ANESTHESIA PATIENT SAFETY FOUNDATION
NEWSLETTER

Volume 5, No. 3, pp 25-32 Fall 1990
Table of Contents

Further Changes in Basic Monitoring Standards Proposed
Patient Safety Again to be Featured at ASA Annual Meeting
Soviet Anesthesiologist is First APSF Visiting Professor
APSF and STA Co-Sponsor Florida Workshop for Industry
Letters to the Editor
Unidirectional PEEP Valves Can Cause Safety Hazards
Current Questions in Patient Safety
Checklists Cited as Contributing to Safety
Notes




Further Changes in Basic Monitoring Standards Proposed

Amendments Up for Vote

by John H. Eichhorn, M.D.

Coming on the heels of last year's vote by the ASA House of Delegates to amend the ASA Standards for Basic intraoperative Monitoring to mandate pulse oximetry, two newly proposed related changes are slated for consideration this October.

The O.R. oximetry amendment that went into effect January 1, 1990 built on the distinction between qualitative (observation) and quantitative (measurement) monitoring. Previously, quantitative monitoring was only "encouraged." Now, the current standard regarding blood oxygenation reads: "During all anesthetics, a quantitative method of assessing oxygenation such as pulse oximetry shall be employed. Adequate illumination and exposure of the patient is necessary to assess color." Due to the virtual absence of popular competing technologies, intraoperative pulse oximetry was functionally made the standard of care by this actions of the ASA at its last annual meeting.

PACU Oximetry

This year, them is a proposal from the Committee on Standards of Care to amend the Standards for Postanesthesia Care originally approved in 1988 to extend essentially mandatory pulse oximetry into the PACU. The current standard mandates continual evaluation of the patient while in the PACU and calls for observation and monitoring by methods appropriate to the patient's condition. Again noting the distinction, the standard now reads: "While qualitative clinical signs may be adequate, quantitative methods are encouraged. The amendment would add: "During recovery from all anesthetics, a quantitative method of assessing oxygenation such as pulse oximetry shall be employed:'

This change emphasizing the use of pulse oximeters in the PACU was initiated by two developments: 1) significantly increased use of pulse oximetry in the PACU, moving the practice towards a de facto standard of cam paralleling what happened in the O. R.; and, 2) information from the ASA Closed Claim Study, insurance carriers, and other sources to the effect that hypoxic injuries in the PACU continue to occur and may, in fact, be increasing. Further, some members of the committee suggested that the average patient may actually be at greater risk in the PACU than in the O.R., making the continuation of pulse oximetry during this vulnerable time both logical and desirable. The ASA Board of Directors has proposed an effective date of January 1, 1992 for amendment to the standards.

Information input similar in type to that outlined above led to the second proposed change, which would again add to the Standards for Basic Intraoperative Monitoring, this time relative to verification of endotracheal tube placement. Specifically, the ASA Closed Claims Study revealed a continued significant incidence of unrecognized esophageal intubation and consequent patient injury at a time when other types of major incidents seemed to be dramatically decreasing. In addition, Fred Cheney, M. D., Chairman of the ASA Committee on Professional Liability, noted that in a great many of those circumstances, the practitioners involved had ausculted the chest and believed that there were breath sounds indicative of correct endotracheal tube placement even though the tube was later found to be in the esophagus.

Under "Ventilation," the existing intraoperative monitoring standards state: "When an endotracheal tube is inserted, its correct positioning in the trachea must be verified. Clinical Assessment is essential and end-tidal C02 analysis, in use from the time of endotracheal tube placement, is encouraged. The committee deliberated how potentially to strengthen this standard while still recognizing that capnography is not universally in place. Practical and economic realities led the committee to stop short of proposing mandatory capnography. Since the issue is correct endotracheal placement, the focus became identification of expired C02

It was recognized that capnography is one effective, popular way to identify expired C02, but that there is also at least one other method available that does not require the capital outlay for capnographs. Therefore, the proposed modification states that endotracheal tube positioning "must be verified by clinical assessment and by identification of carbon dioxide in the expired gas. Continuous capnography is still "encouraged." It was felt by the committee that the compromise will enhance patient safety relative to unrecognized esophageal intubations but leaves enough leeway to cover all circumstances. Currently, the proposed effective date of this change in the standard is "as soon as feasible, but in no case later than January 1, 1991."

