fall 2007 safety topics abound at 2007 asa · 2018-04-05 · bariatric surgery, numerous sleep...

NEWSLETTERVolume 22, No. 3, 41-56 Circulation 81,489 Fall 2007

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

®

Inside: Medication Administration in Anesthesia ........................................................................Page 44

Formulation of Sevoflurane ..................................................................................................Page 48

Donor List ..................................................................................................................................Page 49

Q&A: Pipeline Pressure Primer............................................................................................Page 50

Letter to the Editor: Perils of Labetalol ............................................................................Page 52

Refresher Course LecturesEncompass Variety of Patient

Safety TopicsSaturday, October 13, 2007: The 58th Annual

Refresher Course Lecture Program kicks off Saturdaymorning with Dr. Jan Ehrenwerth discussing pitfallsof A Fire in the Operating Room! It Could Happen to You(#136, 8:30-9:20 am, Rm #3022). Following this pre-sentation, medico-legal lectures include Dr. Christo-pher Spevak providing a Health Law Update forAnesthesiologists (# 126, 9:40-10:30 am, Rm 3014) andDr. Fred Berry outlining What to Do After an AdverseOutcome (#134, 2:50-3:40pm, Rm 3018). Helpfulguidelines and updates to improve patient safety andoutcomes will be provided on the topics of CVP andPAC Monitoring by Dr. Jonathan Mark (#102, 9:40-

Dr. Brenda Fahy (#213, 8:30-9:20 am, Rm 2022), con-current with The ASA Closed Claims Project and itsRegistries moderated by Dr. Karen Domino (#236,Rm 3022). Later in the day, a directed approach toAnesthesia and Patient Safety: It’s Not Only About Get-ting Out of the OR Alive! will be provided by Dr. Eliz-abeth Martinez (#210, 1:40-2:30 pm, Rm 2018).Management of common perioperative problemswill be discussed by Dr. Christian Apfel in PONV:Current Thinking and New Directions (#215, 10:50-11:40 am, Rm 2022), followed in the same room byDr. Jerrold Levy on Anaphylaxis and Adverse DrugReactions (#216, 1:40-2:30 pm). How to protect your-self and your patient from infection will be pre-sented by Dr. Jeanine Wiener-Kronish in her lectureInfection and the Anesthesiologists (#223, 2:50-3:40 pm,Rm 3010). Dr. James Rathmell will elucidate poten-tial Complications in Pain Medicine and their preven-tion (#226, 9:40-10:30am, Rm 3014), followed by asimilar presentation by Dr. Steven Roth entitledComplications in Neuroanesthesia (#221, 10:50-11:40 am, Rm 3010).

Monday, October 15, 2007: Monday morningrefresher courses start with Dr. Steve Hall discussingThe Child With a Difficult Airway: Recognition and Man-agement (#326, 8:30-9:20 am, Rm 3022), concurrentwith Dr. Robert Sladen’s presentation of PerioperativeCare of the Patient With Renal Dysfunction (#301, Rm2014). Dr. Lee Fleisher shares his expertise on PreopAssessment of the Patient with Cardiac Disease (#308,

See “2007 ASA,” Page 43

10:30 am, Rm 2014), concurrent with Dr. RonaldMiller’s Update on Transfusion Medicine (#108, Rm2018). These lectures will be followed by Controver-sies in Perioperative Pacemaker and Defibrillator Man-agement by Dr. Mark Rozner (#110, 1:40-2:30 pm, Rm2018), and in the same room, The ASA ObstructiveSleep Apnea Guidelines by Dr. John Benumof (#111,2:50-3:40 pm). Dr. Jessica Alexander’s lecture on ThePotential Hazards of Perioperative Herb and Dietary Sup-plement Use will provide useful information regard-ing our growing patient population who ascribe tocomplementary and alternative medicine (#118, 4:00-4:50 pm, Rm 2022).

Sunday, October 14, 2007: Sunday morning startswith a broad overview of Evidence Based Medicine inPerioperative Care—Does It Help Us Improve Care? by

Safety Topics Abound at 2007 ASAby Lorri A. Lee, MD

APSF to Co-Sponsor Workshop on TeamworkThe 2007 Annual Meeting of the American Society of Anesthesiologists (ASA) will be held from Saturday, October 13, through

Wednesday, October 17, at the Moscone Center in San Francisco, CA. Patient safety will again be the focus of numerous refreshercourses, special lectures, scientific presentations, panels, and workshops, which are highlighted below. This year the APSF isproud to co-sponsor a workshop on Teamwork and Team Training in the Operating Room (#817) to be led by Drs. DavidGaba and Robert McQuillan on Monday, October 15, from 2:00-5:00 pm in the Moscone Center West (Rm 2001). This work-shop will demonstrate how patient safety can be optimized when everyone in the OR works as a team (see page 53 fordetails). Other workshops that focus on patient safety include Healthcare Team Training in a Virtual Environment (#822Aand B, Tuesday, October 16, from 8:00-9:30 am and 9:30-11:00 am, Rm 2001, Moscone Center West); Applying HumanFactor Methods to Anesthesia Care (#824, Wednesday, October 17, from 8:00-11:00 am Rm 2001, Moscone Center West);and fiberoptic workshops throughout Saturday and Sunday, October 13 and 14 (Rm 130 and 132, Moscone Center North).

APSF NEWSLETTER Fall 2007 PAGE 42

NEWSLETTERThe Official Journal of the Anesthesia Patient Safety Foundation

The Anesthesia Patient Safety FoundationNewsletter is the official publication of the nonprofitAnesthesia Patient Safety Foundation and is pub-lished quarterly at Wilmington, Delaware. Annualcontributor status: Individual–$100, Corporate–$500.This and any additional contributions to the Founda-tion are tax deductible. © Copyright, AnesthesiaPatient Safety Foundation, 2007.

The opinions expressed in this Newsletter are notnecessarily those of the Anesthesia Patient SafetyFoundation or its members or board of directors.Validity of opinions presented, drug dosages,accuracy, and completeness of content are notguaranteed by the APSF.

APSF Executive Committee:Robert K. Stoelting, MD, President; Jeffrey B.

Cooper, PhD, Executive Vice President; George A.Schapiro, Executive Vice President; David M. Gaba, MD,Secretary; Casey D. Blitt, MD, Treasurer; Sorin J. Brull,MD; Robert A. Caplan, MD; Nassib G. Chamoun; RobertC. Morell, MD; Michael A. Olympio, MD; Richard C.Prielipp, MD; Matthew B. Weinger, MD. Consultants tothe Executive Committee: John H. Eichhorn, MD; LorriA. Lee, MD; and Ann S. Lofsky, MD.Newsletter Editorial Board:

Robert C. Morell, MD, Editor; Sorin J. Brull, MD;Joan Christie, MD; Jan Ehrenwerth, MD; John H.Eichhorn, MD; Lorri A. Lee, MD ; Rodney C. Lester,PhD, CRNA; Glenn S. Murphy, MD; Denise O’Brien,MSN, RN; Karen Posner, PhD; Andrew F. Smith,MRCP FRCA; Wilson Somerville, PhD; JefferyVender, MD.

Address all general, contributor, and subscriptioncorrespondence to:Administrator, Deanna WalkerAnesthesia Patient Safety FoundationBuilding One, Suite Two8007 South Meridian StreetIndianapolis, IN 46217-2922e-mail address: [email protected]: (317) 888-1482

Address Newsletter editorial comments, questions, letters, and suggestions to:Robert C. Morell, MDEditor, APSF Newsletterc/o Addie Larimore, Editorial AssistantDepartment of AnesthesiologyWake Forest University School of Medicine9th Floor CSBMedical Center BoulevardWinston-Salem, NC 27157-1009e-mail: [email protected]

www.apsf.org

®

BE SURE TO VISIT THE APSF BOOTH AT THE 2007 ASA IN THE MOSCONE CENTER IN SAN FRANCISCO• Learn About the APSF• Meet Leaders in Patient Safety

• Check Out the Newsletter• Explore the Website

* * * * * * * Make a Donation * * * * * * *

We note with sadness the passing of

Dr. Arthur Keats, whose accomplishments

in anesthesia very many and varied. He

played an important role in the early years

of APSF by being the first chair of our

Scientific Evaluation Committee. He used

his extensive research acumen to organize

the system for soliciting and reviewing

grants, based on his experience on NIH

study sections. The rigor he brought to

that process has remained essentially the

same. His incisive thinking and quick wit

made for serious, yet enjoyable discussions.

In Memorium

Arthur Keats, MD


Scientific Papers HighlightPatient Safety

The Scientific Papers sessions at the 2007 ASAAnnual Meeting include 4 poster discussion sessionsand 4 poster sessions with a focus on patient safetywith 1 or more sessions each day of the meeting.Topics in these sessions include efficiency in operat-ing room scheduling, outcomes after initiation ofnational patient safety initiatives, outcomes withbariatric surgery, numerous sleep apnea patientstudies, the effect of mild hypothermia on intraoper-ative blood loss, and many others.

On Saturday, October 13, 2007, from 9:00-11:00am (Hall D, Area G, Moscone Center North), beginsthe first poster presentation on the topic of Predict-ing Risk and Outcome from Patient Registries andQuality Databases, which includes posters onprospective perioperative adverse event databases in2 different European hospitals (A178, Piacevolli andBarach from A.C.O. San Felippo Neri, Rome, Italy,and A179, Lehman et al. from University Hospital,Basel, Switzerland), a meta-analysis of large trialswith > 5000 patients describing a reduction in peri-operative mortality over time (A189, Bainbridge etal., University of Western Ontario), a presentation byVichova and colleagues from Hospital Louis Pradelin Lyon Bron, France, on Patients with Coronary Stentsand Non-Cardiac Surgery: Preliminary Results of POS-TENT Study (A193), and A Meta-Analysis of the Effectsof Mild Perioperative Hypothermia on TransfusionRequirement (A201) by Rajagopalan et al. from theCleveland Clinic. In the afternoon from 1:30-3:00 pm(Rm 301 Moscone Center South), the first poster dis-cussion session on the Public Health Impact of Anes-thesiology Practice will include studies on DoChronic Oral Opioids Impair Driving Skills? A Random-ized Controlled Trial (A278, Buvanendran et al., RushMedical College), Smoking-Induced Burn Injury Whileon Chronic O2 Therapy (A282, Somers-Dehaney et al.,University of South Florida), and Increases inMethadone Drug Related Emergency Room Visits andPoisoning Deaths (A284, Moric et al., Rush UniversityMedical Center).

Scientific paper sessions for Sunday, October 14,2007 include a morning poster discussion session(9:00-10:30 am, Rm 123, Moscone Center North) onOpportunities for Patient Safety from Practice-Based Learning with studies on Delirium in the Recov-ery Room Is Associated with Preoperative Fasting (A501,Radtke et al., Charité-Universitätsmedizin Berlin)and Validity of Preoperative Stress Testing in VascularSurgery and Its Association with Gender (A502, Sun etal., Beth Israel Deaconess Medical Center). TheSunday afternoon session (2:00-4:00 pm, Hall D,Area O, Moscone Center North) will highlightAirway & Respiratory Risk; Obstructive SleepApnea and consists of multiple studies on screening

tools for obstructive sleep apnea (OSA) syndrome aswell as management of the airway for OSA/mor-bidly obese patients and perioperative complicationsin this patient group.

