APSF.ORG NEWSLETTER THE OFFICIAL JOURNAL OF THE ANESTHESIA PATIENT SAFETY FOUNDATION

Volume 36, No. 1, 1–47 More than 1,000,000 readers annually worldwide February 2021 Health Care Cybersecurity: Is There a Role for the Anesthesia Professional? by Julian Goldman, MD, and Jeffrey Feldman, MD

Keeping patients safe during anesthesia care continue to increase in frequency requiring is a multifaceted challenge. The skills and vigi- hospital systems to spend significant lance of the anesthesia professional are neces- resources to prevent any impact on patient sary, but not sufficient. The ergonomics of the care services. At the current time, health care care environment, systems of care, communi- institutions are predicted to experience 2-3 cation between teams and many other factors times the average number of attacks on other ultimately impact patient safety. Now, it seems industries,2 which can reach thousands of we need to add cybersecurity threats as cyberattacks per month. another dimension to the patient safety battle. Attacks on health care organizations remain One of the most famous health care cyber- an international problem. One university security breaches was the global Wannacry hospital in the Czech Republic was forced ransomware attack that disabled 600 organi- care is well documented. The impact on patient wellness is unknown. The cost to the by a cyberattack to delay surgery and trans- zations in the British National Health System in 3 2017. There were no deaths reported related health system was estimated to be almost 6 fer patients to other institutions for care. to this attack, but the reduced access to health million pounds.1 Unfortunately, cyberattacks See “Cybersecurity,” Page 6

Pharmacovigilence Applied to the Use of Sevoflurane and Desflurane: Nearly 30 years of Adverse Event Reporting by Thomas Ebert, MD, PhD; Alex Ritchay, MD; Aaron Sandock, BA; and Shannon Dugan, BS

SUMMARY airway irritant and associated with laryngospasm, tion into clinical practice.7, 8 When new drugs Sevoflurane and desflurane were introduced sympathetic activation, tachycardia, and hyper- are approved for broad use in the clinical set- 2–6 into the U.S. market in the early 1990s, with each tension. We reviewed the Food and Drug tings with a diverse patient population and mul- having some concerns about their safety. Sevo- Administration (FDA) adverse event reporting tiple co-morbid conditions, the time-tested system to determine if these early concerns flurane had a fresh gas flow restriction due to process called pharmacovigilence can reveal found validity after 25 years of clinical use of new safety concerns.9 As an example, halo- concerns for the formation of compound A and sevoflurane and desflurane. thane-mediated hepatitis and enflurane- an associated renal tubular cell necrosis found in induced renal concentrating defects were first a rat model.1 Desflurane was noted to be an INTRODUCTION In this report, we have explored the FDA identified after these anesthetic gases were Adverse Events Reporting System (FAERS) placed into the clinical setting. To Our APSF database for sevoflurane and desflurane As background, sevoflurane was released seeking evidence, or lack thereof, for adverse into clinical practice in the U.S. in 1995.10 Readers: events during clinical use of these two volatile The most important early safety concern If you are not on our mailing anesthetics. The safety of modern-day volatile with sevoflurane was the development of anesthetics is generally accepted, but con- list, please subscribe at pentafluoroisopropenyl fluoromethyl ether cerns about their safety were debated at the (compound A), a breakdown product formed https://www.apsf.org/ time of their introduction into clinical use and through the interaction of sevoflurane and subscribe and the APSF will thus merit further evaluation. Justifying our carbon dioxide absorbents. Compound A’s send you an email of the efforts to use FAERS database are the histori- effects had not been thoroughly investi- cal adverse events from the use of older vola- gated in patients in FDA Phase 1–3 trials. current issue. tile anesthetics and neuromuscular blocking drugs that were revealed after their introduc- See “Adverse Event Reporting,” Page 8

TABLE OF CONTENTS, NEXT PAGE APSF NEWSLETTER February 2021 PAGE 2

TABLE OF CONTENTS ARTICLES: NEWSLETTER Health Care Cybersecurity: Is There a Role for the Anesthesia Professional?...... Cover Pharmacovigilence Applied to the Use of Sevoflurane and Desflurane: Nearly 30 years of Adverse Event Reporting...... Cover Improving Perioperative Patient Safety: A Matter of Priorities, Collaboration, and Advocacy ...... Page 3 The Official Journal of the Rapid Response: HEPA Filters. Do We Really Know Enough?...... Page 11 Anesthesia Patient Safety Foundation Rapid Response: Breathing System Filters in the Era of COVID-19...... Page 12 The MHC Story: Accelerating Implementation of Best Practices Through Improved Organizational The Anesthesia Patient Safety Foundation Newsletter Macro-Ergonomics Updates from the Perioperative Multi-Center Handoff Collaborative (MHC)...... Page 15 is the official publication of the nonprofit Anesthesia Proactive Perioperative Risk Analysis: Use of Failure Mode and Effects Analysis (FMEA)...... Page 17 Patient Safety Foundation and is published three Rapid Response: Emergency Power and Elective Surgery...... Page 22 times per year in Wilmington, Delaware. Contri­ Safety vs. Quality—The 2020 APSF/ASA Ellison C. Pierce, Jr., MD, Memorial Safety Lecture ...... Page 23 butions to the Foundation are tax-deduct­ible. ©Anes- Enhancing a Culture of Safety Through Disclosure of Adverse Events...... Page 25 thesia Patient Safety Foundation, 2021. APSF Awards 2021 Grant Recipients...... Page 28 Rapid Response: What Type of Operating Room Pressure Should We Use for Patients with SARS-COV-2 Infection?...Page 30 The opinions expressed in this Newsletter are not Rapid Response: Recommendations for OR Ventilation during the SARS COV-2 Pandemic—Staying Positive...... Page 30 necessarily those of the Anesthesia Patient Safety Anesthesia Machine as an ICU Ventilator—A Near Miss During the COVID-19 Pandemic...... Page 34 Foundation. The APSF neither writes nor promul- Perioperative Hypersensitivity: Recognition and Evaluation to Optimize Patient Safety...... Page 36 gates standards, and the opinions expressed herein Rapid Response: Unanticipated Movement of Skytron Operating Room Tables...... Page 39 should not be construed to constitute practice stan- Drug-Induced MH-like Syndromes in the Perioperative Period...... Page 41 dards or practice parameters. Validity of opinions pre- Postoperative Anterior Neck Hematoma: Timely Intervention is Vital...... Page 44 sented, drug dosages, accuracy, and completeness LETTER TO THE EDITOR: of content are not guaranteed by the APSF. The Single-Provider-Operator-Anesthetist Model for Dental Deep Sedation/Anesthesia: APSF Executive Committee 2021: A Major Safety Issue for Children...... Page 33 Mark A. Warner, MD, President, Rochester, MN; Daniel APSF ANNOUNCEMENTS: J. Cole, MD, Vice President, Los Angeles, CA; Steven B. Guide for Authors...... Page 2 Greenberg, MD, Secretary, Chicago, IL; Douglas A. APSF Newsletter Podcast: Now Available Online @ APSF.org/podcast...... Page 5 Bartlett, Treasurer, Boulder, CO; Lynn Reede, DNP, APSF Stoelting Conference 2021: Clinician Safety: To Care is Human...... Page 20 MBA, CRNA, FNAP, Director At-Large, Boston, MA. APSF Donor Page...... Page 21 A Remembrance: Charles Cowles, MD, MBA, FASA...... Page 31 APSF Newsletter Editorial Board 2021: Crowdfunding...... Page 35 Steven B. Greenberg, MD, Editor, Chicago, IL; Jennifer Legacy Members...... Page 48 M. Banayan, MD, Associate Editor, Chicago, IL; Edward 2020 Board Members and Committee Members:...... https://www.apsf.org/about-apsf/board-committees/ A. Bittner, MD, PhD, Associate Editor, Boston, MA; JW Beard, MD, Wilmette, IL; Heather Colombano, MD, Guide for Authors and have appropriate referencing (see http://www.apsf.org/ Winston-Salem, NC; Jan Ehrenwerth, MD, New Haven, authorguide). The articles should be limited to 2,000 words with CT; John H. Eichhorn, MD, San Jose, CA; Meghan The APSF Newsletter is the official journal of the Anesthesia Patient no more than 25 references. Figures and/or tables are strongly Lane-Fall, MD, Philadelphia, PA; Nikolaus Gravenstein, Safety Foundation. It is widely distributed to a variety of anesthesia encouraged. MD, Gainesville, FL; Joshua Lea, CRNA, Boston, MA; professionals, perioperative providers, key industry representatives, 2. Q&A articles are submitted by readers regarding anesthesia Bommy Hong Mershon, MD, Baltimore, MD; Tricia A. and risk managers. Therefore, we strongly encourage publication of patient safety questions to knowledgeable experts or desig- those articles that emphasize and include the multidisciplinary, mul- nated consultants to provide a response. The articles should be Meyer, PharmD, Temple, TX; Glenn S. Murphy, MD, Chi- tiprofessional approach to patient safety. It is published three times limited to 750 words. cago, IL; Steven Shafer MD, Stanford, CA; Brian a year (February, June, and October). Deadlines for each issue are 3. Letters to the editor are welcome and should be limited to 500 Thomas, JD, Kansas City, MO; Felipe Urdaneta, MD, as follows: 1) February Issue: November 15th, 2) June Issue: words. Please include references when appropriate. Gainesville, FL; Jeffrey S. Vender, MD, Winnetka, IL; March 15th, 3) October Issue: July 15th. The content of the news- 4. Rapid Response (to questions from readers), formerly known as, Wilson Somerville, PhD, Editorial Assistant, Winston- letter typically focuses on anesthesia-related perioperative patient "Dear SIRS," which was the “Safety Information Response Salem, NC. Please see the links of international editors safety. Decisions regarding content and acceptance of submissions System,” is a column that allows for expeditious communication at https://www.apsf.org/wp-content/uploads/newslet- for publication are the responsibility of the editors. Some submis- of technology-related safety concerns raised by our readers, with ter/APSF-International-Editors.pdf sions may go in future issues, even if the deadline is met. At the dis- input and response from manufacturers and industry representa- Address all general, contributor, and sub­scription cretion of the editors, submissions may be considered for tives. Dr. Jeffrey Feldman, current chair of the Committee on publication on our APSF website and social media pages. Technology, oversees the column and coordinates the readers’ correspondence to: Articles submitted that are not in accordance with the following inquiries and the response from industry. Stacey Maxwell, Administrator instructions may be returned to the author prior to being reviewed 5. Invited conference reports summarize clinically relevant anesthe- Anesthesia Patient Safety Foundation for publication. sia patient safety topics based on the respective conference P.O. Box 6668 1. Please include a title page which includes the submission’s title, discussion. Please limit the word count to less than 1000. authors' full name, affiliations, conflicts of interest statement for Rochester, MN 55903, U.S.A. Commercial products are not advertised or endorsed by the APSF each author, and 3–5 keywords suitable for indexing. Please [email protected] Newsletter; however, upon exclusive consideration from the edi- include word count on the title page (not including references). tors, articles about certain novel and important safety-related tech- Address Newsletter editorial comments, questions, 2. Please include a summary of your submissions (3–5 sentences) nological advances may be published. The authors should have no letters, and suggestions to: which can be used on the APSF website as a way to publicize commercial ties to, or financial interest in, the technology or com- your work. Steven B. Greenberg, MD 3. All submissions should be written in Microsoft Word in Times mercial product. Editor, APSF Newsletter New Roman font, double-spaced, size 12. If accepted for publication, copyright for the accepted article is [email protected] transferred to the APSF. Except for copyright, all other rights such 4. Please include page numbers on the manuscript. Jennifer M. Banayan, MD as for patents, procedures, or processes are retained by the author. 5. References should adhere to the American Medical Association Associate Editor, APSF Newsletter Permission to reproduce articles, figures, tables, or content from citation style. [email protected] Example: Prielipp R, Birnbach D. HCA-Infections: Can the anes- the APSF Newsletter must be obtained from the APSF. thesia provider be at fault? APSF Newsletter. 2018; 32: 64–65. Additional information: Edward A. Bittner, MD, PhD https://www.apsf.org/article/hca-infections-can-the-anesthesia 1. Please use metric units whenever possible. Associate Editor, APSF Newsletter provider-be-at-fault/ Accessed August 13, 2019. 2. Please define all abbreviations. [email protected] 6. References should be included as superscript numbers within 3. Please use generic drug names. Online Editors: the manuscript text. 4. Please be aware of HIPAA and avoid using patient names or per- Josh Lea, CRNA 7. Please include in your title page if Endnote or another software sonal identifiers. Felipe Urdaneta, MD tool for references is used in your submission. 5. Plagiarism is strictly prohibited. Types of articles include (1) Invited review articles, Pro/Con Debates Individuals and/or entities interested in submitting material for Send contributions to: and Editorials, (2) Q and As, (3) Letters to the Editor, (4) Rapid publication should contact the Editor-in-chief directly at green- Anesthesia Patient Safety Foundation Response, and (5) Conference reports. [email protected]. Please refer to the APSF Newsletter link: http:// P.O. Box 6668 1. Review articles, invited Pro/Con debates, and Editorials are www.apsf.org/authorguide that will provide detailed information Rochester, MN 55903, U.S.A. ­original manuscripts. They should focus on patient safety issues regarding specific requirements for submissions. Or please donate online at www.apsf.org. APSF NEWSLETTER February 2021 PAGE 3

Improving Perioperative Patient Safety: A Matter of Priorities, Collaboration, and Advocacy by Mark A. Warner, MD We live in a world of competing priorities collaboration with others. That is why APSF and when we care for patients. On any given day, health care leaders from around the world con- we are cajoled, pushed, and even prodded to tinually discuss perioperative patient safety provide cost-effective, efficient, highly produc- issues and how we can work together to solve tive patient care. In many environments, the these crucial, prioritized issues that are impor- faster and cheaper we provide anesthesia ser- tant to all of us. That includes every anesthesia vices, the more kudos we receive from our professional who provides patient care. health care leaders. In far too many instances, What can you and the groups in which you there is less emphasis on providing safe care have influence do to improve perioperative because it is assumed that the care we provide patient safety? It is incumbent on each of us to will be safe. While efficiency and safe care can ask what we can do personally and together be balanced effectively, we know that far too within the specialty and outside of it to make a many patients are harmed during their periop- difference. It includes reaching beyond our erative care, including during their anesthetics, usual comfort zones of clinical practice and when the pressure to speed patient through- seeking opportunities that involve working with put is emphasized more than safety. others who are involved in the perioperative When we are patients, our priorities often care spectrum. For APSF specifically, it has included developing our social media capabili- might not match those of the colleagues who Dr. Mark Warner, APSF President are taking care of us. In general, as patients we ties such as Facebook, Twitter, and Instagram tend to place high value on perioperative to reach anesthesia professionals around the safety. Yes, we want our care to be efficient and list of the foundation’s highest priority issues. world who otherwise would not be aware of our surgical outcomes to be excellent, but get- Table 1 provides a list of these priorities and our patient safety priorities and initiatives. We ting through the perioperative period with no actions taken by the APSF to promote and have a remarkably successful podcast initiative complications or unexpected problems is also improve them during the past 5 years. Many of (https://www.apsf.org/anesthesia-patient- safety-podcast/) that provides important anes- an important patient priority. these issues need long-term commitment of resources and advocacy to obtain patient thesia patient safety updates on a variety of THE IMPORTANCE OF SETTING safety improvements. topics, including our patient safety priorities. ANESTHESIA PATIENT SAFETY We then use this list to drive our website and PRIORITIES PROFESSIONAL WELLNESS: AN Newsletter content, research funding, and edu- IMPORTANT NEW APSF PRIORITY As a foundation dedicated to patient safety, cational panels and forums (e.g., the annual A growing number of publications report that the Anesthesia Patient Safety Foundation Stoelting Conferences). While several of these it is important for our anesthesia colleagues to (APSF) strives to help our patients achieve their priorities are specific to intraoperative anesthe- be safe because impaired colleagues increase priority of receiving safe intraoperative and sia care (e.g., distractions in procedural areas), 8 the risk of patient harm. Patient harm associ- perioperative care. In the past decade, training of the 10 have scopes that extend throughout ated with impaired anesthesia professionals is requirements for many new anesthesia profes- the full perioperative spectrum of issues. A very a growing issue as stresses and personal sionals and breadths of clinical practices in the pertinent, timely example is hospital-acquired health risks in anesthesia professionals have U.S. have been extended into the full spectrum infections and environmental microbial contami- risen. The stresses associated with the current of perioperative care, evolving towards those nation and transmission (e.g., COVID infection COVID pandemic provide a good example. in a number of other nations. These changes in and its many ramifications on intraoperative and For example, the intubateCOVID registry, par- the U.S., along with a growing emphasis on perioperative care and provider safety). The tially supported by APSF, has described in July enhanced recovery pathways, have prompted APSF has addressed pandemic-related issues 2020 that there is a 3.1% risk of new lab-con- opportunities to increase patient safety initia- extensively in 2020 (https://www.apsf.org/novel- firmed COVID-19 and an 8.4% risk of new tives throughout the perioperative period. coronavirus-covid-19-resource-center/). More symptoms requiring self-isolation or hospital- As a consequence, anesthesia patient safety than 600,000 individuals from every country ization in health care workers who intubated is now a remarkably broad topic, ranging from worldwide have accessed our website and patients with suspected or confirmed COVID. pulmonary aspiration on induction of anesthe- Newsletter for important COVID patient and pro- (https://www.apsf.org/news-updates/the-intu- sia through postoperative issues such as opi- vider safety information during the pandemic. batecovid-global-registry-describes-risk-of- covid-19-outcomes-in-health care-workers-fol- oid-induced respiratory arrest, prolonged Prioritization matters when there are limited lowing-tracheal-intubation-of-patients-with- cognitive impairment, and failure-to-rescue resources, expertise, and time. This is when covid-19/). patients during acute physiologic deterioration. teamwork becomes so vitally important. No APSF has embraced this expansion of the one organization; no one health system; and no The APSF has recognized the need to inte- scope of anesthesia patient safety. one professional society can have a positive grate anesthesia professional wellness into our Each year, the APSF committees and Board impact on all of the important perioperative foundation’s vision. Our vision previously was of Directors review existing and emerging peri- patient safety issues. It takes a team, with each “that no patient shall be harmed by anesthesia.” operative patient safety issues and develop a member making its own unique contributions in See “President's Report,” Next Page APSF NEWSLETTER February 2021 PAGE 4

From “President's Report,” Preceding Page Table 1: APSF’s 2021 Perioperative Patient Safety Priorities and Ongoing Activities. The following list contains our top 10 priorities and the associated activities. The summary of activities is not exhaustive. 1. Preventing, detecting, and mitigating clinical • APSF has supported two research grants on this issue in the deterioration in the perioperative period past 5 years. a. Early warning systems in all perioperative patients • This issue is addressed in the October 2020 APSF Newsletter. b. Monitoring for patient deterioration 6. Hospital-acquired infections and environmental microbial i. Postoperative continuous monitoring on the hospital floor contamination and transmission ii. Opioid-induced ventilatory impairment and monitoring • APSF helped develop the 2018 Society for Healthcare iii. Early sepsis Epidemiology of America (SHEA) consensus guidelines on c. Early recognition and response to decompensating patient intraoperative infection-prevention (https://www.cambridge.org/ • The 2019 Stoelting Conference was dedicated to this topic. core/journals/infection-control-and-hospital-epidemiology/ • This topic has been highlighted in 2020 APSF Newsletter issues article/infection-prevention-in-the-operating-room-anesthesia- and APSF-sponsored panels and presentations. work-area/66EB7214F4F80E461C6A9AC00922EFC9). • APSF is collaborating with the American Society of • APSF sponsored the 2017 NYSSA and ASA panels on this topic. Anesthesiologists (ASA) and other subspecialty organizations to • APSF made significant contributions to the development and address specific issues related to this topic. sharing of information related to COVID in 2020 and assisted • APSF will support prototype development for several models with development of pertinent shared statements, practice that may reduce failure-to-rescue. guidelines, and frequently asked questions. •  APSF has supported two research grants on this issue in the • APSF has supported two research grants on this topic in the past 5 years. past 5 years. 2. Safety in out-of-operating room locations such as 7. Patient-related communication issues, handoffs, and endoscopy and interventional radiology suites transitions of care •  APSF Newsletter APSF has addressed this issue recently in • APSF serves as the collaborating organization and supporter of articles (e.g., June 2020). the Multi-Center Handoff Collaborative (https://www.apsf.org/ • APSF has supported two research grants on this issue in the article/multicenter-handoff-collaborative/). past 5 years. • This was the topic of the 2017 APSF Stoelting Conference and 3. Culture of safety: the importance of teamwork and several APSF Newsletter articles. promoting collegial personnel interactions to support • APSF provides financial and infrastructure support to the Multi- patient safety center Handoff Collaborative. • APSF addressed this issue in its 2017 ASA Annual Meeting 8. Airway management difficulties, skills, and equipment workshop, as well as in APSF Newsletter articles and presentations. • Several APSF articles have addressed this issue in recent APSF Newsletter • The 2019 Pierce Lecture at the ASA Annual Meeting by Dr. Jeff articles. Cooper highlighted this issue; his remarks were published in the • APSF has supported three research grants on this issue in the February 2020 APSF Newsletter. past 5 years. 4. Medication safety 9. Anesthesia professionals and burnout a. Drug effects • Half of the 2016 Stoelting Conference addressed drug diversion b. Labeling issues (wellness). c. Shortages • Several APSF Newsletter articles have addressed various d. Technology issues (e.g., barcoding, RFID) aspects of this topic in the past two years. e. Processes for avoiding and detecting errors • Matt Weinger, MD, immediate past Secretary of the APSF and present board member, was a major contributor to a 2019 • The 2018 Stoelting Conference was dedicated to this topic. National Academy of Sciences report on this issue (https://www. • APSF representatives presented panels at the 2019 ASA and nap.edu/catalog/25521/taking-action-against-clinician-burnout- New York State Society of Anesthesiologists’ annual meetings. a-systems-approach-to-professional). • APSF will host a consensus workgroup on drug labeling in 2021. • Clinician safety (including burnout) will be the topic for the 2021 • Multiple APSF Newsletter articles have been published on this Stoelting Conference. issue in 2020. 10. Distractions in procedural areas 5. Perioperative delirium, cognitive dysfunction, and brain health • Half of the 2016 Stoelting Conference addressed distractions. • The APSF supports this ASA-American Association of Retired • Several APSF Newsletter articles have addressed various Persons initiative. aspects of this topic.

See “President's Report,” Next Page APSF NEWSLETTER February 2021 PAGE 5

The APSF Collaborates with National and International Organizations to Make Perioperative Patient Care Safer

From “President's Report,” Preceding Page together to advocate for anesthesia patient tries and the development and implementa- It now reads “that no one shall be harmed by safety. We sincerely appreciate the outstanding tion of anesthesia-specific patient safety anesthesia care.” This latter version adds the efforts and contributions of partners such as the curricula for training programs and continuing well-being of anesthesia colleagues to our World Federation of Societies of Anaesthesiolo- education of anesthesia professionals. We’ve vision and extends our role beyond traditional gists (WFSA); regional societies such as the collaborated on clinical patient safety research intraoperative patient safety. European Society of Anesthesiologists, Con- grants with the Foundation for Anesthesia federation of Latin American Societies of Education and Research and the Orthopaedic The 2021 Stoelting Consensus Conference Anaesthesiology, and others; and many Research and Education Foundation to gener- on September 8th and 9th will focus specifically national anesthesia societies that have been ate the next generation of anesthesia patient on anesthesia professional wellness and its major leaders in anesthesia patient safety. safety clinician scientists. potential negative impact on patient safety. It is the union of these groups and their col- This conference will discuss potential interven- Examples from the past several years of laborative contributions that make big impacts. tions to reduce patient and provider harm and these collaborations include our work with the Please support their efforts. However, and provide recommendations to implement the national societies of anesthesiology in Japan, most importantly, please advocate personally best of these interventions. China, Brazil, Portugal, Spain, France, Colum- bia, Mexico, and other countries to develop for patient safety every day and in every way. PRIORITIZING ANESTHESIA PATIENT translated issues of the APSF Newsletter. The It is the right thing to do for our patients and SAFETY: IT TAKES EVERYONE Newsletter is now available in five translated our combined personal advocacy has the big- gest positive impact of all on anesthesia The APSF is fortunate to work closely with languages, allowing us to reach an expanded patient safety. partners around the world to advocate for anes- proportion of the world’s anesthesia profes- thesia patient safety. While the foundation can sionals. APSF has supported patient safety Dr. Mark Warner is currently president of the stimulate discussions, promote the generation education research projects with the WFSA APSF and the Annenberg Professor of Anesthe- of new knowledge related to perioperative and the Patient Safety Movement Foundation. siology, Mayo Clinic, Rochester, MN. safety priority issues, and develop consensus These education projects will lead to improved The author has no conflicts of interest. recommendations, it takes everyone working subspecialty training in low resources coun-

APSF Newsletter Podcast Now Available Online @ APSF.org/podcast

The APSF now offers you the opportunity to learn about anesthesia patient safety on the go with the Anesthesia Patient Safety Podcast. The weekly APSF podcast is intended for anyone with an interest in perioperative patient safety. Tune in to learn more about recent APSF Newsletter articles with exclusive contributions from the authors and episodes focused on answering questions from our readers related to patient safety concerns, medical devices, and technology. In addition, special shows that highlight important COVID-19 information on airway management, ventilators, personal protective equipment, drug information, and elective surgery recommendations are available. The mission of the APSF includes being a leading voice for anesthesia patient safety around the world. You can find additional information in the show notes that accompany each episode at APSF.org. If you have suggestions for future episodes, please email us at [email protected]. You can also find the Anesthesia Patient Allison Bechtel, MD Safety Podcast on Apple Podcasts or Spotify or anywhere that you listen to podcasts. Visit us at APSF Podcast Director APSF.org/podcast and at @APSForg on Twitter, Facebook, and Instagram. APSF NEWSLETTER February 2021 PAGE 6

U.S. Health Care Institutions Have Seen A Recent Increase in Cyberattacks From “Cybersecurity,” Cover Page This hospital was a major testing center for COVID-19 so its ability to manage the pandemic through testing was also impaired. In the United States, a heightened cyberattack threat was identified in October 2020, and there have been a number of successful attacks on health care organizations that have disrupted health care services.4 For example, on October 28, 2020, the same day the New York Times published an article on the increased threat, a successful cyberattack incapacitated the electronic medical record system at the University of Vermont, impacting six hospitals within the care network.5 While every aspect of patient care was affected and numerous patients were unable to receive care, the reported impact on patients undergo- health care institutions very attractive targets. engineering is using deception, manipulation, ing treatment for cancer was particularly heart- Unfortunately, the COVID-19 pandemic has and influence to convince a human who has wrenching. As a result of the cyberattack, all of magnified the potential impact of a successful access to a computer system to do something, the records describing the chemotherapy care cyberattack on patient care, creating a unique like click on an attachment in an email.”6 protocols were inaccessible. Patients arriving for opportunity to exploit the vulnerability of health That same approach continues to be a pri- chemotherapy treatments were denied care care IT systems. Indeed, the increased cyberat- mary hacking strategy and can be extremely simply because the care providers could not tacks on health care organizations that followed effective given the ubiquity of email use in access their records and determine how to treat the notice in October 2020 of an increased modern institutions. them safely. It took almost one month to restore threat level may not be financially motivated. the recordkeeping systems. The recent increase in attacks targeted at IS departments are primarily responsible for Cyberattacks can take different forms. Ran- health care institutions follow particularly suc- working to ensure that cyberattacks are not suc- somware attacks are obvious as they disable cessful efforts by U.S. government agencies to cessful. One strategy is to use the architecture of workstations or EMR databases, and the perpe- disable the ability of hackers to impact the hardware and software systems to create layers trators of the attack offer to restore functionality American election process. The current of security (called “defense in depth”) that com- if the attacked system owners pay a fee. increase in attacks may be a retaliation, and an plicate the navigation of the system by an Although payments do not generally result in effort to make it clear that these hackers are still attacker and limit the spread of malware. Imple- the restoration of service and are not recom- highly effective. menting user policies that can reduce the suc- cess of social engineering is another important mended, many victims have paid the cyber- Unfortunately, one cannot deny the possibil- strategy. Some of the more visible IS strategies criminals. If ransomware infects and encrypts a ity of simple malevolence directed at vulnerable for anesthesia professionals are blocking of cer- system, it also has to be assumed that data populations as a motivator for these cyberat- tain websites or access to personal email while could have been stolen—or “exfiltrated”— tacks. Health care institutions are highly vulner- using a network or computer at work. Commer- opening the door for the abuse of patient able due to the ever increasing reliance on cial site-monitoring services monitor websites to health information (PHI). Other types of cyberat- Information Systems (IS) to provide patient care, identify those that may contain malware and pro- tacks may not be so obvious. Many medical but many lack the resources of large corpora- vide vulnerable organizations with the informa- devices are interconnected to receive and tions to invest in cybersecurity. Sick patients, tion to block access to those sites from internal send data on the hospital network, and are especially during a pandemic, provide an networks. therefore vulnerable to cyberattacks. Cyber- attractive target to criminals due to the likeli- criminals can potentially alter alarms and hood of a negative impact on these patients, WHAT IS THE ROLE OF THE device functionality remotely, and the change and the possibility to create fear or panic. ANESTHESIA PROFESSIONAL IN may not be apparent until a patient suffers an HEALTH CARE CYBERSECURITY? CAN CYBERATTACKS BE PREVENTED? obvious harm. The American Society of Anesthesiolo- Kevin Mitnick, one of the most successful gists (ASA) recently formed a cybersecurity WHY DO CYBERCRIMINALS early hackers, was active from the 1980s until task force (CSTF) with the goal of under- TARGET HEALTH CARE SYSTEMS 1995 when he was jailed for communication- standing the scope of impact on anesthesia IN PARTICULAR? related crimes. He has since become a com- practice by cyberattacks, and collaborating Health care data is especially valuable as a puter security consultant, but the story of his with other organizations to develop recom- rich source of both personal and financial infor- days as a hacker makes for interesting read- mendations for keeping patients safe. mation and can sell on the dark web at a pre- ing.6 One important lesson is that the strategy An introductory article on the task force in the mium compared with simple credit card data. of “social engineering” was essential to his ASA Monitor provides background on the The high value of data combined with relatively success and remains the primary strategy of weak cybersecurity infrastructure, makes hackers today. According to Mitnick, “Social See “Cybersecurity,” Next Page APSF NEWSLETTER February 2021 PAGE 7

Cyberattack Simulation May Help Health Care Professionals Be More Prepared For Down-Time Events

