ANESTHESIA PATIENT SAFETY FOUNDATION
NEWSLETTER

Volume 6, No. 3, pp 25-36 Fall 1991
Table of Contents

FDA Preanesthesia Checklist Being Evaluated, Revised
ASA Meeting Features Sessions on Safety
Checklists: Aviation Shows the Way to Safer Anesthesia
FDA Pre-use Equipment Checklist Spurred by Accidents, Studies
"Human Factors" Improve Safety; Anesthesia Applications Sought
Soviet Anesthesiologist is First APSF Visiting Professor
ICPAMM Meets in Poland, Promotes Safety Studies
Letter to the Editor
Notes




FDA Preanesthesia Checklist Being Evaluated, Revised

by David E. Lees, M.D.

How many anesthesiologists can face themselves in the mirror and honestly claim each morning to perform the infamous step 16 in the FDA Pre Anesthetic Checklist? Not many, the FDA believes, and most anesthesiologist would probably agree. The original checklist was not intended to supplant the manufacturer's specific checklist, but rather offers clinicians a system to checkout any machine they might encounter. At the time the checklist project was begun in 1985, there were a large number of older machines in use which predated the original ANSI Z-79 1979 standard for anesthesia gas machines.

New Developments

Many things have happened since the FDA Checklist was first issued in 1986 with the aid of the ASA, AANA and other interested parties. A large number of these older machines have been retired as a result of withdrawn manufacturer support, state regulations, or aggressive risk management policies. Additionally, the major organizations representing clinical practitioners have promulgated similar monitoring standards and a new generation of anesthesia machines has followed with the Issuance of ASTM F1161-88 standard for anesthesia gas machines.

Presently, the FDA is revisiting the Preoperative Checklist issue in association with the AANA and ASA with an eye towards several goals:

1. A modified checklist must be easily understood by all practitioners.

2. The checklist should contain only those items critically necessary.

3. Certain steps should be modified to ensure complete and thorough performance of the checklist.

4 .An accompanying training guide must be developed that both teaches the correct test methods and also explains the importance and clinical relevance of each step.

The original checklist had 24 steps, with many having four or more sub-steps. It represented an engineering approach to the problem; present thinking sides more with a consumer (clinician) approach to the problem. A draft of a new checklist of 16 steps has been proposed which is now divided into systems that can be readily visualized and understood by the practitioner. New steps have been added and many deleted or combined with others to make a simpler document. A user approach to a checklist might contain the following sections:

Backup Ventilatory Equipment

High Pressure System

Low Pressure System

Breathing System

Scavenger System

Ventilator Monitors

New would be an initial first step that backup ventilation equipment be available; a resuscitator bag should be available if all else fails! This would replace the gratuitous inspection language contained in Step 1 of the extant checklist (ID number, hoses, cylinders, etc.). Additionally Step 19 regarding suction in the old document might be dropped; while checking to ensure adequate suction is a good work habit, it is not integral to the proper functioning of an anesthesia delivery system.

In the old checklist, nitrous oxide and gas cylinders other than oxygen had to be checked in the same manner as oxygen (old Step 5). The new checklist might concentrate only on the oxygen delivery system, as this is the critical component. Old Step II requiring the testing of central pipeline gas supplies might also be substantially reduced; one need only know the pipeline pressure

The new draft is predicated on the use of ascending bellows ventilators, which are far more popular now than models with descending bellows. It is interesting to note, however, that the ASTM F1161-88 standard did not specify the type of ventilator bellows on anesthesia gas machines.

The new checklist could eliminate old step 14, the Sniff Test. Experience has shown the test to be useless and the fear of being mistaken for a substance abuser makes most clinicians reticent to be seen breathing through their own anesthesia machines.

Old Step 16 concerning gas leaks was at worst abstruse; when understood it still remained a cumbersome exercise. An improved low pressure leak check will use a simple suction bulb that will work whether or not the machine incorporates a back check valve in the low pressure circuit.

In homage to the patient monitoring standards, the new checklist would require calibration and establishment of alarm limits for inspired oxygen monitors, oximeters, capnograph, spirometers and airway pressure alarms.

Preliminary tests of modified checklist drafts indicate users find the revised checklists to be straightforward, logical, and easily performed. Assuming that evaluation moves along in a timely manner, a new FDA-endorsed checklist can be expected in early 1992.

Those interested in contributing to the revision efforts for the FDA Checklist should contact either their ASA or AANA representatives. Alternatively, the FDA may be contacted directly by writing or calling:

Mr. Jay Crowley

Center for Devices and Radiological Health

HFZ-240

Food and Drug Administration

1901 Chapman Drive

Rockville, Maryland 20857

(303) 443-2436

Dr. Lees, Georgetown University, Washington, D.C., is Chairman of the ASA Committee on Equipment and Facilities as well as an Associate Editor of the APSF Newsletter.

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ASA Meeting Features Sessions on Safety

by John H. Eichhorn, M.D.

Issues and topics concerned with anesthesia patient safety will be featured prominently at the American Society of Anesthesiologists (ASA) Annual Meeting in San Francisco October 26-30.

In the Refresher Course Lectures, on Saturday, October 26, Dr. Isaac Azar will speak on "Quality Assurance and Peer Review." Also on that day will be presentations by Dr. Robert Caplan on "Adverse Outcome in Anesthetic Practice: What Do We Know?" and by Dr. Ian Ehrenwerth on "Electrical Safety in the Operating Room:' Sunday, October 27 will have a Refresher Course on "Standards in Anesthesia Practice" by Dr. John Eichhorn.

Among the panel discussions, on Tuesday, October 29, 2:00 5:00 p.m., there will be a panel on "Practice Standards, Quality of Care and Physician Reimbursement."

Forty-nine Scientific Papers will be presented in three sessions in the Patient Safety and Education Annual Meeting Section.

Poster Session VI on Monday, October 28, 2:00 - 5:00 p.m. (Moscone Room D, will be the first patient safety-oriented scientific session. Among the presentations concerning safety will be a study presented by Dr. J.J. Andrews demonstrating the significant hazards of filling contemporary vaporizers with desflurane by mistake. In such a circumstance, its vapor pressure and consequent characteristics can lead to an extreme overdose of agent and an hypoxic gas mixture. Recommendations for safety features of equipment that would be used with this new agent are made.

The safety of a new heat-resistant endotracheal tube for use in laser surgery cases was evaluated in a Japanese study to be presented by Dr. S. Kaseno. Two French teams will present: one headed by Dr. Y. Lambert on "Depression of swallowing reflex two hours after midazolam" and the other led by Dr. J. Auffray on "Thromboembolic risk of long-term radial artery cannulation: prospective comparison of two different cannulae."'

"Safety of inhalation anesthetic delivery during patient transport" will be presented by Dr. R. Friedhoff. Dr. K. Deepika will deliver new information on the perpetual question of the need for supplemental oxygen during transport from the operating room to the PACU. The data revealed that 16.2 percent of patients transported without extra oxygen (compared to 0 percent of patients with it) had PACU admission hemoglobin saturations more than 5 percent lower than the preanesthetic control.

