In 1984, there was persuasive evidence that a significant number of anesthesia accidents might be avoided if anesthesiologists and nurse anesthetists made comprehensive pre-use checks of their equipment routine. FDA worked with the American Society of Anesthesiologists (ASA), equipment manufacturers, anesthesia providers, and other professionals to develop a pre-use checkout list for the machines. The list was published in the Federal Register early in 1987, and in the professional journals and newsletters of the Anesthesia Patient Safety Foundation, the ASA, and the American Association of Nurse Anesthetists.

A series of videotapes also was produced by ASA with the help of FDA. A drug manufacturer helped with the program by underwriting the duplication and distribution of some of the videotapes to anesthesiology departments and services.

FDA is a member of the Anesthesia Patient Safety Foundation, an important forum for discussion of issues by health professionals, industry, government, insurers, risk managers, and others interested in continuing and improving the safety record for anesthesia. The foundation has supported a number of important educational programs.

Another important effort in anesthesia safety has been the gathering of information about the age and use of anesthesia equipment. The first phase of the survey, begun in 1985, was conducted in Iowa and Texas and showed that one-third of equipment in use at that time was 10 years old or older, and thus lacked the latest safety features. FDA and the Anesthesia Patient Safety Foundation developed an educational program to make anesthesia departments aware of the features and capabilities of newer equipment.

FDA also began gathering information in 1987 at 130 hospitals in Iowa, Alabama, Colorado, and Washington state on their anesthesia device maintenance procedures, use of the pre-use checklist, and use of patient monitors during anesthesia. Another study is under way to determine the effectiveness of pre-use anesthesia machine checkout routines. The study is a joint effort of FDA and the George Washington University Medical Center's Department of Anesthesiology. It is being conducted in Washington, D.C., hospitals and at professional conferences. The study tests the understanding of procedures and equipment by creating realistic faults in sample machines with which the anesthesiologists are familiar.

Measuring Results

Have these efforts had a measurable effect? Evidence is accumulating that anesthesiologists are experiencing the greatest improvement in the incidence of medical liability claims of any specialty, according to the Anesthesia Patient Safety Foundation's Dr. Pierce.

William A. Cass, risk manager for the Massachusetts Joint Underwriting Association, which insures the majority of Massachusetts anesthesiologists, has said anesthesia professionals "have made the practice a low-risk procedure." And James F. Holzer, vice president of the Risk Management Foundation, Cambridge, Mass., wrote earlier this year that "The results of intensive patient safety activities within the specialty have been, in my opinion, nothing short of remarkable."

A study by the General Accounting Office of rates in six states (North Carolina, Florida, New York, California, Arizona, and Indiana) for malpractice insurance among anesthesiologists and five other medical specialties (general practice, internal medicine, general surgery, OB/GYN, and neurosurgery) showed anesthesiology among the least expensive or the lowest in percent of increase for premiums between 1980 and 1986.

Improved technology and pre-use checks of equipment aren't the only efforts anesthetists are using to maintain and enhance their safety record. Studies have shown that only 1 in 20 deaths relating to the administration of anesthesia is the result of equipment failure alone. Most incidents are related to operator error or a combination of operator and equipment problems.

That brings us back to the 65-year-old man undergoing the mastoidectomy. Fifty-six minutes into his operation, the resident noted an increase in the pressure of the gases being pumped into his lungs. She checked beneath the surgical drapes to be sure the tube was not kinked and warned the surgeon against accidentally obstructing it as he worked close to the patient's airway. The airway pressure reading remained high, and another readout warned her that the patient's carbon dioxide level also was increasing, indicating he was not "ventilating" as well as before. Also, his blood pressure was beginning to climb.

Turning down the output of the ventilator to the patient resulted in a decrease in the pressure reading in his endotrachial tube within two minutes of the time the problem began. Still, there was an indication of trouble — a reduced volume of expired air. And oxygen saturation in the patient's bloodstream had begun to fall. Three minutes had gone by. The resident reacted to these changes in the patient's condition by making more checks on the many connections of tubes and of readout devices. Deciding the tube had been pushed too far into his trachea, the resident retracted the breathing tube a slight distance. Within minutes, the patient's breath sounds were again similar in both lungs and his vital signs were again stable.

But, as the resident began to relax and return to routine monitoring, the patient's intravenous fluids line became blocked and needed attention. Then, when the surgeon drilled on the patient's mastoid ridge, a warning alarm sounded. The patient's heartbeat had shifted to a rapid and dangerous rhythm, and his blood pressure was sinking to a dangerous level. As the resident's mind and hands raced to interpret and react to these gathering problems, the patient went into cardiac arrest. Surgery was stopped and cardiopulmonary resuscitation began.

However, this patient's heart attack did not become another statistic on anesthesia safety. The "patient" is a mannequin, enhanced by computers and other devices to make the simulations of emergencies as lifelike as possible. The scenario describing his "problems" may prevent a real patient from having them. The hypothetical case was developed from the work of David M. Gaba, M.D., of the Department of Anesthesiology, Stanford University in California, and other researchers.

An old saw among pilots is that their work is "hours and hours of sheer boredom interrupted by moments of stark terror." Researchers, finding a parallel between aviation and anesthesiology, are applying increasingly realistic simulators — much as have the makers and users of complicated aircraft — to training for infrequent and complex anesthesia emergency events and procedures.

The National Safety Council's 1989 edition of Accident Facts says 2,200 people died in pedestrian accidents on rural roads in America last year. For the same period, anesthesia was involved in an estimated 150 deaths. Across the United States, almost 60 times every second of every day, someone undergoes some medical or dental procedure that is made easier and more comfortable for them through the use of anesthetics and the skills of anesthesiologists and nurse-anesthetists. Comparing anesthesia's record of safety to the National Safety Council's report, undergoing an anesthetic procedure is about 15 times safer today than going for a walk on a country road.

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About the Author

FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.