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

Volume 36, No. 2, 48-88 More than 1,000,000 readers annually worldwide June 2021 Vaccine Safety: The Benefit-Risk Ratio by Steven L. Shafer, MD

THE SWINE FLU FIASCO flanked by Drs. Sabin and Salk of polio vac- In January 1976, a group of young healthy cine fame, announced: servicemen fell ill with an unknown respiratory “I have been advised that there is a very real illness at Fort Dix, a US Army training center in possibility that unless we take effective counter- New Jersey. Several were hospitalized. One actions, there could be an epidemic of this dan- recruit, refusing hospitalization, died. The cause gerous disease next fall and winter here in the proved to be H1N1, the influenza strain respon- United States. Let me state clearly at this time: no sible for the 1918 pandemic. It was considered one knows exactly how serious this threat could the most dangerous form of influenza, but since be. Nevertheless, we cannot afford to take a 1918 it was mostly limited to those working with chance with the health of our nation. Accordingly, pigs. For the first time in 58 years, H1N1 was I am today announcing the following actions. I am clearly spreading quickly through human to apocalypse was upon us. Armed with technol- asking the Congress to appropriate $135 million, human contact. Out of 500 young men, 13 ogy (vaccination) not available in 1918, or the prior to their April recess, for the production of suf- became sick over a few weeks, and 1 died. smaller influenza epidemics of 1957 and 1968, ficient vaccine to inoculate every man, woman, and child in the United States.”1 It appeared to scientists at the Center for the CDC pressed for mass vaccination. On Disease Control (CDC) that an influenza March 24, 1976, President Gerald Ford, See “Vaccine Safety,” Page 50

The APSF Revisits Its Top 10 Patient Safety Priorities by Steven Greenberg, MD, FCCP, FCCM In 2018 the APSF Board of Directors (BOD) to accurately represent the most current peri- opment, equipment modification, and determi- voted on its top perioperative patient safety pri- operative patient safety issues. nation of operative risk; and (9) clinician safety, orities. This list was generated from a combina- Current APSF Vice President Dan Cole, MD, occupational health, and wellness. tion of a review of the most current literature, led a task force to generate a survey that was The priority of creating a culture of safety was submissions to the APSF Newsletter, and distributed to all APSF BOD and committee elevated to the top priority in 2021 and was mod- expert opinions from the multiprofessional rep- members. The poll responses were then tallied ified to encompass the importance of inclusion resentatives of the BOD. Since then, the APSF by the task force generated from the BOD. From and diversity in perioperative patient safety. All of has devoted its resources to enhancing educa- a list of the top 16 priorities, the BOD voted on these topics represent the current world we live tion, research, and awareness with regards to selection of the Top 10 Patient Safety Priorities for in with respect to perioperative patient safety these priorities (https://www.apsf.org/article/ 2021 (figure 1). Past, present, and future activities and are in line with the APSF’s vision “that no one focusing on these patient safety priorities are improving-perioperative-patient-safety-a-mat- shall be harmed by anesthesia care.” also listed in figure 1. A culture of safety, inclusion, ter-of-priorities-collaboration-and-advocacy/). and diversity ranked number one, while team- Some topics that were ranked at the lower The current BOD has felt the need to revisit the work, collegial communication, and multidisci- end of our priority list in 2018 did not remain top patient safety priorities on an annual basis plinary collaboration, and preventing, detecting, on the top 10 priority list in 2021: (9) cost- determining pathogenesis, and mitigating clini- effective protocols and monitoring that have cal deterioration in the perioperative period were a positive impact on safety; (10) integration of To Our APSF Readers: ranked two and three, respectively. safety into process implementation and con- tinuous improvement; (11) burnout; and (12) If you are not on our mailing list, New additions to the current patient safety pri- distractions in procedural areas. Some of please subscribe at ority list include (2) teamwork, collegial communi- these topics will be integrated into the new https://www.apsf.org/subscribe cation and multidisciplinary communication; (6) prevention, and mitigation of opioid-related harm 2021 patient safety priorities and others did and the APSF will send you an in surgical patients; (8) emerging infectious dis- not gain traction for ranking when compared to the current ones. email of the current issue. eases (including, but not limited to COVID-19), including patient management, guideline devel- See “Top 10 Priorities,” Page 53

