Management Issues prosthetics, rather than as medical equip- Risk management issues vary with the type of ment, the operating room staff manages defibrillator. Issues with external manual these under the same rules, regulations, and defibrillators include those related to battery facility policies as other implants. After problems, skin burns at the paddle contact implantation, the cardiologist programs them sites, and potential fires. Although modern in a similar manner to pacemaker program- units are designed to operate from a

134 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments convenience outlet with a shorted or open Issues with external manual defibrillators include those battery, finding an outlet after encountering a related to battery problems, skin burns at the paddle battery failure wastes precious time, decreas- contact sites, and potential fires. ing the likelihood of cardioversion. To mitigate this risk, biomed organizations should employ a battery maintenance schedule, which may consist of periodic conditioning, replacement, electrode expiration dates and replace them or both. Both nickel-cadmium (Ni-Cd) and promptly. Likewise, since AEDs employ sealed lead acid batteries should generally be primary (nonrechargeable) batteries, respon- replaced after two years of service or when sible individuals must ensure the empirical testing indicates a failing battery. self-monitoring indicator indicates the unit is Some manufacturers offer other battery types, ready for use. Batteries must be replaced

such as nickel-metal hydride (Ni-MH), whenever the self-monitoring indicator or the Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 lithium-ion (Li-ion), or lithium-manganese manufacturers’ recommended replacement (Li-Mn). Facilities should follow both defibril- schedule indicates. Models that have a lator and battery manufacturer instructions published biomed checkout procedure for their maintenance. should have those checks performed in Both first- and second-degree burns may accordance with the manufacturer’s pub- occur if insufficient gel is used, if multiple lished schedule. defibrillation attempts are made, or if the Since implantable defibrillators are outside paddles are not pressed firmly enough onto the biomed’s purview, virtually no clinical the skin. If the paddles are held to the chest engineering risk exists for them. Neverthe- with sufficient force (typically 25 pounds of less, since they are managed as an force is sufficient for good contact), then the implantable appliance, other areas of the burns are probably caused by either insuffi- facility have risk management issues. cient or the increased resistance of dried However, the primary risks— nosocomial (from repeated cardioversion attempts) gel. infection and pocket hematoma from the To remediate both cases, a generous amount implant surgery—already should be man- of conductive gel, sufficient to fully and aged by the facility. uniformly coat the surfaces of both paddles, should be applied and reapplied after a Troubleshooting couple of discharges. Expired self-adhesive or Historically, the most problematic part of Since implantable disposable electrodes can leave similar burns external defibrillators has been the batteries. defibrillators are on the patient’s skin. External manual defibrillators must have outside the biomed’s There also is a small risk of fire coincident their batteries serviced on a regular basis. with the use of external manual defibrillators. Depending on the battery type, batteries purview, virtually no Although rare, these devices have caused should be deep-cycled and proactively clinical engineering risk bedding fires when patients had been replaced before the inevitable failures exists for them. administered supplemental oxygen immedi- manifest themselves. Implantable defibrilla- ately prior to defibrillator use. All medical tors are managed as disposables. Implanting staff should be aware of the effect that oxygen internal defibrillators protects them from the has on the ignition temperature of patient fluctuations in environmental factors and gowns, bedding, and disposable drapes in the reduces the power demand that affect other head and torso area of the defibrillated defibrillators. This serves to minimize their patient. Even the fine body hairs on the failure rate. patient can ignite and burn very easily in an As previously mentioned, skin burns at the oxygen-enriched environment. Staff also electrode or paddle sites have occurred, should be taught appropriate precautions to especially when multiple countershocks are prevent an oxygen-fed fire and actions to attempted, but rarely are they the fault of the mitigate the damage should such a fire occur. device. Most investigated occurrences revealed AEDs can cause the same skin burns as poor skin preparation, dried or insufficient their manual cousins, so those responsible gel, and insufficient pressure on manual for the PAD program must closely monitor paddles to be the most frequent cause of these

ORIGIN AND EVOLUTION

The history of defibrillators has roots in change from what experimenters in already completed research behind the the late 1880s observation by British other parts of the world were doing— Iron Curtain. Finally, Dr. Lown and his physiologist John A. McWilliam that the biphasic waveform discharge that research team began experimenting with ventricular fibrillation traps the organ in we use today. a defibrillator constructed in 1961 by a a helpless quiver, depriving the body of Hungarian engineer named Barouh Meanwhile, in the United States, research- oxygen, and bringing death within Berkovits (who may have been aware of ers were working with a prototype of an minutes. But even a century earlier, the Russian research) and patented under AC defibrillator that worked some of the experimenters knew that electrical the name of the American Optical time. It would inconsistently stop cardiac shocks applied to dogs could apparently Company. In the 1970s, a number of fibrillation, but no one knew why. Direct both stop and restart their respiration. It defibrillator designs entered the market- current defibrillator designs were tried, was not until the development of the place, some by Zoll, Physio-Control, Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 but the designs of the time dictated that electrocardiogram (ECG) in the late American Optical, and a host of other powerful, high-voltage batteries be used 1800s, however, that researchers began manufacturers. The vast majority of these to shock the heart directly. Unfortunately, to understand the mechanism of used some variant of the now famous these did not exist, so experimenters electrical conduction in the heart. By Lown-Barouh monophasic waveform, continued stumbling about with AC 1920, development of the ECG had consisting primarily of a positive pulse defibrillation. Finally, in 1957, William advanced to the point where doctors from the discharge of a capacitor across Kouwenhoven, Dean of the School of could diagnose several different the chest through external paddles. Engineering at Johns Hopkins University arrhythmias in human patients. In 1933, and holder of an honorary medical Meanwhile, about this same time, a group of physicians and an degree, developed a portable (weighing Michael Mirowski, whose mentor died of engineering professor working at Johns more than 250 pounds) closed-chest AC a heart arrhythmia, began the develop- Hopkins University, unaware of defibrillator capable of delivering 480-volt ment of what became the first implant- experimentation in Europe some fifty shocks to the adult heart without able defibrillator. Implanted into its first years earlier, were investigating damaging the surrounding tissue. patient in 1980, weighing slightly more fibrillation and stopped a fibrillating than half a pound and about the size of heart by accidentally giving a second Although not the developer, Paul Zoll, a a deck of playing cards, this defibrillator shock to it. After doing so, they coined Boston cardiologist and Harvard research- used a biphasic waveform. Since power the term “countershock” to explain er, published a paper on this device and consumption is an issue with all implant- what had happened. They literally the use of defibrillators in hospital able electronic devices, Mirowski chose rediscovered defibrillation and began to settings. Beginning in the 1950s, partially the more effective and efficient biphasic develop a protocol that would due to the poliomyelitis epidemic, and waveform over the higher current eventually become known as cardiopul- continuing into the 1970s as medical requirement of monophasic waveform monary resuscitation or CPR. knowledge increased, hospitals became used in popular external defibrillators. In places people went to for cures rather In the United Kingdom, Germany, and 1982 a cardioversion function was added than places to go to die, intensive care even in Russia, physicians and other and in 1985 this first implantable units began springing up in metropolitan scientists were investigating fibrillation cardioverter-defibrillator (ICD) received areas. The (then AC) defibrillator found and publishing various papers on the U.S. Food and Drug Administration its home in these newly created units as subject. Unfortunately, many of these, (FDA) approval. patients were closely monitored during especially those published in Russia their recovery after high-risk surgical The successful outcomes of ICD-equipped remained largely unread by other procedures. This included providing patients caused Western researchers to researchers around the world. This is artificial or assisting in respiration, relook at the question of monophasic vs. partially due to Stalinist policies on scien- electronically monitoring heart activity biphasic waveforms and found that tific developments and the lack of and oxygenation of the tissues. However, biphasic waveforms not only provided western physicians who could read there remained a problem in that the superior results, but they allowed for Russian. In Russia and the rest of the defibrillators of the time, when used to more efficient designs. This change in Soviet Union, Naum L. Gurvich became a correct ventricular tachycardia, often attitude toward biphasic waveforms, key figure in electrophysiology, but he induced ventricular fibrillation. coupled with improved battery technol- remained largely unknown in the West. ogy, and the continued miniaturization He was probably the first to experiment This phenomenon intrigued Bernard of electronic circuitry, improved external with both fibrillation and defibrillation Lown, MD, of Brigham and Women’s defibrillator designs and led to the AED to the point where he experimented Hospital in Boston. He began investigat- we have today. These devices, coupled with capacitor-inductor circuits. In the ing the use of single-pulse capacitor with CPR, continue to save lives. 1940s, he went on to propose a radical discharges, apparently unaware of the

