ANESTHESIA PATIENT SAFETY FOUNDATION
NEWSLETTER

Volume 4, No 2, pp 13-24 June 1989
Table of Contents

New Jersey Enacts Anesthesia Standards
Old Anesthesia Equipment Target of Study, Panel; ASA Policy Recommended
Special Article: A Safety Tutorial?
Letter to the Editor: Retirees as 'Assistants'.?
Editorial: Teaching Safety While in Touch with the Patient
Letter to the Editor: Is Extra Person Free in O.R. a Standard of Care?
URI and Perioperative Desaturation in Children
Safety and the Study of Anesthesia Incidents; Where Are We Now An Australian Perspective
Dr. David Lees, APSF Director, Named to Prestigious FDA Post
The Society for Technology in Anesthesia
FDA Study Organized to Validate Pre-Operative Checkout Recommendations
Letters to the Editor: Falsely Elevated Oximeter Reading Dangerous on One Lung
Medical Decisions Asked of PACU Nurses
Notes:




New Jersey Enacts Anesthesia Standards

by Ervin Moss, M.D.

The publication on February 21, 1989 of Anesthesia Standards as New Jersey state regulations was the culmination of efforts on the part of the New Jersey State Society of Anesthesiologists that started in December, 1984.

Data showing anesthesia machines dating back to the early 1950's in use in New Jersey and clinician's frustration by inspections from the New Jersey Department of Health that focused on trivia precipitated the original ideas. The proposals targeted mandatory replacement of antiquated machines and inspections by the Department of Health including the enforcement of meaningful standards concerning patient monitoring anesthesia machines and their servicing, documentation of daily inspections, and who can administer an anesthetic in New Jersey.

Insurance First Focus

In early 1985, the Risk Management Committee of the Medical Society of New Jersey, representatives of the New Jersey Hospital Association, and representatives of the two major insurers of anesthesiologists in New Jersey met jointly. The initial intention was to put into the malpractice insurance policy language the standards the New Jersey State Society of Anesthesiologists had formulated, with enforcement penalties. The two insurers were reluctant to include standards in policy language and felt that New Jersey's insurance laws would not permit such standards. The New Jersey Hospital Association remained s4ent and noncommittal.

The N.J.S.S.A. next approached the Commissioner of Health, who responded positively but there were administrative delays. Suggestions of trying to interest newspapers in the article, "State Fails to Act on Anesthesia Safety Standards" brought three representative from the State Department of Health to see Dr. Moss (chairman of the N.I.S.S.A.'s Committee on Standards) to be educated on the dangers of outdated machines and the value of the new technology available, such as capnography and oximetry.

In 1985, the new Commissioner of Health recognized the value of the intent of the N.I.S.S.A. and assigned staff to work with the N.I.S.S.A. to develop standards in anesthesia. This paralleled the licensure Reform project of 1988, which was involved in the general development of new standards in 32 hospital departments including anesthesia. A series of anesthetic mishaps in a New Jersey hospital resulted in negative publicity for the hospital and its anesthesia department. The state government was put in the embarrassing position of admitting its lack of knowledge as to anesthesia mortality and morbidity within the state. As a result, the central reporting mechanism in the standard was demanded by the state and that point was accepted by the N.I.S.S.A. against the protests of the New Jersey Hospital Association and many anesthesiologists.

Frequent Meetings

A committee of the N.I.S.S.A. and representatives of New Jersey C.R.N.A:s invited by the state as anesthesia providers met with the Department of Health frequently over a two-year period. Interestingly, the standard that all chiefs of anesthesia departments be board certified in anesthesiology was not on the N.J.S.S.A:s agenda, but put into the regulation by state staff.

There was no lobbying of state senators or assemblymen. The New Jersey Hospital Association attempted to delay the anesthesia standard by protesting its removal from the Licensure Reform Project and its priority status of enactment separately and earlier than the U regulation. The Association also protested the cost of equipping the O.R ''s with new machines and monitors. However, at the final vote of the Board of the New Jersey Health Department (HCAB) there was unanimous approval of the regulation. The Hospital Association remained silent and voted for the regulation.

The Board (HCAB) questioned the failure to address standards for five-standing same-day-surgery units, women's clinic facilities, and recovery rooms. They also suggested the need for anesthesia standards in doctor's offices (e.g. of plastic surgeons and ophthalmologists) in which anesthesia is administered. All of these issues are now being addressed by N.I.S.S.A. and the Department of Health. The issues of endoscopists and I.V. sedation is addressed in the requirement for monitoring including oximetry and the credentialing of those who administer I.V. sedation. The N.I.S.S.A. did not suggest anesthesia personnel in attendance during endoscopy, knowing that the protests by the endoscopists would delay the regulation.

New information received as this article was going to press indicates that there will be new regulations requiring pulse oximetry in recovery rooms and making all existing standards apply equally to free-standing outpatient facilities.

To the ASA motto, "Vigilance' can be added the word "Perservenance". In order to get the regulation passed, it was necessary to deal with two administrations of the State Department of Health. Further, the concept was advanced without active support by some of those most likely to benefit, namely the insurers of New Jersey anesthesiologists and the New Jersey Hospital Association.

Special recognition should be given to Mr. Ned Weisfeld, of the Department of Health, who was able to assimilate all the relevant information and who refused to bend under the pressures of those interests that wanted the regulation weakened or even tabled.

Trained Inspectors

The N.I.S.S.A. has trained the New Jersey Department of Health inspectors and plans to provide volunteer anesthesiologists to assist in the inspection process. Hopefully, as in Massachusetts, New Jersey wig see a decrease in mortality and morbidity and eventually, a decrease in anesthesia premiums for its anesthesiologists. To date, the two major New Jersey insurers, contrary to Massachusetts insurers, have taken a wait and see position on premium reduction.

This summary of the history of the regulation omits the mountains of correspondence by interested parties such as the Hospital Association, the N.I.S.S.A. and the Directors of all the anesthesia departments in New Jersey who were required to answer and in-depth survey developed by the state giving opinions on the proposed standards. Cooperation was unually good (especially compared with other specialties and this helped us by showing the state the unusual support for the regulation by anesthesiologists).

A complete bibliography was given to the New Jersey Department of Health. Included were the Massachusetts experience with the adoption of the Harvard Standards and the American Society of Anesthesiologists' standards passed in 1986. Papers on capnography and oximetry were sent to the Director of the License Reform Project. The Witcher analysis from Stanford in the Journal of Clinical Monitoring with its detailed suggestion of cost savings to the hospitals having standards in place was submitted, as well as publications on how to finance the required improvements.

At the early meetings with the Department of Health, the original objectives of the N.I.S.S.A. to establish machine standards and monitoring standards were expanded by the state to include every facet of anesthesia care. At one point, the mandating of mass spectometry and computer generated anesthetic records were put on the agenda by the state. The N.I.S.S.A. explained that the cost to hospitals might well defeat the regulation on these points and the computerized anesthesia record was not only expensive but a young technology that also had raised many legal issues. The latter was left to regulations to be passed in the 1990's. Thus, through discussion and the obvious on-the-job education of state staffers, formulation of the standards was a process of give and take

Expanded Scope

The anesthesia care standards are under hospital licensing standards (N.I.A.C. 8.43B-18). The Department of Health, as discussed, broadened our original intent and included statements that required written policies to be reviewed annually and to at least include:

1. (P.A.C.U. Standards) The P.A.C.U. standards are to be written as a separate part of a licensure reformed project and are currently being discussed.