From “Cybersecurity,” Preceding Page TABLE 1: Cybersecurity Recommendations. scope and scale of potential risks to our In response to the ongoing threat of cyberattacks on health care institutions, the APSF patients from cyberattacks.7 Given that we are Committee on Technology recommends that all anesthesia professionals take the fol- not trained as information system professionals, lowing actions. is there a role for anesthesia professionals in keeping patients safe from the effects of cyber- STRENGTHEN DOWNTIME PROCEDURES warfare? • Review existing downtime procedures. In response to the U.S. government advisory • Engage other perioperative leaders in planning. “Ransomware Activity Targeting the Health • Inform all providers about how to continue patient care using downtime procedures. Care and Public Health Sector” jointly released • If possible, simulate a downtime event. by the Cybersecurity and Infrastructure Security Agency (CISA), Federal Bureau of Investigation INCREASE VIGILANCE (FBI), and Department of Health and Human 8 • Manage your email! DO NOT ENTER YOUR SYSTEM PASSWORD OR ID in response to any Services (HHS) including the FDA, the APSF request by email. Report suspicious emails to IS services. Committee on Technology released guidance • Cybersecurity attacks can affect any network-dependent medical device. Be vigilant for that can be adopted by every anesthesia profes- unexpected changes in settings or behavior of alarms or function of devices like IV pumps and sional to reduce the risk to patients from cyberat- ventilators. tacks (Table 1).9 The guidance includes personal strategies like email vigilance and password REVIEW REPORTING security as well as departmental strategies. Sim- • Report medical device and system performance issues ASAP to hospital IS and/or biomedical ulations of downtime events are recommended engineering. by the committee and should encompass all of • Extramural reporting: the processes needed to maintain patient care • Device manufacturers when one or more information systems are not • FDA at [email protected] for cybersecurity concerns functioning. Consider, for example, a polytrauma • FDA through the MedWatch Voluntary Reporting System for any type of device malfunction. patient admitted to the emergency department Reporting form https://www.fda.gov/safety/medical-product-safety-information/medwatch- and found to require urgent transport to the forms-fda-safety-reporting operating room to control bleeding. Will you be able to manage the continuum of complex care More complete recommendations will be updated as they become available at https://www.apsf.org/ news-updates/the-apsf-issues-preliminary-guidance-on-cybersecurity-threats-to-u-s-health-care-systems/ required by this patient without computer sys- tems as they move from the ED to the operating a growing patient safety concern. Individual npj Digit Med. 2, 98 (2019). https://doi.org/10.1038/s41746- room to the ICU? How will the urgency be com- 019-0161-6. Accessed December 21, 2020. habits managing email and websites while at municated so that the OR is ready? How will 2. 2020 Healthcare Cybersecurity Report, https://www.herja- blood bank and laboratory services be coordi- work can reduce the risk of a successful attack, vecgroup.com/wp-content/uploads/2019/12/healthcare- but, as always, it is prudent to be vigilant for cybersecurity-report-2020.pdf. Accessed December 21, nated? Will pharmacy supplies be available? 2020. medical device and information systems mal- How will you know who is on call for a particular 3. Bizga A. Mysterious cyberattack cripples Czech hospital service? What computer systems may still func- functions, and maintain backup plans to con- amid COVID-19 outbreak, https://hotforsecurity.bitdefender. tion? Are the paper forms adequate to support tinue to provide safe care in the event of device com/blog/mysterious-cyberattack-cripples-czech-hospital- amid-covid-19-outbreak-22566.html Accessed November continued documentation and care processes? and system failures. 18, 2020. The results of these simulations can inform the Julian M. Goldman, MD, is an anesthesiologist at 4. Perlroth, N. Officials warn of cyberattacks on hospitals as development of procedures for care in the event virus cases spike. New York Times. Oct. 28, 2020. https:// Massachusetts General Hospital; medical direc- www.nytimes.com/2020/10/28/us/hospitals-cyberattacks- of a cyberattack and provide focus for training tor of Biomedical Engineering at Mass General coronavirus.html Accessed November 26, 2020. care providers. Brigham; director, Medical Device “Plug and 5. Barry E, Perlroth N. Patients of a Vermont hospital are left ‘in the dark’ after a cyberattack. New York Times. November Fortunately, government and other agencies Play” Interoperability & Cybersecurity Program 25, 2020. https://www.nytimes.com/2020/11/26/us/hospi- are actively working to identify cyberattack risks (MD PnP); and convener, ISO/TC 121/WG 3 tal-cyber-attack.html? Accessed November 26, 2020. and reduce or eliminate the impact. The prob- Cybersecurity for anaesthetic and respiratory 6. Mitnick K. Ghost in the wires—my adventures as the world’s most wanted hacker. Little, Brown and Co. New York, 2011. lem continues to grow, despite the vigilance equipment. 7. Goldman JM, Minzter B, Ortiz J, et al. Formation of an ASA and support of the public and private sectors to Jeffrey Feldman, MD, MSE, is chair, APSF Com- Cybersecurity Task Force (CSTF) to protect patient safety. address these cybersecurity hazards. Like ASA Monitor. September 2020;84:34. https://doi. mittee on Technology and professor of clinical human viruses, malware, once introduced into org/10.1097/01.ASM.0000716908.49348.5a Accessed anesthesiology at Children’s Hospital of Phila- December 10, 2020. cyberspace, persists as an ongoing risk to delphia, Perelman School of Medicine. 8. CISA Alert (AA20-302A), October 28, 2020, https://us-cert. unprotected computer systems. Cybercriminal cisa.gov/ncas/alerts/aa20-302a Accessed December 10, 2020. enterprises do not seem to be inhibited from The authors have no further conflicts of interest. victimizing health care systems.8 9. The APSF issues preliminary guidance on cybersecurity threats to U.S. health care systems. APSF Newsletter online. Given the degree to which health care November 2, 2020. https://www.apsf.org/news-updates/ REFERENCES the-apsf-issues-preliminary-guidance-on-cybersecurity- depends upon computer systems and net- 1. Ghafur S, Kristensen S, Honeyford K, et al. A retrospective threats-to-u-s-health-care-systems/ Accessed November worked devices, cyberattacks will continue to be impact analysis of the WannaCry cyberattack on the NHS. 10, 2020. APSF NEWSLETTER February 2021 PAGE 8

FAERS Database Used to Identify Adverse Events After Sevoflurane or Desflurane Use Over A Quarter Century From “Adverse Event Reporting,” Cover Page This led to a 2 liter per minute (lpm) fresh gas Cardiac Adverse Events flow (FGF) restriction to reduce human expo- 90 sure to compound A. Studies in rat models indi- 80 cated that Compound A could produce 70 60 dose-dependent renal injury characterized by % of Total 50 proximal tubular necrosis at inspired levels as Reported 40 1 AE 30 low as 114 parts per million (ppm). 20 10 Phase IV trials were subsequently performed in 0 volunteers and patients undergoing long periods 0–1 mo 2 mo–2 yo 3–1 yo 12–17 yo 18–64 yo 65–85 yo >85 yo Unspecified of sevoflurane anesthesia to examine both the Age Range level of exposure to Compound A, as well as to Desflurane Sevoflurane seek harmful effects based on clinical markers of renal function. In one such study, purposely designed to examine prolonged sevoflurane Ventricular Tachyarrhythmia exposure at 1 lpm FGF, maximum compound A concentrations reached 34 ± 6 ppm, but no clini- 30 cally significant changes in biochemical markers 25 11 20 of renal dysfunction were found. Continued % of Total work revealed that humans were nearly devoid Reported 15 of an enzyme called renal beta lyase, a key AE 10 enzyme directing the biodegradation of com- 5 pound A to a toxic renal thiol in rats.12 0 0–1 mo 2 mo–2 yo 3–1 yo 12–17 yo 18–64 yo 65–85 yo >85 yo Unspecified Desflurane was introduced in 1992, and its low Age Range solubility in blood afforded it a clinical advantage of a more rapid induction and emergence from Desflurane Sevoflurane anesthesia and potentially a more rapid titration to a desired anesthetic depth compared with other volatile anesthetics in use. However, after Respiratory Adverse Events the launch of desflurane, it was discovered that 50 desflurane could activate airway reflexes 40 2 because of its extreme pungency. % of Total 30 Reported Preclinical work with desflurane had also AE 20 reported unexplained tachycardia and hyper- 10 tension on occasion, and, in pediatric popula- 0 tions, bronchospasm. Desflurane’s lack of 0–1 mo 2 mo–2 yo 3–1 yo 12–17 yo 18–64 yo 65–85 yo >85 yo Unspecified potency necessitated higher concentrations to Age Range achieve clinical effectiveness, thereby unmask- ing an adverse airway effect from its pungency. Desflurane Sevoflurane The adverse airway effect was associated with sympathetic activation during initial airway exposure after induction of anesthesia and Renal-Specific Adverse Events during upward transitions in concenetration.2,3 12 Our lab had demonstrated a 2.5-fold increase in 10 sympathetic nerve activity, hypertension, and 8 % of Total tachycardia on initiation of desflurane after Reported 6 AE induction of anesthesia and an additional neu- 4 rocirculatory activation with the transition from 2 4 1.0 to 1.5 MAC. Subsequent work indicated that 0 nebulized lidocaine did not obtund the airway 0–1 mo 2 mo–2 yo 3–1 yo 12–17 yo 18–64 yo 65–85 yo >85 yo Unspecified reflex response, but opioids had a dose depen- Age Range dent benefit in reducing the neurocirculatory Desflurane Sevoflurane activation.13,14

In this report, we have explored the FAERS Figure 1: Adverse Events (AE) for Desflurane and Sevoflurane by Age Range. database for sevoflurane and desflurane adverse events after a quarter century of clin- ical use in millions of patients. See “Adverse Event Reporting,” Next Page APSF NEWSLETTER February 2021 PAGE 9

Injury, Poisoning, and Procedural Complications Were the Most Common Category for Both Sevoflurane and Desflurane

From “Adverse Event Reporting,” Preceding Page We sought to determine if the self-reporting of adverse events to the FDA validated the initial concerns surrounding the safety of sevoflurane and desflurane and whether new safety con- cerns had been exposed during clinical use in a broad patient population.

METHODS In order to monitor drug safety in clinical practice, the Food and Drug Administration (FDA) has developed the FDA Adverse Event Reporting System (FAERS).15 FAERS is an online database the FDA uses to monitor all approved drugs and therapeutic biologic products by assessing the quantity, severity, and overall out- comes of new medications including volatile anesthetics. The FAERS database was queried for adverse events (AEs) reported for both sevoflurane and desflurane between 1996 and December 2019. Using demographic filters, arrest, tachycardia, and ventricular tachycardia. group for desflurane, although it tends not to AEs were analyzed for the two volatile anes- Respiratory/Thoracic accounted for 19.4% with be used in those under 2 years old due to dis- thetics with each of the following age groups the top subcategory bronchospasm making up tributor recommendations. The proportion of filters: 0 to 1-month-old, 2 months to 2-years- 2.9% of all desflurane-related AEs. The next respiratory events out of total AEs for desflu- old, 3 to 11-years-old, 12 to 17-years-old, 18 to most common were hypoxia, dyspnea, and rane compared to sevoflurane were notably 64-years-old, 65 to 85-years-old, greater than laryngospasm. 85-years-old, and age unspecified. AEs were higher in the 2 months–2 years of age and sorted by Reaction Group. For example, the Sevoflurane had 4977 reported AEs with 3–11 year age groups. Reaction Group Cardiac Disorder, included spe- the most common category being Injury, Poi- DISCUSSION cific reactions such as cardiac arrest, PEA, and soning and Procedural Complications (30.4%). ventricular tachycardia among others. For this The top four subcategories included anes- The FAERS database contained 1140 adverse article, general reactions Cardiac Disorders, thetic complications, postprocedural complica- events reported for desflurane and 4977 Renal and Urinary Disorders, and Respiratory, tions, anesthetic neurological complications, reported for sevoflurane. The frequency of AE Thoracic, and Mediastinal Disorders are and awareness. As with desflurane, cardiac AEs reporting is influenced by the total number of reported in addition to specific reactions, e.g., were also the second most common reaction each of the anesthetics administered in clinical ventricular tachyarrhythmias (ventricular tachy- group for sevoflurane at 24.4%. The most practice. But the AE reporting does confirm, by cardia, ventricular fibrillation, torsades de common subcategories included cardiac arrest, prevalence of AEs for each anesthetic, a pointes). Renal-specific disorders (oliguria, bradycardia, tachycardia, and ventricular fibrilla- number of areas of potential concern for these anuria, acute kidney injury/renal injury, renal tion. Respiratory/Thoracic events accounted for two volatile anesthetics in clinical use. Cardiac impairment/failure, renal tubular disorder/dys- 18.7%, in similar range with desflurane. The four AEs were the second most commonly reported function, and acute tubular necrosis) were subcategories included pulmonary edema, “reaction group” for both anesthetics. The pro- summed to reduce the incidence of other less hypoxia, apnea, and bronchospasm (1.6% of total portion of ventricular tachyarrythmias was robust urinary reactions, e.g., urinary retention. sevoflurane AEs). Laryngospasm was the sixth higher with desflurane in a younger population, All AEs are reported as a percentage of the most common subcategory in Respiratory/Tho- but was noted to be higher with sevoflurane in total reaction group number for that anesthetic racic complications. Of note, Renal-specific Dis- an elderly population. Respiratory events were within each age group. orders made up only 4.4% of all reported more prevalent than other adverse events in reactions for sevoflurane, compared with 5.3% RESULTS younger patients receiving desflurane. The for desflurane. Use of desflurane yielded 1140 reported AEs greatest percentage of AEs in the Injury, Poi- with the most common category (reaction Figure 1 demonstrates AEs of interest for soning, and Procedural Complications group group), being Injury, Poisoning, and Procedural this report. Both desflurane and sevoflurane were awareness and neurologic AEs, likely cap- Complications (24.9%). The top four subcatego- had high proportions of reported Cardiac AEs turing postoperative agitation and cognitive ries within this reaction group included postpro- in the 85+ age group (80% and 63.6%). Ven- decline. cedural complications, fetal exposure during tricular tachyarrhythmia had a disproportion- There are a number of links between the pregnancy, anesthetic neurological complica- ately high occurrence with desflurane in the tions, and awareness. Cardiac AEs were age range of 12–17 at 26.8% compared to FAERS database and the clinical science for second at 23.9% with the most common sub- 8.2% for sevoflurane. There were very few each anesthetic. categories including bradycardia, cardiac reported adverse events in the neonatal age See “Adverse Event Reporting,” Next Page APSF NEWSLETTER February 2021 PAGE 10

No New or Unexpected Adverse Events Were Found in the FAERS Database for Sevoflurane and Desflurane Use

From “Adverse Event Reporting,” Preceding Page and consumers in the United States, and for this rate of change on responses. Anesthesiology. 1996;84: 1035–1042. reason there are important limitations to the Arrythmias and Volatile Anesthetics: In vitro 3. Welskopf R, Moore M, Eger E, et al. Rapid increase in desflu- studies have shown that desflurane may database. First, there is no certainty that the rane concentration is associated with greater transient car- reported adverse event was caused by the drug diovascular stimulation than with rapid increase in increase intramyocardial catecholamine isoflurane concentration in humans. Anesthesiology. release,16 which could lead to the generation of in question, as the FDA does not require that a 1994;80:1035–1045. arrhythmias. Desflurane has also been associ- causal relationship be proven. Second, the FDA 4. Ebert T, Muzi M. Sympathetic hyperactivity during desflu- does not receive every single adverse event that rane anesthesia in healthy volunteers. Anesthesiology. ated with more arrhythmias than sevoflurane 1993;79:444–453. after off-pump coronary artery bypass grafting,17 occurs for every single drug. There are many fac- 5. Oofuvong M, Geater A, Chongsuvivatwong V, et al. Risk and has been associated with a higher rate of tors that determine whether a report will be filed, over time and risk factors of intraoperative respiratory such as the severity or publicity of the event. It is events: a historical cohort study of 14,153 children. BMC postoperative atrial fibrillation after on-pump car- Anesthesiology. 2014;14:13. diac surgery.18 The interlead variability of the QT expected that more serious side effects, such as 6. Lerman J, Hammer, G. Response to: Airway responses to cardiac arrhythmias, would be reported more desflurane during maintenance of anesthesia and recovery interval, called the QT dispersion (QTd), is a in children with laryngeal mask airways. Paediatr Anaesth. marker for regional differences in ventricular frequently than other less serious reactions, such 2010;20:962–963. repolarization and correlates better with the risk as postoperative nausea. For this reason, the 7. Habibollahi P, Mahboobi N, Esmaeili S, et al. Halothane- 19 database cannot be used to calculate an inci- induced hepatitis: a forgotten issue in developing countries. of dysrhythmia than the QT interval itself. In Hepat Mon. dence of a given adverse event in the popula- 2011;11:3–6. healthy adults undergoing noncardiac surgery, 8. Sosis MB. Further comments on the withdrawal of rapa- induction of anesthesia with only desflurane (no tion. The frequency of use of sevoflurane is curonium. Anesthesia & Analgesia. 2002;95:1126–1127. premedication) appeared to significantly higher than desflurane in pediatric and adult 9. Sloane R, Osanlou O, Lewis D, et al. Social media and phar- patients.24 Thus, the total number of adverse macovigilance: a review of the opportunities and chal- increase the QTd while induction with only sevo- lenges. Br J Clin Pharmacol. 2015; 80:910–920. flurane was not associated with any changes,20 events for any one volatile anesthetic is not rele- 10. Smith I, Nathanson M, White P. Sevoflurane-a long-awaited Br J Anaesth but when midazolam and vecuronium were vant unless the denominator is precisely known. volatile anaesthetic. . 1996;76:435–445. 11. Ebert T, Frink E, Kharasch E. Absence of biochemical evi- used prior to intubation, desflurane and sevoflu- Conclusions: Unlike other anesthesia drugs dence for renal and hepatic dysfunction after 8 hours of rane both prolonged the QTd with no significant where their clinical use revealed new or unex- 1.25 minimum alveolar concentration sevoflurane anesthe- sia in volunteers. Anesthesiology. 1998;88:601–610. difference between the two.21 While a prolonged pected safety concerns such as halothane hepa- 12. Kharasch E, Jubert C. Compound A uptake and metabolism QTd can lead to various arrhythmias, its relation- titis or anaphylaxis from rapacuronium, there do to mercapturic acids and 3,3,3-trifluoro-2-fluoromethoxy- ship to sympathetic activation, more commonly not appear to be any new or unexpected propanoic acid during low-flow sevoflurane anesthesia. Anesthesiology. 1999;91:1267–1278. associated with desflurane is unknown. adverse phenomena after nearly 30 years of use 13. Bunting H, Kelly M, Milligan K. Effect of nebulized lignocaine Respiratory Disorders and Volatile Anesthet- of desflurane and sevoflurane. Early research on airway irritation and haemodynamic changes during identifying the neurocirculatory changes from induction of anaesthesia with desflurane. Br J Anaesth. ics: The proportion of respiratory AEs was high in 1995;75:631–633. the airway irritant effects of desflurane and the the younger age group. As mentioned earlier, 14. Pacentine G, Muzi M, Ebert T. Effects of fentanyl on sympa- absence of renal injury from sevoflurane have thetic activation associated with the administration of des- within the first few years of desflurane being carried forward to explain the findings in the flurane.Anesthesiology . 1995;82:823–831. available clinically there were concerns about 15. U.S. Food and Drug Administration. 2020. Potential signals FAERS self-reported data. Desflurane had a high pungency and airway irritation. As seen in recent of serious risks by FAERS. [online] Available at: https://www. incidence of airway events in a younger popula- fda.gov/Drugs/GuidanceComplianceRegulatoryInforma- studies regarding the respiratory effects of des- tion that did not persist in older patients. Cardiac tion/Surveillance/AdverseDrugEffects/ucm565425.htm flurane, a clear difference exists between adults Accessed March 9, 2020. arrhythmias were noted with both anesthetics, and children. In an historical study of a large 16. Park WK, Kim MH, Ahn DS, et al. Myocardial depressant and a prevalence of ventricular tachycardia was effects of desflurane: mechanical and electrophysiologic cohort of 14,000 children, researchers found that actions in vitro. Anesthesiology. 2007;106:956–966. noted with desflurane in younger patients. the use of desflurane was a risk factor for intra- 17. Hemmerling T, Minardi C, Zaouter C, et al. Sevoflurane Thomas Ebert, MD, PhD, is a professor of anes- causes less arrhythmias than desflurane after off-pump operative respiratory events of all kinds, as well coronary artery bypass grafting: a pilot study. Ann Card as for laryngospasm in particular.5 In a clinical trial thesiology at the Medical College of Wisconsin, Anaesth. 2010;13:116. of 400 healthy children who were randomized to Milwaukee, WI, and chief of anesthesiology at the 18. Cromheecke S, ten Broecke PW, Hendrickx E, et al. Inci- dence of atrial fibrillation early after cardiac surgery: can either desflurane or isoflurane, children who Clement J. Zablocki Veterans Affairs Medical choice of the anesthetic regimen influence the incidence? received desflurane had a significantly higher Center, Milwaukee WI. Acta Anaesthesiol Belg. 2005;56:147–54. 19. Day C, McComb J, Campbell R. QT dispersion: an indication frequency of airway events of any severity, laryn- Alex Ritchay, MD, is an anesthesiology resident at 6 of arrhythmia risk in patients with long QT intervals. Heart. gospasm, and coughing. However, the results the Medical College of Wisconsin in the Depart- 1990;63:342–344. are quite different when looking at adults. One ment of Anesthesiology, Milwaukee, WI. 20. Yildirim H, Adanir T, Atay A, et al. The effects of sevoflurane, meta-analysis of 13 randomized controlled trials isoflurane and desflurane on QT interval of the ECG. Eur J Aaron Sandock, BA, is a medical student at the Anaesthesiol. 2004; 21: 566-570. showed no difference between sevoflurane and 21. Kazanci D, Unver S, Karadeniz U, et al. A comparison of the desflurane in the rates of upper airway events, Medical College of Wisconsin, Milwaukee, WI. effects of desflurane, sevoflurane and propofol on QT, QTc, Ann Card Anaesth. laryngospasm, or cough at emergence.22 Shannon Dugan, BS, is a research assistant at and P dispersion on ECG. 2009;12:107. 22. Stevanovic A, Rossaint R, Fritz H, et al. Airway reactions and Another meta-analysis of seven randomized the Medical College of Wisconsin, Milwaukee, WI. emergence times in general laryngeal mask airway anaes- controlled trials showed no difference between thesia. Eur J Anaesthesiol. 2015;32:106–116. sevoflurane and desflurane in the incidence of The authors have no conflicts of interest. 23. de Oliveira G, Girao W, Fitzgerald P, et al. The effect of sevo- 23 flurane versus desflurane on the incidence of upper respi- overall cough or laryngospasm in adults. ratory morbidity in patients undergoing general anesthesia REFERENCES with a Laryngeal Mask Airway: a meta-analysis of random- LIMITATIONS 1. Gonsowski C, Laster M, Eger E, et al. Toxicity of compound ized controlled trials. J Clin Anesth. 2013;25:452–458. A in rats. Anesthesiology. 1994;80:566–573. 24. Nasr G, Davis M. Anesthetic use in newborn infants: the The FAERS relies on the voluntary reporting 2. Muzi M, Lopatka C, Ebert T. Desflurane-mediated neurocir- urgent need for rigorous evaluation. Pediatr Res. 2015;78: of adverse events by health care professionals culatory activation in humans: effects of concentration and 2–6. RAPID Response TO YOUR IMPORTANT QUESTIONS

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to questions from readers HEPA Filters. Do We to questions from readers Really Know Enough? by Felipe Urdaneta, MD

This article was previously published on the APSF online portal. NThe present version is updated and modified by the author for the present APSF Newsletter.

The global crisis due to COVID-19 has per- meated every aspect of our health care sys- tems. Concerns about the biohazard of RSARS-CoV-2,APID RAPID R APIDR spreadRESPONSE APIDR ESPONSEand R contactESPONSE RESPONSE transmission toto your patients, important health questions care personnel, environN- ment, and equipment have been widespread, especially with regards to procedures that generate aerosols (AGPs).1-3 Transmission of the virus is primarily respiratory in nature. SARS-CoV-2 virion is approximately 120 nano- meters in diameter (0.06–0.14 μm), and travels from person to person in biological carrier par- ticles such as droplets or aerosols.2,3 Recom- mendations regarding adequate levels of PPE, handwashing,RAPID R surfaceAPID R cleaning, APIDR RESPONSE decontaminaAPIDRESPONSE R- ESPONSE RESPONSE tion, and precautions during airway manage- mentto your procedures important have been questions discussed extensively during the pandemic.4-6 As with other respiratory transmissible diseases, we 4. Filters in breathing circuits and anesthesia REFERENCES rely on two important filtering systems: circuit machines are not regulated. There is no 1. Canova V, Lederer Schlpfer H, Piso RJ, et al. Transmission filters when artificial breathing systems are risk of SARS-CoV-2 to healthcare workers—observational used in the operating room and/or intensive national or international standard test for filters results of a primary care hospital contact tracing. Swiss care units (ICU) and face-mask respirators. in breathing circuits. Since there is no standard Medical Weekly. 2020;150:1–5. testing, are all manufactures reporting the same 2. Asadi S, Bouvier N, Wexler AS, et al. The coronavirus pan- demic and aerosols: Does COVID-19 transmit via expira- However, things are a bit complicated: 11 when discussing the level of efficiency? tory particles? Aerosol Sci Technol. 2020;0:1–4. 1. Anesthesia machines and mechanical venti- 3. van Doremalen N, Bushmaker T, Morris DH, et al. Aerosol lators require filters for air quality purification 5. Are current available filters adequate for and surface stability of SARS-CoV-2 as compared with and cross-contamination prevention. The COVID-19? SARS-CoV-1. N Engl J Med. 2020;382:1564–1567. efficiency standard of such filters is termed 4. Asenjo JF. Safer intubation and extubation of patients with 6. Because many COVID-19 patients require COVID-19. Can J Anaesth. 2020:1–3. HEPA for high-efficiency particulate air/ high- 5. Chia SE, Koh D, Fones C, et al. Appropriate use of personal 7 prolonged mechanical ventilation, how often efficiency particulate absorbing capacity. protective equipment among healthcare workers in public The ASA recommends placement of HEPA should these filters be changed in the ICU? sector hospitals and primary healthcare polyclinics during filters between the Y-piece of the breathing the SARS outbreak in Singapore. Occup Environ Med. 7. What should health care professionals do in 2005;62:473–477. circuit and the patient's mask, endotracheal case of filter shortages? 6. Sorbello M, El-Boghdadly K, Di Giacinto I, et al. The Italian 8 tube or laryngeal mask airway. coronavirus disease 2019 outbreak: recommendations These are some of the pressing questions from clinical practice. Anaesthesia. 2020;75:724–732. 2. European and U.S standards to determine with regards to HEPA filters that I would like to 7. First MW. Hepa filters. Appl Biosaf. 1998;3:33–42. filter efficiency are not the same: European see discussed. 8. American Society of Anesthesiologists. Information for standards use 99.95% removal of particles health care professionals. Published 2020. https://www. with a diameter of 0.3 μm in diameter, while Thank you. asahq.org/about-asa/governance-and-committees/asa- the U.S uses 99.97%.9 committees/committee-on-occupational-health/coronavi- Felipe Urdaneta rus. Accessed June, 2020. 9. Wikipedia. HEPA. https://en.wikipedia.org/wiki/HEPA. 3. Face mask efficiency is determined by the Clinical Professor of Anesthesiology level of particle penetration. An N95 mask for Accessed June 9, 2020. University of Florida/NFSGVHS example removes at least 95% of 300 nm 10. Haghighat F, Bahloul A, Lara J, et al. Development of a pro- Gainesville, Florida cedure to measure the effectiveness of N95 respirator fil- particles using an airflow rate of 85 liters/ ters against nanoparticles. 2012. min.10 Face mask respirators are regulated 11. NIOSH-Approved Particulate Filtering Facepiece Respira- The author is a consultant for Medtronic and according to U.S National Institute for Occu- tors. https://www.cdc.gov/niosh/npptl/topics/respirators/ member of the Advisory Board for Vyaire and disp_part/default.html. Accessed June 9, 2020. pational Safety and Health (NIOSH) and inter- has received speaker honoraria on their behalf. nationally recognized standards and testing. See “System Filters,” Next Page

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 APSF. It is not the intention of 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 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. RAPID Response TO YOUR IMPORTANT QUESTIONS

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to questions from readers Breathing System Filters to questions from readers in the Era of COVID-19 by Robert G. Loeb, MD

This article was previously published on the APSF online portal. NThe present version is updated and modified by the author for the present APSF Newsletter.

100% We thank Felipe Urdaneta, MD, for highlight- sols which are less than 5–10 microns in diame- Gas streamlines Overall ing some confusion about the use of anesthesia ter.9 Droplets tend to fall due to gravity, whereas Gas streamlines Gas streamlines Fiber breathing system filters in response to the aerosol particles float in air and follow airstreams. Cross COVID-19 pandemic. The APSF website has a Intermediate-sized particles share some proper- Section APID RAPID R APID RESPONSE APIDRESPONSE RESPONSE RESPONSE Diusion Rpage (https://www.apsf.org/faq-on-anesthesia-R ties of droplets and aerosols. Rapid evaporation to your important questions N Sieved particle path machine-use-protection-and-decontamination- of small droplets results in even smaller droplet Sieving during-the-covid-19-pandemic/) that nuclei that also follow airstreams. Droplets, aero- 50% summarizes current strategies for protecting the sols, and intermediate-sized particles are gener- Fiber Cross anesthesia machine from contamination by a ated during coughing, sneezing, and talking, Section Impacted particle path Impaction potentially infected patient. But it does not pro- whereas aerosols are primarily generated during Filtration E ciency Interception vide some of the details behind the recommen- passive breathing. An important concept in filter- Electrostatic particle path dations. This article will provide details, such as ing pathogens is that respiratory viruses are not the risk of patient trans-infection via the breath- transmitted by isolated virus particles floating in Intercepted particle path Fiber ing system, modes of virus transmission, filtra- air, but by viruses contained within larger parti- Cross tion physics, types of filters, and standardized Section 0% cles. Droplets and some intermediate-sized par- Di usion particle path 0.01 0.1 1 10 tests andAPID specificationsRAPID R APID of Rfilters,ESPONSE APIDR in anESPONSE effortR to ESPONSE RESPONSE R R ticles can settle on surfaces, potentially leading Particle Diameter (microns) answer Felipe Urdaneta’s questions and clear to surface transmission. upto similar your confusions important among our readership.questions Figure 1: Filtration phenomena. No studies have estimated how many virus RISK OF PATIENT CROSS-INFECTION particles SARS-CoV-2 infected patients exhale. VIA THE BREATHING SYSTEM However, one study that quantified exhalation 100% Gas streamlines Overall Circle breathing systems presentGas streamlines a hypo- of other respiratory virus particles, found that thetical risk of patient cross-infectionGas streamlines due to seasonal Fibercoronavirus infected patients exhaled Cross rebreathing of previously exhaled gases. Prior and coughed-outSection 0 to 200,000 virus particles to the 1990s, anesthesia breathing system fil- per hour.10 Diusion Sieved particle path ters were not routinely used and it was thought While a single viral particle can theoretically Sieving that cross-infection of patients was prevented result in systemic infection, the chance of infec- 50% by passage of exhaled gas through the alka- Fiber 1 tion increasesCross with the duration and magnitude Section line carbon dioxide absorbent. Impacted However, particle path 11 Impaction

of viral exposure. Filtration E ciency breathing system filters became increasingly Interception 2 Electrostatic particle path used in the 1990s after a report of nine cases PHYSICS OF FILTRATION of cross-infection by hepatitis C attributed to People generally understand the physics of 3 contaminated anesthesia breathingIntercepted systems. particle pathsieve filtration,Fiber an observable phenomenon in Cross There is conflicting evidence for the potential Section 0% Di usion particle path strainers, whereby a particle that is larger than for cross-infection; almost no cases have been the smallest holes cannot pass through a filter. 0.01 0.1 1 10 in-vitro However, other forces come into play with very Particle Diameter (microns) documented, but tests demonstrate the Figure 2: Individual filtration phenomena sum to yield 4-6 12 possibility. In any case, breathing system fil- small particles (e.g., diameter < 2 microns). overall filtration for different size particles. Note that ters are recommended by a number of anes- Very small particles tend to adhere to the filter the lowest efficiency is around 0.3 microns. thesia societies, but only when breathing material once they make contact, even if they sion. Finally, small charged particles can be circuits are reused between patients.7,8 could fit through openings in the filter. There are four basic mechanisms whereby particles attracted to the charged surface of filter material MODES OF RESPIRATORY VIRUS make contact with filter material. Particles in the through a process called electrostatic attraction. TRANSMISSION range of 0.11 micron can directly impact filter Figure 1 illustrates each of these phenomenon, strands through a process called inertial impac- COVID-19 (SARS-CoV-2) is transmitted pri- and Figure 2 shows how the sum of these phe- tion. Particles in the range of 0.05–1 micron can nomena affects the overall filter efficiency. Note marily via the respiratory route, as are Severe tangentially contact filter strands through a pro- Acute Respiratory Syndrome (SARS-CoV), Mid- that for most air filters, particles around 0.3 cess called interception. As particles get smaller, microns (i.e., 300 nanometers) in size are the dle-East Respiratory Syndrome-associated they increasingly exhibit Brownian motion in most difficult to trap—particles that are larger or coronavirus (MERS-CoV), and other coronavi- addition to moving with air flow—and can con- ruses. It is transmitted via droplets, which are tact filter material as a consequence of this smaller are easier to catch. more than 20 microns in diameter, and via aero- erratic movement through a process called diffu- See “System Filters,” Next Page