Burton S. Epstein, M.D., Chairman of the ASA Committee on Standards of Care which proffered the two standards changes, noted the long lead time on the PACU pulse oximetry implementation. He said, "it is valid to consider how rapidly hospitals and anesthesiologists can tool up to implement these upgraded PACU standards". Further, Dr. Epstein commented that the misconception about whether tmaboutwhetherthis standard should apply to women recovering after regional anesthesia for normal vaginal delivery, particularly because it has been thought by some obstetric anesthesiologists not to be necessary.

Regarding the proposal of C02 identification for verification of endotracheal tube placement, Dr. Epstein did enter a caveat about potential confusion in the clinical setting when the tube is, in fact, in the trachea but there is no cardiac output to carry C02 to the lungs. He stated a question had been raised about cardiac arrest situations and the possible mistaken removal of a correctly placed tube.

These two 1990 proposals will be considered at the ASA annual meeting. Reference Committee hearings will be held Saturday, October 20 and all interested parties are invited to attend and testify if desired. The Reference committee resultant recommendations will be considered by the delegate caucuses and then the House of Delegates will address the proposals at its meeting Tuesday, October 22.

Dr. Eichhorn, Harvard Medical School, is editor of the APSF Newsletter and also a member of the ASA Committee on Standards of Care.

Back to Table of Contents




Patient Safety Again to be Featured at ASA Annual Meeting

by Gerald L. Zeitlin, M.D.

Anesthesia patient safety continues to be a major topic of presentations and discussions at the American Society of Anesthesiologists annual meeting, to be held this year in Los Vegas, October 19-23. After explosive growth of interest in this area during the preceding two years, in 1989 there were over I 00 scientific presentations in the section on Patient Safety, Epidemiology, and Education. The pace continues unabated this year with 98 presentations scheduled in this area alone

Refresher Courses

In the Refresher Course selection this year, on Friday, October 19, Dr. J. Ehrenwerth will speak on " Electrical Safety in the Operating Room." later in the same room, "The Safe Level of Hemoglobin: Is Anemia 'In'?" is the topic of Dr. L. Stehling. Dr. C. Vacanti will present "How Quality Assurance and the Peer Review Process Can Help Your Department" and Dr. E Cheney, Chairman of the Committee on Professional Liability, will follow with "The ASA Closed Claims Study: Lessons Learned." On the second day of the Refresher Courses, Dr. M. Bishop will present "Bronchospasm: Managing and Avoiding a Potential Anesthetic Disaster."

A particularly valuable Panel Discussion is scheduled for Sunday afternoon. Dr. J. Benumof of San Diego will chair a panel on "The Difficult/Impossible Airway: Catastrophes and Solutions."

Scientific Sessions

Scientific sessions on safety, epidemiology, and Education number five with oral presentations Monday, October 22, in the afternoon and Tuesday both in the morning and afternoon. Poster sessions will also be Tuesday at both times.

Among the anticipated presentations, the flow of valuable information from the ASA Professional Liability committee's Closed Claims study continues. In a paper based on 1,541 claims in the database, only 4% were found to be specifically related to the use of anesthesia equipment. Of these, nearly one half were due to misuse of equipment which supports previous findings that in the vast majority of cases, human failure causes the adverse outcomes which lead to malpractice suits.

Two other studies investigated human behavior and fatigue in the operating room. In the first, the investigators looked at the effects of noncognitive variables (motivation, interpersonal skills, and values) on clinical performance. Collecting and analyzing the comments of the faculty on the behavior of residents in five anesthesia departments, the authors found that conscientiousness on the part of the trainee was the trait which best predicted both performance and the avoidance of critical incidents.

In the other related study, the authors exposed residents to critical incidents generated by an anesthesia simulator. The responses were compared to those of both teaching faculty and private practice anesthesiologists. It was found that the more experienced practitioners detected and corrected potentially serious problems more quickly. However, even within the group of experienced practitioners there are marked variability and even a few outliers. This supports the thesis of Dr. T. Vitez and his complicated Las Vegas Model Clinical Competence quality assurance program, which suggests that clinical outliers must be identified and then either retrained or redirected.

There is a study of "Reported Significant Observations" (RSO's) in which all the members of an anesthesia department in a single hospital reported anonymously their deviations from conventionally accepted safe practice (a surprisingly wide variety of types of occurrences). Eighty-three percent were considered " preventable and 20% involved potentially lethal events. RSO's constituted a broader concept than Dr. 1. Cooper's now classic "critical incidents" but the outcome of " work strikes a similar chord to that pioneer work.

