ANESTHESIA PATIENT SAFETY FOUNDATION
NEWSLETTER

Volume 6, No. 2, pp 13-24 Summer 1991
Table of Contents

Meeting Targets Human Error in Anesthesia
N.J. Insurer Cuts Rates
New Law Requires Hospitals to Report Device-Related Injuries and Deaths
Fatal Pipeline Accidents Spur Japanese Standards
Difficult Airway, Part 1, Now Available
In My Opinion: Are Surgeons Needed for Induction?
Letter to the Editor
STA Flourishes, Stages Meetings, Expands Scope
From the Literature: Standards of Care and Capnography
Notes




Meeting Targets Human Error in Anesthesia

by David Gaba, M.D. and Steven Howard, M.D.

Anesthesiologists interested in the role of human error in anesthesia accidents solicited the help of experts on error and human performance at a Spring symposium to explore ways of optimizing the performance of anesthesiologists to improve patient safety.

The three-day meeting, thought to be the fast ever held on the subject of human error in anesthesia, was sponsored by the APSF and the FDA. The small group of invited anesthesiologists, engineers, and psychologists met in Pacific Grove, CA, to investigate research opportunities for combining expertise to advance relevant knowledge in their respective fields.

80% of Accidents

Recognizing that human error has been blamed for approximately 80 percent of anesthesia-related operating room accidents, members of the APSF executive committee organized the meeting with the hope of learning from the extensive research that has been conducted on human error and human performance in fields such as aviation, nuclear power, spaceflight, and military operations. Researchers from these are-as discussed how their findings might be relevant to the world of anesthesiology, while anesthesiologists discussed problems unique to the operating room and encouraged human performance experts to consider the medical arena as a new domain of study. Because the field of anesthesiology is less centralized and regulated than the other involved domains, it presents some unexplored challenges.

The meeting opened with a history of the investigation of patient safety in anesthesia and the recent creation of the APSF, presented by Ellison C. Pierce, Jr. M.D., of Harvard University. Mr. Joseph Arcarese of the FDA's Center for Devices and Radiological Health described the rationale for the FDA's sponsorship of the conference through its role as the regulatory body for medical devices. During the meeting he applauded anesthesia for being the only medical specialty trying to make profession-wide changes. Arcarese explained that the FDA was eager to become involved because of the opportunities to be influential in terms of patient safety and to use anesthesiology as a "window on & rest of medical practice.

Also during the opening session, Jeffrey Cooper, Ph.D., of Harvard, outlined the epidemiology of anesthetic mishaps and emphasized the growing realization of the role of human performance in anesthetic outcome. The "fierce independence" of anesthesiologists and paucity of protocols (including lack of standardized equipment), "macho" attitudes, and production pressure are among the factors that will make it difficult to improve anesthetic outcome through changes in human performance, he explained.

Basis for Decisions

The second session of the conference focused on human errors during dynamic decision making. International experts Jens Rasmmsen, Ph. D., of the Riso National laboratory in Denmark and James Reason, Ph.D., of the University of Manchester in the U.K., presented overviews of the cognitive psychology of human error Rasmussen defined three abstract levels of cognitive operations as skill-based, rule-based, and knowledge-based activities. In this model of dynamic decision making, mental and physical resources cycle among these cognitive levels during a rapid repetitive loop of observation of, decision about, and action upon multiple problems.

Dr. Reason explained that even though accidents are complex events that cannot be controlled, often the general failures that lead to accidents can he avoided, thus helping to prevent accidents. His Generic Error Modelling System (GEMS) incorporates Rasmussen's classification of cognitive operations and emphasizes the matching of environmental cues to a store of rule-based responses. In other words, a person tends to respond in a way that is natural given the context of a situation. Reason also discussed the importance of "Went errors." whose impact is masked until uncovered by evolving mishap.

Dynamic Decisions

Also in the context of dynamic decision making, David Woods, Ph.D., of Ohio State University and Veronique De Keyser, Ph.D., of the University of Liege in Belgium, discussed methods for studying the anesthesiologists' task environment. Woods has analyzed experts' comments at "mortality and morbidity" case conferences and has studied human/ machine interactions after new patient monitors were introduced in the Ohio State cardiac surgery operating rooms. De Keyser has conducted traditional structured interviews and direct observation of anesthesiologists during a variety of cases in an effort to map the causes of anesthesia incidents and to analyze the human factors that make error more likely.

Another session of the conference was devoted to the effects of fatigue and mental workload on human error. William Derment, M.D., director of the Stanford University Sleep Research Center, explained that a "sleep debt" can accumulate in people who consistency don't get enough sleep. He indicated that chronic sleep deprivation is extremely common in our society and that the associated impairment of performance might contribute to anesthetic accidents, just as it is now believed to be a major cause of accidents in the transportation industry. Colonel Gerald Krueger, Ph.D. of the US. Army presented data from Operation Desert Storm noting that the most sleep deprived members of a group involved in sustained and continuous operations are often those with the highest level of responsibility He emphasized the need for developing rational sleep plans for all levels of personnel engaged in around-the-clock duties.

Multi-Tasking

In the same session Daniel Gopher, Ph.D., of Technion Institute of Technology in Israel, explained that there are well-known limits of the individual's ability to perform multiple simultaneous tasks. However, his research has shown it is possible to teach allocation of attention to allow the operator to cope with high workload in complex situations.

In the fourth session, Messrs. John Chappelow of the Royal Air Force in the U.K. and Robert Lee of the Bureau of Air Safety Investigation, Canberra, Australia, described similarities and differences between anesthesia and aviation. They felt researchers exploring human error in anesthesia could learn a lot from the field of aviation in terms of accident investigation, standardization of equipment and operational protocols, promotion of team coordination, and the organization of training.

On this last issue, Dr. William Runcimm of Royal Adelaide Hospital in Australia and Dr. David Gaba of Stanford University, advocated formal training for anesthesiologist on the management of crises in the operating room and described their research in this area. Runciman had developed a generic protocol for the initial management of an anesthetic problem. Gaba described the Anesthesia Crisis Resource Management (ACRM) training program he designed (with funding from the APSF). Modeled on pilots' "Cockpit Resource Management" training, the course teaches anesthesiologists the fundamental skills of crisis management.

During the final session, Caba and Abigail Sellen, Ph.D., of the University of Toronto, presented critical summaries of the conference and directed discussion of a research and policy agenda concerning human performance in anesthesia. The group developed a set of broad research goals to provide the basis for improvements in the performance of anesthesiologists:

Define the "task characteristics" of the anesthesia domain more carefully, including a taxonomy of error modes and an analysis of successful adaptive strategies. This wig involve the application of existing models of dynamic decision-making to anesthesiologist behavior during both mA and simulated cases and to retrospective reports of crisis situations.

Determine the prevalence of sleep deprivation and fatigue in anesthesiologists during and after residency training. Evaluate the effects of fatigue on the performance of anesthesiologists.

Evaluate the effects of workload on human error during anesthesia. This will require the analysis of strategies by which expert anesthesiologists cope with high workload states.

Continue the development of simulator-based training programs in anesthesia crisis management. This will include the development of widely accepted standardized protocols for the initial management of perioperative crisis situations.

Analyze the organization of the "anesthesia system" to define the factors that have an effect on patient safety. "Latent errors" will have to be examined and the sociology and psychology of the complex network of incentives and disincentives that promote or detract from patient safety will be examined.

As pathfinders in this field, many researchers attending the meeting hope that further study of current problem of human error in anesthesia will lead to the ability to more effectively solve problems of the future and lead to improvements in other dynamic medical specialties such as intensive care or cardiology.

