part 2: anesthesia focus

LESSON 25Volume 31*4/23/2009

Chuck Biddle, CRNA, PhDProfessor, Virginia Commonwealth University

Richmond, Virginia

Patient Safety in the New MilleniumPart 2: Anesthesia Focus

*The use of this volume for CE credits will expire 07/31/2010.

Insert inside front cover

Curr Rev Nurs Anesth 31(25):305-316, 2009 307

Patient Safety in the New MilleniumPart 2: Anesthesia Focus

Chuck Biddle, CRNA, PhDProfessor, Virginia Commonwealth University

Richmond, Virginia

LESSON OBJECTIVESUpon completion of this lesson, the readershould be able to:1. Describe the findings of recent studies

that quantify the annual anesthesia re-lated mortality.

2. List the Emergency Care Research Insti-tute’s top 10 technology hazards for 2008.

3. Apply the “roller-coaster” or “roller-ball”model of anesthesia safety to strategiesrelated to patient care.

4. Appreciate that basic anesthesia stan-dards may not routinely be adhered toand may lead to predictable patientsafety issues.

5. Cite clinical research demonstratinghigher than expected rates of peri-operative cerebrovascular accidents in

patients undergoing common surgicalprocedures and consider the anestheticrelevance.

6. Reconsider the use of critical incidents asa measure of anesthetic safety ratherthan simply the metric of death.

7. Identify common themes associated withcritical incidents in anesthetic care.

8. Assess the importance of wrong-site anes-thesia and consider factors that set thestage for its occurrence.

9. Recognize the major patient safety con-cern that involves on-patient fires thatoccur in operating rooms each year.

10. Appraise what the author suggests arethe major patient safety concerns thatmust be dealt with in contemporarypractice.

Current Reviews for Nurse Anesthetists designates this lesson ®

for 1 CE contact hour in medical errors/risk management.

Introduction

It can be argued that the very first study ofanesthesia safety was the sentinel investigation ofBeecher-Todd, which examined the period 1948-1952,reporting a rate of 1:1560 deaths in which anes-thesia was judged to be an important contributingfactor. In 1984 a prestigious Canadian medicaljournal published a paper reviewing the matter ofanesthesia safety in the early 1980s. This worknoted the methodological and interpretive defi-ciencies in the clinical research in this area. The1

article concluded that over the years spanning 1950-

1984 the risk of death directly attributable to anes-thesia decreased from 1 in 2,680 to about 1 in 10,000.The main causes of death over that time framewere due to faulty anesthetic techniques secondaryto human error, drug overdose, coexistent disease,and failure of immediate postoperative care. Rarercauses were equipment failure, poor preoperativeassessment, halothane hepatitis, and malignanthyperthermia.

A 2008 study examining seven years of dataquantified the annual anesthesia-related mor-tality at 0.82 deaths per 100,000 surgical in-patients. Investigators from Columbia University

308 Current Reviews for Nurse Anesthetists®

(New York) examined data, applying patient safetyindicators that were developed and used by theDepartment of Health and Human Services Agencyfor Healthcare Research and Quality. In studyingthese indicators, the investigators used ICD-9 andICD-10 codes that relate specifically to anesthesiacare. The use of ICD-10 codes has improved upon2

previous research as these have an excellent level ofdetail and specificity. The investigators also focusedon mortality data due to its high degree of reliability.

Using a database of all-cause mortality main-tained by the National Center for Health Statistics,and applying the ICD codes to that database over theyears of 1999 to 2005, the researchers were able tosearch out cases of mortality specific to anesthesiamanagement. In this study period there were 2,211anesthesia-related mortal events, resulting in anannual death rate of 0.81 per 100,000 surgicalinpatients. Of particular interest, and a findingfound in other studies as well, was that the mostcommon cause of anesthesia-related death was aresult of relative anesthetic overdose (47%). Theoverall mortality rate in men was about twice that inwomen, with the elderly being the most vulnerable.Using death as an outcome metric of safety, thecomparison to the 1984 study stands in markedcontrast in terms of progress in anesthesia safety.

There is a trend in the clinical researchliterature to focus more heavily on criticalincidents as a measure of anesthetic safetyrather than just mortality.