Examples of other interesting research that will be presented are: the rate of intravenous injection of midazolam does not appear to affect its potential to produce hypoxemia; needles can be recapped for reuse without risk of contamination if injections are made into the ports of intravenous tubing farthest away from the patient; in patients who had suffered anaphylacticrea6onstoanestheficdruSs,skintesting with other drugs accurately predicted a safe choice of medications for a potential subsequent anesthetic; proper use of commonly used predictors of difficult intubation, such as ability to see the pharynx preoperatively, wig reduce the incidence of unpleasant airway surprises after the patient is anesthetized; a study of "Recovery Room Impact Events" (intraoperative occurrences that impact PACU care) strongly supports what has be-en felt intuitively serious complications were reduced when the pulse oximeters were introduced into all the operating rooms. Also, an update (showing changing patterns over the decades) of the classic Medical College of Virginia study on intraoperative cardiac arrests will be presented.

The meeting section on Equipment, Monitoring, and Engineering Technology will also be extremely active. There will be three poster and four oral presentation sessions with a total of 133 scientific papers. Several have implications or polential applications for anesthesia patient safety.

Outlined here is only a representative sampling of the safety-related material available at the ASA meeting. Further details are available in the formal meeting program. Finally, be sure to visit the Patient Safety Booth in the Exhibit Hall for more ideas and several samples of information that can be taken back to practitioners' home departments for individual application.

Dr. Zeitlin, Lahey Clinic, Burlington, MA, is one of the Associate Editors of the APSF Newsletter.

Back to Table of Contents




Soviet Anesthesiologist is First APSF Visiting Professor

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

The Annual APSF International Visiting Professorship has been established to extend and augment the impact of the APSF outside the U.S. This program represents implementations of the first of the ideas generated by the APSF Executive Committee in February intended to enhance the Foundation's future role.

For the first recipient, the Foundation has chosen Professor Elena A. Damir of Moscow, U.S.S.R. Professor Damir had earlier proposed to the Foundation that an American-Soviet exchange program be developed whereby anesthesiologists from the U.S. A. and U.S.S. R. could visit each other's respective countries to foster an open exchange of views and to learn more in the other country about how anesthetic risk can be lowered everywhere.

Professor Damir, who is Chairman, Anesthesia and Reanimatology of the Central Institute of Advanced Training of Physicians at Botkin Hospital, Moscow, and President of the All-Union Society of Anesthesiologists and Reanimatologists, will arrive in Boston on Sunday, October 14. She will then leave on Thursday to attend the ASA Annual Meeting in Los Vegas, and from there go to San Diego, Los Angeles, Gainesville, and New York City.

In each city, she will be hosted by anesthesiologists who have volunteered to extend their hospitality to welcome Professor Damir to America and will visit several medical centers in which there are activities with special emphasis on patient safety. She will give a lecture in each city describing the status of anesthesia and its impact on patient safety in the U.S.S. R. Also, Dr. Damir will be given free time for sightseeing and cultural exchange at each stop.

The APSF is confident that this visit is the beginning of a successful International Visiting Professorship Program and invites comments from Europe-an and other countries regarding patient safety as well as views of the APSF and its goal to have no patient harmed by anesthesia.

Professor Damir, an absolutely delightful person who speaks fluent English, was first encountered by this reporter in Moscow in May at a joint program of the U.S.S.R. Society and the Massachusetts Anesthesia Council on Education. This program provided the opportunity for some 40 American anesthesiologists to learn about anesthesia in the Soviet Union. Several Western European anesthesia professors also contributed to a successful venture.

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

Back to Table of Contents




APSF and STA Co-Sponsor Florida Workshop for Industry

The products provided by industry have a major impact on the practice of anesthesia providers in the operating room and thus on the safety of the patient. AU too often, however, clinicians lament that there are few new and even fewer good ideas coming from industry. Manufacturers, on the other hand, find that understanding what a clinician really wants and needs is no easy task. Further improvements in patient safety will be facilitated if members of industry and clinicians have an understanding of each other's problems, needs, capabilities and goals.