TABLE OF CONTENTS, NEXT PAGE APSF NEWSLETTER June 2021 PAGE 49

TABLE OF CONTENTS ARTICLES: NEWSLETTER Vaccine Safety: The Benefit-Risk Ratio...... Cover The APSF Revisits Its Top 10 Patient Safety Priorities...... Cover Postpartum Peripheral Nerve Injuries—What is Anesthesia’s Role? ...... Page 54 The Official Journal of the APSF Statement on Pulse Oximetry and Skin Tone: Pulse Oximeters are Important for Keeping all Patients Safe...... Page 57 Anesthesia Patient Safety Foundation Establishing a Difficult Airway Response Team for a Regional Hospital: A Case Study in the Adoption and Diffusion of Innovations...... Page 58 The Anesthesia Patient Safety Foundation Newsletter Important Medication Errors and Hazards Reported to the ISMP National Medication Errors Reporting is the official publication of the nonprofit Anesthesia Program During 2020...... Page 61 Patient Safety Foundation and is published three Practice Considerations for the Anesthesia Professional for Methamphetamine Substance Use times per year in Wilmington, Delaware. Contri­ Disorder Patients...... Page 67 butions to the Foundation are tax-deduct­ible. ©Anes- CULTURE OF SAFETY: The Multidisciplinary Anesthesia Professional Relationship ...... Page 74 Lessons Learned from Calls to the MHAUS Malignant Hyperthermia Hotline...... Page 78 thesia Patient Safety Foundation, 2021. One Year After PRODIGY—Do We Know More About Opioid-Induced Respiratory Depression?...... Page 80 The opinions expressed in this Newsletter are not The Evolution and Role of Simulation in Medical Education...... Page 82 necessarily those of the Anesthesia Patient Safety Management of Massive Intraoperative Hemorrhage...... Page 85 Foundation. The APSF neither writes nor promul- RAPID RESPONSE: gates standards, and the opinions expressed herein Rapid Response: Inadvertent Unplugging of Rapid Infuser Causing a Large Volume of Cold Fluid to Be should not be construed to constitute practice stan- Infused With Subsequent Cardiac Arrest...... Page 64 dards or practice parameters. Validity of opinions pre- Rapid Response: Laryngoscope Hook Poses Safety Issue...... Page 72 sented, drug dosages, accuracy, and completeness Rapid Response: Cardiopulmonary Arrest Precipitated by Supraglottic Kinking of Polyvinyl Endotracheal Tube...... Page 76 of content are not guaranteed by the APSF. APSF ANNOUNCEMENTS: Guide for Authors...... Page 49 APSF Executive Committee 2021: APSF Newsletter Podcast: Now Available Online @ APSF.org/podcast...... Page 56 Mark A. Warner, MD, President, Rochester, MN; Daniel A Tribute to Ron Litman, DO, ML...... Page 63 J. Cole, MD, Vice President, Los Angeles, CA; Steven B. APSF 2021 Stoelting Conference: Clinician Safety: To Care is Human...... Page 66 Greenberg, MD, Secretary, Chicago, IL; Douglas A. Anesthesia Quality and Patient Safety Meeting...... Page 70 Bartlett, Treasurer, Boulder, CO; Lynn Reede, DNP, APSF Donor Page...... Page 71 MBA, CRNA, FNAP, Director At-Large, Boston, MA. Crowdfunding...... Page 87 APSF Newsletter Editorial Board 2021: Legacy Members...... Page 88 Steven B. Greenberg, MD, Editor, Chicago, IL; Jennifer 2020 Board Members and Committee Members:...... https://www.apsf.org/about-apsf/board-committees/ M. Banayan, MD, Editor, Chicago, IL; Edward A. Bittner, MD, PhD, Associate Editor, Boston, MA; JW Beard, MD, Guide for Authors Wilmette, IL; Heather Colombano, MD, Winston-Salem, NC; Jan Ehrenwerth, MD, New Haven, CT; John H. A more detailed Guide to Authors with specific requirements for submissions can be found Eichhorn, MD, San Jose, CA; Meghan Lane-Fall, MD, on line at https://www.apsf.org/authorguide Philadelphia, PA; Nikolaus Gravenstein, MD, Gaines- The APSF Newsletter is the official journal of the Anesthesia Patient Types of articles include (1) Invited review articles, Pro/Con Debates ville, FL; Joshua Lea, CRNA, Boston, MA; Bommy Hong Safety Foundation. It is widely distributed to a variety of anesthesia and Editorials, (2) Q and As, (3) Letters to the Editor, (4) Rapid Mershon, MD, Baltimore, MD; Tricia A. Meyer, PharmD, professionals, perioperative providers, key industry representatives, Response, and (5) Conference reports. Temple, TX; Glenn S. Murphy, MD, Chicago, IL; Steven Shafer MD, Stanford, CA; Brian Thomas, JD, Kansas and risk managers. Therefore, we strongly encourage publication of 1. Review articles, invited Pro/Con debates, and Editorials are those articles that emphasize and include the multidisciplinary, mul- City, MO; Felipe Urdaneta, MD, Gainesville, FL; Jeffrey ­original manuscripts. They should focus on patient safety issues tiprofessional approach to patient safety. It is published three times S. Vender, MD, Winnetka, IL; Wilson Somerville, PhD, and have appropriate referencing. The articles should be limited a year (February, June, and October). Deadlines for each issue are to 2,000 words with no more than 25 references. Figures and/or Editorial Assistant, Winston-Salem, NC. Please see the as follows: 1) February Issue: November 15th, 2) June Issue: tables are strongly encouraged. links of international editors at https://www.apsf.org/ March 15th, 3) October Issue: July 15th. The content of the news- wp-content/uploads/newsletter/APSF-International- letter typically focuses on anesthesia-related perioperative patient 2. Q&A articles are submitted by readers regarding anesthesia Editors.pdf safety. Decisions regarding content and acceptance of submissions patient safety questions to knowledgeable experts or desig- for publication are the responsibility of the editors. nated consultants to provide a response. The articles should be Address all general, contributor, and sub­scription limited to 750 words. correspondence to: 1. All submissions should be submitted via Editorial Manager on the APSF website: https://www.editorialmanager.com/apsf 3. Letters to the editor are welcome and should be limited to 500 Stacey Maxwell, Administrator words. Please include references when appropriate. Anesthesia Patient Safety Foundation 2. Please include a title page which includes the submission’s title, P.O. Box 6668 4. Rapid Response (to questions from readers), formerly known as, authors' full name, affiliations, conflicts of interest statement for Rochester, MN 55903, U.S.A. "Dear SIRS," which was the “Safety Information Response each author, and 3–5 keywords suitable for indexing. Please [email protected] include word count on the title page (not including references). System,” is a column that allows for expeditious communication 3. Please include a summary of your submissions (3–5 sentences) of technology-related safety concerns raised by our readers, with Address Newsletter editorial comments, questions, which can be used on the APSF website to publicize your work. input and response from manufacturers and industry representa- letters, and suggestions to: tives. Jeffrey Feldman, MD, current chair of the Committee on Steven B. Greenberg, MD 4. All submissions should be written in Microsoft Word in Times Technology, oversees the column and coordinates the readers’ New Roman font, double-spaced, size 12. Editor, APSF Newsletter inquiries and the response from industry. [email protected] 5. Please include page numbers on the manuscript. Commercial products are not advertised or endorsed by the APSF Jennifer M. Banayan, MD 6. References should adhere to the American Medical Association Newsletter; however, upon exclusive consideration from the editors, Editor, APSF Newsletter citation style. articles about certain novel and important safety-related techno- [email protected] 7. References should be included as superscript numbers within logical advances may be published. The authors should have no commercial ties to, or financial interest in, the technology or com- Edward A. Bittner, MD, PhD the manuscript text. APSF Newsletter mercial product. Associate Editor, 8. Please include in your title page if Endnote or another software [email protected] If accepted for publication, copyright for the accepted article is tool for references is used in your submission. Online Editors: transferred to the APSF. Permission to reproduce articles, figures, 9. Authors must submit written permission from the copyright Josh Lea, CRNA tables, or content from the APSF Newsletter must be obtained from owner to use direct quotations, tables, figures , or illustrations that Felipe Urdaneta, MD the APSF. have appeared elsewhere, along with complete details about the Send contributions to: source. Any permission fees that might be required by the copy- Individuals and/or entities interested in submitting material for right owner are the responsibility of the authors requesting use of publication should contact the Editors (Steven Greenberg, MD, Anesthesia Patient Safety Foundation the borrowed material, not the APSF. Unpublished figures and Jennifer Banayan, MD) directly at [email protected] or P.O. Box 6668 require permission from the author. [email protected]. Rochester, MN 55903, U.S.A. Or please donate online at www.apsf.org. APSF NEWSLETTER June 2021 PAGE 50

SARS-CoV-2 Vaccine Safety and Efficacy From “Vaccine Safety,” Page 48 Field trials for a vaccine began in April. Mass immunization began on October 1st, 1976. Eleven days later, three elderly patients in Pitts- burgh died almost immediately after vaccina- tion. The Allegheny County Health Department suspended the vaccination program. In Minne- sota, health authorities noticed several cases of Guillain-Barré. This was followed by a rising incidence of unexplained deaths and Guillain- Barré (a complication of both influenza itself and other influenza vaccines).2 When no cases of H1N1 appeared in the winter, the perceived risk/benefit ratio shifted to all risk, and the vac- cination program was stopped in December. New programs were set up following this “Swine Flu Fiasco” of 1976. A considerable irony is those vaccinated in 1976 may have been protected as older adults during the 3 Left panel: 1918 influenza pandemic, National Museum of Health and Medicine, Armed Forces Institute of Pathology, 2009 H1N1 pandemic. The 1976 Swine Flu vac- Washington, DC, United States; Right upper panel: Army Cpt. Dr. Isaiah Horton receives COVID-19 vaccine, US Secre- cination program also presaged many of the tary of Defense; Right lower panel: US President Gerald Ford receiving swine flu vaccine, Gerald R. Ford Presidential challenges of communicating vaccine benefits Library; vs. vaccine safety that we see with vaccination programs today. immune system gets activated. Since the vac- Table 1: Vaccine Platforms in Development.33 cines activate the immune system, any of the OPERATION WARP SPEED vaccines can make you feel ill for a couple of Candidate Unlike the 1976 swine flu fiasco, when no hours to perhaps a day or two. Just as you Platform Vaccines subsequent cases of H1N1 were seen after the should expect the shot to hurt a little, because Protein subunit 28 initial outbreak at Fort Dix, as of April 5, 2021, they are sticking a needle in your arm, you there have been over 130 million cases and 2.8 should expect to feel somewhat viral, because Viral Vector (non- 12 million deaths worldwide (figure 1) secondary to the shot activates your immune system. replicating) SARS-CoV-2. In the United States, 1 in 11 have The safety question is: what other unwel- DNA 10 been infected by SARS-CoV-2, and 1 in roughly come effects might the vaccine have, other 600 Americans have died from COVID-19 than making you feel like you have a virus? Inactivated Virus 11 (more than 540,000 as of March, 2021). RNA 11 The COVID epidemic has focused the VACCINE SAFETY AND EFFICACY world’s scientific firepower as never before. In 1. BNT162b2 is an mRNA vaccine developed Viral Vector (replicating) 4 the United States, “Operation Warp Speed” by Pfizer and BioNTech. It is the first vaccine Virus Like Particle 4 was a public/private partnership to provide approved via an Emergency Use Authoriza- nearly unlimited government support to com- tion (EUA)* in the United States. In a study of Live Attenuated Virus 2 panies pursuing vaccines and other therapies 43,548 subjects, the vaccine demonstrated to address COVID-19. Similar programs were an outstanding 95% efficacy and nearly 100% Replicating Viral Vector + 2 established in Europe, India, and China, with efficacy against severe disease.6 This is simi- Antigen Presenting Cell unprecedented success. 7 lar to the efficacy of the MMRV vaccine. Non-replicating Viral Vector 1 According to the World Health Organization, Only 1 patient who received the vaccine (out + Antigen Presenting Cell there are currently 82 vaccines in clinical devel- of > 20,000) developed severe COVID-19. opment (table 1).4 Of these, 13 are presently Common adverse events were limited to approved in at least 1 country.5 All of the vac- injection site pain and flu-like symptoms. The of anaphylaxis was mitigated through intro- cines have demonstrated efficacy. The only safety and efficacy demonstrated in the duction of immediate postvaccination moni- serious safety concern that has emerged is the Phase 3 study was subsequently reproduced toring of individuals for up to 30 minutes, exceedingly small possibility of thrombosis with when the vaccine was deployed on a large reducing the risk of injury from anaphylaxis to the AstraZeneca vaccine. I will repeat that for scale in Israel.8 nearly 0. The CDC estimates that there emphasis: the only serious safety concerns that have no deaths associated with the Shortly after the BNT162b2 vaccination pro- BNT162b2 vaccine.12 has emerged is the very low possibility of gram was launched several cases of anaphy- thrombosis with the AstraZeneca vaccine. laxis were observed.9 The most recent 2. mRNA-1273 is an mRNA vaccine developed Vaccines stimulate the immune system. Very assessment is that the risk of anaphylaxis is by Moderna. It is the second vaccine with obviously, that is the entire point! You know what approximately 1 in 100,000.10 The mRNA vac- EUA approval in the United States. In the this feels like: fatigue, headache, myalgias, leth- cines incorporate a lipid nanoparticle to facili- phase 3 study of 30,420 individuals, the argy, and generalized “flu-like” symptoms. tate mRNA entry into the cell. It is currently mRNA-1273 vaccine also demonstrated out- These responses aren’t caused by the virus per thought that the lipid nanoparticle is respon- standing efficacy of 94%. To place this into se. This is simply what it feels like when your sible for the rare allergic reactions.11 The risk perspective, the FDA set a bar of 50% effi- cacy for vaccine approval.13 *Emergency Use Authorization, an authorization granted by the FDA to permit the use of a drug without full FDA approval to treat a public health emergency. See “Vaccine Safety,” Next Page APSF NEWSLETTER June 2021 PAGE 51