Top 10 Health Technology Hazards

Each year the Emergency Care Research Insti-tute (ECRI) ranks device and technology-relatedhazards that the institute prioritizes as majorhospital/healthcare institutional concerns. The3

most recent list, published in November 2008,ranked the nation’s top 10 biomedical technologyhazards, noted in Table 1.

A number of these hazards have direct orcontributory roots in anesthetic care. For example,hazard number 6 is listed as a “top 10” issue be-cause of reports to the ECRI regarding seriousproblems with anesthesia apparatus that arediscovered just before (or during) patient application.Misconnected breathing circuits, ventilatormalfunctions, empty gas cylinders, and manyother issues occur each year, many of whichresult in catastrophic patient injury.

Though apparatus check-out prior to patient useis standard practice, the fact is that such inspectionsare not always accomplished or may be performedinconsistently. There are many instances that whenpre-use checkout procedures are performed, they areaccomplished using out-dated approaches or one

intended for a different model or generation of de-vice than the one being tested. There is also com-pelling evidence that crucial steps of the inspectionprocess are skipped over because the provider doesnot understand the step or believes that it has beentested by some automatic self-check mechanismembedded in the device’s software.

Current recommendations by the ECRI re-garding ensuring the functional integrity and safetyof anesthesia devices are as follows:

1. Inspect all devices and systems using onlythe procedure designed by the manufacturerfor that particular device model.

2. Include in that inspection process all devicesthat may be connected or associated withthe primary piece of equipment.

3. Make documentation readily available. Inthe case of a checklist, attach the checklistto the device to be inspected and documentthat the inspection has taken place, con-firming that all the necessary checks havebeen accomplished.

4. Educate and train the providers (and otherpersonnel) who are responsible for per-forming the inspections regarding the pro-cedures and their importance.

Other anesthesia-domain hazards abound onthis list. Needlestick injuries happen with greatfrequency and place providers, patients, house-keeping personnel and many others at risk. Airembolic phenomena occur with a wide range ofmedication pumps, rapid infusion devices, and otherintravenous line accessories even when safetyfeatures are installed. Retained devices and un-retrieved fragments involve anesthesia providers

Table 1

The ECRI’s Top 10 Technology Hazards

1. Alarm hazards—where safety alarms

are not properly communicated to

clinicians

2. Needlestick and other sharps injuries

3. Air embolism from automated injector

devices

4. Retained devices and unretrieved

fragments

5. On-patient surgical fires

6. Anesthesia hazards due to

inadequate pre-use inspection of

apparatus

7. Misleading displays—resulting in

ambiguous or counterintuitive

information

8. CT radiation exposure

9. MR imaging burns

10. Fiberoptic light-source burns


primarily when intravenous or neuraxial cathetersare sheared off during placement or removalmaneuvers. Alarm hazards most frequently involveus when we fail to understand the purpose orsignificance of an alarm when we ignore, or in-tentionally disconnect or disable a critical alarm.Reports of setting a saturation alarm too low on apulse oximeter, too high a peak airway pressure, ortoo low a minute ventilation on a ventilator arereported to the ECRI at a disturbingly high rate.

Providers may routinely fail to adequatelycheck out anesthesia-related equipmentfor a variety of reasons, none of which aresatisfactory in a retrospective analysis.

Anesthesia Safer than Ever

If we consider the healthy patient under-going routine surgery, it is clear that anes-thesia is safer than it ever has been. Recentresearch, although still heavily focused on anes-thesia mortality, has employed non-traditional in-vestigative techniques that seek out adverse eventsand discover their underlying characteristics andfactors that set the stage for their occurrence.Recent examples of these approaches include thecritical incident technique, closed claims analysis,case-control studies, data emerging from the Aus-tralian incident monitoring study, and simulation-based reenactments of known negative events.

Improvements in monitors and equipment(technology), establishing minimal standards ofpractice, provider education/skill/proficiency, andexercising good judgment all sum to create a seriesof barriers that prevent an adverse event or cir-cumstance from progressing to a negative patient

outcome. This is a model of patient safety one canterm the “roller-coaster” or “roller-ball” model asillustrated in Figure 1.

