NEWSLETTER The Official Journal of the Anesthesia Patient Safety Foundation www.apsf.org

Volume 30, No. 3, 45-76 Circulation 122,210 February 2016

Editors' Note: This issue contains a series of articles regarding the safe use of nondepolarizing neuromuscular blocking drugs. All anesthesia professionals should understand the importance of appropriately monitoring and reversing neuromuscular blockade. We believe that these articles will increase awareness, provide important educational information, and improve patient safety. Monitoring of Neuromuscular Blockade: What Would You Expect If You Were the Patient?

by Robert K. Stoelting, MD The Anesthesia Patient Safety Foundation Table 1: Potential adverse effects of residual neuromuscular blockade in the immediate (APSF) believes that residual neuromuscular block- postoperative period ade in the postoperative period is a patient safety Need for tracheal reintubation hazard that could be addressed partially by better and consistent use of our qualitative standard train- Impaired oxygenation and ventilation (may be erroneously attributed to opioids) of-four (TOF) nerve stimulator monitors, but will Impaired pulmonary function (reduced forced vital capacity and peak expiratory flow rate) ultimately require quantitative (objective TOF) Increased risk of aspiration and pneumonia monitoring along with traditional subjective obser- Pharyngeal dysfunction vations to eliminate this problem completely.1-2 APSF and other anesthesia professionals believe Delayed discharge from the PACU that every patient receiving nondepolarizing neuro- muscular blocking drugs (NMBDs) should have at The peer review literature supports the conclu- Despite the evidence in the peer review litera- least qualitative, and preferably quantitative moni- sion that residual neuromuscular blockade in the ture and a survey of anesthesia professionals in toring of the intensity of neuromuscular blockade immediate postoperative period is more common which 90% of respondents agreed that quantita- using a peripheral nerve stimulator during the than appreciated. This weakness may contribute tive TOF monitoring should be used routinely for intraoperative period and assessment of the phar- to adverse patient events (Table 1).3-9 Based on patients receiving nondepolarizing NMBDs prior to transfer to the PACU, quantitative measurements of macologic antagonism of neuromuscular blockade quantitative TOF monitoring as many as 40% of drug-induced neuromuscular blockade and the and adequacy of neuromuscular function prior to patients arriving in the PACU have evidence of tracheal extubation.1-10 residual neuromuscular blockade.4,9 See “Blockade Monitoring,” Page 47

Large Anesthesia/Practice Management Groups: How Can APSF Help Everyone Be Safer? by Robert K. Stoelting, MD On September 10, 2015, APSF invited represen- that included all categories of anesthesia profes- tatives of large anesthesia and practice manage- sionals. The American Society of Anesthesiolo- ment groups to meet with members of the APSF gists, which has a committee on Large Group executive committee to discuss mutually relevant Practice, was represented by Daniel J. Cole, MD, anesthesia patient safety issues. The goal was to President Elect, and Paul Pomerantz, CEO. help APSF identify and implement patient safety As an introduction to the conference, Robert K. initiatives of particular interest and value to the conference participants. Stoelting, MD, APSF President, reviewed past, current, and possible future APSF patient initia- Thirty-six attendees representing 23 large anes- tives and provided “his view” of the three options thesia/practice management groups participated available for APSF recommendations to become in the half-day session (Table 1). These 23 groups “best practices.” represented a wide geographical cross-section of the United States and a variety of practice models See “Large Practice Groups,” Page 55 Dr. Robert Stoelting, moderating.

TABLE OF CONTENTS, PAGE 46 APSF NEWSLETTER February 2016 PAGE 46

Table of Contents Articles: Monitoring of Neuromuscular Blockade: What Would You Expect if You Were the Patient? ...... Cover Large Anesthesia/Practice Management Groups: How Can APSF Help Everyone Be Safer?...... Cover NEWSLETTER Expanding Our Influence: How the Perioperative Surgical Home Will Improve Patient Safety...... Page 48 The Official Journal of the Anesthesia Patient Safety Foundation President’s Report Highlights Accomplishments of 2015...... Page 49 The Anesthesia Patient Safety Foundation Newsletter Multi-faceted Initiative Designed to Improve Safety of Neuromuscular Blockade...... Page 51 is the official publication of the nonprofit Anesthesia The Development and Regulatory History of Sugammadex in the United States...... Page 53 Patient Safety Foundation and is published three APSF Sponsors Workshop on Implementing Emergency Manuals...... Page 68 times per year in Wilmington, Delaware. Individual subscription–$100, Cor­por­ate–$500. Contri­butions to FDA Issues Drug Safety Communication About Epidural Corticosteroid Injections...... Page 72 the Foundation are tax deduct­ible. ©Copy­right, Residual Neuromuscular Blockade (NMB), Reversal, and Perioperative Outcomes...... Page 74 Anesthesia Patient Safety Foundation, 2016. The opinions expressed in this Newsletter are not Letters, Q&A and Dear SIRS necessarily those of the Anesthesia Patient Safety Editor’s Q&A: How Do I Prepare for OR Power Failure?...... Page 57 Foundation. The APSF neither writes nor promulgates standards, and the opinions expressed herein should Dear SIRS: Incorrect Network Connection Simultaneously Crashes Multiple Anesthesia Machines.....Page 63 not be construed to constitute practice standards or Letter to the Editor: The Structure and Process of PACU Handoff— practice parameters. Validity of opinions presented, How to Implement a Multidisciplinary PACU Handoff Checklist...... Page 75 drug dosages, accuracy, and completeness of content are not guaranteed by the APSF. APSF Announcements APSF Executive Committee: Save the Date for APSF Workshop: Distractions in the Anesthesia Environment...... Page 47 Robert K. Stoelting, MD, President; Jeffrey B. Cooper, Merck Support of APSF...... Page 50 PhD, Executive Vice President; George A. Schapiro, Executive Vice President; Robert J. White, Vice NBCRNA Support of Grant...... Page 52 President; Matthew B. Weinger, MD, Secretary; Casey Medtronic Support of APSF...... Page 54 D. Blitt, MD, Treasurer; Robert A. Caplan, MD; David M. Gaba, MD; Steven K. Howard, MD; Lorri A. Lee, 2015 Corporate Advisory Council...... Page 55 MD; Robert C. Morell, MD; A. William Paulsen, PhD; APSF Website Offers Online Educational DVDs...... Page 56 Richard C. Prielipp, MD; Steven R. Sanford, JD; Maria A. van Pelt, PhD, CRNA; Mark A. Warner, MD. APSF Corporate Supporter Page...... Page 64 Consultants to the Executive Committee: John H. APSF Donor Page...... Page 65 Eichhorn, MD; Bruce P. Hallbert, PhD. Anesthesia Patient Safety Foundation Officers, Directors, and Committees, 2016...... Page 66 Newsletter Editorial Board: Robert C. Morell, MD, Co-Editor; Lorri A. Lee, MD, APSF Awards 2016 Grant Recipients...... Page 67 Co-Editor; Steven B. Greenberg, MD, Assistant Editor; Procedure for Submitting 2017 Grant Applications...... Page 71 Sorin J. Brull, MD; Joan Christie, MD; Jan Ehrenwerth, MD; John H. Eichhorn, MD; Glenn S. Murphy, MD; Wilson Somerville, PhD; Jeffery Vender, MD. Address all general, contributor, and sub­scription APSF Newsletter correspondence to: Administrator, Deanna Walker guide for authors Anesthesia Patient Safety Foundation Building One, Suite Two The APSF Newsletter is the official journal of the to the editors. Commercial products are not advertised 8007 South Meridian Street Anesthesia Patient Safety Foundation. It is published 3 or endorsed by the APSF Newsletter; however, upon Indianapolis, IN 46217-2922 e-mail address: [email protected] times per year, in June, October, and February. The APSF occasion, articles about certain novel and important Newsletter is not a peer-reviewed publication, and technological advances may be submitted. In such Address Newsletter editorial comments, questions, letters, decisions regarding content and acceptance of instances the authors should have no commercial ties to, and suggestions to: submissions for publication are the responsibility of the or financial interest in, the technology or commercial Robert C. Morell, MD editors. Individuals and/or entities interested in product. The editors will make decisions regarding Senior Co-Editor, APSF Newsletter submitting material for publication should contact the publication on a case-by-case basis. c/o Addie Larimore, Editorial Assistant editors directly at [email protected] and/or Lee@apsf. If accepted for publication, copyright for the Department of Anesthesiology org. Full-length original manuscripts such as those that Wake Forest University School of Medicine accepted article is transferred to the Anesthesia Patient would normally be submitted to peer review journals 9th Floor CSB Safety Foundation. Except for copyright, all other rights such as Anesthesiology or Anesthesia & Analgesia are Medical Center Boulevard such as for patents, procedures, or processes are retained generally not appropriate for publication in the Winston-Salem, NC 27157-1009 by the author. Permission to reproduce articles, figures, e-mail: [email protected] Newsletter due to space limitations and the need for a tables, or content from the APSF Newsletter must be peer-review process. Letters to the editor and occasional Send contributions to: obtained from the APSF. brief case reports are welcome and should be limited to Anesthesia Patient Safety Foundation 1,500 words. Special invited articles, regarding patient All submissions should include author affiliations 1061 American Lane safety issues and newsworthy articles, are often solicited including institution, city, and state, and a statement Schaumburg, IL 60167-4973 by the editors. These articles should be limited to 2,000 regarding disclosure of financial interests, particularly in Or please donate online at www.apsf.org. words. Ideas for such contributions may also be directed relation to the content of the article. APSF NEWSLETTER February 2016 PAGE 47

We As Patients Would Expect Better “Blockade Monitoring,” From Cover Objective functional monitoring (“twitch measurement”) of the adequacy of pharmacologic reversal have not been intensity of neuromuscular blockade should be utilized widely utilized by anesthesia professionals (Fig. 1).1 Achievement of the goal of routine qualitative or routinely intraoperatively and prior to transfer to PACU. quantitative monitoring using a peripheral nerve 90.0% stimulator is difficult when the daily experiences of anesthesia professionals do not predictably demon- strate the existence of a problem that may occur well after the anesthesia professional has turned over care to another health care professional.4 Universal adop- tion of quantitative monitoring is further impeded by the limited availability of easy-to-use, reliable moni- 7.1% 2.9% toring technology. Many anesthesia professionals con- tinue to rely on clinical signs (head lift, hand grip, A. Agree B. Disagree C. I have no opinion/not sure negative inspiratory force, tidal volume) that are insensitive indicators of residual skeletal muscle Figure 1: Stoelting RK. APSF survey results: Drug-induced muscle weakness in the postoperative period safety weakness and applicable only to awake patients. Like- initiative. APSF Newsletter Winter 2013-14:28:69-71. http://www.apsf.org/newsletters/pdf/winter2014.pdf wise, reliance on visual/tactile assessment of the TOF (low sensitivity to detect fade) to titrate the effects and gering drug-induced muscle weakness in the early 2. Stoelting RK. Residual drug-induced muscle weakness in assess the pharmacologic reversal of nondepolarizing postoperative period. the postoperative period—a patient safety issue. ASA Newsletter 2015;79:64-65. Available at: http://www. NMBD is an insensitive and unreliable monitoring What will it take for “North American” anes- technique. Though double-burst stimulation (DBS) asahq.org/search?q=February%202015%20ASA%20 thesia professionals to accept the reality of this and fade with 100 Hz tetanic stimulation significantly Newsletter. patient safety risk? improve the ability to detect residual neuromuscular 3. Brull SJ, Naguib M. What we know: Precise measure- blockade over single twitch or TOF monitoring or Why are “we” so “hesitant” to routinely use ment leads to patient comfort and safety. Anesthesiology 2011;115:918–920. clinical signs, these modalities of assessing neuromus- qualitative or quantitative assessments of neuro- cular blockade are inferior to methods of quantitative muscular function with peripheral nerve stimula- 4. Todd MM, Hindman BJ, King BJ. The implementation of 10 quantitative electromyographic neuromuscular monitor- monitoring such as acceleromyography. tors to guide both the administration and reversal ing in an academic anesthesia department. Anesth Analg of nondepolarizing NMBDs? A recommendation for routine qualitative or 2014;119:323–331. quantitative monitoring of neuromuscular blockade Would “we,” knowing what we know, or should 5. Viby-Mogensen J, Claudius C. Evidence-based manage- with peripheral nerve stimulators as part of the know, regarding the facts relevantSave to residual the weak -Datement of neuromuscular block. Anesth Analg 2010;111:1–2. “Standards for Basic Anesthetic Monitoring” has not ness due to nondepolarizingWednesday, NMBDs, expect, September at a 7,6. 2016 Donati F. Neuromuscular monitoring: what evidence do we need to be convinced? Anesth Analg 2010;111:6–8. been promulgated by any of the North American pro- minimum, qualitative monitoringRoyal Palms with Resort peripheral and Spa, Phoenix, AZ fessional anesthesia associations (American Society nerve stimulators if we were the patient? 7. Kopman AF. Managing neuromuscular block: where are APSF-Sponsored Conference the guidelines? Anesth Analg 2010;111:9–10. of Anesthesiologists, American Association of Nurse My guess is “we” would expect qualitative, Distractions in the Anesthesia Work8. Gopalaiah VK, Nair AP, Murthy HS, et al. Residual neu- Anesthetists, American Academy of Anesthesiologist and more likely, quantitative monitoring of neuro- Assistants, Canadian Anesthesiologists’ Society). To Environment: Impact on Patient Safetyromuscular blockade affects postoperative pulmonary muscular blockade as part of our care! date, these anesthesia professional associations are See details inside function. Anesthesiology 2012;117:1234-44. either silent regarding monitoring neuromuscular It is time to “Do as I would expect, not as I do!” 9. Checketts MR, Alladi R, Ferguson K, et al. Recommenda- blockade or limit their statements to (1) “monitor tions for standards of monitoring during anaesthesia and Robert K. Stoelting, MD recovery 2015: Association of Anaesthetists of Great Brit- neuromuscular response” [no specific quantitative President, APSF ain and Ireland. Anaesthesia 2015; Available at https:// monitor mentioned] or (2) a “peripheral nerve stimu- www.aagbi.org/sites/default/files/Standards%20 lator should be available when patients receive neu- References of%20monitoring%2020150812.pdf romuscular blockers.” 1. Stoelting RK. APSF survey results: Drug-induced 10. Capron F, Fortier LP, Racine S, Donati F. Tactile fade In contrast, the 2015 “Recommendations for stan- muscle weakness in the postoperative period safety ini- detection with hand or wrist stimulation using train-of- tiative. APSF Newsletter Winter 2013-14;28:69-71. Avail- four, double-burst stimulation, 50-hertz tetanus, 100- dards of monitoring during anaesthesia and recov- able at: http://www.apsf.org/newsletters/pdf/ hertz tetanus, and acceleromyography. Anesth Analg 2006 ery” published by the Association of Anaesthetists of winter2014.pdf. May;102:1578–84. Great Britain and Ireland (AAGBI) mandates that “a peripheral nerve stimulator must be used whenever neuromuscular blocking drugs are given.”9 These APSF-Sponsored Conference recommendations also list a peripheral nerve stimu- Royal Palms Resort and Spa, Phoenix, AZ lator (if neuromuscular blocking drugs are used) as part of the “minimum monitoring for anaesthesia” Distractions in the Anesthesia Work along with pulse oximetry and capnography.9 This Environment: Impact on Patient Safety AAGBI mandate reflects the increasing recognition of Distractions in the anesthesia work environment manifest in many different ways and potentially impact patient the role of NMBDs in adverse postoperative pulmo- safety by compromising the anesthesia professional’s vigilance during direct patient care. APSF believes these nary events. distractions need to be identi ed and addressed by open discussion, education, research and appropriate policy statements for individual groups or practice management entities. This 1-day conference will include In my opinion, there is no compelling reason to podium presentations, panel discussions, small group breakout sessions and attendee responses using an ignore this evidence-based patient safety issue and “audience response system.” the obvious change in practice (qualitative, or preferably quantitative/objective monitoring with If you are interested in attending, peripheral nerve stimulators to guide pharmaco- Save the Date please contact Dr. Stoelting logic drug reversal) that would likely reduce the Wednesday, September 7, 2016 ([email protected]) for registration details. risk of potential adverse physiologic effects of lin- APSF NEWSLETTER February 2016 PAGE 48

Expanding Our Influence: How the Perioperative Surgical Home Will Improve Patient Safety The 2015 Ellison C. Pierce, Jr., MD, ASA/APSF Patient Safety Memorial Lecture

Mark A. Warner, remain unacceptably high. Within anesthesiology, cols can result in skin tests that document the MD, presented the 2015 and working with health care colleagues outside of presence or absence of true penicillin allergies. Anes- Pierce ASA/APSF our specialty, we should, can, and must improve both thesiologists, surgeons, and infectious disease spe- Patient Safety Memorial intraoperative and perioperative patient safety. This cialists or internists, can readily work together to Lecture. He started by is where the Perioperative Surgical Home concept develop facility-specific clinical protocols to check for reviewing the anesthesia comes into play. penicillin allergies preoperatively. patient safety impera- In general, we have not looked intensely into Prehabilitation: Anesthesiologists and the teams tive that anesthesiology the long-term consequences of anesthesia care. That with whom they work can develop preoperative has embraced since the is changing—data are increasingly strong that there evaluation processes that extend beyond the typical creation of the APSF in are prolonged physiologic and pathologic changes pre-anesthetic assessment—beyond the ubiquitous 1985: “no patient shall be associated with intraoperative anesthesia care. Sev- “OK for anesthesia.” Issues that have yet undefined harmed by anesthesia.” eral key questions for 2015 are shown in Table 2. contributions to perioperative morbidity and mortal- The APSF used that visionary statement to create Anesthesiologists and members of the anesthesia ity such as weight control, correction of general or goals that still stand today. They specifically state that care team are well positioned to design, assess, and specific nutrition deficits, cessation of smoking, and the foundation will: improve perioperative care of patients who will be improvement of poor physical conditioning all merit 1. Foster investigations that will provide a better anesthetized for surgical, diagnostic and therapeu- additional study and, when appropriate, implemen- understanding of preventable anesthetic injuries tic procedures. tation of clinical protocols that may “prehabilitate” 2. Encourage programs that will reduce the number How can the anesthesia community expand its patients before they proceed through the periopera- of anesthetic injuries influence in the perioperative period and improve tive process. patient safety? Let’s look at several examples. 3. Promote national and international communica- Blood Product Transfusion: Extensive use of tion of information and ideas about the causes and Penicillin Allergy: Nearly 90% of surgical algorithms and clinical protocols for transfusion of prevention of anesthetic injuries patients in the U.S. who indicate that they have a blood products can have a significantly positive penicillin allergy—do not have that allergy. Anesthe- impact on patient safety during the perioperative The following summarizes Dr. Warner’s com- period. In a wide variety of clinical settings, the use of ments from the lecture. siologists and surgeons rarely check, instead ordering broad spectrum third and fourth generation antibiot- predetermined transfusion protocols and mecha- Improvement in anesthetic mortality and several ics because it is expedient. Unfortunately, there is a nisms to proactively intervene when physicians major morbidities was dramatic during the first cost to society and patient safety. Unfiltered, prolifer- transfuse blood products outside of agreed algo- decade of the APSF…and anesthesia care has contin- ate use of these high-end antibiotics is expensive and rithms have reduced blood product use 40–60%. ued to become safer. The specialty provides out- supports the evolution of resistant bacteria—and Blood transfusion has distinct and measurable detri- standing, very safe patient care intraoperatively. these resistant bacteria, of course, require more mental impact on immune responses and susceptibil- ity to infection in surgical patients, especially those With all of that, the anesthesia community can expensive antibiotics that have an increased propor- and must continue to improve because patients are tion of adverse effects. Simple preoperative proto- See “Expanding Influence,” Page 53 still harmed—every day—in the U.S. and elsewhere, during and by anesthesia care. There is still much to Table 2: Key Questions Associated with the Long-Term Impact of Anesthesia study, assess, and improve intraoperatively. Issues that have recently been discussed during workshops • Do volatile anesthetic agents have a long-term effect on neurocognitive development in children? of the APSF are shown in Table 1. • Does the administration of a blood product have long-term effects on immune and organ function? Unfortunately, overall surgical and procedural safety lags. The incidences of a variety of major peri- • Do the various techniques we use to deliver care—the science of anesthesia care delivery—have operative morbidities as well as death rates clearly long-term effects on patient safety and outcomes?

Table 1. Recent APSF Workshop Topics • Is there a negative impact of pharmacologically and surgically induced inflammation on the short- and long-term outcomes of our patients? Cerebral ischemia in head-elevated positions

Medication safety in the operating room Table 3: Quotes from Anesthesiology Leaders About Scope of the Specialty and Patient Safety Opioid-induced postoperative respiratory • Dr. Jim Eckenhoff, former president of the ASA (1977): “anesthesiologists must be adequately pre- depression pared for assuming their roles in patient care services…to the ultimate best advantage of their Perioperative vision loss patients.”