136 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments burns. All of these are within the purview of progress. Improved waveform analysis also the operator to prevent or correct. could lead to better outcomes by determining the optimal time to produce a countershock. Training and Equipment Implantable defibrillators have undergone A good general-purpose medical electronics a rapid and significant development during toolkit is mandatory to perform even mini- their short history. They detect a number of mal work on a defibrillator. For performing arrhythmias that are correctable by cardio- scheduled services on an external manual version, are able to shock or pace as defibrillator, a defibrillator analyzer, battery necessary, and feature extensive program- analyzer/reconditioner/charger system, and a mability and telemetry function. Future safety analyzer coupled with good manufac- units will be smaller, have improved diag- turer’s service literature are necessary. Most nostics thanks to better software, longer battery life, and the ability to handle occur-

modern units require additional test equip- Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 ment and service aids commensurate with rences of atrial fibrillation.n their capabilities. For example, defibrillators with a noninvasive blood pressure (NIBP) References module will require the test equipment for • Akselrod H, Kroll MW, Orlov MV. History testing stand-alone NIBPs. Testing the sync of defibrillation.Cardiac Bioelectric Therapy: mode without the proper service aids is Mechanisms and Practical Implications. New York, virtually impossible. Although device-specific NY: Springer; 2009: 15–38. Available at www.ncbi. Today’s AEDs represent training is useful for performing repairs, a nlm.nih.gov/pmc/articles/PMC3678802. Accessed skilled biomed possessing general biomed March 11, 2014. the state-of-the-art for training alone can perform routine scheduled • ECRI Institute. Healthcare Product Comparison electronic defibrillation services. The level of additional training and System. Defibrillators, External, Manual; devices. They not only experience needed for repairing these devices Defibrillator/Pacemakers, External. Defibrillators, analyze and provide depends heavily on the quality of the manu- External, Automated; Semiautomated. Defibrillator/ countershocks where facturer’s service literature. Pacemakers, Implantable; Resynchronization. Subscription service available at www.ecri.org/ appropriate, but Future Development Products/Pages/hpcs.aspx. Accessed Jan. 15, 2014. modern AEDs contain The core technology of external manual • HHS. Public Access Defibrillation Guidelines: features only dreamt of defibrillators is considered mature. However, Guidelines for Public Access Defibrillation the most recent devices now have additional just a few years ago. Programs in Federal Facilities. U.S. Department noncardiac-related module options such as of Health and Human Services. Available at www. 12-lead ECG, end tidal CO (ETCO ), and 2 2 foh.dhhs.gov/Whatwedo/AED/HHSAED.ASP. pulse oximetry (SpO2), so that they almost Accessed March 11, 2014. become a patient transport monitor. As they evolve in the future, we will see improve- • KSU. The basics of a DC Defibrillator. King ments in both batteries and battery charging Saud University, Riyadh, Saudi Arabia. technology to improve their reliability. Available at http://faculty.ksu.edu.sa/Monif/ Today’s AEDs represent the state-of-the-art Documents/203%20MDE%20defibrillator1%20 for electronic defibrillation devices. They not lectuers.pdf. Accessed March 11, 2014. only analyze and provide countershocks where • Resuscitation Central. History and Science appropriate, but modern AEDs contain of Defibrillation. Available at www. features only dreamt of just a few years ago. resuscitationcentral.com/defibrillation/history- Current AEDs also provide audible prompts to science. Accessed March 11, 2014. aid in performing CPR, document both their own operation and that of the CPR giver, and • UNC. The History and Physics of Defibrillators. University of North Carolina at Chapel Hill. even record background sound. This is Available at www.unc.edu/~goettsch. Accessed available for downloading to a flash drive or March 11, 2014. another device via Bluetooth. Future improve- ments include better software that is not confounded by motion artifact and allows the device to assess the ECG while CPR is in

I met the author, Monique many people in the United Clinical Environment: Data Frize, in 1989 at a conference States have a limited under- Acquisition, Storage and Reading in the historic city of standing of health systems in Retrieval (chapter 9), Weimar, during the dissolu- other countries, a deficit that Knowledge Discovery: Data tion of the German is especially critical as we Analysis and Data Mining Room Democratic Republic, known continue our implementation Tools (chapter 10), and more commonly as East of the Affordable Care Act. In Knowledge Translation, Germany. She was then addition to the material in Integration, and Sharing in a finishing her PhD in clinical Chapter 1, I would recom- Clinical Environment (chapter engineering from Erasmus mend The Healing of America: 11). These chapters are less University in Rotterdam in A Global Quest for Better, directly relevant to typical The Netherlands. Cheaper, and Fairer Health HTM practice, but are useful Frize is a member of the Care by T. R. Reid. introductions to areas that are Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 faculties of Carleton University Following that introduc- rapidly becoming more and the University of Ottawa in tory material, there are three important in our daily work. Canada. During her career, she technical chapters: Measur- The final chapter, Clinical has been a practicing clinical ing Physiological Variables in Trials and Usability Studies in engineer and an academician Humans (chapter 2), Safety a Medical Environment , focusing on technology Considerations, Minimizing addresses (along with Chapter management and on the role Liability, and Continuous 6) another aspect of HTM of women in engineering. Quality Improvement practice that is, fortunately, These two short books are (chapter 4), and becoming more widespread. based on university courses Telemedicine: Applications My experience with incident Frize has taught over the and Issues (chapter 5). investigation leads me to years. They provide over- Interspersed among the believe that careful technology Health Care Engineering views of several related technical chapters are two assessment represents a topics, all firmly based in chapters that put the mate- major opportunity for HTM Part I: Clinical Engineering historical and international rial into an international professionals to head off and Technology Management contexts. It is this broad context. Management of adverse patient incidents that perspective that sets these Medical Technologies in are the result of organizations Part II: Research and books apart. Industrialized and selecting medical equipment Development in the Audience: Healthcare Developing Countries that is poorly designed for Health Care Environment technology management (chapter 3) draws on the their needs. (HTM) professionals will find author’s own survey Author: Monique Frize these books useful in two research. Impact of Assessment Publisher: Morgan & Claypool ways. First, the well-written Technology on Health Care I should note here that these Publication Date: Oct. 1 and summaries and extensive lists and the Technology books are part of Morgan & Nov. 1, 2013 of references will serve as Assessment Process (chapter Claypool’s Synthesis Lectures entry points for further study. 6) addresses how technology on Biomedical Engineering Second, for those familiar affects healthcare delivery series, edited by John About the Reviewer with the technical aspects of throughout the world. Enderle. As such they, and these topics, the historical The second book deals other books in the series, are Matthew F. Baretich, PE, discussions show how we got primarily with a variety of available in electronic format PhD, is president where we are, and the information technology (IT) through many university and of Baretich international material places issues. These include Adverse large medical libraries. Engineering, the Canadian and U.S. Events, Medical Errors, and If you are interested in Inc. (Fort Collins experiences within those of the Role of Information these topics, and especially if CO), which other countries. Technology in Reducing provides clinical engineering and you are interested in their forensic engineering services. He is Features: The first chapter Them (chapter 7), The historical and international a subject matter expert for AAMI’s of first book describes the Electronic Medical Record: aspects, get these books. Benchmarking Solutions – Healthcare health systems in Canada and Design, Safety, and They will give you concise Technology Management. E-mail: the United States. My Meaningful Use (chapter 8), overviews and many refer- [email protected]. observation has been that Knowledge Management in a ences for further reading. n