Although there has been an overall reduction inthe rate of mortal events, a question remains if thisis the most sensitive metric of actual anesthesiapatient safety. For example, errors, mistakes, andsystem failures that do not lead to death still plaguethe field. Non-lethal, catastrophic events such ascardiac arrest, brain damage, awareness underanesthesia, blindness, anaphylaxis, intraoperativefires, blood transfusion reactions, persistent coma,peripheral nerve injury, nosocomial disease tran-smission, and paralysis still occur. Near-missesoccur during the course of routine anesthesiadelivery, the number of which are ill-determined dueto the chronic problem of under-reporting. In manycases the most basic of anesthesia standards are notroutinely adhered to. These breeches include thefailure to adequately monitor a patient, failure tocheck anesthesia equipment, violations of infectioncontrol measures, careless or inadvertent admin-istration of an incorrect drug, programming errorson infusion pumps, returning a patient to the re-covery area with residual neuromuscular paralysis,improper preoperative preparation, and adminis-tration of anesthesia by a provider who is overlyfatigued or under the influence of drugs or alcohol.

Is Our View of AnesthesiaSafety Tainted in Mythology?

Lagasse reviewed the literature from the pastfive decades and provocatively challenged what heviewed as a myth that anesthesia-related mortalityhas improved to the extent than many believe. Dir-4

ectly assessing the contribution of anesthesia care toperioperative mortality and morbidity is a very com-


plex and daunting task. Making fair comparisonsacross epochs in time is even more problematic. Theavailable data may reflect several points: anesthesiafor healthy patients is safer than it once was (butfurther progress is possible); the rate of anesthesia-related mortality for all surgical patients is stillhigher than desired; and safety levels can plateau oreven diminish over time without constant effort atimprovement.

Fred Orkin, a Yale University anesthesiologistand researcher, presented data at the 2007 annualmeeting of the ASA regarding anesthesia-attrib-utable mortality rate. He observed that our successin improving anesthesia safety was noted to be amodel for the health care community by the Insti-tute of Medicine’s 1999 report. He noted that while5

many attribute a dramatic increase in anesthesiasafety to efforts that initiated with the U.S. patientsafety effort that began with advances in monitoringpractices of the late 1980s (such as pulse oximetry),others believe the trend began earlier. Orkin wenton to present compelling epidemiological data thatrevealed a strong improvement trend that wasevident predating the above-noted initiatives.Orkin’s data, it should be noted, is based on mortal-ity trends rather than critical incident monitoring.

Humans, unlike machines, tend to varyin their performance over time; stress,fatigue, and task density can complicatethe management of crisis situations.

In an interesting report, the Japanese Society ofAnesthesiologists began a survey of perioperativecerebrovascular accidents (CVA) in 2004, classifyingthose discovered as attributable to anesthesia, or dueto other causes. The overall rate of CVA was6

1.01/10,000 anesthetics, rising to 2.0/10,000 inpatients over the age of 66.

Anesthetic management was judged to be re-sponsible for 4.1% of the CVA. A remarkable 2009paper in Anesthesiology examined the incidence ofperioperative acute ischemic stroke in three commonsurgeries (hemicolectomy, total hip replacement, andsegmental lung resection), finding an incidence of0.7%, 0.2% and 0.6% respectively. The rates were7

considerably higher in patients over the age of 64.These surprisingly high rates suggest CVA as animportant and previously underappreciated sourceof morbidity and mortality in these commonly per-formed procedures. Atrial fibrillation, renal disease,valvular disease, and previous stroke were majorassociated risk factors for CVA. Hypercoagulability,choice and timing of anticoagulant administration,hemodynamic instability and careful attention tofluid shifts are all within the domain of anestheticmanagement, suggesting that we may have a role inthe genesis and prevention of CVA.

Safety Issues thatDo Not Involve Mortality

Although not recognized as necessarily life-threatening, a host of postoperative adverse eventsplague anesthesia delivery and in some cases mayrepresent potential or actual safety concerns.Postoperative delirium, dental damage, skin abra-sion, corneal abrasion, under or over intravenousfluid hydration, residual curarization, severe un-remitting vomiting, post-spinal dura puncture,awareness under anesthesia, reactions to bloodproducts, and other issues are of great patientconcern. While anesthetic care has justifiably beenheld up as an iconic model of patient safety, even“minor” events may represent an indirect metric ofpatient safety concern.