On Monday, October 15, 2007, one scientificpaper session will take place entitled Patient Risk &Genetic Predisposition; Metabolic Interventions;Substance Abuse (9:00-10:30 am, Rm 125, MosconeCenter North). The poster discussions in this sessioninclude genetic studies on 5 HT3 Antagonists and Car-diac Repolarization Time in Patients Genetically Prone toQTc Prolongation (A1029, Quraishi et al., Pennsylva-nia State University College of Medicine) and NovelCausative RYR1 Mutations in Malignant Hyperthermia(A1030, Girard et al., University Hospital of Basel,Switzerland), and substance abuse studies on detec-tion of drug diversion in an operating room (A1035,Epstein et al., Jefferson Medical College).

On Tuesday, October 16, 2007, 2 patient safety-oriented scientific paper sessions are slated, startingwith Drug and Device Safety, Medical Errors & Pre-vention (9:00-11:00 am, Hall D, Area G, MosconeCenter North). This session has 3 papers dealing withMRI-related adverse events (A1596, A1599, andA1607), 2 papers on perioperative temperature con-trol (A1611, A1612), and 3 papers on the implicationsof differing water content in 3 different sevofluraneformulations (A1591, A1593, and A1597). Seesevoflurane article on page 48 for more on this topic. Theafternoon poster session on National Patient SafetyGoals, Life Safety, Patient Education and SafetyCulture (2:00-4:00 pm, Hall D, Area O, MosconeCenter North) includes original research on patienthandoffs by Joseph and co-authors (A1782, Transferof Anesthesia Care: Are We Compromising PatientSafety?) and by Mayer et al. (A1785, FacilitatingPatient Safety through an Anesthesia Resident Hand-Offof Care Training Module). Three papers deal withhandwashing to prevent transmission of pathogensto patients and staff (A1786-88). Richard Cook andcolleagues provide data on a novel approach toinvestigating medical adverse events similar to theNational Transportation Safety Board investigations(A1789) so that defects in the process of care can beidentified and corrected. Barach and coworkers pre-sent 2 papers on wrong-site anesthesia events(A1783) and risk factors for retained instruments andsponges after surgery (A1791).

Wednesday, October 17, 2007, marks the lastpatient safety scientific paper session with a posterdiscussion on Can We Train More and Use Informa-tion Systems to Enhance Patient Safety and Out-come? (1:30-3:00 pm, Rm 123, Moscone CenterNorth). These 8 posters include 3 papers on increas-ing education about physician handwashing (A2139-41), 2 papers on using automated reminders for

1:40-2:30 pm, Rm 2018), logically followed by Dr.John Ellis’s lecture on Myocardial Ischemia and Postop-erative Monitoring (#314, 2:50-3:40 pm, Rm 2022). Dr.Girish Joshi will try to clarify the hot controversy ofmanaging The Patient with Sleep Apnea Syndrome ForAmbulatory Surgery (#309, 2:50-3:40 pm, Rm 2018),concurrent with another debated topic of Depth ofAnesthesia: Clinical Applications, Awareness and Beyondpresented by Drs. Daniel Cole and Karen Domino(#324, Rm 3018). Dr. David Chestnut will share hisvast experience and expertise to help us manageProblems in Obstetric Anesthesia: Blood Pressure, BloodLoss and Blood Patch (#315, 4:00-4:50 pm, Rm 2022).Lastly, as operating room capacity expands in manycenters, and technology grows, Dr. Keith Ruskin willprovide insight on Perioperative CommunicationDevices: Impact on Patient Safety (#325, 4:00-4:50 pm,Rm 3018).

Tuesday, October 16, 2007: Dr. Lucinda Everettstarts off Tuesday’s Refresher Course lectures witha discussion of Quality and Safety Initiatives: Implica-tions for Ambulatory Anesthesia (#401, 8:30-9:20 am,Rm 2014). Dr. Therese Horlocker will provide herexpert assessment of the safety of Anticoagulationand Regional Anesthesia (#411, 8:30-9:20 am, Rm 2022),followed in the same room by Dr. Ton Gan’s knowl-edgeable guidance with Management of PostoperativeNausea and Vomiting (#412, 9:40-10:30 am). As Hur-ricane Katrina provided us with a shocking glimpseof medical emergencies during disasters, Dr. JosephMcIsaac will provide some insight into considera-tions for Hospital Preparation for Disasters (#413, 1:40-2:30 pm, Rm 2022). With the rapidly expandingwaistlines in America, Dr. Thomas Ebert will dis-cuss the Perioperative Considerations for the MorbidlyObese (#404, 2:50-3:40 pm, Rm 2014). Concurrentwith this talk, Dr. Cliff Deutschman will review TheBiologic Response to Surgery and Injury—ClinicallyRelevant Basic Science (#409, Rm #2018).

Wednesday, October 17, 2007: The ASA RefresherCourses conclude on Wednesday with Dr. KathrynMcGoldrick informing us about the largest growingsegment of our population in The Graying of America:Anesthetic Implications for Geriatric Outpatients (#501,8:30-9:20 am, Rm 2014), concurrent with Dr. JamesEisenkraft’s presentation of the Hazards of the Anes-thesia Workstation (#511, Rm 2022), addressing howto prevent and manage critical incidents associatedwith anesthesia gas delivery systems. As periopera-tive glucose control has become a national patientsafety initiative, Dr. Daniel Brown will describe bestpractice for Perioperative Management of the DiabeticPatient (#513, 10:50-11:40 am, Rm 2022). Lastly, Dr.Carin Hagberg will update us on Current Concepts inthe Management of the Difficult Airway (#510, 1:50-2:40 pm, Rm 2018).

Safety Papers to Be Presented Over 5 Days“2007 ASA,” From Page 41

See “2007 ASA,” Page 54


See “Errors,” Next Page

Congress has recently passed legislation thatincludes steps to prevent hospital medication errors.In part this was in response to the tragic deaths of 3premature infants in Indianapolis in September 2006,after they were accidentally administered adult dosesof heparin. The Institute of Medicine (IOM) has esti-mated that each year medication errors injure at least1.5 million Americans and cost the health systemmore than $3.5 billion.1 Drug errors feature promi-nently in every large-scale study of iatrogenic injuryconducted.2 In 1999 the IOM called for a halving oferrors (including medication errors) in health careover the next 5 years. In 2004 the Food and DrugAdministration (FDA) mandated the use of barcodesat unit-dose level on all medications;3 these are beingphased in over 5 years. However, little else seems tohave changed, and the IOM’s goal of a 50% errorreduction certainly has not been achieved in relationto medication administration. In 2007, the vast major-ity of drugs used in health care are still administeredby traditional means, and drug error remains a signif-icant hazard to the health of patients everywhere.

The Extent of the ProblemThere is no aspect of anesthesia that occupies a

more important place in the safe management of ourpatients than the accurate administration of medica-tions. It is therefore surprising how little has been pub-lished dealing with reducing medication error inanesthesia. A recent systematic review of the literaturefrom 1978 to 2002 identified only 98 references on thissubject, and only 1 involved a randomized trial (con-ducted with a human-patient simulator), only 2 couldbe considered experimental or quasi-experimental,and only 11 contained observational data.4 The land-mark 1978 paper by Cooper et al., the starting point forthe analysis in the above study, identified 359 inci-dents.5 The first, second, and fourth most frequent inci-dent categories were breathing circuit disconnection,inadvertent gas flow change, and gas supply prob-

lems. The third most frequent was syringe swap. In1984 a further critical-incident analysis published byCooper’s team, showed a similar pattern of problems.6The most frequently cited critical incident categorywas breathing circuit disconnection. The next 8 cate-gories included both syringe swap and ampule swap.Drug overdose (via syringe and vaporizer) was alsolisted. Cooper’s group concluded that human errorwas the dominant issue in anesthesia safety andencouraged the specialty to direct patient safety effortstoward monitoring instrumentation and improvementin equipment using human-factors techniques. Todayhistory has vindicated this vision. Engineering inno-vations have virtually eliminated problems with thedelivery of oxygen to patients. A recent review of 4,000incidents and over 1,200 medico-legal notificationsreported by anesthetists in Australia revealed no casesof hypoxic brain damage or death from inadequateventilation or misplaced tubes since the introductionof oximetry and capnography.7 However, no such sys-tematic innovations have yet been widely adopted toreduce medication error.

We don’t know what the rate of medication errorwas in 1978, but recent data have shown that the mag-nitude of the problem today is more serious than pre-viously thought. Using facilitated incident monitoring(which provides a denominator) and prospectivelycollecting data from over 10,000 anesthetics in NewZealand, approximately 1 error was shown to occurfor every 130 anesthetics.8 A very similar rate wasfound in Seattle, using the same study method.9 Otherstudies from various countries and types of institutionsuggest that these estimates are of the correct order ofmagnitude10-13 (Table 1, page 47) and reflect the situa-tion in anesthesia as it is widely practiced today,rather than any local aberrations in standard of care.

Orser’s group took a different approach. Theysent an anonymous survey to all 2,266 members of theCanadian Anesthesiologists’ Society in 1995.14 Thirty

percent of the members responded to the survey and1,038 drug-related events were examined in detail.Most anesthesiologists had experienced >1 drugerror. Syringe swap was the most common categoryof error. Fifteen of the errors (1.4%) resulted in majormorbidity (including 4 deaths). In a similar survey inNew Zealand, 89% of respondents admitted havingmade at least 1 drug error.15 The Canadian studyprovides valuable insights into the root causes ofdrug error. For example, although 86% of respon-dents were aware of the Canadian Standards Asso-ciation labeling standards, and 86.9% agreed orstrongly agreed that these labels reduced the inci-dence of drug errors, only 72% actually used them.Furthermore, fewer than half the respondents“always” read the label. These findings are not edify-ing for a specialty group with a claim to being lead-ers in safety, and there is no reason to believe thatthe practices described, and the attitudes that drivethem, are confined to Canada. One of us adminis-tered a questionnaire to 210 delegates at a NewZealand anesthesiology conference, asking 12 ques-tions concerning perceptions about the drug errorproblem.16 Respondents answered questions in rela-tion to their own practice and anesthesia practice ingeneral (hence their colleagues). The majority ofanesthesiologists felt that drug error in anesthesiawas a significant problem, and one the public wasbecoming increasingly intolerant of; however, fewwere concerned over the chance of harming an indi-vidual patient in this way themselves, and most feltthat error was more of a problem with other anesthe-siologists’ practices than with their own. Similarly, inAustralia, anesthesiologists estimated the risk ofawareness in their personal practices as half as likelythan in that of their colleagues.17 These are classicexamples of optimist bias, a common psychologicalphenomenon in which individuals, on average, view

Medication Administration in AnesthesiaTime for a Paradigm Shift

by Mike Stabile, Craig S. Webster, and Alan F. Merry

In 1999 the Institute of Medicine called for a halving of error in health care within 5 years. Numerousother authoritative calls for improved safety have been made since, including legislative moves by Congress and the Food and Drug Administra-tion. Despite this, the vast majority of drugs used in health care continue to be administered by traditional error-prone means, and drug errorremains a hazard to patients everywhere. The problem is of particular concern in anesthesia, where large numbers of potent drugs are given, oftenin rapid sequence. Historically, system redesign in anesthesia has been successful in eliminating error, for example in the elimination of problemswith the delivery of oxygen to patients. However, we believe that much of the low hanging fruit of the benefit of simple engineering solutions hasnow been plucked. Thus, rather than an entirely blameless culture of safety focused solely on systems, we propose a “just culture,” where acci-dents can be identified as blameless errors, or culpable violations. We all make errors, even when doing our best to avoid them—they are unin-tentional, blame is usually unhelpful, and they are the appropriate target of system redesign. We believe what is now required to further reduceerror in drug administration is a more sophisticated approach, involving a better understanding of the nature of human error itself, and bettercompliance in the adoption of safety procedures and systems.


their own abilities as better than average (a statisticalimpossibility).