2. "Monitoring of patients in any special procedure rooms where patients receive anesthesia:' These monitoring standards include endoscopy rooms. After passage of the regulations, many anesthesia chairmen protested their unwanted and unrewarded involvement in the endoscopy suites. However, the N.J.S.S.A. felt that through this regulation the anesthesiologist could now have legitimate input into endoscopy suite practices by mandating standards of monitoring, credentialing, and record-keeping.

The N.J.S.S.A. since 1977 has attempted to alert malpractice carriers of the dangers of Valium and in later years, Versed. Dr. Moss, after the Versed deaths were reported in the press, was successful in having both New Jersey malpractice carriers publish warnings concerning Versed. Now through regulation, in the interest of patient safety, the expertise and knowledge of the anesthesiologist must be accepted by the endoscopist. It is understood that there may be a medical-legal risk in having standards to which anesthesiologists contributed but have little power to enforce. However, through Q.A. review of complications in endoscopy suites, Q.A. evaluation of record-keeping, and credentialing, hospital Executive Boards and eventually Boards of Trustees would be led to the obvious decision that monitoring equipment and record-keeping do not replace the missing anesthesiologist, C.R.N.A., or trained observer that has been (in the vast majority of cases) kept out of the endoscopy rooms.

Reporting Morbidity and Mortality

Notification of the New Jersey Department of Health within 24 hours and written confirmation within 30 days is required for all deaths and unexpected, severe intraoperative or postoperative untoward events or outcomes related to anesthesia. The written report shall include a summary of the incident and the patient's ASA physical status. AU reports are guaranteed confidential. The reporting process will be evaluated 13 months after implementation.

The reporting mechanism is one of the demands of the Department of Health. A recent series of anesthesia mishaps in a New Jersey hospital received wide publicity, caught the state unaware of the problem, and therefore led to this part of the regulation as a method to prevent future embarrassment to the state. Although protested by many anesthesiologists and hospitals, it is not unreasonable that the Department of Health he involved in a Q.A. study that would give them data on mortality and morbidity and thus the trends of anesthesia mishaps.

Anesthesia Staff Qualifications for Administering Anesthesia

The regulation reads: "There shall be a Physician Director of Anesthesia Service who is a diplomats of either the American Board of Anesthesiology or the American Osteopathic Board of Anesthesiology or who was made a Fellow of the American College of Anesthesiology before 1972."

Only two physicians in New Jersey will retain their Chairmanship under the 1972 Fellow of the American College of Anesthesiology clause.

Also, anesthetic agents including IV conscious sedation shall be administered in operating suites, obstetrical suites, endoscopy room, and any other anesthetizing location only in accordance with medical staff policies and procedures that specify who may administer anesthesia and under what conditions. The regulation defines IV conscious sedation: "it shall consist of the proper administration of drugs to obtund or dull or reduce the intensity of pain and awareness without loss of defensive reflexes."

This section also defines who may administer anesthetic agents other than local or IV sedation. Administration is limited to:

1. Physician

2. A C.R.N.A. with current certification by A.A.N.A.

3. A registered nurse anesthetist who is a qualified candidate for certification provided that no national examination for such certification has been administered since the nurse became a qualified candidate for certification. The C.R.N.A. therefore must pass the first exam given and cannot practice as a C.R.N.A. if the exam is failed.

4. For clinical cases only, a dentist who has successfully completed a nationally approved program of anesthesia training.

5. A dental resident participating in a nationally approved graduate medical education training program in anesthesiology.

The regulation requires an anesthesiologist, anesthesia resident, or C.R.N.A. to be continuously present in the O.R. to monitor the patient and provide anesthesia care whenever a patient is receiving any anesthesia.

Important, too, was the requirement for the administrator of a local block or IV sedation to be continuously present in the O.R. or other anesthetizing location to monitor the patient. Except for local blocks and minor procedures performed in special procedure rooms, anesthesia shag not be administered by the individual who is performing the surgical procedure

The endoscopist in a special procedure room is permitted to administer IV sedation. Dr. Moss requested that the word "minor" before procedure be admitted, since an endoscopy is not always a minor procedure However, the rule does prevent an obstetrician, for example, from performing his own spinal and then operating as has occurred in New Jersey with tragic results.

Availability

"An anesthesiologist shall be on-site or on-call and available to reach the hospital within 30 minutes under normal transportation conditions at all times" The New Jersey Hospital Association wanted "normal transportation conditions" omitted thus requiring 24 hour in-house anesthesia coverage.

Many of our smaller hospitals in New Jersey do not have an O.B. department or emergency volume that warrants a 24 hour in-house anesthesiologist. It was successfully argued that the ASA and the A.C.O.G. joint statement permitted a 30 minute response time

Anesthesia Supplies and Equipment Safety Systems

This section requires the replacement or, if possible, the updating of all anesthesia machines in the state that do not meet the standards. Although criticized as being too simplistic, the various requirements mean that newly ordered machines must be built with technology now available. Included are:

1. An oxygen failure protection device (or "fail-safe" system).

2. A vaporizer exclusion (interlock) system.

3. No vaporizer shall be placed in the circuit downstream of the oxygen flush valve.

4. AU anesthesia vaporizers shall be pressure compensated.

5. Accurate flow meters and controllers must be on the machine.

6. Alarms for high and low circuit pressure must be on the machines.

7. Protocols to assure that when technically feasible, surgery does not proceed when there are disabled alarms, depleted batteries, and inactive sensors, improperly positioned breathing circuit sensors, or other insufficiencies.

Hospitals must have the mandated equipment in place within six months or show proof of ordering it. The Department of Health required a six month deadline while the N.I.S.S.A. recommended that one to two years was a more reasonable period of time, especially for the replacement of anesthesia machines. The Department of Health also requires availability of a backup system in case a capnograph or oximeter becomes nonfunctional. The State will compensate the hospital for the purchase of an additional capnograph and oximeter to be available for replacement. In the case of a central mass spectrometer, the Department of Health will reimburse hospitals for updating the in-room monitors to be capable of analyzing end tidal C02 when the mass spectrometer is down. The N.I.S.S.A. originally used the words "when technically feasible" intending that, in the case of a nonfunctioning monitor, the schedule could continue while the unit was repaired. In the Massachusetts regulations, 72 hours is permitted for repair. In New Jersey, each hospital must have a backup unit for oximetry and -capnography

Anesthesia Supplies and Equipment

Maintenance and Inspection This requires records (including machine identification, name of the service person, work performed, and date of work) be maintained for all service and maintenance of all machines, ventilators, and vaporizers. Credentials of each servicing person shall be approved by the machine manufacturer or determined by the physician director of the department of anesthesia to be equivalent to the credentials of the manufacturer's service person.

Previously, some hospitals used in-house techni6ans or uncredentialed service companies to service anesthesia machines. Because of product liability the manufacturers have rules on who can service their machines and to whom they will sell their parts. The result is that many small companies who have been selling anesthesia service contracts and have been using uncredentialed repair personnel will no longer be able to do so. The chiefs of all New Jersey hospitals have received a statement of policy from both Ohmeda and Drager. The chiefs of the departments are responsible if they certify any individual who does not meet the criteria as spelled out by the manufacturers.

The regulation re-quires inspection of all equipment at the beginning of each day, with documentation. A check list developed by the manufacturer, the FDA, or by the hospital's anesthesia service and approved by the hospital's director of anesthesia, must be used.