OBSERVATIONS AND INSIGHTS Is ‘Old School’ Equipment Testing the Way to Go in Developing Countries? Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021

Patrick K. Lynch

I work a lot overseas. I train local technicians test equipment to simulate or verify the About the Author in developing countries how to maintain proper operation of their medical equipment. Patrick K. Lynch, medical equipment that has been donated to In that context, consider a challenge I CBET, CCE, is a their hospitals. Until recently, I have been faced: I was asked to set up a complete biomedical support using standard U.S. preventive maintenance biomedical shop in the only teaching hospital specialist at Global procedures as the testing protocols for their in Cap Haitien, the second largest city in Medical Imaging equipment. I now question whether this Haiti. The hospital has 250 beds and serves in Charlotte, NC. E-mail: approach is too much work, involves too 800,000 Haitians. It is quite underdeveloped, [email protected] many tests, and takes too much time. Please according to U.S. standards. My task was to allow me to explain. equip the biomedical operations. I was Medical equipment in the countries and starting with a cinder block hut with nothing hospitals I work in is generally limited to no but a table and chair in it. And I could only more than a dozen major types: suction carry 140 pounds of luggage with me. What pumps, sterilizers or autoclaves, electrocar- could I do? diogram (ECG) monitors, noninvasive blood I had a lot of donated medical test equip- pressure or NIBP devices, pulse oximeters, ment and tools. I had initially planned to anesthesia machines, surgical lights, electro- carry it all with me, but the items were bulky surgical units, infant incubators (or and heavy. How could I do more warmers), X-ray machines, and lab analyzers. with less? Using partially Using partially functioning The technicians in these countries tend not functioning equipment in these to be formally trained as biomedical engi- countries is sometimes more equipment in these countries is neers. They are generally the brightest desirable than insisting that sometimes more desirable than maintenance staffers who move up to work only perfectly functioning insisting that only perfectly on the most complex equipment. Their equipment be used. functioning equipment be used. knowledge of electricity, physics, anatomy, With that in mind, should we physiology, and medical procedures is limited adhere to the ultra-complete test at best, as is their knowledge of the theory of forms that we use in the United operation of these devices. States or trim it to what we truly need to test Now consider the facts that they usually do to continue operation in developing coun- not speak English, and equipment manuals tries? There are several reasons to adopt the are scarce or not available in their native latter minimalist approach. language. For all practical purposes, these First, as I go around testing medical equip- technicians lack access to either telephones ment, my time is very limited. I simply do not or the Internet. They lack the special purpose have enough time in five days to test everything

only if the delivered energy exceeded 200 watt-seconds? (I do not know if these can still be found.) Instead of an NIBP tester, why not measure your own blood pressure on several units? If the reported readings are consistent, you can use your own body as the test fixture. Why not do the same with ECG monitors or ECG machines? Attach electrodes and use your own body as the simulator. Verify heart rate with your own body. Check the calibration with a $4 dumbbell weight from a sporting goods store, with the weight verified on a calibrated scale. What about verifying Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 the heating of an incubator with a household thermometer? For invasive blood pressure, use an aneroid manometer and bulb to test static pressures. There are a few items that are very important and cannot be ignored: an oxygen analyzer to measure anesthesia gas mixtures, as well as a Riken (if you can find one) to measure inhalation anesthetic concentration. The author found this label on an anesthesia vaporizer in Rwanda. Likewise, some sort of a beam-analysis device for X-ray producing items is needed. I would rather spend my limited luggage allotment on spare parts rather than complex test using a one- to two-hour checkout procedure. equipment, which itself becomes a calibra- So should I test half the items thoroughly or try tion-and-repair problem. I think it’s better to to check everything for the most important use simple, cheap, verifiable test devices functions and most important safety issues? which can be easily purchased, transported, Second, I cannot possibly carry all of the and replaced. test equipment I need to do thorough tests to Third, the technicians need to be able to U.S. standards. So I am thinking of going old perform go/no go tests. These tests are usually school—using techniques we used when I simple and can be taught in a few hours. It is was new to the industry in the 1970s. Instead not possible to spend an entire week teaching a of an infusion pump tester, use a graduated single equipment type. We need to touch the cylinder and a stopwatch to check the entire inventory in a single week, testing and calibration. Instead of dragging around an repairing as much as possible. electrosurgical (ESU) analyzer, why not use a Fourth, and most important, in the United series or three 100 watt incandescent light States, if any single part of a device is not bulbs? A bipolar ESU uses 100 watts, and functioning, it is removed from service and major ESUs use 300 watts. The brightness of repaired. In the interim, there might be a the bulbs denotes the relative power output. backup piece of equipment. In developing Instead of using a defibrillator analyzer, why countries, such an approach is a luxury. not use the old style arc-light that flashed When medical equipment is scarce and functioning medical equipment is even In the United States, if any single part of a device is not scarcer, the hospital is not going to discard an entire piece of equipment because half of it functioning, it is removed from service and repaired. In the does not work. No, the staff is going to use interim, there might be a backup piece of equipment. In the part that does work, because the alterna- developing countries, such an approach is a luxury. tive is to have nothing for patients. There are no backups, no money for parts, and no source for parts. And there is no one to

140 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments troubleshoot the item, determine the specific developing countries, there would be abso- part to be ordered, and then install it. lutely no medical equipment in developing In underprivileged countries, they use countries. What do you think? Please send medical equipment as long as possible, even me your feedback, and let’s get a discussion when parts of it cease to function. When it no going. Join me at HTMTalk (http://HTMTalk. longer is useful at all, it is finally discarded. wildapricot.org). I am merely trying to make Take for example an anesthesia machine I my limited resources go as far as possible found in Rwanda. We all know that an and do as much good as possible. n anesthesia vaporizer’s only calibration is its output percentage. If too low, the patient will not be asleep. If too high, it can kill the patient. I found one that had a label on it that stated: “Note. Delivers 50% higher than Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 dialed.” Would this be accepted in the United States? Not a chance. But in developing countries, a faulty machine is often better than no machine at all. In conclusion, I ask the following question: Should we accept lower maintenance standards for some medical equipment in developing countries? I think that we have to. Lives depend on a more realistic approach. If we adhered to U.S. standards and practices in

AAMI 2014 Conference & Expo

Join more than 1,500 of your colleagues at AAMI 2014, the premier conference for healthcare technology management. Learn about new technologies and best practices to enhance patient safety, increase productivity, and comply with The Joint Commission. Network and share solutions with your peers from around the world. Discover and examine the latest medical devices.

For full details, visit www.aami.org/ac.