Transfer of AnestheticCare Responsibility

Vilma et al reviewed 243,832 anesthetics at aprominent New York institution finding that trans-fer of anesthetic care from one individual (or team) toanother was associated with increased risk. The8

rate of adverse incidents of all kinds increased dir-ectly as the number of anesthesia providers involvedin the care of the patient increased, regardless of thepatient’s ASA status. These investigators stronglyurged for the development of guideline standardiza-tion with respect to care transfer, citing potentialand real safety concerns.

Aitkenhead strongly urged us to recon-sider “death” as a safety marker, insteadarguing that critical incidents provide betterinsight into the concept of safety. A critical9

Table 2

Partial List of Common Themes

Associated with Critical Incidents*

# Inadequate trainee supervision

# Drug misadventure, commonly an

overdose

# Airway obstruction

# Aspiration

# Insufficient monitoring

# Deficient postoperative care

# Production pressure

# Insufficient information

# Task density to great

# Poor communication (between patient

and provider, among providers)

*An occurrence that could have (if not quicklyresolved) or did lead to a major complication.


incident is defined as an occurrence that could have(if not quickly resolved) or did lead to a majorcomplication. A partial list of common themes rel-evant to the etiology of critical incidents occurringduring anesthetic care and elaborated upon byAitkenhead is shown in Table 2.

There are many factors that complicate anes-thetic management, especially in the face of a crisis.Because humans may vary in their performance (seeFigure 2) from day to day, or even from minute tominute, additional complicating factors can createfurther complexities in managing a clinical scenario.For example, a problem or concern that manifestsmay be vague in its presentation. As a crisis evolves,new complexities may arise. New drugs and tech-nologies often have their own unique complications.Skilled and knowledgeable assistance may be un-available. Additionally, there are usually time andpressure factors operative that make it imperativeto resolve the problem in order to avert disaster.

Monitored anesthesia care is associatedwith a poorly appreciated rate of adverseevents.

Wrong-Site Anesthesia Events

A variety of wrong side, wrong site, wrong pro-cedure, and wrong patient events occur each year,all representing devastating mistakes; but becauseof under-reporting, their exact incidence, and thusadequacy of preventative strategies, is unknown.Wrong-site surgery incidence is thought to be in thevicinity of 1300-2600 incidents per year. Until re-10

cently there have been no published studies exam-ining the issue of wrong-site or wrong-side anes-thetics procedures.

Barach reviewed the National Practitioner Data-bank, the Florida Code Adverse Events registry, theASA Closed Claims Project, and the New York StateReporting Program. finding that wrong-site anes-thesia events are more common than are formallyreported, and that strategies to prevent theiroccurrence are far from optimal. The investigators11

found impressively large numbers of cases, iden-tifying the following factors that clearly contributeto the genesis of incorrect site anesthesia events:1) older female patients, 2) left-sided regionalanesthesia, 3) ambulatory anesthesia, and 4) high-workload environments.

How Safe IsMonitored Anesthesia Care?

A recent study reviewing complications assoc-iated with monitored anesthesia care (MAC) em-ployed closed claims analysis in revealing a sober-ing snapshot of injury and liability with what isgenerally considered a “low risk” enterprise.12

Central nervous system injury and death secondaryto the administration of opiates and sedatives wasfound. Staff attitudes toward the rigor or serious-ness of MAC were often relaxed, not infrequentlygrounded in previous experiences as being unevent-ful, thus leading to a sense of complacency. It wasalso noted that there was the frequent theme of“conflict” between the patient, the surgeon and theanesthesia provider in terms of expectations. Manypatients had the impression that this was going tobe like “a day at the spa.” The disconnect amongproviders and the need for deeper and deeper levelsof sedation proved costly in many cases.