All anesthesia equipment shall be inspected before each use and a record included on the patient's anesthesia record. The record may consist of a single phrase or check mark in a box on the form.

Monitoring

The monitoring required in New Jersey includes:

1 .Oxygen analyzer

2. Respirometer (volumeter)

3. Body temperature monitoring

4. Pulse oximetry

5. Capnography

6. EKG monitoring

7. Blood pressure monitoring

8. Pulse rate monitoring

9. Respiratory rate

In the case of blood pressure pulse and respiratory rate, they should be noted at minimum every five minutes for all patients receiving anesthesia in any anesthetizing location including the endoscopy room.

10. The capacity for invasive monitoring of arterial pressure shall exist within the operating room suite

11. A precordial stethoscope or esophageal stethoscope shall be used. If necessary, the stethoscope may be positioned on the posterior chest wall or tracheal area.

12. A peripheral nerve stimulator shall be available within the O.R. suite and in the P.A.C.U.

This section (along with the anesthetic machine standards) was the principal objective of the N.I.S.S.A. That Massachusetts has experienced no hypoxic deaths since early 1988 confirms the benefits of mandating oximetry and capnography. The temperature monitoring was originally left to the availability of monitors as in the ASA standards, but was changed to be mandatory after questioning of the ASA standard by the N.I.S.S.A. Committee As a result of discussion with Dr. Henry Rosenberg of the Malignant Hyperthermia Foundation, the state felt that this simple and inexpensive form of monitoring should be included and the Committee of the N.I.S.S.A. agreed. Availability of the capacity to monitor arterial pressure in the O.R. would permit a single portable unit to be available in the smallest of hospitals while the relatively inexpensive peripheral nerve stimulators was an obvious asset in both the O.R. and in the P.A.C.U. EKG monitoring is meant as a requirement for all anesthetics, i.e. general, regional and I.V. conscious sedation.

Other Areas

Also covered by the regulation are the areas of anesthesia patient services, staffing, staff education and training, and quality assurance. This latter section includes the mandatory reporting requirements for all anesthesia tragedies as discussed previously. No objection was raised by the N.I.S.S.A., which recognized that this would be the states quality assurance data base.

Current Status

Of the first 31 hospitals surveyed by Ohmeda, only five would meet the standards. Obsolete anesthesia machines are more common than suspected. Entire O.R. suites are equipped with machines capable of delivering pure nitrous oxide, jerry-rigged with vaporizers outside the circle system, still having copper kettles in use, and vaporizers without interlock systems. Some hospital administrators are delaying the ordering of new equipment in the hope that the state will reimburse for new machines. At present, the state will reimburse for capnography, oximetry and for backup monitors. Reliable sources confirm that some hospitals will refuse to obey or attempt to delay the regulation and Dr. Moss has begun to question the state as to its plans for enforcement. The N.I.S.S.A. feels that failure to comply should not only result in a monetary fine but also closing of operating rooms until standards are met. As a last drastic 4peaswr-, newspapers could be given a press release by the N.I.S.S.A. on the standards listing those hospitals that have not complied after six months. If New York City restaurants fading Health Department inspections are listed in the newspaper each week, why not the same for hospitals?

The other pressure brought by a few hospitals is to instruct the anesthesiologists to purchase the machines and monitors themselves. This is completely unacceptable to the N.I.S.S.A. because surgeons do not purchase their instruments, ophthalmologist their microscopes, or radiologists their CT scanners. Although we hope that it will not be necessary, the N.J.S.S.A. will give legal support to any department that is put under such pressure.

Dr. Moss is a member of the East Jersey Anesthesia Group, Elizabeth, NJ and Chairman of the N.J.S.S.A. Ad Hoc Committee on Anesthesia Monitoring and Machine Standards. Also, Dr. Moss is the 1989 recipient of the prestigious Edward J. III Award from the Academy of Medicine of New Jersey, an annual award given for dedication and extraordinary service to the profession and to the citizens of New Jersey.

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Old Anesthesia Equipment Target of Study, Panel; ASA Policy Recommended

by David E. Lees, M.D.

Concern over aging and possibly "obsolete" anesthesia equipment, particularly gas delivery machines, has been growing in the anesthesia community and has prompted discussion, study, and action. Parallels to the aviation industry's questions about aging aircraft are clear.

The aviation metaphor has been aptly applied to describe the practice of modem anesthesiology. Induction and emergence are likened to takeoff and landing. On occasion during a long and uneventful anesthetic, a colleague may casually remark that the patient is on "autopilot" 'An aviation aphorism holds that "There are old pilots, and there are bold pilots, but there are no old, bold pilots".

So too in anesthesia is it hoped that time, experience and training will temper hasty judgement. The anesthesia worksite is often compared to an airplane cockpit. Anesthesiologists seek ergonomically designed workstations with "heads up" displays and intelligent and "harmonized" alarm system in the belief that improved instrumentation will aid clinicians through a "stormy" case.

The majority of accidents in both professions have been attributed to "pilot error". Mechanical faults have been far less frequent, but recently safety issues have become associated with aged equipment. Within the last year, there have been three aviation accidents with serious injury or loss of fife wherein the age of the aircraft was implicated as a possible cause of structural failure One of these airplanes was 19 years old and had logged over 90,000 takeoff-and-landing cycles; this may have directly contributed to the structural failure. With proper maintenance, however, many aerospace engineers indicate an airplane can fly forever. They acknowledge that the costs of maintenance and safety enhancements will increase each year, but claim the age of an aircraft itself is irrelevant to a discussion of safety. They also caution against unbridled faith in leading edge technology and point to the recent crash of a sophisticated "fly-by-wire' European commercial airliner.

Panel Held

In 1988, the ASA Committee on Equipment and Standards undertook the task of examining the issue of aging anesthesia gas machines. Initially a panel was held at the Annual Scientific Meeting in San Francisco to discuss the issue of anesthesia machine obsolescence. Dr. Stanley Weitzner, who has been active in writing national standards for anesthesia equipment for over ten years, spoke on the elements of a modem anesthesia machine. He emphasized that a new anesthesia machine standards (ASTM F 1161 -88) has superseded the familiar, but older 1979 ANSI Z79.8 standard; all machines purchased in 1989 should meet the newer standard.

Dr. Clayton Petty, author of a recent book on anesthesia machines defined the elements of an obsolete anesthesia machine. Dr. Jerry Dorsch, another well-known author on anesthesia equipment spoke to the delicate cost-benefit ratio in trying to update older equipment to reflect modern engineering safety advances. Finally, Mr. Joseph Radzius, an attorney with extensive regulatory and litigation experience defending equipment manufacturers Save a legal opinion on old anesthesia equipment. He counseled that the pejorative adjective "obsolete"' be dropped from the discussion; rather one should speak of the presence or absence of certain safety enhancements.

In the open discussion that followed, the panel and audience recognized that often other issues are intimately associated with equipment failures. These are improper or reduced maintenance, inadequate in service education, substandard equipment monitoring, failure to use checklists, and lack of familiarity with equipment standards. Eventually a technology matures and small gains in safety are achieved only with disproportionately greater expenditures. Anesthesiologists in an era of increasingly restricted funding have questioned whether it is better to first replace an older machine that meets the Z-79 standard or to upgrade patient monitoring to include oximetry, capnometry, and agent-spe6fic concentration monitors?