The Risk of Anaphylaxis to the SARS-CoV-2 Vaccine is Rare

From “Vaccine Safety,” Preceding Page Worldwide Projection as of April 5, 2021 The risks of the Moderna mRNA-1273 are identical to that of the Pfizer/BioNTech.14 This is expected, because both vaccines use the same lipid nanoparticles to facilitate entry into the cell.15 The risk of anaphylaxis is about 1 in 200,000. There have been no deaths or serious injuries. Otherwise, recipients of mRNA-1273 should expect to feel mildly ill while their immune system ramps up. 3. AD26.COV2.S is not an mRNA type vaccine but rather a non-replicating viral vector vac- cine developed by Johnson & Johnson. It is the third vaccine with EUA approval in the United States. The phase 3 trial of 44,325 adults found an efficacy of 72% in the United States, 66% in Latin American countries, and 57% in South Africa.16 No vaccinated patients died of COVID-19. The safety data has not appeared in the peer-reviewed literature. Source: Daily COVID-19 update, used with permission from author. 32 However, the safety profile is well described Figure 1: Worldwide projection as of April 5, 2021. in the FDA briefing document17: “Safety anal- ysis through the January 22, 2021 data cutoff The safety analysis identified two concerning On March 22, 2021, AstraZeneca announced included 43,783 randomized (1:1) participants adverse events: one case of transverse the results of the 32,449-subject phase 3 US 26 ≥18 years of age with 2-month median follow- myelitis, and one instance of a fever following trial. The vaccine was 79% effective, and up. The analysis supported a favorable safety vaccination of 40°C without explanation. Both 100% effective at preventing severe disease. profile with no specific safety concerns iden- cases resolved. One subsequent case of The data safety monitoring board reviewed tified that would preclude issuance of an transverse myelitis was reported, but subse- thrombotic events, including cerebral venous EUA.” There were no instances of anaphy- quently was determined by the site investiga- sinus thrombosis, and found no evidence of laxis in the study, but one individual had a tor to be unrelated. increased risk. No cases of cerebral venous hypersensitive reaction two days after vacci- A paper from South Africa published in the New sinus thrombosis occurred in the trial. The fol- nation that was not classified as anaphylaxis.* England Journal of Medicine after approval of lowing day, the Data and Safety Monitoring 4. AZD1222, also known as ChAdOx1 nCoV-19, AZD1222 showed that it didn’t work against the Board (DSMB) issued through the National is an adenovirus vectored vaccine devel- B.1.351 variant that has become the predomi- Institute of Allergy and Infectious Disease, a oped by a partnership between Oxford Uni- nant strain in South Africa.20 statement disputing the AstraZeneca press versity and AstraZeneca. It is approved announcement, stating that the DSMB throughout Europe, Asia, and South America. In March 2021, three patients in Norway suf- expressed concern that AstraZeneca may AstraZeneca recently completed a phase 3 fered thrombotic events after receiving the have included outdated information from that trial in the United States and has announced AZD1222 vaccine, and one patient died. plans to seek EUA approval in the US. Norway suspended use of the vaccine pending trial, which may have provided an incomplete investigation. Several additional thrombotic view of the efficacy data.”27 AZD1222 would seem to have been cursed events were reported in Europe, including 22 in As mentioned, AZD1222 seems to have since the outset. In the pivotal phase 3 trial, the UK.21 A case has also been reported in Aus- there was a dosing error resulting in a sub- been cursed, starting with a dosing error in tralia.22 What is unusual about these cases is population of patients having a lower dose the clinical trial. Controversy continued with that they are associated with low platelet than intended. Amazingly, these patients had the findings of lower doses producing counts, suggesting a mechanistic link to hepa- a better immune response, but it is unclear 23 greater efficacy, concerns over very rare exactly why that was the case! In an interim rin-induced thrombocytopenia. In response, Denmark, Norway, Iceland, Bulgaria, Ireland, transverse myelitis cases, thrombosis, and analysis, the vaccine was 62% effective in now with concerns over the cherry picking of patients who received the higher dose as the Netherlands, Germany, Italy, France, Spain, data. There is an excellent review of the odd specified in the protocol, and 90% effective Portugal, Sweden, Luxembourg, Cyprus, and 18 Latvia all suspended use of the vaccine. Subse- twists and turns of ADZ1222 in Nature in patients who received the lower dose. In 28 the final analysis, vaccine efficacy was 76% quently the European Medicines Agency, the News. The Medicines and Healthcare prod- after a single standard dose.19 No patients in World Health Organization,24 and AstraZen- ucts Regulatory Agency in the United King- the vaccinated group required hospitaliza- eca25 determined that the cases of thrombosis dom has published guidelines for diagnosing tion after 21 days, and there were no COVID were not related to the vaccine, and recom- and treating thrombosis and cytopenia fol- deaths in the vaccinated group. mended continued use. lowing vaccination.29

*Since this article entered production, the Johnson & Johnson vaccine appears to be associated with the syndrome of thrombosis and low platelets (see https://www.cdc.gov/ coronavirus/2019-ncov/vaccines/safety/JJUpdate.html). The incidence appears to be approximately 1 case per million vaccine doses. The CDC had recommended pausing administration while the association was studied and risk factors were identified. On April 23, 2021, the CDC and FDA lifted the pause for administration of the Johnson & Johnson vaccine, citing that its potential benefits outweigh its risks. See “Vaccine Safety,” Next Page APSF NEWSLETTER June 2021 PAGE 52

SARS-CoV-2 Vaccine Risk Benefit Ratio: Asymptotically 1:0!