Addressing another long-standing question, Dr. P. Popic will present a study of vaporizer contamination showing that over 0.5 percent of vaporizers tested at 22 hospitals contained some incorrect volatile agent, exactly evenly distributed between institutions with and without agent identifying monitors.

Dr. D. Melynk will present "End-tidal C02 monitoring in the recovery room after general anesthesia" and Dr. D. Handlin will present "Use of pulse oximetry as a predictor of post-anesthesia care unit duration in smokers and nonsmokers."

In platform presentations in the morning sessions, Tuesday, October 29, 9:00 a.m. 12:00 noon (Moscone Room 308), Dr. N. Johannessen from Denmark will relate that 5.2 percent of over 20,000 patients from five hospitals suffered anesthesia complications with the greatest number discovered on the second postoperative day, followed closely in number by the first and third days following surgery.

The ASA Closed Claims Study makes another report, to be presented by Dr. W Gild, concerning eye injuries associated with anesthesia. A new technique applied to critical incident analysis will be explained by Dr. R. Cook.

One of the major emphases in patient safety research has been the question of the impact of many of the observations on patient outcome. One study specifically oriented to help address these points, "Pulse oximetry does not reduce postoperative complications; a prospective study of 20,802 patients," will be recounted at the ASA by Dr. J. Moller of Denmark. Another type of investigation will be outlined by Dr. N. Sharrock in the paper "Perioperative mortality following total knee and hip arthroplasty the role of anesthesia care?" Further, Dr. D. Cullen will give a paper entitled, "ASA physical status and age predict morbidity following three surgical procedures," considering total hip replacement, TURP, and cholecystectomy.

Dr. R. Moon will present a paper on "Spontaneous Generation of carbon monoxide within anesthetic circuits" considering the issue of the interaction of potent volatile anesthetic agents reacting with C02 absorbent to produce potentially dangerous amounts of carbon monoxide. Dir. 1. Brooks considers "Anesthesia machine contamination" in a study involving culturing anesthesia breathing systems (25 percent positive) and anesthesia ventilators (44 percent positive) for bacteria.

The second platform presentation session will take place Tuesday, October 29, 2:00 5:00 p.m. (Moscone 308). It focuses largely on educational issues in anesthesia training. Among the presentations are two regarding substance abuse among physicians training in or practicing anesthesia (see the APSF Newsletter, Spring 1991).

In addition to the formal sessions, the Exhibits, both Technical and Scientific, will feature products and topics related in various degrees to patient safety. ASA meeting attendees often find the time touring and viewing the exhibits also significantly educational regarding anesthesia patient safety.

Dr. Eichhorn, University of Mississippi, is Editor of the APSF Newsletter.
 

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Checklists: Aviation Shows the Way to Safer Anesthesia

by V. Chopra, M.B.B.S.; J.G. Bovill, M.D., Ph.D.; and J. Spierdijk, M.D., Ph.D.

Anesthesia and aviation have much in common, not least in the extensive use of modem technology to control and monitor the functioning of the respective patient or aircraft. There are many similarities between the workspace of an anesthetist in a modem operation theatre and that of the cockpit of an aircraft. Both systems are undeniably complex, having many human and technical elements interacting with each other. The ultimate aim of both anesthesia and aviation is to maintain a high standard of "customer" (patient or passenger) saw. Both tend to achieve this goal by utilizing the concept of teamwork (crew concept).

For many years, the routine and disciplined use of checklists has formed an integral part of standard operating procedures in aviation. Considerable time is spent on teaching and practicing these procedures during pilot training so that their use becomes automatic. A pilot, during routine and emergency procedures, backs up his memory with standard checklists. In contrast, an anesthetist in similar circumstances relies heavily on his memory alone.

In aviation, standard checklists am applied before all critical events such as engine start up, takeoff, descent, landing, etc. (Table 1). Items on the list are called out by one of the crew, while the other performs the specific check procedure. If one of them has doubts about an item on the checklist, reading stops until both agree that it is safe to proceed. This minimizes the possibility of misinterpreting or overlooking an item. Such a disciplined approach to the checking of equipment is essential when operating a complex piece of modem technology such as a Boeing 747, where lives of passengers and crew depend totally on the proper functioning of all its many systems.

Many of the items on the checklist will have been preset before carrying out the checklist procedure. Take off speed will have been calculated according to total aircraft weight, number of passengers and prevailing weather and set on the airspeed indicators by means of coloured pointers or 'bugs' set into the rim of the instruments. Engine settings will have been calculated and preset and the correct frequencies chosen for communication and navigation equipment. These actions are the equivalent of an anesthetist presetting tidal volume and ventilation frequency on a ventilator, adjusting alarm limits on monitoring equipment, etc. The checklist procedures serve as a double check that these preset items have been correctly carried out.

Although checklists are used in anesthesia (1,2,3), these have not been standardized, and a structured and disciplined approach to their routine use is often lacking. In the department of anesthesia in Leiden, we have been using checklists analogous to those used in aviation (Table 2). As in the cockpit, the checklist procedures are carried out by two people, usually an anesthetist and an anesthetic nurse(Note: the European anesthetic nurse has a different role than an American C.R.N.A.) One calls out the individual item on the checklist, the other is responsible for performing the check. Each has a joint responsibility for the proper carrying out of the procedure. If a fault is found, this must be corrected before proceeding with the remaining items on the checklist. The procedure covers not only the anesthesia and monitoring equipment but also the identification of drugs that have been drawn up prior to induction of anesthesia, checking of intubation materials and finally, and very importantly, the patient is checked. Though initially developed for a specific anesthesia machine, the list can be modified easily for other anesthetic apparatus.

Working through the complete checklist at the beginning of an operating session lasts about six to seven minutes. Shorter checklists are used between patients. A written record of the checklist procedures is kept on the patient's anesthesia chart. These checklist procedures have been in use for more than two years and have had a very high acceptance rate both from anesthetists and nurses.

Checklists have also been developed for specific emergencies such as cardiac arrest and malignant hyperthermia. These are used, once the emergency situation has been brought under control, as a back up for the anesthetist to ensure that important items that might have been forgotten during the crisis are not overlooked. This is analogous to the emergency procedures in aviation, e-S. a fire in one of the engines.

Evidence that the use of checklists and, in general, better awareness of the relevance of critical incidents as well as the factors associated with them can improve saw was provided by a study by Kumar et al. (4) They carried out a prospective study into two one-year periods, one year before and one year after the introduction of checklist procedures. Eighty-six incidents were reported in the fast period, the majority of which (80%) were attributed to human error. The most common mishaps involved transmission of anaesthetic gases and vapours or errors in drug administration. There was a significant decrease in the number of incidents during the second one-year period, with an overall reduction in the total number of incidents reported from 86 to 43.