To address precisely these issues, the APSF, in cooperation with the Society for Technology in Anesthesia and the University of Florida, will sponsor "Problems and Promises," a two-day workshop for members of industry. Companies can be represented in up to five product categories machines and equipment, diagnostics, drugs, supplies, and information. Anesthesiologists and industry participants will identify the problems that currently confront the clinician and then go on to identify the promises of the future.

The conference will he held on January 16 and 17, 1991 at the Grosvenor Resort in Lake Buena Vista, Florida. A second conference, "Technology in Anesthesia " sponsored by the STA will be held at the same location on January 18 and 19, 199 1. For additional information, contact APSF at (312) 825-5586.
 

Back to Table of Contents




Letters to the Editor

O.R. Radio Seen as Threat

To the Editor:

Several recent letters addressed the dangerous distraction by noise in the operating room. Many of the devices that produce the noise or alarm are necessary equipment for the task.

However, one piece of equipment does nothing to improve patient care, but is greatly distracting: the radio. It irritates by its noise (commercials, news, etc.), and also raises the general noise level. It forces people to speak louder to be heard and thereby makes communication among the anesthesia team members more difficult. If one is concerned about patient safety, a radio has no place in the operating room.

Evamarie Malsch, M.D.

Associate Professor, Department of Anesthesia

Medical College of Pennsylvania, Philadelphia, PA
 

Back to Table of Contents




Unidirectional PEEP Valves Can Cause Safety Hazards

by Jeffrey B. Cooper, Ph.D.

There is a patient safety hazard associated with the use of unidirectional valves that are inserted into the anesthesia breathing system to generate positive-end expiratory-pressure (PEEP). (1,2,3)

One common design for a PEEP valve is shown schematically in the figure correctly inserted in the expiratory limb of a circle breathing system. The potential exists to insert the valve incorrectly, causing a total or near total obstruction of the breathing system. Some believe such devices to be unacceptable for anesthesia? At least one manufacturer warns against using its machines with any". . components that establish a flow direction." Yet, Most Other alternatives for applying PEEP in an anesthesia breathing system present hazards of their own.

It is reasonable to ask: "Shouldn't any competent anesthetist recognize when a unidirectional device has been inserted in the wrong direction?" Yes, but, under some circumstances, that might not happen. Such would be the kind of circumstances in which accidents typically occur. Consider that PEEP is often chosen intraoperatively at a time when some problem has already surfaced. In an attempt to combat hypoxemia, the clinician is already somewhat distracted by trying to sort out the clinical picture. Consider also that most breathing systems do not clearly differentiate between the inspiratory and expiratory limbs of the breathing system. In the haste of the moment with a patient who may be in trouble, it isn't too difficult to imagine placing the device on the wrong port usually at or near the CO, absorber head. Such events have happened more than once. The same potential exists with older models of humidifiers, which also may be unidirectional.

This problem is not an easy one to solve. A bi-directional valve is one approach. It has a second flow channel with its own one-way valve. If inserted correctly, flow passes through the PEEP-generating mechanism. If inserted in the reverse direction, flow bypasses the PEEP-generating mechanism. PEEP is not delivered, but the breathing system is not obstructed. One problem with such a bi-directional valve can arise if it is used with an older model breathing system like the one illustrated in the figure Unlike newer circle breathing systems, airway pressure is monitored on the machine side of the unidirectional valves. Because PEEP is not transmitted past the valves, it will not be indicated on the gauge. The clinician is dependent on the accuracy of the crude valve markings to know the level of PEEP. It is possible to place such a valve between the breathing system and the ventilator. In that case PEEP should be observed on the breathing system pressure gauge. The valve must still be placed in the correct orientation. If it is placed in the wrong direction, PEEP will not be delivered, but again, there will not be a circuit obstruction.

The greater hazard with the common bidirectional valve or any type of PEEP valve that has adjustable settings is that, if left in the circuit, the valve can easily be set to accidentally deliver PEEP in a patient who would not tolerate it well. Again, with older breathing system, this would not be observed on the airway pressure gauge.

A PEEP mechanism may be optionally incorporated into the CO, absorber assembly or ventilator of newer versions of some anesthesia machines. This effectively prevents incorrect placement of an add-on valve and the consequent danger of obstruction. In one design, an adapter is mounted on the exhalation unidirectional valve of the absorber. This has the disadvantage of having a similar appearance to the APL (pop-off valve and can accidentally be left on in the same manner as the bi-directional described above. In another manufacturer's version, there is a more distinguishable on/off switch. In both cases, integral pressure alarms sensing pressure on the patient side of the breathing system inspiratory unidirectional valve add considerably to safety.