Open Meeting Planned

The group planned to generate a special interest committee within the Anesthesia Patient Safety Foundation to promote research and greater awareness in the anesthesia community of human performance issues as a limit to patient safety. An open scientific meeting to exchange research findings among a broader range of investigators has been planned for 1993.

Dr. Gaba, Stanford University and the Veteran's Administration Medical Center, Palo Alto, CA is -Secretary of the APSE He and Dr. Howard of the Department of Anesthesiology, Stanford, University organized this conference.

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N.J. Insurer Cuts Rates

The Princeton Insurance Company, the second largest insurer of anesthesiologists in New Jersey, has reduced malpractice premium for anesthesiologists for the second consecutive year. This year's rate has been reduced by 22 percent, reports Ervin Moss, M.D. of the N. 1. State Society of Anesthesiologists.

This policy rate is for a matured claims made policy as compared to the equivalent premium for an occurrence policy sold by the Medical Inter-Insurance Exchange of New Jersey.

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New Law Requires Hospitals to Report Device-Related Injuries and Deaths

by Jeffrey B. Cooper, Ph.D.

The Safe Medical Devices Act of 1990 was signed into law by President Bush on November 28,1990. Among other things, it requires that "device user facilities" (hospitals, nursing homes, outpatient centers, etc.) report instances in which there is information that "resonably suggests that there is a probability that a device has caused or contributed to the death ... or serious illness of a patient of the facility."

Although the FDA is now preparing regulations to implement the law, the statute specifically requires that reporting begin on November 28, 1991, regardless of the existence of a regulation. The law contains many ambiguities that should be defined by the regulations. The FDA recently held a conference attended by about 200 representatives of a broad spectrum of facilities and organizations that will be affected by the law to solicit opinions in preparation for Creating a first draft of the regulations.

This law is hilly to have important medico-legal implications for facilities and individual users and may create a substantial reporting burden. The FDA is hoping to minimize such negative effects by writing useful but minimally burdensome regulations. The effectiveness of that effort remains to be seen.

How did this law come to be? It appears to have been motivated primarily from the Congress, some members of which have been dissatisfied with the success of the original 1976 Medical Device Amendments in preventing device-related injuries. Some of the evidence for that came from a 1986 study by the General Accounting Office, which found that less than one percent of device-related incidents were being reported to & FDA. Another GAO study in 1989 charged that reporting problems still existed despite the implementation of regulations requiring manufacturers to report serious device-related occurrences (the Medical Device Reporting or MDR regulations). Although the wisdom of the law was questioned by some organizations, &re was apparently little opposition voiced at congressional hearings.

Many participants at the conference noted serious concerns about & heavy reporting burden, the potential for increased numbers of device-related lawsuits and the possibility the reporting will not be useful since no additional resources have been allocated to the FDA, which is already overburdened from MDR reporting. Despite these concerns, the participants in the conference worked diligently to generate ideas for how the law could be implemented in a way that is useful but with minimal negative effects.

There is little for hospitals to do immediately except to become familiar with the law, be aware of the impending need for reporting, and to watch for the appearance of the proposed regulations. It would also be wise to examine existing systems for device event reporting and to consider who should be responsible for implementing the new reporting requirements. One way or another, the following elements of the law will be implemented:

Essentially all healthcare facilities, but not including physicians' offices, wig be required to report events in which there is information to suggest that a device has contributed to death, serious injury, or serious illness. The reports must be filed within ten working days after discovery of the event. Deaths must be reported to the FDA and the manufacturer while serious injuries or illness need be reported only to the manufacturer, if known and, if not known, to the FDA. Summaries will be required semiannually.

What remains to be determined is exactly what constitutes a "reasonable probability," how broad is the definition of serious injury or illness, exactly in what way must the device have "contributed" to the event and how wig reports be filed? The issue of confidentiality and protection of users and facilities, although written into the law, is unclear. Despite prohibitions from disclosing information, there are circumstances under which information would become accessible to the public and, thus, to actual or potential plaintiffs attorneys.

For more information, a good summary of the law and its possible implications for user facilities can be obtained from ECRI (Hospital Risk Control Update, February, 1991 or ELM Advisory on the Safe Medical Devices Act of 1990 (Feb., 1991); contact ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462; (215) 825-6000 or consult your hospital attorney, risk manager, or Biomedical Engineering Department, which may have the information). The FDA will also provide a copy of the user reporting sections of the law (write to Ralph Bunge, FDA (HFZ-250), 1901 Chapman Avenue, Rockville, MD 20857).

Dr. Cooper of the Executive Committee, APSF is Director, Anesthesia Technology, Massachusetts General Hospital, Boston, MA.
 

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Fatal Pipeline Accidents Spur Japanese Standards

Classic 02-N20 Pipe Switch Causes 2 Deaths Before Problem Caught

by Toru Sato, M.D.

Medical gas supply to the anesthesia machine from a hospital pipeline still represents a hazard to patients.

A 77-year-old female was scheduled for orthopedic surgery to repair a broken leg on 21 December 1987 at a Japanese national hospital in Kyushu, Japan. A spinal anesthetic was given and during the intraoperative period she developed hypotension. She was given oxygen by mask as part of the usual cardiovascular support. Shortly thereafter, the patient developed the rapid onset of severe shock, did not respond to medications, and died of "acute heart failure." An autopsy faded to reveal any pathological change to support the diagnosis of acute heart failure

Two days later, 23 December 1987, a nine-year old male was given a mixture of nitrous oxide and oxygen for urological surgery in the same room. The patient went into severe shock after the nitrous oxide was turned off. Death was attributed to "acute heart failure".

The next day, 24 December 1987, a patient was scheduled for surgery in the same room (OR 2) under local anesthesia. When the surgeon asked for oxygen to be administered, the patient objected to the mask and refused. The attending physician then sniffed the gas to see if there was an odor and noted sensations which turned out to be nitrous oxide induced.

Police investigation of the deaths revealed a misconnection of the oxygen and nitrous oxide hospital pipelines. The hospital had remodeled OR I adjoining the previously remodeled and now active OR 2 and had failed to notify the Department of Anesthesiology of & intent to work on the hospital medical gas pipelines. New air conditioning ducts were installed in the ceiling and the medical gas pipelines had to be cut to facilitate installation (see diagram). The pipelines in question were not color-coded or identified in any fashion as containing oxygen or nitrous. Upon completion of remodeling, no tests were done at the OR 2 delivery site for nitrous oxide or oxygen. In addition, the anesthesia machines of the hospital did not have oxygen analyzers in use

Inexperienced Contractor

A small company had contracted the remodeling construction. Inquiry found that the subcontractor for the welding of the pipelines had been given drawings by the hospital of the pipelines without identification of their contents. Those who provided the drawings did not recognize the critical nature of the gases contained within the pipelines and did not tell the subcontractor or the Department of Anesthesiology.

These deaths and subsequent investigation had a major impact throughout Japan. The Ministry of Health and Welfare immediately began to draft a Japanese Industrial Standard which, after its 1990 adoption, sets standards for medical gas pipelines.

Anesthesiologists must recognize the importance of observing what is happening in and around the operating room. Ask questions about remodeling and new construction. We cannot depend on the contractor, welding company, or hospital to inform us of intentions to tamper with the oxygen, nitrous oxide, compressed air, and/or suction lines. If there is any question, test each medical gas outlet to be sure the gas delivered is the gas intended. A simple oxygen analyzer will prevent a major catastrophe. Oxygen analyzers in the patient breathing system are essential but must be turned on! Hospital medical gas pipelines and cylinders must always be viewed with some degree of suspicion.

Patient safety must be foremost in our minds as we administer anesthesia. The two deaths described in this report emphasize the outcome which can result from unobserved factors outside our control when we are not sufficiently vigilant.