RESEARCH Building a 3D Computed Tomography Scanner

From Surplus Parts Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021

Mark A. Haidekker

About the Author Abstract scanners, ranging from more than $100,000 Computed tomography (CT) scanners are for small-animal scanners to several million Mark A. Haidekker, PhD, expensive imaging devices, often out of reach dollars for whole-body scanners, often are is a professor for small research groups. Designing and beyond the reach of small research depart- in the Driftmier building a CT scanner from modular compo- ments or units. Sometimes, on-site CT Engineering nents is possible, and this article demonstrates scanners are available for an hourly fee, Center, College that realization of a CT scanner from compo- which can easily reach several hundred of Engineering, dollars per hour. These costs do not encour- University of Georgia, Athens, GA. nents is surprisingly easy. However, the high E-mail: [email protected] costs of a modular X-ray source and detector age experimentation. limit the overall cost savings. In this article, the One alternative is to build a CT scanner possibility of building a CT scanner with from parts, and one objective of this article is available surplus X-ray parts is discussed, and a to demonstrate that creating a functional practical device is described that incurred costs three-dimensional (3D) CT scanner from of less than $16,000. The image quality of this components is surprisingly easy. However, device is comparable with commercial devices. the cost for X-ray components remains The disadvantage is that design constraints relatively high; an X-ray generator costs imposed by the available components lead to nearly $50,000, and a suitable detector is A visit to the surplus slow scan speeds and a resolution of 0.5 mm. approximately $10,000. By using all-new store may reveal useful Despite these limitations, a device such as this components, total costs for the complete CT X-ray equipment that is attractive for imaging studies in the scanner can potentially remain below can be used in place biological and biomedical sciences, as well as $100,000, but further reduction of the overall for advancing CT technology itself. costs would be difficult to achieve. of new equipment to Many institutions, including hospitals and further cut costs. Computed tomography (CT) is an X-ray– universities, manage surplus equipment. based cross-sectional imaging modality that Often, surplus equipment can be reacquired has a wide variety of applications in the by departments within the same institution, biomedical and engineering sciences. The and the subject of surplus equipment has fundamentals of CT image formation have been briefly covered inBI &T.3 Thus, a visit to been described in BI&T.1,2 Unfortunately, the the surplus store may reveal useful X-ray link from theory to a practical realization of a equipment that can be used in place of new CT scanner often is lacking. Commercial CT equipment to further cut costs. Depending

142 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments on the available surplus equipment (availabil- multiplier, and high-voltage driver circuit, ity of an X-ray generator is the minimum which provides up to 1,000 V for the photo- prerequisite), the design of the CT scanner multiplier cascade, are enclosed in a needs to be adapted, and the final features of compact, light-proof box, and this module the scanner depend on said equipment. also was used without further modification. Therefore, the second objective of this article The tube tank was rotated by 90° to allow is to describe a specific design based on a the beam to be emitted sideways. The tank surplus dual-energy X-ray absorptiometry and the detector box were mounted on (DEXA) scanner and its X-ray generator/ opposing ends of an optical table. In addi- detector system. tion, a 5-mm brass plate was mounted on a The basis for the CT scanner described in motor-driven x-y stage in front of the detec- this article was a Hologic QDR1500 DEXA tor, and two selectable apertures of 0.5 and scanner (Hologic, Bedford, MA), which was 2.5 mm, drilled into the brass plate, provided Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 considered inoperable because its controlling detector-side collimation and suppression of computer had failed and the company no scattered X-rays. longer offered to service the device. Because of the weight of the X-ray assembly (90 kg), a decision was made to place the Materials and Methods sample on a motorized stage and to keep the From the Hologic DEXA scanner, the X-ray tube-detector system stationary. By tube assembly with the associated high- convention, the axis of rotation is defined as voltage board and the detector were extracted. the z-axis (axial direction). When the X-ray These were the only components from the beam is considered to move along the y-axis, Hologic QDR1500 that were used in this sample motion along the x-axis is necessary to project. All other required components, obtain projection scans. Two linear slides with including the mechanical motion stages, 30 cm travel (item no. 37-368; Edmund Optics, control electronics, radiation shielding, and Barrington, NJ) allowed motion in the x image reconstruction computer, were direction. A Thorlabs optical breadboard (12.7 acquired elsewhere. mm thick aluminum, item no. MB2530/M; The Hologic tube assembly is a lead- Thorlabs, Newton, NJ) was placed on the shielded and oil-filled tank that contains the linear slides to support a linear actuator X-ray tube itself and a high-voltage trans- (LS-100-06A; Anaheim Automation, Anaheim, former. The tank assembly was used without CA). The latter was mounted upright for further modification. A separate control sample placement along the z direction. A board that provides the drive current for the motorized rotary stage (item no. 8730; Sher- high-voltage transformer from a 120-V AC line, Vista, CA) was attached to the z actuator utility line also was used without modifica- by means of a custom L bracket. The Sherline tion. The complete tube assembly in this rotary stage comes with various means for form provides alternating X-ray pulses of 4 sample attachment. Last, a linear actuator ms duration at 70 and 140 kVp, synchronized (23A104C with 12-in leadscrew; Anaheim with the 60-Hz current of the AC mains. Automation) was used to actuate the entire Tube current was specified as 1 mA, and assembly in the x direction. Thus, three step feedback control of the tube current was motors are available to move the sample in the provided on the control board. Moreover, the x and z directions and to rotate the sample. tube assembly included a Geneva wheel with Figure 1 shows a sketch of the mechanical multiple apertures that allowed selection of arrangement of these components. collimation apertures from 0.6 to 3.0 mm. Because the smallest collimation aperture The detector module of the Hologic is 0.6 mm, a point-spread function of no QDR1500 was a point detector, consisting of better than 0.6 mm can be expected. There- a CdWO4 scintillator crystal of approximately fore, a voxel size of 0.5 mm was chosen, 2.5 cm by 2.5 cm side length that was which requires the x motor to perform coupled into a Hamamatsu R647-25 photo- exactly 16 half-steps between two zero multiplier tube (Hamamatsu, Hamamatsu crossings of the AC line. To minimize City, Japan). The scintillation crystal, photo- sample deformation and avoid step motor

Sample z several crucial timing signals: a zero-crossing D signal that is active 1 ms before to 1 ms after y the AC signal changes its sign and a control X signal that is active during the central 4 ms of Θ x each AC half-cycle. Only during this 4-ms period, the X-ray tube actually emits radia- S tion. Moreover, during this 4-ms period, the voltage is read from the photomultiplier tube. At the end of the 4-ms exposure period, T intensity data are collected and temporarily stored in the controller memory. After each profile acquisition, line scan data are sent to Figure 1. Sketch of the CT assembly. On an optical table (T), the X-ray tank (X) and the the host computer. Next, the sample is X-ray detector (D) are rigidly mounted and an additional collimator plate is placed in front. Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 The X-ray tank (X) and the detector (D) were the only components reused from the Hologic rotated by a predetermined angle (Δ ). QDR1500 DEXA system. The dashed line indicates the collimated X-ray beam. The sample Projection scans take place in alternating rests on a rotary stage (indicated by ), which in turn is attached to an upright linear directions, and every other scan is reversed actuator that allows sample positioning along the z-axis. The sample holder rests on two linear slides (S) that are actuated in the x direction by a linear step motor. before storage. Acquisition, timing control, and motor control are performed by three microcontrollers (Figure 2), which in turn are x motor controlled by a host computer that is respon- Main Motor z motor sible for high-level control, such as z controller controller positioning, initiating a scan, and collecting host PC Θ motor projection data. To During a tube warm-up phase of 5 s, the tube voltage is reduced to 40 kV while the High-voltage x-ray cathode heating filament reaches its design Timing board tank temperature. Without the warm-up phase, controller the tube current control would overshoot the x-ray filament temperature and thus reduce the life detector span of the X-ray tube. To monitor tube aging Figure 2. Block diagram of the control elements. The main controller interprets high-level and tube usage, a running time meter was commands from the host PC. A dedicated motor controller is responsible for z and motion, added such that it displays the net time and for x motion synchronized with the 60-Hz AC line. In addition, the motor controller is responsible for motorized positioning of the detector collimator (not shown). The timing during which the tube is energized. controller provides the necessary control signals for the high-voltage board, which in turn drives the X-ray tube. The timing controller also reads the detector data and sends those data Image Reconstruction to the main controller for temporary storage. A standard personal computer (PC) was used for high-level data collection, instrument control, and image reconstruction. A fairly slippage, the motor controller was designed powerful computer was assembled from to accelerate the motor to its final speed of modules (AMD Phenom II 3.3 GHz six-core 1,920 half-steps per second in a linear, processor with 8 GB memory and a GPU- trapezoidal profile, and to reach phase The computing power computing capable GeForce GT-430 graphics synchronization with the AC line cycle at full was provided in card on an ASUS M5A97 motherboard, 500 speed. Acceleration was limited to 0.056 m/ GB hard disk, and suitable PC power supply). anticipation of future s2. Motion of the and z motors is not time The computing power was provided in needs, and a much critical and takes place independent of the anticipation of future needs, and a much 60-Hz cycle. more modest PC would more modest PC would have been sufficient have been sufficient for instrument control and basic image Control Electronics reconstruction. The reconstruction PC, the for instrument control Design criteria for the control circuitry were instrument power supply, Hologic high- and basic image dictated by the dependency of the tube on the voltage board, and control electronics each 60-Hz AC cycle. More specifically, the custom reconstruction. were provided with a rackmount case and control circuitry was required to provide joined in a 19-in industry standard rack. The