Following this panel and in response to a charge by the Board of Directors of the ASA, the Committee on Equipment and Standards met in January to write a "Policy for Assessing Obsolescence". This March the ASA Board of Directors approved the following policy submitted by the Committee on Equipment and Standards:

Proposed Policy

The age of an anesthesia gas machine has not been demonstrated to be a factor in anesthetic mishaps. An anesthesia gas machine, however, which no longer functions as designed and is not modified to meet acceptable levels of performance and monitoring should not be used.

Each anesthesia department should establish a protocol to assure that all anesthesia staff members are qualified in the operation of each type of gas machine, ventilator and monitor before use.

Anesthesia and health care in general now face a problem that confronted commercial aviation earlier in the decade; the pressures of economic deregulation and restricted funding have come into conflict with the increasing public and regulatory expectations of improved safety performance Interestingly, neither the States of New Jersey or New York, which have implemented stringent regulation with regard to the practice of anesthesiology have addressed the issue of equipment safety. Rather, these regulations speak to specific safety measures which must be in place, regardless of machine age These safety measures include diameter index safety system, pin index sat* system, fail-safe system, and a vaporizer interlock system.

Dr. Lees, Professor and Chairman at New York Medical College, is a member of the Editorial Board of the APSF newsletter and Chairman of the ASA Committee on Equipment and Standards.
 

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Special Article: A Safety Tutorial?

by E.S. Siker, M.D.

In a recent television commercial, a well know CEO of a major auto manufacturer stated, "Safety is a customer's right." Can this be any less true for a patient about to undergo an anesthetic and "cal procedure? Is it true that one shouldn't have elective surgery in a teaching hospital in IuIY9. Is it for the reason that some staff advise that one shouldn't buy a car assembled on a Monday or Friday?

July sees a changing of the guard: the CA-3s have departed and the CAI s have arrived. Most Anesthesia Residency Training programs have a series of summer tutorials for the new arrivals. These sessions have a number of objectives which can be collectively described as telling the neophytes how to stay out of the sand traps that await them in anesthetic practice.

The makeup of these tutorials differ markedly from program to program while sharing some common goals: an overview of the specialty; preanesthetic evaluation and medication; technical details about anesthetic set-ups; the anatomy of the anesthetic machine and its appendages; airway management (including endotracheal intubation); a sequence of assigned reading and/or advice about when, where, and what to study; bold print talks about anesthetic agents; and intraoperative monitoring. Ultimately, all of this initially imparted information bears upon patient safety. The current reliance upon the now ubiquitous electronic monitors have created, in some, a perception that patient safety can be more readily assured.

Does monitoring imply "patient saw" or do the sessions about monitors deal with the pathophysiology of complications rather than clinical reliability and practicality of the machines? This vast array of electronic devices is now a part of our workplace. Is their presence synonymous with patient safety? What else should our new residents be told about patient safety during the first few weeks of their training? Most, in the course of their medical school days, have spent either elective or clerkship periods in anesthesia they've seen the clusters of monitoring equipment before, but haven't felt intimidated because the responsibility belonged to someone else. Most, however, if asked during their first few days of training will confess concern about the need to pay attention to the input that the monitors provide while listening to and learning from clinical instruction. Too many of us who teach have forgotten that the introduction of these electronic devices occurred gradually over a period of many years. Compare this level of relative comfort among with the complex monitoring array with the experience of the new resident suddenly thrust into the midst of read-outs, bells, and whistles.

At best, unless the new resident is told what not to worry about, he or she is faced with a Hobson's choice. Unless told that it's more important to observe the patient than the array of monitors, they will believe that they must do both.

What the resident should be told about patient safety during the first month of training is and has been the subject of debate. How can anyone dispute the input from a pulse oximeter that announces a falling oxygen saturation or the alarms that report no C02 in the expired mixture? Even if we were to assume that these devices are never wrong (which we know to be untrue), it is the opinion of this observer that the brightest beginner shouldn't have to be concerned with the numbers on every screen.

The "sink or swim" school doesn't work as it did when the patient, his blood pressure, pulse, color and the ECG trace were the prin6ple "monitors" for the beginner. Today's teacher of anesthesia must recognize the need to delay the intrusion of too many diversions and direct the beginner to the basics. It is unreasonable to expect that a new resident will feel any more comfortable with the monitor army than with everything else that there is to learn which can only come with time and experience.

So what do we tell our patients? What is the goal of our tutorial about safety? It begins very simply: "For the first two weeks or so, you watch the patient and don't worry about all the monitors - we'll watch them." The use of monitors is then introduced in a manner aimed at reinforcing clinical judgments. The tutorials include an overview of how they work, and all that can be potentially learned from them. But it also includes input about why they sometimes don't work, why they malfunction, and how to decide whether the monitor or the patient is

to be behind when the numbers just don't add up.

Dr. Siker is Chairman of Anesthesiology, Mercy Hospital, Pittsburgh and an APSF Executive Committee member.
 

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Letter to the Editor: Retirees as 'Assistants'.?

To the Editor:

"Anesthesia Assistants: A Timely Idea for Safety" in the September issue particularly interested me.

I am 74 years old and have been retired for four years. I would still like to be part of a safety team conducting clinical anesthesia. It is a "Catch-2 2 ". I cannot afford the malpractice insurance. However, as a hospital-employed assistant, I could be of considerable assistance with over 35 years of clinical anesthesia experience.

There are quite a few "grey panthers" ready and willing to contribute in the cockpit of anesthesia to help pilot patients through safe take-offs and landings.

Many of us are not that well off financially, existing on retirement income today. The position of "Anesthesia Assistant" could be very rewarding to all involved. Modem day anesthesia is far too complicated to be left to just one individual at the head of the table

I would be anxious to know what the APSF and your readers think of reactivating some of us ready and willing retirees.

Robert A. Beanan, M.D. Far Rockaway, NY
 

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Editorial: Teaching Safety While in Touch with the Patient

In the last several years, anesthesia resident training programs have begun to examine their responsibility for teaching patient safety, risk management, and quality assurance. In fact, at the 1987 ASA Annual Meeting, a workshop on Education in Anesthesiology evaluated a program entitled "What Should Residency Training Programs be doing in the Patient Safety, Risk Management and Quality Assurance Field?" Panelist Ellison Pierce, Richard Ward and Stephanie Duberman examined several aspects of the question, including what some of the more well known programs currently provide and approaches residents may utilize to meet QA requirements.

In this issue of the APSF Newsletter Rick Siker, a long-time anesthesia residency program director and past president of both the American Board of Anesthesiology and the American Society of Anesthesiologists, describes "A Safety Tutorial". Dr. Siker is certainly correct in his assessment and clearly reflects views of the other members of the Anesthesia Patient Safety Foundation who serve with him on the Executive Committee

Along the same lines, I offer the following quotation from a British anaesthetist, "My American experience has also firmly convinced me of the value of the noninvasive techniques of continuous monitoring via an esophageal stethoscope and pulse oximetry, techniques seldom used in Britain. I have also learned from the use of "high tech" monitoring facilities, generally unavailable in the U.K. because of cost, such as transesophageal echocardiography and pulmonary artery oximetry. However, an American could learn much from his British colleague with respect to contact with the actual patient. I have seen patients in the United States with eyes covered by plastic tape to protect against the ultraviolet fiats and then the head placed in a plastic bag to prevent heat loss; the patient vanishes. I seldom see the United States resident palpate the pulse, examine the conjunctiva, feel the skin, or look at the pupil.(1)"

E.C. Pierce, M.D.