From “Vaccine Safety,” Preceding Page Steven Shafer, MD, is professor of Anesthesiol- Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99–111. ogy, Perioperative and Pain Medicine at Stan- doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8. Would I get the AZD1222 vaccine? Abso- Erratum in: Lancet. 2021 Jan 9;397(10269):98. PMID: ford University. 33306989; PMCID: PMC7723445. lutely! The vaccine has been given to more 19. Voysey M, Clemens SAC, Madhi SA, et al. Single-dose than 17 million people. There have been The author has no conflicts of interest. administration and the influence of the timing of the booster about 50 embolic events, a rate of about 3 dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised per million. Case mortality for COVID-19 is REFERENCES trials. Lancet. 2021;397:881–891. currently running about 2.4%, and more 1. Neustadt RE, Fineberg HV. The swine flu affair: decision- 20. Madhi SA, Baillie V, Cutland CL, et al. Efficacy of the making on a slippery disease. Washington (DC): National than 20% of all patients who get COVID-19 ChAdOx1 nCoV-19 Covid-19 vaccine against the B.1.351 vari- Academies Press (US); 1978. ant. N Engl J Med. 2021. doi: 10.1056/NEJMoa2102214. have some level of persistent symptoms. 2. Sivadon-Tardy V, Orlikowski D, Porcher R, et al. Guillain- Epub ahead of print. Barré syndrome and influenza virus infection. Clin Infect Some simple math: 17 million × 75% herd 21. Medicines & Healthcare products Regulatory Agency. Research Dis. 2009;48:48–56. immunity threshold × 2% case rate mortality × and analysis: Coronavirus vaccine - weekly summary of Yellow 3. Xie H, Li X, Gao J, Lin Z, et al. Revisiting the 1976 “swine flu” Card reporting. https://www.gov.uk/government/publications/ 90% efficacy in preventing death ~= 230,000 vaccine clinical trials: cross-reactive hemagglutinin and coronavirus-covid-19-vaccine-adverse-reactions/coronavirus- neuraminidase antibodies and their role in protection vaccine-summary-of-yellow-card-reporting. Accessed April 5, lives saved already through vaccination with Clin Infect against the 2009 H1N1 pandemic virus in mice. 2021. AZC1222. Dis. 2011;53:1179–87. 22. Reuters. Australia to continue AstraZeneca vaccination 4. World Health Organization. Draft landscape and tracker of 5. Sputnik V is a combination of two adenovi- COVID-19 candidate vaccines. https://www.who.int/ despite blood clotting case. https://www.reuters.com/arti- publications/m/item/draft-landscape-of-covid-19-candidate- cle/us-health-coronavirus-australia/australia-to-continue- rus vectored vaccines, developed by Gama- vaccines. Accessed March 25, 2021. astrazeneca-vaccination-despite-blood-clotting-case- idUSKBN2BQ06B. Accessed April 5, 2021. leya Research Institute in Russia and 5. Regulatory Affairs Professionals Society. COVID-19 vaccine currently approved in Russia and multiple tracker. https://www.raps.org/news-and-articles/news-arti- 23. Greinacher A, Thiele T, Warkentin TE, et al. A prothrombotic cles/2020/3/covid-19-vaccine-tracker. Accessed March 25, thrombocytopenic disorder resembling heparin-induced countries in Asia, Africa, The Middle East, and 2021. thrombocytopenia following Coronavirus-19 vaccination. South America. The phase 3 trial of 21,977 6. Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of Research Square Preprint Server. DOI: 10.21203/ 30 the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. rs.3.rs-362354/v1. subjects found an efficacy of 92%. The vac- 2020;383:2603–2615. 24. World Health Organization. Statement of the WHO Global cine was 100% effective against serious dis- 7. Henry O, Brzostek J, Czajka H, et al. One or two doses of Advisory Committee on Vaccine Safety (GACVS) COVID-19 ease and death after 21 days. No serious live varicella virus-containing vaccines: efficacy, persistence subcommittee on safety signals related to the AstraZeneca of immune responses, and safety six years after administra- COVID-19 vaccine. https://www.who.int/news/item/19- adverse events have been reported related tion in healthy children during their second year of life. Vac- 03-2021-statement-of-the-who-global-advisory-committee- to vaccination. cine. 2018;36:381–387. on-vaccine-safety-(gacvs)-covid-19-subcommittee-on- 8. Dagan N, Barda N, Kepten E, et al. BNT162b2 mRNA Covid- safety-signals-related-to-the-astrazeneca-covid-19-vaccine. 6. Coronavac is an inactivated SARS-CoV-2 19 vaccine in a nationwide mass vaccination setting. N Engl Accessed March 25, 2021. J Med. 2021:NEJMoa2101765. doi: 10.1056/ 25. AstraZeneca. Update on the safety of COVID-19 Vaccine vaccine developed by Sinovac, and currently NEJMoa2101765. Epub ahead of print. AstraZeneca. March 14, 2021. https://www.astrazeneca. approved in China and multiple countries in 9. CDC COVID-19 Response Team; Food and Drug Adminis- com/media-centre/press-releases/2021/update-on-the- Asia and South America. The data from large tration. Allergic reactions including anaphylaxis after receipt safety-of-covid-19-vaccine-astrazeneca.html. Accessed of the first dose of Pfizer-BioNTech COVID-19 vaccine - March 25, 2021. MMWR Morb phase 3 trials is currently only available in United States, December 14–23, 2020. 26. AstraZeneca. AZD1222 US Phase III trial met primary effi- Mortal Wkly Rep. 2021;70:46–51. doi: 10.15585/mmwr. cacy endpoint in preventing COVID-19 at interim analysis. press releases, but these suggest “the effi- mm7002e1. cacy rate against diseases caused by COVID- March 22, 2021. https://www.astrazeneca.com/media-cen- 10. Turner PJ, Ansotegui IJ, Campbell DE, et al. COVID-19 vac- tre/press-releases/2021/astrazeneca-us-vaccine-trial-met- 19 was 51% for all cases, 84% for cases cine-associated anaphylaxis: a statement of the World primary-endpoint.html. Accessed March 25, 2021. Allergy Organization Anaphylaxis Committee. World Allergy requiring medical treatment, and 100% for Organ J. 2021;14:100517. 27. National Institues of Health. NIAID statement on AstraZen- eca vaccine. https://www.nih.gov/news-events/news- hospitalized, severe, and fatal cases.31 11. Moghimi SM. Allergic reactions and anaphylaxis to LNP- releases/niaid-statement-astrazeneca-vaccine. Accessed based COVID-19 vaccines. Mol Ther. 2021;29:898–900. March 25, 2021. 7. BBIBP-CorV is an inactivated SARS-CoV-2 12. Gee J, Marquez P, Su J, Calvert GM, et al. First month of 28. Mallapaty S, Callaway E. What scientists do and don’t know vaccine developed by Sinopharm, and cur- COVID-19 vaccine safety monitoring - United States, December 14, 2020–January 13, 2021. MMWR Morb Mortal about the Oxford-AstraZeneca COVID vaccine. March 24, rently approved in China and multiple coun- Wkly Rep. 2021;70:283-288. 2021. https://www.nature.com/articles/d41586-021-00785- 7. Accessed March 25, 2021. tries in Asia, South America, and the Middle 13. Development and Licensure of Vaccines to Prevent COVID- 19 – Department of Health and Human Services, FDA 29. Guidance produced from the Expert Haematology Panel (EHP) East. There seems to be even less safety and Center for Biologics Evaluation and Research. June 2020 focussed on syndrome of thrombosis and thrombocytopenia efficacy data than for CoronaVac. A summary 14. CDC COVID-19 Response Team; Food and Drug Adminis- occurring after coronavirus vaccination. https://b-s-h.org.uk/ in Wikipedia suggested 86% efficacy in a tration. Allergic reactions including anaphylaxis after receipt media/19498/guidance-version-07-on-mngmt-of-thrombosis- of the first dose of Moderna COVID-19 vaccine - United with-thrombocytopenia-occurring-after-c-19-vac- study in Bahrain, with 100% efficacy in pre- States, December 21, 2020–January 10, 2021. MMWR Morb cine_20210330_.pdf. Accessed April 6, 2021. venting severe disease. These data have not Mortal Wkly Rep. 2021;70:125–129. 30. Logunov DY, Dolzhikova IV, Shcheblyakov DV, et al. Safety 15. Cross R. Without these lipid shells, there would be no and efficacy of an rAd26 and rAd5 vector-based heterolo- been published. mRNA vaccines for COVID-19. Chemical & Engineering gous prime-boost COVID-19 vaccine: an interim analysis of News. March 2021 (https://cen.acs.org/pharmaceuticals/ a randomised controlled phase 3 trial in Russia. Lancet. In summary, the currently approved vaccines drug-delivery/Without-lipid-shells-mRNA-vaccines/99/i8). 2021;397:671–681. appear to be highly effective at preventing Accessed March 25, 2021. 31. Mallapaty, S. China COVID vaccine reports mixed results — infection and almost 100% effective in prevent- 16. Janssen Investigational COVID-19 Vaccine: interim analysis what does that mean for the pandemic? Nature. January 15, of Phase 3 clinical data released. National Institutes of 2021. https://www.nature.com/articles/d41586-021- ing severe disease and death. There are some Health News Release, January 29, 2021 (https://www.nih. 00094-z. Accessed March 25, 2021. gov/news-events/news-releases/janssen-investigational- exceptionally rare events, such as anaphylaxis covid-19-vaccine-interim-analysis-phase-3-clinical-data- 32. Source: Steve’s Daily COVID-19 update, distributed by the with the mRNA vaccines, and possibly very rare released). Accessed March 25, 2021 author daily except Sunday. The update is freely available. To be added to the distribution list just send me an e-mail 17. Janssen Ad26.COV2.S vaccine for the prevention of cases of thrombosis from the AstraZeneca ([email protected]). Case and death data are COVID-19. FDA Briefing Document. https://www.fda.gov/ AZD1222 vaccine. Given this profile, and the media/146217/download. Accessed March 25, 2021. from the repository maintained by Johns Hopkins. profound health, social, and economic costs of 18. Voysey M, Clemens SAC, Madhi SA, et al. Oxford COVID 33. World Health Organization. Draft landscape and tracker of Vaccine Trial Group. Safety and efficacy of the ChAdOx1 COVID-19 candidate vaccines. April 6, 2021. https://www. an unmitigated pandemic, the ratio of benefit to nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim who.int/publications/m/item/draft-landscape-of-covid- risk is asymptotically 1:0. analysis of four randomised controlled trials in Brazil, South 19-candidate-vaccines. Accessed April 6, 2021. APSF NEWSLETTER June 2021 PAGE 53