In conclusion, it is our contention that safety in anesthesia will be greatly enhanced if such a standard, structured, and disciplined approach (as exemplified by the use of checklists) is made an integral part of anesthesia training and practice

Dr. Chopra, is a Staff Anesthesiologist; Dr. Bovill is Research Professor; and Dr. Spierdijk is Professor at the Department of Anaesthesiology, University Hospital, Leiden, the Netherlands.

References

1. Cundy J., Baldock G.J. (I 982) Safety check procedure to eliminate faults in anaesthetic machines. Anaesthesia 1982; 37:161-169

2. ECRI. Avoiding anesthesia mishaps through pre-use checks. Health Devices 1982; 1 1:201-203

3. Kilian J., Safety check procedure and maintenance. European journal of Anaesthesiology 1987; 4:211-213

4. Killian V., Barcellos W A., Mehta M. P., Carter J. G. An analysis of critical incidents in a teaching department for quality assurance: A survey of mishaps during anaesthesia. Anaesthesia 1988; 43:879-883.
 
 


 

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FDA Pre-use Equipment Checklist Spurred by Accidents, Studies

by Marcia J. Withiam-Wilson, R.N., M.S.N.

The Food and Drug Administration's (FDA) Center for Devices and Radiological Health has advocated the use of a pre-use checkout procedure for anesthesia gas machines (AGM) because we believe that it assures with a reasonable degree of confidence that a properly functioning device is available at the beginning of an anesthetic.

The data available to FDA through the Medical Device Problem Reporting System and the medical literature suggest that if brief checkout procedures (daily and prior to each case) were conducted by the anesthesia care provider, a significant number of AGM related patient injuries and deaths could be prevented.

In a 1982 study of 190 persons attending an anesthesia meeting, Buffington et al., found that only 3.4 percent were able to identify five faults intentionally created in a standard anesthesia machine. 7.3 percent of participants found no faults, and the average number of identified faults was 2.2 out of 5. These results suggested a need for greater emphasis: 1) on the fundamentals of anesthesia machine design, and 2) on the detection of potential hazards as part of educational programs. At the time, it was thought that the universal acceptance of one standard checkout procedure for AGM's would facilitate the education of all anesthesia professionals regarding equipment issues.

In September, 1986, the APSF Newsletter published the draft FDA issued "Anesthesia Apparatus Checkout Recommendations" (final publication 2/25/87) providing a one-page general checkout and inspection procedure designed to be performed daily and, in an abbreviated form, before each case by anesthesia professionals.

In an attempt to measure the use of the checkout recommendation, the FDA initiated a survey at medical institutions in four states, Alabama, Colorado, Iowa, and Washington in September of 1987. A total of 125 medical facilities were visited. The sample included 37 hospitals with less than 100 beds, 40 hospitals with 100-300 beds, 31 hospitals with more than 300 beds, and 17 ambulatory surgical centers. In total, 404,700 anesthesia procedures were performed at these facilities in 1987 (371,441 in the hospitals, and 33,259 at the ambulatory surgical centers).

A cross-sectional survey with face-to-face interviews was carried out in which participants were asked whether or not there was a documented AGM checkout procedure at their facility. Of the 125 facilities surveyed, 70 percent (87) responded yes. Of these, however, only 26 percent (32) reported that they used the FDA checklist for their checkout procedure.

Ninety-one (73 percent) of the facilities reported that a thorough AGM checkout was performed at the beginning of each day or shift even though some did not have a documented procedure for this. Only 74 (59 percent) reported that a partial checkout of some sort was consistently done between cases.

These results indicate that the AGM checklist issued by the FDA is not widely used. Sources of other checklists reported in the sample included the facility itself, the AGM manufacturer, and the anesthesia professional's memory. While it is encouraging that the majority of facilities surveyed (70 percent) reported using some type of documented AGM checkout procedure, less than half of them (37 percent) used the FDA version.

An internal study of AGM-related death reports in the FDA Medical Device Reporting (MDR) data base covering the period of December, 1984 through December, 1988, revealed 86 reports of deaths which had occurred either during anesthesia, or within 24 hours of anesthesia, or were associated with anesthesia management. Thirty-seven of the 86 reports were judged to be anesthesia mishaps. Twenty-seven of these 37 mishaps were judged to be user error associated with the equipment. It should be pointed out that no equipment failures during anesthesia were noted in any of the reports. A further analysis of the 27 deaths judged to be due to user error related to anesthesia equipment indicated that 19 percent (5) of these deaths may have been avoided by a proper pre-use checkout.

The results of a George Washington University Medical Center/FDA study reported by March and Crowley at the October, 1990 ASA meeting indicate that anesthesiologists using the FDA checklist detected an average of one out of four intentionally created faults in a standard anesthesia machine. Preliminary results of another study suggest that a brief training period prior to testing resulted in almost 100 percent improvement in the subjects' ability to find these faults. However, even after the training, the anesthesia professionals found about 50 percent of the faults.

FDA is in the process of expanding and improving the training materials for anesthesia machine checkout procedure. The agency is also examining and evaluating the existing checklist. It may be that the utility of certain checklist items, for instance, checking of the oxygen fail-safe system, may no longer be necessary, now that advanced monitoring systems such as oxygen analyzers and pulse oximetry have become standard in most operating rooms. (See accompanying article)

Ms. Withiam-Wilson is Nurse Consultant, Division of Technical Development, Office of Training and Assistance, Center for Devices and Radiologic Health, FDA.
 

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"Human Factors" Improve Safety; Anesthesia Applications Sought

by Lee 0. Weltner, M.D.

Human factors analysis (sometimes called "ergonomics") has improved safety and performance in many areas of human endeavor. While medicine, and anesthesiology in particular has benefited from some of this work, a stronger and more direct linkage between anesthesiology and the discipline of "human factors" is needed.

Central questions are: What is the background of human factors? What is its current status? How does human factors relate to anesthesiology?. Why is this connection important? How can we increase the involvement of human factors in anesthesiology? How can this increase safety?

Origins

Human factors had its roots in the pursuit of problems with World War 11 military systems and equipment. The formal study of "vigilance" (the watchword of anesthesia care) sprang from interest in the troubles of early radar operators with their monotonous bid critical task. More recently, the Human Factors Society was commissioned to initiate a study of the Three-Mile Island nuclear power plant accident. Similar to comparisons between anesthesia providers and jetliner pilots, analogies have been made to nuclear power operators and their work environment.

Human factors principles developed in other fields can be applied to anesthesiology. Some human factors problems translate more readily than others to similar issues in anesthesiology. The designing of safe and effective manual controls was relevant to the then-existing aircraft cockpit problem of two nearly identical, side-by-side levers: one to control the flaps; the other to retract the landing gear. The lesson learned from the confusing aircraft controls applies to the shape-coding and standardized location of some formerly confusing nitrous-oxide and oxygen control knobs of early anesthesia machines.

