By Christopher Guadagnino, Ph.D.

Published February 2000

• Impacts of error reduction initiatives
  

• Improving pharmaceutical safety
  

• React to this article in the Discussion Forum.

Ellison C. Pierce, Jr., M.D., is executive director of the Anesthesia Patient Safety Foundation, headquartered in Pittsburgh.

PND: What led to the formation of the Anesthesia Patient Safety Foundation?

EP: In the early 1980s I was in line to become president of the American Society of Anesthesiologists, and I had been collecting data for a decade or so on anesthesia accidents. About that time there was a TV program delineating the terrible accidents that were occurring in anesthesia across the country. As president-elect of the Society, I was able to appoint a new committee called the Anesthesia Patient Safety and Risk Management Committee of the American Society of Anesthesiologists. It was widely accepted and became very active quickly. Among the things it did was start publication of a series of some 30 patient safety videotapes over these 20 years. It called attention to issues and it urged that there be research into this area of anesthesia accidents.

The year I became president in 1984 there was established in Boston an international symposium on anesthesia safety, mortality and morbidity and I was one of the principals involved. Out of that we came to discover that there are great discrepancies in the approach to solving this among people from the United States and people from abroad—England, South Africa, Australia. We were much more interested in technological corrections, whenever possible, than they were. We looked for a vehicle to carry this work on, first at the United Nations and other places, but that obviously would have been a political nightmare. So we decided to establish our own separate foundation. And we did that with seed money from two anesthesia machine manufacturing companies and from the American Society of Anesthesiologists. But we wanted to be independent from them because we thought it was necessary to have, not only anesthesiologists on our board, but also representatives from the manufacturing industry, pharmaceutical industry, the JCAHO, FDA, American College of Surgeons, American Medical Association, lawyers, people from the medical liability insurance companies, which we did, and it was incorporated very quickly and took off.

One of the two main areas of our interest and support over these 15 years has been awarding each year somewhere between $50,000 and $75,000 as starter grants in anesthesia safety research, three of these a year. It’s interesting to note that when all of this started at the annual scientific meeting of the American Society of Anesthesiologists there were virtually zero papers on anesthesia safety. Now, in the last year, there are well above 100. In fact, they have created their own section called Epidemiology and Safety.

The other direction the Foundation went was to publish a quarterly Anesthesia Patient Safety Foundation Newsletter which has been immensely successful. We distribute about 60,000 copies a quarter to every practitioner of anesthesia in this country and many abroad, including anesthesiologists, nurse anesthetists and residents. It’s very popular, perhaps the most widely read anesthesia periodical. We also now have a website which has taken off quite nicely.

PND: What impacts have these two activities had on the way anesthesia is practiced in the U.S.?

EP: We believe that when we started in the early 1980s the death rate from anesthesia was about one in 10,000 anesthetics. We believe today that it’s about one in 200,000. What’s the evidence in favor of that statement? Fifteen, twenty years ago the malpractice insurance premiums for anesthesia were way up at the top. You may know that you take a base malpractice rate in a given jurisdiction and multiply it by the relativity factor, which for anesthesia in those days was about five or six. So, if the base was $5000, you were paying as an anesthesiologist about $30,000. Now we are down to around one or two relative value factor, so it means we’re mostly paying between $5000 and $10,000, which is a dramatic improvement and that’s not been seen in any other specialty. Since the insurance companies run their shops on money, we think that’s strong evidence that things are much safer.

There’s also a closed claim study, looking at lawsuits after the claim is shut down, carried out by the American Society of Anesthesiologists. Fifteen or twenty years ago about 40 percent of the deaths from anesthesia were related to ventilation respiratory failures, that is, either a disconnection between the patient and the breathing machine or failure of the anesthesia person to put the endotracheal tube in the trachea—they would accidentally put it in the esophagus and that wouldn’t be recognized. We have evidence on studying those claims now that those two errors have virtually disappeared. So that’s an enormous savings in deaths. For example, 20 years ago about three percent of all the malpractice claims in this country were brought against anesthesiology. But 12 percent of all the money paid out was paid out to anesthesiology because of the huge seriousness of their accidents and mishaps. Now the number of claims is still about three percent but the payout is three percent. So that would show that we’ve gotten rid of many of the huge claims.