Dr. Sato is from the Department of Anesthesiology, School of Medicine, Tottori University, Tottod-ken, 683, Japan. Dr. Sato thanks Dr. Clayton Petty of the National Naval Medical Center in Bethesda, MD for his assistance.

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Difficult Airway, Part 1, Now Available

The Difficult Airway, Part One, ASA Patient Safety Videotape #15, will be available for distribution by Burroughs Wellcome in the third quarter 199 1, beginning in August. The film examines in detail development of an "algorithm for management of the difficult airway."

The ASA Committee on Patient Safety and Risk Management's Task Force on The Difficult Airway developed the Algorithm. Serving on the Task Force were anesthesiologists Robert A. Caplan, M.D., Chairman, Jonathan L Benumof, M.D., Michael J. Bishop, M.D, Casey D. Blitt, M.D., Frederick W. Cheney, M.D., David M. Gaba, M.D., Ellison C. Pierce, Jr., M.D., and Mark H. Zornow, M.D., as well as Terence M. Davidson, M.D., Professor of Surgery (Head and Neck), Associate Dean for Continuing Medical Education, University of California, San Diego. Dr. Davidson was Scriptwriter and Producer. Also, the Office of Learning Resources Television, School of Medicine, University of California, San Diego, produced the film. Funding was provided by the ASA in its 1990 budget.

Most of the other fourteen tapes in the series are still available from your Burroughs Wellcome representative. A complete listing of the program may be found in the Spring, 199 1, APSF Newsletter, Vol. 6, No. 1.

Ellison C. Pierce, Jr., M.D.

Executive Producer, ASA Patient Safety Videotape Series

President, APSF

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In My Opinion: Are Surgeons Needed for Induction?

"In My Opinion. . ." is not meant to be an official APSF editorial, but rather an opportunity for invited respondents to address interesting and controversial issues. These issures should not be geographically or institutionally unique and are meant to represent areas of broad interest and concern. The focus is to create discussions in response to thought-provoking questions. Example topics will include: "Should the surgeon be present in the OR for induction;" "Conscious sedation in the GI lab Anesthesiology roles and responsibilities."

Newsletter readers are invited to submit questions they would like addressed, or answers to (opinions on) questions they have institutionally (or individually) dealt with.

Jeffrey S. Vender, M.D. Column Editor

Should the surgeon be in the operating mom at the time of induction of anesthesia?

Yes ... I can clearly remember a personal experience over fifty years ago when, as a terrified five-and-a-half-year-old, I was wheeled into an operating room in St. Vincent's Hospital in Erie, Pennsylvania to have my tonsils removed. The relief which I experienced was immeasurable as my surgeon, Dr. Charles Leone, greeted me: "What have we here? Mary Brunner's oldest boy." I put my arms around him, gave him a big hug and lay back, reassured that this trusted friend would take good care of me.

In the last fifty years medicine has changed a good bit. We have become far more technically oriented in the care we give. We have become fair more specialized. And, to some extent, we have become more impersonal. Our patients don't criticize us for lack of knowledge; they don't criticize us for lack of technical skill. They do criticize us for being uncaring.

This complaint underlies the loss of prestige which the profession of medicine has suffered in the last generation. To regain our lost stature we must reorient our behaviour and our attitudes. Our patients deserve the psychological support of their operating surgeon in the period immediately preceding operation.

There are other more practical reasons for the surgeon to be in attendance in the operating room at the time of induction. Operating mom nurses frequently have questions which only the operating surgeon can resolve, especially in this era of nurse shortage and increasingly frequent nurse turnover. A lack of surgical nursing experience is becoming the rule rather than the exception, and inexperienced nurses need instruction.

House staff or surgical assistants also frequently need direction in making immediate presurgical preparations. Patient positioning, preparations for interoperative X-rays, the set-up and checking of specialized, highly technical equipment, and other similar arrangements can all be expedited by the special attention of the operating surgeon, and he/she should be there to give it.

Finally, and most importantly, the issue of patient safety demands the presence of the surgeon, especially in those environments where housestaff Eire not present. Airway management during induction of anesthesia often requires a second informed and experienced participant. If cricothyrotomy is needed, I'll pick a surgeon to help me rather than a nurse every time. In those rare episodes of cardiac arrest during inductions, and these do occur, a surgeon is a blessed help in providing the patient the best chance for a good outcome.

The patient trusts his well-being to us when he enters our operating room. As caring physicians, we own him an obligation to provide him with our best efforts. Our best effort am not forthcoming from the coffee lounge, nor from the locker room, nor even from the scrub sink. The surgeon belongs by his patient's side during one of the most hazardous periods of the surgical experience during the induction of anesthesia.

Edward A. Brunner, M.D., Ph.D. Echenhoff Professor and Chairman Department of Anesthesia Northwestern University

But, on the other hand.

No ... unless the operation is expected to start immediately after induction, such as a bronchoscopy, or the patient is afflicted with a true life-threatening emergency when everything is being done simultaneously. The surgeon otherwise will waste a lot of time while venous and arterial lines are placed, endotracheal intubation is accomplished, monitors are placed and checked, catheters am passed, and so on. In cases of regional anesthesia or the initial placement of continuous epidural catheters for postoperative analgesia, the wait can be even longer.

The modern anesthesiologist is fully trained to handle any cardiovascular or respiratory problem associated with the induction of either general or regional anesthesia. The insertion of new and more complex monitoring devices and fines can take a significant amount of tune and the surgeons' physical presence is simply a waste of his time as well as a potential source of harassment to his anesthesiologist colleague. The surgeon is best out of the operating room at that time scrubbing up, making phone calls or even reading.

On the other hand, the surgeon should not be "off campus" or an inordinate time or distance away. At our hospital, the Department of Surgery constructed a surgical library of generous size and comfort, immediately adjacent to the operating room, which is newly-stocked with current medical and musical text books and journals. Waiting time of the surgeon and his assistants can thereby be put to good use. When the patient is property anesthetized, then the surgeon can position the patient and begin the work at hand, and his physical presence in the operating room at the time of anesthetic induction is not necessary.

Willard A. Fry, M.D. Professor of Clinical Safety Northwestern University Medical School Senior Attending Surgeon Evanston (IL) Hospital
 

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Letter to the Editor

Head Position Key to Ease of Intubation

To the Editor:

Management of the airway is, upon occasion, fraught with difficulties which can lead to increased patient morbidity and mortality Aside from the worst case scenarios of inability to ventilate or unrecognized esaphageal intubations, them is airway trauma (injury to teeth, cords, naso-oro-pharynx); the CNS and myocardial stress of catecholamine release; and face mask neuro-vascular pressure problem. A new type of head support device is now available which can help the anesthetist avoid some of these airway management difficulties, and thus improve patient care and safety.

There have been many head support cushions available to the anesthetist in the past. However, until now none have been able to align and maintain the alignment of the oro-laryngo-tracheal axis, with or without complete muscle relaxation, with comfort for the awake patient and incorporating a pressure point avoidance surface. The new device places the head of the patient in the sniffing position and maintain an optimal airway for the sedated patient. In addition, it makes ventilation of a patient by mask easier, assists in providing a clear view of the cords when the tongue is moved to the side with a laryngoscope blade, and requires at most only a centimeter of lift for complete view of the cords. I find that the majority of "difficult" and emergency intubations become comparatively easy with this device, which allows a complete view of the anatomy of the Larynx from above. If we can help to avoid the unnecessary morbidity and mortality associated with airway management with use of it, it should be made available to all anesthesia providers.

Michael Popitz, M.D. Brigham and Women's Hospital, Boston

Belgium Anesthesia Safety Standards Adopted

To the Editor:

Please find here some comments to the Belgian Standards for Patient Safety in Anesthesia, which were published at the beginning of 1990.