Pre-anesthetic induction checklists • Dr. Larry Saidman, former editor-in-chief of Anesthesiology (1995): “[I]…propose that the term anes- thesiology should be changed to perioperative medicine and pain management.” Cognitive aids and checklists • Dr. Ellison (Jeep) Pierce, former president of the ASA and founder of the APSF: “Patient safety is not Residual neuromuscular blockade a fad. It is not a preoccupation of the past. It is not an objective that has been fulfilled or a reflection of a problem that has been solved. It must be sustained by research, training, and daily application Training for advanced medical technologies in the workplace.” APSF NEWSLETTER February 2016 PAGE 49

President’s Report Highlights Accomplishments of 2015 by Robert K. Stoelting, MD As President of the Anesthesia Patient Safety perioperative care proposed that a fully ACCME-compliant path be Foundation (APSF), it is my privilege to report annu- team to move developed that can include manufacturers’ participa- ally on the activities of the foundation during the past towards the tion. The most cost- and time-effective approach to calendar year. As in my previous annual reports, I acceptance of cog- establishing training of the many advanced techno- believe it is important to recognize that APSF, as an nitive aids (emer- logical devices used in anesthetic practice is to partner advocacy group, does not write standards. Recom- gency manuals, with manufacturers, providing appropriate and care- mendations developed and promulgated by APSF checklists) and ful oversight of educational objectives and content to are intended to assist professionals who are respon- away from the satisfy ACCME guidelines. As an initial project, it is sible for making health care decisions. Recommenda- traditional reli- proposed that ASA partner with manufacturers of tions promulgated by APSF focus on minimizing the ance on memory anesthesia workstations to develop the educational risk to individual patients for rare adverse events and the cultural tool for “teaching advanced medical technology” rather than necessarily on practices that balance all perception of similar to previous ACCME-approved ASA work- aspects of population health quality and cost. APSF individual perfec- shops on the anesthesia workstation. does not intend for these recommendations to be tion. Cognitive Robert K. Stoelting, MD standards, guidelines or clinical requirements nor aids include a APSF President Research does application of these recommendations guaran- variety of physi- The APSF Committee on Scientific Evaluation tee any specific outcome. Furthermore, these recom- cal and electronic representations of knowledge “in chaired by Steven K. Howard, MD, received 44 letters mendations may be adopted, modified or rejected the world” designed to assist those responsible for of intent and invited eight investigators to submit according to clinical needs and restraints. APSF rec- perioperative care in executing complex decision completed applications for studies beginning January ognizes that these recommendations are subject to making in dynamic settings. This expert’s conference 1, 2016. In October 2015, the committee recom- revision as warranted by the evolution of medical concentrated on the practical aspects of systematically mended funding two research awards totaling knowledge, technology, and practice. implementing Emergency Manuals/Cognitive Aids $297,374 (see page 67). and Checklists in the perioperative setting. Ellison C. Pierce, Jr., MD, Patient In addition to the traditional research grant Safety Memorial Lecture Developing the Relationship Between awards, APSF continues its support of the APSF Safety Scientist Career Development Award (SSCDA) A highlight of the opening session of the annual APSF and Large Anesthesia/Practice ($150,000 over 2 years). The current recipient is meeting of the American Society of Anesthesiologists Management Groups Meghan D. Lane-Fall, MD, MSHP, Department of in San Diego, CA on October 24, 2015 was the ASA/ Following the September 9, 2015 conference on Anesthesia, Perelman School of Medicine, University APSF Ellison C. Pierce, Jr., MD, Patient Safety Memo- cognitive aids, APSF sponsored a half-day meeting of Pennsylvania. rial lecture delivered by Mark A. Warner, MD. Dr. on Thursday, September 10 with members of large Warner’s topic was Expanding Our Influence: How the anesthesia groups and representatives from practice In July 2015, APSF and the Anesthesia Quality Perioperative Surgical Home Will Improve Patient Safety. management groups. The goal was for these repre- Institute (AQI) co-sponsored the APSF/AQI Patient Safety Career Development and Research Award This named lectureship continues to be part of the sentatives to meet with members of the APSF Execu- with APSF and AQI sharing the cost of the grant annual ASA meeting thus providing sustained recog- tive Committee to discuss mutually relevant award of $120,000. The current recipient of this award nition for the vision and contributions to anesthesia opportunities to address anesthesia patient safety is Joseph A. Hyder, MD, PhD, Department of Anes- patient safety made by Dr. Pierce as the founding issues and to incorporate potential solutions into thesia, Mayo School of Medicine. president of APSF. best practices. In April 2015, the APSF Committee on Education Anesthesia Professionals and APSF Board of Directors Workshop and Training chaired by Richard C. Prielipp, MD and the Use of Advanced Medical with assistance of committee members, Brian J. Cam- The APSF Board of Directors Workshop occurred Technologies: Recommendations marata, MD, Sandeep Markan, MD, and Lianne Ste- on Saturday, October 24, 2015. The topic for this for Education, Training, phenson, MD, announced the APSF Resident 2-hour workshop was “From APSF Educational Videos and Documentation Quality Improvement (QI) Recognition Program. to your practice: How to make it happen." During this Program submissions will consist of a brief written workshop, the APSF educational videos, Prevention APSF believes that anesthesia professionals narrative and video submission describing the resi- and Management of Operating Room Fires, Periop should demonstrate competence to use advanced - dent’s QI project. The two winners were announced erative Visual Loss (POVL), and Simulated Informed medical technology before applying this technology to patient care. Anesthesia professionals have not at the Annual Meeting of the APSF Board of Directors Consent Scenarios for Patients at Risk for Periopera- meeting in October 2015 during the annual ASA tive Visual Loss were presented followed by small generally been required to demonstrate their compe- tence to use anesthesia technology to care for patients. meeting in San Diego, CA. The first and second place breakout sessions during which attendees met with winners received financial awards of $1,000 and $500, members of the APSF Executive Committee and Demonstrating competency to use medical devices is consistent with safe patient care. respectively and the winning entries will also be shared their opinions regarding strategies and showcased on the APSF website. impediments for implementing the recommenda- The 2015 report from the Committee on Equip- tions in the videos. Drs. Jeffrey M. Feldman and Lorri ment and Facilities recognized the universal agree- APSF is the largest private funding source for A. Lee represented the APSF Board of Directors as co- ment that individuals need to be adequately trained in anesthesia patient safety research in the world. Since the inception of the APSF grant program, 779 grant moderators for the workshop. the complexities of advanced medical technology in applications have been received by APSF. When the order to provide optimum safe care for patients. The Implementing and Using first grants were funded in 1987, funding for anesthe- most practical way to disseminate this information sia patient safety was virtually unknown. Since 1987, Emergency Manuals and Checklists and make it easily accessible is through an electronic APSF has awarded 105 grants for a total of more than to Improve Patient Safety format that can be accessed through the Internet. It is $9,744,227. The impact of these research grants is APSF held a consensus conference on this topic on vital that the content for this educational program more far-reaching than the absolute number of grants Wednesday, September 9, 2015 (Royal Palms Resort come from the manufacturer’s engineers and techni- and total dollars, as APSF-sponsored research has led and Spa, Phoenix, AZ). APSF believes there is a need cal specialists that developed the product to ensure for anesthesia professionals and other members of the that information is accurate. In that regard, it is being See “President's Report,” Next Page APSF NEWSLETTER February 2016 PAGE 50

APSF Seeks Candidates for Next APSF President “President's Report,” From Preceding Page PSF-NYPGA Safety Panel research support is particularly dependent on the A level of financial support received. to other investigations and the development of a Robert K. Stoelting, MD, moderated a panel enti- cadre of anesthesia patient safety investigators. tled APSF Safety Initiative: Implementing and Using Cog- Online Donations nitive Aids (Emergency Manuals and Checklists) to The link for online donations to APSF is http:// Improve Patient Safety on Sunday, December 13 during APSF Newsletter www.apsf.org/donate.php. Contributions may also The APSF Newsletter continues its role as a vehi- the 2015 annual meeting of the NYPGA. be mailed to the Anesthesia Patient Safety Foundation, cle for rapid dissemination of anesthesia patient 1061 American Lane, Schaumburg, IL 60173-4973. safety information with Robert C. Morell, MD, and APSF-AANA Annual Meeting Lorri A. Lee, MD, acting as co-editors. Steven B. APSF sponsored a 1-hour session at the 2015 Seeking Candidates Greenberg, MD, has recently been appointed as AANA annual meeting. The topic was fire safety for the Next APSF President Assistant Editor. with Charles Cowles, MD, and Maria van Pelt, PhD, I informed the 2015 Annual Meeting of the APSF CRNA, presenting. The APSF Newsletter is provided as a member Board of Directors (October 24, 2015) that I will not be benefit by the ASA, American Association of Nurse a candidate for President in October 2016. A Search Anesthetists (AANA), American Association of Prevention and Management Committee chaired by Robert A. Caplan, MD, has Anesthesiologists Assistants (AAAA), American of Operating Room Fires been charged with identifying candidates for the next Society of Anesthesia Technologists and Technicians To date, more than 8,000 individual requests for a APSF President with a term to begin October 22, (ASATT), American Society of PeriAnesthesia complimentary copy of the Prevention and Manage- 2016. The search process and deadline to receive Nurses (ASPAN), American Society of Dentist Anes- ment of Operating Room Fires DVD (http://www.apsf. applications (January 8, 2016) have been widely thesiologists (ASDA), American Dental Society of org/resources_video.php) have been received. APSF announced including in the APSF Newsletter and on Anesthesia (ASDA) and the American Association of has also created a Fire Prevention Algorithm Poster the APSF website. On October 22, 2016, at the Annual Oral Maxillofacial Surgeons (AAOMS) with a result- and an OR Fire Prevention Flyer that are available for Meeting of the APSF Board of Directors, the Search ing circulation of 122,210. In addition to the electronic download from the APSF website (http://www.apsf. Committee will recommend a candidate for the posi- version of the APSF Newsletter, a hardcopy is mailed org/resources_safety.php) tion of APSF President. to all members of the ASA, AANA, AAAA, ASPAN, and ASDA. Medication Safety Concluding Thoughts The “Question and Answers” and “Dear SIRS” in the Operating Room APSF thanks retiring Board Directors Robert A. (Safety Information Response System) columns in To date, more than 3000 individual requests for a Virag and John M. O’Donnell, CRNA, DrPH, and the APSF Newsletter provide rapid dissemination of complimentary copy of the 18-minute educational welcomes new directors, Jenney E. Freeman, MD, and safety issues related to anesthesia equipment in DVD entitled Medication Safety in the Operating Room: Wanda O. Wilson, PhD, CRNA. response to questions from readers. These columns Time for a New Paradigm (http://www.apsf.org/ As in the previous annual report, I wish to reiter- are coordinated by Drs. A. William Paulsen (Chair, resources_video2.php) have been received. ate the desire of the APSF Executive Committee to APSF Committee on Technology) and Robert C. provide a broad-based consensus on anesthesia Morell (Co-Editor, APSF Newsletter). The value of Financial Support patient safety issues. We welcome the comments and industry to anesthesia patient safety is reflected by suggestions from all those who participate in the these columns. Financial support to the APSF from individuals, specialty and components societies, and corporate common goal of making anesthesia a safe experience. There remains much still to accomplish and every- partners in 2015 has been most gratifying. This sus- Communication one’s participation and contributions are important. tained level of financial support makes possible the The APSF website design and appearance (www. undertaking of new safety initiatives, the continua- Best wishes for a prosperous and rewarding 2016. apsf.org) continues under the direction of APSF Exec- tion of existing safety initiatives, and funding for Robert K. Stoelting, MD utive Vice President George A. Schapiro. Online anesthesia patient safety research. The level of President donations to APSF are possible via the website. The APSF website includes a monthly poll ques- tion related to anesthesia patient safety issues. The poll question is coordinated by Timothy N. Harwood, MD, The Anesthesia Patient Safety Foundation a member of the APSF Committee on Education and Training chaired by Richard C. Prielipp, MD. gratefully acknowledges an educational grant from Sorin J. Brull, MD, continues as the Patient Safety Section Editor for Anesthesia and Analgesia. Dr. Brull will complete his tenure on January 1, 2016. APSF and the journal, Anesthesia and Analgesia thank Dr. Brull for his outstanding leadership as the “first anes- thesia patient safety section editor” for our specialty.

APSF-IARS Safety Panel www.merck.com APSF sponsored a panel entitled Three Myths of Anesthesia Patient Safety at the March 2015 annual congress of the International Anesthesia Research to support the February 2016 issue Society. The panel was moderated by Richard C. Pri- elipp, MD, Chair, APSF Committee on Education of the APSF Newsletter and Training. APSF NEWSLETTER February 2016 PAGE 51

Multi-Faceted Initiative Designed to Improve Safety of Neuromuscular Blockade by Maria van Pelt, PhD, CRNA; Hovig V. Chitilian, MD; and Matthias Eikerman, MD, PhD

The hidden universality of residual neuromus- similar occurrence rates of residual neuromuscu- inconsistent use of objective neuromuscular trans- cular blockade was initially brought to the atten- lar blockade as those reported in 1979.2,7-10 mission monitoring as well as the inappropriate dosing of neostigmine may explain the observed tion of anesthesiologists in 1979 by Jorgen Strategies to prevent residual blockade include persistence of residual neuromuscular block- Viby-Mogensen, who reported a 42% incidence of the judicious use of neuromuscular blocking agents ade.2,7-10 What should we do to complete Dr. Viby- unidentified residual neuromuscular blockade in (NMBD), the use of quantitative neuromuscular Mogensen’s mission to eliminate residual the recovery room (defined as a recovery of the monitoring, and the titration of reversal agents to train-of-four (TOF) ratio to 0.7).1,2 Current litera- 11 neuromuscular blockade? Important next steps effect. How then, can we explain the persistent include interdisciplinary efforts to develop and ture supports the idea that quantitative monitor- incidence of postoperative residual neuromuscular ing of the effects of neuromuscular blocking drugs adopt TOF-based guidelines for the intraopera- blockade? The answer may in part be due to the tive management of neuromuscular blockade and reduces the likelihood of unrecognized, clinically over-reliance of anesthesia professionals on clinical to implement these best practices consistently into significant residual muscle weakness in the post- signs, which are incapable of accurately identifying clinical practice.18 operative period, which should improve patient residual neuromuscular blockade. Clinical tests safety.3 National anesthesia societies have taken such as sustained head lift12-14 or grip strength15 are Data from the Massachusetts General Hospital varied stances in support of this patient safety easy to perform, but their sensitivity to residual (MGH) revealed a significant incidence of resid- topic. The American Association of Nurse Anes- ual neuromuscular blockade on admission to the blockade that affects upper airway function with- 19 thetists focused on the neuromuscular monitoring out affecting diaphragmatic function is poor (11– post-anesthesia care unit (PACU). Furthermore, standard as early as 1989.4 However, in 1992 when 14%).16 Clinicians often administer a fixed dose of an association between inappropriate neostig- this standard was revised to ensure that monitor- reversal agent intraoperatively and are predisposed mine dosing and postoperative respiratory com- plications was found.12 These outcomes revealed ing of “the neuromuscular response to assess to over-interpret the clinical exam as full recovery an opportunity to improve the quality of care pro- depth of blockade and degree of recovery” was immediately after anesthesia, when patients are vided with respect to intraoperative NMBD man- included in the basic monitoring standard, the use barely able to participate properly. Although these agement. Under the guidance of a committee 5 clinical tests require the generation of maximum of quantitative monitoring was not specified. consisting of anesthesia professionals (attending volitional muscle strength, in the presence of a fixed While the American Society of Anesthesiologists anesthesiologists, CRNAs, anesthesia residents), dose of reversal agent and a qualitative TOF twitch (ASA) recognizes the importance of the intraoper- PACU nurses, nurse practitioners, and depart- ative monitoring of neuromuscular blockade, it return, the patient’s limited test response is often mental Quality Assurance (QA)/Quality has not made this a component of the ASA moni- attributed to anesthetic recovery rather than resid- Improvement (QI) leadership and personnel, a toring standard. The Anesthesia Patient Safety ual neuromuscular blockade. The suboptimal clini- multifaceted initiative was designed to change Foundation has concluded, based on an extensive cal test results are thus erroneously interpreted as departmental practice with respect to the intraop- review of the literature, that residual neuromuscu- signs of sufficient neuromuscular recovery. erative management of neuromuscular blockade. lar blockade is a common, under-appreciated con- A TOF ratio greater than or equal to 0.9 indi- This initiative consisted of four components: dition that contributes to adverse events in the cates adequate recovery of neuromuscular trans- implementation of an education program; distri- postoperative period.6 Yet, despite the cumulative mission.17 The use of quantitative TOF monitoring bution of a cognitive aid; provision of feedback expert contributions made in this field over the in the operating room has been shown to decrease past 35 years, published studies continue to report the incidence of postoperative weakness.11 The See “Neuromuscular Blockade,” Next Page NEOSTIGMINE REVERSAL GUIDE Type of Monitoring Neostigmine Dose (administer with anticholinergic) Qualitative Quantitative Ideal Body Weight 70 kg patient (5 mg maximum) No twitch No twitch WAIT WAIT 1 twitch 1 twitch WAIT WAIT 2-3 twitches 2-3 twitches ~50 mcg/kg 3 to 4 mg 4 twitches with fade TOF ratio (<0.4) ~40 mcg/kg 2 to 3 mg 4 twitches without fade TOF ratio (<0.4–0.9) 15 to 25 mcg/kg 1 to 2 mg TOF ratio (>0.9) NONE NONE Risk Factors for Residual Postoperative Paralysis High total dose of neuromuscular blockade (>1.5 mg/kg rocuronium; >0.4 mg/kg cisatracurium) High dose neostigmine reversal (>60 mcg/kg) Always dose neuromuscular blockers and reversal/anticholinergic according to monitoring and clinical condition. Design by MJ Meyers 2015 Kopman AF et al, Anesthesia 2009, 51:22-30. APSF NEWSLETTER February 2016 PAGE 52

Residual NMB Remains Common Problem

“Neuromuscular Blockade ,” From Preceding Page Maria van Pelt, PhD, CRNA 8. Sasaki N, Meyer MJ, Malviya SA, et al. Effects of neostig- Team Leader Nurse Anesthesia mine reversal of nondepolarizing neuromuscular block- regarding departmental progress; and the adoption Divisions of Neurosurgery, Vascular and Thoracic ing agents on postoperative respiratory outcomes: a prospective study. Anesthesiology 2014;121(5):959–968. of a TOF documentation requirement for our depart- Department of Anesthesia, Critical Care and Pain ment's quarterly QI incentive bonus. Over the course Medicine 9. Martinez-Ubieto J, Ortega-Lucea S, Pascual-Bellosta A, et of two months, two department-wide presentations al. Prospective study of residual neuromuscular block Massachusetts General Hospital and postoperative respiratory complications in patients (including a case conference) were devoted to a pre- Harvard Medical School sentation of the data regarding the incidence and reverted with neostigmine versus sugammadex. Minerva Hovig V. Chitilian, MD anestesiologica 2015. Available at: http://www.ncbi.nlm. effects of residual paralysis. Attending anesthesiolo- nih.gov/pubmed/26472231. Accessed 12/31/2015. gists, CRNAs, and anesthesia resident champions Assistant Professor of Anaesthesia 10. Murphy GS, Szokol JW, Avram MJ, et al. Residual neuro- were identified and designated as informational Department of Anesthesia, Critical Care and Pain Medicine muscular block in the elderly: Incidence and clinical resources for questions and concerns. Furthermore, implications. Anesthesiology 2015;123:1322-36. an online repository was created with links to the rel- Massachusetts General Hospital Harvard Medical School 11. Murphy GS, Szokol JW, Marymont JH, et al. Intraopera- evant literature in the field. The cognitive aid, a TOF- tive acceleromyographic monitoring reduces the risk of based neostigmine-dosing guide, was developed by Matthias Eikermann, MD-PhD residual neuromuscular blockade and adverse respira- one of our anesthesia residents (Matthew Meyer, Associate Professor of Anaesthesia tory events in the postanesthesia care unit. Anesthesiol- MD) and distributed to the members of the depart- Clinical Director, Critical Care Division ogy 2008;109:389–398. ment in an electronic format. It was also made avail- Department of Anesthesia, Critical Care and Pain 12. McLean DJ, Diaz-Gil D, Farhan HN, Ladha KS, Kurth T, able to them online and affixed to each anesthesia Medicine Eikermann M. Dose-dependent association between machine (Figure 1). Our department participates in a intermediate-acting neuromuscular-blocking agents and Massachusetts General Hospital postoperative respiratory complications. Anesthesiology quarterly QI bonus program. As a "nudge" towards Harvard Medical School 2015;122:1201–1213. the adoption of better NMBD management practices, References 13. Pavlin EG, Holle RH, Schoene RB. Recovery of airway we tied the quarterly QI bonus to the rate of docu- protection compared with ventilation in humans after mentation of twitches within the fifteen minutes 1. Viby-Mogensen J, Jorgensen BC, Ording H. Residual paralysis with curare. Anesthesiology 1989;70:381-385. prior to the administration of neostigmine. Our goal curarization in the recovery room. Anesthesiology 1979;50(6):539–541. 14. Dam WH, Guldmann N. Inadequate postanesthetic ven- was to provide a reminder to evaluate neuromuscu- 2. Eikermann M. The hidden universality of residual neuro- tilation. Curare, anesthetic, narcotic, diffusion hypoxia. lar blocking reversal dosing in a manner that was not muscular blockade. Letter to the Editor. Available at: Anesthesiology 1961;22:699-707. intrusive, easy to implement, and easy to monitor. http://bja.oxfordjournals.org/letters/?first- 15. Bodman, RI. Evaluation of two synthetic curarizing The initiative has succeeded in improving the docu- index=11&hits=10&days=60. Accessed 12/31/2015. agents in conscious volunteers. Br J Pharmacol Che- mentation of TOF. We are currently in the process of 3. Brull SJ, Murphy GS. "Residual neuromuscular block: mother 1952;7:409-416. evaluating its effects on clinical outcomes. lessons unlearned. Part II: methods to reduce the risk 16. Debaene B, Plaud B, Dilly M-P, Donati, F. Residual paral- of residual weakness." Anesth Analg 2010;111:129–140. ysis in the PACU after a single intubating dose of nonde- We know that residual neuromuscular block- 4. Guidelines and Standards for Nurse Anesthesia Practice: polarizing muscle relaxant with an intermediate ade is a relevant problem that leads to a significant Patient Monitoring Standards. American Association of duration of action. Anesthesiology 2003;98:1042-1048. Nurse Anesthetists 1992. Available at: https://www. increase in respiratory morbidity and health care 17. Murphy GS, Szokol JW. Monitoring neuromuscular 8,12,20 aana.com/newsandjournal/Documents/patient_moni- utilization. However, residual neuromuscular toring_0492_p137.pdf. Accessed 12/31/2015. blockade. Int Anesthesiol Clin 2004;42(2):25–40. blockade remains pervasive despite the advances 5. Standards for Nurse Anesthesia Practice. American Asso- 18. Brull SJ, Prielipp RC. Reversal of neuromuscular block- in our understanding of this challenge since Dr. ciation of Nurse Anesthetists 2013. Available at: http:// ade: "identification friend or foe." Anesthesiology Viby-Mogensen’s 1979 report. The fundamental www.aana.com/resources2/professionalpractice/Docu- 2015;122:1183–1185. issue appears to be the continued reliance by anes- ments/PPM%20Standards%20for%20Nurse%20Anes- thesia%20Practice.pdf. Accessed 12/31/2015. 19. Brueckmann B, Sasaki N, Grobara P, et al. Effects of thesia professionals on informal and variable sugammadex on incidence of postoperative residual 6. Stoelting, RK. APSF survey results: Drug-induced neuromuscular blockade: a randomized controlled study. applications of qualitative clinical indicators muscle weakness in the postoperative period safety ini- rather than use of objective and quantitative TOF tiative. APSF Newsletter 2013-14;28:49,70-71. Br J Anaesth 2015;115:743–751. stimulation to determine appropriate reversal of 7. Brueckmann B, Villa-Uribe JL, Bateman BT, et al. Devel- 20. Staehr-Rye AK. GS, Grabitz SD, Thevathasan T, Sasaki N, neuromuscular blockade. The quantitative mea- opment and validation of a score for prediction of post- Meyer MJ, Gätke MG, Eikermann E. Effects of residual surement of TOF stimulation is a reliable and operative respiratory complications. Anesthesiology paralysis on postoperative pulmonary function and hos- 2013;118(6):1276–1285. pital length of stay. ASA Abstract 2015; A4026. objective measurement of adequate return of neu- romuscular activity, and can be effectively used as a guide for appropriate neostigmine dosing. The QA/QI initiative at the MGH is an example of an The Anesthesia Patient Safety Foundation integrated interdisciplinary approach by key stakeholders to promote sustained adoption of gratefully acknowledges the donation from these best practices and improve patient safety. Broader adoption of similar evidenced-based ini- tiatives and guidelines should provide a signifi- cant leap forward towards the elimination of the hidden universality of residual neuromuscular blockade and reduce the co-morbidities and added healthcare utilization associated with resid- ual neuromuscular blockade. Financial Disclosure: Dr. Eikermann has received in support of the grant funding from Merck and holds equity shares at Calabash Biotechnology. The remaining authors report 2016 APSF Grant Program no financial disclosures APSF NEWSLETTER February 2016 PAGE 53