Refining APSF's 2021 Patient Safety Priorities and Activities From “Top 10 Priorities,” Page 48 approaches to improving patient safety on also clinical professor in the Department of The APSF is creating advisory groups whose these important issues to its worldwide con- Anesthesia and Critical Care at the University goals are to develop recommendations on how stituency. Please join the APSF in making the of Chicago and vice chairperson, Education in the Department of Anesthesiology, Critical to best allocate APSF resources to the 2021 Top necessary changes in your own practices as it Care and Pain Medicine at NorthShore Univer- relates to patient safety priorities and beyond. 10 Patient Safety Priorities. These groups will sity HealthSystem. also act as experts on the specific priorities so Steven Greenberg, MD, is secretary of the that the APSF can provide the most novel APSF and editor of the APSF Newsletter. He is The author has no conflicts of interest. Figure 1: APSF’s 2021 Perioperative Patient Safety Priorities and Ongoing Activities The following list contains our top 10 priorities and notes the activities for each that we have done in the past 5 years. The summary of activities is not exhaustive. 1. Culture of safety, inclusion, and diversity 6. Prevention and mitigation of opioid-related harm in surgical • APSF addressed this issue in its 2017 ASA Annual Meeting workshop, patients as well as in APSF Newsletter articles and presentations • This issue has been addressed in 11 articles in the APSF Newsletter • The 2019 Pierce Lecture by Jeff Cooper, PhD, highlighted this issue; since 2016 his remarks were published in February 2020 APSF Newsletter • APSF has supported 1 research grant on this issue in the past 5 years • APSF has supported 1 research grant on this issue in the past 5 years • APSF supports ongoing efforts in the U.S. Congress, Joint Commission, and regulatory agencies to promote postoperative 2. Teamwork, collegial communication, and multidisciplinary monitoring of patients who have received opioids collaboration 7. Medication safety • APSF serves as the collaborating organization and supporter of the a. Drug effects Multicenter Handoff Collaborative (https://www.apsf.org/article/ b. Labeling issues multicenter-handoff-collaborative/) c. Shortages • This was the topic of the 2017 APSF Stoelting Conference and several APSF Newsletter articles d. Technology issues (e.g., barcoding, RFID) • APSF provides financial and infrastructure support to the Multicenter e. Processes for avoiding and detecting errors Handoff Collaborative • The 2018 Stoelting Conferences was dedicated to this topic • APSF presented panels at the 2019 ASA and New York State Society 3. Preventing, detecting, determining pathogenesis, and of Anesthesiologists’ annual meetings mitigating clinical deterioration in the perioperative period • Multiple APSF Newsletter articles have been published on this issue a. Early warning systems in all perioperative patients in 2020 b. Monitoring for patient deterioration • APSF will co-host a summit in 2021 with the Institute for Safe i. Postoperative continuous monitoring on the hospital floor Medication Practices ii. Opioid-induced ventilatory impairment and monitoring 8. Emerging infectious diseases (including but not limited to iii. Early sepsis COVID-19), including patient management, guideline development, equipment modification, and determination of c. Early recognition and response to decompensating patient operative risk • The 2019 Stoelting Conference was dedicated to this topic • APSF helped develop the 2018 Society for Healthcare Epidemiology • This topic has been highlighted in 2020 APSF Newsletter issues and of America (SHEA) consensus guidelines on intraoperative infection- APSF-sponsored panels and presentations prevention (https://www.cambridge.org/core/journals/infection- • APSF is collaborating with American Society of Anesthesiologists control-and-hospital-epidemiology/article/ (ASA) and other subspecialty organizations to address specific issues infection-prevention-in-the-operating-room-anesthesia-work-area/66 related to this topic EB7214F4F80E461C6A9AC00922EFC9) • APSF will support prototype development for several models that • APSF sponsored the 2017 NYSSA and ASA panels on this topic may reduce failure-to-rescue • APSF made significant contributions to the development and sharing • APSF has supported 2 research grants on this issue in the past 5 of information related to COVID in 2020 and assisted with years development of pertinent shared statements, practice guidelines, and frequently asked questions 4. Safety in non-operating room locations such as endoscopy, • APSF has supported 2 research grants on this topic in the past 5 cardiac catheterization, and interventional radiology suites years • APSF has addressed aspects of this issue recently in APSF Newsletter 9. Clinician safety: Occupational health and wellness articles (e.g., June 2020) • This will be the topic of the 2021 APSF Stoelting Conference • APSF has supported 3 research grants on this issue in the past 5 • Five articles on this issue have been published in the APSF years Newsletter 5. Perioperative delirium, cognitive dysfunction, and brain health • APSF has supported 1 research grant on this issue since 2016 • The APSF supports this ASA-American Association of Retired Persons 10.  Airway management difficulties, skills, and equipment initiative. • Several APSF articles have addressed this issue in recent APSF • This issue is addressed in the October 2020 APSF Newsletter. Newsletter articles • APSF has supported 3 research grants on this issue in the past 5 years • APSF has supported 3 research grants on this issue in the past 5 years This list has been adopted from Mark Warner, MD, APSF president. APSF NEWSLETTER June 2021 PAGE 54

Postpartum Peripheral Nerve Injuries—What is Anesthesia’s Role? by Emery H. McCrory, MD; Jennifer M. Banayan, MD; and Paloma Toledo, MD, MPH