President, Anesthesia Patient Safety Foundation

Reference

1. Sebel, PS: Transatlantic lessons: one man's view. Anesth Anals 1987;66:800

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Letter to the Editor: Is Extra Person Free in O.R. a Standard of Care?

To the Editor:

Quality Assurance and Risk Management is a hot item for discussion and review in every aspect of today's medical cam I personally experience great deal of frustration m the interpretation of what constitutes quality care. It seems that quality care is quite often limited by available finances or personnel, or both. In the military medical system, budgets are developed based upon production. The number of patients seen or the number of surgical procedures performed seem to take precedence over assuring quality cam I do not mean to discredit the military Quality Assurance Program. It does provide a solid basis for improving patient cam We do depend upon standards of care from both the military and civilian community to help establish many of our programs.

The Anesthesia Department to which I am currently assigned, administers between 200-225 anesthetics each month. There are five anesthesia providers, two anesthesiologists and three nurse anesthetists. We have a four-bed recovery room, staffed, with one registered nurse and one medical technician. In order to accomplish this work load along with the many extra duties assigned, all anesthesia providers are involved in the administration of anesthesia throughout the day. As a department, we have tried to limit the number of rooms opened on any one day to one less than the number of anesthesia providers available. The obvious or not so obvious reasons are to have available a provider for emergency procedures, primarily Cesarean sections, participation in resuscitation procedures, assistance to the recovery room staff with any patient complication, assistance to any other provider with patient problems, and the giving of breaks in order to prevent provider burnout and improve attentiveness. The department has not been able to accomplish our goal because of what this would do to production. I must also admit that so far we have been lucky and always seem to have someone free when emergencies appear.

My purpose in writing this letter is to gather information that will either support our efforts or demonstrate that the anesthesia community has not yet established a "float" during the O. R. work day as standard of cam I My realize that not every hospital will have or need an anesthesia practitioner assigned to be free to help out. Does data support the premise that a hospital of our size and case load have available a floating assistant? I would certainly appreciate any input the APSF or its members might have on this topic. If statistics are not available, might you have a suggestion?

Richard D. Baker; U. Col., USAF NC Senior Nurse Anesthetist Brandon. FL
 

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URI and Perioperative Desaturation in Children

by E.K. Betts, M.D.; B.E. Miller, M.D.; J.J. Jorgenson, B.S.; C.L. Tiffany, R.N.; L.L. Kay, M.D.; M.S. Schreiner, M.D.

Editor's Note: Dr. Betts was a recipient of an APSF Research Grant. He gives here a preliminary report on a portion of his work.

The optimal timing for anesthesia and surgery for children with an active or recent upper respiratory infection (URI) remains controversial. This study tested the hypothesis that the incidence of perioperative oxygen desaturation, laryngospasm, or bronchospasm in otherwise healthy children receiving general anesthesia who have or have recently had a URI is the same as in controls. The institution's human study review board approved the study.

ASA physical status one or two day surgery patients with an active URI were enrolled in the study after the patient's parents and the attending surgeon gave informed consent. These patients were compared to similar patients who 'Were healthy with and without a history of having had a URI within the past six weeks.

The study protocol did not alter the anesthetic technique, including the premedication. After induction, in addition to the Nellcor N-200 pulse oximeter used clinically, the patient's oxygen saturation and pulse rate were recorded by a Radiometer pulse oximeter in analog and histogram forms. A research technician monitored the study oximeter for artifacts. Data collection continued uninterrupted until the patient was discharged from the recovery room. Desaturation was defined as 90% hemoglobin oxygen saturation for more than 2.5 minutes (the minimum duration displayed by the oximeter histogram). Control patients were selected by matching them with active or recent URI patients primarily by age and procedure and secondarily by weight, sex and surgeon.

In addition, data on the occurrence of laryngospasm, bronchospasm and the necessity of airway maneuvers during the anesthetic and in the recovery room were collected. Telephone follow up one and seven days post anesthetic secured data on the development of post anesthetic complications.

The results are summarized in the Table. There was no statistical difference in the demographics or in the incidence of laryngospasm or desaturation among the three groups. Only one postoperative complication occurred, a case of mild pneumonia in a six month old following a bilateral herniorrhaphy. The patient had had a recent URI and was treated at home with antibiotics. No patients developed bronchospasm or post intubation croup.

The incidence of desaturation appears quite high in this study because the oximeter reports fractional saturation (oxyhemoglobin(oxy + deoxy + deshemoglobins)) rather than functional saturation (oxyhemoglobin (oxy + deoxyhemoglobin)) which the Nellcor and most other American made oximeters report. Functional saturation typically runs four percentage points higher than fractional saturation.

Patients with lower airway disease as manifested by rales, ronchi or a productive cough were excluded from the study. Even so, one patient in the pilot study plus another patient in this study were diagnosed by their pediatricians as having mild pneumonia, treated at home in both cases with antibiotics. No chest x-rays were taken to confirm the diagnosis in either case.

Records were not kept of the number of potential study cases where either the surgeon, attending anesthesiologist or the patient's parents declined to have the patient with an active URI anesthetized. This occurred bemuse most of these decisions were made by the surgeon and attending anesthesiologist before the study team was notified of the potential study patient. However, there was a noticeable softening of the surgeons' and anesthesiologists' attitudes as the study progressed, even though the results of the study were not made known to the medical community. Wormed consent makes this bias unavoidable

In a group of healthy pediatric patients having superficial surgery, the incidence of desaturation, laryngospasm, bronchospasm, and croup was not increased if the patient had or recently had had an upper respiratory infection. Caution should be used in applying the results of this study to the clinical situation as all of these patients were basically healthy and did not appear sick or toxic from their URI when they were anesthetized. In addition, 58 more control patients are needed to complete the study.

Dr. Betts is from the Department of anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia.


 
 

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Safety and the Study of Anesthesia Incidents; Where Are We Now An Australian Perspective

by Dr. John Williamson, EEA.R.A.C.S.

Following Flanagan's pioneer work (stimulated by the ideas of Galton) with the application of his "critical incident" analysis (1), Cooper and colleagues in 197S(2) were the first to expose anesthesia to the power of this technique. Since then, we have come a distance, made some blunders, and learned a few lessons. A decade of international anaesthesia experience with such incident analyses(3-7) is not a had time to stand back, hopefully with a cold but not single eye, and look ourselves, and this approach to anaesthesia safety, over.

Human Error

To some of us, who entered anaesthesia practice when admission of error by surgeons was unthinkable, and by anaesthetists untenable, a revolution in anesthetists' attitude has occurred. We are now beginning to acknowledge that just like the rest of the human race we anesthetists err constantly, repeatedly, and naturally. In fact, as Allnutt reminds us in an elegant paper (8), the learning process depends upon such erring, and has always done so: ". . . all human beings, without any exception whatever, make errors and ... such errors are a completely normal and necessary part of human cognitive function."

The critical incident technique (CI) has helped to foster this international advance m maturity among anaesthetists. CI has enabled us to re-discover that most error (about 70-80%) in our business as in every other occupation so far studied (1,9) is human error. (2,4) (This includes much so-called "equipment failure, which is really human error "at a distance" e.g. misuse, inadequate maintenance, etc.) Has there ever been a better example of rediscovery of the wheel?!

To err is human; To record it is fine!