We have fixed a "deadline": 01.01.1995. At that date compliance with the standards should be effective. At the moment we are not yet well equipped. However, we point out openly the final goal, although this has not yet been made. We are perfectly aware that this can be medico-legally dangerous.

In Belgium, in most hospitals, the person who has power on budgets is the manager, not physicians. The manager also collects fees on behalf of physicians (this is the law). Anesthesiologists are then requested, by the standards, to determine precisely what do they need to comply with the standards and they are strongly advised to present their needs to the manager. In case of an accident which could have been avoided by equipment turned down by the manager, this will be definitely involved in the case. The argument is already taken seriously by the managers in our country.

The second part of the standards, "Safety recommendations for the practice of anesthesia," strongly reminds anesthesiologists of their basic duties for the patient safety in anesthesia.

So far so good ! Positive results are already numerous and they come from anesthesiologists and managers all around the country. The State authorities are also very sympathetic to our request for more patient safety in anesthesia.

Thank you very much indeed for the attention you pay to the Belgian way to increase patient safety in anesthesia.

Professor Bernard Gibomont, Brussels Belgium

Belgian Standards for Patient Safety in Anesthesia

The Belgian Anesthesia Patient Safety Steering-Committee

Reprinted from Acta Anaesth. Belg., 1989, 40, 231-238 with permission.

Editorial Comments

Mortality and morbidity related ID anesthesia is a continuous threat to the practice of anesthesia (Lauwers, 1978). Fortunately anesthetic mortality has decreased from a death rate of 3.7 per 10,000 anesthetics (Beecher and Todd, 1954) to figure 0.76 per 10 000 anesthetics (Tiret et. al., 1986). Even a low figure of 0.066 per 10 000 was mentioned (Eichhorn, 1989).

Elements which contributed to this fortunate decrease of anesthesia-related mortality are multiple. The continuous presence of an anesthesiologist in the operating room during the entire diagnostic or surgical procedure is very important, and allows a patient linked individual observation. The more elaborate education and experience of the anesthesiologists, witch increased over the last decade, and comprises now in Belgium a ha-tune training of 5 years, is a further important factor. The gradual adaptation of monitoring devices, to improve anesthesia care and to decrease the incidence of anesthesia-related patient injuries is the third crucial factor. Although monitoring is routinely encouraged for every patient under anesthesia, it is even still more mandatory if the vital functions of the patients are disturbed or threatened. Therefore nowadays diverse monitoring devices must be available at all times in each anesthesia location. Nevertheless we may not forge that monitoring and monitoring devices are not end targets, but highly sophisticated means to improve anesthesia cam and that only with a judicious use of them we will reach the final patient safety goal. This also implies that according to the practical situation, which the anesthesiologist is facing, he must decide himself which monitoring he is using and depending on the patients' condition minimal monitoring equipment can be extended. Clinical vigilance remains essential because even highly sophisticated monitoring devices such as capnographs and oximeters may occasionally not function correctly and may even fail to reveal dangerous circumstances!

Standards for patient monitoring were first adopted in 1985 by the Harvard-affiliated hospitals and later in 1986 encouraged by the American Society of Anesthesiologists. Them is now already provisional strong suggestion that after the application of these standards anesthesia mortality decreased (Eichhorn, 1989). Standards have also been adopted by the Association of Anesthetists of Great Britain and the French Society of Anesthesia. Already for years in the Netherlands strict rules of anesthesia monitoring exist. It is therefore timely that Belgian Standards for patient safety in anesthesia now are published. Months of discussion amongst the professors of anesthesiology of the Belgian Universities, together with representative of the scientific and professional anesthesiology societies of Belgium preceded the present publication.

The adopted standards have to be met at the latest in January 1995. Indeed for practical reasons each individual hospital, or anesthesia location cannot immediately comply with these rules.

The present standards apply only to anesthesia practice done by anesthesiologists for diagnostic and/or surgical procedures. Of course " is only part of the professional activities of the anesthesiologist. For the practice outside the traditional operating theatre and diagnostic examination room, other standards have still to be elaborated in the future. This concerns activities in the delivery unit, pain clinic, acute pain treatment or intensive care unit.

The Board of Directors of the Belgian Society of Anesthesia and Reanimation.

References

1. Beecher H. K., Todd D. P., A study on the deaths associated with anesthesia and surgery based on a study of 599, 548 anesthesias in ten institutions 1948-1952 inclusive, ANN. SURG., 140, 2-35, 1954

2. Eichhorn J.H., Cooper J.B., Cullen D.J., Maier W R., Philip J.H., Seeman R. G., Standards for patient monitoring during anesthesia at the Harvard Medical School, JAMA, 256, 1017-1020,1986

3. Eichhorn 1. H., Prevention of intraoperative anesthetic accidents and related severe injury through monitoring ANESTHESIOLOGY, 70,572-577,1989

4. Lauwers P., Anesthetic death, ACTA ANAESTH BELG., 29, 19-28, 1978

5. Tiret L, Desmont J.J. Halton F., Vourc'h G, Complications associated with anesthesia. A prospective study in France, CAN. ANAESTH SOC. J., 33, 336-344, 1986

Introduction

The anesthesiologists of the Belgian Society for Anesthesia and Reanimation and of the Belgian Professional Association of Specialists in Anesthesia and Reanimation have undertaken to define safety standards for anesthesia or sedation of patients, undergoing diagnostic or surgical procedures.

These safety standards should be effective by the first of January 1995.

The standards are divided as follows

Part One: Minimal standards

Section I General principles.

Section II Departmental organization.

Section III Assistance for the anesthesiologists. Minimal standards.

Section IV General equipment. Minimal standards.

Section V Monitoring equipment. Minimal standards.

Section VI Transport of the patient.

Section VII Post-anesthetic care unit (PACU). Minimal standards.

Section VIII Maintenance of equipment in anesthesia and PACU.

Part Two: Safety recommendations for the practice of anesthesia

Section I General organization.

Section 11 Preoperative visit.

Section III Basic controls.

Section IV Perioperative patient control.

Section V Transport of the patient.

Section VI Post-anesthetic care unit.

Section VII Anesthesia records.

Section VIII Quality control

Section IX Continuing educational program

In circumstances where the application of the standards in whole or in part is not possible, the reason is noted on the anesthesia record. A lack of staff, equipment or organization is not an acceptable reason.

Until the standards become effective (the transitional period), the chief of a department of anesthesiology, taking into account all local relevant circumstances, submits a written plan listing the requirements for compliance with the new standards, to the hospital management.

During the transitional period, application of the standards receive priority.

1. in workstations outside the main operating theatre area (these locations are frequently poorly equipped),

2. in locations where close observation of the patient is difficult, or where fighting is frequently lowered, or where adequate oxygenation of the patient is more difficult to assess or control.

During the transitional period, it should be useful for the departments of anesthesia to have an independent audit performed by qualified professionals from outside the hospital. In the case of a lawsuit, a previously held audit may provide evidence of the correct running of the department and of the efforts that are being, and have already been, made to comply with the standards.

The standards will be revised in accordance with scientific advances. The upgraded rules will be published in scientific and professional journals.

In a case where hospital management makes it impossible for the anesthesiologist to put these standards into practice despite a duly written request, the anesthesiologist can no longer be held responsible for the consequences. In this situation, the chief anesthesiologist immediately requests an audit.
 

Preanesthetic Checklists Cited as too Long; Brief Version Offered

To the Editor:

I have found virtually all the printed checklists* that I have ever seen for pre-anesthetic machine checkouts to be needlessly lengthy and burdensome. The best checkout routine I ever heard was a mnemonic taught to me before I began my residency.