Lessons from Intensive CareDisguised-observer studies in the ICU literature

offer lessons for the anesthesia professional in theoperating room. The disguised-observer technique isknown to accurately identify rates of error in hospi-tal environments, and there are many similaritiesbetween the ways drugs are given in the ICU and inthe operating room during anesthesia.

At 2 Dutch hospitals van dem Bemt et al. usedthe disguised-observer technique.18 The researchersobserved 233 drug administrations to 24 patientsover the 5-day study period. The error rate was44.6% (104/233) when wrong-time errors wereincluded and 33% (77/233) when wrong-time errorswere excluded. A wrong-time error was defined asthe administration of a drug >60 minutes earlier orlater than prescribed.

If these data are even partially indicative of theproblem in anesthesia, then it is considerably worsethan that suggested by the studies summarized inTable 1. This possibility is reinforced by recent (as yetunpublished) work in New Zealand using directobservation in human-patient simulation involvingcomplex anesthetic cases.

Why Medication Error inAnesthesia Continues to Occur

It is not difficult to inject 1 drug safely, but thechallenge the anesthesia professional faces is to par-ticipate in the administration of perhaps half a mil-lion drugs during a professional lifetime. Doing this100% accurately is very difficult. Many of ourpatients have diminished physiologic reserve to tol-erate drug error. As they are sedated or anesthetizedthey cannot correct or detect drug errors themselves.They depend on us to do this, and this is a responsi-bility we should not take lightly.

Errors, Outcome, and BlameThe outcome of an error is largely determined by

chance. You back out of your driveway and run overan unseen squirrel that dashes under your car. Or,you back out of your driveway and run over anunseen child that does the same thing. The errormechanism is identical in each case, but both you andsociety will judge yourself differently. The same canbe said of drug errors. There is no moral differencebetween a drug error that causes no harm and onethat results in death.

Recently one of us was asked to debrief a traineewho inadvertently administered 200 mg ofdopamine as a bolus, using an unlabeled syringe(this was a look-alike problem, set up by a recentchange in the formulations of 2 drugs). With help

from his supervisor, he was able to respond to thesudden catastrophic rise in blood pressure, thepatient’s life was saved, and in the end no harmensued. In 1990, another anesthesiologist gave theidentical drug in error (having also been set up, thistime by having the ampule of dopamine placed in thecompartment in the drug drawer labeled“Dopram”).19 The patient lost her life and the anes-thesiologist was convicted of manslaughter.

The importance of an adverse event should bejudged by its potential outcome rather than its actualoutcome. The enormity of the potential outcome froma drug error does not justify recourse to the criminallaw, but surely it does justify taking the problem seri-ously, reporting the incident, and (as a minimum)labeling one’s syringes and reading one’s ampules.This concept is encapsulated in a World Health Orga-nization motto, which states, “To err is human; to coverup is unforgivable; to fail to learn is inexcusable.”

Changing CultureIt is impossible to address drug error effectively

without addressing the organizational culture ofanesthesia. In Human Error James Reason advocateda blame free culture as necessary for effectivelyreducing error. In the end, few people are really com-fortable with the notion that blame should be setaside completely. Today most authorities (includingReason) would probably advocate a “Just Culture.”20

This implies early triage of incidents into those inwhich blame may be appropriate, and those in whichit is not. By definition, errors fall into the latter cate-gory. In fact, if the aim is to promote patient safety,the former category should be reserved for clearlyegregious behaviors, such as leaving an anesthetizedpatient unattended, or working under the influenceof alcohol or drugs.

Aviation, for most anesthesiologists and nurseanesthetists, is the obvious model for safety. Thereare lessons to be learned from aviation, as there arefrom high-reliability organizations in other fieldssuch as the nuclear power industry.21 However, themetaphor of the anesthesia professional as a pilot,and the notion that “take-offs” and “landings” arelike induction and emergence is limited. For a start,the system formed by the patient, the anesthesiolo-gist and/or the CRNA, and the surrounding envi-ronment of the operating room (including personneland equipment) is more complex than that whichcharacterizes commercial aviation.2 It does seem thataviation has embraced a safety culture for decades,whereas some anesthesia providers seem to harboran attitudinal barrier to safety.16,22 In a safety culture,accidents are interpreted as evidence of faulty systemdesign. Both accidents and incidents are viewed asopportunities to redesign the work environment andimprove safety. Such cultures, therefore, embrace ahealthy incident reporting system. Individual errorsmay not be foreseeable, but the contributing factorscan be anticipated and addressed.23 By contrast, aperson-centered approach to error involves blaming

individuals for their carelessness, forgetfulness, orother character weakness when things go wrong.Such an approach has been called the culture ofdenial and effort: denial, because it denies the psy-chological reality that error is a statistically inevitableconsequence of human action; and effort, because itimplies that with sheer effort alone all error can beavoided.24 It directs attention away from faulty worksystems, leaving them untouched and able to predis-pose to further errors and failures in the future. Theculture of denial and effort is the antithesis of the cul-ture of safety and is clearly unhelpful and unsound.Despite this, the person-centered approach persistsin health care (including anesthesia), and often hin-ders the adoption of safety systems and procedures.

In the end, perhaps the biggest single differencebetween anesthesia and aviation relates to the percep-tion that expenditure on safety is justified. The num-bers involved in a single airline accident grab publicattention and demand a response. Individual anesthe-siologists or CRNAs harm harm patients 1 at a time.Collectively and over time the harm mounts up, butbecause it is sporadic it is largely invisible. Imagine thepublic’s response to 5,000 plus cases of intraoperativeawareness if they all occurred in 1 hospital in the first2 weeks of January, instead of being spread out overthe calendar year and the entire country.25

In anesthesia, and health care generally, the pre-dominant cultural focus is on productivity. The cur-rent common demand on the part of hospitaladministrators for a “business case” or a “return oninvestment” (ROI) to justify expenditure on safety ismisguided if it doesn’t factor in the wider picturewhich includes the very real cost of iatrogenicharm.24 It is reminiscent of the saga of the FordPinto.26 This car was designed in such a way that thefuel tank would rupture and explode in certain rear-end collisions, burning or killing its occupants. Fordknew about these risks. However, the business casewas taken that it would be cheaper for Ford to con-tinue to sell Pintos, let its customers burn, and to payout the lawsuits on these somewhat infrequent cases,than to recall all Pintos and fix the problem. In theend it turned out cheaper than expected to fix theproblem, so even the business case seems to havebeen flawed. In addition, the public outcry that fol-lowed the exposure of Ford’s commercial cynicismdid enormous damage to the company’s reputationand sales. Ford earned the dubious distinction ofbeing the first corporation to be charged with thecriminal offence of reckless homicide. A similar situ-ation often occurs in health care. Safety should befunded because it is the right thing to do, not becauseof any ROI directives. However, in health care, doingthe right thing, first time to the right patient, usuallyturns out to be the best from a business perspectiveas well. Harming patients during their treatment,and then having to treat them for such harm, is extra-ordinarily inefficient and expensive. The savingsfrom even one avoided case of significant iatrogenic

Expenditure for Safety is Justified


“Errors,” From Preceding Page


harm would pay for a great deal of safety. Further-more, the cost to the health care organization interms of lost reputation can be many times largerthan the cost of treating the harmed patient. Iatro-genic harm simply doesn’t pay.

How Should We Administer Drugs?Administering drugs is fundamental to anesthe-

sia, and its importance should be elevated in pro-grams of continuing professional development, inpriorities for research, and in self-directed reading.For example, in a recent survey of anesthesiologists,only 19% reported having received specific trainingon how to administer drugs safely.16

A systematic literature review has broughttogether received wisdom on how best to reduce therisk of drug administration error during anesthesia.4Five strong recommendations survived testing againstactual incident reports (Table 2, page 47). These wouldseem to be a good starting point for action.

Furthermore, involvement of pharmacists in theoperating room has been recognized as a core princi-ple for improving drug safety in anesthesia.27 Thepreparation and labeling of drugs in a central phar-macy should decrease the incidence of error. In thepharmacy 2 people check each other’s work, multiplesyringes are prepared for 1 drug at a time, and theenvironment is one in which distractions are few,order reigns, and time is available to check andrecheck (and record the checking on a form). In addi-tion, dispensing accuracy generally improves admin-istration accuracy.

One thing is clear—we will not make progresswhile we continue to embrace idiosyncraticapproaches to this problem. Health care organiza-tions must establish sound techniques for drugadministration, teach them to their residents, andprovide role models of their use. There is an increas-ing range of solutions available for the problem ofdrug administration error in anesthesia (Table 3,page 47).27-31 Incident data, prospectively collectedover a period of 5 years, have shown that the use of asystem incorporating a number of these safety prin-ciples has been associated with a significantly lowerrate of drug error per bolus administered.32

The Need for a New ParadigmA few years ago a senior colleague made a drug

error while anesthetizing a human-patient simulator.He admitted it and said, “I must try harder in thefuture.” Here is the heart of the problem. This is theperson-centered view that impedes progress and isdoomed to fail. The truth is that he was trying ashard as he could—he was under the direct observa-tion of several of his peers, and was very motivatedto perform as well as possible. That is the definingpoint about errors; we make them, unintentionally,even when we are trying not to. Trying harder will

Systems Should Incorporate Safety Principlesnot substantially reduce error, but re-designing sys-tems to make them inherently less error-prone will.

Berwick has popularized the quote, attributed toEinstein, that, “Madness is doing the same thingover and over again and expecting a differentresult.” We will not reduce drug error until wechange the way we give drugs. This will includeembracing technological solutions of one sort oranother. However, it will also mean complying withthese solutions. It is unlikely that forcing functionswill ever make drug error in anesthesia impossible.It is certain, however, that redesigning the systemcan make errors much less probable—providedanesthesiologists and nurse anesthetists actuallymake the effort to take proper advantage of theinnovations.

Dr. Stabile is an Adjunct Clinical Professor at Van-derbilt University School of Medicine, Nashville, Ten-nessee, and St. Louis University School of Medicine, St.Louis, Missouri.

Dr. Webster is a Research Fellow in the Department ofAnaesthesiology at the School of Medicine at the Univer-sity of Auckland, Auckland, New Zealand.

Dr. Merry is Professor and Head of the Departmentof Anaesthesiology at the School of Medicine at the Uni-versity of Auckland, Auckland, New Zealand.

DISCLOSURE: All three authors own shares in SaferSleep, LLC., a manufacturer of an automated anesthesiarecord system that includes a barcode-based drug adminis-tration system. This company is also a contributor to theAPSF. Dr. Webster has received research grant support fromthis company, Dr. Merry is a Director of this company, andDr. Stabile is Chief Medical Officer and Chairman of theMedical Advisory Board of Safer Sleep, LLC.

References1. Institute of Medicine. To err is human—building a safer

health system. Washington DC: National Academy Press;2000.

2. Webster CS. Implementation and assessment of a new inte-grated drug administration system (IDAS) as an example ofa safety intervention in a complex socio-technological work-place. University of Auckland: Auckland; 2004.

3. Bar code label requirement for human drug products andbiological products. Fed Regist 2004; 69: 9119-9171.

4. Jensen LS, Merry AF, Webster CS, Weller J, Larsson L. Evi-dence-based strategies for preventing drug administrationerror during anaesthesia. Anaesthesia 2004; 59: 493-504.