144 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments rack also was used to mount the keyboard and computer display. Software for instrument control and data collection was custom written in the C language and run on the PC under the Linux operating system. This software communi- cates with the low-level control components through the RS-232 serial interface with a simple command-data-checksum protocol. A graphical user interface for machine control was created, and its elements are shown in Figure 3. Projection data are collected on the host Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 computer as 16-bit intensity values for each scan line and each rotation angle (sinogram). Because each projection provides intensity values at 70 and 140 kVp, two independent sinograms are stored per slice and reconstructed independently. Intensity is averaged over the leftmost and rightmost 5 mm of each scan and used as the unattenuated reference intensity value I0. For each scan, absorbance (A) is computed from each 4 discrete intensity value I as A = –ln(I/I0. A fast Fourier–based preview is available, but Figure 3. Graphical user interface for instrument control and data collection. High-level the actual reconstruction uses either the settings, such as the scan type, are controlled from the main window (a). Here, the two absorption profiles (140 kVp [red] and 70 kVp [green]) also are displayed to allow quick visual parallel beam–filtered backprojection assessment of X-ray exposure and detector gain. This includes the gain level (light blue dashed algorithm5 or alternatively arithmetic recon- line) at which overexposure occurs. A separate scan setup window (b) is provided for scan- struction techniques.6 The reconstructed specific settings, such as sample size, slice distance, gain, or collimator setting. Sinograms for 70 (c) and 140 (d) kVp are displayed separately as the scan progresses. Profile, sinograms, and images represent apparent X-ray attenuation reconstruction were obtained from a soil sample inside a 4-in PVC tube. and need to be converted to Hounsfield units in a separate step. For 3D scans, the sample is scanned over a Software for instrument control and data collection was total rotation of 180° or 360° to obtain one cross-sectional slice. After two-dimensional custom written in the C language and run on the PC under (2D) slice acquisition is finished, the sample the Linux operating system. is repositioned in the z direction for the next slice. In this fashion, volumetric scans are assembled from 2D cross sections. A variable slice-to-slice distance (Δz) is possible, and shielding at the top and back, where the with Δz = 0.5 mm, voxels are isotropic. X-ray tank provides additional shielding. Lead-lined plywood was ordered to specifica- Radiation Safety tions from Mayco Industries (Birmingham, The original Hologic DEXA scanner was AL) and mounted on a custom steel frame. allowed to operate without additional A sliding door with overlapping lead-lined shielding, and radiation levels, even when edges was provided to allow sample access. scattering inside the patient is considered, An interlock system that was combined with remained below the legal limit of 50 μSv per an emergency shutoff button and a key lock hour and 20 μSv at a distance of 25 cm. allows the unit to operate only when the Nonetheless, a complete enclosure was built door is closed. The interlock system is for the CT scanner, which provides 3 mm completely hardware based, and interrup- lead shielding at both side walls and at the tion of the current at the interlock switch, detector face wall, and 1.5 mm lead emergency stop switch, or keylock directly

shuts off the power supply of the high- therefore not detectable. No difference in voltage board. Thus, the interlock system radiation levels was found near the final CT becomes independent from the microcon- scanner when the X-ray beam was turned on trollers and their software. or off. However, Georgia state law requires that the device becomes inoperable when the Results X-ray warning lamp fails. For this reason The CT scanner was built in three distinct alone, the existing X-ray warning lamp that design stages. The first stage was the devel- was integrated with the X-ray driver board was opment of the timing controller (Figure 2) to replaced by a lamp, for which the current which all timing-critical components syn- could be measured by the main controller. chronize. The timing controller was the With this feature, the main controller briefly prerequisite to test functionality of the X-ray tests whether the lamp is functional before enabling the X-rays and aborts the operation if

tube and the X-ray detector. With proper Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 functioning of the X-ray subsystem ascer- no current through the lamp can be detected. tained, the sample motion subsystem was built and finally the shielding enclosure Alignment added. Figure 4 shows the final CT scanner. Alignment of the mechanical motion system Total costs were approximately $16,000, is of paramount importance. The two most which included compensation for student critical alignment tasks were the angular workers (about $5,000). The lead-shielded alignment of the z-axis and the adjustment of enclosure ($3,000), optical table ($2,700), and the scan center. For alignment of the z-axis, a sample motion components ($3,500) were steel rod was screwed into the center hole of major contributors to the overall cost. Time the rotary stage, and scans taken at different commitment by the author is not included in vertical (z) positions. The angle of the rotary this calculation. stage with respect to the y-axis was adjusted After the device was operational, it was such that the edges of the steel rod in the immediately approved by the Radiation Safety projection stayed within the same window Division of the University of Georgia, because (±1 pixel) along the full height of 15 cm. The radiation levels outside the enclosure were angle of the rotary stage with respect to the below background radiation levels and x-axis required taking 2D projection scans when the beam was placed close to the surface of the rotary stage. The apparent curvature of the resulting image was kept as low as possible. Any angular deviation of the z-axis leads to degraded resolution in the axial direction; however, the actual influence of a misaligned z-axis on the image quality was not further examined. Alignment of the scan center was necessary to remove ring artifacts in the reconstruction. Because the edges of the steel rod can be detected in the projection scan by software, the scan center alignment was implemented in software: eight projection scans were taken at 45° increments, and the center position between the edges was determined. The average center position of the eight projections became the new scan center, and the difference of the center Figure 4. Photo of the complete computed tomography (CT) scanner. The white positions between alternating scan directions enclosure is built from lead-lined plywood, and the entire CT system (Figure 1) is inside was used to compensate for mechanical slack the enclosure. A sliding door provides access to the sample. To the left of the enclosure in the x-axis actuator. is a 19-in rack with the control electronics and host computer.