There are other alternatives to address the very real PEEP hazard. In our own institution, we implemented an intense training program for all attendings and staff and adopted a rule that PEEP valves cannot be used without the attending anesthesiologist being present. We also stress the danger of this specific hazard during the in-service training which is required for all new residents. To help prevent the accidental placement of the valve without the elbow adaptor, an adaptor has been permanently attached with permanent adhesive to every PEEP valve. Needless to say, all patients are monitored with pulse oximetry and almost all with capnography.

Some hospitals have adopted a stricter rule, requiring that two people be present when a PEEP valve is inserted, regardless of the training of the senior person.

THE BOTTOM LINE: If you are using a unidirectional PEEP valve, be aware of the hazards. If inserted before the procedure begins, do an appropriate pre-use inspection to be sure that the system is not obstructed. If inserted in mid-procedure, be extremely cautious about where it is placed and check for appropriate indications of ventilation after insertion.

In any event, establish a protocol or guideline that enhances the safe use of PEEP valves in your practice setting. This should include the steps outlined above or the equivalent. It can be hoped that the new anesthesia machines will address this problem and eliminate a hazard for which there is no simple, comprehensive remedy.

Dr. Cooper, Director, Anesthesia Technology, Department of Anesthesia, Massachusetts General Hospital is a member of the APSF Executive Committee.

1. -: Hazard - PEEP valves in anesthesia circuits, Health Devices, 13:24, 1983 (published by ECRI, Plymouth Meeting, PA 19462).

2. ----: Evaluation - PEEP valves. Health Devices, 14:379-394, 1985 (published by ECRI, Plymouth Meeting, PA 19462).

3. Arellano R, Ross D and Lee K: Inappropriate attachment of PEEP valve acusing total obstruction of ventilation bag. Anesth Analf 66:1049-60, 198 7.

4. North American Drager: Operator's Instruction manual, Markomed 3 Anesthesia System, Telford, PA, 1988.


 

Back to Table of Contents




Current Questions in Patient Safety:

What are Implications for Drug Potency and Contamination during Handling of Local Anesthetic Glass Ampules?

Question: Does autoclaving an ampule of lidocaine diminish the drug's potency? If one draws drug from an unsterilized ampule opened and held by an assistant, will unsterile glass particles contaminate the solution injected for spinal anesthesia. Independent of sterility, are minute glass particles in a spinal solution dangerous?

Answer: Stability of Local Anesthetics During Autoclaving

The amide local anesthetics such as lidocaine and bupivicaine are chemically very stable and will withstand autoclaving without significant degradation. The ester local anesthetics such as tetracaine are less stable and should not be subjected to repeated or prolonged autoclaving.

If the local anesthetic is in solution with other compounds (such as epinephrine, dextrose, or bicarbonate) them may be problem with autoclaving. For example, epinephrine solutions are subject to degradation and special autoclaving cycles may need to be used. The degree of breakdown depends upon several factors such as pH, oxygen content of the air in the ampule and the presence of any additives. Dextrose solutions are subject to carmelization with autoclaving and special autoclaving cycles may be necessary. Most sources suggest a cycle of 250 degrees F (121 degrees C) for 15 minutes at 15 PSI. Some quality assurance assay should be used to determine if your autoclaving cycle is effecting your ampules. Carbonated local anesthetic solutions should not undergo any form of heat sterilization.

Glass ampules are prepared from special medical grade glass. The ampules are filled with sterile solution and flame sealed. This sealing process results in a negative atmospheric pressure in the ampule once it cools down. The neck of the ampules are usually scored using a metal etch or chemical score. Upon breaking the ampule, it is very likely that small glass fragments will be drawn inside the ampule. The quantity and size of these fragments has been studied.

Particulate Contamination in Opening Glass Ampules

Perhaps one of the best reports was from R. L. Sabon from Medical College of Wisconsin, reported at the American Society of Critical Care Anesthesiologists meeting and winner of the 1988 Young Investigator Award.