The Development and Regulatory History Safety Must Extend into of Sugammadex in the United States Perioperative Period “Expanding Influence,” From Page 48 by Glenn Murphy, MD undergoing procedures in body parts that have high The Neuromuscular Research Group at Orga- By Fvasconcellos (Own work) [Public domain], via Wikimedia Commons concentrations of dwelling bacteria. Colorectal sur- non Newhouse Scotland (east of Glasgow) had gery is a good example. been working on the development of fast-onset, Blood products contain much debris, including short-acting, nondepolarizing steroidal neuromus- free hemoglobin and cellular stroma that can be toxic cular blocking agents since the 1960s, which led to to organs such as kidneys. Processes that lead to the development of pancuronium, vecuronium reductions in blood transfusion are cost-effective, and rocuronium. Shortly after the launch of improve patient care in these settings, and help avoid rocuronium, questions arose about a possible prolonged disability, sepsis, and multi-organ failure. action of rocuronium on smooth muscle neuro- Approximately 40% of all blood products are trans- transmission, so Dr. Anton Bom was contacted. Dr. fused into surgical and procedural patients. The spe- Bom was performing smooth muscle studies at the cialty is perfectly positioned to take lead roles in same research site. Rocuronium is not very water developing new algorithms or modifying existing soluble, so buffer solutions with a pH of 4 are algorithms for their specific practices and patient required. Dr. Bom attempted to dissolve Space-filling model of sugammadex sodium. populations. In collaboration with transfusion medi- rocuronium in organic solvents that were tradi- cine specialists, surgeons, and proceduralists, anes- tionally used for smooth muscle studies, none of In March of 1999, the first batch of Org 25969 thesiologists and their care teams can work within which were able to solubilize rocuronium. Next, (now known as sugammadex) was produced. In health care settings to design and implement success- he decided to examine cyclodextrins, which were all pharmacological screening tests, this molecule ful processes to reduce4,5 the use of blood products demonstrated to dissolve steroidal hormones. showed the desired profile. and decrease perioperative complications. Cyclodextrins are rigid, ring-shaped molecules Both the concept of using modified cyclodex- Human factors: Each step in a clinical pathway or composed of sugar units. The outside of the cyclo- trins as reversal agents and the structure and syn- process, whether it has been designed or occurred dextrin is hydrophilic, which makes the molecule thesis of sugammadex and related cyclodextrins naturally, increases the opportunity for human error. water-soluble. The hole in the middle of the cyclo- were patented in 2001. The first human study was Anesthesiologists, working closely with their health dextrin ring is hydrophobic, which allows lipo- performed in healthy volunteers and published in care colleagues and system engineers, can analyze, philic molecules, like steroids, to enter this cavity, 2005.1 This investigation demonstrated that 3 min- design, assess and continuously improve periopera- 1 creating water-soluble complexes. utes after the administration of a normal intuba- tive care pathways and processes by eliminating Since rocuronium has a steroidal nucleus, Dr . tion dose of rocuronium (0.6 mg/kg), 8 mg/kg of unnecessary steps. It is the right thing to do Bom speculated that rocuronium would form com- Org 25969 could completely reverse neuromuscu- financially—reducing­ steps decreases expenses and plexes with cyclodextrins. This binding would pre- lar blockade. Since the publication of this initial increases efficiency. It is the right thing to do clini- vent rocuronium from acting on the nicotinic investigation, sugammadex has been administered cally—reducing steps decreases errors. It is the right acetylcholine receptor and allow rapid reversal of to over 6000 patients in clinical trials. In addition, thing to do for our patients—reducing steps neuromuscular blockade. His initial studies con- sugammadex is approved in 57 countries, with decreases complications and increases patient safety. approximately 11.5 million patients receiving the Expansion of anesthesia care beyond intraopera- firmed that rocuronium formed complexes with 1 cyclodextrins. However, this binding was weak, drug as of March 2015. tive management and into an encompassing periop- allowing rocuronium to easily disassociate. Several The first regulatory approval was in the Euro- erative setting makes sense clinically because patients modifications of the molecule were required to pean Union in 2008. In 2007, an application for will benefit. It is another step forward in expanding increase affinity. The cavity of the cyclodextrin was approval to the FDA was submitted. In 2008, the the influence of the specialty in the safety of patients too small, so the cavity had to be extended by the FDA Advisory Committee unanimously recom- who are anesthetized for their surgical and proce- addition of side-chains to each sugar unit. To ensure mended approval. However, the FDA issued a dural care. that the side-chains did not enter the cavity, nega- Not-Approvable Letter at this time. The FDA Visionary leaders of the specialty during the past tively charged end-groups had to be attached to the requested further characterization of sugamma- generation have noted that anesthesia care must side-chains. These modifications would allow a dex on repeat exposures due to concerns over evolve. Table 3 provides several of the quotes taken tight complex to form between the quaternary hypersensitivity and anaphylactic reactions, as from selected ASA Rovenstine Lectures. These vision- nitrogen of the rocuronium and the negatively well as possible mechanistic causes of events. In ary colleagues had it right—expansion of the spe- charged ends of the side-chains. Dr. Ming Qiang the initial submission, there was one case of ana- cialty to encompass perioperative care is necessary Zhang, a medical chemist, then provided a long list phylaxis and 31 cases of hypersensitivity. In BECAUSE IT IS THE RIGHT THING TO DO FOR addition, a small prolongation of aPTT and PT of commercially available cyclodextrin molecules. 3 OUR PATIENTS. The pharmacologists created in-vitro and in-vivo was noted in an in-vitro study. Further studies evaluating the effects of sugammadex on surgical I propose that the APSF reconsider its vision state- screening models, which allowed the creation of ment, “No patient shall be harmed by anesthesia.” It new cyclodextrin derivatives.1 bleeding were also requested. Finally, the need for additional studies examining the effects of is now time that the statement should read, “No Sugammadex was developed to selectively sugammadex on cardiac arrhythmias and QT patient undergoing an anesthetic shall be harmed in bind to rocuronium. However, other steroidal prolongation was noted. the perioperative period.” This is the imperative you muscle relaxants, such as vecuronium and pan- want to follow if you wish to expand the influence of In response to the FDA's requests, 4 additional curonium, are bound by sugammadex, but with a the specialty into the future. This is the imperative you studies were conducted examining the impact of much lower affinity. There is no affinity of sugam- want to follow if you wish to have a greater influence sugammadex on coagulation. These investigations madex for other classes of muscle relaxants (i.e. on patient safety. This is the imperative you wish to demonstrated a small increase in PT and aPTT that have followed if you are the patient.” succinylcholine and the benzylisoquinoliums occurred within minutes of administration, but (mivacurium, atracurium and cisatracurium). One resolved within an hour. In addition, in a large Dr. Warner is Professor of Anesthesiology and molecule of sugammadex is able to noncovalently Executive Dean at the Mayo Clinic College of Medicine bind one molecule of steroidal muscle relaxant.2 See “Sugammadex” Next Page in Rochester, Minnesota. APSF NEWSLETTER February 2016 PAGE 54

Sugammadex Approved After Multiple Delays “Sugammadex” From Preceding Page (TOF ratio of 0.9) with sugammadex is 1.5 minutes sity of Chicago Pritzker School of Medicine. He is pres- 8 study of patients undergoing hip or knee replace- versus 19 minutes with neostigmine. Further- ently on the editorial board of the APSF. ment surgery, no increase in bleeding or transfusion more, in urgent or emergent reversal of large doses requirements was observed in patients randomized of rocuronium (1.2 mg/kg), the mean time to neu- References to receive sugammadex.3 In order to address con- romuscular recovery is significantly faster with 1. Gijsenbergh F, Ramael S, Houwing N, van Iersel T. First cerns related to cardiac arrhythmias, an analysis of sugammadex (16 mg/kg) compared to spontane- human exposure of Org 25969, a novel agent to reverse the 9 action of rocuronium bromide. Anesthesiology 2005;103: phase 2 and 3 clinical studies was conducted, as ous recovery with succinylcholine. Sugammadex 695–703. 4,5 well as an analysis of postmarketing data. These will allow increased flexibility of neuromuscular 2. Schaller SF, Fink H. Sugammadex as a reversal agent for study findings indicated that QTc was not pro- management in the operating room; deep block- neuromuscular block: an evidence-based review. Core Evi- dence 2013:8 57–67. longed in patients given sugammadex. The studies ade can be maintained until the end of surgery if 3. Rahe-Meyer N, Fennema H, Schulman S, Klimscha W, also indicated that arrhythmias did not occur with required and then quickly reversed. Most impor- Przemeck M, Blobner M, Wulf H, Speek M, McCrary Sisk C, greater frequency with sugammadex compared to tantly, the risk of residual neuromuscular blockade Williams-Herman D, Woo T, Szegedi A. Effect of reversal of neostigmine, although bradycardia can occur with neuromuscular blockade with sugammadex versus usual in the PACU can be significantly reduced if care on bleeding risk in a randomized study of surgical both agents. Finally, a randomized, double-blind, sugammadex is appropriately dosed. In the patients. Anesthesiology 2014;121:969–77. placebo-controlled study in healthy volunteers was absence of consistent neuromuscular blockade 4. de Kam PJ, Kuijk JV, Smeets J, Thomsen T, Peeters P. conducted to evaluate the incidence of allergic reac- monitoring with peripheral nerve stimulators Sugammadex is not associated with QT/QTc prolonga- tions to sugammadex.6 tion: methodology aspects of an intravenous moxifloxa- and/or specified guidelines for reversal, recent cin-controlled thorough QT study. Int J Clin Pharmacol In 2012, another submission for approval was data has demonstrated that the risk of residual Ther 2012;50:595–604. sent to the FDA. In 2013, a Complete Response block in the PACU can be reduced from 43% in 5. de Kam PJ, Grobara P, Dennie J, Cammu G, Ramael S, Jagt- Smook ML, van den Heuvel MW, Berg RJ, Peeters PA. Letter was provided to the sponsor. The FDA patients given neostigmine to 0% in those given Effect of sugammadex on QT/QTc interval prolongation reported that protocol violations in the hypersensi- sugammadex.10 Finally, data from phase 1–3 clini- when combined with QTc-prolonging sevoflurane or pro- tivity study had been observed, which raised data cal studies, volunteer subject investigations and pofol anaesthesia. Clin Drug Investig 2013;33:545–551. reliability issues. However, bleeding and arrhyth- 6. Merck Sharp & Dohme Corp. A study to evaluate the inci- post-marketing data in over 12 million patients dence of hypersensitivity after administration of sugam- mia risks had been adequately addressed. In 2014, have demonstrated that sugammadex is safe, with madex in healthy participants (MK-8616-101). In: the sponsor resubmitted a new hypersensitivity a rare risk of anaphylactic reactions that are treat- ClinicalTrials.gov [Internet]. Bethesda (MD): National trial in awake volunteers. A total of 375 awake sub- 7 Library of Medicine (US). 2000- [cited 2014 Jan 13]. Avail- able with standard therapy. able from: http://clinicaltrials.gov/show/ NCT02028065 jects were given 3 intravenous doses of sugamma- The adoption of sugammadex by hospitals, NLM Identifier: NCT02028065. dex (4 mg/kg, 16 mg/kg, or saline), and patients 7. Merck Sharp & Dohme Corp. NDA 22225: Sugammadex examined for hypersensitivity or anaphylactic reac- pharmacies and anesthesia providers may be Injection Anesthetic and Analgesic Drug Products Advi- tions. One case met the criteria for anaphylaxis in impacted by cost concerns. As with all newly sory Committee (AC) Meeting: Sugammadex Advisory Committee Briefing Document, Kenilworth, NJ, November the 16 mg/kg dose group (no hypotension or FDA-approved drugs, anesthesia providers 6, 2015. wheezing, treated with steroids and diphenhydr- should be aware that post-marketing surveillance 8. Blobner M, Eriksson LI, Scholz J, Motsch J, Della Rocca G, amine), although the mechanism was unclear (no provides a vehicle for communicating with the Prins ME. Reversal of rocuronium-induced neuromuscular tryptase or IgG/IgE specific for sugammadex). Fur- FDA about any concerns of adverse events that blockade with sugammadex compared with neostigmine during sevoflurane anaesthesia: results of a randomised, thermore, no cases of anaphylaxis were reported in may be associated with this new drug. controlled trial. Eur J Anaesthesiol 2010;27:874–81. 3,519 patients administered sugammadex in clinical 9. de Boer HD, Driessen JJ, Marcus MA, Kerkkamp H, Heer- trials. Finally, in postmarketing data, 273 reports of Financial Disclosure: Dr. Murphy discloses that he inga M, Klimek M. Reversal of rocuronium-induced (1.2 anaphylaxis were reported in approximately 11.5 mg/kg) profound neuromuscular block by sugammadex: a is on the advisory board of Merck and has served as a multicenter, dose-finding and safety study. Anesthesiology million sugammadex exposures, with 237 of 241 2007; 107: 239–244. 6 consultant for Merck and CASMED. patients recovering with standard therapy. 10. Brueckmann B, Sasaki N, Grobara P, Li MK, Woo T, de Bie J, Glenn Murphy is Director of Anesthesiology Maktabi M, Lee J, Kwo J, Pino R, Sabouri AS, McGovern F, In 2015, a second Complete Response Letter Research at NorthShore University HealthSystem and Staehr-Rye AK, Eikermann M. Effects of sugammadex on was sent to the sponsor. At one site of the hyper- incidence of postoperative residual neuromuscular block- sensitivity study, staff who dosed subjects in one is Clinical Professor of Anesthesiology at the Univer- ade: a randomized, controlled study. BJA 2015; 115: 743–751. cohort performed adverse assessments in a differ- ent cohort. The FDA requested additional site inspections and sensitivity analysis. In November of 2015, the FDA again convened to review the resubmitted data. After review of all submitted studies as well as postmarketing data, the FDA Advisory Committee again unanimously recom- mended approval.7 Approximately 8 years after The Anesthesia Patient Safety Foundation the initial FDA submission, sugammadex , owned gratefully acknowledges an educational grant from and marketed by Merck, received FDA approval on December 16, 2015. Sugammadex represents a novel and new drug, which offers several important advantages over current anticholinesterase reversal agents. Deep levels of neuromuscular blockade (train-of- four (TOF) count of 0, post-tetanic count of 1–2) www.medtronic.com can be reversed effectively with 4 mg/kg of sugammadex within 3 minutes, whereas neostig- in full sponsorship of the mine is ineffective in antagonizing deep blockade. At moderate levels of neuromuscular block (TOF October 2015 APSF Newsletter count of 2), the mean time to achieve full recovery APSF NEWSLETTER February 2016 PAGE 55

Large Groups Prioritize Safety Issues ANESTHESIA PATIENT “Large Practice Groups,” From Cover APSF’s hope that these entities would individu- SAFETY FOUNDATION ally endorse and adopt selected APSF recommen- dations that are relevant to their practices, needs One option is for professional associations CORPORATE and resources. (ASA, AANA, AAAA) to adopt APSF recommen- dations in the form of policy statements (Stan- Following these introductory comments, the ADVISORY COUNCIL dards, Practice Advisories) that would be attendees met in three breakout groups with mem- applicable to all association members. The reality bers of the APSF Executive Committee to consider of this option is unlikely considering the widely three questions (see below) with the goal of creat- George A. Schapiro, Chair diverse opinions and practice profiles of the mem- ing a report to present to the conference’s general APSF Executive Vice President bers of these organizations. session. Bullet points following the questions rep- resent conclusions/recommendations from each Gerald Eichhorn...... AbbVie The second option for APSF recommendations of the three breakout groups and the number in to become “best practices” is “spreading the word” parentheses represents the number of times this Jimena Garcia...... Baxter Healthcare among individual anesthesia professionals via edu- statement appeared independently in each group. cational materials (such as conference reports in the Timothy Vanderveen, 1. In your practice, what do you consider to be APSF Newsletter) or educational videos. Although PharmD...... Becton Dickinson the written word is the traditional approach, APSF the most important safety issues in terms of potential harm to patients? also believes educational videos provide a robust Mike Connelly...... B. Braun model that could be more powerful than a written • Production pressures (3) Michael Grabel...... Codonics report for effecting change. • Communication (handoffs, coordination of care, culture of ongoing learning) (3) The third option for effecting change and the Dan J. Sirota...... Cook Medical • Distractions in the operating room (2) principal reason to involve large anesthesia • Monitoring postoperative respiratory David Karchner...... Dräger Medical groups and practice management groups is depression (obstructive sleep apnea) (2) • Medication safety (2) Leslie C. North, RN...... Eagle Pharmaceuticals • Anesthesia for surgery in non-operating Table 1: Large Anesthesia/Practice Manage- Matti E. Lehtonen...... GE Healthcare ment Groups Represented at Conference room locations (2) American Anesthesiology 2. Please describe how APSF can best partner Mark J. Scott...... 3M Infection with “your practice” to advocate patient safety Prevention Division Anesthesia Associates of Massachusetts (Boston, MA) initiatives. Chris Dax...... Masimo Cleveland Clinic (Cleveland, OH) • Disseminate information (APSF Newsletter, Community Health Systems (Franklin, TN) videos, social media) Patty Reilly, CRNA...... Medtronic • Stronger statements/recommendations Department of Veterans Affairs • APSF become a conduit/convener of large Rachel A. Hollingshead, RN...... Merck First Colonies Anesthesia Associates (FCAA) anesthesia groups to share information and (Frederick, MD) best practices • Develop toolkits for safety initiatives Jeffrey M. Corliss...... Mindray Integrated Anesthesia Associates (East Hartford, CT) (emergency manuals, checklists) Kathy Hart...... Nihon Kohden Kaiser Permanente • Workshop on developing a “safety officer” (safety champions in each large group) America Linn County Anesthesiologists (Hiawatha, IA) • Confront safety issues resulting from Daniel R. Mueller...... Pall Corporation Mayo Clinic (Rochester, MN) postoperative respiratory depression, production pressures, office-based anesthesia Mark Wagner...... PharMEDium North American Partners in Anesthesia (NAPA) • Design a “better” human (Melville, NY) Services 3. APSF has a specific interest in the “simulation Northside Anesthesiology Consultants (Atlanta, GA) Heidi Hughes, RN...... Philips Healthcare component” of MOCA based on the belief that NorthStar Anesthesia (Irving, TX) simulation provides “practice for managing Steven R. Sanford, JD ...... Preferred Physicians rare emergencies.” Do you believe a require - Medical Risk Old Pueblo Anesthesia (Tucson, AZ) ment for simulation based on “practice for rare Retention Group PhyMED Healthcare Group (Nashville, TN) emergencies” would bring value to members of your group? Sheridan Healthcorp Andrew Greenfield, MD....Sheridan Healthcorp • Could these experiences be transmitted in Southern Arizona Anesthesia (Tucson, AZ) different ways without requiring travel to a Tom Ulseth...... Smiths Medical simulation site (online experiences to TeamHealth Anesthesia Andrew Levi...... Spacelabs practice crisis management)? Tejas Anesthesia (San Antonio, TX) • High value for team training more than for Cary G. Vance...... Teleflex rare events; should not be required Twin Cities Anesthesia Associates (St Paul. MN) Abe Abramovich In addition to the breakout group reports, the US Anesthesia Partners results of a Pre-conference Survey that had been Robert K. Stoelting, MD Valley Anesthesiology and Pain Consultants (Phoenix, AZ) sent to attendees prior to the conference (29 out of a possible 36 surveys were returned) were pre- Vanderbilt University School of Medicine (Nashville, TN) See “Large Practice Groups,” Next Page APSF NEWSLETTER February 2016 PAGE 56

Multiple Large Anesthesia Groups Participate in Workshop and Give Input

“Large Practice Groups,” From Preceding Page • Develop videos of simulated “emergency Based on the breakout group recommenda- situations” tions and the survey responses, it is concluded sented to the attendees (bullet points represent • Provide “nudge” for large groups to pursue that high priority safety issues viewed as placing survey responses). safety initiatives patients at risk for harm were (1) distractions in 1. In your practice, what do you consider to be • Facilitate dissemination of “best practices” the operating room, (2) production pressures, the most important patient safety issues in 4. Do you perceive a downside/risk for your and (3) communication issues. Medication safety, terms of potential harm to patients? anesthesia group partnering with APSF to technology training, monitoring postoperative (responses in order of frequency) incorporate specific safety initiatives? An respiratory depression and monitoring neuro- example would be requiring “advanced medi- muscular blockade were also mentioned as safety • Distractions in the operating room cal technology training” paralleling the pub- concerns. • Production pressures lished APSF recommendations. • Communication (handoffs) Overall, the attendees seemed to endorse a role Yes (3) No (25) • Medication safety for APSF in advocating best practices based on • Postoperative respiratory monitoring, • Stress many are feeling over mandates safety initiatives with reservations related to evi- neuromuscular blocker monitoring • Cost of implementing dence to support the recommendations and cost of • Recommendations based on evidence 2. Please rank the importance of APSF safety ini- implementing these changes. There was agree- • Maximize “brand value” of APSF tiatives in your practice. ment that simulation for “practice for managing APSF safety initiatives that were viewed as 5. APSF has a specific interest in the “simulation rare emergencies” had merit, but logistics and cost “high priority for my practice” were: component” of MOCA based on the belief were problematic. that simulation provides “practice for manag- • Distractions in the operating room ing rare emergencies.” APSF will consider the conclusions and recom- • Production pressures mendations of this conference for implementing Do you believe a requirement for simulation • Medication safety in the operating room based on “practice for rare emergencies” would “best practices” on a broader scale than “one anes- • How to deal with the “outlier” practitioner bring value to members of your group? thesia professional at a time” and for establishing • Confirming competence before using priorities for future safety initiatives. APSF believes Yes (23) No (4) advanced medical technology that large anesthesia/practice management groups 3. Please describe how APSF can best partner • Simulation is a powerful and underleveraged offer an opportunity for an ongoing partnership with with “your practice” to advocate patient safety tool APSF as we pursue our mutual vision that “no initiatives. • Endorsement of APSF would be helpful patient shall be harmed by anesthesia.” • Logistics and cost is problematic • Set priorities for large groups to “consider” • Tried to mandate for our group and Robert K. Stoelting, MD • Use large groups to “test” safety initiatives resistance was enormous President, APSF

APSF Website Offers Online Educational DVDs

Visit the APSF website (www.apsf.org) to view the following DVDs and request a complimentary copy.