Errors During Anesthesia

A recent Anesthesiology Medical Intelligence Article by Weinger and England, "Ergonomic and Human Factors Affecting Anesthetic Vigilance and Monitoring Performance in the Operating Room Environment," offers many valuable insights. The authors emphasize that human failings underlie most anesthetic morbidity and mortality. They divide the anesthesiologic operating room system into three components. environment, human and equipment. Their article focuses on the first two components, touching on many vital issues such as stress, boredom, sleep deprivation, and task organization. Several constructive suggestions are offered to improve the performance and well-being of anesthesiologists and the safety of their patients. Weinger and Englund have successfully strived to apply wisdom harvested from the human factors literature.

Society Meets

The human factors discipline is continuing to grow and develop. Currently the 5,000-member Human Factors Society reflects diversity in its 17 Technical Interest Groups, including Aerospace Systems; Aging; Communications; Computer System; Consumer Products; Environmental Design; Forensics Professional; Organizational Design and Management; Personality and Individual Differences in Human Performance; Safety; and Training. Newly formed is a Special Interest Group comprised of two distinct components: Medical System and The Functionally Impaired (the latter referring to Rehabilitation Medicine).

The 34th Annual Meeting of the Human Factors Society, held October 8-12, 1990 in Orlando, featured several sessions and presentations of potential interest to anesthesiologist. Many of the topics can be readily generalized to direct relevance in anesthesiology: human performance and mental workload; displays and controls; aircraft cockpit; safety and hazard communication; interface design; expert systems. Others were specifically oriented toward medical systems.

One panel session entitled "Human Factors Engineering Standards, Guidelines, Regulations, and Practices for Medical Products and Devices" focused on the history and current status of the "Human Factors Engineering Guidelines and Preferred Practices for the Design of Medical Devices" published by the Association for the Advancement of Medical Instrumentation (AAMI). The AAMI committee revising these Guidelines met most recently in connection with the ASA Annual Meeting in Las Vegas.

Mr. Sidney Hudspith of Baxter Healthcare described in the Orlando meeting the development of an anesthesia workstation featuring the "Private Eye" a head-mounted visual display of monitor data projected into the edge of the field vision of the operator, similar to the "heads up" display used by some fighter pilots. Hudspith reported that despite favorable trials of their prototype his company has withdrawn from further development of this product.

"Glyph" Proposed

In another session, Dr. Lee Deneault of the University of Pittsburgh departments of Anesthesiology and Information Science, described some advantages of presenting multiple monitored parameters m a single integrated polygon "gyph" visual display as opposed to the typical connection of individual digital and time-varying waveform displays. Even limited familiarity with this new type of visual display in experimental trials permitted anesthesiologists to perform better than with conventional displays.

Dr. Richard Cook, of the Ohio State University's Department of Industrial Systems and Engineering, presented a fascinating paper in which he and Dr. David Woods, in collaboration with Dr. Michael Howie, of Ohio State's Department of Anesthesiology, studied the behavior of cardiac anesthesiologist in adapting to the clinical introduction of a new operating room monitoring system. Their description of what is best characters as "dummy automation" highlights the need for greater human factors expertise in the development of such systems.

Dr. Scott Potter, of Ohio State University, presented a critique of a new heated humidifier design which he related to the AAMI human engineering guidelines. He described how the misleadingly simple appearance of the design left users with inaccurate mental models of the device. Simply following the AAMI guidelines would not have avoided the design Haws: that "require professional practice, that is, the application of human engineering principles by experienced practitioners."

In these sessions, and in other discussions and publications, the human factors community has presented a compelling argument. Many consumer and professional products are flawed by the lack of sufficient human factors expertise in their design. Seemingly, the short-sighted focus of corporate top management on short-term profits has precluded the expense and timely involvement of human factors professionals. Alternatively, some design engineers have incorrectly convinced management that human factors expertise is equivalent to "common sense" which, of course, they certainly possess.

Unfortunately, we (and sometimes our patients) am among the victems of these poor corporate management decisions. There can be no doubt that poorly designed equipment detracts from the safety and efficiency of anesthesia practice. We must do what we can to solve this problem. We must demand equipment that avoids these flaws.

How can we facilitate this important interaction of human factors with anesthesiology. Several avenues come to mind, following existing pathways for the development, dissemination, and application of professional knowledge.

One path for increased interaction is for more anesthesiologist to participate as members d the Human Factors Society, or its Medical Systems ... Special Interest Group. Another route is to collaborate with human factors professionals in studies such as those described above.

The vast majority of anesthesiologists are more likely to be reading such articles than to be writing them. The increasing trend for publishing human factors oriented material in the anesthesiology literature deserves encouragement. Though it might not yet warrant formal inclusion in the medical school curriculum, human factors teaching should be definitely incorporated in all anesthesiology residency programs.

Anesthesiologists, clinical engineers, or others responsible for the evaluation and selection of equipment need to be cognizant of human factors issues. Those involved in designing, developing, manufacturing, or marketing medical systems must better utilize human factors knowledge and expertise. Human factors knowledge should be included in the earliest phases of product development.

Those with a spark of interest in this topic and a few hours to spare will enjoy reading the Design of Everyday Things, by Donald A. Norman, ($12.95, Doubleday/Currency). A good overview of human factors science is found in Selected Readings in Human Factors, Michael Venturino, ed., The Human Factors Society, Inc.

Dr. Weltner practices at the Enloe Memorial Hospital, Chico, CA and is a member of the Human Factors Society (P. 0. Box 1369; Santa Monica, CA 90406; (213) 394-1811).

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Soviet Anesthesiologist is First APSF Visiting Professor

by Elena Damir, M.D.

A Recollection of My Visit to the U.S.A., October 14 November 3, 1990:

First of all, let me offer apology for delay in writing to you. I have visited your country nearly half a year ago and have started to write a report immediately, bid could never quite finish it because of more and more thoughts and alterations. After the personal letter from Jeep Pierce in April, I have realized it is not necessary to wait until my style will reach the level of perfection and I send the report as you read it now.

As a Visiting Professor invited by APSF, I have had a chance to come from the U.S.S.R. and spend three weeks in the U.S.A. and to observe the work of several departments of anesthesiology: in Boston, San Diego, Los Angeles, Gainesville, Baltimore and New York. A great experience was the ASA Annual Meeting in Las Vegas. My itinerary was rather tight, but everything ran so precisely that I was able to follow an extremely interesting program, and, in the end, survived my stay in your country. Even my 12 takeoffs and landings were excellent and I was transported exactly according to the timetable. Ut was my second visit, the first one being the 9th World Congress in Washington.

I wish I had better literary ability to explain my many feelings concerning your medicine, surgery, anesthesiology, and life.

First, I shall try to outline some similarities and differences in our practice. I would say that your medicine is much more business-like. You spend much more money, you count the costs precisely, you earn much more and you work much more intensively. It seems that the slow and clumsy are hardly surviving in your anesthesiology or surgery, at least I have not met those during my visit. The number of surgical interventions and anesthetics in your big hospitals differs from ours by as much as 3: 1 or even 5: 1.

Our patients mostly spend in hospitals much longer times. The main reasons are: no reliable prehospital diagnostics and unreliable postoperative care at home. The percentage of outpatients in your OR schedules is much higher. Day-surgery is highly valued and recommended in your country and could be important in our country, but still is underutilized in many regions. I was very impressed by the administrative parts of the departments of anesthesiology. It is rather astonishing the number of personnel working in the offices in each department! Probably we shall need the same after introducing the Health Insurance System and changing the financial support for medicine.