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 APSF. It is not the intention of 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 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. RAPID Response TO YOUR IMPORTANT QUESTIONS

RAPID Response TO QUESTIONS FROM READERS

RAPID Response

APSF NEWSLETTER February 2021 PAGE 13

to questions from readers A Variety of Filters and Testing Are Available

From “System Filters,” Preceding Page STANDARDIZED TESTS AND ate to apply this term to breathing system filters SPECIFICATIONS OF FILTERS because the test methods are different. TYPES OF FILTERS USED IN Particle Filtration ANESTHESIA BREATHING SYSTEMS Microorganism Filtration There is one single international standard for Pleated mechanical N filters Some breathing system filter product litera- testing the filtration efficiency of breathing Pleated mechanical filters contain a thick ture contains statements about bacterial and or system filters,ISO 23328-1: Breathing system viral filtration efficiency. There is no standard test sheet of tightly packed, randomly oriented, 16 filters for anaesthetic and respiratory use. The for determining the bacterial and or viral filtration bonded hydrophobic fibers that capture par- standard describes a method, the salt test ticulates within the depth of the filter. The filter efficiency of breathing system filters, but there method, that quantifies the number of 0.1 to 0.3 are standard methods for determining this for material is pleated to increase the surface area RAPID RAPID R APIDR RESPONSE APIDRESPONSE RESPONSE RESPONSEmicron airborne sodium chloride particles that other types of filters. One of these is ASTM and decrease resistance to airflow. They typi- to your important questions pass through the filter during a short-term chal- F2101–19: Standard test method for evaluating cally have a very high filtration efficiency and lenge at airflow rates likely to be encountered the bacterial filtration efficiency (BFE) of medical may also provide some heat and moisture during the intended use. Pediatric and adult fil- face mask materials, using a biological aerosol exchange when placed close to the airway, at a ters are challenged with either 0.1 mg or 0.2 mg of Staphylococcus aureus.20 A similar procedure site of two-way airflow. When used in a humid of sodium chloride particles at 15 L/min or 30 L/ using biologic aerosols of Bacillus subtilis or environment, their filtration efficiency and min, respectively. Filters are preconditioned in MS-2 coliphage to test breathing system filters is resistance to airflow can get better or worse; humidified air to simulate a period of clinical use described by Wilkes et al.21 and is the same as they still tend to be highly effective when before they are tested. Nonelectrostatically that in Draft BS EN 13328-1 (which never got past 13 damp. Liquids do not easily pass through charged dry salt particles are used for the chal- the draft stage). In both procedures, suspensions 14 pleated mechanical filters. Mechanical filters lenge, because they are very difficult to trap. of bacteria or viruses are aerosolized to a mean tend to cost more, and have a higher internal The method does not assess the filtration per- liquid particle size of 3.0 microns and drawn volume than electrostatic filters. formance for droplets and aerosols, nor does it through the filter material by a downstream proport to test the filtration performance for Electrostatic filters vacuum. Anything that passes through the filter microorganisms. It is for comparison purposes Electrostatic filters contain a thin sheet of is captured either into nutrient broth or onto cul- only and has no proven clinical relevance. The ture plates. Percent filtration efficiency is calcu- less tightly woven electrostatic fibers. Their standard contains no threshold for minimum lated by dividing the number of cultured particles resistance to airflow is less for a given surface performance of breathing system filter effi- downstream of the filter by the number in the area, so they are not pleated. Electrostatic fil- ciency. The test results are expressed as the upstream challenge. At face value, these meth- ters typically have 1000-fold lower filtration effi- percent filtration efficiency, which is the per- ods might seem more clinically relevant than the ciencies than pleated mechanical filters.13 Their cent of particles in the challenge that do not salt test method. They use larger sized fluid par- filtration efficiency and resistance to airflow pass through the filter. For example, if the filter ticles than the salt test method. The fluid parti- 7 can get better or worse in a humid environ- is challenged with 10 million (10 ) particles, and cles may be electrostatically charged. Only 3 ment. Liquids easily pass through an electro- 1000 (10 ) particles are detected on the other viable microorganisms are counted. However, 14 static filter. side, then the percent filtration efficiency is 100 these methods are less reproduceable. In gen- 3 7 Heat and moisture exchange filters (HMEF) * (1 – 10 / 10 ) = 99.99%. eral, the same filter will have greater percent fil- By themselves, heat and moisture exchange Entirely different standards are used for test- tration efficiencies for bacteria, than for viruses, (HME) devices provide no filtering. HMEs that ing and rating other types of filters. Notably, the than for salt particles. National Institute for Occupational Health and contain an electrostatic or a pleated mechanical BUBBLE POINT TESTING filter are denoted HMEF. HMEs and HMEFs are Safety, developed NIOSH 42 CFR Part 84: Respi- Membrane filters are rated by pore size, only effective for humidification when placed ratory Protective Devices17 as a method to test which is indirectly determined using the bubble and rate nonpowered air-purifying respirators. close to the airway, at a site of two-way airflow, point test. The bubble point test is based on the N-series respirators that are used in health care where they absorb water during exhalation and principle that liquid is held in the pores of the 15 are challenged with 200 mg of nonelectrostati- release it during inhalation. filter by surface tension and capillary forces, cally charged dry sodium chloride particles that and that the minimum pressure required to Membrane filters are 0.1 to 0.3 microns in size at a flow rate of 85 L/ force liquid out of the pores is related to the A completely different type of filter is used in min.18 This is a similar but more challenging test pore diameter. However, pore size cannot be respiratory gas analyzers to prevent fluid entry than ISO 23328-1 due to the higher particle mass used as a surrogate for particle or pathogen fil- into the analyzer chamber. While not classified as and flow rate. Another notable filtration testing tration efficiency. Hydrophilic 0.22-micron breathing system filters, hydrophobic membrane standard is IEST-RP-CC001: HEPA and ULPA Fil- membrane filters are commonly used to steril- filters are commonly included in water traps ters,19 which tests the performance of filters used ize pharmaceuticals, and to maintain sterility of because they allow gas to pass when dry, but in clean air devices and clean rooms. HEPA epidural infusions, but their efficiency at filter- become occlusive when wet. Membrane filters refers to high-efficiency particle air filters that ing airborne particles has not been tested. have ultra-small pores and channels that can pre- remove 99.97% of particles whose diameter is vent particle passage primarily by sieving. equal to 0.3 microns. However, it is not appropri- See “System Filters,” Next Page

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 APSF. It is not the intention of 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 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. RAPID Response TO YOUR IMPORTANT QUESTIONS

RAPID Response TO QUESTIONS FROM READERS

RAPID Response

APSF NEWSLETTER February 2021 PAGE 14

Clinicians Should Know Specifications for to questions from readers Breathing System Filters in Use

From “System Filters,” Preceding Page system filter at the airway will capture the same dards-of-practice/policies,-statements,-and-guidelines number of viruses and introduce less airway Accessed July 6, 2020. Some 0.2-micron hydrophobic membrane filters 8. Association of Anaesthetists of Great Britain & Ireland. (e.g., those in the GE D-Fend Pro, Dräger Water- resistance than two electrostatic filters in series, Guidelines: infection prevention and control 2020. https:// but may increase the dead space. anaesthetists.org/Portals/0/PDFs/Guidelines%20PDFs/ Lock® 2, and Covidien FilterLine® water traps) Infection_Control_Guideline_FINAL%202020. have been independently N tested, and have an Clinicians should know the specifications pdf?ver=2020-01-20-105932-143 Accessed July 6, 2020. airborne viral filtration efficiency of 99.99% or for the breathing system filters available to 9. Tellier R, Li Y, Cowling BJ, Tang JW. Recognition of aerosol transmission of infectious agents: a commentary. BMC greater. them. These can be found from the manufac- Infect Dis. 2019;19:101. turer’s web site or help line, in product literature, 10. Leung NH, Chu DK, Shiu EY, et al. Respiratory virus shed- CLINICAL RECOMMENDATIONS online, and in journal articles.13,14 Important ding in exhaled breath and efficacy of face masks. Nat In 2003, the United States Center for Disease specifications are: Med. 2020;26:676–680. RAPID RAPID R APIDR RESPONSE APIDRESPONSE RESPONSE RESPONSE 11. Nicas M, Hubbard AE, Jones RM, Reingold AL. The infec- Control stated, “No recommendation can be • bacterial and viral filtration efficiency (%— tious dose of variola (smallpox) virus. Appl Biosaf. to your important questions made for placing a bacterial filter in the breathing higher is better), 2004;9:118–127. system or patient circuit of anesthesia equip- 12. Hakobyan NA. Introduction to basics of submicron aerosol • NaCl or salt filtration efficiency (%—higher is particles filtration theory via ultrafine fiber media.Armen J ment,” citing now 40-year old studies that better), Phys. 2015;8:140–151. showed failure of sterile breathing circuits or • resistance to flow (pressure drop in Pa or 13. Wilkes A. Breathing system filters: an assessment of 104 breathing system filters to reduce the incidence breathing system filters. MHRA Evaluation 04005. March cmH2O at a given airflow rate in L/min—lower of postoperative pneumonia.22 There is no cur- 2004 https://www.psnetwork.org/wp-content/ is better), uploads/2018/01/An-assessment-of-104-breathing-system- rent regulation to use breathing system filters on • how the former specifications are affected by filters-MHRA-Evaluation-04005-2004-.pdf Accessed July 6, 2020. anesthesia machines. However, it seems pru- filter conditioning in humidity, dent to prevent, as best as possible, the cross- 14. Wilkes AR. The ability of breathing system filters to prevent • internal volume (ml—lower is better), and liquid contamination of breathing systems: a laboratory infection of patients with SARS-CoV-2 during this • humidification study* APPARATUS. Anaesthesia. 2002;57:33–39. COVID-19 pandemic. There are sparse reports of 15. Wilkes AR. Heat and moisture exchangers and breathing – (moisture loss in mgH2O/L of air­—lower is cross-infection from contaminated anesthesia system filters: their use in anaesthesia and intensive care. better), or Part 1–history, principles and efficiency. Anaesthesia. machines prior to SARS, MERS, and COVID-19, – (moisture output in mgH2O/L of air— 2011;66:31–9. but the risk from these pathogens is not currently higher is better). 16. International Organization for Standardization. Breathing known. Out of an abundance of caution and system filters for anaesthetic and respiratory use — Part 1: Note that some publications list evaluations Salt test method to assess filtration performance. (ISO informed by existing knowledge, the APSF and 23328-1:2003) https://www.iso.org/standard/35330.html ASA recommend using breathing system filters, that were done 10 or 20 years ago, and that Accessed July 6, 2020. recognizing that the science is incomplete. products may change, or be manufactured or 17. Department of Health and Human Services. 42 CFR Part 84 (https://www.apsf.org/faq-on-anesthesia- distributed by different companies. Respiratory protective devices; final rules and notice. Fed- eral Register Volume 60, Number 110 (Thursday, June 8, machine-use-protection-and-decontamination- Robert G. Loeb, MD, is clinical professor of anes- 1995). https://www.govinfo.gov/content/pkg/FR-1995-06- during-the-covid-19-pandemic/). thesiology at the University of Florida College of 08/html/95-13287.htm Accessed July 6, 2020. 18. National Institute for Occupational Safety and Health. Deter- Adding breathing system filters is not without Medicine, Gainesville, FL. mination of particulate filter efficiency level for N95 series risk.23,24 Depending on placement, they can filters against solid particulates for non-powered, air-purify- He is employee of the University of Florida, chair ing respirators standard testing procedure (STP). https:// add dead space which increases carbon diox- of the American Society of Anesthesiologists www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR- ide rebreathing and slows inhalation induction Committee on Equipment and Facilities, and he STP-0059-508.pdf Accessed July 6, 2020. and emergence. They increase resistance to is on the Masimo, Inc. Technical Advisory Board. 19. Institute for Environmental Sciences and Technology. HEPA and ULPA Filters. (IEST-RP-CC001) https://www.iest.org/ inspiratory and/or expiratory flow, which Standards-RPs/Recommended-Practices/IEST-RP-CC001 increases spontaneous work of breathing, and REFERENCES Accessed July 6, 2020. affects pulmonary mechanics (testing methods 1. Murphy PM, Fitzgeorge RB, Barrett RF. Viability and distribu- 20. ASTM International. Standard test method for evaluating tion of bacteria after passage through a circle anaesthetic the bacterial filtration efficiency (BFE) of medical face mask are described in international standard ISO system. Br J Anaesth. 1991;66:300–304. materials, using a biological aerosol of Staphylococcus 25 9360-1). Filters can become obstructed lead- 2. Atkinson MC, Girgis Y, Broome IJ. Extent and practicalities aureus. (F2101 – 19) https://compass.astm.org/EDIT/html_ ing to life-threatening hypoventilation and baro- of filter use in anaesthetic breathing circuits and attitudes annot.cgi?F2101+19 Accessed July 6, 2020. towards their use: a postal survey of UK hospitals. Anaes- trauma. They add weight to the breathing circuit 21. Wilkes AR, Benbough JE, Speight SE, et al. The bacterial thesia. 1999;54:37–41. and viral filtration performance of breathing system filters. and add sites for accidental disconnection. 3. Chant K, Kociuba K, Munro R, et al. Investigation of possible Anaesthesia. 2000;55:458–465. patient-to-patient transmission of hepatitis C in a hospital. 22. CDC Healthcare Infection Control Practices Advisory Com- The filtration efficiency required to prevent New South Wales Public Health Bulletin. 1994;5:47–51. mittee. Guidelines for preventing health-care--associated infection from exhaled viruses via the breathing 4. Spertini V, Borsoi L, Berger J, et al. Bacterial contamination pneumonia, 2003. MMWR 53(RR03); 1–36, 2004. system is not known. If a patient exhales of anesthesia machines’ internal breathing-circuit-systems. 23. Lawes EG. Hidden hazards and dangers associated with GMS Hyg Infect Control. 2011;6(1). 200,000 virus particles per hour, then an elec- the use of HME/filters in breathing circuits. Their effect on 5. Lloyd G, Howells J, Liddle C, et al. Barriers to hepatitis C toxic metabolite production, pulse oximetry and airway trostatic filter that traps 99.9% of them will allow transmission within breathing systems: efficacy of a pleated resistance. Br J Anaesth. 2003;91:249–264. only 200 to pass. Placing two of these filters in hydrophobic filter.Anaesth Intensive Care. 1997;25:235– 24. Wilkes AR. Heat and moisture exchangers and breathing series (e.g., one at the airway and one on the 238. system filters: their use in anaesthesia and intensive care. 6. Heinsen A, Bendtsen F, Fomsgaard A. A phylogenetic anal- Part 2–practical use, including problems, and their use with expiratory limb) will multiply the filtration effi- ysis elucidating a case of patient-to-patient transmission of paediatric patients. Anaesthesia. 2011;66:40–51. ciency to 99.9999%, making the risk of virus hepatitis C virus during surgery. J Hosp Infect. 2000;46: 25. International Standards Organization. Anaesthetic and passage almost nil, but will double the resis- 309–313. respiratory equipment—heat and moisture exchangers 7. Australian & New Zealand College of Anaesthetists. PS28 (HMEs) for humidifying respired gases in humans—part 1: tance to flow. Using a single higher efficiency Guideline on infection control in anaesthesia 2015. Avail- HMEs for use with tracheostomized patients having mini- (e.g., 99.9999%) pleated mechanical breathing able at: https://www.anzca.edu.au/safety-advocacy/stan- mal tidal volume of 250 ml (ISO 9360-2: 2001).

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 APSF. It is not the intention of 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 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. APSF NEWSLETTER February 2021 PAGE 15

The MHC Story: Accelerating Implementation of Best Practices Through Improved Organizational Macro-Ergonomics Updates from the Perioperative Multi-Center Handoff Collaborative (MHC) by Bommy Hong Mershon, MD, and Philip E. Greilich, MD, MSc

Scaling and sustaining change in health care As a boundary-spanning organization, the is complex and generally requires aligning the MHC seeks to accelerate the development of efforts of interdisciplinary groups on multiple scalable solutions for handoffs through experi- levels. Examples include the use of participatory mentation and thoughtful expansion of its collab- design to adapt a best practice to a given clinical orative partnerships. Although its membership unit, forming guidance teams to scale successful now comprises a substantial interdisciplinary unit-based efforts throughout a hospital or “brain trust” that represents more than 20 aca- health system, and incentivizing wide-spread demic medical centers within the United States, dissemination of effective implementation strat- strategic partnerships will be required to gener- egies by medical societies, large group prac- ate products for discovery (grants, manuscripts), tices, and regulatory and funding agencies. multilevel education (curriculum), and imple- Some of the most successful efforts to date have mentation (tools, strategies) for both the public used a “learning collaborative” to focus on a and private sectors. One such example is the specific patient safety priority over an extended collaborative partnership created in 2018 with period of time. This type of organizational macro- Epic, the electronic medical record (EMR) ergonomic facilitates alignment of context vendor for over half of the institutions providing experts (clinicians), subject matter experts (e.g., anesthesia in the United States. Given growing evidence of a relationship between number of human factors, implementation science, sys- handoffs and morbidity and mortality,5-7 the tems engineering, information technology), and MHC’s Implementation Working Group began organizations that promote patient safety. The working with an Epic Foundation team to Michigan Keystone Project (for central lines)1 and design a platform that would improve the intra- the Safe Surgery program in South Carolina (for operative anesthesia handoff process. Here we surgical checklists)2 are two such exemplars, describe the process and achievements of that though other examples continue to emerge. collaboration. The Perioperative Multi-Center Handoff Col- After official formation of the MHC, our EMR laborative (MHC) is a national learning collabora- workgroup first met in December 2017. The tive whose primary objective is to create core members consisted of the Epic team— pragmatic, scalable, and sustainable practices Felix Lin, Adam Marsh, and Spencer Small— that will increase the efficiency and effective- along with anesthesiologists from different ness of handoffs and care transitions for clini- institutions: Philip Greilich, MD (UT Southwest- cians, patients, and their families. It was formed ern, MHC founding chair), Aalok Agarwala, MD in 2015 by a group of academic anesthesiolo- (Massachusetts General, MHC steering board gists who were leading pilot efforts at their member), Patrick Guffey, MD (Children’s Hospi- Figure 1: First version of the intraoperative handoff tool respective institutions. A partnership with the tal of Colorado, Epic Steering Committee), Guy (reprinted with permission from ©2020 Epic Systems Anesthesia Patient Safety Foundation (APSF) led De-Lisle Dear, MD (Duke), Trent Bryson, MD (UT Corporation) in the Epic intraoperative record. to the planning and conduct of the first Stoelting Southwestern), and Bommy Hong Mershon, Consensus Conference on Perioperative Hand- MD (Johns Hopkins). We met monthly over the ing” that was prevalent when navigating within offs in 2017. This interprofessional conference of next two years, with additional members joining the Epic intraoperative record. It was also patient safety experts achieved high levels of throughout. Our workgroup’s goal was to important that we incorporate mandatory docu- 3 consensus over 50 recommendations that laid design an intraoperative handoff tool in Epic mentation such as the staffing time grid when the foundation for the formation of the MHC’s through this collaborative partnership. the handoff occurs. We applied quality improve- initial working group on education, implementa- Initially, we compared each institution’s own ment principles of standardizing critical informa- tion, and research. The collaborative relationship intraoperative handoff tools in Epic: what tion elements8,9 and integrated these was solidified when APSF sponsored the MHC worked, what needed improvement, and the guidelines into the workflow to ultimately make as its special interest group (SIG) for champion- limitations that our local Epic programmers it accessible and easy to use. However, institu- ing handoffs and care transitions, one of its encountered. Led by Felix Lin (Epic), we sur- tions could customize the specific data points patient safety priorities (#7 Handoffs & Care veyed the clinicians in our group on the critical displayed within the different standardized criti- Transitions).4 This support was instrumental for and necessary elements that needed to be in cal information elements according to the their the launch of MHC’s website (www.handoffs. an intraoperative handoff tool. Based on this specific workflow and preference in a process org), which is intended to increase visibility and information, our design approach was to considered “adapting standard work to individ- connect its members to other medical societies, reduce clutter, streamline the most crucial infor- ual customers.”10 industry, medical groups, insurers, and regula- mation elements essential to an intraoperative tory agencies. handoff, and minimize the “clicking” and “scroll- See “MHC Story,” Next Page APSF NEWSLETTER February 2021 PAGE 16

Handoffs Can Be Integrated into the Electronic Medical Record

From “MHC Story,” Preceding Page We also recognized that good handoff com- munication is not just about information transfer. The most important factor for successful hand- offs is interactive communication, supported by the cognitive load theory of working memory.11 Our consensus was to add a static text box to prompt the handoff giver and receiver to engage with each other. Within 18 months of forming this collaborative partnership, Epic was able to launch the first official version (Figure 1) of the handoff tool in August 2019. The latest version (Figure 2), released in February 2020, contains additional information elements. This handoff tool was dis- seminated to more than 50% of all Epic custom- ers in this short time. Because of limitations related to program- ming and internal review within Epic, these ver- sions do not include all of the elements our group had originally designed and requested. Epic developers decided to focus on creating a tool that offered the available elements in the most user-friendly format for easier adoption by more institutions. Our group is continuing to work with Epic to further refine this tool and to develop a set of user requirements that could be adopted by other EMR vendors. Moving forward, our goals are to 1) improve the functionality of the Epic mobile version, or Haiku, in a way that makes viewing a patient’s record more clinician-centered and enables it to be used for handoffs and 2) focus on the operat- Figure 2: Current version of the handoff tool (reprinted with permission from ©2020 Epic Systems Corporation) in the ing room to postanesthesia care unit and operat- Epic intraoperative record. In the live Epic intraoperative record, this sidebar is shown as a continuous vertical ing room to intensive care unit (ICU) handoffs. column that can be viewed by scrolling up and down. Future plans include expansion to improving handoffs in other perioperative environments Philip E. Greilich, MD, MSc, is professor in the 5. Hyder JA, Bohman JK, Kor DJ, et al. Anesthesia care transi- tions and risk of postoperative complications. Anesth such as ICU, ER, floor to OR handoffs. Department of Anesthesiology & Pain Manage- Analg. Published online 2016. doi:10.1213/ ANE.0000000000000692 Accessed December 21, 2020. Complex health processes such as handoffs ment at the University of Texas Southwestern Medical Center, Dallas, TX. 6. Jones PM, Cherry RA, Allen BN, et al. Association between benefit greatly if we approach them through handover of anesthesia care and adverse postoperative out- comes among patients undergoing major surgery. JAMA. collaborative partnerships. Design, implemen- The authors have no conflicts of interest. Published online 2018. doi:10.1001/jama.2017.20040 tation, and dissemination of guidelines, best Accessed December 21, 2020. practices, and tools can be achieved more effi- 7. Saager L, Hesler BD, You J, et al. Intraoperative transitions REFERENCES of anesthesia care and postoperative adverse outcomes. ciently and effectively and thereby help 1. Reames BN, Krell RW, Campbell DA, et al. A checklist-based Anesthesiology. Published online 2014. doi:10.1097/ improve health care at the national level. A intervention to improve surgical outcomes in Michigan. ALN.0000000000000401 Accessed December 21, 2020. JAMA Surg. Published online 2015. doi:10.1001/jama- national conference, funded by the Agency for 8. Rozich JD, Howard RJ, Justeson JM, et al. Standardization surg.2014.2873 Accessed January 11, 2021. as a mechanism to improve safety in health care. Jt Comm Healthcare, Quality and Research (AHRQ), is 2. Donahue B. In South Carolina, proof that surgical safety J Qual Saf. Published online 2004. doi:10.1016/S1549- scheduled to convene in 2021 to bring major checklist really works. Outpatient Surgery Magazine. http:// 3741(04)30001-8 Accessed December 21, 2020. www.outpatientsurgery.net/newsletter/ 9. Quisenberry E. How does standard work lead to better stakeholders together to plan scalable solu- eweekly/2017/04/18/in-south-carolina-proof-that-surgical- patient safety. https://www.virginiamasoninstitute.org/how- tions for teaching, implementing, and investi- safety-checklist-really-works#:~:text=At the heart of does-standard-work-lead-to-better-patient-safety/ Safe,incision of the skin (%22time Accessed July 21, 2020. gating best practices for perioperative handoffs Accessed December 21, 2020. 3. Agarwala AV, Lane-Fall MB, Greilich PE, et al. Consensus 10. Goitein L, James B. Standardized best practices and indi- and care transitions. recommendations for the conduct, training, implementa- vidual craft-based medicine: a conversation about quality. tion, and research of perioperative handoffs. Anesth Analg. JAMA Intern Med. Published online 2016. doi:10.1001/ Bommy Hong Mershon, MD, is assistant pro- Published online 2019. doi:10.1213/ANE.0000000000004118 jamainternmed.2016.1641 Accessed December 21, 2020. fessor at the Johns Hopkins Department of Accessed January 11, 2021. 11. Young JQ, Wachter RM, Ten Cate O, et al. Advancing the next Anesthesiology and Critical Care Medicine, Bal- 4. APSF’s Perioperative Patient Safety Priorities. apsf.org. Pub- generation of handover research and practice with cognitive lished 2018. https://www.apsf.org/patient-safety-initiatives/ load theory. BMJ Qual Saf. Published online 2016. doi:10.1136/ timore, MD. Accessed November 12, 2020. bmjqs-2015-004181 Accessed December 21, 2020. APSF NEWSLETTER February 2021 PAGE 17

Proactive Perioperative Risk Analysis: Use of Failure Mode and Effects Analysis (FMEA) by George Tewfik, MD, MBA, CPE

Failure mode and effects analysis (FMEA) is Table 1: Examples of Anesthesia and Perioperative Processes to which failure mode an invaluable tool that has been used in indus- and effects analysis (FMEA) may be applied. try to identify potential points of failure in a pro- cess, to evaluate their causes and effects, and Medication Safety Equipment Clinical care Hospital processes 1 to determine ways to decrease risks. Patient Allergy avoidance Routine check Airway management OR Scheduling safety initiatives have incorporated strategies such as FMEA in addition to other techniques, Ordering Equipment failure Avoid laryngospasm Patient transport e.g., root cause analysis (RCA) and the safety Administration Availability Prevention of PONV Bed management assessment code (SAC). The patient safety pro- 2 Postadministration Emergency equipment Perioperative pain OR turnover gram at the Dept. of Veterans Affairs (VA) monitoring management dates back nearly 30 years; approaching error reduction on a systemic basis in the VA was Surgical site infection associated with a significant reduction in MRI prevention hazards and cardiac pacemaker malfunction, Pre-operative PACU processes Regional Anesthesia supporting the role of proactive analysis.2 Sys- workup temic analysis for patient safety improvement Case booking Patient monitoring Consent/Scheduling has a long history, including such programs as the Safer Patients Initiative launched in the PAT booking Patient evaluation Equipment preparation United Kingdom (2004–2008), which in its first Consultations PONV management Catheter management year saw a decrease of adverse events from 7% Labs/testing Pain management to 1.5% per 1,000 patient days by improving reli- ability in general ward care, critical care, periop- Anesthesia evaluation erative care, and medication management.3 Risk assessment using FMEA has been used effectively in hospitals to minimize medical errors; it has been deployed in many different Identify anesthesia Form a team of stakeholders Form a process map & to participate in FMEA settings.4,5,6 One study of administration of process for improvement list all steps involved in and FMEA analysis (ensures accurate data and the process unfractionated heparin identified hundreds of subsequent buy-in) potential failures with a hundred more causes, and deployed dozens of countermeasures to Identify the e‡ects of each 7 improve medication administration safety. List all potential causes for failure and score the List all potential failures After an extensive study at a 367-bed academic failure of each step severity of each (1–no e‡ect, of the process 10–very severe) pediatric hospital, 233 potential points of failure were identified with the administration of unfractionated heparin including mathematical For each of the causes, score Assign a score for each cause Identify processes in place errors, unknown requirements for administra- the likelihood of occurrence for the detectability of the failure to avoid each possible (1–unlikely to occur, 10–almost (1–certain to be detected, tion, incorrect timing, difficulties accessing infor- failure mation from hospital EMR, poor patient certain occurrence) 10–likely to be missed) education, and the ability to administer incor- rect dosages.7 The application of countermea- sures for the process steps identified as having After interventions, recalculate Determine corrective Calculate the RPN, or Risk RPN and update FMEA with actions for each potential Priority Number—product of the highest Risk Priority Number yielded a sta- regular team reviews failure using RPN to severity, occurrence, and tistically significant improvement in the scores prioritize interventions detectability scores (1–100) with resultant improvement in safety for the administration of unfractionated heparin.7 Figure 1: Application of FMEA and the steps involved for an anesthesia process. FMEA has been successfully deployed to enhance the safety of radiotherapy,8-10 hospital or community pharmacy processes,11,12 clinical tal complications such as posture syndrome of the practice of anesthesiology, which is a sys- laboratory processes,13 blood transfusion,14 and thyroid surgery19 or venous thromboembolic tems-based specialty with numerous processes 15 20 clinical trials. Deployment of FMEA across a disease in critically ill patients. that have similarities to manufacturing, lends unit or service has also been demonstrated to Despite its demonstrated benefit, there is itself to the use of FMEA to both identify poten- improve such processes as transfers of care, lab/radiology requests or admission in Emer- sparse literature examining the role of FMEA in tial adverse outcomes resulting from errors and gency Departments,16,17 and overall systemic anesthesiology. Past studies have been limited to improve productivity. Table 1 illustrates cate- functionality in intensive care units (ICUs).18 to examining maintenance and repair of anes- gories and subcategories of anesthesia pro- thesia equipment,21 avoiding medication errors Finally, FMEA has been successful at attempts cesses to which FMEA could be applied. to not only improve systemic processes, but in pediatric anesthesia,6 and enhancing safety also to identify points of failure leading to hospi- of propofol sedation in endoscopy.22 However, See “FMEA,” Next Page APSF NEWSLETTER February 2021 PAGE 18

FMEA Can Be Applied to a Variety of Anesthesia Related Practices

From “FMEA,” Preceding Page effect of failure is recorded. Next, the severity of thesia evaluations. Those are conducted for The steps involved in conducting an FMEA each failure is scored (1–least severe to 10–most outpatients at the Pre-Admission Testing Clinic, for an anesthesia process are demonstrated in severe), the potential causes for each failure are who are referred for evaluation by surgeons’ Figure 1. The first two steps are critically impor- identified, and the likelihood of occurrence is offices after cases have been booked. Table 2 tant for success—namely the identification of the scored (1–least likely to 10–near certain occur- shows a simplified version of the FMEA analysis rence). Any “controls” to prevent the failure are process for optimization and assembly of a team we conducted in the first two months of 2020 identified and the levels of potential detection for involvement in the analysis and subsequent to evaluate the process. The process begins are scored (1–certain detection to 10–unlikely interventions. The necessary stakeholders in any with booking an appointment in the clinic and detection). The Risk Priority Number (RPN) is complicated system must be involved to ensure ends with giving the patient instructions for the adequate input during analysis so that buy-in is determined by multiplying the severity, occur- day of surgery. Each of the process functions present when corrective actions are identified. rence, and detection scores; this number can be are displayed in Column 1 with subsequent anal- For example, “Prevention of postoperative used by the working group to prioritize which ysis using the steps above to calculate an RPN nausea and vomiting” is a process that likely will steps to mark for corrective actions and re-evalu- require corrective actions that involve the phar- ation. A higher RPN score indicates an area of for each function. As shown in Table 2, the func- macy, surgical services, and preoperative nurs- more urgent need for intervention and process tions with the three highest RPN scores are: ing, without whose participation remedies might improvement, whereas a lower RPN denotes a “Patient present for evaluation,” “Available staff,” not be successfully deployed. task or step of less immediate importance. and “Consults.” This information has allowed the senior leadership to focus efforts to make the The next step is also critical: Creating a list of APPLYING FMEA TO PRE-ANESTHESIA all steps in the process. It’s usually helpful to EVALUATIONS most impact to improve the process of obtaining create a process map. For each step, all potential At University Hospital in Newark NJ, we per- a thorough pre-anesthesia evaluation. modes of failure are listed and the possible formed an FMEA for the process of pre-anes- See “FMEA,” Next Page