• Opioid-Induced Ventilatory Impair- • Perioperative Visual Loss (POVL): • APSF Presents Simulated Informed ment (OIVI): Time for a Change in Risk Factors and Evolving Man- Consent Scenarios for Patients at the Monitoring Strategy for Postop- agement Strategies (10 minutes) Risk for Perioperative Visual Loss erative PCA Patients (7 minutes) Ischemic Optic Neuropathy (18 minutes) APSF NEWSLETTER February 2016 PAGE 57 EDITOR’S How Do I Prepare for OR Power Failure? by Erica L. Holland, MD; Carli D. Hoaglan, MD; Martha A. Carlstead, CRNA; Ryan P. Beecher, CRNA; Grete H. Porteous, MD Introduction Table 1. Vulnerability of operating room equipment and hospital services to power failure Loss of electrical power in a hospital is a This table is intended as an overview, as actual equipment performance may vary based on institution patient safety hazard that has been neglected in and make and model of device. Devices with limited or no battery back-up should operate if plugged medical training and research.1,2 The technol- into an emergency circuit (“red outlet”) and generators are working. ogy-rich environment of the operating room Substantial battery back-up, or not dependent on electrical power (OR) puts patients at risk should a sudden loss Anesthesia machine/ventilator Portable ultrasound machines of power occur, as lights and critical equipment EDITOR’S may fail without warning. Regional disasters Non-desflurane vaporizers Intra-aortic balloon pump and extreme weather events are the most Portable patient monitors Laptop computers common causes of power outages. Extreme Portable infusion pumps Medical gases (e.g., pipeline oxygen) weather events have become more common in the past two decades, and it is projected that Portable suction regional power failures will occur more fre- Limited or no battery back-up quently and last longer in future years, despite Room lights Patient warming devices 3,4 efforts to improve power grid resiliency. Hos- End-tidal gas analyzer Transesophageal echocardiography pital power failure may also be the result of a machines local disruption of municipal power, or be lim- Automated medication dispensing devices Wall suction and scavenging systems ited to a single institution. Published case (e.g., Cerner’s RxStation®) reports (Appendix 1 on page 62) suggest that ® frequent root causes of intraoperative power loss Desflurane vaporizer Da Vinci Surgical System* are a failure of emergency generators to function Patient monitors without battery back-up Video towers during a widespread power outage, and hospi- Electrosurgical units Cardiopulmonary bypass machine tal construction work that unmasks faults in Fluoroscopy/portable X-ray units Desktop computers without battery internal electrical systems.5-11 These reports Fluid warmers/rapid infusion devices Cell salvage machine underscore the fact that hospital emergency generators and back-up systems are not com- Depends on institution pletely reliable. Anesthesia providers need to WiFi/Internet access Badge-activated door locks know as much about responding to power fail- Paging systems Electronic medical record ure as they do about managing any other intra- Telephones operative crisis. As there is no centralized reporting system for hospital power failure *Battery allows undocking of patient from robot. events, the true incidence of this emergency is unknown. Based on anecdotal experience, we their batteries are finally depleted. Electronic Our anesthesia department at a tertiary-care believe it may be more common than is gener- patient monitors, desflurane vaporizers, and medical center was recently faced with the chal- ally appreciated. end-tidal gas analyzers often lack battery lenge of preparing for electrical upgrades in a In addition to direct effects on critical back-up. Hospital power failure may new hospital building that could temporarily anesthesia equipment, other repercussions of compromise communications (telephones, compromise emergency generator power deliv- ery to a suite of operating rooms and other criti- power outage in the OR can be extensive (Table pagers, WiFi), electronic medical records, access cal areas. Published reports suggest that 1). Power failure often translates to loss of to critical medications from automated lighting in the OR and adjacent hallways. anesthesia departments should be knowledge- dispensing cabinets, room temperature control, able about the battery life and capabilities of their Surgeons are faced with loss of electrosurgical sterilization capabilities, elevators, and staff units, video display monitors, and suction.6,8 equipment, should have sources of back-up light- access to clinical areas through badge-secured ing and monitoring immediately available, and Anesthesia machines and ventilators revert to 12,13 battery power, which may last from 30 to 90 doors. In some cases, operations may need to should have a disaster plan that engages the minutes depending on device and manufacturer be aborted and patients evacuated. Prolonged entire OR staff. We thus embarked upon a project specifications. Surprisingly, there are few reports hospital power failure eventually impacts to review our current emergency plans, test the on how well anesthesia machines function on sanitation, access to food and clean water, functionality of key anesthesia equipment during battery power, and what can be expected when transportation and security. See “Power Failure,” Next Page

The APSF sometimes receives questions that are not suitable for the Dear SIRS column. This Q and A column allows the APSF to forward these questions to knowledgeable committee members or designated consultants. The information provided is for safety-related educational purposes only, and does not constitute medical or legal advice. Individual or group responses are only commentary, provided for purposes of education or discussion, and are neither statements of advice nor the opinions of the APSF. It is not the intention of the APSF to provide specific medical or legal advice or to endorse any specific views or recommendations in response to the inquiries posted. In no event shall the APSF be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with the reliance on any such information. EDITOR’S

APSF NEWSLETTER February 2016 PAGE 58

EDITOR’S OR Power Failure Can Be a Critical Event “Power Failure,” From Preceding Page Table 2. Results of anesthesia equipment testing

power failure, and develop a safety checklist and Hours to “0% battery” inexpensive emergency patient monitoring kit. Devices display Device Testing mode Tested Mean (Range) Anesthesia Equipment Testing Dräger Apollo® anesthesia Ventilator on 2 4.8 (4.3–5.5) We tested two different anesthesia machines, machine Ventilator off 1 5.6 one portable monitor and one infusion pump for duration of battery life and functionality on bat- Dräger Fabius® anesthesia Ventilator on 2 3.5 (3.2–3.7) tery power (Table 2). Multiple examples of each machine Ventilator off 2 4.6 (4.4–4.8) device were tested, and all devices were charged Phillips IntelliVue x2® With BP cuff 3 3.0 (2.6–3.6) overnight prior to testing. Anesthesia machine, portable monitors ventilator, infusion pump, and portable monitor Without BP cuff 1 3.4 function were observed until display screens Alaris PC® infusion pumps 2 channels 4 4.2 (3.9–4.5) indicated “0% battery,” and then until devices Anesthesia machines on battery power were tested both with ventilator on (set to tidal volume of 500 mL and failed and screens became dark. respiratory rate 10 breaths per minute), or ventilator off (simulating a “manual ventilation” state). Fresh gas We found that all types of equipment had a flow was set to 2 L/min, sevoflurane was dialed to 2%, and end-tidal sevoflurane was measured. Alaris pumps battery life longer than expected, approximately were set-up to run two channels, simulating a carrier infusion at 150 mL/hour and a phenylephrine infusion at 3 to 4 hours. Anesthesia machine battery life was 25 mcg/min. In addition to measuring infusion pump battery life, the function of infusion pumps was measured extended by approximately 1 hour by turning by comparing pump output in mL/hour for devices on battery power compared to alternating current (AC) the ventilator off and using manual ventilation. power. Phillips monitors were tested for battery life both with a non-invasive blood pressure (NIBP) cuff cycling Ventilators on Fabius machines continued to every 5 minutes, and with no NIBP cuff measurements. operate for <10 minutes after “0% battery” was displayed, but Apollo ventilators continued Emergency Monitoring The kits are sealed with break-away tags to dis- functioning for several hours longer. Sevoflu- courage component theft, and batteries in head- rane vaporizer output on both types of anesthe- Supplies lamps, pulse oximeters, and LED flashlights sia machines was consistent with dialed settings While it is helpful to know how anesthesia kept in all anesthesia machines are replaced as long as there was fresh gas flow, and did not equipment will generally perform during a every 6 months. A paper anesthetic record is depend whether the anesthesia machine was crisis, it is also wise to plan for contingencies. included not only for anesthesia charting, but as using alternating current (AC) power, battery In order to be prepared for a worst-case scenario a critical part of patient identification and docu- power, or had a completely depleted battery. in which patient monitors fail and portable mentation during an evacuation. Fresh gas flow, rotometers, and the oxygen flush monitors are unavailable, we designed and dis- valve were unaffected by AC power loss or bat- tributed “Emergency Monitoring Kits” to carts OR Power Failure Checklist in every anesthetizing location. Figure 2 shows tery depletion. These observations are consistent Checklists are useful cognitive aids for clini- the contents of the $60 kits, of which the most with the manufacturer’s specifications, except cians that have been proven to increase patient important are an inexpensive pulse oximeter that battery life was consistently longer than the and a light-emitting diode (LED) headlamp. See “Power Failure,” Next Page 30–90 minutes advertised for these machines (Dräger anesthesia machine user manuals cour- tesy of Dräger Medical, Inc). Alaris pumps failed within minutes of “battery failure” warning screens. Their fluid volume output was no dif- ferent whether on battery or AC power. Phillips monitors also failed within about 15 minutes of a “0% battery” indicator screen. In general, dis- plays on all devices underestimated actual bat- tery life. It is unsurprising that manufacturers err on the side of caution in displaying this value to the user, particularly for critical medical devices. All types of devices displayed increasingly loud, visible, and difficult-to-ignore warnings when close to battery failure (Figure 1). No device failed without warning during testing. It is important to note that complete battery depletion during tests such as these can adversely affect subsequent bat- tery function, so repeated tests are not advised. Figure 1. Screens displayed on Dräger Apollo and Fabius GS anesthesia machines at time of battery failure. EDITOR’S

APSF NEWSLETTER February 2016 PAGE 59

EDITOR’S Preparedness and Institutional System Are Important Steps “Power Failure,” From Preceding Page mean the end of a crisis, however, as sophisti- OR readiness to receive patients during an cated medical equipment may be damaged by emergency. safety in numerous areas of medicine.14,15 For power surges or forced to undergo a prolonged anesthesiologists and nurse anesthetists, check- This project has allowed us to explore our restarting process. Recently at our institution, lists are particularly helpful guides for patient capabilities “in the dark” as an anesthesia ser- municipal power interruption of less than a management during rare, life-threatening intra- vice practicing in an earthquake hazard area, second caused by an accident at a local electrical operative events such as malignant hyperther- and has also allowed us to engage the entire mia and local anesthetic systemic toxicity.16-18 In substation resulted in unanticipated problems: medical center in preparations and simulations published reports, anesthesia providers have had damage to delicate electronics in some fluoros- for disaster planning. Anesthesiologists, nurse variable responses to operating room power fail- copy equipment, malfunction of a transesopha- anesthetists, and anesthesia technicians should ure, including switching to manual ventilation geal echocardiography machine during a cardiac learn about the battery capabilities of their and discontinuing volatile anesthetics.6,7 These case, and loss of video imaging for several min- equipment and the projected impact of a power ® actions may be appropriate in some power fail- utes during a da Vinci robot-assisted laparo- outage on key services necessary for patient ure situations, and inappropriate in others. scopic case in which significant bleeding was care. Anesthesia departments should have extra occurring. A delay of care for several minutes as equipment for patient monitoring readily avail- As we were unable to find any published equipment reboots during a critical part of a pro- able, most importantly, LED headlamps and checklists on crisis management for OR power cedure can be dangerous. Regardless of whether battery-powered pulse oximeters. A checklist failure, we created our own (Figure 3). Based a crisis is brief or prolonged, or whether genera- may help clinicians remember to perform key upon the results of equipment testing and mul- tors work or not, patients remain at significant steps when the lights go out: finding alternative tiple simulations, we decided that the crucial risk whenever power is interrupted. light sources, preventing hypoxemia, and con- first step during power failure was to determine firming that critical equipment is plugged into whether the anesthesia machine and ventilator Management of intraoperative power failure generator-powered outlets. We continue to were functional, and if so, to continue using should be part of a coordinated medical facility refine and practice this checklist and our disas- them. This step allows the clinician’s hands to response. While preparedness within the oper- ter response protocols, and hope that others be free to perform other necessary tasks, allows ating room is important, it is equally important may use our experience as a starting point for continued delivery of a reliable anesthetic, and to develop an institutional system for disaster discussing preparedness for power failure and minimizes the chance of barotrauma and respi- response that allows for a clear chain of com- other emergencies at their own institutions. ratory alkalosis from manual ventilation. Confi- mand with recognized roles and protocols, dence that volatile anesthetic will continue to be rapid assessment of patient needs, and deploy- Disclosures and conflicts of interest: None delivered removes the immediate burden on the ment of resources. The Hospital Incident Com- Authors: anesthesia provider to urgently convert to a mand System (HICS)20 is the basis of our Erica L. Holland, MD total intravenous anesthetic (TIVA) in the dark. institution’s efforts to build a robust emergency Carli D. Hoaglan, MD Furthermore, as electronically controlled medi- preparedness program. Within the HICS Martha A. Carlstead, CRNA cation dispensing stations are not operational system, protocols in perioperative areas are Ryan P. Beecher, CRNA without power, supply of intravenous sedatives being developed that allow staff to rapidly Grete H. Porteous, MD* and anesthetics may be rapidly depleted if mul- assess operating room needs and triage care Department of Anesthesia, B2-AN tiple ORs are affected. Another crucial element even in the presence of darkness and loss of Virginia Mason Medical Center of the checklist involves repeated steps to assure normal avenues of communication. Individual Seattle, WA the delivery of oxygen to the patient. In the case operating room needs are triaged by color to *Corresponding author of a disaster such as an earthquake, pipeline direct assistance to the most critical, and gauge See “Power Failure,” Next Page oxygen supply may be damaged or turned off as a fire control measure. We also include prompts for the anesthesia provider to confirm that criti- cal equipment is plugged into a generator-pow- ered circuit (“red outlets”), to communicate with the surgical team and nursing staff regard- ing prioritization of help for patient care, and to prepare for patient evacuation if necessary. Discussion Operating room power failure is a critical event that merits advance preparation to pre- vent catastrophic patient harm. Hospitals are rightly subject to rigorous regulations regarding emergency generator power testing and reliabil- ity, and required to develop plans for power failure emergencies.19 In most cases, it is likely that in the event of intraoperative power loss, approximately 10 seconds (or longer) of dark- Figure 2. Emergency patient monitoring kits. Kits contain an LED headlamp, sphygmomanometer, ness will be followed by restoration of power by stethoscope, pulse oximeter, colorimetric CO2 detector, paper anesthetic record, and copy of the power failure generators. Return of electrical power does not emergency checklist. EDITOR’S

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EDITOR’S

Power Out? “Power Failure,” From Preceding Page

Is Ventilator Still Working?

YES Call for HELP while doing the following… n Continue normal use of ventilator & non-desflurane vaporizers

n Change FiO2 to 100% @ 2 L/min

NO Call for HELP while doing the following…

n Adjust APL and manually ventilate utilizing pipeline O2 or E-cylinder @ 100% FiO2

n O2 flush valve may need to be pressed multiple times to refill circuit to manually ventilate Figure 4: Fabius On/Off Switch (back of machine). n O2 flowmeter & 2O flush valve will still function n Non-desflurane vaporizer will still function at approximate dialed setting

n Obtain additional light source if not already done (e.g., flashlight, headlamp, laryngoscope, cell phone) n Open emergency monitoring kit in bottom drawer of anesthesia cart. Apply manual patient monitors (pulse ox, NIBP). Listen for breath sounds, use colorimetric CO2 detector as needed. • If available, use portable transport/“brick” monitors • Check patient vital signs and chart every 5 minutes on paper anesthetic record

n Confirm Ambu-bag available and 2O E-cylinder on back of anesthesia machine is at 2000 psi • If pipeline O2 fails, utilize O2 E-cylinder on back of machine • Anticipate possible need to switch to Ambu-bag with auxiliary O2 tank or room air n Notify anesthesia attending, anesthesia tech, & charge anesthesiologist of situation n Communicate with surgical team regarding status & determine patient triage category: Red, Yellow, Green, Blue, or Black (see “Patient Triage Guidelines” in binder) n Confirm that critical room equipment is plugged into RED outlets Figure 5: Apollo On/Off Switch (hold for 3 sec). n Obtain additional propofol, opioids, and midazolam, if needed n Maintain 100% FiO at 2 L/min unless contraindicated Acknowledgments: 2 We are grateful for the assistance and support of n Anticipate possible upcoming need for IV anesthesia (see “Quick Propofol Drip Guide” in Randy Johnson, Cert. A.T., without whom this binder) project would not have been possible. n Prepare for possible patient evacuation (see “Patient Evacuation Kit” in binder) References n Anticipate that anesthesia machine battery and Alaris pumps may last as long as 3 hours (not 1. Eichhorn JH, Hessel EA. Electrical power failure in the guaranteed) operating room: a neglected topic in anesthesia safety. • Consider transition from controlled to spontaneous ventilation to conserve battery Anesth Analg 2010;110:1519–21. 2. Klinger C, Landeg O, Murray V. Power outages, extreme events and health: a systematic review of the TROUBLESHOOTING VENTILATOR literature from 2011–2012. PLoS Curr 2014 Jan 2; 6:ecur- rents.dis.04eb1dc5e73dd1377e05a10e9edde673 n If ventilator fails to operate, try turning machine Off/On 3. Larsen PH, LaCommare KH, Eto JH, Sweeney JL. • Fabius switch location: back lower right corner (Figure 4) Assessing changes in the reliability of the U.S. electric power system. Lawrence Berkeley National Labora- • Apollo switch location: front lower right corner, hold for 3 sec (Figure 5) tory 2015. Available at: https://publications.lbl.gov/ islandora/object/ir%3A188741. Accessed October 20, n Attempt to plug ventilator into different red outlet 2015. n If difficulties manually ventilating, try pressing 2O flush valve several times to fill circuit 4. DOE-PI (U.S. Department of Energy’s Office of Policy and International Affairs): U.S. Energy sector vulnera- bilities to climate change and extreme weather. 2013. Figure 3. Operating room power failure checklist. ©2015 Virginia Mason Medical Center See “Power Failure,” Next Page EDITOR’S