Methods of anesthesia in American hospitals are more or less similar to those used in our country but the assortment of available drugs makes a great difference. At present time, we can only envy your ability to choose individual medication for every patient. Many of us have to give our patients the drugs available at the moment, which are not always among the best choices. For example: we would rather have preferred to use enflurane and isoflurane instead of halothane. We still have no experience with many widely used drugs (examples: long-acting local analgetics, a new generation of narcotics and muscle relaxants, Diprivan, and many others) and are interested to have them in our practice. Probably there are still many places in the world where either the economics or inadequacy of the pharmaceutical industry dictate the choice of anesthesia and therapy. We happened to have both.
 

Professor Elena Damir (top center), president of the equivalent of the ASA in the U.S.S.R. and the first APSF Visiting Professor, was greeted at a large reception at the ASA annual Meeting last October. Top photo, from left: Mr. Burton A. Dole, Jr., APSF Treasurer; Jeffrey B. Cooper, Ph.D., APSF Executive Committee; Dr. Damir; Ellison C. Pierce, Jr., M.D., APSF President; J.S. Gravenstein, M.D., APSF Executive Committee. Lower left: John H. Eichhorn, M.D., APSF Newsletter Editor explains a point to Dr. Damir. Lower right: G.W.N. Eggers, Jr., M.D., ASA President-Elect, discusses comparisons of U.S. and Soviet anesthesiology practice.

The great impression I have had from the anesthesiology in U.S.A. was technology and monitoring. I have seen this in every operation room of all the University and Veteran Hospitals I have had the chance to visit. Most of us in the U.S.S.R. live and work in quite different technological conditions. This might be partly the reason why many of us believe that the only possibility to diminish the risk of anesthesia is with monitoring systems and other modern technical devices. We know another point of view, explaining any better outcome of anesthetics by improved skills, methods, and techniques. Observing the work of anesthesiologists in your country, I cannot say there is great difference in professional skills or clinical thinking abilities. Statistics show the favorable result of your high technological anesthesiology: the anesthesia mortality and morbidity are noticeably lower in your country. I do believe that your system can increase patients' safety during anesthesia and operation. In the same time, it is obvious that your system is much more expensive and not every country can afford it.

Unforgettable was my first experience of participation in ASA Meeting in Las Vegas. I have spent most of my time in Refresher Course lectures and the very impressive exhibition. I could never imagine any meeting with more than 10,000 participants, and in Las Vegas there were more than 13,000 anesthesiologists! Very interesting and educational for me was to observe some special activities and committees: Educational, Board Examination, Patient Safety, Election of the President and Officers. It was a little bit astonishing to learn that the Presidentship term is so short, only one year. I wish I could learn more about the system of the ASA organization, activity, and its relations with the Societies of the different states. The position of AU-Union Societies in our country is actively discussed now and your experience could be real help in the period of Republic sovereignty and all those political changings, national problems, and permanently arising difficulties. I am most grateful to those who made possible my participation in the meeting. The hospitality of the officers and committees was tremendous.

Very interesting were discussions with residents and observing the training system. The hard work of residents could be called probably slave-like. Compared to our two-year residents, it seems unbelievable. The high professional skills of the senior residents proves the Russian saying: "hard in training easy in battle:" Very important in early training could be the simulator for diagnostics and tactics of dealing with complications and incorrect functioning of monitors. I have seen the simulator in the process of construction and trial in Gainesville.

How shall I finish my short and never completed report? I have not mentioned the names of my hosts, of all the anesthesiologists who helped to organize my stay in many places. Please believe I am deeply grateful to all of you. My address file includes about 100 new names. I remember all of you and I hope many of you will visit me in the future with your families.

Thank you all!

Professor Elena Damir is President of the All-Union Society of Anesthesia and Reanimation, U.S.S.R., and in the Fall of 1990 was the first APSF Visiting Professor.
 

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ICPAMM Meets in Poland, Promotes Safety Studies

International Committee Focuses on Eastern Europe

by Jeffrey B. Cooper, Ph.D.

The International Committee for the Prevention of Anesthesia Mortality and Morbidity (ICPAMM) met in Warsaw, Poland on September 9, 1990, to discuss methodologies and data related to adverse anesthesia outcomes. This was a continuation of earlier meetings to disseminate ideas on how such studies can best be conducted. A special theme of this meeting was promotion of similar studies in Eastern European countries, where previously there appears to have been less openness to connecting these kinds of data.

Randomized Trial of Pulse Oximetry

Dr. Jakob Trier Moeller reported on the Danish-American Randomized Trial of Pulse Oximetry The objective of the study was to test the hypothesis that routine use of pulse oximetry would reduce the rate of complications. The Planning Group estimated that ten thousand patients would be required in a control and experimental group to attain a power of 90 percent for a meaningful reduction in pulmonary and cardiovascular outcomes.

The investigative team had to address the serious question of the ethics of randomizing considering the presumed benefit of pulse oximetry. After much debate, there was unanimous consensus that this was reasonable considering that pulse oximetry was, at the outset of the study, rarely used in Denmark. The decision was approved by the ethics committee of each hospital.

The study included all elective, acute patients receiving either general or regional anesthesia expected to last at least 20 minutes. Excluded were children, cardiac surgical, neurosurgical patients, outpatients, and most patients unable to give consent. Emergency patients seems included and consent sought postoperatively.

Randomization was achieved by drawing envelopes that assigned oximetry to specific operating room after patients had already been scheduled. If a patient was reassigned to another room, the original pulse oximetry assignment was maintained for that patient.

Data on complications was collected intraoperatively and postoperatively up to the seventh hospital day. At the close of the study, 21,600 patients had been randomized, with essentially equal participation in each group. Approximately 20 percent of all operative patients meeting inclusion criteria were not randomized. The vast majority of these were due to either a failure to acquire consent or merely the anesthetist's inadvertent failure to perform the randomization. There was no difference between patients randomized or not randomized into the study regarding ASA patient status or concurrent risk factors.

Data entry was validated at three different points in the collection sequence. Dr. Trier Moeller noted that, while data collection has been completed, the analysis is preliminary. Them does not, at " point, appear to be a significant difference in overall outcomes between the two groups, although specific complications have not yet been examined individually. There also does not appear to he a difference in the rate of hypotension or hypovolemia.

During the discussion, Dr. William Runciman (Australia) and Dr. Michael Rosen (U.K.) both questioned the hypothesis and the expectation that differences in serious outcomes would be significant in such a small sample Dr. Cooper responded that the hypothesis was partly based on the unexpected finding in an earlier study. Dr. Trier Moeller also noted that psychological testing of a subset of patients was performed based on the hypothesis that pulse oximetry may prevent hypoxic events which lead to subtle changes in cerebral function.

Mortality and Morbidity Studies in the U.S.A.