Postpartum peripheral nerve injuries occur in COMMON PERIPHERAL NERVE approximately 0.3–2% of all deliveries. The INJURIES L2 majority of nerve injuries are attributed to intrin- The incidence of postpartum peripheral L3 sic obstetric palsies secondary to compression nerve injuries varies in the literature from 0.3 to or stretch of the nerve during delivery; however, 2-4 2% of all deliveries. In a study of over 6,000 Iliacus Nerve L4 the possibility that neuraxial anesthesia/analge- parturients, the most common peripheral nerve sia contributes to the injury exists. It is important injuries found postpartum were to the lateral that anesthesia professionals create systems to femoral cutaneous nerve and the femoral identify women who have experienced postpar- nerve. Less common nerves affected include Inguinal Ligament tum lower extremity nerve injuries and connect common peroneal, lumbosacral plexus, sciatic, patients with resources. obturator, and radicular nerves (table 1).4 Childbirth is the most common reason for Lateral femoral cutaneous nerve injury admission to the hospital within the United occurs in approximately four out of 1000 partu- 1 States. While neurologic complications during rients.4 The nerve, which supplies sensation to Anterior and Posterior Divisions of pregnancy and delivery are still fortunately a rela- the anterolateral thigh, courses under the ingui- the Femoral Nerve tively rare event, when they do occur, they can nal ligament, which makes it susceptible to have a significant impact. Nerve injuries during compression while in lithotomy position. This childbirth are traditionally attributed to intrinsic Figure 1. Illustration of the femoral nerve coursing purely sensory dysfunction, also known as underneath the inguinal ligament, and the iliacus obstetric palsies, either due to compression or meralgia paresthetica, is typically self-limited nerve branching off more proximal to the inguinal stretch of the nerve. Although this is still true in a with a short recovery period, and can often be ligament. majority of cases, neuraxial procedures may con- treated with nonsteroidal anti-inflammatory RISK FACTORS tribute to a small proportion of these injuries. drugs or lidocaine patches.5 Given the rarity of these injuries, there are not A variety of risk factors have been identified accurate risk-prediction models. Therefore, anes- Femoral nerve injury is slightly less common, that contribute to peripheral nerve injuries. thesia professionals should work with obstetri- but involvement causes weakness in thigh flex- Some of these risk factors, such as duration of cians and nurses to develop systems to identify ion, knee extension, loss of patellar reflex, and labor and mode of delivery are not modifiable. women who do develop postpartum lower sensory loss to the medial thigh and calf. The The attributable risk of any individual risk factor femoral nerve also courses under the inguinal extremity nerve injuries and also provide these to the development of nerve injuries is not ligament (figure 1) and compression at this point women with resources regarding symptomatol- known. In this section, we will discuss several of is traditionally believed to be the mechanism of ogy and mobility safety, especially if there is a the known risk factors. motor component to the injury. injury. Parturients who suffer a nerve injury are Table 1. Common Postpartum Peripheral Nerve Injuries and Proposed Mechanisms of Injury more likely to be nulliparous and spend longer time in the second stage of labor while in the Proposed mechanism and location of lithotomy position than those without injury.4 Nerve Observed deficit injury and risk factors Patients who have an assisted vaginal delivery Lateral femoral Sensory: decreased on Compression under the inguinal (either with forceps or a vacuum device) are cutaneous nerve anterolateral thigh, “meralgia ligament with prolonged hip flexion, paresthetica” obesity (secondary to increased also more likely to have a postpartum periph- 4 pressure at the inguinal ligament) eral nerve injury. Patients with neuraxial cath- Femoral nerve Sensory: decreased on anterior Compression under the inguinal eters are typically less mobile and maintain the thigh and medial calf ligament secondary to prolonged hip same position for longer periods of time, which Motor: weak thigh flexion (if flexion, abduction, and external rotation; may make compression injury more likely. Ana- involvement of the iliacus nerve), retraction during cesarean delivery; tomical variations in the epidural space could weak knee extension possibly decreased perineural flow to the iliacus nerve cause a high concentration of local anesthetic surrounding individual nerve roots (detected as Lumbosacral Sensory: decreased on posterior Compression due to fetal position, plexus and thigh compression against pelvic rim, forceps an unequal distribution of a block) which could sciatic nerve Motor: weak quadriceps, weak hip assisted vaginal delivery be neurotoxic at a high enough dose.6 In addi- adduction, foot drop, involves tion, a low concentration of local anesthetic multiple levels through the epidural catheter should be con- Obturator nerve Sensory: decreased on medial Compression due to fetal position, sidered. Although this has not been explicitly thigh improper positioning, forceps assisted studied, it is reasonable to assume that patients Motor: weak hip adduction, wide vaginal delivery gait with a dense analgesic block may be more likely to have compressive nerve injuries, as the Common Sensory: decreased on lateral calf Lower extremity positioning, local anesthetic may inhibit nociceptive warn- peroneal nerve Motor: foot drop compression at fibular head either by hand or stirrups while anesthetized, ing signs of neuropathic pain. compression while pushing See “Nerve Injury,” Next Page APSF NEWSLETTER June 2021 PAGE 55

Nerve Injury Prognosis During Labor Is Favorable

From “Nerve Injury,” Preceding Page A large retrospective study evaluating 20,000 laboring parturients who received neur- axial anesthesia identified a nerve injury inci- dence of 0.96%, with a higher incidence of lumbosacral plexus injuries.7 Risk factors identi- fied included a forceps assisted vaginal deliver- ies, newborn birth weight >3.5 kg, late gestational age (≥41 weeks), and late initiation of the neuraxial procedure.7 They did not find any significant difference when looking at time of day of neuraxial placement or provider level of training. Out of the 19 injuries identified, four were attributed to direct trauma from either the Touhy needle or catheter to the nerve root, based on either electromyography, magnetic resonance Imaging, or a computerized tomog- be due to compression under the inguinal liga- Anesthesia professionals should work with raphy scan within 48 hours of delivery. Of those ment in lithotomy position; however, four of the obstetricians and nurses at their institution to four injuries, three of the patients experienced a these patients had a scheduled cesarean sec- ensure that all patients are evaluated after deliv- paresthesia during placement at the same tion. In addition, all 22 of the femoral nerve inju- ery and asked about symptoms consistent with level.7 In addition, in three of the four patients, ries had iliopsoas weakness, which is postpartum lower extremity nerve injuries. If the the neuraxial procedure was performed with a anatomically more cranial than the inguinal liga- post-anesthetic evaluation occurs immediately cervical dilation greater than five centimeters, ment, and also supporting the theory that nerve after delivery, the residual effects of the neuraxial and all four of the patients had a documented hypoperfusion may contribute to postpartum block may mask any new-onset lower extremity difficult neuraxial placement with either severe nerve injuries.4,8 Further work is needed to eluci- nerve injuries. Ideally, on postpartum day one, 7 pain or several attempts. Given this signifi- date the role of blood pressure management on either anesthesia professionals, obstetricians, or cance, it is especially important to include nerve nerve injuries, and understand if treatment of postpartum nurses should ask patients, are you injury in anesthetic consent for neuraxial proce- blood pressure can prevent or mitigate certain having any difficulty walking or do you have any dures, and appropriately counsel patients if a nerve injuries. Our group is currently investigat- new numbness or weakness in your legs? If the traumatic placement occurs. Further evaluation ing risk factors for new onset postpartum lower- patient endorses a new sensory deficit or weak- needs to be conducted regarding appropriate ness, these patients should have a more thor- extremity nerve injuries in an Agency for troubleshooting when a paresthesia occurs ough evaluation by the anesthesia team (if the Healthcare Research and Quality (AHRQ)- during neuraxial placement, as this limited patient had a neuraxial anesthetic), or by a phys- funded study. The study will evaluate the contri- study indicated that these patients may be at iatrist or physical therapist if the patient did not bution of patient-related, as well as obstetric, higher risk of postpartum neuralgia. Our institu- have an anesthetic for delivery. If the pattern of neonatal, and anesthetic risk factors. We hope to tional practice is as follows: If a patient com- injury is unclear, a neurology consult may be indi- further our understanding of these nerve injuries plains of a transient paresthesia with either the cated as electromyography could assist in spinal or epidural needle, and it resolves with- and identify potentially-modifiable factors. revealing individual nerve and muscle dysfunc- out further intervention, injection may proceed. 10 OUR ROLE AS ANESTHESIA tion. It is critically important for patients with any If the patient has a persistent paresthesia, the PROFESSIONALS weakness to be evaluated for safe ambulating needle is moved away from the direction of the because there is the potential that the new Anesthesia professionals in collaboration paresthesia. If the paresthesia occurs with mother could injure herself, or her infant, if she is with obstetrics play an important role in the spinal injection of local anesthetic, the injection unable to bear weight due to the nerve injury. A identification of nerve injuries and connecting is aborted and the intrathecal space is re-identi- physical therapy evaluation will identify if any patients to resources for management of these fied prior to injecting local. Finally, if the patient assistive devices such as a knee brace, orthotic experiences a persistent paresthesia when the injuries. An important consideration after a shoe, or walker are needed prior to leaving the epidural catheter is threaded, the catheter is nerve injury is that patients are at a significant hospital. While typically no medical treatment is typically removed. At this point saline can be fall risk. If there is significant motor dysfunction, needed for new onset lower extremity nerve infused prior to re-attempting to thread the cath- as seen with femoral neuropathies and lumbo- injuries, gabapentin could be considered if the eter to help expand the epidural space or the sacral plexus injuries, patients should be thor- patient complains of neuropathic pain. Studies in Touhy needle can be directed away from the oughly assessed and counseled prior to this patient population have been small, but gab- direction of the paresthesia and the epidural discharge. Thankfully, prognosis on nerve injury apentin has not been shown to have an effect on space located again. during labor is favorable as recovery typically the neonate through breast milk exposure.11 The 2 In a prospective observational study of new- occurs on the order of weeks. In one study, the more significant risk is that gabapentin has a onset postpartum lower-extremity nerve injuries, median duration of symptoms was two wide side-effect profile, including increased there were some injuries which did not fit the months.4 In another prospective study, the fatigue, which may be undesirable. Lastly, emo- classic mechanism of nerve compression or median time to recover from nerve injury was 18 tional support is crucial, as a debilitating injury stretch.4 Twenty-four patients had lateral femoral days, but three women continued to have a could further exacerbate any postpartum cutaneous nerve injuries, which are believed to neurologic deficit after a year.9 See “Nerve Injury,” Next Page APSF NEWSLETTER June 2021 PAGE 56