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EDITOR’S

Preparedness and Institutional System Are Important Steps

“Power Failure,” From Preceding Page Available at: http://energy.gov/sites/prod/ files/2013/07/f2/20130710-Energy-Sector-Vulnerabil- Supplemental Materials ities-Report.pdf. Accessed October 20, 2015. 5. Riley RH. Power failure to a tertiary hospital’s operat- ing suite. Anaesth Intensive Care 2010; 58:785. PATIENT TRIAGE GUIDELINES 6. Carpenter T, Robinson ST. Response to a partial power failure in the operating room. Anesth Analg 2010; Needs immediate help and/or evacuation within 30 minutes, unsta- 110:1644–6. Red ble patient, mechanically ventilated (outside of OR environment), or 7. Yasny J, Soffer R. A case of a power failure in the operat- requiring significant cardiac or pulmonary resuscitation ing room. Anesth Prog 2005; 52:65–69. Can wait 30 min–2 hr for evacuation, relatively stable patient but 8. Pagán A, Curty R, Rodriquez MI, Pryor F. Emer- Yellow requiring ongoing supportive care or continuation of procedure gency—Total power outage in the OR. AORN J 2001; beyond 30 min 74:514–516. 9. Tye JC, Chamley D. Complete power failure. Anaesthe- Can abort or finish procedure within 30 min…OR…can wait > 2 hr for sia 2000; 55:1133–1134. Green evacuation, patient otherwise stable 10. Troianos, CA. Complete electrical failure during cardio- pulmonary bypass. Anesthesiology 1995; 82:298–302. 11. Norcross DE, Elliott BM, Adams DB, Crawford FA. Blue Can be discharged home within 30 min, stable patient Impact of a major hurricane on surgical service in a uni- versity hospital. Am Surg 1993; 59:28–33. 12. Nates JL. Combined external and internal hospital disaster: Impact and response in a Houston trauma Black Deceased center intensive care unit. Crit Care Med 2004; 32:686–690. 13. O’Hara JF, Higgins TL. Total electrical power failure in a cardiothoracic intensive care unit. Crit Care Med 1992; Quick Propofol Drip Guide 20:840–845. 14. Treadwell JR, Lucas S, Tsou AY. Surgical checklists: a (To Approximate 100 mcg/kg/min) systematic review of impacts and implementation. BMJ Qual Saf 2014; 4:299–318. Route 50 kg Patient 100 kg Patient 15. Byrnes MC, Schuerer DJE, Schallom ME, et al. Imple- Intermittent Syringe Bolus 2.5 ml every 5 min 5 ml every 5 min mentation of a mandatory checklist of protocols and objectives improves compliance with a wide range of evidence-based intensive care unit practices. Crit Care Mini-dripper (60 drop/ml) 1 drop every other second 1 drop every second Med 2009; 10: 2775–81. 16. Ziewacz JE, Arriage AF, Bader AM, et al. Crisis check- lists for the operating room: development and pilot testing. J Am Coll Surg 2011; 213:212–19. PATIENT EVACUATION KIT 17. Neal JM, Mulroy MF, Weinberg GL. American Society n Ambu-Bag n Manual Monitors n Propofol of Regional Anesthesia and Pain Medicine checklist for managing local anesthetic systemic toxicity: 2012 ver- sion. Reg Anesth Pain Med 2012; 37(1):16–8. n Mask n Full O2 Tank n Midazolam/Opioid 18. Harrison TK, Manser T, Howard SK, Gaba DM. Use of cognitive aids in a simulated anesthetic crisis. Anesth n Emergency Binder n Extra Gloves n Muscle Relaxant Analg 2006; 103(3):551–6. 19. JCAHO (Joint Commission on Accreditation of Health- care Organizations): Preventing adverse events caused n Oral Airway n Extra IV Fluids n Phenylephrine by emergency electrical power system failures. The Joint Commission Sentinel Event Alert 2006; 37: 1-3. n LMA #4 n Extra Syringes n Ephedrine Available at: http://www.jointcommission.org/senti- nel_event_alert_issue_37_preventing_adverse_events_ caused_by_emergency_electrical_power_system_fail- n ETT/Stylet n Extra Needles n Atropine ures/. Accessed October 20, 2015. 20. Arnold JL, Dembry LM, Tsai MC, et al. Recommended n Laryngoscope n Tape n Code Epinephrine Box modifications and applications of the Hospital Emer- (100 mcg/ml) gency Incident Command System for hospital emer- gency management. Prehosp Disast Med 2005; 20(5):290–300. See “Power Failure,” Next Page EDITOR’S

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“Power Failure,” From Preceding Page EDITOR’S

Appendix 1. Reports of intraoperative power failure. Abbreviations: OR – operating room; PACU – post-anesthesia care unit; ESU – electrosurgical unit; ICU – inten- sive care unit; CABG – coronary artery bypass graft; CPB – cardiopulmonary bypass; ACT – activated clotting time; TOF – train-of-four; TIVA – total intravenous anesthesia. †Year of publication. Year† Scenario Root Cause Outcome Recommendations • Complete loss of power on • Fault within the switching • Anesthesia monitors failed and “clinical monitoring” • An uninterruptible power supply system for the OR two consecutive days panel that controlled was used until portable transport monitors arrived should be installed as this would allow at least one • 9 operations in progress whether the hospital used • Video towers and imaging systems failed hour of power in the ORs in order to complete ongoing municipal power or emer- procedures • Outage lasted 13 minutes • Surgical lights, ventilators, gas delivery systems and gency generator power 2010 on day 1 and 9 minutes on CPB continued because of built-in batteries • Staff should be familiar with power requirements of 5 day 2 • Unclear if generators worked equipment • Partial hospital power fail- • During construction, a • Most anesthesia providers switched to manual venti- • Communication should be improved by notifying staff ure with loss of power to phase loss relay in main lation, while two continued to use the battery-pow- of potential power loss during possible service inter- emergency (generator) hospital circuit became dis- ered anesthesia machine ventilator ruption and developing a “batch paging” system to system lodged, simulating loss of • 3 providers switched from desflurane to sevoflurane notify key personnel during an emergency • 8 operations in progress, municipal power or isoflurane. One switched to propofol infusion with • Anesthesia providers should focus on “ABCs”, call for including a craniotomy, • A critical branch transfer midazolam help, utilize emergency equipment and ensure delivery Whipple procedure, and switch then connected hos- • All patient monitoring was interrupted except in the of anesthesia to the patient kidney transplant pital power to an emer- one room where anesthesia equipment was errone- • All rooms should have portable backup lights 2010 gency generator that was • Outage lasted 15 minutes ously not plugged into red outlet. Portable monitors • If some equipment is functional in a room, consider disabled for servicing were brought into rooms plugging failed equipment into different outlets • “Red outlets” that were • Room lights continued to function except in one room • Phase loss relay component should be secured to supplied by generator lost • ESUs and automated drug supply cabinets failed avoid a similar accident in future6 power • Complete loss of hospital • Multistate power outage • Room lights failed • Anesthesiologists have a critical leadership role in the power (Northeast blackout of • Anesthesia machine display and monitors worked, but OR during crisis. Clear communication and thoughtful • Emergency generators 2003) ventilator bellows could not be seen in the dark planning are key to avoiding panic failed in wing of hospital • TIVA initiated. Patient ventilated with self-inflating • Daily equipment checks should include flashlights and with operating room, but resuscitation bag and tank oxygen batteries in every room functioned elsewhere • Once portable lights confirmed normal bellows func- • The battery life of anesthesia equipment should be • Complex oral and maxillo- tion and pipeline gas supply, anesthesia machine determined facial operation in progress 2005 resumed ventilation with volatile agent • Consider resuming spontaneous ventilation under • Outage lasted days • Operation was suspended, patient was left intubated anesthesia as a safety precaution in case anesthesia 7 and transported to PACU machine battery fails • Operation completed the next day in a different build- ing which had generator power • Complete loss of hospital • Fire in electrical vault • Flashlight used for light source in ORs • Create emergency staffing plan that identifies specific power • Electricity still supplied to • Anesthesia machines continued to function on battery staff member responsibilities and roles • 3 operations in progress: building by municipal power • Wall suction failed and portable suction unit used • Battery operated ESUs and suction should be available ankle fusion, pelvic exten- but unable to be distributed • Electrosurgical units failed and battery-powered bipo- • Perform mock disaster drills quarterly teration, and radical neck throughout hospital lar eye electrosurgery units and vessel ligation were • Pharmacy services should have a plan to ensure dissection • Main and backup genera- used to achieve hemostasis availability of medications to operating rooms 2001 • Outage lasted >1 week, tors destroyed by fire • Automated drug supply cabinets failed • Flashlights and paper intraoperative records should be requiring evacuation of all available in ORs8 hospital patients • All operative procedures were near completion and incisions were closed • Complete loss of hospital • Construction workers acci- • Room lights failed except for one light with a back-up battery • Emergency generator planning should take into power dentally drove a steel pile • Anesthesia machine ventilator continued to function account the load placed on one generator in case a through the hospital’s main second generator fails9 • Both emergency genera- • Patient monitors failed, including gas analyzer and incoming power cables tors failed capnography. Surgeon watched pulsations of the • Carotid endarterectomy in • The first generator did not carotid artery until a portable monitor was available

2000 start at all. The second gen- progress • Capnography and agent monitoring remained unavailable erator started, but was quickly • Outage lasted 30 minutes overloaded and then failed • The case was aborted, and the patient was taken to the ICU • Complete loss of hospital • Loss of municipal power • Room lights, CPB machine, communications (intercom, • Hand-cranking a CPB machine is exhausting, and relief power during heat wave pager), patient monitors, and suction failed staff must be brought in for this purpose immediately • Ongoing cardiac case with • Emergency generators • Roller head in CPB circuit was manually cranked to • The capabilities of various functions of the CPB machine patient on CPB started, then failed after 15 maintain a venous saturation > 70% and battery life must be determined in advance of a crisis • Outage lasted 53 minutes minutes • Flashlights and laryngoscope lights were used for illu- • When communications fail, all available anesthesia mination personnel should systematically check each OR to • Portable monitors and suction brought to room determine priority needs 1995 • Measurement of ACT performed manually with flash- • Battery powered lighting in hallways, workrooms and PACU light and stopwatch is also necessary to find equipment and prevent staff injury • Not possible to rewarm patient. Came off CPB on • Staff in ORs must be assessed periodically for heat exhaus- 10 dopamine. CPB reinstituted when power restored tion when air conditioning fails during a heat wave • Operating room loss of • Regional power outage • All lighting, ventilator and monitors except for pulse • Clinicians should be ready to use manual monitors and power. No mention of other (likely Hurricane Hugo) oximeter failed physical exam to monitor patients if battery-powered hospital areas • Generator cooling system • Ventilation was continued manually via anesthetic circle system devices fail 11 • Ongoing laparotomy had been accidentally • Portable monitors were used, including manual BP • Develop a plan for OR power outage and rehearse it • Emergency generators deactivated. When the gen- cuff, esophageal stethoscope, TOF monitor, oxygen worked for approximately 3 erator activated in response analyzer, pulse oximeter and EKG 1993 to the power failure, it minutes, then failed • Flashlights used, but inadequate for continuation of sur- quickly overheated and • Outage lasted 45 minutes gery. When power returned 45 min later, surgery resumed failed APSF NEWSLETTER February 2016 PAGE 63

Dear SIRS Incorrect Network Connection Simultaneously Crashes Multiple Anesthesia Machines

Dear SIRS: of a cabling error where a Kalispell anesthesia I work in Kalispell, Montana, as an anesthesi- technician inadvertently connected a cat5 cable ologist and head of our group of 20 anesthesiolo- from one wall connection to another wall connec- S AFETY gists. We have two adjoining hospitals, one that tion, forming a loop on the Kalispell-installed and functions as an outpatient surgery center, the maintained hospital network. Mindray deter- other an acute care hospital and trauma center. mined the cause of the shutdown was due to over- whelming network broadcast traffic. The issue I NFORMATION We recently had an incident involving our Min- was resolved by disconnecting the Ethernet to dray anesthesia machines and monitors. Six (6) EMR cable. The systems then restarted and func- Mindray A5 anesthesia machines and eight (8) tioned normally. No patient injury was reported. R ESPONSE DPM 7 patient monitoring systems were in use delivering anesthesia care at the time of the inci- The customer requested an investigation as to dent. We have both Mindray anesthesia machines why Mindray’s devices were unable to withstand S YSTEM and a few Fabius Gas machines. All of our moni- the problem caused by the user error. The results toring is Mindray. of the investigation are as follows: While one of the Mindray machines was being • Mindray was initially unable to reproduce the moved from one anesthetizing location to another, issue using the specific Kalispell LAN settings Dear SIRS refers to the Safety Infor- a network connection was made incorrectly by an provided, but upon further examination of mation Response System. The purpose of anesthesia technician, who plugged both ends of Kalispell’s network topology, Mindray was able the network cable into the network receptacle to recommended specific LAN switch settings this column is to allow expeditious rather than one end into the network receptacle that would disable any switch port that communication of technology-related and the other end to the anesthesia machine. This received network broadcast or multicast traffic safety concerns raised by our readers, network was installed for the exclusive use of the at a rate that would cause Mindray’s A5 or with input and responses from manufac- Mindray equipment, thus no other equipment was DPM 7 systems to shut down. turers and industry representatives. This affected. This misconnection resulted in a loop • Mindray Engineering and Kalispell Biomedical where the network traffic consumed 100% of the process was developed by Dr. Michael Engineering concurrently but independently bandwidth. When the misconnection occurred, no determined that turning off the Cisco port-fast Olympio, former chair of the Committee other Mindray anesthesia machines or patient feature would enhance the solution. on Technology, and Dr. Robert Morell, co- monitors were able to communicate with the net- • When reproducing the identified issue in the editor of this newsletter. Dear SIRS made work. As a result, every Mindray machine and patient monitor in both buildings simultaneously Mindray lab, it was observed that while the A5 its debut in the Spring 2004 issue. Dr. A shut off and refused to turn back on as long as they User Interface did go blank, the ventilator con- William Paulsen, current chair of the were connected to the network. It was discovered tinued to ventilate as intentionally designed. Committee on Technology, is overseeing that if the machine was disconnected from the net- We appreciate the collaborative nature of the the column and coordinating the readers' work, the machine and monitor returned to effort put forth by the Kalispell staff to work with inquiries and the responses from industry. normal function. Word spread to all anesthesiolo- Mindray’s engineering team. Through this process gists to unplug the machines from the network we have identified the cause of the shutdown and and, within 15 to 20 minutes, everything was back made recommendations for Kalispell’s network. The information provided is for safety- in service, but disconnected from the network. Additionally, Mindray will make software related educational purposes only, and does Fortunately, there were no untoward sequela for enhancements to strengthen the network interface not constitute medical or legal advice. Indi- the patients, but every patient had their anesthetic, and will continue to develop and incorporate, vidual or group responses are only commen- monitoring, and mode of ventilation changed. where possible, future product and software tary, provided for purposes of education or Hospital information technology found the source enhancements to provide additional protection of the excessive network traffic and broke the loop discussion, and are neither statements of against unanticipated broadcast or multicast traf- by unplugging the offending cable from the net- fic, as our goals include providing the safest and advice nor the opinions of APSF. It is not the work. The network operation was returned to most reliable products possible. intention of APSF to provide specific medical normal within a few hours. or legal advice or to endorse any specific Rich Cipolli views or recommendations in response to the Carl Tinlin D.O. Vice President, Product Development Kalispell, MT inquiries posted. In no event shall APSF be Mindray, North America Mahwah, New Jersey responsible or liable, directly or indirectly, for Mindray Reply: any damage or loss caused or alleged to be On May 19, 2015, Mindray was notified of a caused by or in connection with the reliance situation involving six (6) A5 and eight (8) DPM 7 on any such information. systems which unexpectedly shutdown; the result APSF NEWSLETTER February 2016 PAGE 64

Anesthesia Patient Safety Foundation

CORPORATE SUPPORTER PAGE

APSF is pleased to recognize the following corporate supporters for their exceptional level of support of APSF

Medtronic is committed to creating innovative medical solutions for better patient outcomes and delivering value through clinical leadership and excellence in everything we do. www.medtronic.com

Today’s Merck is a global health care leader working to help the world be well. Through our prescription medicines, vaccines and biologic therapies, we operate in more than 140 countries to deliver innovative health solutions. www.merck.com

CareFusion combines technology and intelligence www.usa.philips/com Preferred Physicians Medical providing to measurably improve patient care. Our clinically malpractice protection exclusively to proven products are designed to help improve the anesthesiologists nationwide, PPM is safety and cost of health care for generations to anesthesiologist-founded, owned and governed. come. www.carefusion.com PPM is a leader in anesthesia specific risk management and patient safety initiatives. www.ppmrrg.com

Baxter’s Global Anesthesia and Critical Care Business is GE Healthcare a leading manufacturer in anesthesia and preoperative (gemedical.com) medicine, providing all three of the modern inhaled anesthetics for general anesthesia, as well as products for PONV and hemodynamic control. www.baxter.com

Masimo is dedicated to helping anesthesia professionals provide PharMEDium is the leading national provider of outsourced, optimal anesthesia care with immediate access to detailed compounded sterile preparations. Our broad portfolio of prefilled clinical intelligence and physiological data that helps to improve O.R. anesthesia syringes, solutions for nerve block pumps, anesthesia, blood, and fluid management decisions. epidurals and ICU medications are prepared using only the www.masimofoundation.org highest standards. www.pharmedium.com APSF NEWSLETTER February 2016 PAGE 65

Online donations accepted at Anesthesia Patient Safety Foundation www.apsf.org Corporate Donors Founding Patron ($425,000) American Society of Anesthesiologists (asahq.org) Sustaining Professional Organization Grand Patron Supporting Patron ($150,000 and higher) ($100,000 and higher) ($50,000 to $99,999) American Association of Nurse Anesthetists Medtronic Merck and Company (aana.com) (medtronic.com) (merck.com)

Sponsoring Patron ($30,000 to $49,999) Benefactor Patron ($20,000 to $29,999) Preferred Physicians CareFusion (carefusion.com) Philips Healthcare Medical Risk (usa.philips/com) Retention Group Baxter Anesthesia and GE Healthcare (ppmrmg.com) Masimo Foundation PharmMEDium Services Critical Care (baxter.com) (gemedical.com) (masimo.com) (pharmedium.com) Patron ($10,000 to $19,999) Codonics (codonics.com) Sponsoring Donor ($1,000 to $4,999) Corporate Level Donor ($500 to $999) AbbVie (abbvie.com) Cook Medical (cookgroup.com) AMBU, Inc (ambu.com) Paragon Service (paragonservice.com) Dräger Medical (draeger.com) Eagle Pharmaceuticals (eagleus.com) Anesthesia Business Consultants (anesthesiallc.com) ProMed Strategies Spacelabs Medical (spacelabs.com) Mindray North America (mindray.com) Anesthesia Check (anesthesiacheck.com) Wolters Kluwer (lww.com) Teleflex Medical (teleflex.com) Nihon Kohden America, Inc. (nihonkohden.com) B. Braun Medical, Inc. (bbraun.com) 3M Infection Prevention Division Pall Corporation (pall.com) Hospira, Inc. (hospira.com) Subscribing Societies (3m.com/infectionprevention) Respiratory Motion (respiratorymotion.com) Intersurgical, Inc. (intersurgical.com) American Society of Anesthesia Technologists and Sustaining Donor ($5,000 to $9,999) Sheridan Healthcorp, Inc. (shcr.com) Sedasys (sedasys.com) Technicians (asatt.org) Becton Dickinson (bd.com) Smiths Medical (smiths-medical.com) W.R. Grace (wrgrace.com) American Society of Dentist Anesthesiologists (asdahq.org)