The mnemonic is as follows: TV LAD IS BEST

T tanks

V vaporizers, ventilator

L leaks (includes connection of ETCO2 monitoring line)

A airway

D drugs

I IV

S suction

B blood pressure (cuff)

E EKG

S stethoscopes (esophageal, precordial)

T temperature

The only new item I add is a fifth monitoring device, the pulse oximeter.

To this day, I go through the mnemonic and set up my machine and supplies in the same order before every anesthetic I administer and it has not failed me yet. As far as I can tell it covers in simple fashion all the items of the more elaborate printed checklists.

Leo I. Stemp, M.D. Atlanta, GA

* Anesthesia Patient Safety Foundation Newsletter. Checklists cited as contributing to safety. 5:30-31, Fall 1990

Special Autoclaving Suggested for Ampules

To the Editor:

The APSF Newsletter is always very informative and it is a pleasure to read it. It is a great source of practical details and it conveys a lot of safety rules that helps us all; patients and physicians alike.

In the Fall 1990 issue, Dr. Mark P. Fritz answered on the problem of contamination while handling local anesthetic ampoules. We would like to contribute with our experience to the subject.

In a "Letter to the Editor" addressed to the revista Brasileira de Anestesiologia (1) we stressed the need of autoclaving all local anesthetic agents, specially the ones to be used for spinal and epidural analgesia.

In Brazil them have been two reports of deaths after spinal analgesia due to meningitis. (1,2,3) In both instances, the fact that the ampoules were not sterilized on the outside was blamed as the cause of the infection.

One of these misfortunes happened at the hospital we were working in 1957.(2) Since then, we have instituted the routine autoclaving of all drugs used for central nerve blocks. No infections were seen after the adoption of this procedure.

We did not observe any physical change or lack of potency in the agents so treated, even when we were dealing with procaine or pontocaine. Of cease, with bupivacaine and lidocaine heat is no problem. Ten percent solutions of glucose and 1: 1000 ampoules of epinephrine have also been prepared in the same way, without any difficulties.

The autoclave is kept at 121 degrees C and under two atm pressure for 15 minutes. The ampoules are sterilized inside clear glass test tubes, marked with the date and the name of the person in charge. It is closed by sensitive tape, to confirm that the sterilization operation was done correctly. The tubes are kept up to one month. If they are not opened within this time, the process is repeated once month.

After 32 years' experience, we are convinced that this system should be mandatory for all ampoules intended to be applied for spinal or epidural analgesia. Without any doubt this will increase the patient's safety.

As a fringe benefit, this procedure will abolish or decrease almost to zero the chances of one injecting the wrong drug when doing a spinal or an epidural block. In Brazil, in places where this procedure is not utilized, there have been reports of over ten cases of spinal blocks where gallamine, dipyrone, cedilanid or pancuronium were administered by mistake into the subarachnoid space with fatal or dire results.','

We hope that this observation can be of value to our colleagues.

Professor Armando Fortuna, M.D.

Director, Department of Anesthesia, Post Graduate Training Center, "Centro Integrado de Santos"

Anibal de O. Fortuna, M.D.

Instructor at the Post Graduate Training Center Brazil

References

1. Fortuna A; Esterilizacao de Ampolas para Anestesias Espinhais, Cartas ao Editor. Rev Bras Anesth 39:241, 1989

2. Fortuna A; Bloqueios Anestesicos: Rev Bras Anesth 13:227-262, 1963

3. Vieira ZEG: Complicacoes da anestesia raquidea. Relato de um caso de meningite pos-raquianestesia (Miscelanea); Rev Bras Anesth 12:77, 1962
 

Newsletter Editor Moves

To the Editor:

This letter is written to offer congratulations to John H. Eichhorn, M.D. in his appointment as Professor and Chairman, Department of Anesthesiology, University of Mississippi Medical Center, Jackson Mississippi.

Dr. Eichhorn has served as Editor of this letter since its inception in 1985 an undertaking that he has, simply, carried out in a superb manner. May we take this opportunity to offer him thanks from the entire APSF Board of Directors and membership.

John, we wish you well in the deep South and we look forward to your continued service in this important role

Ellison C. Pierce Jr., M.D. President, APSF

Editor's Note: Thanks.
 

What is NPO Really?

To the Editor:

I am in active practice in a teaching hospital and I am involved in resident teaching. From time to time, we have differences of opinion regarding the NPO status of our patients coming for elective surgery.

I take a strong stand against anesthetizing a patient who comes for an elective surgery and is not NPO, specially solid food, no matter how many hours ago the patient ate.

I am sure that them is more than one opinion about this over the country. We think the final decision should be up to the anesthesiologist involved.

I will appreciate comments, opinions, and concerns about NPO status (particularly as it bears on patient safety) from your readers.

Parimal K. Nandy, M.D.

Dayton, Ohio

Very Long Hours in Survey Seen as Unbelievable; Comments Sought

To the Editor:

In response to the article "APSF Survey Reveals Long Work Hours in Anesthesia" (APSF Newsletter, Winter 1990-91, page 43), let me say that I agree with the Editor in finding the summary of responses to reveal some "astounding information."

In having worked as a C.R.N.A. in anesthesia for 32 years, in civilian and military hospitals ranging in size from 35 to 3,000 beds, from Maine to Seattle and Germany to Vietnam, I have never encountered conditions in which any anesthetist or anesthesiologist worked the kinds of hours reported in this survey. I cannot remember ever working more than four, possibly five, hours without a break. The average would have been closer to 1 Y2-2 hours. Although I have practiced alone for six years now, I can't believe working conditions in anesthesia have deteriorated to the extreme degree reflected in this article. I would hope that these are extremely unrepresentative data.

Ted Kehn, C.R.N.A. Norway, ME

[Editor's NW: Comment at the time of the original publication suggested that those with unusually long working hours would be most likely to respond to the survey. Readers' opinions on this point and on work hours in general are invited.]

Multidose Vials, Injections, and Infections

To the Editor:

Thank you for including my abstract "Quality Assurance in Infection Control" among those cited in the review of the 1990 American Society of Anesthesiologists' Annual Meeting. (Winter 1990-91, Vol. 5, page 3 5.) Of primary concern in my abstract is prevention of transmission of AIDS, hepatitis, and other blood borne diseases.

A clarification is needed. I did not recommend abandoning use of multidose vials (MDVS) for more than one patient as long as proper aseptic technique is used and a new sterile syringe and needle are used each time medication is obtained. I did, however, question the continuing use of MDVs since 1) viral viability and transmission of disease has been documented if the vial becomes contaminated (ie. hepatitis B virus), 2) bacterial contamination of MDVs has resulted in nosocomial bacterial infections, and 3) health care workers' (HCWs) compliance with aseptic technique and appropriate use of MDVs will likely continue to be less than the optimal 100 percent, despite continuing education programs and institution of department and hospital infection control standards.

Although use of MDVs for multiple patients is currently an accepted technique in medicine today if appropriate precautions are taken to avoid potential cross contamination (as described above), I question the risk-benefit analysis in which reuse risks potentially fatal blood borne infections from cross-contamination, whereas the only "benefits" of continued reuse of MDVs on multiple patients are perhaps a small cost savings.

This issue needs to be addressed not only by anesthesia personnel but by the entire health care field for adoption of uniform practice recommendations. At the present time it would be unrealistic to recommend anesthesia personnel abandon use of MDVs unless other HCWs also do so.

My study recommended continuing updates for HCWs on Universal Precautions and infection control, and utilization of quality assurance surveys to assess compliance and provide education and feedback to HCWs to further improve practice patterns. These practices include following all Universal Precautions including. obtaining hepatitis B vaccination, avoiding improper handing of contaminated needles, appropriate disinfection and/or sterilization for reused equipment, proper use of rnuitidose vials, and singe patient-use for all syringes, needles, intravascular tubing and fluids, drugs and other items where potential cross-contamination from one patient to another might occur. Also recommended was increased use of needleless systems for administration of intravenous drugs. Finally, I emphasized the need to use single-patient-use bacterial breathing filters on spirometers and inspiratory-force meters in the Post-Anesthesia Care Unit to prevent potential cross-infection via these items..