5. Cooper JB, Newbower RS, Long CD, McPeek B. Pre-ventable anesthesia mishaps—a study of human factors.Anesthesiology 1978; 49: 399-406.

6. Cooper JB, Newbower RS, Kitz RJ. An analysis of majorerrors and equipment failures in anesthesia manage-ment—considerations for prevention and detection. Anes-thesiology 1984; 60: 34-42.

7. Runciman WB. Iatrogenic harm and anaesthesia in Aus-tralia. Anaesth Intensive Care 2005; 33: 297-300.

8. Webster CS, Merry AF, Larsson L, McGrath KA, Weller J.The frequency and nature of drug administration errorduring anaesthesia. Anaesth Intensive Care 2001; 29: 494-500.

9. Bowdle A, Kruger C, Grieve R, Emmens D, Merry A.Anesthesia drug administration error in a university hos-pital. Anesthesiology 2003; 99: A1358.

“Errors,” From Preceding Page 10. Craig J, Wilson ME. A survey of anaesthetic misadven-tures. Anaesthesia 1981; 36: 933-936.

11. Kumar V, Barcellos WA, Mehta MP, Carter JG. An analy-sis of critical incidents in a teaching department for qualityassurance—a survey of mishaps during anaesthesia.Anaesthesia 1988; 43: 879-883.

12. Short TG, O’Regan A, Lew J, Oh TE. Critical incidentreporting in an anaesthetic department quality assuranceprogramme. Anaesthesia 1993; 48: 3-7.

13. Fasting S, Gisvold SE. Adverse drug errors in anesthesia,and the impact of coloured syringe labels. Can J Anesth2000; 47: 1060-1067.

14. Orser BA, Chen RJB, Yee DA. Medication errors in anes-thetic practice: a survey of 687 practitioners. Can J Anaesth2001; 48: 139-146.

15. Merry AF, Peck DJ. Anaesthetists, errors in drug adminis-tration and the law. N Z Med J 1995; 108: 185-187.

16. Webster CS, Grieve DJ. Attitudes to error and patientsafety. Prometheus 2005; 23: 253-263.

17. Myles PS, Symons JA, Leslie K. Anaesthetists’ attitudestowards awareness and depth-of-anaesthesia monitoring.Anaesthesia 2003; 58: 11-16.

18. van den Bemt PM, Fijn R, van der Voort PH, Gossen AA,Egberts TC, Brouwers JR. Frequency and determinants ofdrug administration errors in the intensive care unit. CritCare Med 2002; 30: 846-850.

19. Skegg PDG. Criminal prosecutions of negligent health pro-fessionals—the New Zealand experience. Med Law Rev1998; 6: 220-246.

20. Merry AF, McCall Smith A. Errors, medicine and the law.Cambridge: Cambridge University Press: 2001.

21. Webster CS. The nuclear power industry as an alternativeanalogy for safety in anaesthesia and a novel approach forthe conceptualisation of safety goals. Anaesthesia 2005; 60:1115-1122.

22. Gaba DM, Singer SJ, Sinaiko AD, Bowen JD, Ciavarelli AP.Differences in safety climate between hospital personneland naval aviators. Hum Factors 2003; 45: 173-185.

23. Reason J. Managing the risks of organisational accidents.Aldershot: Ashgate; 1997.

24. Webster CS. The iatrogenic-harm cost equation and newtechnology. Anaesthesia 2005; 60: 843-846.

25. Preventing and managing the impact of anesthesia aware-ness. Issue 2, October 6, 2004, Sentinel Event Alert, TheJoint Commission. Available at http://www.jointcom-mission.org. Accessed August 31,2007.

26. Flammang JM. Ford Pinto rear-impact defect. In SchlagerN, editor. When technology fails—significant technologicaldisasters, accidents and failures of the twentieth century.Gale Research Inc.: Detroit; 1994. p. 156-162.

27. Merry AF, Webster CS, Mathew DJ. A new, safety-ori-ented, integrated drug administration and automatedanesthesia record system. Anesth Analg 2001; 93: 385-390.

28. Safer Sleep LLC. http://www.safersleep.com. AccessedAugust 31, 2007.

29 DocuSys: Digital Medical Solutions.http://www.docusys.net. Accessed August 31, 2007.

30. Standard specification for user applied drug labels in anes-thesiology (D4774-94). American Society for Testing andMaterials: Philadelphia; 1995.

31 Merry AF, Webster CS, Connell H. A new infusion syringelabel system designed to reduce task complexity duringdrug preparation. Anaesthesia 2006; 62: 486-491.

32. Merry AF, Webster CS, Larsson L, Weller J, Frampton CM.Prospective assessment of a new anesthestic drug admin-istration system designed to improve safety. Anesthesiology2006; 105: A138.



Table 1. Prospective estimates of rates of drug administration error in anesthesia (1978-present)

1. The label on any drug ampule or syringe should be carefully read before a drug is drawn up or injected.

2. Legibility and contents of labels on ampules and syringes should be optimized according to agreedstandards in respect to some or all attributes of font, size, color, and the information included.

3. Syringes should be labeled (always or almost always).

4. Formal organization of the drug drawers and workspace should be used with attention to tidiness,position of ampules and syringes, separation of similar or dangerous drugs, removal of dangerousdrugs from the operating rooms.

5. Labels should be checked specifically with a second person or a device (such as a barcode reader linkedto a computer) before a drug is drawn up or administered.

Study Sample No. of Anesthetics No. of Drug Errors Drug Error Rate

Craig & Wilson10 6 Months 8312 12 0.14%

Kumar et al.11 April 1984-January 1985and April 1985-January 1986

28965 31 0.11%

Short et al.12 1990 16739 26 0.16%

Fasting & Gisvold13 September 1996-October 1999 55426 63 0.11%

*Webster et al.8 February 1998-October 1999 10806 81 0.75%

*Bowdle et al.9 21 weeks 6709 41 0.61%

* Studies that used the facilitated collection technique.

Table 2. Strong safety recommendations based on a systematic review of the entire literature on drug admin-istration error in anesthesia and as validated against actual incident reports

1. The provision of all labels in a standardized format emphasizing the class and generic names of eachdrug, incorporating a bar-code and class-specific color-code consistent with international drug labelingstandards.27,30

2. The presentation of selected, commonly used drugs in pre-filled syringes prepared under qualityassured conditions and pre-labeled as above.27

3. The use of a bar-code reader to scan the drug at the point of administration immediately before it isgiven, linked to an auditory prompt (i.e., the computer speaks the name of the scanned drug) and avisual prompt (i.e., the computer displays the name of the drug, in prominent color-coded format) tofacilitate checking of the drug’s identity.27

4. Integration of scanned information into an automated anesthetic record, facilitating accuracy of thedrug information in the record and reducing the cognitive load on the anesthesia professional.27

5. The use of devices at the point of care to automatically measure the dose of drug administered.29

6. The use of purpose designed drug trays to facilitate the layout of syringes and ampules and organiza-tion of the anesthesiologists’ or nurse anesthetists’ workspace.27

7. Infusion syringe labels consistent with the standardized labels described above, which incorporate adosing nomograph into the label itself, thus removing the need for look-up tables or dose calculationsand reducing the cognitive load on the anesthesia provider.31

8. The use of automated medication dispensing systems with features such as single-issue drawers andbarcode scanners to facilitate safer dispensing of drugs in the operating room.

Table 3. Possible additional measures to promote safer drug administration in anesthesia

A N E S T H E S I A P A T I E N T

S A F E T Y F O U N D A T I O N

CORPORATE ADVISORY COUNCIL

George A. Schapiro, ChairAPSF Executive Vice PresidentJohn F. Heden ......................Abbott Laboratories

Sean Lynch ..........................Anesthesia Healthcare Partners

Cliff Rapp ............................AnesthesiologistsProfessional InsuranceCompany

Jim Fitzpatrick ....................Arrow International

Nassib G. Chamoun............Aspect Medical System

Stanley Horton, PhD ..........Bayer Pharmaceuticals

Raul A. Trillo, MD ..............Baxter Healthcare

Michael S. Ferrara................Becton Dickinson

Timothy W. Vanderveen, PharmD ............................Cardinal Healthcare

Andrea Wilt..........................Cerner Corporation

Roger S. Mecca, MD............Covidien

Thomas W. Barford ............Datascope Corporation

Robert Clark ........................Dräger Medical

Mike Gustafson....................Ethicon Endo-Surgery

Carolyne Coyle ....................GE Healthcare

Steven Pregulman, MD ......Hospira

Steven R. Block ....................LMA of North America

Dana Capocaccia ................Luminetx

Joe Kiana ..............................Masimo

Nancy Stahulak ..................Medical Protective

Anne Young ........................Merck & Co.

Vacant ..................................Organon

Dominic Corsale ..................Oridion

Walter Huehn ......................Philips Medical Systems

Edward C. Mills ..................Preferred PhysiciansMedical Risk RetentionGroup

Vacant ..................................ResMed

Michael Stabile, MD............Safer Sleep LLC

Andrew Rose ......................Smiths Medical

Joseph Davin........................Spacelabs

Christopher M. Jones ..........Tensys Medical

Ann S. Lofsky, MD..............The Doctors Company

Terry Wall ............................Vital Signs

Abe Abramovich

Casey D. Blitt, MD

Robert K. Stoelting, MD

“Errors,” From Preceding Page

Data and Proposals SupportSafer Drug Administration


Sevoflurane: The Challenges of Safe Formulationnor can they contain water in concentrations higherthan 130 ppm. As Dr. Baker concludes, “a potentialremains for sevoflurane instability, . . . thereforesome vigilance regarding product integrity remainsprudent.”1

Recent information from the European Medi-cines and Healthcare Products Regulatory Agency,8and in abstract form,9,10 reinforces the need for suchvigilance. The Penlon Sigma Delta sevofluranevaporizer, distributed by Baxter, was found to inter-act with lower-water sevoflurane formulations,with the production of certain degradation byprod-ucts. This caused etching of the vaporizer sightglass and partial disintegration of the indicator ball,etching of the metal filling port shoe, corrosion ofthe plastic keyed-filler stoppers with resulting leak-age of anesthetic, and yellow discoloration of thesevoflurane. Sight glass etching made the sevoflu-rane liquid levels in the vaporizer hard to read. TheEuropean Agency recommended that the vaporiz-ers be removed from use. Although the degradantswere not identified in the above reports, sight glassetching suggests the potential formation of hydro-fluoric acid.

Recent laboratory findings also reinforce theneed for vigilance.11-13 Vaporizers from various man-ufacturers were disassembled and found to containpotential Lewis acids (metal oxides) on surfaces thatcontact both liquid or vapor sevoflurane. Degrada-tion of lower-water generic sevoflurane by alu-minum oxide, a prototypic Lewis acid, was up to90-fold greater than that of higher-water Ultane®

sevoflurane. Lower-water generic sevoflurane, butnot higher-water Ultane®, when stored in PenlonSigma Delta vaporizers under accelerated storageconditions, underwent substantial degradation.There were substantial increases in fluoride (as highas 600 ppm) and reduced pH (as low as 3), as well assight glass etching and metal filler shoe corrosion.Thus, lower-water generic sevoflurane underwentLewis-acid mediated degradation to HF. Theabsence of such degradation with water-addedUltane® sevoflurane is consistent with the knownability of water to prevent Lewis acid-mediatedsevoflurane degradation.