Community Donors (includes Individuals, Anesthesia Groups, Specialty Organizations, and State Societies) Grand Sponsor Frederick W. Cheney, MD Stockham-Hill Foundation Kathleen A. Levitt, MD, and Johan P. Matthew B. Weinger, MD ($15,000 and higher) Connecticut State Society of Anesthesiologists Tejas Anesthesia Suyderhoud, MD Andrew Weisinger, MD Jeffrey B. Cooper, PhD Texas Association of Nurse Anesthetists Kevin and Janice Lodge US Anesthesia Partners (GHA-Houston, JLR- Wichita Anesthesiology, Chartered Dr. and Mrs. Robert A. Cordes Texas Society of Anesthesiologists Michael J. Loushin, MD G. Edwin Wilson, MD Orlando, Pinnacle-Dallas) District of Columbia Society of TCAA-Associated Anesthesiologists Division Philip and Christine Lumb Philip J. Zitello, MD Benefactor Sponsor Anesthesiologists Washington State Society of Anesthesiologists Alfred E. Lupien, PhD, CRNA Deborah J. Culley, MD Mark and Heidi Weber Maine Society of Anesthesiologists In Memoriam ($5,000 to $14,999) In memory of Karl K. Birdsong, MD Alabama State Society of Anesthesiologists David S. Currier, MD Wisconsin Society of Anesthesiologists Christina M. Martin, AA-C John H. Eichhorn, MD Edwin Mathews, MD (Texas Society of Anesthesiologists) American Academy of Anesthesiologist Sponsor ($200 to $749) In memory of Harold C. Boehning, MD Assistants Gerald Feldman Gregory B. McComas, MD AllCare Clinical Associates (Asheville, NC) (Texas Society of Anesthesiologists) Anaesthesia Associates of Massachusetts Florida Society of Anesthesiologists Russell K. McAllister, MD Anesthesia Associates of Kansas City In memory of Raymond Boylan, MD American Dental Society of Anesthesiology David M. Gaba, MD E. Kay McDivitt, MD Anesthesia Associates of Northwest Dayton, Inc. (Raymond J. Boylan, Jr., MD) Timothy J. Dowd, MD Georgia Society of Anesthesiologists Mississippi Society of Anesthesiologists Donald E. Arnold, MD In memory of James J. Brill, MD Indiana Society of Anesthesiologists Goldilocks Anesthesia Foundation Roger A. Moore, MD Balboa Anesthesia Group (Madison Anesthesiology Consultants) Minnesota Society of Anesthesiologists James D. Grant, MD Soe Myint, MD Steven Greenberg, MD Robert L. Barth, MD Joseph J. Naples, MD In memory of Richard Browning, MD Frank B. Moya, MD, Continuing Education Michael P. Caldwell, MD Programs International Anesthesia Research Society (in John B. Neeld, MD (Brett L. Arron, MD) recognition of Sorin J. Brull, MD) Lillian K. Chen, MD New Hampshire Society of Anesthesiologists In memory of W. Darrell Burnham, MD North American Partners in Anesthesia Joan M. Christie, MD PhyMED Management (Nashville, TN) Illinois Society of Anesthesiologists New Jersey State Society of Anesthesiologists (Mississippi Society of Anesthesiologists) Iowa Society of Anesthesiologists Marlene V. Chua, MD Robert K. Stoelting, MD New Mexico Society of Anesthesiologists In memory of Michelle Cohen Kaiser Permanente Nurse Anesthetists Melvin Cohen, MD Mark C. Norris, MD Valley Anesthesiology Foundation (Jerry A. Cohen, MD) Association (KPNNA) Daniel J. Cole, MD Michael A. Olympio, MD In memory of Hank Davis, MD Colorado Society of Anesthesiologists Sustaining Sponsor Kansas City Society of Anesthesiologists Susan K. Palmer, MD (Sharon Rose Johnson, MD) Charles E. Cowles, MD ($2,000 to $4,999) James J. Lamberg, DO Stephen D. Parker, MD In memory of Eugene H. Flewellen, III, MD Kathleen DeBoer Academy of Anesthesiology Kentucky Society of Anesthesiologists Mukesh K. Patel, MD (Texas Society of Anesthesiologists) John K. Desmarteau, MD Anesthesia Resources Management Lorri A. Lee, MD Pennsylvania Association of Nurse In memory of Margie Frola, CRNA Andrew E. Dick, MD Arizona Society of Anesthesiologists Anne Marie Lynn, MD Anesthetists (Sharon Rose Johnson, MD) Peggy E. Duke, MD Madison Anesthesiology Consultants Maryland Society of Anesthesiologists Lee S. Perrin, MD In memory of Tzivia Gaba and Florence Mann Marcel E. Durieux, PhD, MD Massachusetts Society of Anesthesiologists Missouri Academy of Anesthesiologist Drs. Beverly and James Philip (David M. Gaba, MD) Michiana Anesthesia Care Assistants Richard P. Dutton, MD, MBA Tian Hoe Poh, MD Duke Eason, MD In memory of Andrew Glickman, MD Michigan Society of Anesthesiologists Missouri Society of Anesthesiologists Richard C. Prielipp, MD (Sharon Rose Johnson, MD) Michael D. Miller, MD Northwest Anesthesia Physicians Stephen B. Edelstein, MD Neela Ramaswamy, MD Jan Ehrenwerth, MD In memory of Philip A. Hoffman, MD North Carolina Society of Anesthesiologists Ohio Academy of Anesthesiologist Assistants Maunak E Rana, MD (Madison Anesthesiology Consultants) Old Pueblo Anesthesia Group Ohio Society of Anesthesiologists Michael R. England, MD Christopher Reinhart, CRNA In memory of Donna M. Holder, MD Society of Academic Anesthesiology Oklahoma Society of Anesthesiologists Thomas R. Farrell, MD Howard Schapiro and Jan Carroll (Karen P. Branam, MD) Associations Oregon Society of Anesthesiologists Georgia Association of Nurse Anesthetists Sanford H. Schaps, MD In memory of Paul C. Kidd, MD Springfield Anesthesia Service at Baystate Frank J. Overdyk, MSEE, MD (in honor of Ian J. Gilmour, MD Jeffrey Shapiro, MD (Texas Society of Anesthesiologists Medical Center Robert K. Stoelting, MD) Richard Gnaedinger, MD Stephen J. Skahen, MD In memory of Russell Morrison, CRNA Tennessee Society of Anesthesiologists Pamela P. Palmer, MD Joel G. Greenspan, MD Dr. David Solosko and Ms. Sandra Kniess (Jeanne M. Kachnij, CRNA) Mary Ellen and Mark A. Warner Srikanth S. Patankar, MD Allen N. Gustin, MD South Carolina Society of Anesthesiologists A. William Paulsen, PhD, AA-C John A. Hamel, MD Shepard B. Stone, PA In memory of Ellison C. Pierce, Jr., MD Contributing Sponsor Pennsylvania Association of Nurse Alexander Hannenberg, MD (Pierce Research Steven L. Sween, MD (Alexander A. Hannenberg, MD) ($750 to $1,999) Anesthetists Fund) James F. Szocik, MD In memory of William Roady, MD Affiliated Anesthesiologists of Oklahoma James M. Pepple, MD Timothy N. Harwood, MD Joseph Szokol, MD (James S. Hicks) City, OK Physician Specialists in Anesthesia (Atlanta, GA) Gary R. Haynes, MD Bijo J. Thomas, MD In memory of Paul A. Stern, MD Alaska Association of Nurse Anesthetists Rhode Island Society of Anesthesiologists John F. Heath, MD Dr. and Mrs. Stephen J. Thomas (in honor of (Texas Society of Anesthesiologists) American Association of Oral and Carol E. Rose, MD Simon C. Hillier, MD Robert K. Stoelting, MD) In memory of Jack D. Stringham, MD Maxillofacial Surgeons Society for Ambulatory Anesthesia Glen E. Holley, MD University of Maryland Anesthesiology (Gregory Peterson, MD) American Society of PeriAnesthesia Nurses Society for Obstetric Anesthesia and Shelly Ikeda, CRNA Associates In memory of Stewart A. Wilber, MD Anesthesia Consultants Medical Group Perinatology Janice J. Izlar, CRNA Andrea Vannucci, MD (Texas Society of Anesthesiologists) Casey D. Blitt, MD Society for Pediatric Anesthesia Patient Safety Paul M. Jaklitsch, MD Susan A Vassallo, MD (in honor of In memory of Alon P. Winnie, MD (Frank Sorin J. Brull, MD and Education Fund Kansas State Society of Anesthesiologists Neelakantan Sunder, MD) Moya Continuing Education Programs) California Society of Anesthesiologists South Dakota Society of Anesthesiologists Catherine M. Kuhn, MD Virginia Society of Anesthesiologists In memory of Peter Y. Wong, MD Dr. and Mrs. Robert A. Caplan Spectrum Medical Group of Portland, ME Paul G. Lee, MD Thomas L. Warren, MD (Texas Society of Anesthesiologists) Note: Donations are always welcome. Donate online ( http://www.apsf.org/donate_form.php)or mail to APSF, 1061 American Lane, Schaumburg, IL 60167-4973. (Donor list current through December 31, 2015.) APSF NEWSLETTER February 2016 PAGE 66

Anesthesia Patient Safety Foundation Officers, Directors, and Committees, 2016

Board Members Bruce P. Hallbert, PhD Richard C. Prielipp, MD, FCCM Tetsu (Butch) Uejima, MD Andrew Levi Battelle Energy Alliance-Idaho Wilmington, DE Spacelabs Executive Committee National Laboratory Lynn J. Reede, CRNA Officers Idaho Falls, ID Park Ridge, IL Maria A. van Pelt, PhD, CRNA James H. Philip, ME (E), MD Boston, MA Robert K. Stoelting, MD Board of Directors Steven R. Sanford, JD Committee on Scientific APSF President Evaluation James F. Szocik, MD Shane Angus, AA-C, MSA George A. Schapiro Indianapolis, IN Steven K. Howard, MD, Chair Ann Arbor, MI Washington, DC Robert K. Stoelting, MD Jeffrey B. Cooper, PhD Palo Alto, CA Robert H.Thiele, MD David J. Birnbach, MD APSF Executive Vice President Rebecca S. Twersky, MD Karen L. Posner, PhD, Vice Chair Charlottesville, VA University of Miami New York, NY Massachusetts General Hospital Kevin Tissot Boston, MA Miami, FL Allison F. Perry Timothy W. Vanderveen, PharmD Grant Administrator GE Healthcare George A. Schapiro Casey D. Blitt, MD Becton Dickenson Anesthesia Patient Safety Timothy W. Vanderveen, PharmD APSF Executive Vice President Sorin J. Brull, MD San Diego, CA Foundation Becton Dickinson Hillsborough, CA Jacksonville, CA Maria A. van Pelt, PhD, CRNA Peter J. Davis, MD Robert J. White Jason R. Byrd, JD Corporate Advisory Shane Varughese, MD Pittsburgh, PA Council APSF Vice President Carolinas Healthcare System AbbVie Covidien Charlotte, NC Richard H. Epstein, MD George A. Schapiro, Chair North Chicago, IL Philadelphia, PA Matthew B. Weinger, MD Robert A. Caplan, MD APSF Executive Vice President Mark A. Warner, MD APSF Secretary David B. Goodale, PhD, DDS Susan Carter, RN, BSN AbbVie Vanderbilt University Matthew B. Weinger, MD American Society of Jeana E. Havidich, MD (Gerald T. Eichhorn) Nashville, TN PeriAnesthesia Nurses Robert J. White Lebanon, NH Baxter Healthcare Casey D. Blitt, MD Cherry Hill, NJ Gary R. Haynes, PhD, MD (Jimena Garcia) APSF Treasurer Wando O. Wilson, CRNA, PhD Joan M. Christie, MD Coronado, CA Park Ridge, IL Alfred E. Lupien, PhD, CRNA Becton Dickinson Tampa, FL (Timothy W. Vanderveen, xecutive ommittee APSF Committees David J. Murray, MD E C Jerry A. Cohen, MD PharmD) embers at arge St. Louis, MO (M L ) University of Florida Newsletter Editorial B. Braun Medical, Inc. Robert A. Caplan, MD Gainesville, FL Board Sadeq Ali Quraishi, MD (Michael Connelly) Virginia Mason Medical Center Daniel J. Cole, MD Lorri A. Lee, MD, Co-Editor Boston, MA Seattle, WA Codonics UCLA Robert C. Morell, MD, Co-Editor Harish Ramakrishna, MD David M. Gaba, MD Los Angeles, CA Phoenix, AZ (Michael Grabel) Stanford University Steven B. Greenberg, MD, Jeffrey B. Cooper, PhD Rebecca S. Twersky, MD Cook Medical Palo Alto, CA Assistant Editor (Dan J. Sirota) T. Forcht Dagi, MD Evanston, IL Yan Xiao, PhD Steven R. Sanford, JD Dräger Medical American College of Surgeons Wilson Somerville, PhD Dallas, TX APSF Vice President Chicago, IL (David Karchner) Shawnee Mission, KS Winston-Salem, NC Committee on Technology Marcel E. Durieux, PhD, MD Eagle Pharmaceuticals Sorin J. Brull, MD Maria A. van Pelt, PhD, CRNA University of Virginia A. William Paulsen, PhD, (Leslie C. North, RN) Massachusetts General Hospital Charlottesville, VA Joan M. Christie, MD AA-C, Chair Boston, MA Hamden, CT GE Healthcare (Matti E. Lehtonen) Jan Ehrenwerth, MD Jan Ehrenwerth, MD Mark A. Warner, MD Yale University Patty Reilly, CRNA, 3M Infection Prevention Division Mayo Clinic New Haven, CT John H. Eichhorn, MD Strategic Relations Director (Mark J. Scott) Rochester, MN Medtronic Jeffrey M. Feldman, MD Glenn S. Murphy, MD Masimo Executive Committee Children’s Hospital of Philadelphia Chicago, IL Mike Argentieri (Chris Dax) (Committee Chairs) Philadelphia, PA Jeffery S. Vender, MD ECRI Medtronic Richard C. Prielipp, MD Jenney E. Freeman, MD Winnetka, IL Christopher Easter (Patty Reilly, CRNA) Patient Safety Section Editor, Respiratory Motion Committee on Education Pall Medical Merck Anesthesia and Analgesia Boston, MA Jacksonville, FL and Training Jeffrey M. Feldman, MD (Rachel A. Hollingshead, RN) David M. Gaba, MD Philadelphia, PA Steven K. Howard, MD Richard C. Prielipp, MD, Chair Mindray Chair, Committee on Scientific David B. Goodale, PhD, DDS Kenneth J. Abrams, MD Jenney E. Freeman, MD (Jeffrey M. Corliss) DBG Pharma Respiratory Motion Evaluation Great Neck, NY Nihon Kohden America Stanford University West Chester, PA David J. Birnbach, MD Tong Joo Gan, MD (Kathy Hart) Palo Alto, CA Linda Groah, RN Stonybrook University Association of periOperative Brian J. Cammarata, MD Pall Corporation Lorri A. Lee, MD Julian M. Goldman, MD (Daniel R. Mueller) Co-Chair, Editorial Board Registered Nurses Tucson, AZ Denver, CO Boston, MA Nashville, TN Susan Carter, RN PharMEDium Services Heidi Hughes Nikolaus Gravenstein, MD (Mark Wagner) Robert C. Morell, MD Joan M. Christie, MD Gainesville, FL Co-Chair, Editorial Board Philips Healthcare Philips Healthcare Niceville, FL Lorri A. Lee, MD Timothy N. Harwood, MD Thomas Green (Heidi Hughes) Winston-Salem, NC Paragon Service A. William Paulsen, PhD, AA-C Matti E. Lehtonen Preferred Physicians Medical Chair, Committee on Technology GE Healthcare Jeana E. Havidich, MD Casey Harper (Steven R. Sanford, JD) Frank Netter School of Medicine Madison, WI Lebanon, NH Northwestern University Hamden, CT Sheridan Healthcare Ana P. McKee, MD Samsun (Sem) Lampotang, PhD Michael B. Jaffe, PhD (Andrew Greenfield, MD) Richard C. Prielipp, MD The Joint Commission Gainesville, FL Wallingford, CT Chair, Committee on Education and Smiths Medical Sandeep Markan, MBBS David T. Jamison Training Terri G. Monk, MD (Tom Ulseth) Houston, TX Oricare, Inc. University of Minnesota University of Missouri Columbia, MO Spacelabs Minneapolis, MN Tricia A. Meyer, PharmD Carsten Bech-Jensen, (Andrew Levi) Roger A. Moore, MD Temple, TX Philips Healthcare Consultants to Executive University of Pennsylvania Teleflex Committee N. Ty Smith, MD David Karchner Philadelphia, PA (Cary G. Vance) San Diego, CA Dräger Medical John H. Eichhorn, MD Robert C. Morell, MD Abe Abramovich University of Kentucky Lianne Stephenson, MD Tom Krejcie, MD Lexington, KY A. William Paulsen, PhD, AA-C Madison, WI Chicago, IL Robert K. Stoelting, MD APSF NEWSLETTER February 2016 PAGE 67

APSF Awards 2016 Grant Recipients by Steven K. Howard, MD The APSF’s mission statement explicitly partial upper airway obstruction—are at a greater Dr. Weaver’s educational submission is entitled includes the goal to improve continually the safety risk of developing postoperative delirium. The “Development and Evaluation of an Online of patients during anesthesia care by encouraging prevalence of OSA increases with age, yet elderly Improvement Project Implementation Course for and conducting safety research and education. individuals with this condition often remain undi- Anesthesia Trainees” Since 1987, the APSF has funded safety projects agnosed. Unrecognized OSA may be a treatable Background: Developing anesthesia providers totaling over 9 million dollars. cause of postoperative delirium. However, no stud- ies have investigated whether diagnosing and treat- with the skills and experience necessary for imple- In 2015, the APSF investigator-initiated grant ing OSA preoperatively reduces the incidence of menting and leading patient safety improvement program had 43 letters of intent (LOIs). Members of postoperative delirium. work is crucial for delivering reliably safe care. the APSF Scientific Evaluation Committee reviewed Patient safety improvement methods are key com- and invited the top eight scoring grants to submit Aims: The primary objectives of this multicenter, randomized, controlled trial are to determine ponents of ACGME Systems-Based Practice and full proposals—six full proposals were submitted Practice-Based Improvement milestones for resi- for final review and discussion on October 24, 2015 whether identifying OSA using a portable diagnostic device—and treating OSA with auto-titrating con- dents. Education developing the knowledge, skills, at the ASA Annual Meeting in San Diego, CA. Two tinuous positive airway pressure (CPAP)—will pre- and attitudes underpinning successful completion proposals were recommended to the APSF Execu- vent the occurrence of delirium in elderly patients and evaluation of improvement interventions is tive Committee for funding and both received undergoing knee- and hip-replacement surgery. We still emerging as an important component of many unanimous support. This year’s recipients were will also determine whether auto-titrating CPAP residency programs. While semi-structured faculty Jean Wong, MD, from the Department of Anesthe- treatment of OSA will decrease the incidence of other mentoring is critical, formal training in project sia at the University of Toronto, and Sallie Weaver, OSA-related perioperative complications. All development, management, and evaluation stands PhD, from the Armstrong Institute for Patient patients will be evaluated for the development of to strengthen the capacity of residents and other Safety and Quality, the Department of Anesthesiol- postoperative delirium after surgery. ogy and Critical Care Medicine at Johns Hopkins trainees to implement successful safety improve- University School of Medicine. Implications: Delirium is associated with ment projects from the ground up. increased morbidity and mortality, and higher Aims: In line with APSF’s mission to create The principal investigators of this year’s APSF healthcare costs. Our study will increase knowl- grant provided the following description of their edge of the effect of OSA on postoperative delirium, young safety scientists and practitioners, this project proposed work. and may reduce the risks for delirium and other will develop and evaluate an online training module OSA-related perioperative complications. The tailored to anesthesia residents and trainees that will results of our study may be used to design future provide instruction and practical tools for planning, delirium prevention and management strategies to implementing, and evaluating a patient safety improve the safety and surgical outcomes of this at- improvement project. The first phase includes a risk population since there are few effective preven- semi-structured needs analysis to elicit key safety tative interventions for delirium. improvement competency areas identified by a Funding: $149,262 (January 1, 2016 – December national panel of experts and development of the 31, 2017). This grant was designated as the APSF/ course. Phase two includes implementation and a American Society of Anesthesiologists (ASA) Presi- multilevel evaluation that will examine learner reac- dent’s Research Award. Dr. Wong is also the recipi- tions, cognitive and affective learning, transfer, and ent of the Ellison C. “Jeep” Pierce, Jr., MD Merit the quality of resident-led patient safety projects. Award, which provides an additional, unrestricted Results will inform refinements and public dissemi- amount of $5,000. nation of the online course. Implications: This work has the potential to improve the safety of patients in the care of anesthe- Jean Wong, MD, FRCPC sia providers by strengthening resident and trainee Associate Professor, Department of Anesthesia competencies in patient safety improvement, project University of Toronto management, and evaluation. Additionally, through Dr. Wong’s Clinical Research submission is enti- partnerships with the APSF, American College of tled “Prevention of Delirium in Elderly with Medical Quality and other partners, this project will Obstructive Sleep Apnea (PODESA)” result in educational resources available to residency programs and individual trainees seeking to Background: Delirium is one of the most strengthen their knowledge and skills in patient common postoperative complications in elderly patients after major surgery. It is an extremely dis- safety improvement. tressing problem for elderly patients and their fami- Funding: $149,944 (January 1, 2016–December lies, and increases their risk for other serious 31, 2017). This grant was designated as the APSF/ complications, including death. The pathophysiol- Sallie J. Weaver, PhD American Society of Anesthesiologists (ASA) ogy of delirium is poorly understood, but is Assistant Professor Endowed Research Award. believed to be a multifactorial process resulting from a combination of predisposing and precipitat- Armstrong Institute for Patient Safety and Quality Dr. Howard is Professor of Anesthesiology, Periop- ing factors. Recent studies show that patients with Department of Anesthesiology and erative and Pain Medicine at Stanford University obstructive sleep apnea (OSA)—a sleep disorder Critical Care Medicine, School of Medicine and Chair of the APSF Committee characterized by repeated episodes of complete or Johns Hopkins University School of Medicine on Scientific Evaluation. APSF NEWSLETTER February 2016 PAGE 68

APSF Sponsors Workshop on Implementing Emergency Manuals by Robert C. Morell, MD and Jeffrey B. Cooper, PhD On September 9, 2015, in Phoenix, Arizona, the APSF convened an experts’ workshop entitled Implementing and Using Emergency Manuals and Checklists to Improve Patient Safety. The background for this conference addressed the need for anesthe- sia professionals and other members of the periop- erative care team to move towards the acceptance of cognitive aids (emergency manuals, checklists) and away from the traditional reliance on memory and the cultural perception of individual perfec- tion. Cognitive aids include a variety of physical and electronic representations of knowledge “in the world” designed to assist those responsible for perioperative care in executing complex decision- Speakers from the first panel of the workshop, seated left to right, include Matti E. Lehtonen (GE Healthcare); Laura making in dynamic settings. The reality is that no E. Schleelein, MD (Assistant Professor of Clinical Anesthesiology, Children's Hospital of Philadelphia, Perelman one can function as the lone expert recalling every School of Medicine, University of Pennsylvania); Steven K. Howard, MD (Professor of Anesthesiology, Perioperative procedure and drug dose from memory. Success- and Pain Medicine, Stanford University School of Medicine, and Chair, APSF Committee on Scientific Evaluation); ful care of the patient in the perioperative period, and David L. Hepner, MD, MPH (Associate Professor of Anesthesia, and Associate Director of the Weiner Center for particularly during critical events, has previously Preoperative Evaluation, Brigham and Women's Hospital, Harvard Medical School). been considered to be the exclusive responsibility of an individual’s knowledge and skill. This is Dr. Gaba’s presentation audience response data now being recognized as not optimal because demonstrated that 82% of participants felt that human memory is limited and fallible, especially every site of perioperative care should have one or under stress. A recognized principle of human fac- more emergency manuals (EMs) readily accessible. tors research is the use of both knowledge “in the head” (memory) and “knowledge in the world” Historical Background (presented externally) combined with inter-profes- Provided sional teamwork. The combination of these may allow the best opportunity for optimal outcome, David Hepner, MD, MPH, from the Brigham particularly in crisis situations. and Women’s Hospital in Boston, presented a review of relevant literature. He noted a 1924 his- The goals of this conference focused on the torical report of such a manual by Babcock. Yet, it practical aspects of systematically implementing was many years until the concept gained serious Emergency Manuals/Cognitive Aids and Check- interest in hospitals. Runciman, in 2005, introduced lists in the in the perioperative setting. With Dr. the idea of a crisis management algorithm based on Robert Stoelting, APSF President, and Dr. David studies of anesthesia critical events. A Stanford Gaba serving as conference co-moderators, Dr. team led by Gaba and colleagues in 2006, reported Stoelting opened the conference, welcoming the on the use of cognitive aids on laminated cards. over 100 participants representing diverse stake- Those who used cognitive aids during simulated holders including anesthesiologists, CRNAs, anes- emergencies were more effective in performing create, don’t require special revisions dependent thesia associates, surgeons, OR nurses and critical steps compared with those who did not use on a specific platform or operating system (vs. technicians, insurance providers and several such aids. Dr. Hepner provided a number of exam- electronic systems), and can be easily modified by healthcare companies with anesthesia interests. ples of studies demonstrating the value of cognitive adding or replacing pages. In addition hard copy The program began with a series of informational aids, including a 2012 study by Dr. Joseph Neal can withstand power failures and Wi-Fi outages. podium presentations, followed by panel discussions demonstrating improved trainee performance However, he noted that there are problems intrin- and culminating in small group breakout sessions, during a simulated episode of local anesthetic toxic- sic to the hard-copy model, including the need to which led to a number of recommendations. ity using the ASRA checklist. Dr. Hepner also dis- identify an obvious place to put them where they cussed how Pronovost reported on the use of Dr. Gaba, who provided background informa- are accessible, yet not in the way. Most challenging checklists to reduce central line infections in the tion addressing why crisis management cognitive is that hard copies can and do easily disappear ICU setting. In addition, Zieacz et. al., published aids are needed in anesthesia and perioperative from the OR. The concept of hard copy vs. elec- their study of the use in simulation of a surgical care, delivered the first presentation. Some reasons tronic was studied in simulation. Interestingly, one crisis checklist, which garnered national attention. included that “even smart people need help in third of people didn’t use the cognitive aid despite dynamic settings” and that oftentimes factors such Hard Copy Manuals good instruction in its use. The hard copy seemed as subconscious complacency and premature clo- to be favored somewhat over the electronic ver- sure may play roles in limiting optimal perfor- Tend to Disappear sion. Dr. Howard also shared his perspective that mance when dealing with diagnosis, planning and Dr. Steven Howard, from Stanford and a co- other issues are much more important than the treatment. Dr. Gaba also provided perspective author of the 1994 book that holds what may be format of the tool. These important issues include obtained from Dr. Gawande’s Checklist Manifesto, the first extensive compilations of emergency pro- “training with the tool,” cultural acceptance, prac- simulation-based studies of manual use and the cedures in anesthesia, described the advantages of titioner acceptance, and determining how best to role of the reader, and the Emergency Manual using hardcopy versions of an EM. Hard copies Implementation Collaborative (EMIC). Following are familiar to all clinicians, relatively easy to See “Manual Workshop,” Next Page APSF NEWSLETTER February 2016 PAGE 69