It is possible to reduce the number and average size of particulate contaminants by using a filter needle when aspirating ampules. There are several reports of the effects of these particles when injected intravascularly but I could not find any reports of the effect of intrathecal injection of these contaminants. Based on intravascular complications one might theorize they could impair reabsorption of C.S.L (intravascular particles may cause microembolization to the lungs, cause local phlebitis and inflammation, and granulomas). Again, I have not found any reports of complications of spinal anesthetics attributed to particulate contamination. It was interesting to note that reusable ground-glass syringes can also be a source of glass particles and final filtration during injection may be the best means of reducing particles.

Microbiological Contamination Via Glass Fragments

Since the exterior of glass ampules are often not sterile, any glass fragment from the exterior could introduce microbiological contamination into the sterile solution. The type of organism and quantity would determine the degree of risk from this contamination. Wiping the exterior of the ampule would reduce the risk but would not assure external sterility. Filtration of the solution with a 0.2 2 micron fiber has been advocated to avoid bacterial and fungal contamination but does not protect from viral contamination. Despite this theoretical risk, I have found no reports of infection attributed to contamination through glass fragments upon opening the ampule.

Consequences of Intrathecal Injection of Particulate Contaminants

The consequences of intravenous injection of particulate contaminants have been studied by a number of investigators. Even small (5 micron) particles have been implicated in an increased incidence of phlebitis and pulmonary microemboli. Small fiber contaminants have been known to cause granuloma formation but this is unlikely with inert glass particles. As mentioned earlier, there is no data on the effects of intrathecal injection. Opinions vary on the significance of intravenous particular contamination with some recommending routine in-line wiring of all intravenous lines and others arguing the risk doesn't justify this additional expense. Most practitioners I questioned routinely use a disk filter for epidural catheter injections but not for single-shot epidurals or spinal anesthetics. Few departments have specific policy of when to filter spinal and epidural injections.

Answer by: Mark P. Fritz, M.D., B.S. (Pharrn) Member, ASA Committee on Patient Safety and Risk Management, Medical College of Virginia

Richmond, VA

References

1. Annon: Selected References to Particulate Matter in Parenteral Solutions: Drug Intelligence 1:21-25 (Ian) 1967.

2. Brewer IH, Dunning IHF: An in-vitro and in-vivo Study of Glass Particles in Ampules: Journal American Pharmaceutical Association 36(10):289-293.

3. Cartwright PD, Fyhr P: The Manufacture and Storage of Local Anesthetics: Review Article. Regional Anesthesia 13:1-12,1988.

4. Ernerot L, Sandell E: The Shedding of Particles from Syringes: Acta Pharm Suetica 2:411-420, 1965.

5. F.D.A.: National Symposium on Safety of Parenteral Solutions. U.S. Dept. of Health, Education and Welfare, Washington DC, 1966.

6. Grow MA: The Danger of Particulate Matter in Solutions for Intravenous Use: Drug Intelligence 1: 12-13 (Jan) 1967.

7. Garvan JJ, Gunner BW. Particulate Contamination of Intravenous Fluids: British Journal of Clinical Practice 25(3):119-121 (Mar) 1971.

8. Garvan JJ, Gunner BW: The Harmful Effects of Particles in Intravenous Solutions: Medical Journal of Australia 2:1-6, 1964.

9. Ho NFH: Particulate Matter in Parenteral Solutions A Review of the Literature: Drug Intelligence 1: 7-1 1 Dan) 1967.

10. Ho NFH, Church RL, Lee H: Particulate Matter in Parenteral Solutions: Drug Intelligence 1.3W361 (Nov) 1967.

11. Pinnock CA: Particulate Contamination of Solutions for Intrathecal Use: Ann R Coll Surg Engl 66:423, 1984.

12. Turco S, Davis NM: Particulate Matter in Intravenous fluids: American Journal of Hospital Pharmacy 30:61 1 041973.

13. Turco S, Davis NM: Glass Particles in Intravenous Injections: New England Journal of Medicine 287(23): 1204-1205 (Dee) 1972.

14. Turco S, King RE: Sterile Dosage Forms: Their Preparation and Clinical Application (2nd Edition). Phil: Lea & Febiger, 1979.

15. Young-Sun Lim, Turco S, Davis NM: Particulate Matter in Small Volume Parenterals As Determined by Two Methods: American Journal of Hospital Pharmacy 30:518 (Jun) 1973.
 