Dr. Ellison C. Pierce, Jr. and Dr. Gerald Zeitlin jointly reported on several activities in the United States. Dr. Pierce first noted that there have been dramatic decreases in rates for malpractice insurance for anesthesiologists in recent years. He explained the relativity scale by which physician specialties are assigned a number from one to seven according to the severity of their exposure to financial losses from malpractice suits. Anesthesiologists started the 1980's with a relativity of five. The St. Paul Insurance Company, which represents 15 percent of all U.S. physicians, has reduced anesthesiologists to relativity of three as has the Massachusetts state insurance underwriting organization. The Harvard affiliated Hospital Insurance Group has reduced anesthesiologists to a relative rate of 2.5, which is expected to be reduced even lower soon. For Harvard-insured anesthesiologists, this represents a decrease of from $21,000 annually to the current rate of $8,000 per physician.

Dr. Pierce also reported on the recently completed pilot study of anesthesia outcomes jointly conducted by the Center for Disease Control, the American Society of Anesthesiologists, and the American Association of Nurse Anesthetists. The objective of the study was to test the feasibility of a larger surveillance system and assessment of adverse anesthesia outcomes in the U.S. Five hospitals of varying characteristics participated. Mortality and serious morbidity, including myocardial infarction, aspiration, and neurologic injury within 48 hours of operation were documented by different means in each hospital. An independent panel including two anesthesiologists and one surgeon reviewed all cases of adverse outcome and assigned anesthesia responsibility according to several different scales. The entire study included 8,000 patients of which 21 suffered some adverse outcome. Only one was assessed as being due to anesthesia alone. Five other adverse outcomes were believed to include anesthesia as one of several causative factors.

The CDC concluded as a result of this study that it was indeed feasible to successfully design and conduct a larger surveillance involving 300 hospitals in the U.S. The total cost was estimated to be $15,000,000. In February, 1990, agreement to pursue funding for this study was achieved among the participating groups. However, objections were raised by some individuals about the lack of the study's innovation, its great expense, and its failure to adequately address important methodologic questions such as patient case mix. Also, the U.S. government recently established an agency with the objectives of setting practice standards and collecting outcome data. It is now unlikely that the larger scale study will be conducted as originally planned. Efforts are underway to modify the study objectives and methods so that some national surveillance mechanism, acceptable to all parties can be established. Dr. Pierce also noted that the joint Committee on Accreditation of Hospitals Organizations (JCAHO) is currently entering the second phase of pilot studies to establish a surveillance mechanism for anesthesia quality in U.S. hospitals. It will be collecting data on eight different outcome indicators including death, MI, and re-intubation in the recovery room. These and other efforts represent the interest in the U.S. of establishing some form of quality and outcome measures in anesthesia although substantial obstacles remain in the way of doing that. Nevertheless, Dr. Pierce believes that some mechanism surely will be established.

Dr. Zeitlin then reported on some methodologic aspects of the American Society of Anesthesiologists-sponsored study on anesthesia malpractice claims (closed claim study). Dr. Zeitlin noted that he was representing Dr. Fred Cheney, Dr. Richard Ward and Dr. Robert Caplan, who constitute the committee conducting this study under the auspices of the American Society of Anesthesiologists Committee on Professional Liability. Concentrating on the issue of inter-rater reliability, Dr. Zeitlin first noted that past studies of closed claim did not assess judgments about the anesthesia in relationship to the outcome. Contrary to this, the closed claims study required that reviewers of data describe exactly how they made their judgments about who was responsible for the event. In particular, they describe for every case a possible or probable mechanism by which the injury occurred. They also judged whether the standard of care was equal to, below, or above that which would be given by a prudent anesthesiologist in the U.S. In the precursor to this study by Dr. David Davis, only the standard of care in the local community was used as a basis for judgement.

In an earlier paper arising from the closed claims study, it was shown that patients were given a payment for injury in 40 percent of cases in which the care had been judged satisfactory by the closed claims reviewers. This suggests that the American legal system results in compensation often even in cases where the physician did everything reasonable to prevent an adverse outcome.

Critical to establishing its credibility, the closed claim study carefully assessed the ability of reviewers to come to similar conclusions about the appropriateness of care, the presence of human error and the potential for prevention of the event. Using 48 cases and 42 reviewers, it was found that reviewers reach a more than reasonable degree of agreement, where agreement is defined as by at least 75 percent of reviewers of each case. Thus, it has been shown that a group of peers is an effective way to judge important issues related to adverse anesthesia outcomes after the fact using retrospectively collected data. Dr. Cooper noted the importance of conducting such validity assessments whenever judgments of culpability are made.

Australian AIMS: Update

Dr. Runciman reported on the two experiences in the AIMS study. He reminded that they consider an incident to be any event during anesthesia that could have caused harm to the patient. There are now 70 hospitals and 5,500 anesthesiologists participating, representing an estimated one half million anesthetics annually. Over 1,000 reports have now been reviewed and analysis of some issue conducted. For instance, he noted that approximately 25 percent of incidents occurred during induction and 50 percent during the maintenance phase of anesthesia. Over 50 percent of incidents in this study involve some interaction with equipment. They have focused in particular on the involvement of monitors in detection of incidents. Pulse oximetry, capnometry, and ECG monitors each played a role in approximately 80 of the incidents. Of all incidents, 156 involved some major physiologic change, 42 some morbidity and 21 ended in death.

Of particular interest has been the fact that endobronchial intubations are the most frequent cause of desaturation events intraoperatively. As an example of how AIMS should be used, Dr. Runciman expects that some data should change the algorithm by which people react to desaturation. Surprisingly, there are still numerous incidents of disconnection and hypoxic mixtures occurring which are detected by oximetry He noted that many anecdotes of dose calls are still never reported in the literature.

There are still many breathing circuit incidents occurring among which tracheal tube problems are the most frequent (107 in this set of data). Confirming earlier suggestions, disconnections in particular are frequently not detected by pressure based alarms.

There has been a substantive increase in the use of monitoring since the start of the Australian study in early 1988. Pulse oximeter use has increased from approximately two-thirds of all cases to 98 percent. Capnometry has increased from approximately 50 to 70 percent of all cases. Dr. Runciman noted that, in 93 percent of all incidents, detectable incidents during induction were detected by either pulse oximetry or capnography. Of the entire data-set, approximately 50 percent of incidents were detected by some form of monitoring.

These data have be-en used to great effect in local and regional quality assurance meetings and as motivation for at least 15 modifications of equipment. Study organizers are seeing the loop being closed as evidenced by feedback from participants who note how AIMS has affected their practice habits.

In response to a question, Dr. Runciman said that there have been exceptionally few incidents reported that were caused by monitors.