Imaging Performance and Image Quality Mechanical constraints limit the sample size to a width of approximately 20 cm and a height of 15 cm. Depending on sample size and number of projections taken, the scan time for a single slice is between 7 and 15 min. The slow scan time is a consequence of the parallel-beam design imposed by the existing X-ray equipment, because it requires a mechanical scan motion for the acquisition of each projection. Acquiring multiple slices for a volumetric scan takes proportionally

longer, and 3D scan times of several hours Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 can be required with the present device. Figure 5. Aluminum stair-step phantom (a), projection image (b; scout scan) of the phantom, and rendering of the volumetric image (c). In b and c, a steel mounting screw is visible (white arrows). During acquisition, the tube dissipates approximately 50 W (alternating 70 and 140 kV for 4 ms during one AC cycle of 16.7 ms with a tube current of 1 mA) and therefore profile, a Gaussian line-spread function slowly heats up the oil in the X-ray tank. After would be expected, but resolving the edge several hours of uninterrupted operation, the over 4 pixels makes it impossible to distin- tank tends to become hot to the touch guish different models for the line-spread (estimated 50°C), and forced-air cooling was function. The important result is that the later added by means of three 120 mm beam diameter is indeed the key factor that computer fans. limits detail resolution. Moreover, during the The scan of an aluminum stair-step wedge acquisition phase of 4 ms, the motor (Figure 5) allowed the system’s signal-to- advances by only 0.12 mm, and the resulting noise ratio and line-spread function to be motion blur is lower than the beam diameter measured. With artificially reduced pixel and therefore negligible. sizes of 0.2 mm (motor steps smaller than Noise is introduced predominantly by the the beam diameter), the thinnest edge of the photomultiplier tube detector, and the noise aluminum step wedge was imaged as an component increases with the detector gain. approximately linear gradient of 0.6 mm If the signal-to-noise ratio is defined as the width, which is consistent with the 0.6-mm achievable contrast divided by the standard collimation aperture. With a Gaussian beam deviation of pixels in a homogeneous area,

Figure 6. Averaged intensity along 10 horizontal scan lines of the projection image (Figure 5a) at 70 and 140 kVp (a), and plot of the averaged X-ray absorbance over the aluminum thickness, where linear regression reveals the apparent aluminum absorption coefficientμ at the 70 and 140 kVp settings (b). The apparent nonlinear behavior of the curve at high step thicknesses likely is caused by beam hardening.

the device delivers projection scans with a thickness. The slopes in Figure 6b indicate 45-dB signal-to-noise ratio at the highest gain apparent X-ray absorption coefficients for setting. Smaller or less dense objects can be aluminum of 0.69 cm–1 for 140 kVp and 1.39 imaged at lower gain settings, and the cm–1 for 70 kVp. By comparing these values to signal-to-noise ratio increases accordingly. those published by the National Institute of Standards and Technology, effective apparent Image Value Calibration beam energies of 66 and 43 keV were found The projection image of the stair-step wedge for the aluminum phantom. (Figure 5b) can be used to obtain the approxi- Typically, CT scanners provide recon- mate value of the effective beam energy. structed images calibrated in Hounsfield units Figure 6 shows averaged intensity profiles (HU), which define air as –1,000 HU and over the steps and the linear regression of water as 0 HU. A linear relationship between the reconstructed absorption coefficient and

base e absorption against aluminum Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 Hounsfield units is assumed. For this reason, the scan of a simple water phantom provides

the two required calibration values μwater and 7 μair. In this special case, the detector gain setting influences the calibration in Houns- field units, and the inclusion of a water phantom in each image allows the calibrated reconstruction even after acquisition. To provide an orientation of the values in this CT scanner, the reconstructed cross section of a 50-ml centrifuge tube filled with distilled water and imaged with the same parameters as the aluminum wedge had a mean value of 0.21 cm–1 for 140 kVp and 0.31 cm–1 for 70 kVp. A conversion of the aluminum absorption coefficients to Hounsfield units yielded approximately 2,300 HU at 140 kVp and 3,500 HU at 70 kVp. The dependency of the aluminum CT number on the beam energy is not unexpected8,9 and rather highlights the shortcomings of the Hounsfield unit system than those of the CT scanner.

Image Examples Some example images that emerged from ongoing studies are shown in Figure 7. Cross-sectional images of an onion (Figure 7a and 7b) reveal the individual layers and the internal structure. These images are part of an investigation whether CT can be used to detect bacterial rot in onions. Volumetric Figure 7. Example images taken with the computed tomography images can serve as the starting point for system. In a and b, cross-sectional images (axial and sagittal, patient-specific biomechanical studies. A respectively) of an onion are shown. A volumetric rendering of a volume rendering, created from a stack of 2D denture is shown in c. This three-dimensional image reveals internal features, such as stabilizing metal rods, and the image can be used to slices of a denture, can be seen in Figure 7c. generate a mesh (d) suitable for finite element analysis. In e, a cross The CT image reveals interior structures, section through bone density phantoms with 50, 200, and 500 mg/ml such as defects or supporting metal inserts. mineral content is shown, arranged around a water-filled glass vial (w) From the image, a mesh can be generated and placed inside a 50-ml centrifuge tube Finally, f shows the cross section of a similar arrangement but without the vial and with the (Figure 7d), which serves as the starting point centrifuge tube completely filled with water. for finite-element analysis of the load-bearing

148 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments capacity. Figure 7e and 7f show the cross- Very slow acquisition may affect degradable samples, but sectional image of bone density phantoms with 50, 200, and 500 mg/ml bone mineral even more importantly, it has a direct effect on the lifetime embedded in a resin (Computerized Imaging of the device because of the natural degradation of the X-ray Reference Systems, Norfolk, VA). In the first tube due to material evaporation from the cathode. case (Figure 7e), the phantoms were arranged around a water-filled glass vial and placed in a 50-ml centrifuge tube for imaging. In the second case (Figure 7f), the centrifuge tube itself was filled with water. Shown are images scanner by Ross et al.11 In both cases, the created from weighted sums of the 140-kVp design focus was to achieve a combination of and the 70-kVp image (70% and 30%, high speed with high resolution, and com- respectively). Correlation between mercial components were used. A cost Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 Hounsfield units and mineral content (107 overview was not given. HU for 50mg/ml, 453 HU for 200mg/ml, At the other end of the spectrum, the and 1,094 HU for 500mg/ml) was extremely high-value components are available at a low high, with an increase of about 2.2 HU per cost, for example, from surplus equipment. mg/ml mineral density and R2 > 0.999. Only the sample motion unit and control for the entire system needs to be provided. The Discussion resulting costs likely are between one and The underlying idea for this article was to two orders of magnitude lower. However, use key components from surplus stock to strict design limitations are imposed by the build a very low-cost yet fully functional X-ray features of the available X-ray units. In our CT scanner. Clearly, the X-ray components case, the tightly collimated beam allowed (X-ray tube with high-voltage generator and only a first-generation parallel-beam geom- X-ray detector) are the most expensive etry with accordingly long acquisition times, individual components in any custom CT which likely is the most noteworthy drawback project. Design of the final CT scanner of the present device. therefore depends almost exclusively on the Very slow acquisition may affect degradable available components. samples, but even more importantly, it has a At one end of the spectrum, for example, a direct effect on the lifetime of the device CT scanner could be built from selected because of the natural degradation of the X-ray modules, such as a modular X-ray generator, tube due to material evaporation from the X-ray camera module, and three-axis motion cathode. No information is available on the stage, with the additional capability to either cathode temperature or filament current, but a rotate the X-ray system around the sample or crude estimate for an assumed tungsten rotate the same inside the X-ray beam. On cathode would place its operating temperature one hand, this solution offers the greatest near 2,400 K to achieve a thermionic emission design flexibility and allows to steer the of 0.13 A/sq.cm.4 Such low-current tubes design in the direction of desired imaging typically have long life spans of more than parameters, such as beam energy, resolution, 10,000 hours. This estimate is consistent with or field of view. On the other hand, this the operation of the original DEXA device, for solution arguably is the most expensive which the tube might have been energized for option, and total costs can reach those of up to 2,000 hours per year. Unfortunately, no lower-priced off-the-shelf scanners. Moreover, information about the history of the tube is modular commercial components often available, which is a typical scenario for come with their own software, and the surplus parts. Therefore, estimating the integration of disjunct software control remaining lifetime of the tube is impossible. modules may pose a challenge. On the other hand, net tube usage of only 260 Custom-built CT systems that follow this h was logged over the past year, where a study design principle have been reported in the on bacterial rot detection in onions was literature. Two examples are the micro-CT performed, and tube aging during lab usage system of Paulus et al.10 and the volumetric appeared to be quite limited.