Degradation of lower-water sevoflurane to toxiccompounds is a potential patient safety issue. The1996 Lewis acid degradation of original low-watersevoflurane to HF was considered a clinically signif-icant safety issue prompting widespread practitionernotification and reformulation of sevoflurane to con-tain at least 300 ppm water as a Lewis acid inhibitor.Recent clinical and laboratory reports of new lower-water sevoflurane formulation degradation inPenlon vaporizers to HF recapitulate those of 1996.Patient harm was not needed in 1996 in order to gen-erate safety concerns about degradation of lower-water sevoflurane, and lead to its replacement with

higher-water sevoflurane. Therefore, the absence ofreports (to date) of patient harm with currently mar-keted lower-water sevoflurane should not mitigateappropriate concerns about the degradation andsafety of lower-water sevoflurane.

The FDA defines drugs as pharmaceuticalequivalents if they 1) contain the same active ingre-dient(s), 2) are of the same dosage form and route ofadministration, and 3) are identical in strength orconcentration.14 The FDA also defines drugs as ther-apeutic equivalents only if they are pharmaceuticalequivalents and if they can be expected to have thesame clinical effect and safety profile when admin-istered to patients under the conditions specified inthe labeling.15

Although the active ingredient (sevoflurane) invarious manufacturers’ formulations is chemicallyidentical, the formulations differ in their water con-tent. Recently approved lower-water sevoflurane for-mulations do not contain enough water to preventLewis acid-mediated degradation and the produc-tion of toxic hydrogen fluoride. Nevertheless, low-water sevoflurane is considered therapeuticallyequivalent (AN rated) to high-water sevoflurane.Recent laboratory and clinical case reports thatdemonstrate degradation of lower-water sevofluraneto toxic and corrosive hydrogen fluoride, anddamage to vaporizers, suggest that the higher- andlower-water sevoflurane formulations may not havethe same safety profile. While they may be consid-ered pharmaceutical equivalents, they may not betherapeutic equivalents. Again, vigilance, the maximof anesthesiology, is warranted.

Dr. Kharasch is the Russell D. and Mary B. SheldenProfessor of Anesthesiology, Director, Division of Clinicaland Translational Research, Department of Anesthesiol-ogy, Washington University, St. Louis, MO.

DISCLOSURE: Dr. Kharasch is also an occasionalconsultant to Abbott, a manufacturer of sevoflurane.

References

1. Baker MT. Sevoflurane: are there differences in products?Anesth Analg 2007;104:1447-51.

2. Baker MT, Naguib M. Propofol: the challenges of formu-lation. Anesthesiology 2005;103:860-76.

3. Dalbey W, Dunn B, Bannister R, et al. Acute effects of 10-minute exposure to hydrogen fluoride in rats and deriva-tion of a short-term exposure limit for humans. RegulToxicol Pharmacol 1998;27:207-16.

4. Bertolini J. Hydrofluoric acid: a review of toxicity. J EmergMed 1992;10:163-8.

5. Leary JP. Contaminated sevoflurane use reported fromNew York State (Letter to Editor). APSF Newsletter 1996-97;11(4):37, 39.

6. Callan CM. Sevo manufacturer outlines circumstances,response. (Response) APSF Newsletter 1996-97;11(4):37, 39.

by Evan D. Kharasch, MD, PhD

Sevoflurane is a widely used inhalational anes-thetic, first introduced in 1990 by Maruishi Pharma-ceuticals in Japan, and subsequently (1995)marketed by Abbott Laboratories in the UnitedStates as Ultane® and worldwide as Sevorane®.Beginning in 2006, generic versions of sevofluranebecame available, first by Baxter Healthcare andthen by Minrad International. Although Ultane® andthe generic versions are considered by regulatoryagencies to be therapeutically equivalent, there arepotentially important differences between them.These include the methods of synthesis, impurities,the containers in which they are sold, and the for-mulation (sevoflurane itself and any additives).

A recent publication by Dr. Max Baker, professorof anesthesiology at the University of Iowa, thor-oughly reviewed the differences in sevofluraneproducts, and the potential patient safety implica-tions.1 Dr. Baker is an accomplished chemist, hold-ing patents on the synthesis of volatile anesthetics,and has written previously on the challenges of drugformulation.2 The methods for synthesizing sevoflu-rane differ between manufacturers, resulting in dif-fering impurities and their amounts. The good newsis that, as Dr. Baker states, “the quantities of impuri-ties are low and qualitative differences minor” andare “not expected to be of clinical significance, if theyremain so” (italics mine).

It is this last caveat that is the focus of the remain-der of the Baker paper. Sevoflurane is susceptible tovarious types of chemical degradation. Most perti-nent is the degradation of sevoflurane by Lewis acids(such as metal oxides and metal halides), to hydro-fluoric acid, and to other toxic compounds. Hydro-fluoric acid (HF), even in minute amounts, is highlyreactive, corrosive, profoundly toxic, and can causerespiratory irritation or pulmonary hemorrhage.3,4

An incident of Lewis acid mediated sevofluranedegradation occurred in 1996.5,6 Several bottles ofsevoflurane had cloudy drug, a pungent odor,marked acidity (pH <1), and high fluoride (863ppm), all indicating substantial anesthetic degra-dation and formation of HF, in quantities farexceeding the safe limits of 3 ppm over an 8 hraverage. Abbott subsequently determined thatincreasing the water content in sevoflurane formu-lations decreased Lewis acid-dependent sevoflu-rane degradation.7 They changed the sevofluraneformulation to contain at least 300 ppm water, inorder to prevent Lewis acid degradation and for-mation of toxic degradants. The new “water-enhanced” sevoflurane formulation was approvedlater that year by the U.S. Food and Drug Adminis-tration (FDA), and awarded patent protection.

Why is all this important? Generic sevofluraneformulations do not contain Lewis acid inhibitors, See “Sevoflurane,” Page 55

Anesthesia Patient Safety Foundation


Corporate DonorsFounding Patron ($500,000 and higher)American Society of Anesthesiologists (asahq.org)

CommunityDonors

(includes Anesthesia Groups,Individuals, Specialty Organizations,and State Societies)

Grand Sponsor ($5,000 and higher)Alabama State Society of

AnesthesiologistsAmerican Academy of Anesthesiologists

AssistantsAmerican Association of Nurse

AnesthetistsAsheville Anesthesia AssociatesFlorida Society of AnesthesiologistsDr. and Mrs. Thomas R. HillIndiana Society of AnesthesiologistsIowa Society of AnesthesiologistsFrank B. Moya, MD, Charitable

FoundationRobert K. Stoelting, MDVance Wall FoundationSustaining Sponsor ($2,000 to $4,999)Academy of AnesthesiologyAnaesthesia Associates of

MassachusettsAnesthesia Consultants Medical GroupAnesthesia Resources ManagementArizona Society of AnesthesiologistsCritical Health Systems, Inc.Nassib G. ChamounGeorgia Society of AnesthesiologistsMadison Anesthesiology ConsultantsMassachusetts Society of

AnesthesiologistsMichigan Society of AnesthesiologistsMinnesota Society of AnesthesiologistsOhio Society of AnesthesiologistsOld Pueblo Anesthesia GroupPennsylvania Society of

AnesthesiologistsProvidence Anchorage Anesthesia

Medical GroupSociety of Cardiovascular

AnesthesiologistsTennessee Society of AnesthesiologistsContributing Sponsor ($750 to $1,999)Affiliated Anesthesiologists, Inc.American Association of Oral and

Maxillofacial SurgeonsAmerican Society of Critical Care

AnesthesiologistsAmerican Society of PeriAnesthesia

Nurses J. Jeffrey Andrews, MDAnesthesia Associates of Northwest

Dayton, Inc.Associated Anesthesiologists of

St. Paul, MNAssociation of Anesthesia Program

DirectorsSorin J. Brull, MDFrederick W. Cheney, MDConnecticut State Society of

AnesthesiologistsJeffrey B. Cooper, PhDSteven F. Croy, MDMark T. Destache, MD

(Associated Anesthesiologists)District of Columbia Society of

AnesthesiologistsDavid M. Gaba, MDJohn H. Eichhorn, MDWilliam L. Greer, MDIllinois Society of AnesthesiologistsKentucky Society of AnesthesiologistsJohn W. Kinsinger, MDThomas J. Kunkel, MDRodney C. Lester, CRNAEdward R. Molina-Lamas, MDMadison Anesthesiology ConsultantsMaryland Society of AnesthesiologistsMichiana Anesthesia CareMissouri Society of AnesthesiologistsRobert C. Morell, MDNebraska Society of AnesthesiologistsJohn B. Neeld, MD, in honor of Orin F.

Guidry, MDNorthwest Anesthesia PhysiciansNeshan Ohanian, MDNevada State Society of AnesthesiologistsNurse Anesthesia of MaineOklahoma Society of AnesthesiologistsOregon Society of AnesthesiologistsOregon Anesthesiology GroupPhysician Anesthesia ServicePittsburgh Anesthesia AssociatesSanta Fe Anesthesia Specialists Society of Academic Anesthesia ChairsSociety for Ambulatory Anesthesia Society of Neurosurgical Anesthesia

and Critical Care

Society for Pediatric AnesthesiaSouth Dakota Society of AnesthesiologistsStockham-Hill FoundationTexas Society of AnesthesiologistsDrs. Mary Ellen and Mark WarnerWashington State Society of

AnesthesiologistsWisconsin Society of AnesthesiologistsSponsor ($100 to $749)Sean S. Adams, MDEllen Allinger, AA-C, and

James Allinger, MDRobert L. Barth, MDRam J. Bhat, MDTerrence D. Bogard, MDManuel E. BonillaPhilip F. Boyle, MDE. Jane Brock, DOCalifornia Society of AnesthesiologistsRobert A. Caplan, MDJames W. Chapin, MDMelvin A. Cohen, MDColorado Society of AnesthesiologistsKathleen A. Connor, MDStephen C. Cotton, MD David M. Clement, MDPaula A. Craigo, MDMark L. D’Agostino, MDEric R. Davies, MDJ. Kenneth Davison, MDJohn DesMarteau, MDSteven R. Dryden, MDWalter C. Dunwiddie, MDRobert J. Egan, MDJan Ehrenwerth, MDNorig Ellison, MDJames Ellwood, MDBruce W. Evans, MDThomas R. Farrell, MDHerbert M. Floyd, MDAnthony Frasca, MDB. L. Friedberg, MDThomas R. Farrell, MDJane C. K. Fitch, MD/Carol E. Rose, MDIan J. Gilmour, MDGregory E. Ginsburg, MDBarry M. Glazer, MDRichard Gnaedinger, MDJames D. Grant, MDGriffin Anesthesia AssociatesAlexander A. Hannenberg, MDDaniel E. Headrick, MDWilliam D. Heady, CRNAPeter L. Hendricks, MDJames S. Hicks, MDDavid P. Holder, MD

Dr. and Mrs. Glen E. HolleyHoward E. Hudson, Jr., MDEric M HumphreysAnna Barczewska-Hillel, MDJay C. Horrow, MDIndianapolis Society of

AnesthesiologistsRobert. H. Intress, MDSharon R. Johnson, MDRobert E. Johnstone, MDKaiser Permanente Nurse Anesthetist

AssociationTamos Kallos, MDC. Herschel King, MDDaniel J. Klemmedson, DDS, MDKansas Society of AnesthesiologistsBettyLou Koffel, MDForrest Krause, MDGopal Krishna, MDGeorge Lederhaas, MDJason P. Lujan, MDAnne Marie Lynn, MDMaine Society of AnesthesiologistsAlan P. Marco, MDMaryland Association of Nurse