Another reason that respiratory problems have declined so markedly is that, in the mid 80’s, there came into general use two devices. One was the pulse oximeter, a device that’s attached to the fingernail and it tells you the level of oxygen saturation in the blood at all times, so you have a constant recording on a screen of whether or not the patient is adequately oxygenated. The other device was a capnometer or capnograph, a device that measures expired carbon dioxide from the lungs, and if something happens and the lungs aren’t being ventilated, obviously there’s no expired carbon dioxide so the screen would tell you that. That machine also would detect if the breathing tube were placed in the esophagus instead of the trachea. Those two technological devices have made an enormous difference, but the improvement lies in many other areas. The anesthesia machines have been redesigned to be much safer. They have automatic devices that shut them down or give an alarm if something is going wrong. The anesthesia drugs are better now than they were 15 or 20 years ago. Training in anesthesia residency programs and in nursing schools is much better than it was. Studies of mishaps and morbidity and mortality in a given hospital are much better than they were.

PND: Are there any reporting mechanisms or databases used to reduce anesthesia errors?

EP: Not in this country. We’ve tried for years but because of the legality, the possibility of lawsuits anytime you report anything to anybody, there’s no protection. We’ve not been able to figure out a way to do it. There’s a critical incident reporting system in Switzerland and there’s one in Australia. But we don’t have one. In the recently issued Institute of Medicine report, one of their strong recommendations is mandatory reporting. There’s a lot of mixed feeling about whether that’s going to be protected adequately or not. I’ve not made up my mind about that yet. They do recommend that the report go to the state level, but in the 20 or so states which are already doing this the reporting system is usually very bad and not working. Anonymity to do this is very difficult to come by because of the political leverage of the plaintiff’s bar, I guess. And little is done to study the data for lack of funding and resources.

PND: Does the Foundation offer substantive safe practice guidelines and protocols for anesthesiologists?

EP: The standards movement for anesthesia practice really began in Harvard in 1984 and included such basic things as that the person giving anesthesia must remain in the room at all times, that there must be adequate observation of the oxygenation, ventilation and blood pressure of the patient. Those spread rapidly and were adopted a year later by the American Society of Anesthesiologists. Since that time, there have been another dozen or more standards and/or guidelines published by the American Society of Anesthesiologists. But, since we have on our board more than just anesthesiologists—we have manufacturers—we were advised and totally agreed that we would not do standard guidelines because they could be construed as a conflict of interest as far as the manufacturers were concerned. So it’s been the American Society of Anesthesiologists that has drafted and printed the guidelines and standards and they’re readily available from the Society. We have a few suggested guidelines on our website taken from other areas, such as what to do when you have an accident, but we deliberately stay out of the business of prescribing guidelines.

PND: How is the Foundation organized?

EP: We have a board of directors on which there are 40 people—20 anesthesiologists and 20 non-anesthesiologists, including a president of a drug company, general manager of Hewlett Packard, members of the AMA, the American Hospital Association, several insurance companies, the FDA. There are four committees, one each for newsletter publication, research grants, education and technology. The education committee has looked at ways of distributing questions that are sent in to our website from different anesthesiologists and having them reviewed by experts. They’ve looked into urging each hospital to have its own safety committee in anesthesiology. The technology committee is currently looking at hazards of office-based anesthesia, which are severe now. They’re going to primarily report literature so far. Office-based surgery is completely unregulated. It’s not unusual for the surgery to be going on in an office in which there’s no resuscitation equipment available, no one trained in resuscitation, in recovery room care. Grossly inadequate anesthesia equipment. Since the Foundation is not a regulatory organization, all we can do is recommend that the states look at this. We are working closely on this subject with the American Society of Anesthesiologists, which is going to make even stronger recommendations.

PND: How might the Foundation’s activities be translated to other specialties?

EP: Not all of it can be. The technological successes with those two devices I described are only transferable to a few other specialties. But I think many other areas can be transferred. For example, I think every specialty society should have a very active patient safety committee that supports research and communicates safety.