Nevertheless, this attitude change is a giant step forward for safety improvement in anaesthesia. Until we acknowledge the existence of our own errors, only then can we hope to be* to (a) record them, (b) analyze them, and (the "punch fine") develop corrective strategies (3) that will eliminate or reduce their recurrence. The anaesthesia world now seems to be on the way to biting these two "bullets" (error acknowledgment, and error recording), and indeed may at present be showing the way to other medical specialties in this regard.

The "Australian Incident Monitoring Study" (AIMS)

Just how to record and analyze these recurring human errors anonymously, validly, and continuously, especially in the face of threatening medicolegal activities, is the challenge with which many countries (including Australia) are presently grappling. Australia, with the cooperation of New Zealand, has as part of the newly created Australian Patient Safety Foundation (APSF) (10) recently launched AIMS (11), following an introductory workshop held in Brisbane in May of this year. Preliminary nation-wide Australian data from AIMS will be presented at the next AGM of the Australian Society of Anaesthetists.

From an Australian ten year overview position it is now possible to perceive some other encouraging trends as well as some present and looming challenges associated with incident reporting.

Encouraging Trends

(a) From its inception in anaesthesia (2), CI has correctly "fingered" the most common day-to-day threats to patient safety the world over, via: accidental breathing circuit disconnection, wrong drug administration ("actual" and "judgmental"), and endotracheal-tube-related problems. Disconnect alarms ("corrective strategy") are saving lives and brains now; interestingly the value of the "obvious" step of labeling syringes remains unclear at present, at least in Australia; it is hoped further AIMS data will assist with evaluation of this strategy. It is worth noting that incident studies have already shown that the similarities of anaesthesia error vastly outnumber the differences, the world over, irrespective of country of training or practice. We are all human, and all rather alike!

(b) The studies have begun to dispel some formerly cherished but dangerous anaesthesia myths (e.g. "anaesthetists must never change during the administration of anaesthesia" (12), and "only inexperienced or junior anaesthetists are likely to intubate the esophagus and fail to recognize it." (13)).

(c) The successful introduction of incident reporting into most Departments of Anaesthesia has the happy effect of increasing mutual trust among clinical staff who work within it. (4) As the study "bites" into safety improvement within the Department, as measured by the regular feed-back meetings, "esprit-de-corps" is enhanced, morales lift, and individuals come to recognize that their colleagues no matter how "exalted" make the same mistakes, and suffer from the same limitations as they do! And, of course, the vast majority of these incidents produce no patient harm whatever an significant CI attribute. (14)

(d) Experience and/or supervision is the anesthetists most valuable commodity for the safety of his or her patient. (3,4) Indeed inexperience is dangerous (15) a clearly signposted warning for all senior and teaching anaesthetists.

(e) Incident studies would appear to be enhancing the intelligent selection of monitoring devices from among the bewildering array offered to us these days. Sane monitoring guidelines currently being attempted in several countries (including Australia) (17) may be expected to be usefully influenced by future data from incident reports.

Some Current Challenges

(a) Few problems associated with reporting one's incidents loom as large as the anonymity and medico-legal threat. The anesthetic literature is becoming increasingly dotted with publications (many of them unhelpful) related to this problem. Hopefully most countries will have learned something from the bitter American experience, where behavior by some legal practitioners has become actually counterproductive to patient safety

In Australia at present, legislation is in place within four of our seven States, which protects the confidentially of the voluntary report to anesthetic mortality and morbidity committee; similar legislative protection is currently being sought for AIMS (at Federal level). The writer believes that anaesthetists must now direct their efforts toward disarming aggressive medico-legal tendencies with the hard data of validated patient safety improvement, rather than the endless and capitulative tack of underwriting expensive insurance premiums, based as they are in many cases upon clinically nonsensical medico-legal precedents. We know our business better than lawyers, and we place the safety of our patients above anything else. In the meantime AIMS continues to liaise closely with the various Australian medical protection societies, and looks to constantly upgrading its anonymity safeguards, using its electronic capabilities.

(b) Morgan has emphasized the value to training and education, of broadening the scope of anaesthesia incident reporting to include "interesting and/or unusual" anesthetic experiences. (18) AIMS is presently addressing the formidable problem of classifying and incorporating this considerable body of data, but its value is promising. Future dispersal of such pertinent information will be assisted by ASA's existing national electronic Anesthetic Bulletin Board Service ("ABBSIN'), based on the Royal Adelaide Hospital a service which is already in extensive use by the AIMS network.

(c) Safety in anaesthesia is certainly "the flavour of the month" in Australia and New Zealand at present, with meetings, themes, journal issues and workshops devoted to this topic appearing monthly. We need to keep our efforts directed along practical, clinical lines.

There is now a population of anaesthetists-in-training in this country who have never administered an anesthetic to a patient without using an army of expensive monitoring equipment (e-g. noninvasive automatic sphygmomanometer, pulse oximeter, ECG, capnograph, disconnect alarm, oxygen analyzer, peripheral nerve stimulator, temperature probe!). A fearful tendency is now reasonable for the assumption that all is well with the patient if no alarm sounds, and/or "the displayed numbers" are "O.K.". Teachers beware!

(d) One of the greatest "on-the-ground" difficulties with incident reporting is the initiation of enthusiasm and compliance among colleagues to submit reports ("Oh no! Not more paperwork!"). The current design of the AIMS report form represents many months of thought and trial, to simplify its accurate use; and already preliminary usage has suggested improvements. It is now attested Australian experience that those anaesthetists who initially will not submit reports ("I don't have any incidents"!), not infrequently have the greatest need to do so! AIMS relies principally upon the enthusiasm of its appointed representative in each locality (person-on-the-spot, POS (1)), and the regular feed-back of anonymous data (both local, and down-loaded national) by the POS to his or her Departmental colleagues. The future possible automation of anaesthetic records on a real-time basis should also reduce the number of incidents lost through genuine human forgetfulness.

(e) Our preliminary data is beginning to identify a subgroup of incidents which are dearly "surgeon initiated" (e.g. surgical equipment absence or failure, thoughtless alteration of surgical procedure during operations, sudden list order changes, etc.). There appears to be both a need and an opportunity for us to positively influence surgical safety; this will require tact with firmness but first hard data.

So with all its present limitations and yet-to-be-discovered problems, the future of incident reporting in anaesthesia, as a tool for improving the already high level of patient safety, looks encouraging. As further careful data is collected and analyzed, we may reasonably anticipate an increasing ability for nations (including hopefully third world countries) to be able validly to compare their safety studies (scarely possible up to now), with all the attendant advantages that will permit. Additionally a descalation of prevailing unfriendly medico-legal activities should be possible; but there are no shortcuts! As Karl Popper has observed, "The Truth is hard to come by"!

Dr. Williamson, Queensland Australia, is Co-ordinator of the Australian Incident Monitoring Study.

References

1. Flanagan IC. The critical incident technique Psychol Bull 1954; 51:327-358.

2. Cooper IB, Newbower RS, Long CD, McPeek B. Preventable anesthesia mishaps: a study of human factors. Anesthesiology 1978;49:399-406.

3. Cooper IB, Newbower RS, Kitz RI. On analysis of major errors and equipment failures in anesthesia management. considerations for prevention and detection. Anesthesiology 1984;60:34-42.

4. Williamson IA, Webb RK, Pryor GL. Anaesthesia safety and the "critical incident" technique. Aust Clin Rev 1985;5:57-61.

5. Cohen MM, Duncan PG, Pope WD, Wolkenstein C. A survey of II 2,000 anaesthetics at one teaching hospital (1975-83). Can Anaesth Soc 1 1986;33:22-31.