AnesthetistsGregory B. McComas, MDE. Kay McDivitt, MDJohn P. McGee, MDTom L. McKibban, CRNACora B. McKnight, CRNAMedical Anesthesiology Consultants

CorporationMississippi Society of AnesthesiologistsA. J. Montes, MDRoger A. Moore, MDErvin Moss, MDCarlos E. Neumann, MDNew Hampshire Society of

AnesthesiologistsNew Jersey State Society of

AnesthesiologistsNew Mexico Society of AnesthesiologistsL. Charles Novak, MDDenise O’Brien, RNMichael A. Olympio, MDCarmelita S. Pablo, MDPennsylvania Association of Nurse

AnesthetistsMukesh K. Patel, MDGaylon K. Peterson, MDBeverly K. Philip, MDJames K. Philip, MDPhysician Specialists in AnesthesiaRichard C. Prielipp, MDDebra D. Pulley, MD

Rhode Island Society ofAnesthesiologists

Gail I. Randel, MDHenry C. Safford, CRNAEduardo A. Salcedo, MD (Salmon

Medical Innovations)Drs. Chris and David SantamoreLarry M. Segers, MDGeorge P. Sessions, MDMuthia Shanmugham, MBEugene P. Sinclair, MDLiberacion L. Soriano, MDSociety for Obstetric Anesthesia and

PerinatologySociety for Technology in AnesthesiaSouth County Anesthesia AssociationSouth Carolina Society of

AnesthesiologistsShepard and Marlene StoneSara L. Strom, AA-CRohan Sundaralingam, MDGary E. Takahashi, DOHaig G. Tozbikian, MDThe Woodlands Anesthesia AssociatesUniversity of Maryland Anesthesiology

AssociatesVermont Society of AnesthesiologistsPrem K. C. Vindhya, MDVirginia Society of AnesthesiologistsMartin D. Wagner, MDT. F. Walker, MDSCThomas L. Warren, MDMatthew B. Weinger, MDWest Virginia Association of Nurse

AnesthetistsWest Virginia State Society of

AnesthesiologistsAndrew S. Weisinger, MDDr. and Mrs. WetchlerWichita Anesthesiology, CharteredG. Edwin Wilson, MDBenjamin and Elizabeth YoderPhilip J. Zitello, MD

In MemoriamIn memory of Dr. Marc Balin

(anonymous)In memory of Maurice Chait, MD

(Texas Society of Anesthesiologists)In memory of Oneita M. Hedgecock, MD

(Texas Society of Anesthesiologists)In memory of Laurie A. Noll, MD

(The Coursin family)In memory of Bonnie J. Slarsky

(Jeffrey B. Cooper, PhD)In memory of Rex E. Thomas, MD

(Texas Society of Anesthesiologists)

Note: Donations are always welcome. Send to APSF; c/o 520 N. Northwest Highway, Park Ridge, IL 60068-2573 (Donor list current through August 21, 2007)

Philips Medical Systems (medical.philips.com)Tyco Healthcare (tycohealthcare.com)

Grand Patron ($150,000 to $199,999)Anesthesia Healthcare Partners, Inc.

(AHP) (ahphealthcare.com)Cardinal Health Foundation (cardinal.com)

Sustaining Patron ($100,000 to $149,999)Merck & Co. (merck.com)Sponsoring Patron ($75,000 to $99,999)GE Healthcare (gemedical.com)

Benefactor Patron ($25,000 to $49,999)Abbott Laboratories (abbott.com)

Aspect Medical Systems (aspectms.com)Hospira (hospira.com)

Masimo Corporation (masimo.com)Organon (organon.com)

Supporting Patron ($15,000 to$24,999)

Baxter Anesthesia and Critical Care (baxter.com)Dräger Medical (draeger.com)Preferred Physicians Medical Risk Retention

Group (ppmrrg.com)

Patron ($10,000 to $14,999)Cardinal Health, Alaris Products

(alarismed.com)DocuSys (docusys.net)Ethicon Endo-Surgery (ethiconendo.com)iMDsoft (imd-soft.com) Oridion Capnography (oridion.com)

Spacelabs Medical (spacelabs.com)Sustaining Donor ($5,000 to $9,999)Anesthesiologists Professional Assurance

Company (apacinsurance.com)Arrow International (arrowintl.com)Bayer Healthcare (bayerhealthcare.com)Becton Dickinson (bd.com)Cerner Corporation (cerner.com)Datascope Corporation (datascope.com)LMA of North America (lmana.com)Luminetx Corporation (luminetx.com)ResMed (resmed.com)Safer Sleep LLC (safersleep.com)Smiths Medical (smiths-medical.com)

Tensys Medical (tensysmedical.com)The Doctors Company (thedoctors.com)Medical Protective (medpro.com)Vital Signs (vital-signs.com)Sponsoring Donor ($1,000 to $4,999)Anesthesia Business Consultants

(anesthesiallc.com)Allied Healthcare (alliedhpi.com)Armstrong Medical (armstrongmedical.net)Cook Critical Care (cookgroup.com)King Systems (kingsystems.com)Medical Education Technologies, Inc. (meti.com)Micropore, Inc. (extendair.com)TRIFID Medical Group LLC (trifidmedical.com)

W.R. Grace (wrgrace.com)Corporate Level Donor ($500 to $999)Belmont Instrument Corporation

(belmontinstrument.com)Lippincott Williams and Wilkins (lww.com)ProMed Strategies, LLCParticipating AssociationsAmerican Association of Nurse Anesthetists

(aana.com)Subscribing SocietiesAmerican Society of Anesthesia Technologists and

Technicians (asatt.org)


S P E C I A L E D I T I O N O F

Numerous questions to the Committee on Technology are individually and quickly answered each quarter by knowledgeable committee members. Manyof those responses would be of value to the general readership, but are not suitable for the Dear SIRS column. Therefore, we have created this simple columnto address the needs of our readership.

The information provided in this column is for safety-related educational purposes only, and does not constitute medical or legal advice. Individual or group responses areonly 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 providespecific 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.

Dear Q&A,

In looking at the schematics of some of thenewest anesthesia machines (e.g., Aisys andAvance, GE Healthcare, Inc., and the formerJulian, Dräger Medical, Inc.), I am struck byhow they have finally eliminated the hydraulicflow controls (i.e., needle valves) for computercontrolled valves. This means, in the absence ofpower, no gas will flow, except for the redun-dant oxygen system. The question I’d like opin-ions on from the group is, “What has driventhis change in anesthesia machine design?” Ihave several hypotheses (locally generated), butI’d like input from a wider group. I’ll share myideas afterwards so as not to bias anyone’sthoughts.

James F. Szocik, MDUniversity of Michigan

Dear Dr. Szocik,

One can postulate many reasons for thechange. The primary rationale is likely the abil-ity to control and measure fresh gas flow bysoftware. In recent years the most notablechange in the anesthesia delivery system designhas revolved around the anesthesia ventilator.Looking forward, designs that allow more effi-cient delivery of anesthetic vapor would be thenext evolutionary step. Platforms which utilizemechanical fresh gas flow delivery will be moredifficult or impossible to evolve into designsthat can manipulate the fresh gas/anestheticvapor concentration relationship to achievemore efficient vapor delivery. Electronic freshgas control opens up the possibility of engi-neering that relationship.

From a safety point of view, all of themachines on the market provide some means ofdirect oxygen delivery in the event of electricalfailure even if it is an oxygen flow metermounted to the machine. One question iswhether or not you want to deliver vapor ifelectricity fails. Interesting question to raise!

Jeffrey M. Feldman, MDUniversity of Pennsylvania School of Medicine

Dear Dr. Szocik,

I am reminded of the story, a few years ago,in which the anesthesia machine engineersfrom a certain company went out to varioushospitals to ask anesthesiologists what they didnot like about their anesthesia machines andwhat new features they wanted.

The engineers WANTED people to tell themthey needed electronic flow meters, electronicvaporizers, electronic ventilators, new ventila-tor modes, etc. Instead, the anesthesiologistscomplained the wheels did not roll very well—they should be redesigned and equipped with“cow-catchers” to push cables and hoses out ofthe way. The drawer space was inadequate. Apull-out writing desk was needed. A small aux-iliary light was needed for endoscopy cases sothe anesthesia record could be seen in the dark.And so on.

Of course, the engineers departed in a moodof frustration, because what the anesthesiolo-gists asked for was NOT what they wanted tobuild.

It should be noted that one CAN design con-trols that can be both manually operated andelectronically operated. For instance I canincrease or decrease the volume on my home

stereo system by manually turning the bigvolume knob on the receiver, or by pushingthe buttons on the remote control and watchingthe knob “turn itself” from across the room. It iseasy to imagine a combination manual-auto-mated system to adjust gas flows and vaporizersettings. The precise gas flow can be measuredby electronic flow meters (or even by a simplesystem that measures the pressure drop acrossa known resistance). This measurement can beused to provide feedback for the flow metercontroller.

One challenge for the new machines is thatthe old, mechanical machines had becomenearly 100% safe—nearly 100% failure-free.With new complexity, there are new opportu-nities for failure, new opportunities that wemay not have even thought of yet!

Frank Block, MDUniversity of Arkansas for Medical Sciences

Dear Dr. Szocik,

I also agree that there is much to be gained byadding electronic controls to the anesthesiamachines if they enhance patient safety andimprove the delivery of anesthesia. We need tohave a machine that defaults to a safe basicmachine, at least until the new controllers, soft-ware, and hardware have a very low probabilityof failure; and clinicians must feel comfortableusing them under all circumstances. I favor par-allel controls, like the electronic flow control inline with the needle valve. Permitting cliniciansto use as much or as little of the new technology,in the beginning, is a wise marketing strategyin addition to providing a safe environment forthe patient.

Featuring Contributions from the Society for Technology in AnesthesiaThe Anesthesia Patient Safety Foundation’s Committee on Technology would like to thank those members of the Society for Technology in Anesthesia (STA) who contributed to the

discussion below. This string was originally posted to their listserv, and the STA Board of Directors graciously allowed the APSF to edit and publish the following commentary.

Computer Controlled Systems Replace Conventional Needle Valves

See “Q&A,” Next Page

S P E C I A L E D I T I O N O F


As our description of the Dear SIRS column states, “The pur-pose of this column is to allow expeditious communication of tech-nology-related safety concerns . . . with input and responses frommanufacturers and industry representatives.” What the descriptiondoes not state, however, is how complicated it can be for Dear SIRSto bring clinician and industry together to formulate not only mean-ingful dialogue, but to effect some type of change that improvespatient safety. Although we are working on several new Dear SIRS issues, they simply are not optimalfor current publication. We look forward to presenting helpful information whenever it is available.Stay tuned!

Drs. Olympio and Morell

Dear SIRSS AFETY

I NFORMATION

R ESPONSE

S YSTEM

We don’t need additional catastrophic failuremodes, which represent the worst outcome ofreplacing needle valves with electronic valves.Clinicians need to have enough familiarity withmore advanced machines, that they can use it outof the box, like making Xerox copies or drivingaway in a new rental car, and then move into themore advanced features as they gain confidence.

I would like to see an affordable machine thatmakes the successful transition to a new andsafer technology, even for the Luddites* amongus. Don’t we have a responsibility to the lowestcommon denominator of user?