A goal to these ends is generation and promulgation of relevant national standards of practice.

Elliot S. Greene, M.D.

Assistant Professor of Anesthesiology

Albany (NY) Medical College

References

1. Longfield R, et al. Multidose medication vial sterility: an in-use study and a review of the literature. Infection Control 1984; 5:165-9.

2. Alter MJ et al. Hepatitis B virus transmission associated with a multiple-dose vial in a hemodialysis unit. Ann Intern Mod 1983; 99:330-2.

3. Oren I et al. A common-source outbreak of fulminant hepatitis B in a hospital. Ann Intern Med 1989; 110:691-8.

4. Greene E. Quality assurance in infection control. Anesthesiology; 73:A1061.

5. Greene E. Infection control in anesthesia and critical care medicine. Anesthesiobgy Report 1990; 3:280-90.

IV Valve Prevents Sticks

To the Editor.

The Center for Disease and Control has recommended that all hospitals adopt an infection control policy of "universal precautions".(1) This policy assumes the blood and body fluids of all patients are infected with blood-borne pathogens and the health care workers should protect themselves with barrier devices. While the use of gloves in anesthesia is widespread, the use of a one way valve in the intravenous line to prevent patient blood into the drug line is not.

I have requested the manufacture of an intravenous line which is constructed with a one way valve inline between the patient and the first injection port. The intravenous fine is of concern because accidental needlesticks are an arm of continued problem in anesthesia personnel. For infection with human immunodeficiency virus type I (HIV 1), needlestick injuries carry the highest risk of transmission at 0.4 percent per incident but the estimate for the more prevalent hepatitis B virus (HBV) is 6 to 32 percent (2)

If the intravenous line utilized for injection of drugs is free of pathogens, the needlestick becomes a discomfort rather than an inoculation. The clean injection line will also preclude inoculation of other patients from contaminated needles and lessen the likelihood of contaminating multiple dose vials. The recommended use of the one way valve in the drug injection should be an additional safety feature for patients who are under the care of anesthesia personnel. This approach should also be used in the general hospital for the same reasons. It is a potential benefit for both health care professionals and patients. I suggest the placement of a one way valve in line before the injection port be universally adopted.

Paul J. Schaner, M.D. Mercy Hospital Pittsburgh, PA

References

1. Centers for Disease Control: Recommendations for Prevention of HIV transmission in health care settings. MMWR 1987:36 (suppl 2S); 3S-18S

2. Viahov, David et al.: Prevalence of Antibody of HIV-1 Among Entrants to US Correctional Facilities. JAMA 199 1; 265:1129-32.
 

Defends PACU Oximetry

To the Editor.

I respond to Dr. Priano's letter in the APSF Newsletter (Vol. 5, No 4, page 45) concerning his objections to pulse oximetry as a standard of care in the P.A.C.U. (and ostensibly in anesthesia). As an anesthetist and former P.A.C.U. nurse, I contend that in spite of any supposed shortage of conclusive, "uncontestable" confirming the efficacy of pulse oximetry for patient saw, empirical evidence supporting its indispensability abounds.

I assume that Dr. Priano accepts electrocardiography, blood pressure monitoring, and temperature monitoring as reasonable basic standards of care. Given the often indirect relationship between the information provided by these monitors and the problems that this information helps us to detect (most of which are not immediately life-threatening), it is hard to imagine not embracing a device that alerts us to one of the most rapidly life-threatening events in anesthesia. Even with its artifactual potential, the pulse oximeter's information is valid and reliable enough to warrant mandating N use as an adjunct to observing, listening to, and touching the patients under our care.

Regarding the allegations that mandating its use camouflages anesthesia caregivers' incompetencies and propagates incompetence through monitor dependency, I can only wonder if that fine of reasoning would be carried through to eliminating all other monitors that provide objective patient information simply because that information could be obtained by direct clinical methods. The obvious point is that though clinical correlation is necessary, the simultaneous gathering of multiple data and immediate recognition of abnormalities through electronic monitoring devices is a fundamental aspect of modem anesthesia practice. If monitor dependency is a result of monitor availability, it seems clear that the issue to be addressed is not that of the equipment.

The gravity of designating something as a "Standard of Care' is clear and it is certainly incumbent upon those that make such designations to insure validity first. Given that consideration, the cam and safety of patients with compromised respiratory function is still dearly enhanced by proper adjuctive use of the pulse oximeter vis-a-vis other methods alone. Considering the myriad of other costly and frequently invasive equipment we readily incorporate into our patient management, the pulse oximeter would seem welcomed by all whose patient care involves respiratory function monitoring. I respectfully submit to Dr. Priano that the ASA House of Delegates made a good call on this issue

Darryl M. Lodato C.R.N.A., Education Coordinator Parish Anesthesia Associates

East Jefferson General Hospital Metairie, Louisiana
 

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STA Flourishes, Stages Meetings, Expands Scope

by N. Ty Smith, M.D.

The Society for Technology in Anesthesia (STA) continues to grow and to experience exciting times; the future holds even more promise. Following is one perspective of the past, present and future of STA.

STA's first annual Scientific Meeting was a smashing success, despite the onset of the Persian Gulf conflict the day before attendees were due to arrive in Orlando. Even with last minute concellations, over 170 attended the meeting, and they all enjoyed the science and the ambience. The tutorials and panels were very well received, the audience acting as if they were riveted to their chairs. The highlight of the meeting was the STA Sapcelabs Distinguished Lecture presented by Dr. Richard J. Kitz, Professor of Anaesthesia, and Codirector of the combined Harvard Medical School MIT Health Sciences Technology program. Dr. Kitz outlined the status of medical technology, and proceeded to lay down some challenges for STA in the '90s. STA has already begun to respond to one of those challenges, by forming a task force to examine the need to "identify and promulgate the information and experience each resident ought to acquire concerning the technology he uses." The Board of Directors decided to put together a position paper that would describe in some detail what this body of knowledge should be. In charge of the task force assembled to attack this challenge are Drs. Wes Frazier and Jim Philip. Those interested in helping with this important function can contact either Wes or Jim. Dr. Kitz's full presentation will be published in the Journal of Clinical Monitoring.

There were several major reasons for the success of STA '91. Good speakers came through with outstanding material. The scientific presentations were well done and exciting. But most of all, we were able to keep the registration fee low because of the generosity of our sponsors and friends. These generous patrons include STA's Founding Sponsor, Diatek, Inc. and Corporate Sponsor Spacelabs, as well as Meeting Sponsors Anaquest, Applied Biometrics, Becton-Dickinson, Datex, Deseret, Dragerwerk, Fiberoptic Sensor Technologies, IVAC, Kendall Health Products, Medasonics, Nellcor, Organon, Ohmeda, and VIA Medical.

Both of the tours emphasized technology, and were well received: the behind the scenes NASA tour and a special tour at the Epcot Center, arranged by Dr. Ira Rampil.