Update on Confidential Inquiry on Intraoperative Deaths

Dr. John Lunn reported that CEPOD study continues to promote the joining of forces between anesthesiologists and surgeons seeking causes and recommendations for prevention of deaths. Each year, the focus will be on a different sample group. In 1989, deaths of children less than ten years of age were examined. Each surgeon also provided information of the management of "index" cases which served as controls for the deaths. For the entire national sample, there were 2 1,000 deaths of which 417 were less than ten years of age. Unfortunately, no denominator data is yet available since that is obtained from the government and will not be completed until early 1991. Dr. Lunn report that there continues to be exceptional cooperation on the part of both surgeons and anesthetists in providing information, although the return rate on information about deaths was 70 percent from surgeons and 62 percent from anesthetists.

The most important finding of the analysis of deaths in this year's sample was a disproportionate number of cases involving physicians with only "occasional" experience with pediatric patients. For children less than six months of age, physicians with less than 20 cases per year experience were involved in 28 percent of the deaths.

Data from the study also points to increasing utilization of monitors during anesthesia. In the 1989 sample, fully 88 percent of all intraoperative patients, were monitored by an ECG and 65 percent with pulse oximetry. The collection of data will likely lead to standards, for instance requiring that patients be seen preoperatively and that some forms of monitoring be required rather than recommended.

In 1990, the focus of CEPOD was on a random sample of deaths in England, North Wales and Ireland, comparing them with index cases. In response to a question from the audience about cost of the study, Dr. Lunn noted that in the first two years, approximately 1.2 million P was allocated by the national government. Unfortunately, the status of funds for future years is not guaranteed.

Continuation of the "Manitoba" Study

Building on her reports at the past two meetings, Dr. Marsha Cohen described the continuing investigations of anesthesia outcomes in Manitoba. Her most recent efforts were detected toward asking the question "Can patient outcomes be compared between hospitals?" A related question was "Can morbidity from anesthesia be measured in some reproducible way to be useful for quality assurance?" Dr. Cohen briefly summarized the anesthesia follow-up program at the Health Sciences Center in Winnipeg between 1975 to 1983. Complications within 72 hours of anesthesia were reported via data collected from charts and patient interviews, including information on 40 major and minor anesthesia outcomes. This study was limited in that it only involved one hospital and spanned a time during which occurred dramatic changes in anesthetic drugs, monitors, techniques, patients and surgical procedures. Also, many definitions of outcome were vague and information was not differentiated to ascertain its source from either the patient interviews or chart reviews.

The latest study was begun in 1987 and involves four hospital departments of anesthesia. It employs an occurrence screening technique in which information is gathered on every patient directly from the anesthesia record, from chart reviews by nurses and from patient interviews. Data has been collected from over 35,000 anesthetics. The disadvantage of this technique is that it is more expensive than sampling only some patients. The advantage is that there are fewer problems with missing data, major and minor events are included and training of staff to complete forms is easier. Spin-offs include the availability of information on resource utilization and practice profiles. Also, information for resident education and performance appraisal is provided. The approach provides good public relations for the department of anesthesia via patient contact after each procedure Also, this is a good approach to getting a "first look" before undertaking the even more expensive randomized control trial.

In the analysis of these data, inpatients and outpatients are being examined separately. There is a case mix adjustment for age (three groups), physical status score (ASA PS I to 2 and ASA PS 3 to 5), sex, length of anesthesia procedure and emergency versus elective status of procedure Hospitals are compared via a multiple logistic regression using hospital A as the reference.

The preliminary results suggest that there are substantial differences found for virtually all 60 outcomes across the four hospitals. Dr. Cohn addressed the question of possible causes of these differences. There was some suggestion that anesthetists in one hospital were less compliant in completing data. But, no one hospital was consistently different for all complications. There does not seem to be differences in institutional case-mix. Differences in institutions, e.g., recovery room size and criteria for use, nursing/patient ratio, monitoring equipment availability and differences in physician practice patterns, e.g., anesthetic techniques and drugs for the same surgical procedure are possible explanatory factors for the differences. These are being examined in the analysis.

There were barriers to conducting this research. Anesthetists are not particularly good at completing forms. Despite training, there were problems in interpreting definitions of the variables and coding complications. There were the inevitable unexpected problems. The four hospitals could not agree upon the exact same anesthesia record although they were quite similar. A threatened nursing strike reduced data collection from what was expected.

Despite extensive preparation and attention to detail, Dr. Cohen noted that it is difficult to compare "soft" anesthesia outcomes across institutions. Still, the variations they have identified in anesthesia care are not unexpected considering that similar variations are found in medical and surgical care

A question was asked about the findings of differences in non-life-threatening outcomes, particularly patient satisfaction. Dr. Cohen reported that most patients were satisfied with their care as measured on a one to five scale. There were some interesting findings such as that patients with headaches were less likely to be satisfied and those called at home were more likely to be satisfied. Having trained nurses who asked the same questions of all the patients added to the reliability of the measurements.

Anesthesia Accidents, Near Accidents, Faults and Complications in One Hospital in the Netherlands

Dr. Vimal Chopra reported on the findings of a committee organized at the University of Leiden. AU medical and nursing staff are required to report all accidents, faults and near accidents and complications to the committee. There are specific definitions for each event. The results of ten years of data collection were described. There were 148 reports to the committee for the over 1 13,000 anesthetics during this period. The most common events reported were dental injuries, cardiac arrests, drug related problems, e.g., drug swap, overdose, and nerve injury. fourteen events met the definition of "complication." In examining causal factors more carefully, the familiar factor of "failure to check" was frequently noted. The overall rate of fatalities related to anesthesia was one in 16,000. Dr. Chopra noted the difficulty in drawing conclusions from such retrospective analysis and noted their expectation of more useful information from their ongoing prospective study.

Accident Investigation

Dr. Cooper described how accident investigation techniques can be used as still another form of outcome study. In particular, this method is powerful for locating new mechanisms of injury and for altering behavior locally. An example of accident investigation techniques had been published in an article describing a bum from a neuromuscular stimulator. For accident investigation to he most effective, preparations must be made to collect information immediately following a critical event.

Dr. Jan Davies spoke of her work with Dr. Rob Lee, Director of the Bureau of Air Safety Investigation in Canada. They have developed a system for examining anesthetic accidents using investigative techniques developed for air craft accident investigations. They have investigated 12 accidents to date.

Study of Maternal Deaths in Poland

Dr. Teresa Tribus described a study of maternal deaths in Poland. Their approach was retrospective, using a modification of the data collection instrument described by Lunn and Mushin. Using information gathered solely from medical and anesthesia records, the investigators determined if anesthesia was totally, partially, or not all responsible for the death. Contributory factors were also identified including poor judgment, lack of vigilance, incomplete knowledge and experience, etc.

Records from the southeast region of Poland during the period 1976 to 1986 were examined. This represents approximately 15 percent of the Polish population and 1, I 00,000 deliveries. A total of 363 deaths were found of which 17 were determined to be primarily caused by anesthesia and 3 7 of which anesthesia was at least partially contributory. Of the deaths for which anesthesia was primarily responsible, the most frequent cause was aspiration and inability to intubate. For deaths to which anesthesia was partially contributory, inadequate treatment of hypovolemia and wrong choice of anesthetic technique was identified as the predominant causes.