Bill Paulsen, MMSc, PhD, CCE, AACSouth University School of Health ProfessionsMercer University School of Medicine

Dear Dr. Paulsen,

The important aspect of your last paragraph is“affordable.” Every feature costs money and atthe end of the day the companies always wonderif people will pay for what is included in themachine. In an ideal world an evolutionaryapproach that incorporates the old and the newwould be appealing. Economics speak against it.Dr. Block made a good point that what excites anengineer is not always what excites a user.

Jeffrey M. Feldman, MD University of Pennsylvania School of Medicine

Dear Dr. Szocik,

I agree with Dr. Feldman that one of the mainreasons for considering computer controlled

valves is control, but I think the other is some-thing else. For billing purposes, vendors wantusers to be able to measure how much vapor theyuse, measure how much gas they use, and thenbill for those as they would for any other service.To make it even more efficient, you transfer con-trol to the machine itself so that it can adjust gasflows and agent concentration while monitoring“MAC” with other parameters.

Obviously, inherent machine control is not soobvious. I want such mechanisms to be provenreliable. And, I would rather buy a machinewhere the underlying control platform wasalready well established, before it controllednewly developed computerized valves.

Ryan FordeMassachusetts General Hospital

Dear Dr. Szocik,

I think the reasons for going to electronicallycontrolled flow include 1) a pathway to auto-mated control of flow, 2) input for the electronicrecord and cost calculations, 3) input for freshgas flow compensation for the ventilator andvaporizer, and 4) decreased maintenancerequirement for electronic versus glass flowmeters. It is interesting that anesthesiologists areso wary of electronic flow meters. Microproces-sor-based ICU ventilators have been the standardfor almost 20 years. All of the new anesthesiamachines have battery backup, and most hospi-tals have emergency generators, so power loss atthe electrical outlet is not really a concern.

I am more worried about the complex ventila-tion modes that are found in the new machines.This is where the “Luddites” will get into trou-ble, in my opinion.

Robert “Butch” Loeb, MDUniversity of Arizona

In Reply to All,

Our 2 local hypotheses for the progression tocomplete electronic control are 1) the continuingsearch for good information to put into the elec-tronic medical record, and 2) “TechnologicalInertia,” analogous to Newton’s law, wherebythe system and engineering were already on aroll in this direction, and would likely take alarge amount of energy to stop or redirect it.

The biggest issue I have with the electroniccontrol is the “failure” mode with prolongedpower outage. With the great Eastern poweroutage a few years ago, we came within hoursof running out of fuel for the generators. Cylin-der oxygen is finite as well, but can be rationedbetter than generator power, and TIVA pumpbatteries will last about 3 days. I’d be interestedto know what plans others have for regionalwide disasters, wherein the infrastructure is alsodisrupted.

James F. Szocik, MDUniversity of Michigan

*Lud·dite [luhd-ahyt] – noun: A member of any of variousbands of workers in England (1811–16) organized to destroymanufacturing machinery, under the belief that its usediminished employment. [Dictionary.com Unabridged (v1.1)]

What Has Driven This Change in Anesthesia Machine Design?

More

“Q&A,” From Preceding Page

Photograph showing electronic selection of the second gas(e.g., nitrous oxide or air), electronic metering of fresh gasflow (0.7 and 0.3 l/min, respectively), electronic selectionof desired oxygen concentration (29%), and the electronicselection of volatile agent (Iso) and desired percent (1.0).Corresponding buttons are depressed, and selections aremade with the com wheel (not shown). (This is a photo-graph of the GE Healthcare, Inc. Aisys anesthesia work-station control panel.)


that have yet to be fully determined. I agree with theauthors that the use of the beach chair position com-bined with deliberate hypotension will likely com-promise cerebral perfusion. But using labetalol forany reason—thereby blocking all of the body’s usualresponses to postural change: vasoconstriction,increased heart rate, and increased contractility—might also affect cerebral perfusion in patients whoare positioned head-up. I applaud Drs. Cullen andKirby for spotlighting many of the potential prob-lems with this situation and for advocating cautionwhenever one is positioning a patient in beach chair.Let us hope we can continue to identify ways ofdecreasing the anesthesia risk for a patient positionthat improves surgical technique.

Ann S. Lofsky, MDSanta Monica, CA

References

1. Cullen DJ, Kirby, RR. Beach chair position may decreasecerebral perfusion; catastrophic outcomes have occurred.APSF Newsletter 2007;22(2):25,27.

2. Pohl A, Cullen DJ. Cerebral ischemia during shouldersurgery in the upright position: a case series. J Clin Anesth2005;17:463-9.

3. Bedford Labs labetalol hydrochloride injection packageinsert. Available at http://www.bedfordlabs.com/prod-ucts/inserts/LBTL-P02.pdf. Accessed August 13, 2007.

4. Mayne Pharma labetalol hydrochloride injection packageinsert. Available at http://dailymed.nlm.nih.gov/daily-med/fda/fdaDrugXsl.cfm?id=2227&type=display.Accessed August 13, 2007.

5. Moraine JJ, Berre J, Melot C, et al. Is cerebral perfusionpressure a major determinant of cerebral blood flowduring head elevation in comatose patients with severeintracranial lesions? J Neurosurg 2000;92:606-14.

6. Kalyanaraman M, Carpenter RL, McGlew MJ, et al. Car-diopulmonary compromise after use of topical and sub-mucosal α-agonists: possible added complication by theuse of β-blocker therapy. Otolaryngol Head Neck Surg1997;117:56-61

7. FDA drug labeling changes. November, 1996. Available athttp://www.fda.gov/medwatch/SAFETY/LABEL/nov96.htm#normod. Accessed August 13, 2007.

8. Groudine SB, Hollinger I, Jones J, et al. New York stateguidelines on the topical use of phenylephrine in theoperating room. Anesthesiology 2000;92:859-64.

9. Jay GT, Chow MS. Interaction of epinephrine and beta-blockers. JAMA 1995;274:1830, 1832.

10. Centeno R, Yu Y. The propanolol-epinephrine interactionrevisited: a serious and potentially catastrophic adversedrug interaction in facial plastic surgery. Plast ReconstrSurg 2003;111:944-5.

11. Chung PCH, Li AH, Lin CC, et al. Elevated vascular resis-tance after labetalol during resection of a pheochromocy-toma. Can J Anaesth 2002;49:148-50.

To the Editor:

I read with interest the 2 case reports and discus-sion by Drs. Cullen and Kirby of central nervoussystem (CNS) catastrophes that occurred in patientsundergoing shoulder procedures in the beach chairposition.1 I noticed that the 2 cases had anothercommon factor that was not discussed in their article;both patients had received labetalol while in the oper-ating room. According to the original article, the firstpatient was given 50 mg of labetalol to treat highblood pressure readings obtained immediately priorto induction2—while the second patient received 20mg of labetalol in divided doses as part of a deliberatehypotensive technique. Interestingly, neither patienthad a history of hypertension.2

Labetalol is marketed for control of blood pres-sure in severe hypertension. It combines selectivealpha1 blocking action with non-selective beta1 andbeta2 blockade. The ratio of alpha to beta blockade is1:7 when used intravenously.3,4 Relatively weakalpha1 blockade causes vasodilation, while strongerbeta1 blocking decreases heart rate and contractility.Beta2 blocking prevents sympathetically mediatedvasodilation and bronchodilation. Labetalol itself pro-duces postural hypotension. The package insertsreport a 58% incidence of “symptomatic posturalhypotension” in awake patients when tilted or placedupright following labetalol injection, presumablyreferring to complaints of lightheadedness or dizzi-ness. This is a sufficiently concerning effect that theadministration guideline reads: “Patients shouldalways be kept in a supine position during the periodof intravenous drug administration.”3,4 Manufactur-ers’ recommendations do not constitute a legal stan-dard of care, and the fact remains that manyanesthesiologists do administer labetalol intra-venously in patients in beach chair positions withoutcomplications. I personally question, however,whether this could be a contributing factor to someinstances of CNS infarcts, such as the 2 presented inthe Newsletter article.

Despite autoregulation, in the standing position,cerebral blood flow (CBF) in healthy individuals fallsby 14-21% of supine values.5 Only with tilts up to 20degrees does CBF remain constant. There is evidencethat in the upright position, CBF is more dependenton the arterial-venous pressure gradient than it is onmean arterial pressure,5 so extra caution might beadvisable when using drugs that alter hemodynamicsunder these circumstances, especially when measur-ing cuff pressures alone. Labetalol injection hasalready been shown to act synergistically with at least2 potent inhalational anesthetics in producing

hypotension, reducing cardiac output, and increasingCVP.3,4,6 Since 1996, package inserts for the drug haveincluded the following warning: “Several deathshave occurred when Labetalol HCl injection wasused during surgery (including when used in cases tocontrol bleeding).”3,4,7

I first became interested in the clinical pharma-cology of labetalol after reviewing a number of anes-thesiology malpractice claims in which otherwisehealthy patients became bradycardic and arrestedwithin 20 minutes of being given the drug to treatepinephrine-induced hypertension. I was surprisedto find that literature regarding the physiologicexplanation for this is available,8-11 although itremains a rather underappreciated phenomenon inmuch of the anesthesia community. In the presenceof epinephrine, norepinephrine, or phenylephrine,the weak alpha-adrenergic blockade of labetalol, inaddition to strong combined beta-blockade, allowsfor unopposed adrenergic stimulation. This canresult in severe increases in systemic vascular resis-tance along with declines in cardiac output, and hasbeen associated with cases of pulmonary edema anddeath—even in healthy adults and children.8 In thecurrent article, while discussing patient safety in thebeach chair position, the authors suggest using“vasopressor infusion, as needed during the time ofthe procedure when the patient is upright and atrisk.” I am concerned that the infusion of phenyle-phrine or epinephrine in a patient who has alreadyreceived labetalol (or another beta-blocker) mightpotentially produce the life-threatening complicationdescribed above.

Labetalol is not a short-acting drug, and its effectswould likely have lasted the duration of both surg-eries described in the article—and substantially intothe postoperative periods. Its elimination half-lifeafter IV administration is estimated at 5.5 hours. Indrug company studies, it took an average of 16 to 18hours for blood pressure to return to pretreatmentvalues.3,4 Accordingly, the not uncommon practice ofusing labetalol to treat transient episodes of highblood pressure and tachycardia in otherwise non-hypertensive patients that result from preoperativeanxiety, intubation stimuli, or surgical stress, strikesme as odd, considering its pharmacology. There arecertainly other means available to treat temporarilyhigh heart rates and vasoconstriction.

While the beach chair position has now becomestandard of care for shoulder procedures in manyorthopedic practices, the addition of labetalol to gen-eral anesthesia adds another layer of complexity tophysiology in the upright position, with implications

Letter to the Editor

Labetalol May Decrease CerebralPerfusion in Beach Chair Position


Team training is an ideal process to improve com-munication, which is a vital link in the delivery ofsafe, effective health care. Therefore, the APSF will co-sponsor a workshop at the ASA Annual Meeting inSan Francisco to foster strategies of team training(#817, Monday, October 15, 2:00-5:00 pm, MosconeCenter West, Rm 2001). Although a variety of avail-able programs will be discussed, the focus will beintroduction of a cost-effective mechanism of teamtraining via a curriculum that is available in the publicdomain after development by the Department ofDefense (DoD) and the Agency for HealthcareResearch and Quality (AHRQ). This unique work-shop should attract the attention of anesthesiologyclinicians, medical center leaders, and other healthcare educators and researchers. Experts in the field ofpatient safety and team training will share their prac-tical experience and identify best practices based onthe science of teamwork and training. Those whowish to conduct teamwork training within their owninstitutions will find the workshop particularly valu-able. The objective will be to describe a large-scaleDoD initiative to reduce medical error by embracingand applying team training programs. This initiativewas developed based on extensive experience gath-ered during application of this approach for anesthe-siologists, intensivists, and other health care leaders.