Table 2: An Example of FMEA Analysis Done at University Hospital in Newark, NJ Analyzing the Steps Involved in Obtaining a Pre-anesthesia Evaluation at the Pre-Admission Testing Clinic, Run by the Anesthesiology Department. Severity scored 1–10 (1–least severe to 10–most severe), Occurrence scored 1–10 (1– least likely to 10–near certainty) and Detectability scored 1–10 (1–cer- tain detection to 10–unlikely detection); RPN is the product of Severity, Occurrence, and Detectability scored 1–100 and is used to prioritize processes to avoid failure and deploy appropriate resources/manpower for improvement (highest scores given most urgent attention). Pre-Anesthesia Evaluation (in Pre-Admission Testing Clinic)

Potential Effect of Potential Cause Process Function Failure Failure Severity of Failure Occurrence Process Controls Detectability RPN Booking an appt for Unable to No Pre-Anesth 7 Poor comm. from 3 Auto-booking of all 1 21 Pre-Anesthesia book appt eval prior to Surgery to book surgical patients in Evaluation Day of Surgery appt Pre-Anes Clinic Reminder for appt Reminder No-show 6 No phone, email 3 Reminder by phone, 1 18 doesn’t reach etc text, email; Surgeon's patient office reminds pt. for appt Patient presents for No-show for No Pre-Anesth 7 Failed transport, 5 Medical transport, 1 35 evaluation appt eval no vehicle Family transport, Ride-sharing svc. Available NP, None Delayed or no 7 Staff shortages, 4 Hiring additional NP, 1 28 resident, CRNA or available eval unexpected call- increase tele-visits physician outs by residents anesthesiologist for evaluation Accurate history Incorrect info Poor quality 4 Language/ 2 Translator, family 1 8 eval cognitive barrier Consults Not obtained No consult 8 Unable to 3 Anes follow up 1 24 received schedule, pt no show Labs drawn Not drawn Labs not 3 Veins, pt not 3 Venipuncture train 1 9 available cooperative Lab referrals Not given CXR, TTE, etc 5 Rx, 3 Office F/U 1 15 not ready communication w/ pt Instructions for DOS Not done Not prepared 5 Language/ 2 Translator, family 1 10 for Sx cognitive barrier APSF NEWSLETTER February 2021 PAGE 19

FMEA May Improve Patient Safety While Optimizing Efficiency

From “FMEA,” Preceding Page the model in Table 2, the process function developed by the National Center for Patient Steps that have been implemented, or are in “booking in clinic” may emerge as the most sig- Safety and implemented by the VA National 24 the process of implementation, include improv- nificant potential failure once the three most Center for Patient Safety. This approach dif- ing patient transport to appointments and con- problematic processes have been improved. fers from traditional FMEA by combining detect- ability and criticality steps of FMEA into a firmation of transport with patients when Despite its established potential for identify- decision-making algorithm and replaces the booking with office staff. To address a lack of ing risks and process failures in health care, RPN with a hazard score, yielding a process in available staff to evaluate patients in clinic, an FMEA does not appear to be as widely which deliberation on interventions for potential anesthesia resident is assigned for a pre-anes- employed as might be expected generally and failures is simpler and more responsive to user thesia evaluation clinic rotation to see patients there are few applications in perioperative input/expertise.24 in addition to the two nurse practitioners who medicine and anesthesiology. There are sev- routinely staff it. In addition, plans are being eral possible reasons for its lack of regular use, An important consideration when using made to deploy telemedicine to replace many such as the tedious nature of the steps FMEA is that hospital systems often have of the in-person evaluations, which will likely involved, requiring a multidisciplinary team and unique process functions that differ greatly improve efficiency of visits, and relieve the detailed information-gathering.23 Franklin et al. between institutions, necessitating individual- strain of limited staff. Finally, we addressed pos- recommend a more targeted approach using ized analysis for each facility. For example, an sible failures in obtaining timely consults, such FMEA, emphasizing the significance of the mul- examination of steps to prevent surgical site as cardiology to evaluate for congestive heart tidisciplinary mapping process and its potential infections may find that surgical residents place failure (CHF) or pulmonology to evaluate wors- for further analysis and intervention.23 The orders for preoperative antibiotics, and that ening or uncontrolled chronic obstructive pul- authors further raise a critical limitation of the antibiotics are kept in a central drug-dispensing monary disease (COPD), by improving RPN, in that all three variables from which the machine. In such a scenario, compliance with communication with the consultants’ offices score is derived (severity, occurrence and perioperative antibiotic administration requires and scheduling consult appointments through detectability) are equally weighted, resulting in the successful placement of the order, a nurse anesthesia, instead of relying on patients. In situations where RPNs may be the same for dif- to check the order, the nurse to retrieve the addition, anesthesia office staff follow up with ferent process steps, but the underlying factors medication and deliver it to the anesthesia consultants to ensure patient presence for significantly consequential.23 team, and anesthesia to administer the medica- appointments and enlist surgeons’ offices to tion, with numerous additional substeps and In 2013, Liu H-C et al. conducted an extensive also assist with this process. potential failures for each. This differs from review concerning FMEA use in health care and many other institutions where anesthesia pro- FMEA is a powerful tool to improve health showed that the most common major short- fessionals may be responsible for determining care facility processes and can be particularly comings cited in the literature include not con- antibiotic administration and those antibiotics effective in perioperative medicine. After sidering the relative importance of occurrence, are stored in anesthesia carts in the operating deployment of each intervention and corrective severity, and detectability, difficulty assessing rooms. The mapping of an institution’s process action, the analysis can be repeated; rescoring the three risk factors, inability to evaluate similar may not translate to other facilities. of the RPN will elucidate success or failure of RPNs with different underlying scores, and a such actions. In addition, an updated score will questionable equation used to calculate RPN CONCLUSION 1 allow leaders to redeploy resources including amongst numerous other limitations. A possi- Although FMEA has its limitations, it is a valu- time and money to process functions that have ble alternative to FMEA may be Healthcare Fail- able tool for proactive process analysis to the highest failure potential. For example, using ure Mode and Effects Analysis (HFMEA) improve both patient safety and optimize effi- ciency. Assembling a multidisciplinary team to conduct an FMEA enables leadership to focus on the most problematic and high-impact steps of a process that may fail and to assign resources to those functions to bring about cor- rective action. FMEA further enables a team to continually assess the usefulness of interven- tions and redeploy resources where they will continue to make the biggest impact. This author strongly recommends its use in anesthe- siology and perioperative medical processes to assist in improving quality and safety via a sys- tematic process to identify where attention and resources will be most effective. George Tewfik, MD, is an assistant professor and director of Quality Assurance in the Depart- ment of Anesthesiology at Rutgers-New Jersey Medical School in Newark, NJ.

The author has no conflicts of interest. See “FMEA,” Next Page APSF NEWSLETTER February 2021 PAGE 20

FMEA References

From “FMEA,” Preceding Page 8. Frewen H, Brown E, Jenkins M, O'Donovan A. Failure mode 17. Taleghani YM, Rezaei F, Sheikhbardsiri H. Risk assessment and effects analysis in a paperless radiotherapy depart- of the emergency processes: healthcare failure mode and REFERENCES ment. J Med Imaging Radiat Oncol. 2018;62:707–715. effect analysis. World J Emerg Med. 2016;7:97–105. 1. Liu H-C, Liu L, Liu N. Risk evaluation approaches in failure 9. Giardina M, Cantone MC, Tomarchio E, et al. A review of 18. Yousefinezhadi T, Jannesar Nobari FA, Behzadi Goodari F, et al. A case study on improving intensive care unit (icu) ser- mode and effects analysis: a literature review. Expert Sys- healthcare failure mode and effects analysis (HFMEA) in vices reliability: by using process failure mode and effects tems with Applications. 2013;40:828–838. radiotherapy. Health Phys. 2016;111:317–326. analysis (PFMEA). Glob J Health Sci. 2016;8:52635. 2. Bagian JP, Gosbee J, Lee CZ, et al. The Veterans Affairs 10. Xu Z, Lee S, Albani D, et al. Evaluating radiotherapy treat- 19. Zhang L, Zeng L, Yan Y, et al. Application of the healthcare root cause analysis system in action. Jt Comm J Qual ment delay using failure mode and effects analysis (FMEA). failure mode and effects analysis system to reduce the inci- Improv. 2002;28:531–545. Radiother Oncol. 2019;137:102–109. dence of posture syndrome of thyroid surgery. Medicine 3. Improvement IfH. Safer patients initiative leads to reduc- 11. Castro Vida M, Martínez de la Plata JE, Morales-Molina JA, (Baltimore). 2019;98:e18309. et al. Identification and prioritisation of risks in a hospital tions in mortality and adverse events in the United King- 20. Viejo Moreno R, Sánchez-Izquierdo Riera J, Molano Álvarez pharmacy using healthcare failure mode and effect analy- dom. http://www.ihi.org/resources/Pages/ E, et al. Improvement of the safety of a clinical process using sis. Eur J Hosp Pharm. 2019;26:66–72. ImprovementStories/SaferPatientsInitiativeLeadstoReduc- failure mode and effects analysis: Prevention of venous tionsinMortalityandAEsintheUK.aspx. Published 2006. 12. Stojković T, Marinković V, Jaehde U, et al. Using failure thromboembolic disease in critical patients. Med Intensiva. Accessed July 19, 2020. mode and effects analysis to reduce patient safety risks 2016;40:483–490. 4. Asgari Dastjerdi H, Khorasani E, Yarmohammadian MH, et related to the dispensing process in the community phar- 21. Rosen MA, Lee BH, Sampson JB, et al. Failure mode and al. Evaluating the application of failure mode and effects macy setting. Res Social Adm Pharm. 2017;13:1159–1166. effects analysis applied to the maintenance and repair of analysis technique in hospital wards: a systematic review. J 13. Jiang Y, Jiang H, Ding S, Liu Q. Application of failure mode anesthetic equipment in an austere medical environment. Inj Violence Res. 2017;9:51–60. and effects analysis in a clinical chemistry laboratory. Clin Int J Qual Health Care. 2014;26:404–410. 5. Aranaz-Andrés JM, Bermejo-Vicedo T, Muñoz-Ojeda I, et al. Chim Acta. 2015;448:80–85. 22. Huergo Fernández A, Amor Martín P, Fernández Cadenas F. Failure mode and effects analysis applied to the administra- 14. Lu Y, Teng F, Zhou J, Wen A, Bi Y. Failure mode and effect Propofol sedation quality and safety. failure mode and tion of liquid medication by oral syringes. Farm Hosp. analysis in blood transfusion: a proactive tool to reduce effects analysis. Rev Esp Enferm Dig. 2017;109:602–603. 2017;41:674–677. risks. Transfusion. 2013;53:3080–3087. 23. Dean Franklin B, Shebl NA, Barber N. Failure mode and 6. Martin LD, Grigg EB, Verma S, et al. Outcomes of a failure 15. Mañes-Sevilla M, Marzal-Alfaro MB, Romero Jiménez R, et effects analysis: too little for too much? BMJ Qual Saf. mode and effects analysis for medication errors in pediatric al. Failure mode and effects analysis to improve quality in 2012;2:607–611. anesthesia. Paediatr Anaesth. 2017;27:571–580. clinical trials. J Healthc Qual Res. 2018;33:33–47. 24. Safety VNCfP. The basics of healthcare failure mode and 7. Pino FA, Weidemann DK, Schroeder LL, et al. Failure mode 16. Sorrentino P. Use of failure mode and effects analysis to effect analysis. U.S. Dept. of Veterans Affairs.https://www. and effects analysis to reduce risk of heparin use. Am J improve emergency department handoff processes.Clin patientsafety.va.gov/docs/hfmea/HFMEAIntro.pdf. Pub- Health Syst Pharm. 2019. Nurse Spec. 2016;30:28–37. lished 2001. Accessed July 20, 2020.

APSF 2021 Stoelting Conference Clinician Safety: To Care is Human Hosts:

Patricia Mullen Reilly, CRNA Brian Thomas, JD Matthew Weinger, MD September 8–9, 2021 Royal Palms Resort and Spa, Phoenix, AZ

For registration and conference inquiries, please contact Stacey Maxwell, APSF Administrator ([email protected]). Hotel reservation block to be opened at a later date. APSF NEWSLETTER February 2021 PAGE 21 Anesthesia Patient Safety Foundation Founding Patron ($360,000) American Society of Anesthesiologists (asahq.org)

2021 Corporate Advisory Council Members (current as of December 21, 2020) Platinum ($50,000) Gold ($30,000)

Preferred Physicians Acacia Pharma GE Healthcare Medical Risk (acaciapharma.com) (gehealthcare.com) ICU Medical Merck (merck.com) Medtronic Retention Group (icumedical.com) (medtronic.com) (ppmrrg.com)

Silver ($10,000) Bronze ($5,000) Senzime Ambu Codonics Dräger Fresenius Kabi Masimo Medasense Respiratory Motion, Inc. Smiths Medical (fresenius-kabi.us) (masimo.com) Special recognition and thank you to Medtronic for their support and funding of the APSF/Medtronic Patient Safety Research Grant ($150,000); The Doctor's Company Foundation for their support and funding of APSF Patient Safety Prototype Development Project ($100,000); and Merck for their educational grant. For more information about how your organization can support the APSF mission and participate in the 2021 Corporate Advisory Council, go to: apsf.org or contact Sara Moser at: [email protected]. Community Donors (includes Specialty Organizations, Anesthesia Groups, ASA State Component Societies, and Individuals)

Specialty Minnesota Society of $5,000 to $14,999 Drs. Ximena and Daniel Sessler Thomas Hennig, MD (in honor of R. K. Adam Setren, MD Stoelting, MD) Organizations Anesthesiologists Mrs. Isabel Arnone (in memory of Ty Slatton, MD Emily Sharpe, MD Tennessee Society of Lawrence J. Arnone, MD, FACA) Michael Hofkamp $5,000 to $14,999 Robert K. Stoelting, MD Ms. Sandra Kniess and David Anesthesiologists Mary Ellen and Mark A. Warner, (in Brian J. Thomas, JD (in honor of Steven K. Howard, MD Solosko, MD American Academy of $2,000 to $4,999 honor of Alan D. Sessler, MD) Anesthesiologist Assistants Matthew B. Weinger, MD) Jeffrey Huang, MD Marjorie A. Stiegler, MD Massachusetts Society of $2,000 to $4,999 Lynn and Laurence Torsher Rebecca L. Johnson, MD (in honor of Drs. $2,000 to $4,999 Anesthesiologists Steven L. Sween, MD Robert Caplan, MD Stephanie Wolfe Heindel Robert E. Johnstone, MD Mary Ellen and Mark Warner) Society of Academic Associations of North Carolina Society of Susan E. Dorsch, MD Mark C. Kendall, MD (in honor of Anesthesiology and Perioperative Anesthesiologists $200 to $749 Joseph W. Szokol, MD (in honor of Medicine Steven Greenberg, MD Joseph W. Szokol, MD) Steven Greenberg, MD) Wisconsin Society of Arnoley Abcejo, MD Kevin King, DO The Academy of Anesthesiology Anesthesiologists Dr. Eric and Marjorie Ho Paul Terna, MD Aalok Agarwala, MD, MBA James J. Lamberg, DO Ann Kinsey, CRNA Ellen and Butch Thomas $750 to $1,999 $750 to $1,999 Shane Angus, AA-C Patty Mullen Reilly, CRNA Gopal Krishna, MD Benjamin D. Unger, MD American Society of Dentist Arizona Society of Anesthesiologists Douglas R. Bacon, MD, MA (in honor Anesthesiologists James M. Pepple, M.D. Laurence A. Lang, MD District of Columbia Society of of Mark Warner) Gregory Unruh Society for Airway Management Joyce Wahr, MD (in honor of Mark Joshua Lea, CRNA Anesthesiologists Warner) Marilyn L. Barton (in memory of Richard D. Urman, MD, MBA (in honor Society for Pediatric Anesthesia Michael C. Lewis, MD, FASA (in honor Florida Society of Anesthesiologists Darrell Barton) of Jeffrey Cooper, PhD) $750 to $1,999 of David Birnbach MD) $200 to $749 Georgia Society of Anesthesioloigsts William A. Beck, MD Bruce Van Dop Donald E. Arnold, MD, FASA Della M. Lin, MD Florida Academy of Anesthesiologist Illinois Society of Anesthesiologists David and Samantha Bernstein (in Andrea Vannucci, MD Doug Bartlett (in memory of Diana honor of Jeff Cooper) Dr. Martin London Assistants Siva Sai Voora Iowa Society of Anesthesiologists Davidson, CRNA) Michael Loushin Anesthesia Groups K. Page Branam, MD (in memory of Missouri Society of Anesthesiologists Allison Bechtel Donna M. Holder, MD) Fredric Matlin, MD Matthew B. Weinger, MD $15,000 and Higher Nebraska Society of Casey D. Blitt, MD Graham W. Bullard Edwin Mathews, MD Andrew Weisinger Anesthesiologists, Inc. US Anesthesia Partners Fred Cheney, MD Matthew W. Caldwell Stacey Maxwell James M. West, MD Ohio Society of Anesthesiologists $5,000 to $14,999 Daniel J. Cole, MD Marlene V. Chua, MD Gregory McComas, MD Richard N. Wissler (in memory of Jerry Oregon Society of Anesthesiologists Modell) Associated Anesthesiologists, PA Jeffrey B. Cooper, PhD Jerry A. Cohen, MD Sharon Merker, MD South Carolina Society of Jennifer Woodbury North American Partners in Mrs. Jeanne and Robert A. Cordes, Jeremy Cook, MD Emily Methangkool, MD (in honor of Anesthesiologists MD Anesthesia Christian David Cunningham Drs. Mark Warner, Marjorie Stiegler, Arpad Zolyomi Texas Society of Anesthesiologists (in Karen B. Domino, MD and Amy Pearson) NorthStar Anesthesia memory of Sigurdur S. Sigurdsson, John K. DesMarteau, MD Kenneth Elmassian, DO, FASA (in Jonathan Metry Legacy Society MD) Andrew E. Dick, MD $2,000 to $4,999 memory of Dr. Archie Attarian) Tricia Meyer, PharmD https://www.apsf.org/ Washington State Society of Madison Anesthesiology David M. Gaba, MD, and Deanna Richard P. Dutton, MD, MBA Anesthesiologists Michael D. Miller, MD donate/legacy-society/ Consultants, LLP Mann Thomas Ebert, MD Sara Moser (in honor of Matthew B. Dan and Cristine Cole TeamHealth $200 to $749 James D. Grant, MD, MBA Steven B. Edelstein, MD, FASA Weinger, MD) Karma and Jeffrey Cooper $200 to $749 Arkansas Society of Beverly and Marty Greenberg (in Mary Ann and Jan Ehrenwerth, MD David Murray, MD Anesthesiologists honor of Dr. Steven Greenberg) Dr. John H. and Mrs. Marsha Eichhorn Anesthesia Associates of Columbus, Bola Faloye, MD Robert F. Olszewski, Jr., MD, FASA GA Colorado Society of Allen Hyman, MD (in honor of Robert Burton A. Dole, Jr. Anesthesiologists Epstein, MD) Thomas R. Farrell, MD Ducu Onisei MD Children's of Alabama (in honor of David and Deanna Gaba Catherine Kuhn, MD Steven Frank Dr. Fredrick Orkin Jennifer Dollar, MD) Hawaii Society of Anesthesiologists Drs. Alex and Carol Hannenberg Maine Society of Anesthesiologists Meghan Lane-Fall, MD, MSHP Anthony Frasca, MD Frank Overdyk, MD Hawkeye Anesthesia, PLLC Drs. Joy L. Hawkins and Randall M. Ronald George, MD Lee S. Perrin, MD Perfect Office Solutions, Inc. New Mexico Society of Lorri A. Lee, MD Clark Anesthesiologists Ian J. Gilmour, MD Aaron N. Primm, MD UNC Student College of Clinical David P. Maguire, MD Dr. Eric and Marjorie Ho Pharmacy Rhode Island Society of Mark C. Norris, MD Linda K. Groah Sheila Riazi Anesthesiologists Drs. Michael and Georgia Olympio Wichita Anesthesiology Chartered Parag Pandya, MD Allen N. Gustin, MD Drew Emory Rodgers, MD (in honor Dr. Ephraim S. (Rick) and Eileen Siker Virginia Society of Anesthesiologists (in honor of Fred Spies, MD) ASA State Gianna Pino Casini Alexander Hannenberg, MD of Mark A. Warner) David Rotberg, MD Robert K. Stoelting, MD Component Societies Individuals Elizabeth Rebello, MD (in honor of Drs. Mark Warner and Jerome Gary Haynes, MD, PhD, FASA and Brad and Allison Schneider (in honor Mary Ellen and Mark Warner $15,000 and Higher $5,000 to $14,999 Adams) Debra Haynes of Dr. Steven Greenberg) Matthew B. Weinger, MD, and Lisa Indiana Society of Anesthesiologists Steven J. Barker, MD, PhD Lynn Reede, CRNA John F. Heath, MD Scott Segal Price Note: Donations are always welcome. Donate online (https://www.apsf.org/donate/) or mail to APSF, P.O. Box 6668, Rochester, MN 55903. (Donor list current as of December 1, 2019–November 30, 2020.) RAPID Response TO YOUR IMPORTANT QUESTIONS

RAPID RAPID ResponseResponse TOTO YOUR QUESTIONS IMPORTANT QUESTIONS FROM READERS

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APSF NEWSLETTER February 2020 PAGE 22

to questions from readers Emergency Power and to questions from readers Elective Surgery

Dear Rapid N Response: on site. Usually these sources are the utility com- hours of fuel. If life safety systems will need pany and a generator. As for the generator capa- emergency power, other codes and standards I read your safety guidelines often for bilities, the requirements for electrical capacity might specify minimum durations of required answers, but I could not find one that and available fuel supplies to support run times operation.1" Interviews with experts from NFPA addresses the question of what types of proce- are addressed by NFPA codes but ultimately indicate that 48 hours of generator capacity is a dures should be done when only emergency determined by your local authorities. good target for run times, but in some locations power is available. Specifically, is there any RinformationAPID RAPID R APIDaboutR RESPONSE APIDR theESPONSE RadvisabilityESPONSE RESPONSE of perform- There is an established hierarchy for prioritiz- (e.g., earthquake zones) 96 hours is desirable. to your important questions Ning power distribution, which is determined by ing an "elective" surgery during a known black- While generators are a mature technology, 1 out and using a back-up generator? the NFPA's National Electrical Code (NEC). unfortunately, they are well known to fail. For Power to the life safety branch, is first and I am aware of a surgeon who is planning example, during Hurricane Sandy in 2012, a includes power to exit signs, door unlocking number of hospitals encountered problems elective surgery during power outages related mechanisms, alarms, and emergency hallway to wildfires and relying solely on back-up with their generators when utility power lighting. Next is the critical branch, which is for power sources for the day. stopped, including complete power failure in a the well-being of patients and includes clinical major academic center.2 The surgeon wants some sort of published equipment plugged into "red outlets" present in guidelines stating it is a bad idea to do elective the operating rooms, ICU, nursery, nurse call sys- We would suggest that you engage the local surgery on backup power. Do you know of any? tems, and pharmacy storage. Last is the equip- facilities management to understand the capa- RThankAPID youR forAPID anyR helpful APIDR R informationESPONSE APIDRESPONSE Ryou ESPONSE mentR branchESPONSE, which is everything else. bilities of the emergency electrical supply. To can provide. Understanding the capabilities of on-site gen- make an informed decision, you will need to know the maximum power of the generators rel- Sincerely,to your important questionserators is essential to making an informed deci- sion about what type of activities can be ative to the anticipated power needs, whether or Chante Buntin, MD supported when the utility power is not available. not there is more than one generator in case of Diplomat of the American Board of All generators have a rated capacity in kilowatts. failure, how long the generators will run with the Anesthesiology One generator may be able to provide emer- available fuel supply, and the anticipated needs Board Certified in Anesthesia, Pain Medicine, gency power to the hospital but will be limited by for power to care for existing patients and sup- Addiction (tbc), Palliative Care and Hospice its maximum capacity. Two or more generators is port any urgent and emergent care needs. desirable as it provides redundancy in the event The author has no conflicts of interest. Jeffrey Feldman, MD, MSE, is professor of clinical that one of the generators fail. Generators also anesthesiology, Children’s Hospital of Philadel- will be limited by the available fuel supply. Reply: phia, Perelman School of Medicine, University of The amount of time the generators will be Pennsylvania, Philadelphia, PA, and chair of the Dear Dr. Buntin, able to supply power will be determined by the APSF Committee on Technology. We are not aware of any specific guidelines available fuel and the power requirements that indicating that doing elective procedures under will need to be satisfied. While NFPA does not Charles E. Cowles, Jr., MD, MBA, FASA, was conditions of emergency power is a “bad” idea. prescribe the minimum run time required, lan- associate professor and chief safety officer at That said, emergency power systems are lim- guage in the NFPA guidelines provides direction the University of Texas MD Anderson Cancer ited in capability when compared with the for hospitals to determine their needs. NFPA 110 Center, Houston, TX. power available under normal conditions and is the standard for emergency and standby Jan Ehrenwerth, MD, is professor emeritus at should be used to prioritize the needs for urgent power for different types of facilities. Hospitals Yale University School of Medicine, New and emergent care. The limitations imposed by are considered Class X facilities and are pro- Haven, CT.. emergency power will vary from institution to vided the flexibility to determine minimum institution. So, your local capabilities become needed run times based upon their needs and The authors have no conflicts of interest. important in determining what you can or local codes. NFPA 99 is the standard governing cannot do safely. In general, when power is lim- fire and life safety requirements for health care ited, using the power for non-essential services REFERENCES facilities. NFPA 99 includes the following state- 1. Overview of NFPA codes and standards that apply to will have an impact on the power available to ment to guide the minimum run time for genera- emergency power systems in healthcare facilities. https:// provide urgent or emergent care. “The hospital should determine the nfpa.org/Codes-and-Standards/Resources/Standards-in- tors: action/NFPA-resources-for-CMS-requirements-on-NFPA- The National Fire Protection Association appropriate run time for the emergency electri- 99-and-NFPA-101/Action-for-emergency-power-in-Florida (NFPA) authors standards and codes for power cal supply and size the fuel tanks accordingly. Accessed December 21, 2020. Careful consideration should be given to the 2. Lessons learned from Hurricane Sandy and recommenda- requirements in health care facilities which are tions for improved healthcare and public health response followed in the U.S. by the Center for Medicare potential types of outages anticipated and the and recovery for future catastrophic events. American Col- & Medicaid Service and the Joint Commission.1 availability of fuel. It should be noted that in lege of Emergency Physicians, Dec 22, 2015. https://www. acep.org/globalassets/uploads/uploaded-files/acep/by- All health care facilities are required to have 2 some situations it might be permissible to size medical-focus/disaster/lessons-learned-from-hurricane- independent sources of power with one being the fuel system to accommodate less than 48 sandy-webpage.pdf Accessed December 21, 2020.

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 APSF. It is not the intention of 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 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. APSF NEWSLETTER February 2021 PAGE 23

Safety vs. Quality—The 2020 APSF/ASA Ellison C. Pierce, Jr., MD, Memorial Safety Lecture by Matthew B. Weinger, MD, MS

To watch the Ellison C. Pierce, Jr., MD, Memorial Safety Lecture in its entirety, please visit: https://www.apsf.org/asa-apsf-ellison-c-pierce-jr-md-memorial-lecturers/ This piece summarizes the content of the A key problem with the current view of just the right amount of personnel, tools, and sup- 2020 Ellison C. Pierce, Jr., MD, Memorial Patient patient safety (Safety 1.0) in most health care plies available just when they are needed. In con- Safety Lecture, which was presented on Octo- organizations is its focus on detecting and ana- trast, safety or high reliability organizations want ber 3, 2020, at the American Society of Anes- lyzing adverse events or aggregate poor out- built-in redundancy and have a “just in case” men- thesiologists Annual Meeting (held virtually). It comes to drive mitigation or improvement. tality. The production organization treats adverse highlights the conflict between quality and While useful, the effectiveness of such an events as anomalies while the safety organization safety, and is a call to action for anesthesia pro- approach is limited due to hindsight bias and its views adverse events as valuable information fessionals to recognize their important role in inability to provide sufficient insight as to how about potential system dysfunctions. The produc- improving health care safety. My presentation best to prevent future adverse events. So, tion organization tends to have a “shame and first reviews the emerging role of the anesthe- instead, in health care as in other industries, blame” culture, whereas, in the safety organiza- sia professional in today’s health care safety patient safety professionals need to study how tion, those who report errors or issues are praised environment. I then explore an important yet experienced clinicians are successful despite and even rewarded. Thus, with a production ori- under-appreciated consequence of unsafe the dysfunctional processes and systems in entation, the system is more error prone while in a work environments—the impact of dysfunc- which they must work and then design pro- safety organization, it is error tolerant, and more tional systems on clinicians. Next, I talk about cesses and technology to support and foster importantly, will be resistant to serious accidents the push for greater health care quality in the these resilient behaviors (Safety 2.0). through better error detection and recovery. U.S., followed by a summary of conflicting CLINICIAN SAFETY Table 1: Production vs. Safety Focused approaches to safety and quality efforts. Finally, Degraded clinician well-being and burnout is Health Care Organizations. I review principles in human factors engineering more likely when a hospital unduly emphasizes Production Focus Safety/Reliance and human-centered design which may con- production, has dysfunctional processes and tribute to the solution of this dilemma. technology that predispose to unsafe care, or Optimization (Just Redundancy (Just PATIENT SAFETY has a culture and leaders that inadequately in Time) in Case) Based on my review of the literature, it understand and support front-line clinicians’ Promote Accept diversity/ appears that about one-half of perioperative needs. Studies show that clinician burnout is standardization variability deaths are preventable. While primarily anesthe- associated with adverse effects not only on the Resistant to Adaptive and sia-related mortality is quite low, surgical mortal- clinicians, but on patient safety and organiza- 3 change flexible ity is at least 100-fold higher. Thus, anesthesia tional performance. Further, many of the system professionals can and must play a greater role in factors associated with an increased risk of burn- Adverse events as Adverse events as anomalies information reducing not just anesthesia, but surgery-related out are the same factors associated with the risk morbidity and mortality. Toward this goal, for of NREs and preventable adverse events. Optimism about Pessimism about example, we need to take more responsibility for SAFETY VS. QUALITY outcomes outcomes reducing surgical infections through correct and Data suggest that health care in the United Shoot the Reward the timely prophylactic antibiotics, as well as better States, when compared with other developed messenger messenger sterile technique by anesthesia professionals countries, is generally of lower quality, is often Error prone Error tolerant when administering intravenous drugs, espe- less safe, and has a higher proportion of total cially during induction.1 Maintaining effective expenditures going toward activities that don’t Conflict between production and safety often mean blood pressure throughout perioperative directly benefit patients (see numerous articles occurs in procedural areas which are high cost care is another way anesthesia professionals and figures atwww.commonwealthfund.org ). (and potentially high revenue). Here, there is con- can improve surgical outcomes. Thus, there is tremendous pressure to increase stant organizational pressure to improve produc- More than two decades ago, I introduced to value in health care, here defined as the quality tivity (i.e., throughput) and financial performance. health care the concept of a “non-routine of the care delivered divided by the cost of pro- Both of these can be easily measured whereas event” (or NRE). We define an NRE as anything viding that care. Because cost is the dominator we can only infer safety—when accidents that’s undesirable, unusual, or surprising for a in the value equation, the effectiveness and happen, we know we are in unsafe territory. particular patient in their specific clinical situa- efficiency of care have become a predominant However, when there have been no accidents, tion. My colleagues and I have demonstrated focus in most organizations’ quality initiatives. the organization can have a false sense of safety. that NREs: 1) are common—ranging from Table 1 shows the contrasts between an organi- There will thus be a tendency to “push the 20–40% in various perioperative settings; 2) zation that is primarily production- or value- [safety] envelope” over time increasing the risk are multifactorial; 3) can contribute to and/or be focused versus one where safety and reliability of harm events. To date, the only perioperative associated with adverse patient outcomes and, are the predominant focus. I modified this table “safety meter” we have is individual clinicians— importantly, 4) provide addressable evidence from the work of Landau and Chisholm.4 To sum- your willingness to speak up, to stop the line, and for improving defective processes and technol- marize just a few of the contrasts, a production to advocate for patient and clinician safety. ogy within care systems.2 focus emphasizes optimization, wanting to have See “Pierce Lecture,” Next Page APSF NEWSLETTER February 2021 PAGE 24