Anesthesia Professionals Can Help Assess Postpartum Patients For New Onset Nerve Injuries From “Nerve Injury,” Preceding Page described in the medical record (motor, sen- REFERENCES: sory, or mixed). The patient should also be eval- 1. HCUP fast stats - most common diagnoses for inpatient depression or anxiety; therefore, close follow-up stays. https://www.hcup-us.ahrq.gov/faststats/NationalDi- with their obstetrician after delivery is vital. Typi- uated by physical therapy or physiatry to agnosesServlet. Accessed March 2, 2021. cally, follow-up with a neurologist or physical ensure that the patient is safe to ambulate with 2. Richards A, McLaren T, Paech MJ, et al. Immediate postpar- medicine and rehabilitation is not needed, as her infant prior to discharge from the hospital. tum neurological deficits in the lower extremity: a prospec- tive observational study. Int J Obstet Anesth. 2017;31:5–12. long as symptoms continue to resolve and are Emery McCrory, MD, is an assistant professor of 3. Scott DB, Tunstall ME. Serious complications associated not worsening in nature. Anesthesiology at Northwestern University Fein- with epidural/spinal blockade in obstetrics: a two-year pro- spective study. Int J Obstet Anesth. 1995;4:133–139. berg School of Medicine, Chicago, IL. SUMMARY 4. Wong CA, Scavone BM, Dugan S, et al. Incidence of post- Jennifer Banayan, MD, is editor, APSF Newslet- partum lumbosacral spine and lower extremity nerve inju- Postpartum nerve injuries are very rare, but ries. Obstet Gynecol. 2003;101:279–288. can be very worrisome to both the patient and ter, and an associate professor of Anesthesiol- 5. Meier T, Wasner G, Faust M, et al. Efficacy of lidocaine patch the anesthesia professional. The majority of ogy at Northwestern University Feinberg School 5% in the treatment of focal peripheral neuropathic pain nerve injuries are attributed to intrinsic obstetric of Medicine, Chicago, IL. syndromes: a randomized, double-blind, placebo-con- trolled study. Pain. 2003;106:151–158. palsies secondary to compression or stretch of Paloma Toledo, MD, MPH, is an assistant profes- 6. Verlinde M, Hollmann MW, Stevens MF, et al. Local anes- the nerve during delivery. However, it is impor- Int J Mol Sci. sor of Anesthesiology at Northwestern University thetic-induced neurotoxicity. 2016;17:339. tant to be aware of our role as it relates to hypo- 7. Haller G, Pichon I, Gay FO, Savoldelli G. Risk factors for Feinberg School of Medicine, Chicago, IL. perfusion of nerves, traumatic neuraxial peripheral nerve injuries following neuraxial labour analge- sia: a nested case-control study. Acta Anaesthesiol Scand. placement, and decreased motor function Ermery McCrory, MD, and Jennifer Banayan, 2017;61:1203–1214. during labor secondary to dense local anes- MD, do not have any conflicts of interest. Paloma 8. Biedmond A. Femoral neuropathy. In: Vinken P, Bruyn, GW, thetic. Further research is needed to help Toledo, MD, is supported by grants from the ed. Handbook of clinical neurology. Vol 8. New York: John Wiley & Sons; 1977:303–310. understand which factors place patients at Agency for Healthcare Research and Quality 9. Tournier A, Doremieux AC, Drumez E, et al. Lower-limb neu- increased risk for these injuries. Anesthesia and National Institute on Minority Health and rologic deficit after vaginal delivery: a prospective observa- professionals can directly impact safety by edu- Health Disparities (R03MD011628, tional study. Int J Obstet Anesth. 2020;41:35–38. cating other perinatal providers and ensuring R03HS025267, R18HS026169). The content is 10. Richard A, Vellieux G, Abbou S, Benifla JL, et al. Good prog- solely the responsibility of the authors and does nosis of postpartum lower limb sensorimotor deficit: a com- that all patients, regardless of whether or not bined clinical, electrophysiological, and radiological they had a neuraxial procedure, are assessed not necessarily represent the official views of the follow-up. J Neurol. 2017;264:529–540. by a provider for new-onset postpartum nerve Agency for Healthcare Research and Quality or 11. Ohman I, Vitols S, Tomson T. Pharmacokinetics of gabapen- injuries. If a nerve injury is detected, the nerve(s) the National Institute on Minority Health and tin during delivery, in the neonatal period, and lactation: Health Disparities. does a fetal accumulation occur during pregnancy? Epilep- affected should be identified, and the injury sia. 2005;46:1621–1624.

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 June 2021 PAGE 57

APSF Statement on Pulse Oximetry and Skin Tone Pulse Oximeters are Important for Keeping all Patients Safe by Jeffrey Feldman, MD, and Meghan Lane-Fall, MD, MSHP