Experts in the field of team training as well asindividuals involved in the development of the cur-riculum will present their past experience and futureexpectations for perioperative team training. Back-ground information includes an overview of the mili-tary health system and its specific challenges, withinsights into how the DoD became a lead organizationpromoting safer health care. Initial and current DoDteam training initiatives will be described, includinga comprehensive analysis using case studies. The cur-rent program, called “TeamSTEPPS” (Team Strate-gies and Tools to Enhance Performance and PatientSafety) will be described, along with a review of itsstrengths and limitations. Course materials are avail-able for public use and lessons learned by the pro-gram developers will be reviewed. Attendees willhear the experience at one Midwestern academicmedical center (Creighton University) during imple-mentation of TeamSTEPPS. Important elementsinclude benchmarks and measurement tools to deter-mine effectiveness of program interventions. Anadjunct to the curriculum highlights how simulationis integrated into team training modules. Practicalpointers include a number of “lessons learned”during launch of a large-scale health care initiativefrom those most familiar with the program. Lastly,issues and questions for future research will be iden-tified with input from workshop attendees. Join us!

Teamwork and Team Training in the Operating Room:Can It Make a Difference in Patient Safety?

Presenters:

• Robert J. McQuillan, MD, Associate Professorand Chair, Department of Anesthesia, CreightonUniversity (moderator)

• Heidi King, Tricare Management Activity, Officeof the Chief Medical Officer

• Eduardo Salas, PhD, Department of Psychologyand Institute for Simulation and Training, Uni-versity of Central Florida

• Mary Salisbury, RN, The Cedar Institute, Provi-dence, Rhode Island

• David Gaba, MD, Professor of Anesthesia andAssociate Dean for Immersive and SimulationBased Learning, Stanford University

• Kim Galt, PharmD, Associate Dean of Research,School of Pharmacy and HealthProfessions/Director of Creighton HealthResearch Program, Creighton University

The workshop will be held during the ASA meeting onMonday, October 15, 2007, Moscone Center.

Dr. Sem Lampotang, from the University of Florida, speaks withvisitors to the APSF Booth at a recent ASA meeting.

COT Selects Paulsenand Reilly for NewLeadership Positions

Dr. Michael Olympio, chair of the Committee onTechnology (COT) is pleased to announce the selec-tion of Dr. William A. Paulsen, MMSc, PhD, CCE,AAC, as the first Vice Chairman of COT. Dr. Paulsenhas served COT for a number of years, most recentlyand actively within the Q&A column and the Tech-nology Training Initiative. Bill is professor and chairof the Department of Anesthesia Sciences at SouthUniversity in Savannah, GA, and brings quite exten-sive technical and leadership skill to this position.Dr. Paulsen will assume direct management ofCOT's Q&A Column within the APSF Newsletter, andwill develop and coordinate the technology safetyinitiatives of individual COT members. We areequally pleased to announce the selection of PatriciaMullen Reilly, CRNA, BSN, as the first COT StrategicRelations Director. Ms. Reilly has extensive experi-ence on the COT, most recently and actively withinthe Technology Training Initiative. She brings awealth of clinical, managerial, and interpersonalexperience to this position and will help COT reachout to its membership to improve communications,recruitment, and developmental strategies. Welcometo Dr. Paulson and Ms. Reilly.


Important New Safety Issues to BeDiscussed at the 2007 ASA Conventionon-time antibiotic administration and administrationof antiemetics for prophylaxis (A2142, A2144), 2papers on using simulation to decrease anesthesiarisk with the introduction of new procedures (A2138)and to practice health care team training (A2145),and 1 paper on the value of an educational lectureprior to an anesthesia machine check (A2143).

Numerous Panels Focus onPatient Safety

Numerous panels at this year’s ASA AnnualMeeting focus on patient safety starting Saturday,October 13, with Dr. Michael O’Reilly and ClinicalAnesthesia Decision Support: Fact or Fantasy (#PN12,1:30-3:00 pm, Rm 307, Moscone Center South). OnSunday, October 14, Dr. William Furman will discussAnesthesia Information Systems (AIMS) and CareImprovement (#PN20, 9:00-11:00 am, Rm 308,Moscone Center South). Later in the afternoon, Dr.

Tracy Stierer will moderate a panel on Identificationand Management of Patients with Obstructive SleepApnea (#PN24, 1:30-3:30 pm, Rm 305, MosconeCenter South). Monday, October 15, Dr. NormanCohen will participate in a panel on The Pay-For-Per-formance Train Has Left the Station: Now What?(#PN33, 9:00-11:00 am, Rm 307, Moscone CenterSouth). Tuesday, October 16, Dr. Daniel Sessler willmoderate a panel on Prevention of Surgical WoundInfections (#PN45, 9:00-11:00 am, Rm 305, MosconeCenter South), followed in the afternoon by Dr. Gre-gory Crosby moderating a panel on General Anes-thetic Neurotoxicity: Can It Be Bad When It’s So Good?(#PN55, 1:30-3:30 pm, Rm 308, Moscone CenterSouth). The patient safety panels conclude onWednesday, October 17, with Dr. Lee Fleisher moder-ating Strategies To Improve Perioperative Outcomes(#PN57, 9:00-11:00 am, Rm 303, Moscone CenterSouth), followed by Dr. Dorothy Pavlin moderatinga session on improving ambulatory patient safety

“2007 ASA,” From Page 43

Support Your

APSF!• Timely and Relevant

Newsletters

• User-friendly Website

• Important Safety Initiatives

• Major Grant Funding

Make a Donation• By Mail

• At the APSF Booth at the2007 ASA in San Francisco

and recovery (#PN64, 1:30-3:30 pm, Rm 303,Moscone Center South).

Rovenstine Lecture to DiscussAnesthetic Morbidity and

MortalityDr. James Cottrell, this year’s presenter of the

Emery A. Rovenstine Lecture (Monday, October 15,11:15-12:20 pm, Rm 134, Moscone Center North), willdiscuss the complications and adverse effects ofanesthetics in his lecture entitled “We Care, ThereforeWe Are: Anesthesia-Related Morbidity and Mortality.”

From the preceding list of exciting presentations,it is clear that patient safety remains in the forefrontof research and clinical endeavors for anesthesiolo-gists. We have provided only some highlights ofpatient safety-related lectures and presentations.Please visit the ASA website or review the meetingprogram for a complete list of topics and schedules.

To the Editor,

I write in response to the letter by Dr. John Beau-regard (APSF Newsletter, Spring 2007) about labelingmedications. Recently the Washington State Depart-ment of Health cited our hospital because we (theanesthesiologists) do not label syringes of propofol.We are an MD-only anesthesia group that draws upand administers our own drugs, we lock thesyringed in a Pyxis so they are constantly under ourcontrol, and we do our own cases “start to finish.”

The inspectors cited JCAHO standards andNPSG Requirement 3D, which refers to thelabeling of "high alert" medications.These regulations do not endorse theASA Standards on Labeling of Phar-maceuticals for Use in Anesthesiologyor the ASTM color coded label systemwe use currently. Instead, JCAHO Stan-dard MM4.30 must be adhered to (drugname, strength, and amount). I contacted

JCAHO and received the following e-mail reply onJuly 5, 2007:

The National patient safety goals are very spe-cific with regards to what must be included inthe labeling of medications on and off the ster-ile field. Color coding, etc., are not now norwere they ever allowed under this goal. Mem-bership on the Sentinel Event advisory councilthat does the research and development of thegoals does include the ASA.

We have 45 days to comply with the DOH. Thereis no appeal process.

Greg Allen, MD, FRCPCOlympia, WA

Letter to the Editor

Labeling Syringes


APSF Executive Committee Invites Collaboration

From time to time the Anesthesia Patient Safety Foundation reconfirms itscommitment of working with all who devote their energies to makinganesthesia as safe as humanly possible. Thus, the Foundation invitescollaboration from all who administer anesthesia, and all who provide thesettings in which anesthesia is practiced, all individuals and all organizationswho, through their work, affect the safety of patients receiving anesthesia. Allwill find us eager to listen to their suggestions and to work with them towardthe common goal of safe anesthesia for all patients.

Contact Information

Anesthesia Patient Safety FoundationBuilding One, Suite Two8007 South Meridian StreetIndianapolis, IN 46217-2922

President: Robert K. Stoelting, MDAdministrator: Deanna M. Walker

Please address all inquires by email ([email protected]) or facsimile (317-888-1482).

www.apsf.org

®

Anesthesia Patient Safety Foundationis pleased to announce the

APSF/American Society of Anesthesiologists (ASA)Endowed Research Award

in full support ($150,000) of a grant tobe awarded in October 2007 for initiation in January 2008.

The funds for this named grant will be providedfrom the APSF Endowment Fund, which was made possible

by the generous contributions of ASA to APSF overthe last several years.

www.apsf.org

®

Check out the Virtual Anesthesia Machine Website

and theAPSF Anesthesia

Machine Workbookat

www.anest.ufl.edu/vam

7. McLeskey CH. Anesthesiologist executive reports howAbbott made sevoflurane safer: water stops formation ofhighly toxic acid. APSF Newsletter 2000;15(3):39.

8. Vaporizer – Penlon – Sigma Delta Sevoflurane vaporizer–updated.Available athttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2024730&ssTargetNodeId=967. Accessed August 9, 2007.

9. O’Neill B, Hafiz MA, DeBeer DA. Corrosion of Penlonsevoflurane vaporizers. Anaesthesia 2007;62:421.

10. Gupta A, Ely J. Faulty sevoflurane vaporizer. Anaesthesia2007:62:421.

11. Stephens D, Kharasch E, Cromack K, Shrivastava S,Saltarelli M. Commercially marketed sevoflurane vapor-izers contain Lewis acid metal oxides that can potentially

“Sevoflurane,” From Page 48

References Document Formulation Concernsdegrade sevoflurane containing insufficient protectivewater content. Anesthesiology, 2007, in press.

12. Cromack K, Kharasch E, Stephens D, Subbarao G,Saltarelli M. Influence of formulation water content onsevoflurane degradation in vitro by Lewis acids, Anesthe-siology, 2007, in press.

13. Kharasch E, Subbarao G, Stephens D, Cromack K,Saltarelli M. Influence of sevoflurane formulation watercontent on degradation to hydrogen fluoride in commer-cial vaporizers. Anesthesiology, 2007, in press.

14. Glossary of Terms. Available atwww.fda.gov/cder/drugsatfda/glossary.htm. AccessedAugust 9, 2007.

15. FDA Center for Drug Evaluation and Research:Approved Drug Products with Therapeutic EquivalenceEvaluations, 27th edition. Available atwww.fda.gov/cder/ob/docs/preface/ecpreface.htm.Accessed August 9, 2007.

Anesthesia Patient Safety FoundationBuilding One, Suite Two8007 South Meridian StreetIndianapolis, IN 46217-2922

NONPROFIT ORG.U.S. POSTAGE

PAIDWILMINGTON, DEPERMIT NO. 1387


Be sure to visit theAPSF Booth located in the exhibit hall at the Moscone Centerduring the 2007 ASA Annual Meeting,October 13-17, 2007, in San Francisco, CA.

APSF Booth at a recent ASA meeting.

fall 2007 safety topics abound at 2007 asa · 2018-04-05 · bariatric surgery, numerous sleep...

Documents