Human Factors Engineering Provides Methods for Designing Safer Delivery of Patient Care

From “Pierce Lecture,” Preceding Page Design for Safety. Human factors engineer- ing (or HFE) provides methods to design pro- cesses, technology and systems to achieve higher levels of safety and quality. HFE is the scientific and practical discipline of under- standing and improving systems to increase overall safety, effectiveness, efficiency and user satisfaction.5 The Human- (or User) Centered Design Cycle (Figure 1) is how HFEs design, evaluate and deploy any new or revised tool, technol- ogy, process, or system. The cycle starts with gaining a full under- standing of the problem you’re trying to address. This user research leads to a full description of users’ needs. Next, you specify the use-related design requirements. Working through multiple iterations of design and evalu- ation yields an optimized product or interven- tion that meets the desired requirements. You then assess, prior to full implementation, Figure 1: Human-Centered Design Cycle. whether the resulting product or intervention actually meets your users’ needs. In the presen- tive and should fully engage all relevant clini- REFERENCES tation, I provided examples of each phase of cians and other stakeholders. Finally, an 1. Loftus RW, Koff, MD, Birnbach DJ. The dynamics and the human-centered cycle based on our prior organization needs enlightened leaders who implications of bacterial transmission events arising research (see, for example,references 6–9). from the anesthesia work area. Anesth Analg. actually understand and prioritize patient and 2015;120:853–860. POPTEC (PeOple, Processes, Technology, worker safety, and who put real effort into cre- 2. Liberman, JS, Slagle JM, Whitney, G, et al. Incidence Environment, and Culture) is how HFEs think ating a robust safety culture. and classification of nonroutine events during anesthe- about the performance-shaping factors that sia care Anesthesiology. 2020;133:41–52. In closing, anesthesia professionals must not affect the risk of non-routine and adverse 3. Committee on Systems Approaches to Improve Patient events. POPTEC thus provides a framework, simply be “the people who put people to sleep.” Care by Supporting Clinician Well-Being, National not only for user research, but to guide We have the training, knowledge, and skills that Academies of Science, Engineering, and Medicine. make us uniquely suited to be the safety lead- Taking action against clinician burnout: a systems design and evaluation throughout the entire approach to professional well-being. Washington, DC: HCD cycle.5 ers in our organizations. To have an impact, we The National Academies Press, October 2019, 334 pp. need to take a broader view of our role in health doi.org/10.17226/25521. ISBN: 978-0-309-49547-9. CONCLUSION care to fully realize our potential to improve 4. Landau M, Chisholm D. The arrogance of optimism: To improve patient safety, the health care both safety and quality. notes on failure-avoidance management. J Contingen- organization needs to create resilient human- cies Crisis Manage. 1995;3:67. Matthew B. Weinger, MD, MS, is the Norman Ty centered systems. Individuals and teams 5. Weinger MB, Wiklund M, Gardner-Bonneau D. (editors): Smith Chair in Patient Safety and Medical Simula- Handbook of human factors in medical device design. should be trained in serious event manage- tion and professor of anesthesiology, biomedical Boca Raton, FL: CRC Press, 2011. ment. Standardization is important for both informatics and medical education at the Vander- 6. Anders S, Miller A, Joseph P, et al. Blood product posi- quality and safety. But, especially for safety, it tive patient identification: comparative simulation- bilt University School of Medicine, Nashville, TN. must be flexible and open to continual refine- based usability test of two commercial products. He also is the director, Center for Research and ment. Processes and technology need to be Transfusion. 2011;51: 2311–2318. Innovation in Systems Safety, Vanderbilt Univer- engineered to be safety-oriented, error-toler- 7. Anders S, Albert R, Miller A, et al. Evaluation of an inte- sity Medical Center, Nashville, TN. grated graphical display to promote acute change ant, and facilitate error recovery. A robust detection in ICU patients. Inter J Med Inform. 2012; 81: event-reporting system will encourage report- 842–51. Dr. Weinger is a founding shareholder and paid ing and provide feedback. All meaningful 8. Weinger M, Slagle, J, Kuntz A, et al. A multimodal inter- consultant of Ivenix Corp., a new infusion pump events need to be analyzed to identify the vention improves post-anesthesia care unit handovers. manufacturer. He also received an investigator- Anesth Analg. most important safety problems. Then, poten- 2015;121:957–971. initiated grant from Merck to Vanderbilt tial interventions should be developed and 9. Weinger MB, Banerjee A, Burden A, et al. Simulation- University Medical Center to study clinical based assessment of the management of critical evaluated using HFE principles. This difficult decision making. events by board-certified anesthesiologists.Anesthesi - work must be multidisciplinary and collabora- ology. 2017;127:475–89. APSF NEWSLETTER February 2021 PAGE 25

Enhancing a Culture of Safety Through Disclosure of Adverse Events by Christopher Cornelissen, DO, FASA; R. Christopher Call, MD; Monica W. Harbell, MD, FASA; Anu Wadhwa, MBBS, MSc, FASA; Brian Thomas, JD; Barbara Gold, MD, MHCM CLINICAL VIGNETTE This clinical scenario provides an opportunity but rather there exists a supportive environ- It is Friday evening and you are preparing to for the anesthesia team to model, through ment to learn from experiences with the goal of hand off a femoral-popliteal bypass case to the behavior and actions, a culture of safety as it preventing errors and improving care for future night team when you receive a page from your pertains to the disclosure of adverse events. patients. The Agency for Healthcare Research We will review guiding principles of disclosure and Quality (AHRQ) highlights the following four trainee that the “heparin isn’t working.” You pro- which may be applied by anesthesia profes- key features that define a culture of safety:2 ceed to the room and learn that your trainee sionals when harmful events occur. We will also has given 5,000 units of heparin per surgeon 1. Recognition of the high-risk nature of health examine how a culture of safety serves as the request with a resultant rise in the activated care with a commitment to “achieve consis- foundation for adverse event disclosure, iden- tently safe operations” clotting time (ACT) value from 121 to 128. The tify leading practices, and outline resources that surgeon requests an additional 3,000 units be facilitate patient-centered disclosure. 2. A blame-free environment where individuals given and a second ACT returns at 126. Review- can report errors or near misses without fear ing the situation, you notice an opened vial of HOW A CULTURE OF SAFETY RELATES of reprimand or punishment tranexamic acid (TXA) on the anesthesia cart. TO ADVERSE EVENT DISCLOSURE 3. Teamwork across ranks and disciplines to You inquire about the vial, and the trainee A culture of safety reflects the shared values, address patient safety problems acknowledges that he accidentally swapped commitments, and actions that promote patient safety within an organization. It is the product of 4. Commitment from the organization to pro- (TXA) for heparin. The surgeon, who had not individual and group attitudes, competencies, vide resources to address safety concerns. overheard your conversation, asks your opinion and patterns of behavior that determine the The Joint Commission, which accredits as to why the ACT has not risen. How do you organization’s commitment to quality and health care organizations throughout the answer? Should the case continue? Should this patient safety. It is not just what is thought or United States, requires that health care facil- event be disclosed to the patient? If so, when said, but what is demonstrated by behaviors ities create a safety program that promotes should the disclosure occur and who should be and actions.1 In work environments with a reporting adverse events and near misses present? What support is available for care robust culture of safety, there is no fear in dis- and learning from them.3 Disclosure to the team members affected by this event? cussing near misses, errors, and patient harm, patient is required when the adverse event 1) has a perceptible effect on the patient that Table 1: Summary of the Key Components for an Effective Disclosure of a Medical was not discussed in advance as a known Error. risk; 2) necessitates a change in the patient’s care; 3) potentially poses an important risk Preparation to the patient’s future health, even if that risk is extremely small; 4) involves providing a Review the event with the involved parties. treatment or procedure without the patient’s Plan your discussion with patient or family in advance. consent.2 Select a quiet and private location for the discussion. ANESTHESIA CARE AND DISCLOSURE Offer language interpreters, social workers, and clergy to be present. WITHIN A CULTURE OF SAFETY Have all involved parties at the initial disclosure. Anesthesia professionals aspire to minimize risk, prevent harm, and learn from errors. This Delivery prinicipled mindset has helped establish anes- Deliver a compassionate and unhurried explanation. thesia professionals as leaders in patient 4 Explain the conditions under which the medical error occurred. safety. However, in complex systems, errors and harm will continue to occur despite our Discuss objectively what you know and don't know. best efforts. When an error does occur, it is Verify that the patient and family understand your explanation. imperative that we respond in an equally prin- Describe the process for investigation and performance improvement. cipled manner. This includes disclosing what is known, committing to a thorough review, and Consider incorporating an apology for confirmed medical errors. sharing what is learned with our patients, while Follow-up being mindful that all organizational quality Provide frequent updates to the patient and family. improvement protections are adhered to. With this process, patients come to understand that Make yourself easily accessible to the patient and family. the organization learned from their experiences Facilitate discussions between risk management, the hospital, and the patient or family. and that conclusions drawn from the review will Table 1 on page 15 of the ASA Physicians Series, Manual on Professional Liability is reprinted with permission of the lead to reforms that support the “learning cul- American Society of Anesthesiologists, 1061 American Lane, Schaumburg, IL 60173-4973. © November 2017 ture” emblematic of a safety culture.1 https://www.asahq.org/standards-and-guidelines/~/media/9bd16ced606247a19d31aa15236f842f.ashx See “Adverse Events,” Next Page APSF NEWSLETTER February 2021 PAGE 26

Health Care Team Members Should Be Aware of Institutional Policies That Guide Disclosure

From “Adverse Events,” Preceding Page Consideration should be given to consulting Institutions seeking to build a more robust Multiple articles in the patient safety literature with these resources prior to disclosure. disclosure program have a variety of estab- have highlighted essential elements of disclo- Thoughout this process, it is imperative that all lished models to consider. These models origi- sure to patients and their families. Suggested health care team members are aware of and nated in the public sector as well as in private elements of the disclosure conversation include follow their institutional policies that guide dis- and academic institutional settings. Realizing describing the known facts, expressing regret closure. Physician practice groups that provide that adverse events vary in scope and severity, for what occurred, and letting patients and fam- services within hospitals may also have specific the Veterans Health Administration developed ilies know that as information becomes avail- guidelines to follow based on medical malprac- a three-tiered disclosure protocol consisting of able, they will be kept fully informed.5 The tice and insurance requirements. Furthermore, a provider-driven clinical disclosure, hospital- American Society of Anesthesiologists (ASA) each practice setting may have specific report- driven institutional disclosure, and an enterprise Manual on Professional Liability has summa- ing requirements for anesthesia professionals. large-scale disclosure.9 The Defense Health rized key components needed for an effective Hospital-employed physicians should seek Agency, which manages the United States mili- disclosure of a medical error; these are summa- input from legal resources offered by the facility tary health care system, created a robust rized in Table 1.6 The Anesthesia Patient Safety whenever possible. Similarly, members of inde- Healthcare Resolutions Program that preemp- Foundation (APSF) has also developed an pendent groups and solo practitioners should tively educates clinicians, provides real-time adverse event protocol for anesthesia profes- consult their insurance carriers and legal coun- event coaching, and supports an extensive sionals and perioperative care team members sel who represent their interests. When the peer-support network to assist providers to utilize following an adverse event.7 adverse event is directly linked to the anes- throughout the disclosure process.10 One of the thetic care, it is critical that the anesthesia pro- earliest proponents of disclosure in academia Once it is determined that event disclosure fessionals are present at the initial disclosure to was the University of Michigan, who developed with the patient should take place, it is impor- the family and patient. The initial discussion and tant that any anesthesia professionals involved an innovative approach to medical errors and relay of information provided to the patient and 11 in the event collaboratively discuss with the sur- disclosure called the “Michigan Model”. In May family is one that will be remembered and, gical and nursing teams what is known, what 2016, the Agency for Healthcare Research and therefore, all of the facts should be conveyed in remains unknown, and what steps will follow. It Quality used the “Michigan Model” results an accurate and concise manner. is ideal for the provider most centrally involved along with contributions from others including with the event to lead the discussion with the Disclosure is a process, not a single event. the University of Washington, the University of patient. Multiple specialties may need to be An empathetic expression of caring along with Illinois, and MedStar Health to develop the involved. The discussion should be rehearsed ongoing communication with the patient and Communication and Optimal Resolution 12 and provide a genuine and open explanation of family are foundational to successful disclosure (CANDOR) process. CANDOR provides a events using terms that are understandable to of adverse events. Many states have adopted framework for hospitals to improve their the patient. Transparent communication is statutes protecting apologies and other benev- response to unexpected harm events, includ- based on available facts and not speculation. olent gestures from being used as an admis- ing an online checklist to assist providers in the Some institutions employ staff specifically sion of fault in the event of a lawsuit.8 In addition disclosure process (https://www.ahrq.gov/ trained to assist with disclosure and they can to conveying empathy, the anesthesia profes- patient-safety/capacity/candor/modules/check- play a vital role in communication with patients sional should avoid speculation and resist any list5.html.) and families, especially on an ongoing basis. impulse to point fingers at other clinicians. Through the Michigan Model and CANDOR, which are also referred to as Communication and Resolution Programs (CRPs), organizations may offer patients compensation if they deter- mine care was not reasonable under the cir- cumstances.13,14 Organizations that have implemented this type of approach have seen a significant increase in incident reporting with- out an increase in claims or legal costs.7,13-15 While these are positive outcomes, they may be surrogates for the laudable goals of normal- izing honesty and accountability, while cultivat- ing safety as an ethical obligation.4 Notably, early adopters of CRPs have been large, inte- grated health systems that serve as both the medical staff’s employer and insurance car- rier.16 Organizations that contract with indepen- dent providers and entities may find it challenging to compensate patients during the disclosure process. See “Adverse Events,” Next Page APSF NEWSLETTER February 2021 PAGE 27

Surveys Suggest Health Care Professionals Are Negatively Impacted by Patient Harm

From “Adverse Events,” Preceding Page discussion. This may lead to subsequent con- 6. Excerpted from ASA Physicians Series, Manual on Profes- versations with the patient in consultation with sional Liability (3rd Edition) of the American Society of Anes- Physicians protected under traditional insur- thesiologists. A copy of the full text can be obtained from ance models are typically precluded from risk management or other institutional entities ASA, 1061 American Lane Schaumburg, IL 60173-4973 or assuming any obligation, making voluntary involved in adverse event disclosure. All team online at www.asahq.org. Accessed December 21, 2020. payments, or incurring expenses for an members involved in the event must be sup- 7. Eichhorn JH. Organized response to major anesthesia APSF Newsletter adverse event without the consent of the ported, with numerous peer-to-peer models accident will help limit damage. . and disclosure programs available for institu- 2006;21:11–13. https://www.apsf.org/article/organized- insurer. Disclosures made outside the formal response-to-major-anesthesia-accident-will-help-limit-dam- 11,21-23 peer review process are discoverable during tions to emulate. age/ Accessed December 12, 2020. litigation, and all parties involved in adverse As stewards and advocates for patient safety, 8. National Conference of State Legislatures Medical Profes- events will have an interest in the investiga- anesthesia professionals play a key role in sional Apologies Statutes. https://www.ncsl.org/research/ tion. This can make it difficult to conduct com- financial-services-and-commerce/medical-professional- avoiding patient harm. When adverse events apologies-statutes.aspx. Accessed July 16, 2020. prehensive investigations quickly, especially if do occur, our response should be as principled 9. Veteran’s Health Affairs (VHA) Disclosure Policy, VHA Direc- an adverse event involves multiple providers as our commitment to patient safety. Paramount tive 1004.08 dated 10/31/18, https://www.ethics.va.gov/docs/ or the extent of the injury cannot be immedi- to this process is active engagement in patient- policy/VHA_Handbook_1004_08_Adverse_Event_Disclo- sure.pdf. Accessed July 16, 2020. ately determined. centered disclosure, authentic and ongoing 10. Defense Health Agency (DHA) Healthcare Resolutions, Dis- Multiple surveys have shown that health care communication with the patient and family, closure, Clinical Conflict Management and Healthcare Pro- professionals are affected when their patients team support, and a commitment to process vider (HCP) Resiliency and Support in the Military Health experience adverse events of harm. This improvement. System (MHS), DHA Procedural Instruction 6025.17 dated includes emotional distress with potential 6/28/19, https://health.mil/Reference-Center/Poli- Christopher Cornelissen, DO, FASA, is an anes- cies/2019/06/18/Healthcare-Resolutions-Disclosure-Clini- 17-20 effects on performance. Psychological thesiologist at Anesthesia Service Medical cal-Conflict-Management-and-HCP. Accessed July 16, recovery and resilience may be enhanced with Group in San Diego, CA, and clinical associate 2020. structured peer support, and numerous professor in the Department of Anesthesiology 11. University of Michigan Health website, https://www.uofm- health.org/michigan-model-medical-malpractice-and- resources exist for anesthesia professionals to at Western University of Health Sciences. learn about effective peer support pro- patient-safety-umhs. Accessed July 16, 2020. grams.21-23 The Joint Commission acknowl- R. Christopher Call, MD, is an assistant professor 12. Agency for Healthcare Research and Quality, CANDOR in the Department of Anesthesiology at Uni- website, https://www.ahrq.gov/patient-safety/capacity/ edges the importance of peer support to candor/index.html. Accessed July 16, 2020. formed Services University of the Health Sci- prevent the domino effect that adverse events 13. Boothman RC, Imhoff SJ, Campbell DA. Nurturing a culture can have on health care worker performance.23 ences, Bethesda, MD. of patient safety and achieving lower malpractice risk Paramount to this process is promotion of a Monica W. Harbell, MD, FASA, is an assistant pro- through disclosure: lessons learned and future directions. Front Health Serv Manage. 2012;28:13–28. robust patient safety culture for learning from fessor in the Department of Anesthesia and Peri- system defects, engaging all team members in 14. Lambert BL, Centomani NM, Smith KM, et al. The "seven operative Medicine at Mayo Clinic, Phoenix, AZ. pillars" response to patient safety incidents: effects on med- a postevent debrief and peer-to-peer emotional Anu Wadhwa, MBBS, MSc, FASA, is a clinical pro- ical liability processes and outcomes. Health Serv Res. support. 2016;51:2491–2515. fessor in the Department of Anesthesiology at Uni- 15. Kachalia A, Sands K, Niel MV, et al. Effects of a communica- CONCLUSION versity of California San Diego, San Diego, CA. tion-and-resolution program on hospitals' malpractice claims The events that followed the clinical vignette Brian Thomas, JD, is vice president, Risk Man- and costs. Health Aff. (Millwood). 2018;37:1836–1844. illustrate key principles of authentic error disclo- agement, Preferred Physicians Medical in Over- 16. Mello MM, Boothman RC, McDonald T, et al. Communica- sure that reflect a culture of safety. The error tion-and-resolution programs: the challenges and lessons land Park, KS. learned from six early adopters. Health Aff. 2014;33:20–29. was immediately disclosed to the surgical team. Barbara Gold, MD, MHCM, is a professor in the 17. Shanafelt TD, Balch CM, Bechamps G, et al. Burnout and Discussion and consultation ensued, resulting Ann Surg. Department of Anesthesiology at University of medical errors among american surgeons. in a collective decision to proceed. The event 2010;251:995–1000. Minnesota, Minneapolis, MN. was disclosed in clear and unambiguous lan- 18. Waterman AD, Garbutt J, Hazel E, et al. The emotional guage to the patient at a time when it could be impact of medical errors on practicing physicians in the The authors have no conflicts of interest. J Comm J Qual Pat Saf. understood and processed. The error was dis- United States and Canada. 2007;33:467–476. closed by all involved care team members, REFERENCES 19. Tawfik DS, Profit J, Morgenthaler TI, et al. Physician burnout, namely the surgeon, and anesthesia profes- 1. Sentinel Event Alert 57: The essential role of leadership in well being, and work unit safety grades in relationship to sionals. The risk management team was developing a safety culture, The Joint Commission Sentinel reported medical errors. Mayo Clinic Proc. 2018;93:1571– informed of the event and supported the pro- Event Alert. 2017;57:1–8. 1580. cess. Counseling was provided to the fearful 2. Patient Safety Primer Culture of Safety: An overview. http:// 20. Shapiro J, Galowitz, P. Peer support for clinicians: a pro- psnet.ahrq.gov/primer/culture-safety. Accessed July 16, Academic Medicine. and distraught provider. Lastly, an invitation for grammatic approach. 2016;91:1200– 2020. 1204. ongoing communication was extended by the 3. Sentinel Event Alert 60: Developing a reporting culture: 21. Edrees H, Connors C, Paine L, et al. Implementing the RISE Learning from close calls and hazardous conditions. The anesthesia professional to the patient and second victim support programme at the Johns Hopkins Joint Commission Sentinel Event Alert. 2018;60:1–8. family should questions arise in the future. Hospital: a case study. BMJ Open. 2016;6:e011708. 4. Cohen JB, Patel SY. Getting to zero patient harm: from Disclosure by anesthesia professionals improving our existing tools to embracing a new paradigm. 22. Scott SD, Hirschinger LE, Cox KR, et al. Caring for our own: Anesth Analg. 2020;130:547–549. deploying a systemwide second victim rapid response should occur in a timely manner, be stated in team. J Comm J Qual Pat Saf. 2010;36:233–240. 5. Souter KJ, Gallagher TH. The disclosure of unanticipated terms that the patient can understand and outcomes of care and medical errors: what does this mean 23. Supporting Second Victims. The Joint Commission. Quick should provide the platform for fair and open for anesthesiologists? Anesth Analg. 2012;114:615–621. Safety. 2018;39:1–3. 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APSF Awards 2021 Grant Recipients by Steven K. Howard, MD

The APSF’s mission statement explicitly lenge. NORA cases in the North American rare, given the high prevalence of NORA, even includes the goal to improve continually the Clinical Outcome Registry (NACOR) increased a small reduction of preventable harm with pre- safety of patients during anesthesia care by from 28% in 2010 to 36% in 2014.1 Nearly 75% of procedural use of a NORA TT to result in action- encouraging and conducting safety research NORA cases occurred in the outpatient setting, able changes in the anesthetic plan, will and education. The APSF grant program has with sicker and older patients than those receiv- improve patient safety for a large number of been funding safety-related grants since 1987 ing anesthesia care in the operating room.1 Addi- patients. and this support has been integral in the tionally, NORA cases were more frequently Funding: $149,879 (January 1, 2021–Decem- careers of many anesthesia professionals. started after normal working hours (17% vs. 10% of OR cases, p<0.001).1 The combination of more ber 30, 2022). This grant was designated as the The 2020-21 APSF investigator-initiated procedures, patient comorbidities, suboptimal APSF/Medtronic Research Award and was also grant program had 33 letters of intent (LOIs) case planning, lack of standard OR equipment, designated the APSF Ellison Pierce, Jr., MD, Merit submitted with the top 16 scoring grants under- isolation, and limited resources creates the high Award for $5,000 of unrestricted research. going statistical review as well as detailed dis- potential for adverse events (AEs) in NORA set- The author has no conflicts of interest. cussion among members of the Scientific tings.2 Most of the understanding of risk associ- Evaluation Committee. The top five scoring ated with NORA comes from retrospective REFERENCES grants were invited to submit full proposals for registry analysis or facility-based data.3,4 final review and were discussed via Zoom vir- 1. Nagrebetsky A, Gabriel RA, Dutton RP, et al. Growth of nonoperating room anesthesia care in the United States: tual meeting on October 3, 2020. Two propos- Trigger tools are an important new develop- 5 a contemporary trends analysis. Anesth Analg. als were recommended for funding to the APSF ment in detection of adverse events. Trigger 2017;124:1261–1267. Executive Committee and Board of Directors tool methodology uses surveillance algorithms 2. Chang B, Urman RD. Non-operating room anesthesia: the to identify patients at high risk for an adverse principles of patient assessment and preparation. Anesthe- and both received unanimous support. This event. The presence of risk factors identified via siol Clin .2016;34:223–240. year’s recipients were Karen Domino, MD, from a preprocedure checklist could trigger a 3. Bhananker SM, Posner KL, Cheney FW, et al. Injury and lia- the University of Washington and May Pian- bility associated with monitored anesthesia care. A closed change in location, anesthetic plan, and addi- Smith, MD, from the Massachusetts General claims analysis. Anesthesiology. 2006;104:228-34. tional staffing and equipment support to reduce Hospital. 4. Metzner J, Posner KL, Domino KB. The risk and safety of potential patient harm. anesthesia at remote locations: the U.S. closed claims The principal investigators of this year’s APSF analysis. Curr Opin Anaesthesiol. 2009;22:502–508. Aims: We will adapt trigger tool technology grant provided the following description of their 5. Griffin FA, Resar RK. IHI Global Trigger Tool for measuring to the NORA clinical context and to the need for adverse events (second edition). IHI Innovation Series white proposed work. prospective action to prevent patient harm. paper. Institute for Healthcare Improvement, Cambridge, MA 2009 (available on www.IHI.org). Potential triggers include patient factors (e.g., advanced age, comorbidities), anesthetic plan- ning (e.g., lack of preoperative evaluation and preparation), procedure type and complexity, procedure site (e.g., office vs. other settings), anesthetic factors (e.g., deep sedation without ventilation monitoring; availability of equipment, supplies, and personnel), and timing of proce- dures (daytime hours vs. nighttime or week- end). We will develop the NORA Trigger Tool (TT) to identify cases at risk for AEs in NORA using the modified Delphi technique with an expert panel of anesthesiologists, CRNAs, NORA RNs, and proceduralists. We will utilize data from the Anesthesia Closed Claims Project with case comparison with NACOR, and a sys- tematic literature search to inform the trigger tool. We will incorporate feedback from an Karen Domino, MD, MPh expert user panel and then test user accep- May Pian-Smith, MD, MS Professor of Anesthesiology and Pain tance and modify the TT based results. We will Associate professor of Anesthesia, Critical Medicine, University of Washington. prospectively test the sensitivity and specificity Care and Pain Medicine, Massachusetts of the NORA TT to identify cases at risk for AEs General Hospital, Harvard Medical School Dr. Domino’s Clinical Research submission is in NORA using low-fidelity simulation. entitled “Development and testing of a trigger Dr. Smith's Clinical Research submission is Implications: NORA care has grown signifi- tool to identify cases at risk of adverse events entitled: “Trust between surgeons and anes- cantly over the past decade with 30–40% of in non-operating room anesthesia (NORA).” thesiologists: developing and implementing a anesthesia cases occurring in NORA areas. qualitative method to identify keys to rela- Background: Providing anesthesia services There were over 2 million NORA cases in 2019 tionship and teamwork success.” in non-operating room anesthesia (NORA) set- alone, which represents only a sample of total tings is a rapidly changing and growing chal- NORA cases in the U.S. While severe AEs are See “2020 Grant Recipients,” Next Page APSF NEWSLETTER February 2021 PAGE 29

2021 Grant Recipients

From “2020 Grant Recipients,” Preceding Page gists and surgeons, including their perspectives assessment tool of non-technical skills of OR Background: Work in the operating room and preferences, based on sex, practice set- personnel and such tools can subsequently be (OR) is characteristically complex and requires ting, or whether teams are “dynamic” vs. used to link observed behaviors with real that skilled workers are both independent and “intact”? Are there specialty-identities and patient clinical outcomes. assumptions or stereotypes that individual interdependent. The Institute of Medicine (IOM) Funding: $149,601 (January 1, 2021–Decem- anesthesiologists and surgeons hold toward has called for increased trust, respect, and ber 31, 2022). This grant was designated the their counterparts that may help or interfere transparency in communication to improve the APSF/ASA 2021 President’s Research Award. quality of care. The important impact of the sur- with an effective, patient-safe working relation- geon-anesthesiologist dyad to set the tone for ship? May Pian-Smith, MD, currently serves on the board of directors for the APSF. collaboration in the OR has been highlighted by Implications: We do not know the incidence Jeffrey Cooper, PhD, in his recent article in the of poor outcomes in the OR that are precipi- 1 REFERENCES APSF Newsletter. According to relational coor- tated specifically by poor interactions between 1. Cooper JB. Healthy relationships between anesthesia pro- dination theory, colleagues can collaborate anesthesiologists and surgeons. Personal fessionals and surgeons are vital to patient safety. APSF best when there is high-quality communication anecdotes about the OR and published studies Newsletter. February 2020;35:8–9. https://www.apsf.org/ (frequent, timely, accurate, and problem-solv- article/healthy-relationships-between-anesthesia-profes- on ICU interactions suggest the incidence of sionals-and-surgeons-are-vital-to-patient-safety/ Accessed ing), which is enhanced by high-quality relation- conflict is significant and that this is an impor- December 12, 2020. ships (shared goals, shared knowledge, and tant area for study and improvement. Studies 2. Gittell JH, Weinberg DB, Pfefferle S, et al. Impact of rela- mutual respect).2 tional coordination on job satisfaction and quality have shown that optimizing teamwork has outtcomes: a study of nursing homes. Human Resource This project is intended to gather pilot data impact on the patient experience, and improv- Management Journal. 2001;18:154–170. for further study. Lingard and others have ing quality outcomes (such as length of hospital 3. Lingard L, Espin S, Whyte S, et al. Communication failures in the operating room: an observational classification of recur- described observations of the differing per- stay, and mitigating harm from errors and intra- rent types and effects. BMJ Qual Saf. 2004;13(5):330–334. spectives between members of the OR team, operative adverse events). Improved relation- 4. Katz JD. Conflict and its resolution in the operating room. J but with no specific focus of that between sur- ships can enhance worker resilience, support Clin Anesth. 2007,19:152–158. 3 joy and meaning in the workplace, and 5. Cooper JB, Newbower RS, Long CD, et al. Preventable geons and anesthesiologists. Katz has written anesthesia mishaps—a human factors study. Anesthesiol- about conflict in the OR and how to manage it, decrease the costs of workforce turnover. ogy. 1978,49:399–406. but without empirical data of the type we are This will be the first study to identify behav- The APSF would like to thank the above 4 proposing to gather. iors and characteristics that can engender researchers and all grant applicants for their Aims: We will build on the qualitative inter- “trust” across surgeon and anesthesiologist dedication to improve patient safety. view-based methodology used by Cooper et al. role-groups during perioperative care. This Steven Howard, MD, is a professor of anesthesi- in the Critical Incident studies5 to answer the fol- information will be important for defining pro- ology, perioperative and pain medicine at Stan- lowing questions: What are key behaviors fessionalism within both specialties and will ford University School of Medicine, staff between individual anesthesiologists and sur- impact training methods and content. The anesthesiologist at the VA Palo Alto Health Care geons that facilitate trust and collaboration or results can inform and improve interdisciplinary System and the outgoing chair of the APSF’s Sci- create barriers to trust and collaboration during and interprofessional team-training aimed at entific Evaluation Committee. perioperative care? Are there differences in the improving patient safety outcomes. Key behav- The author has no other conflicts of interest. personal relationships between anesthesiolo- iors can also be incorporated into a novel

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DTC #: 2085 Account Name: Anesthesia Patient Safety Foundation Account #: FBO APSF / #7561000166 RAPID Response TO YOUR IMPORTANT QUESTIONS