Upcoming Meetings

Pleased with the success of its three recent meetings, STA is already planning for its future meetings. STA '92 will be held in San Diego on January 30-February 1, 1992. The venue will be & U.S. Grant Hotel, an historical site and beautifully renovated. It is dose to most of San Diego's major attractions, as well as to Tijuana, either by walking or by easily accessible public transportation. Dr. Jerry Calkins is in charge of the meeting, and some very exciting plans have already been laid. The theme will be Decision Making in Anesthesia, and the Anesthesia Workstation. In addition to scientific sessions, panels, and tutorials, there will be a cracker-barrel type session, where participants can meet on an informal basis with "experts" The most fun will be an extemporaneous dew where several eloquent and quick-witted experts will debate a topic without knowing until the last minute what the topic is and how the Warm will be composed. Tentative plans for a spouses' program include a reception, a hospitality suite, a party, shopping, sightseeing, and CPR instruction. Spouses will also attend the dinner and the Distinguished Lecture. Dr. Reyn Saunders will be in charge of this program. Tours may include the Zoo, the Wild Animal Park, Sea World, Old Town, and Horton Plaza.

Dr. Jim Philip will be in charge of the Scientific Session for STA '92. The format for the Scientific Session will be poster presentation of all abstracts preceded by three minute (four-slide maximum) verbal presentations to the assembled audience. Those who wish to present at STA '92 should call 617-732-7330 or FAX 617-732-6798. Abstract forms and information will be available later in the Spring. THE DEADLINE FOR THE ABSTRACT IS AUGUST 1, the same as last year. As before, presentors are encouraged to demonstrate their software, systems, devices, displays, or clever ideas. As before, we ask that commercial products be demonstrated at the industrial exhibits.

Companies are encouraged both to help sponsor the meeting and to exhibit at it. The Grant has a large room for industrial exhibits. Those wishing to exhibit should contact Ms. Kuzava. Exhibitors are encouraged to attend the sessions and to visit the poster presentations.

The STA Breakfast Panel will be in its third year at & ASA Meeting in San Francisco. In charge of this panel is the Chairman of STA's Education Committee Alan Grogono, who will also moderate the panel. The topic will be "When the lights Go Out." Dr. Sandy Eames will talk about Power Distribution and Backup, or "The New York City Blackout." Dr. David Paulus will discuss the "Anatomy of Some Failures." while Dm Jeff Feldman and David Cullen will describe their experiences of "Working in the Dark." Dr. Reynolds Saunders will assure us that these new fangled electronic anesthesia machines will indeed work in these situations, and Dr. Arthur Yeats will enlighten us on how to educate and prepare all of us for this potentially uncomfortable scenario. Finally, the audience will be invited to join in, with the titles "We've been in the dark too" and "What would we do?"

Thanks to the resounding success of the Alarming Dinner at last year's ASA Meeting, the increasingly popular STA Dinner will be repeated this year, with an entertaining and informative speaker from an important area such as human factors. Reserve 1830 on Sunday evening, October 27 for another entertaining and educational evening.

Tentative plans have already been laid for STA '93. These plans call for STA '93 to take place in New Orleans in May, during either Mardi Gras or the Jazz Festival.

Speaking of meetings, there is still time to attend the 6th ISCAIC in Hamamatsu. Please be reminded that our hosts at that meeting have done everything possible to make the meeting riot only outstanding scientifically and educationally, but also as affordable as possible for those from other countries. In addition, several airlines have opened new west coast routes to Japan, and the flights are available for about $ 1,000. Those interested in attending should contact Dr. Kazuyuki Ikeda, Chairman of the Organizing Committee

INTERFACE

The STA newsletter (INTERFACE) has had a true jump start, and a smashing one at that, under the inspiring leadership of Jeff Feldman. We want to emphasize that the APSF and STA newsletters complement each other. One takes a broad approach, gathering together any information to do with patient safety. INTERFACE emphasizes the impact of technology good or bad on patient safety. Several features in INTERFACE have already attracted considerable attention. For example, "The Devil's Advocate' column allows members to speak their piece on a controversial topic behind the safety mask of anonymity. The first two topics were "Agent Specific Analysis" and "How To Solve the Alarms Problem: Think Japanese!" In addition, the "Perspective on Technology" column allows a representative each from the manufacturer's side and from the users' side to present their views on a timely topic. An upcoming feature of INTERFACE will be the publishing of abstracts translated from other languages, often from small meetings or hard to find American Societies, or of the Life Support Technology Society (Japan), you may obtain a copy by contacting Gerri Kuzava. In addition, those wishing to contribute to The Devil's Advocate may contact Ms. Kuzava, who wig pass the information on to the column editor. Those wishing to contribute to Perspectives on Technology or to submit abstracts forms in other languages should contact Dr. Jeff Feldman directly.

What You Can Do To Help

Our original assessment on the life blood of STA still holds the individual member is incredibly important to STA. Please participate in the He of STA. Your ideas are always welcome. Would you like to help with any of the committees? Do you have any suggestions for future directions? Please contact any member of the STA Board of Directors.

Dr. Smith, San Diego is an APSF Director and President, STA.
 

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From the Literature: Standards of Care and Capnography

Failure to Provide Capnograph. "Anesthesiology Malpractice Reporter", Vol. 10, No. 2, March/April 1991, 1-2, 12.

Described in this monograph is a malpractice case in which a jury verdict was recently affirmed by the District of Columbia Court of Appeals. The issue was whether a reasonably prudent tertiary care hospital, at the time of the injury (November, 1987) and based on national standards, should have supplied an end-tidal carbon dioxide monitor (capnograph) for a patient undergoing general endotracheal anesthesia for elective surgery. The court held that the testimony of the medical expert and the chairman of the hospital's department of anesthesiology as to the standard of care was sufficient to create an issue for a jury.

The case involved a nurse anesthetist supervised by an anesthesiologist who administered anesthesia to a previously healthy 36-year-old woman for an elective tubel ligation. She inserted an endotracheal tube and while she ventilated the patient, the anesthesiologist observed the rise and fag of the patient's chest and listened for breath sounds on both sides Five minutes later, the surgeon notified the nurse anesthetist that the blood was dark. She checked and found the vital signs stable. Soon after, the patient suffered a cardiac arrest from which she was resuscitated. However, the patient remains disabled and completely unaware of her surroundings from hypoxic brain injury. The anesthesiologist and nurse anesthetist agreed to an out of court settlement with the plaintiff. The allegation that the hospital had a duty to provide a capnograph, on the unargued assumption that it would haw prevented the tragedy, was litigated. There was a jury award against the hospital. The hospital appealed, but without success.

Standards Questions

This case raises a number of questions:

1 . What is a standard of care?

2. Was there a standard of cam requiring the use of capnography in November, 1987?

3. If a standard of care is suggested or adopted by a professional organization, what are the members' obligations?

4. If a standard of care involves the use of a specific piece of equipment which would normally be supplied by a hospital, what is the hospital's responsibility and how soon must it buy the equipment?

5. Are hospitals held by the courts to similar standards of care as are physicians?

Eddy (1) states that to write a standard requiring "the use of an intervention, the main health and economic consequences must be known sufficiently well to permit decisions. There must be virtual unanimity among patients about the desirability of the outcome." His definition of "virtual unanimity" of preferences is that at lease95 percent, perhaps even 99 percent (of patients) should agree on the desirability of the outcome. There is little doubt that all patients, on being informed that capnography is probably the most reliable method known to avoid esophageal intubation 2 would vote for such a standard. Eddy says that once adopted, a standard must be applied rigidly and must be followed in virtually all cases.

In trying to answer the question whether there was a standard requiring capnography in November, 1987, the following history must be considered. In August, 1986, Brimingham, Cheney, and Ward (2) published a review article on techniques to detect esophageal intubation. They discussed 16 commonly prescribed methods and found them all except one to be flawed or misleading. Their conclusion was both clear and well-supported: "Endtidal carbon dioxide measurement is at present perhaps the most reliable means under all circumstances of determining proper tube position and should be employed routinely whenever possible.