Back to Table of Contents




Checklists Cited as Contributing to Safety

Editor's Note: The following is an editorial from Anesthesia (I 990;45:425) reprinted with permission from the author and publisher.

by Dr. J. E. Charlton

Most anaesthetists ensure there has been some check of an anaesthetic machine before its use. (1) This procedure may entail the use of a formal checklist, or it may be a more rudimentary version of the 'kick the tyres, slam the doors, turn the lights on and off' kind. The latter method is akin to a pilot throwing his leather jacket over the back of the seat with merry cries of 'chocks away'; then off into the wide blue yonder, and it is only a matter of time before a 'wizard prang' occurs!

Those of us used to the relatively unsophisticated anesthetic machines of the 60s and 70s may make basic mistakes when confronted with one of the 'mighty Wurlitzer' variety that are becoming more common. Checklists have been available for some time and yet there is ample evidence to suggest that their application is by no means universal (2) despite the fact that many fists were introduced after a serious accident with an anaesthetic machine. (3) The argument follows from this that it is both reasonable and prudent to introduce mandatory checklists as an aid to patient safety.

The United States of America is in the forefront of the introduction of mandatory checklists. The Food and Drug Administration introduced anaesthesia apparatus checkout recommendations in August 1986. The preamble states 'this checkout, or a reasonable equivalent, should be conducted before anesthesia. This is a guideline which users are encouraged to modify to accommodate differences in equipment design and variations in local clinical practice. Such local modifications should have appropriate peer review. (4) Recommendations from a federal body that contain the word 'should' are not voluntary; they are mandatory.

An Association of Anaesthetists of Great Britain and Ireland Working Party has considered the matter of checklists. (5) The Working Party does not suggest that checklists be mandatory as they are in other countries like the U.S.A., Australia and Germany. The Association does not work by prescription, but responds to the demands and needs of its members. The Association has responded in this instance, by obtaining the best advice and passing it on to the membership to do as it pleases. Nevertheless, an 'Association view' is clearly stated. The report recommends that anaesthetic machine check procedures should be performed at the beginning of each operating theatre session.

The anaesthetic machine is a key component of safety, and more and more machines will have automatic monitors build into them to provide added vigilance over both machine and patient. System oxygen concentration and exhaled patient volume monitors may provide early warning of hypoxic mixtures, system leaks or accidental disconnections. Integration of these and other monitors (capnometry, pulse oximetry, noninvasive blood pressure) into the anesthesia system helps to ensure that monitors are switched on and functional before activation of gas delivery and improves the management of the multiple machine and patient connections. (6)

The argument has been advanced that a simple check at the beginning of anesthesia is sufficient, and that any faults will be picked up and dealt with intraoperatively. This may be true in the majority of cases, but modern anesthetic machines are both large and complex: They need to be checked carefully to avoid potential problems. It is just as important to check the older, simpler machines as they approach the end of their working lives. Many hospitals may have found it difficult to replace older machines because of restraints placed upon their equipment budgets.

U.K. Recommendations

The anaesthetic machine checking procedure recommended by the Working Party is simple, and should ensure high compliance. It is not intended to replace schemes devised by individual manufacturers for their machines. The belief of the Working Party is that the introduction of a checklist based on the use of an oxygen analyzer will mean safer practice. This piece of equipment therefore, will become standard. It is pleasant to speculate on the prospect of managers dashing round to anaesthetic departments to offer extra money for such equipment, having be-en won over by the argument that anything that will increase patient safety and reduce the possibility of litigation and thus cost, is a worthwhile use of their hard-won resources.

Performance of such checks forms part of our working day and should not be viewed as an additional burden. However, the concept of making a preanesthetic machine check compulsory is both controversial and provocative. There will be arguments that checks are already carried out by qualified personnel such as anaesthetic nurses, operating department assistants (ODAs), and that for the anaesthetist to repeat them would be a time-consuming reduplication of effort.

The question of who should carry out the checks has already been raised by members who have tried out the proposed checklist after it was circulated for comment. Them is no doubt in the writer's mind that the anaesthetist must check the anaesth6c machine before a theatre session, since ultimate responsibility lies with the anesthetist and cannot be delegated or denied. This does not mean that the anaesthetist should carry out every part of the check personally. It is probably sufficient for the check to be carried out by the anesthetist with another appropriately trained person who could be a nurse or ODA, rather as pilot and copilot check before take-off. This suggestion has the additional advantage that the time taken to perform the check would be reduced.