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to questions from readers What Type of Operating Room to questions from readers Pressure Should We Use for Patients with SARS-COV-2 Infection? The following articles were previously published on the APSF online portal. The present version is updated and Nmodified by the authors for the present APSF Newsletter. Dear Rapid Response: Recommendations for OR Ventilation during the Has APSF developed definitive recommen- SARS COV-2 Pandemic—Staying Positive dations regarding negative pressure operating RroomsAPID R APIDfor R patients APIDR RESPONSE APIDR ESPONSEwho R ESPONSE areR ESPONSEknown or sus- by Charles Cowles, MD topected your important to have SARS-COV-2 questions infection?N If not, when will it happen? Positive pressure, where the pressure in the operating room is greater than the adjacent Thank you and kind regards areas, is the typical approach to OR ventilation. Marshal B. Kaplan, M.D. This approach is employed to prevent circula- Clinical Professor tion of pathogens that could contaminate an Director of Airway Management open wound from entering the OR. For all Co-Chair Performance Improvement patients undergoing a surgical procedure, posi- Committee tive pressure is an accepted infection preven- Department of Anesthesiology tion strategy. Negative pressure, where the CedarsRAPID Sinai R MedicalAPID R Center APIDR RESPONSE APIDRESPONSE RESPONSE pressureRESPONSE in the room is less than the adjacent areas, can be used to prevent airborne patho- The author has no conflicts of interest. to your important questionsgens from leaving the room. While not a stan- dard, negative pressure has been advocated Reply: for hospital rooms where a patient is known or Dear Dr. Kaplan, suspected to be infected with an airborne pathogen. While APSF does not have definitive recom- mendations as you have requested, the follow- What is the best strategy for OR ventilation Figure 1: Depicts the creation of a temporary wall with ing response from Dr. Charles Cowles, ASA when a COVID-19 patient, or a person under a door to create an anteroom from an OR hallway. liaison to the National Fire Protection Associa- investigation (PUI), requires a procedure in the tion (NFPA), details the important consider- operating room? The existing approach of posi- ations for developing a local approach to tive pressure ventilation is best to protect the caring for these patients. patient coming to the OR, but how can the risk to staff and other patients from any aerosol Thank you for your inquiry. generating procedures be minimized? The fol- Jeffrey Feldman, MD, MSE is professor of Clinical lowing is intended to provide the information Anesthesiology, Children’s Hospital of Philadel- needed to make an informed decision about phia, Perelman School of Medicine, University of the approach to OR ventilation best suited to Pennsylvania, and Chair of the APSF Committee the local conditions. on Technology. What are the current recommendations for The author has no conflicts of interest. ventilation in the operating room? The American Institute of Architects (AIA) REFERENCES: recommends 15 air exchanges per hour com- 1. Overview of NFPA codes and standards that apply to bined with a minimum of 3 air exchanges of out- emergency power systems in healthcare facilities. https:// 1 nfpa.org/Codes-and-Standards/Resources/Standards-in- side (fresh) air for operating rooms. In addition, action/NFPA-resources-for-CMS-requirements-on-NFPA- air flow should be designed to create positive 99-and-NFPA-101/Action-for-emergency-power-in-Florida pressure in the operating room relative to areas Accessed December 21, 2020. 2. Lessons learned from Hurricane Sandy and recommenda- outside the OR to prevent the entry of common tions for improved healthcare and public health response pathogens (e.g., Staphylococcus aureus) that and recovery for future catastrophic events. American Col- Figure 2: Portable air handler inside anteroom to lege of Emergency Physicians, Dec 22, 2015. https://www. could contaminate an open wound. These acep.org/globalassets/uploads/uploaded-files/acep/by- basic requirements are the standard for all create negative pressure. medical-focus/disaster/lessons-learned-from-hurricane- patients receiving care in the operating room. sandy-webpage.pdf Accessed December 21, 2020. See “Negative Pressure,” Next Page

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 APSF. It is not the intention of 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 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. RAPID Response TO YOUR IMPORTANT QUESTIONS

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to questions from readers

From “Negative Pressure,” Preceding Page Should the operating room (OR) ventila- A Remembrance: Charles Cowles, MD, MBA, FASA tion be converted Nto negative pressure to protect the staff from COVID-19 exposure In the last few days before this publication was to go to when caring for known or suspected COVID- press, we learned the tragic news that Charles Cowles, MD, 19 positive patient? lost his life in a car accident on a family trip. Thankfully, his wife No, the American Society for Healthcare and three children, although injured, have all survived. Engineering (ASHE) recommends the same Charles contributed so much to APSF and our specialty RstrategyAPID RAPID Rfor APIDR COVIDRESPONSE APIDR patientsESPONSE RESPONSE R inESPONSE the operating throughout his career including two articles in this issue of the Newsletter. With heavy hearts, we offer this remembrance. toroom your asimportant they do questions for other airborne diseases 2 such as TB. This includes the following, if Charles possessed many qualities that made him such an feasible: effective advocate for patient safety. He possessed a wealth • Only medically necessary procedures of knowledge gained through innate curiosity, and the disci- pline to pursue learning until he had a thorough understand- should be scheduled “after hours.” Charles Cowles, MD, MBA, FASA • Minimize staff in the room and all staff ing of the topic of interest. He had the insight to understand how to apply his knowledge to enhance patient safety and the dedication to put his efforts involved should wear N95 or HEPA respira- towards that end. Finally, he generously shared his time and energy in the pursuit of improv- tors. ing patient care. • The door to the operating room should be kept closed throughout the procedure. As a trained firefighter, Charles worked consistently for many years in an effort to ensure • Recovery should be accomplished in an Air- that no patient is injured by fire. He provided lectures and educational material as well as representing ASA at the National Fire Prevention Association (NFPA). He was an expert on borne Infection Isolation Room (AIIR). facilities and the systems needed to keep patients and providers safe. Whenever called • Terminal Cleaning should be performed upon for an opinion, Charles provided valuable information in a form that was accessible to after sufficient number of air changes has the clinician. removed potentially infectious particles. We will never know the impact Charles would have had on future safety efforts. There is Pathogens such as staphylococcus can be no question that APSF will need to respond to patient safety concerns where we will imme- pulled into the operating room if a negative diately feel the loss of his guidance. Of course, our loss pales in comparison to that of his pressure configuration is chosen.3 Taking all family. Our thoughts and prayers go out to them with the hope they will find some comfort factors in to account, negative pressure should being together and holding on to his memory. not be instituted in operating rooms. When treating a positive COVID patient or a person We will miss Charles Cowles greatly, hold his contributions dear, and honor his memory by under investigation (PUI) for COVID, aerosol- continuing our work on patient safety. generating procedures (AGPs) such as intuba- ­—Anesthesia Patient Safety Foundation tion, should be performed in an Airborn Infection Isolation Room (AIIR), separate from the OR, if feasible. The AIIR can be positive pressure if a nega- constructed (see Figure 1). This anteroom is a tive pressure anteroom (see below) is used. small room built adjacent to the patient entry What exactly is an Airborne Infection Iso- The AIIR should be negative pressure in rela- lation Room and how does this differ from a door to the OR and contains a portable air han- tion to the corridor in the absence of an ante- negative pressure room? dler that creates a negative pressure which room. A negative pressure room can be According to the American Institute of prevents airborne particles from being pushed created by having a return air system rate Architects (AIA) guidelines, AIIRs must meet out of a positive pressure operating room and greater than the supply of air, but it is not an AIIR several criteria for room ventilation unrelated into a hallway or other adjacent room. Ante- unless it meets the other criteria. Rooms in the to the pressure differential: rooms should be large enough to maneuver a • ICU, PACU and repurposed spaces can be con- At least 12 air exchanges per hour bed into the OR and also hold a small air han- • figured to meet the AIIR criteria to facilitate Inability to inadvertently change the dling unit. Locating the anteroom near a return ventilation modes from a negative mode to a caring for COVID-19 patients. air duct simplifies the routing of the air handling positive mode Are there other actions we can take to pro- duct work. These rooms can be designed in a • Tightly sealed doors tect the staff and other patients if the OR does hallway with self-closing doors which can allow • Self-closing doors not have negative pressure? personnel to walk through the area. If an ante- • A permanent indicator of airflow that is Creating a negative pressure anteroom to visible when the room is occupied and the OR can help control the movement of con- room is deployed, then other doors to the OR • A filtration system with at least 90% taminated air and is a fairly simple modification should be sealed to airflow. efficiency.1 which can either be temporarily or permanently See “Negative Pressure,” Next Page

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 APSF. It is not the intention of 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 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. RAPID Response TO YOUR IMPORTANT QUESTIONS

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to questions from readers

From “Negative Pressure,” Preceding Page COVID-19 patients. The availability and location of AIIRs outside of the operating room will Both the Anesthesia Patient Safety Founda- determine where airway management can be SUPPORT YOUR tion and the American Society of Anesthesiolo- performed and where patients should be gists offer additional N guidance. In the absence APSF allowed to recover. Negative pressure ante- of a negative pressure anteroom to the OR, rooms to the OR are useful to prevent spread of Your Donation: efforts should be made to minimize environ- airborne pathogens outside of the OR but may mental contamination and staff risk during any • Funds Research Grants not be feasible. The number of air exchanges aerosol-generating procedure. Intubating, extu- per hour will also vary and dictate the time • Supports Your bating, and recovering the patient in an AIIR APSF Newsletter RseparateAPID RAPID R from APIDR R theESPONSE APIDR ORESPONSE R is oneESPONSE R approach,ESPONSE but it required for airborne pathogens to be cleared torequires your important transporting questions an intubated patient and from the OR environment. Resources for cur- • Promotes Important Safety the need to filter any exhaled gases during rently accepted standards and recommenda- Initiatives transport. If the airway is managed in the OR, tions include the following. • Facilitates Clinician- staff in the room should be the minimum • American Society for Healthcare Engineering Manufacturer Interactions required to secure the airway, all must wear PPE, (ASHE)­—https://www.ashe.org/ • Supports the Website and other doors to the OR should remain closed. • American Institute of Architects (AIA)—https:// Once the airway is secured, or the patient has Donate online www.aia.org/ been extubated, other staff should not enter the (https://www.apsf.org/donate/) or OR until sufficient time has elapsed to clear the • American Society of Heating, Refrigeration, mail to 4,5 room of any airborne pathogens. and Air Conditioning Engineers (ASHRAE)— APSF https://www.ashrae.org/ How long does it take after an aerosol- P.O. Box 6668 generating procedure (AGP) for the air in the • Facilities Guidelines Institute (FGI)—https:// Rochester, MN 55903 room to be completely filtered? fgiguidelines.org/ U.S.A. The CDC provides a chart which shows that • Center for Disease Control (CDC)—https:// at 15 air exchanges per hour, 99% of airborne www.cdc.gov/infectioncontrol/guidelines/ contaminants can be removed in about 14 min- environmental/appendix/air.html#tableb1 utes.6 However, these data are an estimate of fairly complex calculations for which many fac- Charles E. Cowles, Jr., MD, MBA, FASA, was tors need to be taken into account. The effi- associate professor and chief safety officer at ciency of 99% assumes that all of the air is the University of Texas MD Anderson Cancer cycled by pushing air in a laminar flow pattern. Center, Houston, TX. However, large nonaerodynamic objects such The author has no conflicts of interest. Vision as anesthesia machines, OR tables, and other The vision of the Anesthesia Patient equipment can result in turbulent airflow and REFERENCES create dead air spaces where air is not circu- Safety Foundation is to ensure that no 1. American Institute of Architects. 2006 American Institute of patient shall be harmed by anesthesia lated. This air does not consistently participate Architects (AIA) Guidelines for Design and Construction of care. in the 15 air exchanges, but also airborne con- Hospital and Health Care Facilities. 2016. taminants would likely bypass these dead air 2. American Society for Healthcare Engineering. https://www. & ashe.org/covid-19-frequently-asked-questions Accessed spaces as they circulate from the infected August 6, 2020. Mission source to the exhaust vents. Another factor for 3. Chow TT and Yang XY. Ventilation performance in operat- determining adequate time is air filtration. A ing theatres against airborne infection: review of research The APSF’s mission is to improve the safety of patients during anesthesia High Efficiency Particulate Air (HEPA) filter is activities and practical guidance. J Hosp Infect. 2004;56:85–92. care by: one common type of filter. Air filtration is actu- 4. Anesthesia Patient Safety Foundation. https://www.apsf. ally rated using the Minimum Efficiency Report- org/covid-19-and-anesthesia-faq/#clinicalcare Accessed • Identifying safety initiatives and ing Value (MERV) system. The higher the August 10, 2020. creating recommendations to implement directly and with partner MERV number, the more efficient the filter is at 5. American Society of Anesthesiologists. https://www.asahq. org/about-asa/governance-and-committees/asa-commit- organizations filtering small particles. Hospital ORs should tees/committee-on-occupational-health/coronavirus. have a filtration system rated 14 or greater.7 A Accessed August 10, 2020. • Being a leading voice for anesthesia HEPA filter exceeds this MERV threshold. 6. US Health and Human Services Center for Disease Control patient safety worldwide (CDC) https://www.cdc.gov/infectioncontrol/guidelines/ Where can I find more information on ven- environmental/appendix/air.html#tableb1 Accessed August • Supporting and advancing tilation standards and recommendations? 6, 2020. anesthesia patient safety culture, 7. Barrick JR, Holdaway RG. Mechanical Systems Handbook knowledge, and learning Every facility will have different constraints for Health Care Facilities. American Society for Healthcare that will dictate the procedures to care for Engineering. 2014.

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 APSF. It is not the intention of 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 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. APSF NEWSLETTER February 2021 PAGE 33

LETTER TO EDITOR: The Single-Provider-Operator-Anesthetist Model for Dental Deep Sedation/Anesthesia: A Major Safety Issue for Children by Charles J. Cote, MD, FAAP; Raeford Brown Jr, MD, FAAP; and Anna Kaplan, MD In 2019 the American Academy of Pediatrics Individuals who pass the examination are (AAP) published a joint statement with the expected to “possess the expertise to provide American Academy of Pediatric Dentistry supportive anesthesia care safely and effec- (AAPD) updating the AAP sedation guideline.1,2 tively. The Dental Anesthesia Assistant (DAA) is This revision was prompted by the preventable knowledgeable in the perioperative and emer- death of Caleb, a healthy 6-year-old sedated for gent care management of patients undergoing removal of a supernumary tooth. Multiple sedat- office-based outpatient anesthesia. The DAA is ing medications caused apnea and airway able to effectively communicate pertinent infor- obstruction, the oral surgeon was unable to mation to patients and their escorts as well as clear the airway, and there was no other skilled members of the health care team.”7 help in the office. Caleb was asystolic when the It is astonishing to assume that a person with no EMTs arrived and he died.3 Caleb’s aunt, Anna practical or clinical experience would be certified safety may be compromised. It is critical for Kaplan, now a pediatric resident, worked to to be the independent observer with all of the skill- health care professionals, patients, and parents introduce legislation (Caleb's law)4 in California sets described above learned in just 36 hours of to speak to their associated legislatures to that required an anesthesia-trained provider for internet reading. Such an individual would likely oppose proposals that support the single-pro- deep sedation/anesthesia. This was opposed be incapable of providing any meaningful help vider-operator-anesthesia model for oral sur- by the oral surgery lobby,5 and the California with a genuine life-threatening emergency as geons since California’s approval of this law has Legislature codified the single-provider-opera- they lack hands-on medical training, are not encouraged oral surgeons across the U.S. to tor-anesthetist model for oral surgeons skilled in starting an IV, and not licensed to draw propose similar legislation. whereby the operating dentist/oral surgeon up and administer life-saving medications. simultaneously provides deep sedation/anes- Charles J. Cote, MD, FAAP, is professor emeritus at thesia and performs the dental procedure (two Consider the patient who developed airway Harvard Medical School, Division of Pediatric tasks concurrently). The single-provider-opera- obstruction, with the operating dentist the only Anesthesia, and at the Massachusetts General tor-anesthetist model codified in this law con- person present with any medical knowledge. He/ Hospital for Children in the Department of Anes- tradicts all known anesthesia standards.6 she must recognize the problem, manage the thesia, Critical Care and Pain Management, airway to provide oxygen, and then cease airway Boston, MA. The 2016 AAP guideline clearly stated the support to administer rescue medications; the skills required for administering deep sedation: Raeford E Brown, Jr., MD, FAAP, is professor of only backup is 911. The DAANCE provider may be anesthesiology and pediatrics at the University of The person administering/directing the sedation able to inform the dentist that something is wrong, Kentucky/The Kentucky Children’s Hospital and must be “able to provide advanced pediatric life but they cannot do much to help. It is truly danger- chair of the Section on Anesthesiology, Lexing- support and capable of rescuing a child with ous to substitute a DAANCE observer for a skilled ton, PA, and Pain Medicine, The American Acad- apnea, laryngospasm, explicit or airway obstruc- anesthesia professional. emy of Pediatrics. tion. Required skills include the ability to open the airway, suction secretions, provide CPAP, Following introduction of the DAANCE oral Anna Kaplan, MD, is a resident in pediatrics at insert supraglottic devices (oral airway, nasal surgery practice model, the AAP and AAPD the University of California San Francisco trump, laryngeal mask airway) and perform suc- crafted new wording. The 2019 sedation guide- Benioff Children’s Hospital, Oakland, CA. She is cessful bag-valve-mask ventilation, tracheal intu- line now states explicitly that deep sedation/ co-author of Caleb’s Law. bation, and cardiopulmonary resuscitation.”2 It anesthesia must be provided by an anesthesia- The authors have no conflicts of interest. explicitly states that there must be an indepen- trained provider and the operating dentist must dent observer whose only responsibility is to be currently PALS-certified to assist the anesthe- REFERENCES observe the patient and is capable of assisting sia provider with an adverse event. This provides 1. Coté CJ, Wilson S. Guidelines for monitoring and manage- with or managing emergencies. The AAP model a ready-to-respond sedation team on site. The single-provider-operator-anesthetist oral surgery ment of pediatric patients before, during, and after seda- is a multiple-provider-sedation-care team tion. Pediatrics. 2019;143:6 e1–31. model must be replaced with the multiple-pro- whereby multiple individuals are immediately 2. Coté CJ, Wilson S, American Academy of P, American vider-sedation-care team AAP/AAPD model. Academy of Pediatric D. Guidelines for monitoring and present to initiate rescue. management of pediatric patients before, during, and after It is essential that patient safety advocates be sedation for diagnostic and therapeutic procedures: In response, the oral surgery community informed of this significant safety issue; healthy Update 2016. Pediatrics. 2016;138(1). developed a Dental Anesthesia Assistant patients continue to suffer adverse outcomes 3. Caleb's Parents Cs. 2018. Parental permission to discuss National Certification Examination (DAANCE) child's death. specifically because of this single-provider-oper- with no pre-examination educational require- 4. Caleb's Law. http://www.calebslaw.org/caleb-s-story-and- ator-anesthetist oral surgery practice model. We law/. Accessed December 21, 2020. ments. It consists of 36 hours of internet study have a professional and personal responsibility 5. Moran D. How $3 million in political donations stands in the covering the following: way of justice for this boy's death. https://www.sacbee.com/ to educate parents and patients to ask their oral opinion/opn-columns-blogs/dan-morain/article147407899. “The self-study materials and the final exam surgeon very specific questions: “How will I/my html2017. Accessed December 21, 2020. cover five major areas: child be monitored and by whom? Is there an 6. Gelb AW, Morriss WW, Johnson W, Merry AF, International 1. Basic sciences independent observer whose only responsibility standards for a safe practice of anesthesia W. World Health Organization-World Federation of Societies of Anaesthesi- 2. Evaluation and preparation of patients with is to watch me/my child, certified in and up-to- ologists (WHO-WFSA) international standards for a safe systemic diseases date in resuscitation and trained in the delivery of practice of anesthesia. Can J Anaesth. 2018;65:698–708. 3. Anesthetic drugs and techniques anesthestics? Is the equipment for resuscitation 7. Surgeons AAoOaM. Dental anesthesia assistant national certification examination (DAANCE). https://www.aaoms. 4. Anesthesia equipment and monitoring immediately available?” If the answer to these org/continuing-education/certification-program- 5. Office anesthesia emergencies.7 questions is ambiguous or “no,” then patient daance2018. Accessed December 21, 2020. APSF NEWSLETTER February 2021 PAGE 34

Anesthesia Machine as an ICU Ventilator—A Near Miss During the COVID-19 Pandemic by Matthew A. Levin, MD; Garrett Burnett, MD; Joshua Villar, AS; Joshua Hamburger, MD; James B. Eisenkraft, MD; and Andrew B. Leibowitz, MD

This article was previously published on the APSF online portal. The present version is updated and modified by the authors for the present APSF Newsletter.

Disclaimer: Viewers of this material should review the information contained within it with appropriate medical and legal counsel and make their own determinations as to relevance to their particular practice setting and compliance with state and federal laws and regulations. The APSF has used its best efforts to provide accurate information. However, this material is provided only for informational purposes and does not constitute medical or legal advice. This response also should not be construed as representing APSF endorsement or policy (unless otherwise stated), making clinical recommendations, or substituting for the judgment of a physician and consultation with independent legal counsel.

The COVID-19 pandemic in New York City tion CS2, GE Healthcare, Waukesha, WI) were immediately connected to a different electrical during spring 2020 resulted in an unprece- being used as ventilators in this temporary outlet, the AC power indicator light came on, and dented number of patients requiring mechani- ICU, managed 24/7 by a group of anesthesia the workstation rebooted. After a pre-use check- cal ventilation. With the need for intensive care professionals. The rooms had no interior or out had been performed, the patient was recon- unit (ICU) beds and ventilators exceeding door windows, but indirect viewing was pro- nected to the breathing circuit and mechanical supply, anesthesia machines were used as ven- vided via a remote visual patient monitoring ventilation resumed normally. tilators in non-OR locations, an off-label use.1 system (AvaSys Telesitter, Belmont, MI). The APSF/ASA document “Guidance on Pur- Monitoring was via a central station telemetry The Aisys workstation was subsequently posing Anesthesia Machines as ICU Ventila- network (GE CareScape, GE Healthcare, removed from the room for interrogation and tors” includes “Key Points to Consider in Waukesha, WI) to which the workstation physi- replaced with a new one. Hospital engineering Preparing to Use Anesthesia Machines as ICU ologic monitor had been connected, with high staff found that a circuit breaker for the room Ventilators,” which notes that any location with volume audio alerts for abnormal rhythms and had tripped and it was reset. No problem was high pressure air and oxygen might be accept- bradycardia/tachycardia, and the default low found with the extractor fan and it was 2 able. We report the case of an anesthesia volume audio alarm for low SpO2. restarted. machine ventilator failure in a COVID-19 patient On hospital day 10, an audible alarm sounded ROOT CAUSE ANALYSIS who was being managed in a windowless neg- at the central station and the SpO was noted to The workstation’s failure was caused by inter- ative pressure room in a telemetry unit that had 2 be 45%. The care team donned PPE, entered the ruption of its power supply due to a tripped cir- been converted to a temporary COVID-19 ICU. patient’s room and observed that mechanical cuit breaker. Review of the service log revealed This case highlights that novel use of standard ventilation had ceased, the extractor fan was off, an AC power loss, appropriate cutover to the equipment is subject to unforeseen problems. and the room was very warm. The Aisys control backup battery, and eventual complete dis- THE CASE screen was dark, the AC power indicator light charge of the battery. Several alarm messages A 66-year-old man with a history of noninsu- was off, but the physiologic monitor was on and had been displayed on the workstation screen lin-dependent diabetes was admitted to a tem- functioning. The patient was immediately discon- beginning 28 minutes after the AC power loss porary COVID-19 ICU for acute respiratory nected from the breathing circuit, ventilated progressing from “Battery Low”, “Battery V Low” failure requiring tracheal intubation and using a self-inflating manual ventilation bag, and to “Battery V VERY LOW” and, after 1 hour 43 mechanical ventilation. Temporary negative the SpO2 rapidly returned to baseline levels. It minutes, to “Battery Empty.” The system shut pressure rooms had been created by replacing was noted that the bed (HillRom Progressa Pul- down after 1 hour 52 minutes. The service log the exterior window of each room with a hard- monary, HillRom, Chicago, IL) was plugged into verified that the system operated as intended,3 board panel that contained a cutout for a HEPA an auxiliary outlet on the extractor fan, the fan but these alarm messages were not visible to filter/extractor fan exhaust duct (Air Shield 550 was plugged into a floor-level electrical outlet, the staff outside the patient’s room. HEPA Air Scrubber, AER Industries, Irwindale, and the Aisys workstation was plugged into a CA). Anesthesia workstations (Aisys Caresta- separate floor-level outlet. The workstation was See “ICU Ventilator,” Next Page APSF NEWSLETTER February 2021 PAGE 35

Anesthesia Ventilator Failure Caused By Loss of External Power

From “ICU Ventilator,” Preceding Page same problem could also have occurred with a and Pain Medicine, Icahn School of Medicine at DISCUSSION standard ICU ventilator, since they also have Mount Sinai, New York, NY. This case illustrates some of the problems limited backup power, and aside from some Garrett Burnett, Joshua Villar, Joshua that could be encountered during the COVID- very new models, lack remote monitoring capa- Hamburger, James Eisenkraft, and Andrew bility. One solution not available to us at the 19 pandemic, namely creating a makeshift ICU Leibowitz report no conflict of interest. on short notice and using an anesthesia work- time is to detach the control and monitoring station to ventilate a critically ill patient in a screens from the Aisys workstation and, using Matthew Levin reports having received closed room, with less-than-ideal remote moni- special extension cables, move them to outside publication fees from the McMahon Group and consultant fees from ASA PM 2020, and has toring. During normal use of an anesthesia the room thereby allowing control of gas flows filed a provisional patent for the split ventilation workstation, a qualified anesthesia professional 9 and ventilation as well as remote monitoring. circuit design with the Stryker Corporation for is in constant attendance, able to view the In conclusion, the use of an anesthesia which he received no fee or equity interest. screens, hear audible alerts, and make adjust- workstation as an ICU ventilator is feasible in a ments as necessary. The backup battery on the crisis situation, but increased vigilance is REFERENCES Aisys workstation is specified to last from required to recognize and manage unantici- 1. Haina KMK Jr. Use of anesthesia machines in a critical care 50–90 minutes depending on the model, but in setting during the coronavirus disease 2019 pandemic. A A this case it lasted almost two hours. In contrast, pated problems. Pract. 2020;14:E01243. Doi:10.1213/Xaa.0000000000001243 an ICU ventilator such as the Puritan Bennett Matthew A. Levin, MD, is associate professor in 2. APSF/ASA guidance on purposing anesthesia machines as icu ventilators. https://www.asahq.org/in-the-spotlight/ 980 (Medtronic, Boulder, CO) is specified to the Department of Anesthesiology, Periopera- coronavirus-covid-19-information/purposing-anesthesia- 4 have a one-hour backup battery. While ventila- tive and Pain Medicine, Icahn School of Medi- machines-for-ventilators Accessed August 6, 2020. tor failure in this case was caused by loss of cine at Mount Sinai, New York, NY. 3. GE AISYS CS2 user’s reference manual. https://www.manu- external electrical power, failure of a ventilator’s alslib.com/manual/1210542/ge-aisys-cs2.html Accessed Garrett Burnett, MD, is assistant professor in the August 10, 2020. internal power supply has also been reported.5 Department of Anesthesiology, Perioperative 4. Technical Specifications for U.S. Puritan Bennett™ 980 Ven- Fortunately the physiologic monitor (Care- and Pain Medicine, Icahn School of Medicine at tilator System. Medtronic/Covidien; 2016. https://www. Scape b650, GE Healthcare, Waukesha, WI) medtronic.com/content/dam/covidien/library/us/en/prod- had its own backup battery with a 1–2 hour run Mount Sinai, New York, NY. uct/acute-care-ventilation/puritan-bennett-980-ventilator- 6 system-tech-specifications.pdf. Accessed December 21, time, and was connected to the telemetry net- Joshua Villar, AS, is the head anesthesia techni- 2020. work, thus alerting staff. The cause of the cian in the Department of Anesthesiology, Peri- 5. Davis AR, Kleinman B, Jellish WS. Cause of ventilator failure tripped circuit breaker is unknown. The electri- operative and Pain Medicine, Icahn School of is unclear – Anesthesia Patient Safety Foundation. Pub- cal power supply to the room comprised two lished 2005. https://www.apsf.org/article/cause-of-ventila- Medicine at Mount Sinai, New York, NY. tor-failure-is-unclear/ Accessed August 6, 2020. dedicated 15A circuits with white outlets, two Joshua Hamburger, MD, is assistant professor in 6. GE Healthcare. Carescape Monitor B650.; 10/2010. https:// 20A circuits that were shared with the adjacent www.gehealthcare.com/-/jssmedia/e4c9c6ed549f43a- room and also had white outlets, and one 20A the Department of Anesthesiology, Periopera- 0b2efdba2adfe2687.pdf?la=en-us Accessed August 10, emergency circuit with red outlets. The white tive and Pain Medicine, Icahn School of Medi- 2020. cine at Mount Sinai, New York, NY. 7. Carpenter T, Robinson ST. Response to a partial power fail- electrical outlets had no markings to indicate to ure in the operating room. Anesthesia & Analgesia. which of the circuits they were connected. James B. Eisenkraft, MD, is professor in the 2010;110:1644. Doi:10.1213/Ane.0b013e3181c84c94 Department of Anesthesiology, Perioperative 8. August DA. Locked out of a box and a process. Anesth It is unlikely that a device in the adjacent Analg. 2011;112:1248–1249; Author Reply 1249. Doi:10.1213/ room caused the circuit breaker to trip because and Pain Medicine, Icahn School of Medicine at Ane.0b013e31821140e4 that room did not lose power. The most likely Mount Sinai, New York, NY. 9. Connor CW, Palmer LJ, Pentakota S. Remote control and explanation is that the bed, extractor fan, tele- monitoring of GE AISYS anesthesia machines repurposed Andrew B Leibowitz, MD, is professor in the as intensive care unit ventilators. Anesthesiology. medicine monitor, and anesthesia workstation Department of Anesthesiology, Perioperative 2020;133:477–479. Doi:10.1097/Aln.0000000000003371 were all connected to the same 15A circuit, and the total current draw from all devices exceeded 15A. The extractor fan draws 2.5A, and the bed can draw up to 12A, leaving a very Join the #APSFCrowd! small margin before the circuit would be over- loaded. Notably, in many hospitals (including Donate now at https://apsf.org/FUND ours) the circuit breaker panels are locked and can only be accessed by engineering due to security concerns. Limited accessibility can cause a delay in reinstating power.7,8 The APSF/ASA Guidance includes the rec- ommendation that “An anesthesia professional needs to be immediately available for consulta- The Anesthesia Patient Safety Foundation is launching our first-ever crowdfunding tion, and to “round” on these anesthesia machines at least every hour.” During the height initiative, defined as raising small amounts of money from a large number of people. of the pandemic, with limited PPE, limited staff, Just $15 can go a long way to reach our goals. 168 ventilated patients and 18 patients being ventilated using anesthesia workstations, Help support the vision that “no one shall be harmed by anesthesia care.” hourly rounding was simply not possible. The APSF NEWSLETTER February 2021 PAGE 36

Perioperative Hypersensitivity: Recognition and Evaluation to Optimize Patient Safety by David A. Khan, MD; Kimberly G. Blumenthal, MD, MPH; and Elizabeth J. Phillips, MD