Another issue raised by these researchers (andelsewhere in the literature) was that of on-patientfires. While the incidence is difficult to determine


due to under-reporting, and a lack of a mandatorynational reporting system, expert estimates suggestthat there are 50-200 of these fires a year, with 20%leading to serious injury or even death. I believe13

it was summed up best by the authors of thestudy when they wrote, “MAC is no less riskythan general anesthesia in terms of centralnervous system injury for those having out-patient, elective procedures.”

12

In closing, I would like to humbly offer a per-sonal view on what I perceive as the major, currentproblems that we must come to manage in order toimprove the safety of anesthesia care:! Task density and production pressure are in-

creasing, not decreasing! Wrong-site nerve blocks are occurring too fre-

quently! Nerve blocks are performed by many with

inadequate education and training

! Medication: too much, too fast, too many “look-a-likes” (as illustrated in Figures 3 and 4)

! Familiarity may lead to complacency, creatingsafety concerns

! Anesthesia machines have become too complex(Figure 5)

! Failure to appreciate the risks of sleep apneaand residual muscle relaxants in the postoper-ative period

! Poorly monitored postoperative pain control! Personal factors of the provider (sleep. hygiene,

drug/alcohol use, stress)! Flowing oxygen + ignition source = genuine fire

hazard! Poor handwashing and aseptic practice, and

iatrogenic transmission of pathogens.Technology has provided us with new and

effective approaches to care. Ultrasound-guided re-gional nerve blocks and central line placement,


better monitors, and greater appreciation for humanfactors in the design of equipment are examples.Protocols are in place in all avenues of anes-thetic delivery, such as the “time out,” basicand advanced cardiac life support, the diffi-cult airway algorithm, and the malignanthyperthermia protocol that are designed toenhance safety by making our behaviors incertain situations consistent and evidence-based. Checklists help us achieve proper anes-thesia apparatus functionality, routine servicing ofequipment, and proper administration of bloodproducts. Continuing educational endeavors, suchas the Current Reviews series, improved curricula inbasic programs, and the widespread emphasis onpatient safety, hopefully are generating a globalappreciation among providers of its importance.

Patient safety is a never-ending process whosesuccess may not be measured strictly by countingnumbers of patients who die or who suffer badoutcomes. It is clear that the professional societiesthat represent the bulk of the U.S. anesthesia work-

force target anesthesia care and safety as processes.The profession has virtually institutionalized safetyin its scientific and governing bodies, and a quickvisit to either of the major organizations’ websites(www.aana.com or www.asahq.org) offers an in-depthperspective on this commitment.

Perhaps the major variable in predictingthe safety of a patient during anesthesia isthe attentiveness, judgment and expertiseof anesthesia providers.

So how safe is anesthesia in 2009? It all de-pends. It is entirely dependent upon the vigilance,thoughtfulness, experience and care that each of usdelivers in each and every case.

Chuck Biddle, CRNA, PhD, Professor, Virginia Com-monwealth University, Richmond, Virginia. [email protected]


References

1. Davies JM, Strunin L: Anesthesia in 1984: Howsafe is it? Can Med Assoc J 1984;131:437-441.

2. Guohua L: Report of anesthesia mortality, Ab-stract A845. ASA Annual Meeting 2008.

3. ECRI Institute. Health Devices. Nov 2008 pp343-350. www.ecri.org

4. Lagasse R: Anesthesia safety: Model or myth?Anesthesiology 2002;97:1609-1617.

5. Orkin F: Personal communication. Feb 20, 2009.6. Irita K, et al.: Major CNS complications in the

operating theatre: Cerebrovascular accidents.Anesthesiology 2007;107:A180.

7. Bateman BT et al.: Perioperative acute ischemicstroke in noncardiac/nonvascular surgery. Anes-thesiology 2009;110:231-238.

8. Vilma AJ et al.: Transfer of anesthesia care: Arewe compromising paient safety? Anesthesiology2007;107:A1782.

9. Aitkenhead AK: Injuries associated with anes-thesia: A global view. Br J Anaesth 2005;95:95-109.

10. Seiden S, Barach P: Wrong-site, wrong-side,wrong patient surgery. Arch Surg 2006;141:931-939.

11. Barach P, Seiden S, Morley D: Wrong-site anes-thesia. Anesthesiology 2008;109:A773.

12. Bhananker SM et al.: Injury and liability associ-ated with monitored anesthesia care. Anesthesi-ology 2006;104:228-234.