An additional constraint imposed by the control motion, X-ray generation, acquisition, existing equipment was the limitation of the and safety. Integrating some or all of these spatial resolution to 0.5 mm by the given functions in software that runs on a personal beam collimation. The travel distance of the computer is possible. Labview (National translation motor per pixel could be Instruments, Rockville, MD) is a popular decreased easily, which would lead to a software to realize control and automation higher apparent resolution. However, blur systems. However, the Labview license and the caused by the beam diameter would prevent necessary interface cards incur additional details at the pixel size from being recogniz- costs. Alternatively, programming the soft- able. Although further collimation with a ware in, for example, C or C++ is feasible. pinhole aperture would be possible in This approach allows easy integration with the principle, an unacceptable degradation of the reconstruction and display modules. The two signal-to-noise ratio can be expected. main challenges in this case are precise Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 To provide one hypothetical example for timing and interfacing with the hardware. different design constraints, let us assume Interface cards can be purchased, for which that the available components are a wide-field software libraries are sometimes available. At X-ray generator and a digital detector array. this point, however, Labview and similar With the cone-shaped beam that the X-ray high-level programming systems allow faster generator emits, much faster acquisition software development. On the other hand, the times are possible through fan-beam or use of microcontrollers provides unmatched cone-beam techniques. However, the tube’s design flexibility at extremely low costs. focal spot would be the primary factor that Microcontrollers provide integrated on-chip timers and analog-to-digital converters. Microcontrollers therefore are ideal for Radiation safety compliance is a fundamental aspect of the timing-critical tasks, such as step motor design, as radiation sources are regulated by federal and state acceleration, or for data collection. laws far beyond radiation exposure levels. Radiation safety compliance is a fundamental aspect of the design, as radiation sources are regulated by federal and state laws far beyond radiation exposure levels. limits the resolution, and scattered radiation Radiation shielding usually is only one issue, may cause a substantial noise component in with the choice being between a device that is the projection scans. Moreover, image operated in a shielded room (for easier reconstruction becomes more complex. For access) or a cabinet-type device that is housed an idealized fan-beam geometry, geometrical in its own shielded cabinet. Additional correction terms can be introduced that map considerations include the safety interlocks, the fan-beam geometry to parallel-beam indicator lamps, and keyed access, as well as geometry and also that correct the frequency documentation, operator training, regular response of the reconstruction filter.12 radiation surveys, and regular tests of the Fan-beam reconstruction therefore is safety features that are necessary after the fundamentally similar to parallel-beam design phase is complete. Consultation with reconstruction. The complexity of the the institutional radiation safety division in reconstruction algorithm grows dramatically the early stages of the design is recom- with the cone-beam geometry. The algorithm mended, and in our case, the radiation safety that is probably most widely used is the division at the University of Georgia was iterative 3D generalization of the filtered instrumental in identifying necessary steps backprojection by Feldkamp et al.,13 but a to bring the device in compliance. Fourier-based approach also exists.14 A number of options exist to further After considering constraints imposed by improve the device, but most of these options the X-ray source and detector, however, design revolve around reconstruction. First and of the additional components becomes more foremost, no consistent dual-energy recon- flexible. In our design, we made use of the struction has been implemented for this versatility of low-cost microcontrollers to device. Although dual-energy reconstruction

150 Biomedical Instrumentation & Technology March/April 2014 © Copyright AAMI 2014. Single user license only. Copying, networking, and distribution prohibited. Columns and Departments is not a novel method,15–17 the different noise levels at 70 and 8. Schmitt WG. Energy Dependence of Hounsfield Numbers [article in 140 kVp pose a challenge18 for dual-energy subtraction German]. Rofo. 1986;145(2):221–3. images. On the other hand, implementation of dual-energy 9. Johnson TR, Krauss B, Sedlmair M, et al. Material Differentiation by reconstruction is attractive because it allows the density of Dual Energy CT: Initial Experience. Eur Radiol. 2007;17(6):1510–7. one material (e.g., water content) to be determined in a sample, as well as allows material contrast to be improved9 10. Paulus MJ, Sari-Sarraf H, Gleason SS, et al. A New X-ray Computed and beam-hardening artifacts to be suppressed.19 The CT Tomography System for Laboratory Mouse Imaging. IEEE Trans Nucl device itself, rather than the more commonly used simulation Sci. 1999;46:558–64. methods, could be used to provide data for the evaluation of 11. Ross W, Cody DD, Hazle JD. Design and Performance 20 new methods for noise reduction or streak artifact suppres- Characteristics of a Digital Flat-Panel Computed Tomography 21 sion. In a similar fashion, the influence of signal System. Med Phys. 2006;33(6):1888–901. conditioning on the hardware side (e.g., use of a high-order antialiasing filter before the digital data collection) can be 12. Natterer F. Numerical Methods in Tomography. Acta Numerica. Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 examined. 1999;8(1):107–41. 22 Furthermore, a conversion to a helical scanner is straight- 13. Feldkamp LA, Davis LC, Kress JW. Practical Cone-Beam Algorithm. J forward with the current design: either the rotary stage is Opt Soc Am A. 1984;1(6):612–9. mechanically coupled with the z-translation stage or the z stage is programmed to advance incrementally after every 14. Grangeat P. Mathematical Framework of Cone Beam 3D projection scan. The second option particularly is attractive Reconstruction via the First Derivative of the Radon Transform. New because it is a pure software solution and can be selectively York, NY: Springer; 1991:66–97. enabled. The main advantage of helical scanning in this 15. Sukovic P, Clinthorne NH. Penalized Weighted Least-Squares Image device likely would be accelerated 3D scanning, because a Reconstruction for Dual Energy X-ray Transmission Tomography. compromise can be found between axial speed and axial IEEE Trans Med Imaging. 2000;19(11):1075–81. detail loss through interpolation. 16. Oehler M, Buzug TM. Modified MLEM Algorithm for Artifact In fact, notwithstanding the cost aspect, the open nature of Suppression in CT. IEEE Nucl Sci Symp Conf Rec. 2006;6:3511–8. a CT device designed and built from the ground up arguably is its most attractive aspect, because it enables implementa- 17. De Man B, Nuyts J, Dupont P, et al. An Iterative Maximum- tion of, and experimentation with, different acquisition Likelihood Polychromatic Algorithm for CT. IEEE Trans Med protocols and reconstruction techniques. A device such as the Imaging. 2001;20(10):999–1008. one described here is not only suitable for imaging studies at 18. Kelcz F, Joseph PM, Hilal SK. Noise Considerations in Dual Energy the quality level of commercial devices, but it also enables CT Scanning. Med Phys. 1979;6(5):418–25. researchers to advance CT technology itself. n 19. Yan CH, Whalen RT, Beaupré GS, et al. Reconstruction Algorithm References for Polychromatic CT Imaging: Application to Beam Hardening 1. Launders JH. The Fundamentals of ... Computed Tomography. Correction. IEEE Trans Med Imaging. 2000;19(1):1–11. BI&T. 2002;36(1):53–7. 20. Borsdorf A, Raupach R, Flohr T, Hornegger J. Wavelet Based Noise 2. Mitchell R. An Overview: Radiography for the Imaging Technician. Reduction in CT-Images Using Correlation Analysis. IEEE Trans Med BI&T. 2012;46(3):202–6. Imaging. 2008;27(12):1685–703.