SUMMARY opioids. Radiocontrast dyes may also cause Cefazolin is currently the most commonly non-IgE mediated mast cell activation. identified cause of anaphylaxis in the United POH reactions typically present with cardio- States, occurring in 1 in 10,000 surgeries; how- vascular and/or respiratory involvement includ- 1 ever, it is often overlooked. If anaphylaxis is sus- ing signs of hypotension, tachycardia, pected, serum tryptase drawn within 2 hours bronchospasm, and cardiac arrest. Mucocuta- may be helpful to identify or differentiate the epi- neous reactions such as erythema, urticaria, or sode from other causes. Cefazolin is a first gen- angioedema can also occur, but may be missed eration cephalosporin with R1 and R2 side chain due to draping of the patient. Cardiorespiratory groups that are distinct from other beta-lactms, symptoms are not specific for POH and may and most patients with cefazolin allergy can tol- occur for a variety of other reasons such as erate penicillins and other cephalosporins. medications, hypovolemia, underlying respira- WHAT DOES CEFAZOLIN tory disease, and multiple attempts at intuba- ANAPHYLAXIS LOOK LIKE? tions. Recently, an expert panel of anesthesia A REAL LIFE CASE EXAMPLE professionals and allergists developed a clinical A 50-year-old African-American woman pre- scoring system to assist with determining the sented to an Allergy and Immunology clinic fol- likelihood of a reaction being due to POH (Table 3 lowing two suspected discrete episodes of 1). A weighted scale with points for or against anaphylaxis prior to an intended right hip POH are tabulated based on clinical parameters replacement at an outside hospital. She gave which produces a score yielding the likelihood of no other significant past medical history. Her an immediate hypersensitivity reaction. This medication history was significant for long- Figure 1: Illustration of positive prick and intradermal scoring system underwent content, criterion, and standing use of rosuvastatin 20 mg orally and skin tests to cefazolin (Cp) following two discrete epi- discriminant validity but has not undergone inde- sodes of anaphylaxis temporally associated with pendent external validation.3 acetaminophen 500 mg orally as needed. On cefazolin two months prior. Prick testing to histamine the first occasion, she received vancomycin 2g (H) is positive as a control. Prick and Intradermal testing The most useful laboratory test for helping to and cefazolin 1g prior to the planned joint to saline is negative as a negative control. Intradermal confirm an immediate hypersensitivity reaction replacement. No sedation or anesthetic agents skin tests to other reagents including ampicillin 25 mg/ is a serum tryptase level. Tryptase is a protease had been given. Within minutes of the cefazolin ml, benzyl penicillin 1000 and 10,000 IU/ml, minor determinant mixture (MDM) and major determinant released by mast cells during anaphylaxis and is infusion, she had skin flushing, facial and lip (Pre-pen) were negative. specific for evidence of mast cell activation. A swelling, and hypotension. She received a tryptase level is ideally obtained within 2 hours single dose of epinephrine 0.3 mg intramuscu- be clearly documented as a severe reaction of a reaction and will not be affected by medica- larly, diphenhydramine 50 mg and hydrocorti- (anaphylaxis) in all electronic health records and tions used to treat a reaction. Elevations in trypt- sone 125 mg both intravenously, and was pharmacy records and she should wear a medic ase have high positive predictive values transferred to the intensive care unit under alert bracelet. (82–99%) for anaphylaxis in suspected periop- observation for an additional day. Ten days erative reactions.4 However, patients may have later, preparation for right hip replacement was HOW TO IDENTIFY PERIOPERATIVE anaphylaxis without an elevated tryptase level again attempted, and this time she received HYPERSENSITIVITY? (> 11.4 ng/ml). A tryptase > 7.35 ng/ml has a 99% cefazolin 2 g (without vancomycin) and within Perioperative hypersensitivity (POH) reac- positive predictive value for POH in patients with minutes developed facial swelling and flushing; tions are unexpected and unpredictable events severe cardiovascular collapse or cardiac arrest. epinephrine 0.3 mg intramuscularly and diphen- that present suddenly without warning. The An acute serum tryptase level greater than ([1.2 x hydramine 50 mg intravenously were immedi- severity of reactions can range from mild reac- serum baseline tryptase] + 2) can help confirm ately given, and she was observed for several tions to severe anaphylaxis, which in some anaphylaxis (especially in those with normal hours without recurrence. Two months later, she cases may be fatal. The incidence of POH acute tryptase levels) and has a positive predic- was seen in allergy clinic where she underwent ranges widely and by country of origin with tive value for POH of 94%. Severe reactions can skin prick testing to cefazolin followed by intra- recent studies suggesting an incidence of 1 in occasionally occur even with non-IgE mediated dermal testing to penicillins, cefazolin, and ceftri- 10,000.2 The majority of cases of POH are mast cell activation such as with vancomycin axone (Figure 1). Skin tests were weakly positive 5 thought to be allergic, caused by IgE-mediated infused rapidly. In about 10% of cases, serum to cefazolin prick testing and strongly positive to tryptase may be elevated in the setting of non- mast cell activation. However, non-IgE-depen- intradermal cefazolin but negative to all other IgE mediated mast cell activation. reagents. She tolerated challenges with amoxi- dent mechanisms that activate mast cells may cillin and cephalexin, both 250 mg orally. Based also occur in association with many drugs given While there are many causes of POH, antibi- on these data, she was diagnosed with cefazolin perioperatively. Recently, the Mas-related otics, neuromuscular blocking agents, and dis- anaphylaxis and given advice that it was safe for G-proten-coupled receptor X2 (MRGPRX2) has infectants are among the most common causes 2 her to take penicillins and cephalosporins other been shown to be a cause of reactions to cer- documented internationally. In the U.S., how- than cefazolin and also safe for her to take van- tain medications such as neuromuscular block- ever, cefazolin is the most commonly identified comycin. We emphasized that cefazolin should ing agents, vancomycin, fluoroquinolones, and See “Hypersensitivity,” Next Page APSF NEWSLETTER February 2021 PAGE 37

International Consensus Recommendations Suggest A Comprehensive Allergic Evaluation For Patients with Perioperative Allergic Reactions

From “Hypersensitivity,” Preceding Page keeping with this, patients allergic to cefazolin was aborted at the time of the allergic reaction, cause of POH, reported to be associated with are typically not allergic to penicillin or other but is still needed or recommended. Second, 6 >50% of cases of POH, and may occur with the cephalosporins. even if that specific surgery was completed first exposure to cefazolin.6 The pathway of WHY IS TESTING IMPORTANT despite the reaction, most patients will require sensitization to cefazolin has not been deter- IN THE SETTING OF PERIOPERATIVE subsequent anesthesia in the future. Interna- mined. It is important to recognize that cur- HYPERSENSITIVITY? tional consensus recommendations by an rently most episodes of anaphylaxis to After a suspected allergic reaction in the peri- expert panel of anesthesia professionals and cephalosporins are thought to be related to the operative setting, it is critical to use all possible allergists recommend a comprehensive allergy R1 side chains. Cefazolin has R1 and R2 side diagnostic investigational tools to identify the evaluation, ideally with collaboration between chains that are distinct and not shared with any culprit drug. First, it is possible that the event anesthesia professionals and allergists, for all other beta-lactams used in North America. In occurred prior to the surgery and the surgery patients with perioperative allergic reactions.7

Table 1: Clinical scoring system for suspected perioperative hypersensitivity reactions.*

Cardiovascular System (CVS) (Choose hypotension, severe Points Dermal/mucosal (D/M) (Choose any items that apply) Points hypotension or cardiac arrest if appropriate, then any other items that apply) Generalised urticaria 4 Severe hypotension 6 Angioedema 3 Hypotension 4 Generalised erythema 3 Cardiac arrest 9 A generalised rash is itchy in the awake patient who has not 1 received epidural/spinal opioids Tachycardia 2 Dermal/Mucosal/Confounder A poor or unsustained response of hypotension to standard 2 doses of sympathomimetics used to treat pharmacological Angioedema in a patient taking an ACE inhibitor -3 hypotension during anaesthesia (e.g., ephedrine, phenylephrine, metaraminol) Combinations (Choose a maximum of one item)** A point-of-care echocardiogram showing a hyperdynamic and 2 poorly-filled heart CVS>2 & RS > 2 5 Recurrence or worsening of hypotension after a further dose 1 CVS>2 & D/M >2 5 of a drug given prior to the initial event RS>2 & D/M >2 5 Cardiovascular Confounders (choose any that apply) CVS>2 & RS>2 & D/M >2 8 Excessive dose of anaesthetic drug or drugs -2

Surgically induced hypovolemia or relative hypovolemia from -1 Timing (Choose a maximum of one item) prolonged fasting/dehydration Onset of cardiovascular or respiratory features within 5 min of 7 Acute illness predisposing to hypotension -1 possible IV trigger Medications affecting cardiovascular responses during -2 Onset of cardiovascular or respiratory features within 15 min of 3 anaesthesia possible IV trigger Neuraxial regional anaesthesia (epidural/spinal) -1 Onset of cardiovascular or respiratory features within 60 min 2 Onset of hypotension after development of increased peak -2 of possible non-IV trigger airway pressure during mechanical ventilation of the lungs Onset of cardiovascular or respiratory features more than 60 -1 min after possible non-IV trigger

Respiratory System (RS) (Choose bronchospasm or severe bronchospasm if appropriate, then any other items that Likelihood of immediate hypersensitivity reaction Total (net) apply) score Bronchospasm 2 Almost certain >21 Severe Bronchospasm 4 Very likely 15 to 21 Recurrence or worsening of bronchospasm after a further 1 Likely 8 to 14 dose of a drug given prior to the initial event Unlikely < 8 Bronchospasm occurring before airway instrumentation 2 (having excluded airway obstruction) *Table modified from Hopkins PM, Cooke PJ, Clarke RC, et al. Consensus clinical Respiratory Confounders scoring for suspected perioperative immediate hypersensitivity reactions. Br J Anaesth. 2019;123(1):e29–e37. Respiratory disease associated with reactive airways -1 **For a score from one of the 3 organ systems (CVS, RS, D/M) to contribute to a combinations score, the net score for that system must be > 2. The net score is the Prolonged or multiple attempts at tracheal intubation -1 sum of scores for positive features minus the sum of scores for confounders within scores for that system. Inadequate dose of drugs to obtund airway responses prior to -1 airway instrumentation See “Hypersensitivity,” Next Page APSF NEWSLETTER February 2021 PAGE 38

Patients With Low-Risk Histories Can Safely Receive Cefazolin for Surgical Prophylaxis

From “Hypersensitivity,” Preceding Page antibiotics, which can have additional clinical penicillin allergy are not truly allergic, the vast implications in the future.11 If cefazolin is identi- majority of patients with an unverified penicillin The ideal time for allergy evaluation is thought fied as the causative drug, tolerance to other allergy can receive cefazolin for surgical pro- to be approximately 4 weeks after the event; beta-lactams can be confirmed through spe- phylaxis without increased risk of an allergic however, this is not evidence-based and test- cialized allergy testing. reaction. ing up until at least 6 months after the event is still useful.8 For patients allergic to cephalospo- Most patients in the U.S. who are labeled as David A. Khan, MD, is professor of medicine in rins, approximately 60–80% will lose skin test being allergic to penicillin report histories of the Division of Allergy & Immunology at the Uni- reactivity 5 years after acute anaphylaxis.9 benign rashes, remote reactions, or unknown versity of Texas Southwestern Medical Center, reactions. Patients with these low-risk histories Dallas, TX. It is important that the allergist have access can safely receive cefazolin for surgical prophy- to the full anesthesia record and operative note Kimberly G. Blumenthal, MD, MPH, is assistant laxis.6 Recently, a multi-disciplinary group at that includes timing of administration and any professor of Medicine at Harvard Medical Emory Univeristy developed a simple algorithm other detail related to potential exposures School in the Division of Rheumatology, Allergy for administration of cefazolin or cefuroxime for including disinfectants, latex, lubricants, con- and Immunology at Massachusestts General perioperative antibiotic prophylaxis to patients Hospital, Boston, MA. trast, dyes, gelatin sponges used for hemosta- with histories of penicillin allergy.12 If patients did sis, foreign devices, and local anesthetics and Elizabeth J. Phillips, MD, is a professor of medi- not have histories of severe drug reactions their timing in relation to the suspected allergic cine and John A. Oates Chair in Clinical Research such as Stevens-Johnson syndrome or toxic event. This will help guide the appropriate in the Department of Medicine at Vanderbilt Uni- epidermal necrolysis, drug reaction with eosin- assessments. After a negative skin test, versity Medical Center, Nashville, TN. ophilia and systemic symptoms, liver or kidney observed challenges whereby a full dose of a injury, anemia, fever, or arthritis following pencil- drug is given to the patient in an observed set- The authors have no conflicts of interest. lin, they were allowed to receive cefazolin or ting in 1 or 2 steps is performed to all potential cefuroxime. After implemnation of this simple REFERENCES culprit medications that are possible in an out- algorithm, cephalosporin use increased nearly 1. Saager L, Turan A, Egan C, et al. Incidence of intraoperative patient clinic setting. Most allergy practices do Anesthesiol- 4-fold in penicillin allergic subjects and none of hypersensitivity reactions: a registry analysis. not do intravenous challenges and challenges ogy. 2015;122:551–559. the 551 penicllin allergic patients who received cannot be safely performed in outpatient 2. Mertes PM, Ebo DG, Garcez T, et al. Comparative epidemi- a cephalosporin had an immediate allergic ology of suspected perioperative hypersensitivity reactions. allergy practices to opioids, benzodiazepines, Br J Anaesth. reaction. Another study revealed that even in 2019;123:e16–e28. neuromuscular blocking agents, and propofol. 3. Hopkins PM, Cooke PJ, Clarke RC, et al. Consensus clinical patients with confirmed anaphylactic penicillin As such, negative skin testing to agents not scoring for suspected perioperative immediate hypersensi- allergy, the risk of cefazolin allergy is < 1%.13 tivity reactions. Br J Anaesth. 2019;123:e29–e37. challenged by the allergist warrant a “test 4. Volcheck GW, Hepner DL. Identification and management dose” to be given immediately prior to subse- For patients with POH, we recommend a of perioperative anaphylaxis. J Allergy Clin Immunol Pract. quent anesthesia. The best evidence to date standard approach that optimizes patient safety 2019;7:2134–2142. from the U.S. suggests that we will identify at and includes anesthesia professionals working 5. Alvarez-Arango S, Yerneni S, Tang O, et al. Vancomycin hypersensitivity reactions documented in electronic health least one-third of culprits with this strategy by with an allergist/immunologist to identify the records. J Allergy Clin Immunol Pract. 2020. finding patients with positive skin tests.8 culprit or compose a logical plan for subse- 6. Khan DA, Banerji A, Bernstein JA, et al. Cephalosporin Approximately 9 in 10 of the patients assessed quent anesthesia that minimizes allergic risk, allergy: current understanding and future challenges. J Allergy Clin Immunol Pract. 2019;7:2105–2114. by an allergy specialist, regardless of whether while considering the importance of antibiotic 7. Garvey LH, Dewachter P, Hepner DL, et al. Management of they have a positive skin test, will tolerate their prophylaxis.1 If the anesthesia professional suspected immediate perioperative allergic reactions: an subsequent anesthesia without a recurrent does not have an allergist to work with, aller- international overview and consensus recommendations. Br J Anaesth. 2019;123:e50–e64. 8 allergic reaction. gists can be found through a professional soci- 8. Banerji A, Bhattacharya G, Huebner E, et al. Perioperative ety link (https://allergist.aaaai.org/find/). allergic reactions: allergy assessment and subsequent Several patients presenting for surgery Additionally, with the expansion of telemedicine anesthesia. J Allergy Clin Immunol Pract. 2020;S2213– report allergies to penicillin or cefazolin without 2198. that accompanied the COVID-19 pandemic, vir- a formal allergist evaluation. Therefore, periop- 9. Romano A, Gaeta F, Valluzzi RL, et al. Natural evolution of tual appointments with allergists at the major skin-test sensitivity in patients with IgE-mediated hypersen- erative providers often seek alternative prophy- academic medical centers that routinely evalu- sitivity to cephalosporins. Allergy. 2014;69:806–809. lactic antibiotics to administer to these patients. ate these patients, for formal triage and risk 10. Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers However, alternative perioperative antibiotics for Disease Control and prevention guideline for the pre- stratification preceding specialized testing is JAMA Surg for surgical site infection prophylaxis can result vention of surgical site infection, 2017. . now possible. 2017;152:784–791. in an increased risk of prophylaxis failure and 11. Blumenthal KG, Peter JG, Trubiano JA, Phillips EJ. Antibiotic infection.10 Furthermore, perioperative In summary, POH reactions are rare events allergy. Lancet. 2019;393:183–198. clindamycin and vancomycin are associated with many potential culprits with cefazolin being 12. Kuruvilla M, Sexton M, Wiley Z, et al. A streamlined approach to optimize perioperative antibiotic prophylaxis in with an increased risk of Clostridium difficile the most frequent in the U.S. Collaboration the setting of penicillin allergy labels. J Allergy Clin Immunol colitis and acute kidney injury. Additionally, a between anesthesia professionals and aller- Pract. 2020;8:1316–1322. patient with a cefazolin allergy documented in gists can help to identify the culprit and develop 13. Romano A, Valluzzi RL, Caruso C, et al. Tolerability of cefazolin and ceftibuten in patients with IgE-mediated ami- their electronic health record without specific a plan for safe administration of anesthesia in nopenicillin allergy. J Allergy Clin Immunol Pract. allergist guidance may avoid all beta-lactam the future. While most patients with a label of 2020;8:1989–1993.e1982. RAPID Response TO YOUR IMPORTANT QUESTIONS

RAPID RAPID ResponseResponse TOTO YOUR QUESTIONS IMPORTANT QUESTIONS FROM READERS

RAPID Response TO QUESTIONS FROM RAPID READERS Response RAPID Response

APSF NEWSLETTER February 2021 PAGE 39

to questions from readers Unanticipated Movement of to questions from readers Skytron Operating Room Tables by Stephen D. Weston, MD; Claudia Benkwitz, MD, PhD; and Richard J. Fechter N

A 4.3kg 6-week-old patient was in the oper- ating room (OR) for repair of a ventricular septal defect. After a minor adjustment in table height using the pendant (hand controller), our Sky- RtronAPID R 3602APID R OR APIDR R tableESPONSE APIDRESPONSE continuedRESPONSE RESPONSE to rise on its to your important questions N own until it reached its full height. The bed's motion could be paused by continuously pressing any of the other buttons on the pen- dant, but only while the button remained depressed. As the bed went to full height, we ensured our lines and monitors were not under tension. The ventilator circuit only just reached the patient's endotracheal tube. Our clinical engineering team changed out the bed control pendant, and we regained normal control of theR bed.APID RFortunately,APID R thisAPIDR R eventESPONSE APIDR happenedESPONSE R ESPONSE RESPONSE after the surgery was complete and the dress- ingto on; your had theimportant bed malfunction questions occurred achieved by a single stuck button on the hand under development, but the time-line for during cardiopulmonary bypass, decannula- controller. We found 4 reports that are at least release is unclear. tion and exsanguination could easily have suggestive of experiences similar to ours. Two Skytron’s examination of our pendant resulted. were reports of unintended vertical motion, one showed evidence of fluid invasion, most likely 2 Our biomedical engineering group was of which bundled four separate incidents. The related to overly wet cleaning cloths used 3 familiar with the problem, diagnosing a stuck other 2 reports are of unintentional airplaning. during room turnovers. In addition, Skytron’s button on the pendant. Our hospital first Investigation by one of our biomedical engi- testing leads them to posit a different mecha- noticed the same problem in May of 2019, neers suggested the cause of the unintended nism for the fault, one more directly related to when unanticipated upward movement of a motion was a stuck button. There is a disk- component wear over many uses. The Skytron bed occurred during a robotic hernia shaped piece of plastic underneath the button authors of this letter are unable to adjudicate repair. Fortunately, the robot was not docked, overlay the operator presses. This piece inter- the most likely mechanism of the unantici- as this would have the potential to do cata- faces with the actual switch behind it. With just pated movement. strophic damage to the patient. Since then, we the right (or wrong) vector of force applied to Our institution has implemented a program have documented 4 additional incidents at our the button, the plastic disk can jam into the of training and review for our hospitality staff to institution, 3 with Skytron 3602 and 1 with Sky- switch, resulting in continuous bed movement. ensure cleaning processes that reduce the risk tron 6701 beds. The motion in each case was While difficult, it has been possible to recreate of leaving the pendant wet beyond the neces- upward vertical motion. Two of these incidents the fault in our lab. sary dwell time of our cleaning agents. We were the subject of prior Medwatch reports to have also undertaken a program of education the FDA.1 All of the buttons on this pendant style share for every member of the OR team. If a Skytron the same design, suggesting that any of them We queried the U.S. Food and Drug Admin- OR table is moving when no button is being could trigger this kind of fault. We suspect that istration Manufacturer and User Facility Device pressed: Experience (MAUDE) database from 2015 to because the table up button is frequently used 1. Press any other button on the bed controller the present for unintended movement in Sky- for its table lock function, that particular button tron OR tables. Although the level of detail in may be more prone to wear, explaining why all to arrest the table's motion. the MAUDE database is not deep, we were of our cases have involved vertical motion. But 2. If time and clinical circumstances allow, try able to exclude some reports that pointed to the role of component wear is unclear, since the pressing the activated button to see if it will different etiologies, such as sudden movement failure leading to unintended motion appears to unstick. consistent with a component failure, or other be inherent in the pendant design. Our events 3. Have someone go under the OR table to electro-mechanical failures indicated by visible have occurred with pendants that are less than press the red emergency stop button. smoke or leaking hydraulic fluid. We also 5 years old. We understand that a pendant bed excluded bed movements that could not be control with a different underlying design is See “OR Tables” Next Page

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 APSF. It is not the intention of 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 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. RAPID Response TO YOUR IMPORTANT QUESTIONS

RAPID Response TO QUESTIONS FROM READERS

RAPID Response

APSF NEWSLETTER February 2021 PAGE 40 Operating Room Table Control Can Lose to questions from readers Functionality When Immersed in Liquids

From “OR Tables,” Preceding Page Pendant Control Cleaning It is now our policy to turn off the OR table once final positioning N is achieved for robotic CAUTION cases. However, there are many cases, such as DO NOT submerge the pendant control those with cardiopulmonary bypass, for which in any water or cleaning solutions! intermittent bed repositioning is required 1. Apply cleaning solutions to the pendant throughout the case, yet where large unin- control and cord. tended changes in patient position could have 2. Using a clean, damp, lint-free cloth, wipe the RcatastrophicAPID RAPID R APIDR results.RESPONSE APIDR TurningESPONSE RESPONSE R offESPONSE the bed for the pendant control to remove the cleaning solution. toduration your important of surgery questions is rarely a viable solution, nor 3. Using a clean, dry, lint-free cloth, wipe the even a broadly applicable band-aid. pendant control and cord to remove all moisture. Stephen Weston, MD, is associate professor in Figure 1: Pendant Control Cleaning. the Department of Anesthesia and Periopera- tive Care at the University of California, San Francisco. cal use and uncommonly displayed both instructions are clear. Skytron specifically cau- Claudia Benkwitz, MD, PhD, is associate profes- external and internal damage, along with result- tions against immersing pendant controls in sor in the Department of Anesthesia and Peri- ing loss of functionality. Specifically, the damage liquids and allowing fluid entry into electrical operative Care at the University of California, and observed loss of functionality in the 22 San Francisco. connectors: UCSF returned units included: Richard Fechter is a clinical engineer at the Uni- When properly maintained, the pendant • 20 Units with fluid ingress versity of California, San Francisco. controls are sufficiently robust and operate • 10 Units with corrosion related to fluid ingress safely and reliably. To be sure, as part of the The authors have no conflicts of interest. investigation, Skytron and its manufacturer • 5 Units backlight failure examined the entire history of complaint data REFERENCES: • 22 Units physical damage to cover and MDR reports for the pendants across all 1. Food and Drug Administration, MAUDE (Manufacturer and user facilities, taking into consideration the fre- User Facility Device Experience) Database. Reports • 2 Units inconsistent or failed battery on/off 8619119 and 9409491. https://www.accessdata.fda.gov/ function quency of occurrence and the number of scripts/cdrh/cfdocs/cfmaude/search.cfm Accessed June tables in distribution. The data demonstrated • 1 Unit continuous table up movement 4, 2020. an extremely low complaint rate, and do not 2. Food and Drug Administration, Manufacturer and User • 9 Units with damage to button face indicate a failure of the device design or sug- Facility Device Experience Database. Reports 8752471, 8939952. https://www.accessdata.fda.gov/scripts/cdrh/ Thus, over 90% of the UCSF units revealed gested maintenance procedures. cfdocs/cfmaude/search.cfm Accessed June 4, 2020. internal evidence of fluid ingress to the elec- The experience of the UCSF team, however, 3. Food and Drug Administration, Manufacturer and User tronic components (consistent with dipping of is being considered as we develop future Facility Device Experience Database. Reports 9340635, the controls and/or other improper cleaning 6081727. https://www.accessdata.fda.gov/scripts/cdrh/ product design enhancements and continuing cfdocs/cfmaude/search.cfm Accessed June 4, 2020. techniques), and 50% of the units exhibited cor- education of our customers regarding proper rosion to the circuit boards and/or wiring. One maintenance of the pendants. Skytron’s focus control with fluid ingress and external damage remains on understanding and meeting the Response: was also found to have internal physical damage specific needs of our users as we develop This letter follows up a comprehensive to the button resulting in a continuous table up products that ensure patient safety and cus- investigation and review by Skytron and its movement. Skytron has concluded that the tomer satisfaction. manufacturer, Mizuho, of reported UCSF pen- reported issues with the UCSF controls were dant control concerns regarding inadvertent caused by a combination of fluid ingress and Skytron continues to work with UCSF to meet table movement, and responds to your request atypical use and force applied to the pendants. its user needs and ensure product satisfaction, including reinforcement of proper maintenance, for information dated September 14, 2020. The use and maintenance of the pendant Skytron and Mizuho have concluded their controls contributed to the malfunction experi- cleaning, and inspection protocols. investigation of the UCSF pendant controls, enced by UCSF. Skytron understands and Please call or email me if you have any fur- which included extensive physical examination appreciates the challenges of the clinical envi- ther questions. and testing of the UCSF controls. As discussed ronment and strives to ensure that its products Sincerely, in a meeting with the UCSF team on Friday, are sufficiently robust to meet such challenges. September 4, 2020, the returned UCSF pen- With respect to maintenance of pendants, Erin Woolf dant controls exhibited a high degree of atypi- however, Skytron’s manual and cleaning Quality Manager, Skytron

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 APSF. It is not the intention of 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 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. APSF NEWSLETTER February 2021 PAGE 41

Drug-Induced MH-like Syndromes in the Perioperative Period by Charles Watson, MD; Stanley N. Caroff, MD; and Henry Rosenberg, MD

MALIGNANT HYPERTHERMIA VS. anticholinergic effects are relatively contraindi- prochlorperazine can also trigger NMS. These DRUG-INDUCED MH-LIKE SYNDROMES cated because they inhibit heat dissipation and are often given perioperatively for nausea or Anesthesia professionals recognize malig- sweating.4 Dantrolene sodium is a specific anti- nausea prophylaxis. The onset of hypermeta- nant hyperthermia (MH) in the perioperative dote to the MH crisis because of its direct action bolic signs with fever, abnormal muscle activity period as a rapidly progressing, life-threatening, on muscle, but it may also be helpful in control- (including rigidity), and abnormal mentation can hypermetabolic syndrome that’s triggered in ling fever caused by muscle hyperactivity and be seen within hours and up to one or two the muscle of genetically susceptible individu- heat production caused by these CNS and weeks after neuroleptics are started. Progres- als by potent inhalational anesthetic agents other problems.5-8 sion of these signs is usually reversed over time and/or succinylcholine. Unless recognized and The volunteer MH Hotline that is supported by when the causative agents are discontinued, treated expeditiously by withdrawal of the trig- donations and the Malignant Hyperthermia but unrecognized NMS can progress to muscle gering agent(s), intravenous dantrolene sodium Association of the United States [MHAUS] injury, cardiorespiratory failure, and death. Pri- and other supportive measures, MH crisis has a receive calls from anesthesia and surgical practi- mary treatment requires early diagnosis, neuro- high morbidity and mortality. Evolving signs of tioners, perioperative nursing staff, and others leptic withdrawal, and supportive medical care. MH include rapidly rising temperature, heart with questions about the recognition and man- In the absence of randomized controlled trials, rate (HR), CO2 production, end-tidal CO2, respi- agement of MH crises, post-crisis management, benzodiazepines, dopaminergic drugs like bro- ratory rate (RR), spontaneous or required and other conditions that resemble MH. (https:// mocriptine or amantadine, dantrolene, and ECT minute ventilation, increased muscle tone with www.mhaus.org) Review of MH Hotline calls (electroconvulsive therapy) have been rigidity, and multiple organ system failure shows that some of these calls are associated employed with varying success. Neither labora- (MOSF). Muscle injury can lead to renal failure, with MH-like conditions that are drug- or toxin- tory tests nor presenting symptoms make the even when the MH crisis is treated effectively. induced (unpublished data-author’s personal diagnosis of NMS. Diagnosis requires a thor- Fever with unmet metabolic demand together communication with MHAUS Hotline Database). ough medical history and examination together with cardiac and microcirculatory failure can with elimination of other organic or drug- lead to coagulopathy, hepatic dysfunction, Drug-induced, MH-like syndromes include induced conditions.9,10 If NMS is suspected, the other MOSF, and death.1,2 Neuroleptic Malignant Syndrome (NMS), Parkin- Neuroleptic Malignant Syndrome Information sonism/Hyperthermia Syndrome (PHS), Sero- Service (NMSIS) sponsored by MHAUS pro- MH is best known by anesthesia profession- tonin Syndrome (SS), baclofen withdrawal, vides literature, and email and telephone sup- als because it is triggered by anesthetic drugs. intoxication caused by stimulants like amphet- port through its website (www.NMSIS.org) Since anesthesia intervention causes an MH amine, MDMA and cocaine, and psychoactive crisis, it has become an anesthetic-related prob- drugs like phencyclidine (PCP, “angel dust”) and PARKINSONISM-HYPERTHERMIA lem. But there are other drug-induced hyper- lysergic acid diethylamide (LSD) (see Table 2). SYNDROME (PHS) metabolic conditions that are caused by While the clinical setting of these is most often PHS is caused by withdrawal of centrally abnormal central nervous system (CNS])activity not perioperative and the presentation may not acting dopaminergic drugs that control the and have signs resembling those of an MH be so fulminant as classic MH, these conditions muscle rigidity, motor retardation, and other crisis (See Table 1).3 Moreover, anesthetic drugs also can pose life-threatening medical prob- symptoms of Parkinson’s disease. Symptoms or interventions may contribute to or precipitate lems that the anesthesia and surgical team often fluctuate and drug dosing may vary these. Such CNS crises can present in the have to address intra- and postoperatively. And, because patients can become relatively insen- extended perioperative period with MH-like of course, these evolving drug-induced prob- sitive to dopaminergic drugs. Dopaminergic signs of hypermetabolism (elevated HR, RR, lems should be differentiated from inflamma- drugs are sometimes stopped during acute temperature, and carbon dioxide production), tory and central neurologic effects of organic hospitalization for medical or surgical condi- abnormal motor activity, abnormal mentation, conditions like encephalitis, sepsis, CNS tions or preoperatively in order to minimize their and progressive cardiorespiratory failure. abscess, tumor, head trauma, and some autonomic side effects. PHS, a semi-acute con- Although these drug-induced crises are more strokes. Also, confusion, together with hyper- commonly seen by emergency medicine, neu- dition that resembles NMS and MH, may follow metabolism is seen with thyrotoxicosis, heat- sudden withdrawal of Parkinsonian drug ther- rology, psychiatry, and critical care providers as stroke, and untreated lethal catatonia. evolving medical emergencies, they can also apy. It is reported in up to 4% of patients in present around the time of surgery. Central NEUROLEPTIC-MALIGNANT whom dopaminergic drugs are acutely discon- drug-related hypermetabolic conditions are SYNDROME (NMS) tinued and approximately a third of patients who develop the syndrome have long-term important to anesthesia professionals because NMS is a relatively rare condition associated 11 they can be seen in the perioperative period, with administration of chronic or increasing sequellae. Fever, abnormal muscle activity, are not MH (although they may resemble MH), doses of neuroleptic drugs that block dopami- and other signs of hypermetabolism together and may have different management require- nergic activity in the brain. Neuroleptics are with autonomic instability are seen. PHS may ments if morbidity and mortality are to be given for sedation, behavioral control, and be facilitated by dehydration, infection, and avoided. Although these are not caused primar- management of psychotic disorders. Postop- other system stresses, or following administra- ily by anesthetic drugs, some can be precipi- eratively they may be used for behavioral con- tion of central dopamine-blocking drugs like tated by drugs commonly given or withheld in trol during emergence delirium, for antiemetic droperidol or neuroleptics like haloperidol. It the perioperative period. Fever associated with properties, or in the ICU following surgery. can also be induced in Parkinson’s patients MH crisis and these central hypermetabolic Individuals who take these drugs, and are ill, after sudden loss of deep brain stimulation conditions respond poorly to antipyretic drugs. dehydrated, agitated, or catatonic are more (DBS) for Parkinson’s disease or following Anticholinergic and antipsychotic drugs with susceptible to NMS. “Occult” neuroleptics like See “MH-like Syndromes,” Next Page APSF NEWSLETTER February 2021 PAGE 42

MH-like Syndromes (Cont.)