13. Practice advisory: Operating room fires. Anes-thesiology 2008;108:786-801.

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25MARK ONLY THE ONE BEST ANSWER PER QUESTION ON YOUR

ANSWER CARD. MARK THIS PAGE AND KEEP FOR YOUR RECORDS.

In accordance with AANA directives, you must get 80% of the answers correctto receive one credit for each lesson, and “if there is a failure, there is no retaking”.

POST-STUDY QUESTIONS

1. Columbia University investigators published a 2008study quantifying the annual anesthesia relatedmortality at:G A. 0.82 deaths per 100,000 patients.G B. 10 deaths per 100,000 patients.G C. 20 deaths per 100,000 patients.G D. 30 deaths per 100,000 patients.G E. 40 deaths per 100,000 patients.

2. Which of the following was NOT on the ECRI’s top10 technology hazards:G A. Needlestick and other sharps injuries.G B. Surgical fires.G C. Anesthesia hazards due to inadequate pre-use

inspection.G D. Factory contamination of crystalloid solutions.G E. Air embolism from automated injector devices.

3. The “roller-coaster” or “roller-ball” model of anes-thesia safety includes which factor(s):G A. Technology.G B. Professional standards of practice.G C. Proficiency of the provider.G D. Judgment of the provider.G E. All of the above.

4. Basic anesthesia standards that may lead to patientsafety issues when not adhered to include:G A. Checking anesthesia equipment.G B. Adequately monitoring patients.G C. Following infection control measures.G D. Not administering anesthesia when overly fa-

tigued or under the influence of drugs or alcohol.G E. All of the above.

5. In 2009, a large research report suggests a higherthan expected rate of perioperative cerebrovasc-ular accidents (CVA) in patients undergoing hemi-colectomy, total hip replacement, and segmentallung resection as:G A. 0.04%, 0.09%, and 0.14% respectively.G B. 0.20%, 0.10%, and 0.21% respectively.G C. 0.40%, 0.10%, and 0.21% respectively.G D. 0.50%, 0.02%, and 0.35% respectively.G E. 0.70%, 0.20%, and 0.60% respectively.

6. Aitkenhead in his 2005 paper in the British Journalof Anaesthesia urges us to reconsider the rate of

which event as a patient safety marker rather thandeath:G A. Stroke.G B. Hypotension.G C. Critical incidents.G D. Bradycardia.G E. Cardiac arrest.

7. Common themes associated with critical incidentsinclude all of the following EXCEPT:G A. Inadequate trainee supervision.G B. Insufficient monitoring and insufficient infor-

mation.G C. Task density and production pressure too great.G D. Carefully following professional society recom-

mendations.G E. Poor communication between patient and pro-

vider and among providers.

8. Barach examining the issue of wrong-site anes-thesia found the following factors as contributory:G A. Older female, left side regional anesthesia,

ambulatory anesthesia, high workload.G B. Black male, leg surgery, inpatient surgery, rural

hospital.G C. White male, orthopedic surgery, ICU inpatient,

metropolitan hospital.G D. Child, eye or ear surgery, ambulatory anes-

thesia, rural hospital.G E. Young female, extremity surgery on the arm, two

surgeons, low workload.

9. By some reports there may be ____ on-patient firesoccurring in the operating room each year, with____ leading to serious injury or death:G A. 10, 2%.G B. 10, 5%.G C. 25, 10%.G D. 40, 15%.G E. 50-200, 20%.

10. The author suggests that which of the following isa major current patient safety issue:G A. Task density and production pressure continue

to increase.G B. Too many “look-a-like” medications.G C. Flowing oxygen + ignition source = fire hazard.G D. Poor hand washing and aseptic practice.G E. All of the above.

CORRECT ANSWERS TO LESSON 23, VOLUME 31 (KOVAC)

1. D 2. D 3. C 4. D 5. B 6. C 7. D 8. C 9. D 10. D

part 2: anesthesia focus

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