6. Tiret L, Desmonts IM, Hatton F, Vourc'h G. Complications associated with anaesthesia a prospective study in France. Can Anaesth Soc 1 1986;33:336-344.

7. Currie M, Pybus DA, Torda TA. A prospective study of anaesthetic critical events: a report on a pilot study of 88 cases. Anaesth lntens Care 1988;16:103-107.

8. Allnutt MF. Human factors in accidents. Brit J Anaesth 1987;59:856-864.

9. Knight 1. Medical standards for sports divers. SPUMS 1 1986;16:22-27.

10. Runciman WOL The Australian patient safety foundation. Anaesth lnten Care 1988;16:114-116.

11. Webb RK, in APSF Newsletter, September 1988:26(col.1).

12. Cooper IB, Newbower RS, Long CD, Philip IH. Critical incidents associated with intra-operative exchange of anesthesia personnel. Anesthesiology 1982;56:456-461.

13. Utting JE. Pitfalls in anesthetic practice Brit J Anesth 1987;59.877-890.

14. Williamson J. Critical incident reporting in anaesthesia. Anaesth lntens Care 1988;16:101-103.

15. Lunn IN, Mushin WW. Mortality associated with anaesthesia. Nuffield Provincial Hospitals Trust, 3 Prince Albert Road, London. 1982:70(Table 4.23).

16. Cooper IB, Cullen DI, Nemeskal R, Hoaghn DC, Gervitz CC, Csete M, Venable C. Effects of information feedback and pulse oximetry on the incidence of anesthesia complications. Anesthesiology 1987;67: 686-694.

17. Monitoring during anaesthesia (Australia). faculty of Anesthetists, R.A.C.S. Policy Statement June 1988. APSF Newsletter, September 1988. p.23.

18. Morgan C. Incident reporting in anesthesia. Anaesth lntens Care 1988; 16:98-100.
 

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Dr. David Lees, APSF Director, Named to Prestigious FDA Post

David Eric Lees, M.D. a Director of the Anesthesia Patient Safety Foundation, was recently honored with an appointment as a member of the Anesthesiology and Respiratory Therapy Devices Panel of the Food and Drug Administration. The Panel consists of seven members serving four-year terms. Members are chosen from recognized authorities in clinical medicine, engineering, and related professions.

This panel reviews and evaluates available information concerning the safety and effectiveness of anesthesiology and respiratory therapy devices. Presently medical devices are classified into one of three regulatory categories: Class I where only general controls are necessary, such as good manufacturing Practices, Class 11 where performance standards are necessary, and Class III where premarketing approval is required before a device is released on the market. The Panel also advises the Commissioner of the MA regarding the recommended classification of a new device and the priority for the application of regulatory requirements in Class 11 (Standards) or III devices (Premarket Approval). In addition, the Panel advises on any possible health risks associated with the use of a device and the possible necessity to ban a device. The Panel also responds to requests from the MA to review and make recommendations on specific issues or problems concerning the saw and effectiveness of various devices.

Dr. Lees has been a member and Director of the APSF since its inception in 1985. He also serves as Chairman of the Committee on Equipment and Standards of the ASA. Dr. Lees is Professor and Chairman of the Department of Anesthesiology at the New York Medical College and serves as the Medical Director of the Westchester County Medical Center.
 

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The Society for Technology in Anesthesia

by N. Ty Smith, M.D.

In the last APSF Newsletter and in the April issue of the journal of Clinical Monitoring (page 148), we described the origin and background of the Society for Technology in Anesthesia (STA). Since the last advisory, STA has progressed rapidly, and it is now possible to be more specific regarding upcoming STA events.

STAs first Annual Breakfast Panel will be held at the Annual Meeting of the American Society of Anesthesiologists (ASA), in New Orleans on Wednesday, October I 8, from 7:30 to 8:45 a.m. The subject will be "Who Deserves the Credit for the Recent Improvement in Anesthetic Mortality and Morbidity?" Each member of the outstanding panel will try to convince you that his area can take the credit. Panel members and their topics are as follows: Moderator. N. Ty Smith, M.D.; The Monitors: William New, Jr., M.D.; The Educators: Susan L. Polk, M.D.; The Clinicians: William K. Hamilton, M.D.; The Standards Makers: Frederick W. Cheney, Jr., M.D.; The Researchers: Jeffrey B. Cooper, Ph.D.; the Anesthesia Patient Saldy Foundation: Ellison C. Pierce, Jr., M.D.; The Insurance Companies. Mark Wood; The lawyers: Richard F. Gibs, M.D., J.D.; and The Anesthetic Agents: George Griffiths.

STA will hold its Second Annual Business Meeting on Saturday, October 14 from 5:00 to I 0:00 p.m. It will begin with a hosted reception from 5:00 to 6:00 p.m., followed by a dinner from 6:15 to 7:00 p.m. Following the dinner will be a business meeting which will run until approximately IO.-OO p.m. We shall cover several important topics, including the annual scientific meeting, society bylaws, future directions of the society, and what the society can do for its members. The recommendations of the Board of Directors in these and other arm will be presented. Those who attend the business meeting and join STA at or before the meeting will be designated charter members.

The STA newsletter wig be headed by two very capable editors, Drs. Dwayne Westenskow and Jim Philip, representing the technical side and the clinical arena; respectively. The Fu3t Annual Scientific Meeting of STA has tentatively been set for early spring, 1991, in Disney World, Florida.

STA has engaged the services of the International Convention and Travel Service, Inc., a professional group that will provide excellent services for the members of the society, including membership fulfillment, the use of credit card payment for membership dues, a toll-free telephone service for members, maintenance of administrative correspondence with members, and the handling of all meeting arrangements, including air transportation.

STA is strongly considering implementing an information clearinghouse for its members. There are many other ways in which the society could serve its members. Any member of the board of directors (see the April, 1989, issue of the Journal of Clinical Monitoring, page 148) will be delighted to hear from members or prospective members about this or any other pertinent subject. This is your society, and we want to make it as useful as possible to you.

Dr. Smith, V.A. Medical Center, San Diego, is President of the STA and an APSF Director.
 

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FDA Study Organized to Validate Pre-Operative Checkout Recommendations

by Mollyann G. March, M.D. and Jay Crowley

The failure to perform a thorough pre-use check of the anesthesia equipment has been cited as the most frequently noted single factor associated with intra-operative anesthesia critical incidents(1,2). The consistent, careful use of an anesthesia preuse checklist will greatly reduce the risk of a broad variety of anesthesia related incidents(3). However, some practitioners may have difficulty finding errors and faults in anesthesia equipment, especially faults that do not render the equipment inoperable(4).

In March, 1986, the FDA issued a pre-use checkout recommendations list to aid the clinician in the checkout of anesthesia equipment. A study is being undertaken to assess anesthesiologists' machine checkout routines and to determine to what extent the FDA checkout recommendations assist clinicians in detecting faults in the anesthesia equipment. Utilizing the study results, the investigators will (1) measure the effectiveness of anesthesiologists' checkout methods, (2) assess anesthesiologists' understanding of anesthesia equipment, and (3) determine to what extent the FDA checklist is a useful tool in the detection of machine faults.

The study should be completed by the end of 1989. The investigators plan to submit the analysis of the results of the study for publication, and present them at the 1990 ASA annual meeting. For more information, please contact Mollyann G. March, M.D.; Assistant Professor; Department of Anesthesiology; George Washington University Medical Center; 901 23rd Street, Northwest; Washington, D.C. 20037.