The report also suggests that a written record of the check he kept in either a specific logbook or on the patient's anaesthesia record. Is this necessary? A simple test of negligence is whether or not the anaesthetist has maintained a reasonable standard of care in treating the patient. A standard of care is, in general, determined by review of written records and the importance of good record keeping is emphasized every year by the defense organizations in their annual reports. Records made today may have to be defended many years from now. A general rule says 'if it isn't written down, it wasn't done.' Keeping a written record of check procedures makes sense.7

There may be other potential benefits. Anaesthetists in the United States have found that their malpractice insurance can be reduced by declarations that they have adopted and abide by checklist procedures and minimal monitoring standards. They are paying the same rates as general practitioners in some states ! This may he an idea that could be taken to our defense organizations.

It is recognized that it may not be possible to carry out a full check in an emergency situation. This should not be a problem where there is a dedicated emergency theatre since it should have been possible to check the machine at an earlier time. Should a true emergency occur it is unreasonable to insist that a full check be carried out, but it would seem reasonable to document the circumstances when time permits.

The recommendations for standards of monitoring published by the Association in July 1988 were "somewhat watered-down before publication because some members of Council had strongly objected to too many words such as 'must' " (9) Times change, and by the College of

Anaesthetists' symposium in November of the year the recommendations were thought to be in need of strengthening. The current mood seems to favour the adoption of higher standards of safety and patient care. The use of checking procedures seems an excellent way to achieve these objectives.

Recent articles have suggested that the introduction of checklists may be a potent factor in reducing both the number and frequency of critical incidents during anaesthesia (10) and that use of checklists and adequate monitoring with current technology may avoid up to 50% of patient injuries: this makes these procedures cost effective in injury prevention. (11) However, we should never forget that one of the many corollaries to Murphy's Law applies; 'it is impossible to make anything foolproof because fools are so ingenious' (12)

Dr. Charlton is Assistant Honourary Secretary of the Association of Anaesthetists of Great Britain, Ireland and London.
 
 
 

References

1. Association of Anesthetists of Great Britain and Ireland. Report of the Survey of Anaesthetic Practice, 1988.

2. Graig 1, Wilson ME. A survey of anaesthetic misadventure. Anaesthesia 1981: 36: 933-6.

3. Leading article. the Westminster inquiry. Lancet 1977: ii: 175-6.

4. Food and Drug Administration. Anesthesia Apparatus Checkout Recommendations. Anesthesia Patient Safety Foundation Newsletter 1986; 1. 15.

5. Association of Anesthetists of Great Britain and Ireland. Checklist for an anesthetic machines. A recommended procedure based on the use of an oxygen analyzer. To be published. 1990.

6. Berssenbrugge A, Plantes K. Anesthesia machine key component of safety. Anesthesia Patient Safety Foundation Newsletter 1986; 1: 16.

7. American Society of Anesthesiologists. Professional liability and the anesthesiologist. Park Ridge, Illinois, 1987.

8. Sabella JD. CA insurer notes fewer claims, lower premiums. Anesthesia Patient Safety Foundation Newsletter 1987; 2:22.

9. Adams AP. Recommendations for monitoring standards in the U. K. and Ireland. Anesthesia Patient Safety Foundation Newsletter 1989; 3. 32-3.

10. Kumar V, Barcellos WA, Mehta MP, Carter JG. An analysis of critical incidents in the teaching department for quality assurance A survey of mishaps during anaesthesia. Anaesthesia 1988; 43: 879-83.

11. Whitcher C, Ream AK, Parsons D, Rubsamen D, Scott 1, Champeau M, Sterman W, Siegel L. Anesthetic mishaps and the cost of monitoring: a proposed standard for monitoring equipment. Journal of clinical Monitoring 1988; 4:5-15.

12. Martin TL Jr. Malice in Sunderland New York: McGraw Hill, 1973.
 

Back to Table of Contents




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 Patent 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 B. Cooper, Ph.D.; Joachim S. Gavenstein, M.D.; James E Holzer, J.D.

Newsletter Editorial Board: John H. Eichhorn, M.D., Stanley J. 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 correspondence to:

Administrator Anesthesia Patient Safety Foundation

515 Busse Highway

Park Ridge, IL 60068

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

John H. Eichhorn, M.D. Editor, APSF Newsletter; Dept. Anesthesia

Beth Israel Hospital, DA-7 1 7 Boston, MA 02215

Back to Table of Contents