3. Cambpell S. Equipment Can Find New Life at the Vet. BI&T. 21. Zhao S, Robeltson DD, Wang G, et al. X-Ray CT Metal Artifact 2002;36(4):222. Reduction Using Wavelets: An Application for Imaging Total Hip Prostheses. IEEE Trans Med Imaging. 2000;19(12):1238–47. 4. Haidekker MA. Medical Imaging Technology. New York, NY: Springer; 2013. 22. Heiken JP, Brink JA, Vannier MW. Spiral (Helical) CT. Radiology. 1993;189(3):647–56. 5. Kak AC, Slaney M. Principles of Computerized Tomographic Imaging. New York, NY: IEEE Press; 1998.

6. Herman GT. Fundamentals of Computerized Tomography: Image Reconstruction From Projections. New York, NY: Springer; 2009.

7. Brooks RA. A Quantitative Theory of the Hounsfield Unit and Its Application to Dual Energy Scanning. J Comput Assist Tomogr. 1977;1(4):487–93.

FINAL WORD Healthcare Technology AAMI Guidance Management Is Not an Island For Healthcare Providers Managing Medical IT-Networks Mary Logan

Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 American National About the Author AAMI’s strategic planning process is under- it’s easy to slash their expenses; an add-on Standard way. A multidisciplinary committee recently service component to technology purchases; Mary Logan, JD, ANSI/AAMI/IEC 80001-1:2010, Application of risk spent two days discussing what forces are at a headache for information technology (IT); a CAE, is president management for IT Networks incorporating medical of AAMI. E-mail: work in healthcare that create opportunities capital equipment competition; something [email protected]. or pose threats for AAMI as it looks to the new for nurses to learn; a treasure trove of ANSI/AAMI/ devices— Part 1: Roles, responsibilities and activities IEC 80001-1: future. The committee discussions were clinical data for research; or an opportunity to 2010 Application of risk Order Code: 8000101 or 8000101-PDF management for IT Networks lively and covered a gamut of changes in make care safer. It’s easy to see what HTM incorporating medical devices—Part 1: Roles, List $120 / AAMI member $60 healthcare, such as the growing pressure to should be, and the smart departments have responsibilities and activities reduce costs, the pressing need for regulatory moved in that direction or are on their way. policies and standards to address the When HTM is viewed strictly as some expansion of healthcare delivery beyond the isolated service department, we miss the hospital, the upcoming retirement of large bigger picture, which takes me back to my numbers of Baby Boomer technology experts, earlier point: HTM is increasingly interdiscipli- the continued rise of interoperability, and the nary, and relatively few professionals have TIR80001-2-1:2012, Part 2-1: Step by step TIR80001-2-3:2012, Part 2-3: Guidance for promise of innovation coming from many expertise in all of the disciplines needed to carry risk management of medical IT-networks; wireless networks new entrants to the technology market. out the responsibilities. The top executives in What I found more provocative, though, medicine, nursing, pharmacy, IT, finance, Practical applications and examples Order Code: 800010203 or 800010203-PDF were two seemingly disparate insights: (1) operations, clinical safety, infection control, Order Code: 800010201 or 800010201-PDF List $120 / AAMI member $60 healthcare technology management (HTM) is and risk management—and the top execu- List $130 / AAMI member $65 increasingly interdisciplinary, tives in industry—need us to help them and relatively few professionals understand HTM more holistically, viewing it TIR80001-2-4:2012, Part 2-4: Application The best place to start in have expertise in all of the as a crucial component of and link to every TIR80001-2-2:2012, Part 2-2: Guidance for guidance -- General implementation guidance promoting a new mindset is for disciplines needed to carry out element of safe, efficient, and effective the communication of medical device security for healthcare delivery organizations HTM departments to consider the responsibilities; and (2) patient care. The best place to start in needs, risks and controls how they view themselves. short-term cost pressures and a promoting a new mindset is for HTM Order Code: 800010204 or 800010204-PDF lack of executive understanding departments to consider how they view Order Code: 800010202 or 800010202-PDF List $100 / AAMI member $50 often stand in the way of HTM themselves. If they see themselves as an List $130 / AAMI member $65 evolving beyond the traditional “repair a afterthought, that’s what they will be. If we device” focus to a broader focus on the life they see themselves as key partners in the cycle of technology. Together, these two full life cycle of technology, then they will be. insights shine a bright light on the fact that We all have a role to play to eliminate the one HTM is not a service department in the lens that is not helpful to anyone: seeing Order your Copy Today! basement of a hospital, even though that’s HTM as an island. n the view of many hospital and industry Call +1-877-249-8226 executives. They see HTM as a cost center, Visit http://my.aami.org/store ripe for expense reduction. Depending on the lens one uses, HTM is an opportunity to outsource; a group of

people who can’t stand up for themselves so Source code: PB

Sterile Processing In 2nd Edition AAMI Guidance Healthcare Facilities: Sterile Processing In For Healthcare Providers Healthcare Facilities: Preparing for Preparing for Accreditation Surveys Managing Medical IT-Networks Accreditation Surveys, nd American Downloaded from http://meridian.allenpress.com/bit/article-pdf/48/2/fmi/1489742/0899-8205-48_2_i.pdf by guest on 25 September 2021 2 Edition National Rose Seavey Standard

Now in its second edition, this popular resource ANSI/AAMI/IEC 80001-1:2010, Application of risk management for IT Networks incorporating medical is filled with valuable tools for preparing ANSI/AAMI/ devices— Part 1: Roles, responsibilities and activities for accreditation surveys and maintaining IEC 80001-1: 2010 Application of risk Order Code: 8000101 or 8000101-PDF compliance with accreditation requirements. management for IT Networks incorporating medical devices—Part 1: Roles, List $120 / AAMI member $60 responsibilities and activities Nearly doubled in size, the book features: ► Information on accreditation organizations and requirements ► The current National Patient Safety Goals ► Information on CDC’s Guide to Infection Prevention for Outpatient Settings TIR80001-2-1:2012, Part 2-1: Step by step TIR80001-2-3:2012, Part 2-3: Guidance for ► CMS worksheets risk management of medical IT-networks; wireless networks ► Audit tools for immediate-use steam sterilization best practices and high- Practical applications and examples level disinfection best practices Order Code: 800010203 or 800010203-PDF Order Code: 800010201 or 800010201-PDF List $120 / AAMI member $60 List $130 / AAMI member $65 Sterile Processing in Healthcare Facilities also includes information on policies and procedures, the creation of audit sheets, root cause analysis, failure modes TIR80001-2-4:2012, Part 2-4: Application and effects analysis, tracer methodology, and much more. TIR80001-2-2:2012, Part 2-2: Guidance for guidance -- General implementation guidance the communication of medical device security for healthcare delivery organizations needs, risks and controls Authored by Rose Seavey RN, MBA, BS, CNOR, CRCST, CSPDT. Order Code: 800010204 or 800010204-PDF Order Code: 800010202 or 800010202-PDF List $100 / AAMI member $50 Order Code: SPHC or SPHC-PDF List $130 / AAMI member $65 List $195 / AAMI member $115

Order your Copy Today! Order your Copy Today! Call +1-877-249-8226 Call +1-877-249-8226 or Visit http://my.aami.org/store visit http://my.aami.org/store

SOURCE CODE: PB Source code: PB