On December 17, 2020, Sjoding et al. pub- lished a retrospective analysis of pulse oximetry (SpO2) data from two patient cohorts indicating that in some patients, occult hypoxemia was not detected when compared to paired oxyhemo- globin saturation measured by laboratory co- 1 oximetry (SaO2). Occult hypoxemia was defined as an SaO2 of < 90% when the paired SpO2 measurements were 92% or greater. The authors compared sub-groups from the cohorts self-identifying as Black and White, and found that the incidence of occult hypoxemia was three times greater in Black patients (11.7%) compared with White patients (3.6%). As the authors noted, these findings, if correct, have important patient safety implications since patient triage based upon pulse oximeter mea- measurements could be used to titrate oxygen February 19, 2021, the FDA issued a safety com- surements could fail to lead to appropriate to maintain a PaO2 > 60. Those authors identi- munication entitled: “Pulse Oximeter Accuracy escalation of care. As a retrospective, uncon- fied a greater bias in SpO2 measurements in and Limitations.” That communication empha- trolled study without objective measurements patients with dark skin tones and recom- sizes the known accuracy limitations of pulse of skin tone, the analysis performed by Sjoding mended that a threshold of 95% be used for oximeters including patients with dark skin tones et al. has important limitations. Nevertheless, it oxygen titration versus 92% for White patients.4 stating that “if an FDA-cleared pulse oximeter is important to verify these findings to under- No known studies to date investigate the reads 90%, then the true oxygen saturation in stand if there is the potential for pulse oximeter impact of sex and skin tone together, which the blood is generally between 86 and 94%.⁶ It is measurements to mislead clinicians, especially could potentially lead to greater measurement important to note that FDA clearance of a pulse in patients with dark skin tones. bias in female patients with dark skin tones. oximeter requires that 15% of test subjects with The measurement bias demonstrated in the dark pigmentation, or two subjects (whichever is WHAT IS THE EVIDENCE? Bickler et al. and Jubran and Tobin publications greater) be included in the participant pool.⁷ The The impact of skin tone on pulse oximeter was apparently not well known by medical pro- FDA safety communication addresses the Sjod- measurements has been documented in the fessionals, as gauged by a lack of description of ing publication, identifying the limitations of that scientific literature since at least 2005. The this phenomenon in major textbooks of medi- retrospective analysis and recognizing the putative source of bias in measurement is over- cine, surgery, and emergency medicine. The “need to further evaluate and understand the lapping absorption of light in the red region phenomenon is described in textbooks of anes- association between skin pigmentation and (660 nm) for both oxyhemoglobin and the skin thesiology, though the degree to which this is oximeter accuracy.” pigment melanin. Laboratory studies into the considered in current clinical practice is unclear. impact of skin tone on pulse oximeter measure- The Sjoding et al. publication, if replicated, is CONCLUSIONS ments have documented a bias, although not of concerning because measurement bias was The preponderance of evidence supports the magnitude identified in the Sjoding data. demonstrated at SpO2 levels thought to be the conclusion that there is a measurement bias Bickler et al. found that SpO2 measurements consistent with normoxemia. Since the Sjoding in pulse oximeter measurements due to skin overestimated SaO2 measurements to a publication, there has been significant work by tone such that pulse oximeter measurements greater degree in patients with dark skin tones. pulse oximeter manufacturers, the United may overestimate the actual oxyhemoglobin The bias increased as saturation decreased States Food and Drug Administration (FDA) and saturation in patients with dark skin tones. Lab- and varied with the type of oximeter. They independent testing laboratories to further oratory data obtained under controlled condi- found a maximum bias of 3.56 ± 2.45% for test investigate the potential for bias due to skin tions does not indicate that the magnitude of subjects with dark skin in the 60–70% satura- tone (Personal communications). The results of the bias is significant enough to influence clini- tion range but no more than 0.93 ± 1.64% for this work will be forthcoming, but are not yet cal decision making until the saturation is less 2 saturations above 80%. The same group stud- ready for publication. than 80%. Clinical performance is likely to be ied additional pulse oximeters in test subjects different from that obtained in the laboratory, REGULATORY RESPONSE TO DATE with dark and light skin tones and concluded and it is clear that many factors will influence that several factors were predictive of errors in The FDA began to investigate the Sjoding et the accuracy of pulse oximetry in addition to pulse oximeter measurements including skin al. findings shortly after they were published and skin tone. Therefore, clinicians should not make tone, probe type, saturation level, and sex. They that work is ongoing. On January 25, 2021, patient care decisions such as hospital or inten- also stated that bias would be important for United States Senators Warren, Wyden, and sive care unit discharge on the basis of a single patients with a saturation less than 80%.3 Of Booker requested that the FDA “conduct a SpO2 value. note, Jubran and Tobin prospectively studied a review of the accuracy of pulse oximeters across 5 cohort of ICU patients to determine if SpO2 racially diverse patients and consumers.” On See “Pulse Ox and Skin Tone,” Next Page APSF NEWSLETTER June 2021 PAGE 58

The APSF Supports Renewed Attention to the Accuracy of the Pulse Oximeter Reading

From “Pulse Ox and Skin Tone,” Preceding Page how pulse oximetry is used in the clinical setting in the Perelman School of Medicine, University Despite the known limitations of the pulse and to heighten awareness of the factors that of Pennsylvania. oximeter, APSF believes that patients are safer can lead to inaccurate measurements. Like any The authors have no conflicts of interest. with continued use of pulse oximetry to esti- monitoring device, the measurements obtained mate arterial oxygenation. It is potentially more by a pulse oximeter are estimates of the actual harmful if the known bias in measurement physiologic condition and can be erroneous. REFERENCES related to skin tone resulted in a lack of confi- Factors other than skin tone known to affect the 1. Sjoding MW, Dickson RP, Iwashyna TJ, et al. Racial bias in pulse oximetry measurement. N Engl J Med. 2020;383: dence in pulse oximetry as a monitoring tool for accuracy of pulse oximetry include perfusion, 2477–2478. patients with dark skin tones. dyshemoglobinemias, anemia, brand of oxime- 2. Bickler PE, Feiner JR, Severinghaus JW. Effects of skin pig- ter, and motion. Sound clinical decision making mentation on pulse oximeter accuracy at low saturation. The findings by Sjoding et al. require verifica- Anesthesiology. 2005;102:715–719. depends upon a complete assessment of the tion but present at least two opportunities to 3. Feiner, JR, Severinghaus JW, Bickler PE. Dark skin improve clinical care and outcomes. First, there patient, not a reliance on a single monitored decreases the accuracy of pulse oximeters at low oxygen is an opportunity for manufacturers, regulators, parameter. saturation: the effects of oximeter probe type and gender. and clinicians to work together to ensure that Anesthesia Analgesia. 2007;105:S18–S23. APSF supports the renewed attention to the technology is developed and tested to docu- 4. Jubran A, Tobin MJ. Reliability of pulse oximetry in titrating accuracy of the pulse oximeter, which has supplemental oxygen therapy in ventilator-dependent ment clinical performance in demographically Chest. rightly revolutionized medical care and aug- patients. 1990;97:1420–1425. and clinically diverse populations. The FDA’s 5. 2020.01.25 Letter to FDA re bias in pulse oximetery mea- requirement for inclusion of “darkly pigmented mented patient safety. We call on clinicians, surements. https://www.warren.senate.gov/imo/media/ subjects” in device development warrants manufacturers, and regulators to work together doc/2020.01.25%20Letter%20to%20FDA%20re%20 to ensure that this device offers equitable ben- Bias%20in%20Pulse%20Oximetry%20Measurements.pdf. reconsideration. Requirements for objective Accessed February 24, 2021. measurement of skin tone should be specified. efits to all the patients we serve. 6. Pulse Oximeter Accuracy and Limitations: FDA Safety Com- More importantly, including 15% darkly pig- Jeffery Feldman is an anesthesiologist at Chil- munication. https://www.fda.gov/medical-devices/safety- mented subjects in the study group may reduce communications/pulse-oximeter-accuracy-and dren’s Hospital of Philadelphia and clinical pro- -limitations-fda-safety-communication?utm_medium= the average measurement bias in that popula- fessor of Anesthesiology in the Perelman School email&utm_source=govdelivery. Accessed February 24, tion, but not necessarily result in ideal perfor- of Medicine University of Pennsylvania. 2021. mance for the individual patient. Closer scrutiny 7. Pulse Oximeters - Premarket Notification Submissions to minimizing measurement bias in subjects Meghan Lane-Fall is vice chair of Inclusion, [510(k)s]: Guidance for Industry and Food and Drug Admin- Diversity, and Equity and David E. Longnecker istration Staff. https://www.fda.gov/regulatory-information/ with dark skin tones is warranted, including search-fda-guidance-documents/pulse-oximeters-premar- reconsideration of the 15% threshold. Second, Associate Professor of Anesthesiology and Criti- ket-notification-submissions-510ks-guidance-industry-and- this is an opportunity to examine more closely cal Care & Associate Professor of Epidemiology food-and-drug. Accessed February 24, 2021.

Establishing a Difficult Airway Response Team for a Regional Hospital: A Case Study in the Adoption and Diffusion of Innovations by Sarah K. Pierce, CRNA, and Gary E. Machlis, PhD

INTRODUCTION familiarity with specialized airway techniques. THE ADOPTION AND DIFFUSION Difficult airway adverse events are the fourth The hospital created a Difficult Airway OF INNOVATIONS most common event in the American Society of Response Team (DART) program to prevent One strategy for developing such scaled pro- Anesthesiologist Closed Claims Database, with related morbidity and mortality. Their system- grams is to consider the challenge as an “adop- based approach resulted in a reduction in detrimental or devastating consequences to tion and diffusion of innovations” problem. In adverse events.² patients, their families, health care providers, the social sciences, significant research litera- 1 and hospitals. In response, Johns Hopkins Hos- Difficult airway adverse events are not limited ture provides theory and evidence as to how pital conducted a two-year evaluation of actual to large institutions and occur at hospitals of all innovations are initially adopted and then, over and near-miss events related to emergency dif- sizes. Adapting a DART program established at a time, diffused throughout a social system. Ever- ficult airway management in non-OR areas. The major metropolitan research hospital for use in a ett Rogers’ Diffusion of Innovations (now in its comprehensive review revealed a set of critical small regional hospital is both a significant chal- fifth edition) provides a general introduction challenges: inconsistent communication pro- lenge and an important opportunity. Regional and a wide set of examples, beginning with the cesses (including paging issues and delays), hospitals have limited financial resources, no lack of knowledge among providers in non-OR residents or fellows, and fewer in-house medical 18th century adoption of oranges and lemons areas on wh