FDA Applauds APSF Efforts

Joseph S. Arcarese; Peter B. Carstensen

Four years ago this past September, officials of the U.S. Food and Drug Administration (FDA) were called to appear before a U.S. House of Representatives subcommittee on oversight and investigations to testify on anesthesia incidents and explain what the FDA had done to fulfill its responsibility to ensure that anesthesia machines were safe and effective. During that hearing, the Congressional subcommittee received testimony from more than one witness that thousands of Americans were dying each year as a consequence of anesthesia incidents and that most of these deaths appeared to be avoidable. It was further disclosed that these avoidable deaths were, for the most part, a consequence of human error and not a result of failure or malfunction of the equipment. These were disquieting revelations which clearly could not he left unaddressed.

In response, FDA witnesses testified that an education and information sharing program directed at anesthesia health care providers appeared to be needed and that FDA believed it could play a role in helping the anesthesia community implement such a program. FDA emphasized that for such a program to succeed, it was essential that it work in a cooperative and coordinated way with anesthesiologists and nurse anesthetists, rather than attempting to implement such a program unilaterally. The Congressional committee was also told that the FDA’s Center for Devices and Radiological Health was prepared to devote significant resources to a long range program in this area.

FDA wasn’t alone in its assessment of the need for a cooperative educational program. This was a conclusion already reached by the three major anesthesia machine manufacturers and most importantly, by the leadership of the ASA. Soon afterward, concerned health professionals working in conjunction with the ASA leadership took the initiative of organizing and chartering the Anesthesia Patient Safety Foundation (APSF) for the expressed purpose of “encouraging activities that wig prevent patients from being harmed by the effects of anesthesia.”

APSF Role

In FDA’s opinion, the APSF has done much to further the cause of anesthesia patient safety. The APSF has provided a needed forum in which manufacturers, health care professionals, malpractice insurance providers, government agencies and other interested parties could share information, ideas and concerns as well as identify activities and develop programs and approaches to improve patient safety. It was dear from the outset that all parties agreed that anesthesia needed to be safer and could be made safer, and that all parties had a major self interest in achieving this goal. The APSF has been especially effective in establishing and fostering a spirit of trust among these different parties. This is a trust without which effective cooperation would have been impossible.

The Foundation, through the APSF Aleu4efter has provided anesthesiologists and nurse anesthetists as well as other interested parties with useful, timely information and news specifically related to anesthesia patient safety. This is the only periodic publication of its kind solely dedicated to fulfilling this very important educational need. The Foundation has assured its wide distribution by mailing it to every anesthesiologist and nurse anesthetist in the U.S. whether they are APSF members or not.

The newsletter is not the only educational product of the Foundation. It has also produced three educational videotapes on patient safety, a much needed text on “Capnography” and one on “Safety and Cost Containment in Anesthesia”.

The APSF’s research grants program has made possible a number of important research studies in anesthesia patient safety Considering the modest dollar amounts of research funding which the Foundation has been able to contribute, the program is a remarkable success. The Foundation I& a great need in its support of research aimed specifically at patient safety. Unfortunately, it remains one of the few sources of support for such research.

Much has been accomplished to advance anesthesia patient safety over the past four years, and in large measure that progress can be traced to the Foundation’s educational and research activities. Much, however, still remains to be doneIn FDA!s view, hospitals still need to be encouraged to upgrade equipment. There are far too many hospitals still operating with outdated anesthesia mach–Although many hospitals have purchased pulse oximeters, capnographs, and other modem monitoring equipment, many other hospitals have not yet taken advantage of this important way of helping to improve patient safety.

FDA is enthusiastic about the potential of anesthesia simulators and training aids to dramatically improve anesthesia training programs m the futureThe APSF, through its wwarch grants program and the activities of its Committee on Education and Trainms, is at the forefront in heipms to advance this promising new training modality.

It is FDA’s hope and expectation that the APSF will continue to contribute to the advancement of anesthesia patient safety. The APSF serves as a model for other medical specialties seeking to improve the quality of medical care for their patients through a cooperative forum involving the health care professions, industry, government and other interested organizations.

Mr. Arcarese is Director, Office of Training and Assistance, Center for Devices and Radiologic Health, FDA, and Mr. Carstensen is Engineering Consultant in the same agency.