Dr. Tribus noted the recognized difficulty in identifying cause of death from retrospective records. Still, the investigators believed that 76 percent of deaths to be attributable to anesthesia and 54 percent of deaths partly attributable to anesthesia should have been avoided. Overall, the unavailability of adequately trained anesthesiologists was believed to be the most important deficiency in the system.

New South Wales (Australia) Study Committee Report

Dr. John Warden briefly noted the continuing work of the New South Wales (Australia) Committee on Anesthetic Deaths. Since 1983, the Committee has examined 141 anesthesia related deaths during which time there were approximately 500,000 anesthetics per year for a rate of 1125,000 procedures. This includes deaths in which the Committee attributed solely to anesthesia (class 1), to which anesthesia alone partly attributed (class 2), and deaths for which anesthesia and surgery contributed (class 3). Approximately 50 deaths were in the Class I category for a rate of approximately 1/80,000 procedures.

Dr. John Lunn commented that such estimates should he interpreted with caution considering that the denominator is not carefully documented.

Study of Anesthetic Cardiac Arrests in West Berlin

Dr. Jurgen Link reported on data that he has been collecting in his hospital in West Berlin since 1973. Information has been documented on all patients undergoing anesthesia. He has recently focused on the incidence of cardiac arrest, comparing the incidence and contributory factors for the periods 1973-1980 and 19W 1 989. The rates of cardiac arrest for the two periods were respectively 1:2079 and 1:2439 procedures. Not unexpectedly, the rate is much higher for the very young, the very old and patients with pre-existing diseases. He has identified respiratory insufficiency, error during emergence, faulty apparatus monitoring, insufficient fluid replacement, inadequate treatment of hemorrhage, and insufficient handling of complications as factors exhibiting notable changes between the two time periods. There were reductions in all of the above with the exception of the last category.

Discussion Groups

How should mortality and morbidity and quality assurance be studied with minimal resources?

The group discussion began with a report from Dr. Gribomont about the system of event reporting and mortality and morbidity conferences as practiced in his hospital in Brussels. That system is believed to be a very inexpensive and effective method for study and quality assurance The group agreed that the term "incident" was preferable to I 'critical incident." The term "critical" could imply "criticism" and therefore, is less desirable. Many such systems have been devised to facilitate collection and analysis of incidents. The prime virtue of such systems was that individual groups could use the information to improve their own performance. It was noted that measuring quality means identifying good things as well as bad. Working to identify such events and promote them is believed to be a good objective.

Patient Safety in the 1990's

Dr. Davies identified four major areas covered by the group. 1.) Education the need for uniformity in training including the problem that will be faced in Europe with the consolidation of multiple standards. There was controversy about the impact of continuing education on patient safety. The use of simulators is seen as a potential value with the caveat that recognition of problems will still be problematic. 2.) The need for feedback to anaesthetists and & public about what are minimal standards and about anesthetic outcomes. 3.) Equipment: greater efforts in developing uniformity among manufacturers. The use of automated record keeping is likely to increase and should be tied to quality assurance. Monitoring of depth of anesthesia and EEG monitoring is expected to increase as well. 4.) Well-being of the anaesthetist great differences exist between countries regarding the work load of anaesthetists. In some cases, vacations or any time off is rarely granted while in other countries it has become a common practice to allow the anaesthetist to be relieved from responsibilities the day after a night on call. Greater emphasis is expected to be placed on the impaired anaesthetists, e.g., abuse of alcohol or narcotics.

What strategies for reducing risk are most effective given limited resources?

Despite the fact that this group consisted of only six individuals, there was quite a spread of opinion on this question. Dr. Marx from Uruguay reported on an excess of anesthesiologists to the point of often having two anesthesiologists in one operating theatre. The opposite situation exists in countries such as Poland and Romania where there are very few trained anesthesiologists. Yet, there was agreement that the most pressing issue was improved training for anesthesiologists, which would generally be cheaper than purchasing technology because of the problem of foreign currency exchanw. Dr. Jastrzebski personally emphasized the need for more training on regional techniques. The monitoring standard felt to be most important was the presence of an anesthetist at all times. The technology believed to be of most importance is pulse oximetry. Legal protection will be needed to permit the collection of outcome data related to errors given the concerns of people about retribution. Dr. Cooper noted the broad contrast between the group discussions. In one group the emphasis was on the need for training individuals in the most rudimentary concepts of anesthesia while in another group discussion focused on technologies for monitoring depth of anesthesia. Perhaps, developing countries need purchase only the most highly leveraged monitor and put other resources toward basic education. To this end, the more developed countries could provide such educational materials and methods, e.g., video cassettes and video cassette players. The developing countries now have the unique opportunity of studying the impact of these various safety efforts as they are introduced and have an effect.

The next meeting of ICPAMM is planned for June 1992 in the Hague, Netherlands, coincident with the next World Congress of Anaesthesiology. Attendance is by invitation, but suggestions for presentations from new countries and investigators are welcome.

Dr. Cooper, Massachusetts General Hospital, is a member of the APSF Executive Committee and co-founder and organizer of ICPAMM.
 

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Letter to the Editor

Awake Capnograph Improves

To the Editor:

I would like to submit the following letter in reference to two specific articles in the APSF Newsletter, Spring, 199 1. "ASA Standards Amended," by John H. Eichhorn, M.D. and "Capnography Se-en Advantage to Awake Patients," by Dean L. Melnyk, M.D., Ph. D. and Shep Cohen, M.D.

Capnographic monitoring for monitored anesthesia care (MAC)/intravenous sedation is rapidly becoming a reality with the development of several sampling devices designed specifically for the purpose of end-tidal C02 monitoring in the awake patient. However, all currently available products are not capable of optimal continuous end-tidal gas sampling in this situation. All of these capnographic sampling devices lack the capability to appropriately sample oral breathing as well as nasal breathing.

During MAC procedures concurrent monitoring of end-tidal C02 from both the mouth and nose revealed that approximately 40% of the patients alternate between oral, nasal and simultaneous oral/nasal modes of breathing (unpublished data). A sampling device that monitors nasal or oral breathing only, will frequently underestimate the true end-tidal C02 when a majority of the breathing is taking place at the non-sampled airway passage. This can lead to the misinterpretation of ventilatory adequacy when in fact, hypoventilation exists. All existing capnographic devices for sedation cases are only capable of monitoring either the nose or the nose and mouth simultaneously. To date, there is no device available which is capable of discriminate sampling of all possible modes.

A new capnographic monitoring device does provide for this capability in the sedated patient. It will also allow for concurrent 02 administration if desired and is no more invasive than an oxygen nasal cannula. This product should be available by the Fall of 199 1. It should provide more accurate end-tidal C02 monitoring during sedation and a safer anesthetic for the patient.

Steven J. Derrick, C.R.N.A. West Mifflin, PA

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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, 199 1.

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. Eichhorn, 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. Eichhorn, M.D.

Editor, APSF Newsletter

Department of Anesthesiology

University of Mississippi Medical Center

2500 North State Street

Jackson, MS 39216-4505

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