15 From “MH-like Syndromes,” Preceding Page Table 1: MH-Like Signs and Symptoms. blood vessels. Consequently, a number of implantation of electrodes for DBS.12,13 While antidepressant drugs have been designed to Rising Temperature NMS is a life-threatening condition caused by manipulate CNS serotonin levels. These drugs that block central dopamine, PHS is Tachycardia include the Selective Serotonin Reuptake Inhib- itors (SSRIs), Selective Norepinephrine Reup- caused by withdrawal of dopaminergic therapy. Tachypnea For this reason, complete discontinuation of take Inhibitors (SNRIs), tricyclic antidepressants, Increasing Hypercarbia—Especially with and monoamine oxidase inhibitors (MAOIs). dopaminergic therapy in the perioperative Fixed, Controlled Ventilation period should be avoided, if at all possible. Also, The incidence of SS has been reported as those patients who have had their Parkinsonian Confusion, Agitation, Altered Mentation 0.9–2% of patients on chronic therapy and as drugs discontinued in the perioperative period, Muscle Rigidity, Cramping, Tremor, high as 14–16% after overdose.16 SSRIs and should restart therapy as soon as possible.14 Spasms SNRIs are most commonly associated with SS. Hypertension/Hypotension Commonly used anesthetic adjuvant drugs and SEROTONIN SYNDROME (SS) Cardiac Arrhythmia other major classes of drugs—including some SS is usually seen when several drugs that sold without prescription—may contribute to or increase central serotonin levels are given con- precipitate SS (see Table 3).17-20 comitantly, but it may also occur following a platelets. Serotonin modulates a broad array of single dose or overdose of one or more seroto- central and peripheral actions that include regu- SS may present with altered mental status, nergic drugs. Serotonin or 5-hydroxytrypta- lation of mood, appetite, sleep, some cognitive autonomic dysfunction, hypotension, neuro- mine, a monoamine derived from tryptophan, is functions, platelet aggregation, and smooth muscular rigidity, agitation, ocular and periph- a neurotransmitter in the brain, gut, and on muscle contraction of uterus, bronchi, and small eral clonus, diaphoresis, and fever.

Table 2: Drug-Induced MH Look-Alike Conditions.

Probable Syndrome Drug Cause Implicated Drugs Factors Onset Signs & Symptoms NMS CNS Neuroleptics like haloperidol. Dehydration, 1–2 weeks Fever, hypermetabolism, dopamine Dopamine blocking antiemetics like overdose, rigidity, shivering, abnormal deficit metoclopramide & prochlorperazine increasing or mixed CNS, unstable BP, rising drug doses creatinine kinase, MOSF PHS Dopamine Parkinsonian dopaminergic Abrupt Hours to As above deficit withdrawal discontinuation, days dehydration & stress SS CNS & SSRIs, SNRIs, triptans, MAOIs, TCAs, Overdose or 1–24 hours As above & myoclonus, peripheral some anesthetic adjuvants, increasing doses, agitation, confusion, dilated serotonin methylene blue, some OTC drugs like multidrug pupils, GI symptoms, evolving excess loperamide, dextromethorphan interactions MOSF Baclofen Withdrawal Baclofen Pump failure, Hours to Hypertension, rigidity, prescription stop days dysautonomia, depressed CNS, coagulopathy, & MOSF Amphetamines Direct CNS Amphetamines, dexamphetamine, Dehydration, stress, Hours Hyperdynamic circulation, & CNS & MDMA, cocaine other illness fever, sweating, pupillary stimulants peripheral dilatation, cardiorespiratory, & effects MOSF PCP Direct CNS PCP or “angel dust” Dehydration, stress, Hours Slurred speech, abnormal & other illness gait, rigidity, sweating, peripheral hypersalivation, convulsions, effects coma, MOSF LSD Direct CNS LSD & LSD preparations Dehydration, major Hours Hallucinations, rigidity, & stress, intercurrent psychosis, CNS depression, peripheral illness respiratory arrest, effects coagulopathy, MOSF Table Abbreviations: NMS (neuroleptic malignant syndrome), CNS (Central Nervous System), MOSF (multiple organ system failure), PHS (Parkinsonism- Hyperpyrexia Syndrome), SS (Serotonin Syndrome), SSRIs (selective serotonin reuptake inhibitors), SNRIs (selective norepinephrine reuptake inhibitors), Triptans (a class of Triptamine-based drugs used to abort migraines & cluster headaches), TCAs (tricyclic antidepressants), MAOIs (Monoamine Oxidase Inhibitors), OTC (sold without prescription “over the counter”), GI (gastrointestinal), MDMA (3,4-methylenedioxy-methamphetamine or "ectasy"), PCP (phen- cyclidine or “angel dust”), LSD (lysergic acid diethylamide). See “MH-like Syndromes,” Next Page APSF NEWSLETTER February 2021 PAGE 43

Drug-Induced Hypermetabolic Syndromes May Present in the Perioperative Setting

From “MH-like Syndromes,” Preceding Page Baclofen is commonly given orally or by direct for elective surgery. Just as some patients pre- Onset can be abrupt following drug adminis- injection/infusion into cerebrospinal fluid by medicate themselves with alcohol or “medical” tration or overdose. SS can present as a hyper- anesthesia and other pain specialists to control marijuana prior to surgery in order to control thermic, hypermetabolic syndrome that’s spasticity seen following CNS damage in condi- anxiety, habitual users of these psychoactive difficult to distinguish from NMS, PHS, and MH. tions like cerebral palsy, spinal cord injury, and drugs may do the same. While initial subjective As with NMS and PHS, progression of symp- dystonia. Since anesthesia pain specialists use symptoms vary as each of these drugs takes baclofen, it isn’t that uncommon for other anes- effect, all may produce signs of sympathetic toms may lead to cardiorespiratory failure, thesia practitioners to become involved in hyperactivity, abnormal motor activity, fever, muscle damage, multiple organ injury, and pump refills, assessment of a malfunctioning and hypermetabolism with cardiorespiratory death. The incidence of SS may be underesti- baclofen pump, or a baclofen prescription for a and MOSF in the perioperative period. Patients mated, possibly because of mild cases that are colleague. Hence it’s important for members of presenting for surgery with abnormal menta- overlooked or because more serious presenta- the anesthesia care team to know that the MH- tion, signs of sympathetic hyperactivity, and tions can mimic other causes. Hence it may be like syndrome following acute baclofen with- other unusual symptoms that are not caused by that SS is more common in the perioperative drawal, with relative CNS deficiency of GABA, their primary medical problem should have toxi- period than we know. It is important for anes- can be dramatic with fever, abnormal menta- cology screening if at all possible. thesia practitioners to remember that a number tion, autonomic hyperactivity, respiratory dis- of anesthetic adjuvant drugs we commonly use tress, rhabdomyolysis, and coagulopathy. CONCLUSION: can precipitate or increase risk of SS. Treatment Treatment involves supportive medical care While anesthesia professionals know MH as requires cessation of all drugs that contribute to and reinstitution of baclofen therapy.23 a perioperative crisis, it is important to be aware serotonin excess together with supportive ther- of other drug-induced hypermetabolic syn- apy.15,16 Although unproven, some authorities RECREATIONAL DRUGS dromes that may be seen in the perioperative recommend use of the central 5-hydroxytrip- Selected CNS stimulants used for “recre- setting. Indeed, commonly used anesthetic tamine 2a receptor blocker, cyproheptadine, ation” or in overdose cause hypermetabolic adjuvant drugs may contribute to or precipitate because the 5 hydroxytriptamine 2a receptor is conditions that may resemble MH crisis through some of these. Dantrolene sodium is the critical thought to be one of the primary central activa- direct peripheral and CNS effects. These drug for treatment of MH crisis, but it is non- tors of hyperthermia in SS.16,21,22 include amphetamines, dextroamphetamine, specific in that it may ameliorate some of the methamphetamine, MDMA (methylene-dioxy- hypermetabolic signs of other conditions. BACLOFEN WITHDRAWAL methamphetamine), cocaine, and psychoactive Because these can closely mimic the MH crisis NMS and MH-like reactions have been drugs like PCP and LSD. Although a drug his- and dantrolene may control some of the symp- reported following baclofen withdrawal. tory and toxicology screening usually identify toms, misdiagnosis as MH could delay or pre- Baclofen enhances the central effects of such problems before emergency surgery for vent other effective treatment. gamma-aminobutyric acid (GABA), an inhibitory trauma or other acute conditions, “recreational” Charles Watson, MD, is a volunteer MH Hotline central nervous system (CNS) neurotransmitter. use may be encountered in patients scheduled Consultant for the Malignant Hyperthermia Association of the United States (MHAUS), Sher- Table 3: Some Drugs that Cause or Potentiate Serotonin Syndrome. burne, NY. Anesthesia Stanley Caroff, MD, is professor of psychiatry at Antidepressants Triptans Adjuvants Miscellaneous the University of Pennsylvania School of Medi- SSRIs Almotriptan Cocaine Buspirone cine and director of the Neuroleptic Malignant Citalopram Eletriptan Meperidine Cyclobenzaprine Syndrome Information Service (NMSIS) and an officer of MHAUS. Fluoxetine Frovatriptan Methadone Dextromethorphan Ergot Fluvoxamine Naratriptan Ondansetron Henry Rosenberg, MD, is the president of 5-hydroxytryptophan MHAUS. Paroxetine Rizatriptan Tramadol Linezolid Trazodone Sumatriptan Fentanyl Loperamide Drs. Watson and Rosenberg have no conflicts of interest. Zolmitriptan Methylene blue Dr. Caroff is a consultant for Neurocrine SNRIs St. John’s wort Duloxetine Biosciences, Teva Pharmaceuticals. He has also received research grants from Neurocrine Sibutramine Biosciences, Osmotica Pharmaceuticals, Eagle Venlafaxine Pharmaceuticals. Tricyclics REFERENCES 1. Rosenberg H, Davis M, James D, et al. Malignant hyperther- MAOIs mia. Orphanet Journal of Rare Diseases. 2007:2:21. Phenelzine 2. Rosenberg H, Hall D, Rosenbaum H. Malignant hyperther- mia. In: Brendt J, ed. Critical Care Toxicology. Elsevier- Tranylcypromine Mosby; 2005:291–304. Abbreviations: SSRIs (selective serotonin reuptake inhibitors), SNRIs (selective norepinephrine reuptake inhibitors), MAOIs (monoamine oxidase inhibitors). See “MH-like Syndromes,” Next Page APSF NEWSLETTER February 2021 PAGE 44

MH-like Syndromes (Cont.-References)

From “MH-like Syndromes,” Preceding Page 9. Caroff SN, Rosenberg H, Mann SC, et al. Neuroleptic malig- 17. Nguyen H, Pan A, Smollin C, et al. An 11-year retrospective nant syndrome in the perioperative setting. Am J Anesthe- review of cyproheptadine. J Clin Pharm Ther. 2019;44:327– 3. Parness J, Rosenberg H, Caroff SN. Malignant hyperthermia siology. 2001; 28: 387–393. 334. doi: 10.1111/jcpt.12796 and related conditions. In: Kellum JA, Fortenberry JD, Fuchs BD & Shaw A, eds. Clinical Decision Support: Critical Care 10. Caroff SN. Neuroleptic malignant syndrome. In: Mann SC, 18. Basta MN. Postoperative serotonin syndrome following Medicine. Wilmington, Delaware: Decision Support in Med- Caroff SN, Keck PE, Lazarus A, eds. Neuroleptic Malignant methylene blue administration for vasoplegia after cardiac icine, LLC: 1913. Syndrome and Related Conditions. 2nd Ed. Washington, surgery: a case report and review of the literature. Semin DC: American Psychiatric Publishing; 2003:1–44. 4. Mann SC. Thermoregulatory mechanisms and antipsy- Cardiothoracic Vasc Anes. 2020: 1089253220960255. chotic drug-related heatstroke. In: Mann SC, Caroff SN, 11. Newman EJ, Grosset DG, Kennedy, PGE. The parkinson- (pre-pub) Keck PE, Lazarus A, eds. Neuroleptic Malignant Syndrome ism-hyperpyrexia syndrome. Neurocrit Care 2009;10:136– 19. Orlova Y, Rizzoli P, Loder E. Association of coprescription of and Related Conditions. 2nd Ed. Washington, DC: American 140. triptan antimigraine drugs and selective serotonin reuptake Psychiatric Publishing; 2003:45–74. 12. Artusi CA, Merola A, Espay AJ, et al. Parkinsonism-hyperpy- inhibitor or selective norepinephrine reuptake inhibitor anti- 5. Goulon M, de Rohan-Chabot P, Elkharrat D, et al. Beneficial rexia syndrome and deep brain stimulation. J Neurol. 2015; depressants with serotonin syndrome. JAMA Neurol. effects of dantrolene in the treatment of neuroleptic malig- 262:2780–2782. 2018;75:566–572. Neurology. nant syndrome: a report of two cases. 13. Caroff SN. Parkinsonism-hyperthermia syndrome and deep 20. Boyer EW, Shannon M. The serotonin syndrome. N Engl J 1983;33:516–518. brain stimulation. Can J Anaesth. 2017;64:675–676. Med. 2005;352:1112–1120. 6. Pawat SC, Rosenberg H, Adamson R, et al. Dantrolene in 14. Newman EJ, Grossett DG, Kennedy PG. The parkinsonism- 21. Simon L, Kennaghan M. Serotonin syndrome [review]. Stat- the treatment of refractory hyperthermic conditions in criti- hyperpyrexia syndrome. Neurocrit Care. 2009;10:136–140. Pearls. NCBI Bookshelf. 2020:5. Published Jan 2020, cal care: a multicenter retrospective study. Open Journal of Accessed October 2020. Anesthesiology. 2015;5:63–71. 15. Frazer A, Hensler JG. Serotonin involvement in physiologi- 7. Hadad E, Cohen-Sivan Y, Heled Y, et al. Clinical review: cal function and behavior. In: Siegel GJ, Agranoff BW, Albers 22. Nguyen H, Pan A, Smollin C, et al. An 11-year retrospective treatment of heat stroke: should dantrolene be considered? RW, et al., editors. Basic Neurochemistry: Molecular, Cellular review of cyproheptadine use in serotonin syndrome cases Crit Care. 2005;9:86–91. and Medical Aspects. 6th edition. Philadelphia: Lippincott- reported to the California Poison Control System. J Clin Raven; 1999. Available from: https://www.ncbi.nlm.nih.gov/ Pharm Ther. 2019:44;327–334. 8. Shih TH, Chen KH, Pao SC, et al. Low dose dantrolene is books/NBK27940/ Accessed December 12, 2020. effective in treating hyperthermia and hypercapnea, and 23. Coffey RJ, Edgar TS, Francisco GE, et al. Abrupt withdrawal seems not to affect recovery of the allograft after liver trans- 16. Francescangeli J, Karamchandani K, Powell M, et al. The from intrathecal baclofen: recognition and management of plantation: case report. Transplantation Proceedings. 2010; serotonin syndrome: from molecular mechanisms to clinical a potentially life-threatening syndrome. Arch Phys Med 42:858–860. practice. Int J Mol Sci. 2019;20:2288. Rehabil. 2002;83:735–741.

Postoperative Anterior Neck Hematoma (ANH): Timely Intervention is Vital by Madina Gerasimov, MD, MS; Brent Lee, MD, MPH, FASA; and Edward A. Bittner, MD, PhD

INTRODUCTION An Anterior Neck Hematoma (ANH) can quickly progress to an airway obstruction that can occur at any time following a surgical inter- vention of the neck. Typically, most patients present within 24 hours of their original proce- dure.1 Patients with an ANH need swift inter- ventions to mitigate any life-threatening emergencies. We illustrate this important surgi- cal complication and its associated challenges with a specific case of ANH.

CASE STUDY A 49-year-old man underwent a total thyroid- ectomy for the diagnosis of thyroid cancer. His past medical history included transient ischemic attacks, hypertension, chronic obstructive pul- monary disease/asthma. He was a current heavy smoker whose preoperative medications included aspirin (81 mg) and an albuterol inhaler, which he took as needed. His labs were all within normal limits. After an uneventful surgery, the patient was discharged from the postanes- thesia care unit after five hours of observation and transferred to a surgical ward. The following day he complained of neck swelling, associated Figure 1: Arrows indicate active contrast extravasation from superior thyroid artery to the right of cricoid with pain, dysphagia, and odynophagia. He cartilage with hematoma formation anterior to the trachea. (P and I are not relevant to this illustration.) denied voice changes and difficulty breathing. See “Neck Hematoma,” Next Page APSF NEWSLETTER February 2021 PAGE 45

Anesthesia Professionals Should Understand the Signs and Symptoms of Anterior Neck Hematomas

From “Neck Hematoma,” Preceding Page tings including the postanesthesia care unit, Table 1: Procedure-Specific Risk Factors. operating room, intensive care unit, emergency On initial exam he appeared in no acute dis- department, or on a hospital ward. The true inci- Procedure-Specific Risk Factors tress, exhibited no drooling or stridor, and was dence of ANH is hard to estimate, as these Anterior Discectomy10 alert and oriented. His vitals were 98% on room cases are likely under-reported in the current • Exposure of >3 vertebral bodies air, blood pressure 167/97, heart rate 70, respira- literature.2 Closed-claims data obtained from • Excessive retraction tory rate 18, T 37.2°C, Weight 123 kg, body mass medical malpractice insurance carriers is infor- • Blood loss >300 ml index 36. After removing the dressing, a fluctu- mative, but represents only a fraction of all clini- • Exposure of upper cervical levels ant swelling of the anterior neck compartment cally significant cases. Proposed factors measuring approximately 8 cm in diameter was contributing to ANH may be associated with the • Operative time >5 hours appreciated. Physical exam demonstrated lim- procedure, patient’s characteristics, or underly- Thyroidectomy/ ited mouth opening when compared to pre- ing conditions (Table 1). Parathyroidectomy11-15* operative examination due to pain, a large • Retching and vomiting during recovery tongue, and Mallampati Class 4 airway. PATHOPHYSIOLOGY • Postoperative hypertension Based on these findings the difficult airway When considering the potential source of • Constipation equipment cart was brought to the bedside. An bleeding, one should keep in mind that venous • Bilateral/total (vs. unilateral/partial)* urgent anesthesia consult was called and the bleeding is often more complex in distribution Carotid Endarterectomy16 patient was taken to the radiology department and more difficult to isolate the site of origin. for a computerized tomography angiography of Arterial bleeds conversely are more obvious • Incomplete reversal of heparin the neck to evaluate for a potential source of and amenable to different interventions, includ- • Intraoperative hypotension bleeding. The imaging revealed significant ing embolization. A recent case series and • General anesthesia anterior neck swelling, trachea midline, patent review points out that arterial bleeding from the • Preoperative antiplatelet medications airway, and active contrast extravasation to the superior thyroid artery can present up to 16 • Inadequate hemostatis right of cricoid cartilage (Figure 1). days postoperatively.3,4 • Placement of carotid shunt The decision was made for immediate trans- Contrary to common belief, the pathophysiol- Neck Dissection (radical or partial) port to the operating room (OR) to secure the ogy of ANH leading to airway compromise and • Excessive tissue retraction17 difficulty in securing the airway is only partially airway. Topicalization of the airway was performed Central Line Placement18,19 with lidocaine 4% administered via a nebulizer for related to the direct effect of the hematoma • Multiple attempts five minutes. Shortly after administration, the compression resulting in tracheal deviation, pha- patient became anxious, agitated, and less coop- ryngeal airway obstruction, or posterior tracheal • Use of anatomical landmarks (vs. ultrasound guided) erative. Several attempts were made at oral fiber- compression where bony support is lacking. Nerve blocks20 optic intubation but were unsuccessful secondary A major cause of airway compromise is to friable edematous mucosa and bleeding inter- hematoma-induced interference with venous Patient-Associated Risk Factors2 fering with visualization. 5 and lymphatic drainage. These low-pressure • Coagulopathy capacitance vessels are easily compressed by After phone consultation with the trauma sur- • Male gender the expanding hematoma while the arterial ves- geon, the sutures were opened along the • Black race sels continue to pump blood into the laryngeal wound by the anesthesia professional and gen- • ≥4 comorbiditites (e.g., renal eral anesthesia was induced with propofol. An soft tissue, tongue, and posterior pharynx. As insufficiency, diabetes, coronary I-gel laryngeal mask airway was inserted to pro- the back pressure increases, plasma leaks out disease, hypertension) vide immediate ventilation. The platysma clo- of these vessels and diffuses into the surround- sure was opened using blunt dissection, as ing tissues, which further accelerates the com- *Data regarding the prevalence of bilateral/total thyroidectomy vs. unilateral/partial is still inconsistent; instructed by the surgeon, exposing the tra- pression of the veins and lymphatics in a rapidly however, the presence of radiation therapy and extent chea. Hematoma and clots were partially worsening feedback loop. It is important to note of resection, as well as the degree of dissection, has extruded. An endotracheal tube (ETT) 6.0 was that the degree of edema does not necessarily been implicated. advanced through the LMA into the trachea correlate with the degree of external swelling and correct placement was confirmed initially and may not resolve immediately upon clot Although the patient in the case presented was by direct palpation of the trachea and presence evacuation, making diagnosis and treatment sent to CT scan for evaluation, this practice may 5 of end tidal CO2. The patient remained hemo- more challenging. not be advisable given the lack of close moni- dynamically stable throughout. The trauma sur- Finally, communicating neck spaces promote toring of the patient while in the scanner and geon arrived after intubation and evacuated the the expansion of the bleeding with worsening the delays that may result from transport and remaining hematoma. The patient remained edema secondary to blood dissection along imaging time. Use of bedside ultrasound may intubated postoperatively for concern of airway tissue planes.5 Thus, when evaluating a patient be a better alternative as it is often more acces- edema and was successfully extubated the fol- with ANH, it is important to keep in mind that sible and familiar to anesthesia professionals to lowing day. sudden and catastrophic airway compromise assess the internal structures of the neck for DISCUSSION can occur without warning. It is, therefore, para- size and location of hematoma, degree of tissue edema, and patency of the airway.17 An anesthesia professional can encounter mount to be ready with difficult airway, suture patients with ANH in many different clinical set- removal, and tracheotomy equipment. See “Neck Hematoma,” Next Page APSF NEWSLETTER February 2021 PAGE 46

Anesthesia Professionals Should Understand the Signs and Symptoms of Anterior Neck Hematomas

From “Neck Hematoma,” Preceding Page Table 2: Anterior Neck Hematoma—Signs & Symptoms Timely recognition and intervention of a EARLY LATE developing ANH is potentially lifesaving. All providers caring for such patients should, there- Increased neck pain Difficulty or painful swallowing/drooling fore, be well versed in understanding the signs Asymmetry of neck Facial edema and symptoms of ANH leading to airway obstruction (Table 2) and be trained to inter- Change in neck circumference Enlarged tongue vene rapidly. Several factors that may contrib- Change in drain output Tracheal deviation ute to a delay in making the diagnosis include Tightness of neck Convexity of neck opaque dressing, C-collar, infrequent exams, and overall lack of vigilance and/or awareness. Voice change, hypertenstion Shortness of breath/tachypnea Discoloration of neck Stridor MANAGEMENT To assist with prompt clinical management of Agitation the ANH patient we have developed an algo- Tachycardia rithm which in our opinion proposes a care pathway for patients with ANH (Figure 2). This algorithm has not yet been published or clini- Anterior Neck Hematoma: cally validated. Airway Management Pathway Prompt notification and evaluation by the sur- gical team should occur as soon as ANH is sus- EARLY SIGNS Rapid non-linear deterioration. LATE SIGNS pected. Prior to more invasive interventions, & SYMPTOMS Can occur any time up & SYMPTOMS to 24–48 hours post-op supportive measures such as head elevation, administration of 100% oxygen or Heliox, intra- • Worsening neck pain • Diƒculty swallowing/ drooling venous steroids, and/or inhaled racemic epi- • Neck assymetry • Page Surgeon STAT • Voice change 5 • ↑Neck circumference • nephrine may be beneficial. Call for Help/Rapid • • Change in drain output Response (Respiratory Stridor Flexible fiberoptic nasopharyngo-video- • Neck tightness Therapy, ICU, Hospitalist) • SOB/tachypnea • HTN • • Facial edema, enlarged laryngoscopy using a 6 mm scope (for adults) or Alert OR team • Diƒcult airway cart to tongue 1.99 mm (pediatrics) can be useful to identify bedside • Tracheal deviation displacement of the larynx, degree of laryngeal • Suture Removal, Trach kit • Agitation, HR↑ edema, location, and size of any mass. to bedside • Continue supportive • Surgeon opens incision at Caution must be exercised, however, when measures (see below) bedside • performing any procedure on these patients, as If respiratory symptoms • Prepare for diƒcult rapidly progressing/ intubation, including similar to patients with epiglottitis, ANH patients impending airway 18 Awake FOB are susceptible to full airway collapse. In those collapse, consider with • surgeon on the phone Transport to OR for patients with a very narrow airway lumen and opening the suture line to definitive hemostasis, high air flow resistance (breathing through a evaculate superficial NO SURGEON YES once stable narrowed orifice), the work of breathing may be hematoma IMMEDIATELY • Transport to ICU and • Surgeon recommends significantly increased, resulting in hypoventila- inform the surgeon AVAILABLE observation in ICU and/or tion and elevated carbon dioxide levels. As a • Diƒcult airway cart at further evaluation (e.g., result, any actions that increase pain and/or bedside CT, US) • Keep intubation/Trach anxiety and, therefore, elevate blood pressure, • Prepare for Awake FOB or RESPIRATORY emergency scalpel/bougie ARREST equipment at bedside heart rate, or oxygen consumption can lead to cricothyroidotomy if respiratory arrest. feasible AT ANY TIME SUPPORTIVE As exhibited by the patient in the case study MEASURES presented here, new onset of anxiety and agi- • 100% Oxygen tation may also be signs of hypercarbia and/or • Keep head elevat- • Attempt diƒcult intubution hypoxia and, therefore, impending airway ed/upright position • Facilitate tube placement via open • Consider racemic compromise. If a surgeon is not immediately palpation of trachea epinephrine nebulizer available, an anesthesia professional may be • If unable to intubate, use scalpel for • Consider heliox called upon to evacuate the hematoma and emergency cricothyroidotomy • Consider IV steroids secure the airway while waiting for a surgeon to arrive. In the absence of a surgeon, opening Figure 2: Anterior Neck Hematoma: Airway Management Pathway. the suture line and evacuating the hematoma Abbreviations: CT (Computed tomography), FOB (Fiberoptic bronchoscopy), ICU (Intensive Care Unit), IV (Intravenous), may be the only recourse to prevent and/or HTN (Hypertension), HR (Heart Rate), OR (Operating Room), SOB (Shortness of breath), US (Ultrasound). relieve total airway obstruction. See “Neck Hematoma,” Next Page APSF NEWSLETTER February 2021 PAGE 47

Complete Airway Obstruction from ANH Can be Rapid and Without Warning From “Neck Hematoma,” Preceding Page Table 3: Furthermore, in the event of total airway col- lapse, a percutaneous (needle) cricothyroidot- QUESTIONS OPTIONS omy may not be sufficient to reestablish a patent WHAT? • Open suture line airway due to anatomic distortion. In such a cir- • Evacuate hematoma cumstance, a surgical cricothyroidotomy may be • Intubate the only effective means to reestablish an airway, • Awake fiberoptic bronchoscopic evaluation of airway due to a completely swollen neck with distorted WHEN? • Await arrival of surgeon landmarks.1,4,8 • Act without delay We recognize that anesthesia professionals WHERE? • Operating room may not be comfortable performing these inva- • ICU sive surgical procedures, and, therefore, we • Emergency Department recommend simulation training and other • Bedside on the ward hands-on education be undertaken proactively. HOW? • Awake vs. under general anesthesia? Based on our experience, in emergency situa- If asleep: tions such as this, omission bias may be an • Intravenous vs. inhalational induction? obstacle resulting in delayed care.9 The follow- ing two suggestions may bolster one’s level of be prepared to intervene in such cases when a 8. Heymans F, Feigl G, Graber S, et al. Emergency cricothy- confidence, overcome omission bias, and surgeon is not immediately available, and, rotomy performed by surgical airway–naive medical per- sonnel. Anesthesiology. 2016;125:295–303. empower the anesthesia professional to per- therefore, should be familiar with and train to form these lifesaving interventions: perform surgical techniques that generally fall 9. Stiegler MP, Neelankavil JP, Canales C, et al. Cognitive errors detected in anesthesiology: a literature review and a) call for help from an in-house physician, pref- outside of our usual skill sets. pilot study. Br J Anaesth. 2012;108:229. erably someone with some form of airway Madina Gerasimov, MD, MS, is assistant profes- 10. Sagi HC, Beutler W, Carroll E, et al. Airway complications expertise sor at the Donald and Barbara Zucker School of associated with surgery on the anterior cervical spine. b) have the surgeon on the phone while one Medicine at Hofstra/Northwell; site director, Spine. 2002;27:949–953. performs such maneuvers for guidance and Quality Assurance, North Shore University Hos- 11. Bononi M, Amore Bonapasta S, Vari A, et al. Incidence and support. pital, Manhasset, NY. circumstances of cervical hematoma complicating thyroid- ectomy and its relationship to postoperative vomiting. Depending on the clinical presentation of the Brent Lee, MD, MPH, FASA, is director of Clinical Head Neck. 2010;32:1173–1177. patient, a decision must be made as to whether Excellence and Performance Improvement, 12. Shun-Yu C, Kun-Chou H, Shyr-Ming S-C, et al. A prospective invasive interventions are needed immediately, North American Partners in Anesthesia (NAPA). randomized comparison of bilateral subtotal thyroidectomy or whether one has time to observe and/or wait versus unilateral total and contralateral subtotal thyroidec- Edward A. Bittner, MD, PhD, is associate profes- World Journal of Surgery. for a surgeon to arrive and evaluate. tomy for Graves’ Disease. sor of anesthesiology, Harvard Medical School, 2005;29:160–163. The following questions should be asked: Massachusetts General Hospital, Boston, MA, 13. Yu NH, Jahng TA, Kim CH, Chung CK. Life-threatening late 1. Should the suture line be opened or a more and is associate editor of the APSF Newsletter. hemorrhage due to superior thyroid artery dissection after aggressive hematoma evacuation be per- anterior cervical discectomy and fusion. Spine (Phila Pa formed? The authors have no conflict of interest. 1976). 2010;35:E739–742. 2. Should a more definitive airway be placed, 14. Dehal A, Abbas A, Hussain F, et al. Risk factors for neck hematoma after thyroid or parathyroid surgery: ten-year such as an endotracheal tube? And, if so, REFERENCES analysis of the nationwide inpatient sample database. Perm should this be done with the patient awake 1. Hung O, Murphy, M. Airway management of the patient with J. 2015 Winter;19:22–28. or asleep? a neck hematoma. In: Hung’s Difficult and Failed Airway Management. [online] New York: McGraw Hill, 3rd ed. 2018. 15. Rosenbaum M A, Haridas, M, McHenry CR, Life-threatening neck hematoma complicating thyroid and parathyroid sur- Given that total airway collapse can occur at 2. Shah-Becker S, Greenleaf EK, Boltz MM, et al. Neck hema- toma after major head and neck surgery: risk factors, costs, gery. Am J Surg. 2008;195:339–343. any time, one must always be prepared to Head Neck. 8 and resource utilization. 2018;40:1219–1227. 16. Self DD, Bryson GL, Sullivan PJ. Risk factors for post-carotid establish a surgical airway. 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Epiglottitis: it airway obstruction due to hematoma following stellate gan- complication. Anesthesia professionals should hasn’t gone away. Anesthesiology. 2016;124:1404–1407. glion block. Reg Anesth Pain Med. 1998;23:516–519. APSF NEWSLETTER February 2021 PAGE 48

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