Implementation of Emergency Manuals Presents Challenges and Risks

“Manual Workshop,” From Preceding Page already happening based on the world map of central display for everyone to see or a personal downloads of the application demonstrated by Dr. device preferred? These questions remain unan- use while recognizing potential pitfalls. Audience Schleelein. Electronic platforms have disadvan- swered. Preliminary work suggests many advan- participation results revealed that 84% of partici- tages as well. Technology failures are possible, it tages to an embedded EM, e.g., the interface will pants felt that hard copy manuals had several can be difficult to navigate, easy to accidently be familiar, and real-time patient data can be advantages over electronic versions. In addition, jump to the wrong place and struggle to get back, accessed. But such systems could limit individual 92% of participants believed that more studies are and the display size can be limited. Electronic adjustments to EMs if they are standardized by a necessary to determine how to best utilize emer- apps are expensive to make and need to be operat- manufacturer. The audience strongly agreed that gency manuals. ing system compatible. It can be cumbersome to a central visible display (83%), context-sensitive hold a device, which might be overcome with a information (85%), and predictive algorithms Pros and Cons reader. Research about electronic vs. hard-copy (85%) would be beneficial in crisis management of Electronic EM Explored aids is conflicting, so it’s currently unclear which situations. In addition, 86% of the audience Laurie Schleelein, MD, from the Children’s is the most desired approach. Audience participa- believed that combining electronic patient infor- Hospital of Philadelphia, described how electronic tion results showed that 41% of participants mation with caregiver input would allow more apps could be used on personal devices for access- agreed and 40% disagreed that the advantages of appropriate and efficient checklists. 62% of the ing an emergency manual. Advantages of electronic electronic apps far outweigh the disadvantages, audience felt that the primary barrier to utilizing versions include the ability to interact with the user, while 74% of participants felt that there is a risk EMs and checklists is cultural, while only 9% for which some improvement in performance cognitive aids will distract the team from the believed barriers to be technological. 76% of the audience thought that a trained reader of the during resuscitations has been reported. The inter- emergency situation. manual should be designated during the time-out. action can include a form of checklist that branches Matti Lehtonen of GE Healthcare subsequently depending on what is done or observed. An elec- discussed how emergency manuals could be EM Use Can Have Pitfalls tronic version also allows the input of patient spe- embedded in clinical equipment. This has the Following a short break, APSF Executive Com- cific information, such as entering the patient’s advantage of enabling patient-specific data being mittee member Maria van Pelt, PhD, CRNA, mod- weight, to allow a weight-based dose. It can include accessible as part of the EM algorithm. He thinks it erated the second session, which began with Dan a clock to enable decision-making based on elapsed may be possible to build some intelligence into Raemer, PhD, from Massachusetts General Hospi- time and warn when critical times are passed. An technology that can actually give early warning of tal (MGH) who spoke about the pitfalls and risks app can be used to record what has been done, an impending crisis to avoid it. His engineering associated with the use of emergency manuals. He which can be used for debriefing and to facilitate team has many pilots; they study what’s been learning from prior events. explained that he had been a proponent of EMs for learned and what’s being done in aviation. many years; however, he has shifted his thinking, Emergency manual apps can be updated auto- Embedded, paperless versions of checklists are having seen many real and simulated anesthesia matically via a server. Mobile phones and tablets being integrated into new aircraft. This potential crises and instances where the EMs have not been are now widely used, so downloading to a very technology raises several questions. If the checklist as helpful as hoped and perhaps harmful. He large population of users is possible. That is is integrated, where should it be displayed? Is a acknowledged that he did not have data to support his concerns, rather anecdotes from his observa- tions. Dr. Raemer illustrated pitfalls with examples he has seen. In one case of septic shock, the team perseverated on a diagnosis of malignant hyper- thermia (MH). This occurred after someone sug- gested MH as a possibility and turned to that page in the manual. This was an example of a fixation by being on the wrong page. In another case of a mixed diagnosis with possible components of ana- phylaxis and/or transfusion reaction, the team went back and forth between pages and to other pages without getting to a correct course of treat- ment. In yet another case, the correct diagnosis was septic shock, for which there is no page in the manual. This team became distracted and did not provide appropriate treatment. A relevant audience response question revealed that 99% of participants believed that the introduction of EMs, like any new technique or Pediatric Critical technology in medicine, presents unanticipated Events Checklist: risks and potential complications. Free App for a Amanda Burden, MD, of Cooper Medical checklist from the School of Rowan University, made the next pre- Children's Hospital sentation. Dr. Burden described ways to mitigate of Philadelphia. See “Manual Workshop,” Next Page APSF NEWSLETTER February 2016 PAGE 70

Simulation Can be Vehicle to Implement Emergency Manuals

“Manual Workshop,” From Preceding Page Dr. Berry. He asked what would it take to stan- dardize? His rationale was, in part, that there is a the risks of using checklists and the role of a reader cost to each hospital creating its own manual. It during crisis management. She reviewed the his- would be easier to implement if less time was tory of checklists in aviation, beginning around needed to select an EM and thus more time could WWII. Despite the evidence of the effectiveness of be available for training. Having standardization checklists, pilots were resistant to them because of would enable EM integration into an electronic their culture of independence and reliance on their record, current vendors of which do not allow skills. She went on to review how stress and much customization. He also sees a great advan- expansion of knowledge impact the ability of phy- tage for those who travel between institutions, sicians to do the right things during critical situa- although of course some local information, such as tions. The kinds of stresses and challenges in phone numbers, would be different. In audience aviation and perioperative medicine are similar response, 86% agreed that it would be helpful to and the resistance to using checklists was the same have a standardized set of EMs, which could be during the introduction in aviation, as they appear to be now in health care. In aviation, the solution tailored and used for regular emergency drills. was to do research and training to both optimize Only 35% of the audience felt it would be impor- their use and teach people to use them effectively. tant for each institution to design its own set of She presented a number of pitfalls and possible EMs to reflect their clinical situation. solutions including the development of better Dr. Sara Goldhaber-Feibert from Stanford checklists, the use of a reader, use of crisis resource shared her expertise and extensive experience in management (CRM) skills, team training and a implementing and studying EMs. She elucidated supportive culture. some of the best practices for implementation. Dr. Hannenberg shares his perspective with workshop Champions, leadership buy-in and local teams are The audience response indicated that only 19% participants. of participants believed that limitations of check- keys to success. Local adaptation and customiza- lists must be overcome before their use should be tion has been shown to be vital, as well as learning “team sport” of the use of EMs. Dr. Hannenberg widely adopted. Similarly, 92% of respondents from what others have done. She stressed that it is is a member of the board of directors of the Coun- disagreed with the position that if teams and indi- important to avoid aiming for perfection. It is cil on Surgical and Perioperative Safety, which is viduals practice CRM, checklists are not necessary. important to synergize the EM implementation a multidisciplinary coalition of 7 associations with other patient safety goals and context. representing professionals involved in surgical Consensus Building is Not Easy Having the EM can be an incentive to beginning care. He sees simulation as being a vehicle to full OR teamwork training. Getting input and Dr. William Berry, one of the early pioneers in introduce emergency manuals to all the players buy-in from multidisciplinary leaders is another introducing the concept of checklists into periop- on the team. In his experience, the process of piece of the successful implementation puzzle. erative care, addressed the question if a standard- introducing EMs locally can help identify system Success is also aided by a diverse training plan ized EM should be developed. He described how weaknesses. Each discipline sees weaknesses that that includes getting buy-in to do it, what goes he and his colleagues got involved with the topic are invisible to the others. He emphasized the into it and then how to use the manual and imple- of checklists based on an adverse surgical event importance of involving all of the specialties in experienced by a surgical colleague. He took the ment it. Encouraging self-review and educational the process of creating, editing, implementing, opportunity to describe the efforts of EMIC. He use is also very effective. She also stressed the and training for EM introduction and use. In this acknowledged that, currently, there are many dif- importance of publicizing success stories and way, a “team of champions” is created, all of who ferent tools from different groups; there is no con- bright spots in anthropological terms. It was made own the product. Dr. Hannenberg advised that sensus on what items should be included in an clear that there is much to be learned in the grow- we create a “we use checklists” mentality, the EM, on the format, or on needed training. The pro- ing field of implementation science. The steps idea being that good clinicians use cognitive aids. cess of implementing a checklist locally is a great noted above are generally used in other fields so He wants the nurse to be able to say, “Dr. benefit for getting people to consider how to pre- there is evidence that they have some science Hannenberg, do you want me to bring the code pare for, and how to manage emergencies. He behind them. There are also many reports in cart in here, do you want me to get the Emer- gave an example of how one hospital developed health care regarding successful implementations gency Manual?” He told the story of how one of their own new checklist for bronchospasm, which of patient safety and quality interventions. 96% of his senior surgical colleagues, when asked how was not in some other manuals. Much more inno- the audience agreed that there are many steps he’d feel about being asked to read the manual, vation and creativity are needed to optimize the between an individual downloading a useful EM replied, “You have no idea how it feels when use of EMs. It would be very challenging to create and an institution effectively implementing it clin- your patient is dying on the table and there’s a standard manual, to reach consensus on what ically. 66% agreed that literature on EM imple- nothing you’re involved in doing about it. I’d belongs in such a manual, the steps for each situa- mentation and clinical use is accurately described happily read out the checklist.” Dr. Hannenberg tion, and then be able to maintain the product. He as “nascent.” Interestingly, only 31% of respon- quoted a 2012 Study from the Annals of Surgery does not feel the time has come to do that, nor dents agreed that the greatest barrier to imple- demonstrating that the success of implementation believe that it may ever come to fruition. 87% of menting EMs and checklists seems to be the belief of a safety checklist was improved when a multidis- the audience agreed that there are a number of that their use denotes some sort of failure on the ciplinary team led the process, rather than when a questions that need to be answered prior to creat- part of the anesthesia professional. single staff member led it. Audience response ing a single standardized manual. revealed that 79% agreed that anesthesia profes- Dr. Bill Paulsen moderated the final series of sionals should lead the development of the content Dr. Paul Preston from the Permanente Medical presentations, which began with Dr. Alex Group took a somewhat different position from Hannenberg describing ideas for how to make a See “Manual Workshop,” Next Page APSF NEWSLETTER February 2016 PAGE 71

Breakout Sessions Lead to Constructive Ideas

“Manual Workshop,” From Preceding Page does not set standards; rather this organization the team that anyone can suggest its use, and can spread the word via the APSF Newsletter, that a reader be designated as appropriate to for cognitive aids for OR emergency management; which is the most widely disseminated anesthe- the situation. however, 96% disagreed that only anesthesia pro- sia publication in the world. He also suggested • Invest in research and career development that fessionals should call for the use of an EM. videos and visibility in the APSF booths at the improves implementation science related to the ASA and AANA annual meetings. Further, the Matt Weinger, MD, Vanderbilt University pro- use of checklists. fessor and Director of the Center For Research and APSF could lobby its constituents. He noted that Innovation in Systems Safety, spoke to the ques- APSF recommendations about audible alarms • Advocate for the processes and education it takes tion of what research is needed to evaluate the were adopted by the ASA. The question of sup- to successfully engage local environment teams safety and effectiveness of EM use. He presented porting a new standard of care would necessitate to implement the use of unified checklists. preliminary results from a large study of board- the ASA as the best pathway. It’s not likely that • Use research to determine how one could certified anesthesiologists who were participating new standards will be created, but guidelines are design an EM that is so simple that no training in MOCA simulation courses at 10 different U.S. possible. is required. sites. In a highly organized, controlled study, A large majority of the audience felt that the • Use research to examine the effect of a manual experts rated 364 CRM scenarios. Only 74% of all APSF should take a leading role in promoting or checklist focused on a single more common critical items were actually performed. For some EMs; however, the audience was split on the ques- critical actions, as few as 7% of anesthesiologists event (intraoperative hypotension) on compos- tion of whether EMs should ever become a stan- performed a task that experts had determined was ite patient outcomes. dard of care with only 67% voicing that opinion. critical in that situation. Only 54% actually used • Determine if the APSF should play a leading Many of these issues were discussed and revisited the MH protocol during the simulated MH event. role in developing and testing a new national during the final panel discussion. For overall performance, the average score was in crisis event management curriculum intended the middle of the scale, or just average perfor- Finally, the small group breakout sessions for all perioperative learners. resulted in very creative and constructive ideas mance. These results were supportive of the need The conference demonstrated that we are on for significant improvement and the potential ben- and recommendations. Some examples follow: the right track, but much work needs to be done. efit of training with, and implementation of, emer- • Create an APSF education/advocacy package, gency manuals and CRM. including a video and a PowerPoint about imple- Dr. Morell is the Senior Co-editor of the APSF News- mentation and use of EMs along with a “toolkit” letter, a member of the APSF Executive Committee, and a Not Feasible for interested individuals/champions. private practice anesthesiologist in Niceville, FL. to Conduct Ideal Study • Develop, implement, and maintain a strong Jeffrey B. Cooper, PhD, is Professor of Anaesthesia at Dr. Weinger generated numerous questions that social media presence for proper use of EMs. Harvard Medical School, Department of Anesthesia, Crit- that needed to be addressed with further research. He • Recommend that a part of the pre-surgical ical Care & Pain Medicine, Massachusetts General Hospi- focused on the design of an ideal outcome study, timeout should consist of the verification of the tal, and Executive Director at the Center for Medical introducing cognitive aids into practice and measur- presence of an emergency manual, to remind Simulation, Boston, MA. ing patient outcome. With an estimated event rate and effect size, he estimated it would require 1.6 mil- lion patients and over three years to conduct such a study. His conclusion is that it just is not feasible to conduct such a study for EMs. Conversely, such a Anesthesia Patient Safety Foundation study could be done for the WHO checklist introduc- ANNOUNCES THE PROCEDURE FOR SUBMITTING tion, since it is used in all cases, not just rare emergen- GRANT APPLICATIONS cies. Dr. Weinger recommends that large prospective studies have to focus on teamwork interventions and DEADLINE TO SUBMIT THE LETTER OF INTENT (LOI) that cognitive aids need to be used, but not studied as FOR AN APSF GRANT AWARD TO BEGIN JANUARY 1, 2017 IS: the cause of the outcomes. There was strong agree- ment with Dr. Weinger’s conclusion that studying outcome improvement resulting from EM introduc- FEBRUARY 22, 2016 (5 PM EST) tion is not likely useful. • LOI will be accepted electronically beginning January 8, 2016. Dr. John Eichhorn’s presentation followed, in • The maximum award is $150,000 for a study conducted over a maximum of which he suggested actions APSF could take to 2 years to begin January 1, 2017. further implement using EMs to improve patient safety. Dr. Eichhorn, as founding editor of this • Based on the APSF’s Scientific Evaluation Committee’s evaluation of these newsletter, recommended that the APSF should LOIs, a limited number of applicants will be invited to submit a full proposal. work to dispel the message that the use of cogni- • Investigators will be notified of the status of their LOI electronically on tive aids is a weakness, but rather is a strength. Wednesday, June 1, 2016. He also noted that the APSF had been highly influential in the success of widespread use of Instructions for submitting a Letter of Intent can be found at: simulation. In discussing how the APSF could http://www.apsf.org/grants_application_instructions.php effect change, he suggested that efforts should primarily be via education and advocacy. Dr. Eichhorn reminded the audience that the APSF APSF NEWSLETTER February 2016 PAGE 72

FDA Issues Drug Safety Communication About Epidural Corticosteroid Injections by Joan Christie, MD In April 2014, the U.S. Food and Drug Admin- Challenges: and radiating pain in the arms and legs. These istration (FDA) issued a drug safety communica- serious problems include loss of vision, stroke, Both the FDA and the external consensus panel tion entitled “FDA requires label changes to warn paralysis, and death. were confronted with numerous confounding of rare but serious neurologic problems after epi- • The effectiveness and safety of injection of corti- 1 variables and a striking lack of scientific data to dural corticosteroid injections (ESI) for pain.” In illuminate the myriad issues surrounding SNE costeroids into the epidural space of the spine May 2015 an expert panel convened by the FDA after ESI. The FDA recognized potential causes of have not been established, and the FDA has not published their recommendations to prevent neu- SNE including technique-related issues such as approved corticosteroids for this use. rologic complications after ESI.2 The purpose of intrathecal injection, epidural hematoma, direct • Discuss the risks and benefits of ESI with your this article is to review the FDA warning and to nerve or spinal cord injury, and embolic infarction. health care professional along with the benefits summarize the expert panel recommendations.* Patient- and procedure-related contributors and risks associated with other possible treat- included selection criteria, anatomy, spinal level, ments. Timeline: approach (interlaminar or transforaminal), the • Seek emergency medical attention if you experi- degree of patient sedation, and use of fluoroscopy. 2009: The FDA begins evaluating serious neuro- ence any unusual symptoms after receiving ESI, A central question was the role of glucocorticoid such as loss of vision or vision changes, tingling logic events (SNE) associated with ESI. Cases in preparations themselves including particulate ste- the medical literature and FDA adverse event in your arms or legs, weakness or numbness of roid suspensions and non-particulate solutions. your face, arm, or leg on one or both sides of the reporting system (FAERS) included stroke, paraly- The vast majority of SNEs with infarction were body, dizziness, severe headache, or seizure. sis, spinal cord infarction, seizures, nerve injury, associated with particulate steroid suspensions, brain edema, loss of vision, and death. which was supported by two animal studies. The • Report any side effects following ESI to the FDA MedWatch program using the information in 2011: The FDA Safe Use Initiative facilitated the FDA database with 1.3 million Medicare ESIs found that 80% utilized suspensions thereby the “contact FDA” box: Visit www.FDA.gov/med- formation of an external advisory committee. The making the relative frequency of this rare event watch or call 1-800-FDA-1088. working group was to develop recommendations with the different steroid preparations unclear. Information for Health Care for minimizing risk of SNE with ESI. The use of solutions increased from 5% to 15% in 2014 May: FDA Drug issues a Safety Communica- younger patients and 4% to 9% in Medicare recipi- Professionals: tion requiring label change to warn of SNE after ESI. ents between 2009 and 2013. However, there were • Rare but serious neurologic events have been SNEs with both suspensions and solutions during reported with ESI including spinal cord infarc- 2014 Nov.: FDA confers with the FDA’s Anes- that review period. thetic and Analgesic Drug Products Advisory Com- tion, paraplegia, quadriplegia, cortical blind- mittee to discuss the necessity of further regulatory The Safe Use Initiative consensus group was ness, stroke, and death. actions. Concerns were raised by the FDA advisory charged with reviewing the existing scientific evi- • These serious events have been reported with dence and assembling clinical considerations aimed committee regarding particulate steroids (methyl- and without the use of fluoroscopy. at reducing the risk of severe neurologic complica- prednisolone, triamcinolone, betamethasome) in • The effectiveness and safety of epidural cortico- tions after ESI. The members of the Safe Use Initia- steroid administration have not been estab- suspension having a higher risk for SNEs than non- tive committee consisted of experts from many lished, and the FDA has not approved particulate steroids (dexamethasome) in solution, disciplines and stakeholder national medical orga- corticosteroids for this use. but there was not clear agreement on the best nizations, and the consensus group generated their course of action from the advisory committee. The specific clinical practice parameters without any • Discuss with patients the risks and benefits of FDA did not modify the safety communication decision-making input from the FDA. ESI and other possible treatments. warning. The group concluded that adherence to spe- • Counsel patients to seek emergency medical 2015 May: The FDA Safe Use Initiative multidis- cific practice recommendations should lead to a attention immediately if they experience symp- ciplinary and national organization working group reduction in the incidence of neurologic injuries toms after receiving ESI such as loss of vision or publishes their consensus report and recommenda- after ESI. vision changes, tingling in arms or legs, sudden weakness or numbness of face, arm, or leg on tions in a paper entitled "Safeguards to Prevent one or both sides of the body, dizziness, severe Neurologic Complications after Epidural Steroid 1 The FDA Warning: headache, or seizure. Injections".2 This report addresses numerous poten- Facts, information for patients, tial safety issues including sedation level, tech- information for health care professionals • Report adverse effects following ESI to the FDA nique, use of fluoroscopy or other imaging MedWatch program using the information in guidance, injection of contrast prior to injection of Facts: the “contact FDA” box. steroid and avoidance of particulate steroids for • Injectable corticosteroids include methylpred- Statements and Clinical injection, particularly in the cervical region. nisolone, hydrocortisone, triamcinolone, beta- Considerations of the Safe Use 2015 Oct: FDA publishes "Serious Neurologic methasone, and dexamethasone. Working Group2 Events after Epidural Glucocorticoid Injection— • Corticosteroids are not approved by the FDA 3 1. Cervical interlaminar ESIs are associated with a The FDA’s Risk Assessment," explaining their for injection into the epidural space. rare risk of catastrophic neurologic injury. rationale for not differentiating the warning for particulate versus non-particulate steroids. Information for Patients: 2. Transforaminal ESI using particulate steroid is associated with a rare risk of catastrophic neu- • Rare but serious problems have occurred after * The FDA warning and consensus panel recommendations did rovascular complications. not include cases of contamination of compounded products injection of corticosteroids into the epidural reported in 2012. space of the spine to treat neck and back pain See “Corticosteroid,” Next Page APSF NEWSLETTER February 2016 PAGE 73