As noted, Dr. March is from George Washington University. Mr. Crowley is a staff member of the Food and Drug Administration.

References

1. Cooper JO: Toward prevention of anesthetic mishaps. International Anesthesiology Clinics, Analysis of Anesthetic Mishaps, Pierce and Cooper (eds), Little, Brown and Company, Vol 22, No 2, 1984.

2. Cooper JB Newbower RS, Kitz RJ: An analysis of major errors and equipment failures in anesthetic management: considerations for prevention and detection. Anesthesiology, 60.34-42, 1984.

3. Spooner PA " RR: Experiment related incidents. International Anesthesiology Clinics, Analysis of Anesthetic Mishaps, Pierce and Cooper (eds), Little, Brown and Company, Vol 22, No 2, 1984.

4. Buffington CW, Ramanathan S, Tumdorf H: Detection of anesthesia machine faults, Anesthesia and Analgesia, 63:79-82,1984.
 

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Letters to the Editor: Falsely Elevated Oximeter Reading Dangerous on One Lung

To the Editor:

Use of the Pulse oximeter has been suggested as the standard of care for general anesthetics 1. It is well recognized that continuous assessment of arterial oxygenation is important in the clinical management of anesthetized patients. The use of Pulse oximetry has become widespread as evidence has accumulated that this non-invasive monitor of oxygen saturation is accurate over a wide clinical ranse2.

Vasopressor use, peripheral vascular disease hypothermia, hypotension, intravascular injection of dyes and hemoglobinophathies can all contribute to inaccurate arterial saturation readings by pulse oximetry 3,4, most of which are interpreted as falsely low readings.

Factitously high pulse oximeter readings have been reported as a consequence of interference of the probe by ambient light or infrared fight, and as the result of "default" readings from the instrument which occur when the pulse signal is low or contains interferences. Recently, we obtained a falsely high pulse oximeter reading, despite a normal signal, in a patient who was hypoxemic.

The patient was a 70 year-old male undergoing elective repair of a thoracoabdominal aortic aneurysm under one-lung anesthesia. After intubation with a double lumen endobronchial W the patient was positioned in the right lateral position. Monitors included EKG, ETC02, temperature, esophageal stethoscope left radial arterial line and Pulmonary artery catheter A pulse oximeter probe was placed on the right index finger and shielded from ambient fight by a towel wrapped around the hand. Approximately 15 minutes after deflation of the patient's left (nondependent) lung, arterial blood gases were obtained to assess the adequacy of ventilation. Prior to the blood gas being drawn, the oximeter had intermittently indicated poor signal quality. However, at the time that the blood gas v-s drawn, the pulse oximeter indicated a normal pulse wave form and arterial oxygen saturation of I 00%. Arterial blood gas results were pH 7.4 1, pCO2 40, paO2 56. A second arterial blood gas reading obtained with the oximeter indicating 100% saturation and a normal wave form was pH 7.41, paCO2 41, PaO2 72. A new probe was obtained and the oximeter read I 00% saturation. A reading from the same instrument on an O.R. colleague whose usual room air saturation is 95%, was also falsely elevated at 99%. A new oximeter was obtained and determined our colleague's arterial saturation as 96%. Throughout the remainder of the case, the new oximeter was utilized. The original pulse oximeter was returned to the manufacturer for inspection and was reportedly free of defects.

We report this case as an episode of unexplained factitiously elevated arterial oxygen saturation readings by pulse oximetry. This was seen in a patient undergoing one-lung anesthesia, when noninvasive monitoring of arterial oxygen saturation is highly desirable because of the potential for changes in intra-pulmonary shunt (6). We found this incident particularly disturbing because while most other reported instances of inaccurate pulse oximetry data involves saturation readings which are inaccuratel low, this case represents an instance in which inaccurate readings from a pulse oximeter were potentially falsely reassuring.

Gail Van Norman, Fellow in Cardiothoracic Anesthesia, F.W. Cheney, Acting Director, Cardiothoracic Anesthesia, University of Washington Department of Anesthesiology

References

1. American Society of Anesthesiologist: Standards for basic intro-operative monitoring Anesthesia Patent Safety Foundation Newsletter, March, 1987.

2. Yelderman, M and New, W. Evaluation of pulse oximetry. Anesthesiology 59:349-352.

3. Kessler, MR et al.: Spurious pulse oximeter desaturation with methylene blue injection. Anesthesiology 65:435-436. 1986.

4. Tremper, KK and Barker, SI: Pulse oximetry. Anesthesiology 70:98-108. 1989.

5. Cosarino, AT et al.: Falsely normal saturation reading ,with the pulse oximeter. Anesthesiology 67: 830-83 1. 1987.

6. Brodsky, IB et al.: Pulse oximetry during one-lung ventilation. Anesthesiology 63:212-214. 1985.
 

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Medical Decisions Asked of PACU Nurses

To the Editor:

Please let us refocus not so much on the issue of a litigious society, but rather on the safety of patient care when talking about whether PACU nurses should be extubating patients.

It is generally not within the scope of professional practice for registered nurses to intubate patients unless they are certified registered nurse anesthetists. Thus, the question to be asked is whether the nurse who extubate a patient is prepared to deal with any of the complications (one of which is reintubation) which may arise. If the nurse cannot handle the complications, the nurse should not extubate the patient.

It would be appropriate to first check with your State Board of Nursing to determine their position on the issue. If the Board determines registered nurses may extubate patients with appropriate training, then an extensive and intensive training program could be offered to PACU nurses. This program should contain not only the appropriate considerations for extubation, but also considerations for re-intubations, and specifically those frequent complications following extubation after surgery. It should be conducted by an anesthesiologist or CRNA, and be approved by the Medical Staff. You would want to be certain there is mandatory annual recertification, and each nurse who is credentialed to do extubations has an adequate number of re-intubation procedures throughout the yew to maintain competency. Even if the nurses are certified to extubate patients, there should be an anesthesiologist or CRNA available to assist in the event complications arise.

It is my advice to nurses in my facility: "Do not extubate a patient if you cannot re-intubate, or if you cannot handle every complication which may arise following extubation of a post-anesthesia surgical patient".

I would question the quality of mean anesthesia care if patients are frequently arriving in the PACU intubated. This is an anesthesia issue, and should be dealt with by your department of anesthesia.

As a risk manager in a large health care system, I certainly am interested in decreaseing our exposure to liability, and am aware of an increasing litigiousness of our society. The most important aspect of good risk management is a firm, steady focus on quality patient cam Competent, trained, CARING people am the best risk management tools we have

E. Lin Tuthill, B.S.N., J.D., Director, Corporate Risk Management Counsel, Presbyterian Healthcare System, Dallas, TX.
 
 
 

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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 in March, June, September, and December 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, 1988.

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; E.S. Siker, M.D., Secretary; Burton A. Dole, Jr., Treasurer; Jeffrey & Cooper, Ph.D.; Joachim S. Gavenstein, M.D.; James E Holzer, J.D.

Newsletter Editorial Board: John H. Eichhorn, M.D., Stanley 1. Aukburg, M.D., Jeffrey M. Beutler, C.R.N.A., M.S., Ralph A. Epstein, M.D., David E. Lees, M.D., Bernard V. Wetchler, M.D., Mr. Mark D. Wood

Address all general, membership, and subscription tion 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; Dept. Anesthesia

Beth Israel Hospital, DA-717 Boston, MA 02215

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