In July, 1985 the combined Anesthesia Departments of the Harvard Medical School hospitals adopted their "Standards for Minimal Monitoring during Anesthesia," and in August, 1986 published them in the Journal of the American Medical Association. These standards stated "Monitoring end-tidal C02 is an emerging standard and is strongly preferred." What did the authors of these standards mean when they used the word "emerging?" A subsequent discussion by Eichhorn et. al .3 of how the-se standards were conceived, gestated, and delivered strongly suggests that they intended capnography to be a standard as soon as possible. Even though they took into account the expense of universal installation of these devices they say, "This need for the earliest possible warning of adverse events led to mandating genuinely continuous monitoring' Later in the discussion they hedged their position by saying, "there was intense debate about whether to mandate one or both of these devices (oximeters and capnometers) ... the emphasis was on behavior and attitudes rather than technology." Yet two sentences later they admit that some sort of alarm device was necessary to monitor for disconnection. Criticism of the group of Harvard anesthesiologists who are truly among the small band of founders of the contemporary patient safety movement is not intended. This analysis is offered merely to illustrate how hard it was to admit that machines can do a better job than even the most conscientious and vigilant physician, in some circumstances.

Even though the ASA had rejected the idea of formal published standards ten years earlier, it reconstituted the Standards of Care Committee in October, 1985 and one year later the House of Delegates approved a set of standards which stated "end-tidal C02 analysis, in use from the time of endotracheal tube placement, is encouraged." In the preamble to these standards one finds the following statement. "The standards maybe exceeded at any time based on the judgement of the responsible anesthesiologist " As is seen below, it seems that the chief of anesthesiology involved in this case had made just such a judgement.

Capno-History

There was also some informal information available about capnography to all anesthesiologists practicing in the United States during 1986 and 1987. An example can be found in the July, 1986 issue of the ASA Newsletter. Dr. Erwin Lear, the Editor, took space on the front page to discuss whether, now that oximeters were available, in-line oxygen monitors could be eliminated. He said, "factors that lead to hypoxia other than oxygen source failure are best detected not only with an oximeter but also an end-tidal carbon dioxide monitor "

If one accepts that in early 1987 there was a de facto standard requiring capnography, what should have been the response of hospitals and how soon should they have bought the equipment? Again one must look at the available history. In the December, 1986 issue of this APSF Newsletter Dr. Ralph Epstein described how, in November, 1985 the chiefs of anesthesiology in 13 northern Connecticut hospitals agreed to a uniform policy for oxygenation and C02 monitoring. The minutes of these meetings were routinely sent to the chief executive officers of the member hospitals. He concludes by saying, "There is now a consensus among the anesthesiology chiefs that the action one year ago has significantly increased their ability to convince their respective hospitals of the importance of such equipment for patient safety."

In the September, 1987 issue of the APSF Newsletter, Mr. William Cass, Director of Risk Management for the Joint Underwriting Association (JUA) of Massachusetts authored an article on strategies by which anesthesiologists could convince their hospitals to buy monitoring equipment.

In the current New Jersey Standards for Hospital Facilities, with which hospitals must comply on pain of losing their licenses, one finds the following in the section on anesthesia supplies and equipment; patient monitoring: "End-tidal carbon dioxide monitoring shall be performed continuously on all patients receiving general anesthesia." Hospitals were given six months to comply from the date of publication of these regulations.

In his testimony, the Chairman of the Anesthesia Department where this adverse outcome occurred, displayed documentary evidence dated December, 1986 or January, 1987 of a procurement request to the hospital for capnographs. In his requisition he stated that if the monitors were not provided, the hospital would fail to meet the national standard of care. He also said that the monitors were to be fully operational by July, 1987. There can be no doubt that his actions strongly suggest his belief that capnography was the standard of care. However, the hospital argued that at the time, his statement concerning standards lacked an adequate factual basis.

Are hospitals held to the same standards as physicians? In previously litigated malpractice cases, courts have defined the "standard of care" as the course of action that a reasonably prudent (professional) with the defendant's specialty would have taken under the same or similar circumstances. Other courts have applied the same criteria to the behavior of hospitals and also, as for physicians, have rejected the 'locality rule' in favor of a national standard.

In this case, the hospital contended that the plaintiff's expert gave no testimony as to the number of hospitals having capnometers in place in November, 1987. There is little information available pertinent to this contention. The expert said that at the time of the incident he knew of four tertiary care hospitals, and also his own, that had installed capnometers. This incident occurred in a tertiary care hospital. Some tangential evidence is the finding by the JUA of Massachusetts that within six months of the signing of a Risk Management Premium Discount Agreement in July, 1987 (through which the use of oximeters and capnometers was mandatory) 97 percent of their insured Massachusetts' anesthesiology members had installed both devices. There seems in all of this to be a relatively common thread of about a six month hiatus between the adoption of a standard and the installation of the device

The hospital also argued (without legal citations to support the argument) that widespread mandated practices are necessary to establish a standard of care. However, the plaintiffs cited a case in which a standard of due care embodied what a reasonably prudent hospital would do and hence care and foresight exceeding the minimum required by law or mandatory professional regulation may be necessary to meet that standard.

The jury agreed with these arguments, and the Court of Appeals affirmed their decision. There was a judgment against the hospital and a $4.5 million award to the plaintiff.

Reported by Dr. Gerald Zeitlin, Senior Staff Anesthesiologist, Lahey Clinic, Burlington, MA and a member of the APSF Newsletter Editorial Board. He wishes to acknowledge the assistance of Mr. Edward Brennan, Counsel to the Massachusetts Society of Anesthesiologists and Mr.

William Cass, Head of Risk Management at the Joint Underwriters Association of Massachusetts.

References

1. Eddy DM. Designing a practice policy. Standards, guidelines, and options. JAMA. 1990; 263:3077

2. Birmingham PK, Cheney FW, Ward RJ. Esophageal intubation: a review of detection techniques. Anesthesiology. 1986; 65:886

3. Eichhorn JH, Cooper JB, Cullen DJ, Gessner JS, Holzman RS, Maier WR, Philip JH. Anesthesia Practice Standards at Harvard: A Review. 1. Clin. Anesth. 1988; 1:55
 

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Notes
The Anesthesia Patient Safety Foundation Newsletter is the official publication of the nonprofit Anesthesia Patient Safety Foundation and is published quarterly at Overland Park, Kansas. Annual membership: Individual $25.00, Corporate $500.00. This and any additional contributions to the Foundation are tax deductible. (Copyright, Anesthesia Patient Safety Foundation, 1992

The opinions expressed in this newsletter are not necessarily those of the Anesthesia Patient Safety Foundation or its members or board of directors. Validity of opinions presented, drug dosages, accuracy and completeness of content are not guaranteed by the APSF.

APSF Executive Committee:

Ellison C. Pierce Jr., M.D., President; W. Dekle Rountree Jr., Vice-President; David M. Gaba, M.D., Secretary; Burton A. Dole, Jr., Treasurer; Casey D. Blitt, M.D.; Jeffrey B. Cooper, Ph.D.; Joachim S. Gravenstein, M.D.; E.S Siker, M,D.

Newsletter Editorial Board:

John H. Eichhom, M.D., Editor; David E. Lees, M.D. and Gerald L. Zeitlin, M.D., Associate Editors; Stanley J. Aukburg, M.D., Nancy Gondringer, C.R.N.A.; Jeffrey S. Vender, M. D., Ralph A. Epstein, M.D., Bernard V. Wetchler, M.D., Mr. Mark D. Wood.

Address all general, membership, and subscription correspondence to:

Administrator

Anesthesia Patient Safety Foundation

515 Busse Highway

Park Ridge, IL 60068

Address Newsletter editorial comments, questions, letters, and suggestions to:

John H. Eichhom, M.D. Editor, APSF Newsletter

Department of Anesthesiology

University of Mississippi Medical Center

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