FDA and Advisory Committee Address Risks of Epidural Steroid Injections

“Corticosteroid” From Preceding Page Discussion particulate steroid formulations, imaging prior to and during the procedure, radiocontrast test doses, The FDA drug safety communication is impor- 3. All cervical interlaminar ESIs should be per- degree of sedation, approach, etc. tant to help clinicians and patients understand the formed using image guidance with appropriate FDA perspective and database experience with epi- The Safe Use Initiative working group consen- AP, lateral, or contralateral oblique views and a dural steroid injections. Between 1997 and 2014, a sus recommendations were published in an anes- test dose of contrast medium. total of 90 serious and sometimes fatal neurologic thesiology journal although ESIs are also performed 4. Cervical transforaminal ESI should be per- events were reported to the FDA Adverse Report- by specialists from other disciplines. Areas not formed using contrast medium under real-time ing System (FAERS) excluding contaminated com- addressed in the recommendations include the use fluoroscopy or digital subtraction imaging, pounded products. Statistics for Medicare and IMS of a local anesthetic test dose, patient selection crite- using an AP view before injecting any substance Health suggested almost two million ESIs were per- that may be hazardous to the patient. ria, the anticoagulated patient, chlorhexidine in formed from 2009 to 2013. Thus, clearly these cata- alcohol for skin preparation, and the use of specific 5. Cervical interlaminar ESI are recommended to strophic adverse events are rare. Both the advisory needle types. be performed at C7-T1, but preferably not higher committee and FDA concurred that these events do than C6-C7 level. occur. The FDA acknowledges ambiguity sur- The two documents begin from the position 6. No cervical interlaminar ESI should be under- rounding the effectiveness of ESI in their informa- that significant neurologic injury may rarely occur taken at any segmental level without reviewing, tion for patients and information for health care after ESI. They diverge as a function of different prior to the procedure, prior imaging studies professional sections of the warning.4-5 In Novem- areas of focus. The FDA's job was to warn patients showing adequate epidural space for needle ber 2014, after the warning had already been and doctors of these rare events. The FDA did not placement at the target level. released, the FDA asked their advisory committee endorse the use of ESIs for chronic pain, a specific 7. Particulate steroids should not be used in thera- on Anesthetic and Analgesic Drug Products approach (transforaminal versus interlaminar), a peutic cervical transforaminal injections. whether a contraindication was warranted to specific formulation (particulate steroid suspen- 8. All lumbar interlaminar ESIs should be per- restrict the injection of glucocorticosteroids into the sion or non-particulate steroid solution), or the use 3 formed using image guidance with appropriate epidural space. The FDA considered the advisory of fluoroscopy or other type of imaging. The Safe AP, lateral,or contralateral oblique views and a committee feedback and decided not to modify the Use Initiative working group complimented the test dose of contrast medium. warning which states that the "effectiveness and FDA warning by delineating clinically substantive 9. Lumbar transforaminal ESI should be per- safety of injection of corticosteroids into the epi- relevant recommendations which could reduce formed using contrast medium under real-time dural space of the spine have not been established, SNE after ESI. Although research is needed to fluoroscopy or digital subtraction imaging using and the FDA has not approved corticosteroids for clarify issues, the low incidence of these events an AP view before injecting any substance that this use." The FDA also did not find that the avail- may preclude detection in even very large studies. may be hazardous to the patient. able data warranted either a contraindication or The SafeUse Initiative authors conclude "Our hope warning focused on cervical transforaminal injec- 10. A nonparticulate steroid (e.g., dexamethasone) is that these clinical considerations will help every tion of particulate steroid suspension preparations. should be used for the initial injection in lumbar practitioner who performs epidural injections of There was a concern that data did not support transforaminal epidural injections. steroids to become familiar with the risk of neuro- labeling non-particulate steroid solutions safer than logic complications and to adopt the best safe- 11. There are situations where particulate steroids particulate steroid suspensions and that such label- could be used in the performance of lumbar guards to avoid complications and provide the ing might encourage practitioners to use solutions 3 transforaminal epidural steroid injection. even though their relative safety and effectiveness safest care for their patients". 12. Extension tubing is recommended for transfo- remain an open question.3 The Safe Use expert Dr. Christie reports no financial disclosures related raminal ESIs. panel overwhelmingly felt that particulate steroids to this article or topic. 13. A face mask and gloves must be worn during the were the culprit in transforaminal approaches.6 The Dr. Christie is Associate Clinical Professor in the procedure. FDA safety warning urges clinicians to discuss the Department of Anesthesiology at the University of risks and benefits of ESIs and alternative therapy 14. The ultimate choice of what (interlaminar vs. South Florida College of Medicine in Tampa, FL. She is with patients presumably as a part of the pre-proce- transforaminal ESI) to use should be made by a member of the APSF Editorial Board and the APSF the treating physician by balancing potential dure informed consent process. Committee on Education and Training. risks vs. benefits with each technique for each The multispecialty external working group given patient. from the FDA Safe Use Initiative contended with References 15. Cervical and lumbar interlaminar ESIs can be numerous scientific obstacles and clinical uncer- 1. Food and Drug Administration. FDA Drug Safety Communi- performed without contrast in patients with cation: FDA requires label changes to warn of rare but seri- tainties inherent in the data surrounding ESI. There ous neurologic problems after epidural corticosteroid documented contraindication to the use of con- were 13 organizations voting to agree, disagree, or injections for pain. April 23, 2014 (http://www.fda.gov/ trast (e.g., significant history of contrast allergy abstain with the clinical recommendations. The DrugsSafety/ucm394280.htm). or anaphylactic reaction). largest degree of disagreement was 11 in agreement 2. Rathmell JP, Benzon HT, Dreyfuss P et al. Safeguards to pre- vent complications after epidural steroid injections. Consen- 16. Transforaminal ESIs can be performed without and 2 disagreeing or unable to reach consensus sus opinions from a multidisciplinary working group and contrast in patients with documented contrain- (85% agree). The document is clinically oriented national organizations. Anesthesiology 2015:122:974–984. dication to use, but in these circumstances par- and the recommendations are quite specific includ- 3. Racoosin JA, Seymour SM, Cascio L, Gill R. N Engl J Med ticulate steroids are contraindicated and only ing some that may not be ubiquitously followed by 2015. DOI:10.1056/NEJMp1511754. 4. Friedy JL, Comstock BA et al. A randomized trial of epidural preservative-free, particulate-free steroids all at present. There was a focus on the particulate glucocorticoid injections for spinal stenosis. N Engl J Med should be used. steroid suspensions as being a major harmful factor 2014;371:11–21. 17. Moderate to heavy sedation is not recommended in spinal cord infarctions, and the group recom- 5. Cohen SP, Bicket MC, Jamison D, Wilkinson I, Rachmell JP. for ESI but if light sedation is used, the patient mended to restrict particulate steroid suspension Epidural steroids: a comprehensive, evidence-based review. 2 Reg Anesth Pain Med 2013;38:175–200. should remain able to communicate pain or use, particularly in the cervical region. Recommen- 6. Benzon HT, Huntoon MA, Rathmell JT. Improving the safety of other adverse sensations or events. dations include the use of particulate versus non- epidural steroid injections. JAMA 2015;313:1713–1714. APSF NEWSLETTER February 2016 PAGE 74

Residual Neuromuscular Blockade (NMB), Reversal, and Perioperative Outcomes by Karl E. Hammermeister, MD; Michael Bronsert, PhD; Joshua S. Richman, MD, PhD; and William G. Henderson, PhD Historical was tubocurarine in 55%, decamethonium bro- There are surprisingly few publications of ade- mide in 37%, and succinylcholine in 4% of cases. quate sample size examining the effect of NMB with The earliest description of curare, a naturally They found 6 times as many anesthetic deaths and without a reversing agent on substantive out- occurring predecessor of the neuromuscular were associated with “curare,” compared to comes important to the patient. Two of the largest blocking agents commonly used today in anesthe- patients managed without. Recognizing the need studies examining this issue had significant limita- sia, has been attributed to Sir Walter Raleigh in his for risk-adjustment, 13,204 patients sampled in tions with respect to propensity matching for patient 1596 book, The Discoverie of the Large, Rich, and Bew- 1952 were classified as “good or poor physical co-morbidities and/or for administration of neostig- tiful Empyre of Guiana, in which he describes, “the status” (this was not the ASA classification, which mine. These issues limit the clarity of the associations most strong poyson on their arrows” used by an had been published in 1941,7 but rather a seven- between poor outcomes and the use of NMB agents, indigenous tribe of Guiana.1 However, Ibanez cites reversal, inadequate monitoring, and inadequate numerous descriptions by Spanish explorers of point scale devised by the authors, which was reversal. These relationships are difficult to study in a lethally tipped arrows used by natives of northern effectively similar to the ASA classification). The retrospective manner with incomplete datasets and South America in the century preceding the publi- distribution of this scale was similar between variable practice patterns and are better examined in cation of Raleigh’s book.2 patients receiving a NMB and those not. large prospective studies.14,15 While some providers Although Ibanez also describes therapeutic Contemporary Studies may believe that near complete spontaneous recovery uses of what may have been curare, it was not Residual NMB postoperatively has been known does occur by the end of a surgical procedure without until 1932 that West described experiments in for more than 35 years,8 and occurs commonly the use of NMB reversal agents, a variety of studies patients with rigidity disorders at the Hospital for despite reversal with neostigmine with a reported contradict this notion. One most notable large clinical Epilepsy and Paralysis in Maida Vale, London; he incidence of 4 to 50%.9,10 Studies prior to 2005, sug- trial by Debaene and colleagues in more than 500 concluded, (there was) “a definite, measurable gested residual neuromuscular block should be patients suggested that 45% of patients examined reduction in the muscular rigidity resulting from defined by a train-of-four ratio (TOFR) of <0.7. after a single dose of an intermediate acting NMB diseases of the pyramidal and extrapyramidal (without a NM reversal agent) had a TOFR <0.9 in However, subsequent studies have discovered that motor system...[at] doses which produce no PACU.16 In addition, even 2 hours after administra- residual neuromuscular blockade can occur at TOFR detectable signs of weakness.”3 An early therapeu- tion of a single intermediate acting NMB, the TOFR ≥0.9, as per the review by Murphy and Brull in tic use in humans to prevent fractures occurring was < 0.7 in 10% of patients and < 0.9 in 37% of the 2010.11 These authors concluded that, “Residual with convulsive therapy for depression was patients studied. Therefore, cautious titration of NMB neuromuscular block is an important patient safety described by Bennett in 1940.4 The earliest descrip- reversal by using NM monitoring may reduce the risk issue and that neuromuscular management affects tion of the use of curare in general anesthesia to 11 of residual neuromuscular blockade. achieve muscle relaxation during surgery we have postoperative outcome.” Current Practice found was at the Homeopathic Hospital of Mon- Reversal of NMB treal by Griffith, published in 1942.5 In 1954, Naguib and colleagues conducted an internet Beecher and Todd, both at Harvard and the Mas- Acetylcholinesterase inhibitors, such as neostig- survey of active members of the Anesthesia sachusetts General Hospital, reported their mas- mine, are commonly used to reverse NMB at the Patient Safety Foundation and the European Soci- sive study of 599,548 anesthetics in 10 university conclusion of surgery; however, they may have ety of Anaesthesiologists in 2008; 2,636 completed hospitals in the U.S. between 1948 and 1952.6 They unwanted side-effects such as tachycardia, nausea, surveys were received.17 We did not find a more 12 undertook this study because of their, “…belief confusion, constipation, and dry mouth. More recent survey of U.S. anesthesiologists. The major- that anesthesia has an unnecessarily high death importantly, when used without appropriate nerve ity of both U.S. and European respondents esti- rate.” All deaths were classified by a surgeon and stimulator monitoring and dosing, they may actu- mated the incidence of clinically significant anesthesiologist at each hospital; however, precise ally increase NMB by creating very high concentra- postoperative residual neuromuscular weakness criteria for cause of death were not provided. A tions of acetylcholine at the neuromuscular to be <1%. Routine pharmacologic reversal was muscle relaxant was used in 2.8% (16,560), which junction, which can have an antagonistic effect.13 reported by 18% of respondents in Europe and 34% in the U.S. Conclusions There is a consensus in the recent literature that residual neuromuscular blockade is common and is associated with an increased risk of adverse outcomes, particularly respiratory. It is also clear that the use of NMB monitoring and appropriate reversal with neostigmine is highly variable among anesthesia providers and is thought to be primarily responsible for the high incidence of residual NMB in the recovery room. The authors report no financial conflicts of interest related to this article and topic. Karl E. Hammermeister, MD; Professor Emeritus, Department of Medicine (Cardiology), University of Colorado School of Medicine, Aurora CO; Surgical Outcomes and Applied Research, Department of Surgery, University of Colorado School of Medicine, Aurora CO; Train of four ratio (TOFR) correlation with clinical signs of reversal and ability to detect fade with TOF. See “Residual NMB,” Next Page APSF NEWSLETTER February 2016 PAGE 75

Reversal of NMB Highly Variable Among Anesthesia Providers

“Residual NMB,” From Preceding Page 2. Ibanez FM. Three enigmas in the history of curare before physiologic effects of residual neuromuscular block. Anesth Sir Walter Raleigh. Int Rec Med Gen Pract Clin 1951; Analg 2010;111:120–128. Adult and Child Consortium for Health Outcomes Research 164:700–710. 12. Abad-Gurumeta A, Ripolles-Melchor J, Casans-Frances R et and Delivery Science, University of Colorado School of 3. West R. Curare in man. Proc R Soc Med 1932;25:1107–1116. al. A systematic review of sugammadex vs neostigmine for Medicine, Aurora CO. 4. Bennett AE. Preventing traumatic complications in convul- reversal of neuromuscular blockade. Anaesthesia Michael Bronsert, PhD; Adult and Child Consortium for sive shock therapy by curare. J Am Med Assoc 1940;114:322– 2015;70:1441-1452. Health Outcomes Research and Delivery Science, University 324. 13. Goldhill DR, Wainwright AP, Stuart CS, Flynn PJ. Neostig- of Colorado School of Medicine, Aurora CO; Surgical Out- 5. Griffith HR. The use of curare in general anesthesia. Anes- mine after spontaneous recovery from neuromuscular thesiol 1942;3:418–420. blockade. Effect on depth of blockade monitored with train- comes and Applied Research, Department of Surgery, Uni- of-four and tetanic stimuli. Anaesthesia 1989;44:293–9. versity of Colorado School of Medicine, Aurora CO. 6. Beecher HK, Todd DP. A study of the deaths associated with anesthesia and surgery: based on a study of 599, 548 14. Arbous MS, Meursing AE, Van Kleef JW et al. Impact of Joshua S. Richman, MD, PhD; Department of Surgery, anesthesias in ten institutions 1948–1952, inclusive. Annals anesthesia management characteristics on severe morbid- University of Alabama Birmingham, Birmingham VA Medi- of Surgery 1954;140:2-35. ity and mortality. Anesthesiol 2005;102:257–268. cal Center, Birmingham AL. 7. Saklad M. Grading of patients for surgery. Anesthesiol 1941; 15. Grosse-Sundrup M, Henneman JP, Sandberg WS et al. Inter- William G. Henderson, PhD; Professor, Department of 2:281–284. mediate acting non-depolarizing neuromuscular blocking agents and risk of postoperative respiratory complications: Biostatistics and Informatics, Colorado School of Public 8. Viby-Mogensen J, Jorgensen BC, Ording H. Residual cura- prospective propensity score matched cohort study. BMJ Health, Aurora CO; Surgical Outcomes and Applied rization in the recovery room. Anesthesiol 1979;50:539–541. 2012; 345:e6329. Research, Department of Surgery, University of Colorado 9. Plaud B, Debaene B, Donati F et al. Residual paralysis after 16. Debaene B, Plaud B, Dilly MP, Donati F. Residual paralysis School of Medicine, Aurora CO; Adult and Child Consor- emergence from anesthesia. Anesthesiol 2010;112:1013–1022. in the PACU after a single intubating dose of nondepolar- tium for Health Outcomes Research and Delivery Science, 10. Donati F. Residual paralysis: a real problem or did we izing muscle relaxant with an intermediate duration of University of Colorado School of Medicine, Aurora CO. invent a new disease? Canadian Journal of Anesthesiology action. Anesthesiology 2003;98:1042–8. 2013;60:714–19. 17. Naguib M, Kopman AF, Lien CA et al. A survey of current References 11. Murphy GS, Brull SJ. Residual neuromuscular block: les- management of neuromuscular block in the United States 1. Carman JA. History of curare. Anaesthesia 1968;23:706–707. sons unlearned. Part I: definitions, incidence, and adverse and Europe. Anesth Analg 2010;111:110–119.

Letter to the Editor: The Structure and Process of PACU Handoff—How to Implement a Multidisciplinary PACU Handoff Checklist To the Editor: checklist is encouraged. Even the most experi- We would like to thank Tan and colleagues for We would like to thank Tan and colleagues for enced clinicians are at times distracted or leave out providing their thoughtful feedback. We welcome their response to our study, “Improving Post important information. continued discussion as we improve the exchange Anesthesia Care Unit (PACU) Handoff by Imple- We agree with another point emphasized by of information during the crucial moments of 1,2 menting a Succinct Checklist.” They address Tan and colleagues—it is not sufficient to address PACU handoff. many of the important challenges in standardiza- the content of PACU handoffs, we must also Dr. Christopher Potestio tion of healthcare processes and we are happy to address the process. We are now engaged in a CA-2 resident continue the discussion. This topic is of growing PACU handoff initiative that includes our surgical Department of Anesthesiology concern among anesthesia providers as evidenced colleagues. This multidisciplinary PACU handoff Medstar Georgetown University Hospital by several studies published in the past year that will bring all parties to the (bedside) table to Washington, DC have examined the benefit of a standardized hand- ensure complete, efficient handoff of care in the 3,4 References off. Tan and colleagues bring up two important PACU. Our multidisciplinary handoff allows for a topics that we would like to emphasize in this structured handoff, starting with "Patient Admis- 1. Tan J, Bhavsar S, Hagan K, Lasala J. An alternative letter: the structure and process of PACU handoff. sion and Assessment," where each of the three succinct checklist offered for PACU handoff commu- At their institution, Tan and colleagues found handoff teams engages in specific activities to nication. APSF Newsletter 2015; 30(2):37–38. that: "following a rigid checklist may elicit resis- ensure a quick, efficient admission to the PACU. 2. Potestio C, Mottla J, Kelley E, DeGroot K. Improving tance among more experienced clinicians because This first step addresses patient safety and stabil- post anesthesia care unit (PACU) handoff by imple- APSF Newsletter it interferes with the 'flow' of their practiced, yet ity prior to focusing on face-to-face handoff. menting a succinct checklist. not necessarily complete, handoff reports." A less- 2015;30:13–15. structured handoff/checklist may appeal to expe- We are encouraged that Tan and colleagues 3. Weinger MB, Slagle JM, Kuntz AH, Schildcrout JS, rienced clinicians; however, at Medstar include a surgical handoff on their checklist and Banerjee A, Mercaldo ND, Bills JL, Wallston KA, Sper- Georgetown University Hospital (MGUH), the we wonder whether it is included in a structured off T, Patterson ES, France DJ. A multimodal interven- handoff effort or whether the two handoffs exist tion improves post-anesthesia care unit handovers. majority of PACU handoffs are completed by Anesthesia and Analgesia 2015;121:957–971. trainees (residents and student nurse anesthetists). independently. At MGUH, one of the keys to suc- 4. Caruso TJ, Marquez JL, Wu DS, Shaffer JA, Balise RR, Patient handoff is a clinical skill that we expect all cess in an organized multidisciplinary handoff Groom M, Leong K, Mariano K, Honkanen A, Sharek of our trainees to master. Reinforcing this struc- effort is the support we have received from PACU nursing as well as both anesthesia and general sur- PJ. Implementation of a standardized postanesthesia tured format of PACU handoff establishes a cul- care handoff increases information transfer without ture of patient safety that will continue as our gery departments. The appointment of "local increasing handoff duration. Joint Commission Jour- trainees graduate into practice. Our experienced champions" has been cited as an important ingre- nal on Quality and Patient Safety 2015;41:35–42. clinicians may adopt a similar handoff structure dient to success in previous successful checklist 5. Conley DM, Singer SJ, Edmondson L, Berry WR, 5 described by Tan and colleagues with a verbal endeavors. We feel that strong support, from Gawande AA. Effective surgical safety checklist "story" preceding a "Read and Verify" review of both the resident leaders and department faculty, implementation. Journal of the American College of the checklist, although a structured reading of the has been integral in our overall success. Surgeons 2011;212:873–879. Anesthesia Patient Safety Foundation NONPROFIT ORG. Building One, Suite Two U.S. POSTAGE 8007 South Meridian Street PAID WILMINGTON, DE Indianapolis, IN 46217-2922 PERMIT NO. 1858

APSF NEWSLETTER February 2016

In This Issue: Monitoring of Neuromuscular Blockade: What Would You Expect if You Were the Patient? ------Expanding Our Influence: How the Perioperative Surgical Home Will Improve Patient Safety ------President’s Report Highlights Accomplishments of 2015 ------How Do I Prepare for OR Power Failure? ------Save the Date APSF Awards 2016 Grant Recipients Wednesday, September 7, 2016 Royal Palms Resort and Spa, Phoenix, AZ ------APSF-Sponsored Conference Distractions in the Anesthesia Work FDA Issues Drug Safety Communication About Environment: Impact on Patient Safety Epidural Corticosteroid Injections See details inside

APSF-Sponsored Conference Royal Palms Resort and Spa, Phoenix, AZ Distractions in the Anesthesia Work Environment: Impact on Patient Safety Distractions in the anesthesia work environment manifest in many different ways and potentially impact patient safety by compromising the anesthesia professional’s vigilance during direct patient care. APSF believes these distractions need to be identi ed and addressed by open discussion, education, research and appropriate policy statements for individual groups or practice management entities. This 1-day conference will include podium presentations, panel discussions, small group breakout sessions and attendee responses using an “audience response system.”

If you are interested in attending, Save the Date please contact Dr. Stoelting Wednesday, September 7, 2016 ([email protected]) for registration details.