Volume 6, No. 3 • Fall 1991

FDA Pre-use Equipment Checklist Spurred by Accidents, Studies

Marcia J. Withiam-Wilson, R.N., M.S.

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health has advocated the use of a pre-use checkout procedure for anesthesia gas machines (AGM) because we believe that it assures with a reasonable degree of confidence that a properly functioning device is available at the beginning of an anesthetic.

The data available to FDA through the Medical Device Problem Reporting System and the medical literature suggest that if brief checkout procedures (daily and prior to each case) were conducted by the anesthesia care provider, a significant number of AGM related patient injuries and deaths could be prevented.

In a 1982 study of 190 persons attending an anesthesia meeting, Buffington et al., found that only 3.4 percent were able to identify five faults intentionally created in a standard anesthesia machine. 7.3 percent of participants found no faults, and the average number of identified faults was 2.2 out of 5. These results suggested a need for greater emphasis: 1) on the fundamentals of anesthesia machine design, and 2) on the detection of potential hazards as part of educational programs. At the time, it was thought that the universal acceptance of one standard checkout procedure for AGM’s would facilitate the education of all anesthesia professionals regarding equipment issues.

In September, 1986, the APSF Newsletter published the draft FDA issued “Anesthesia Apparatus Checkout Recommendations” (final publication 2/25/87) providing a one-page general checkout and inspection procedure designed to be performed daily and, in an abbreviated form, before each case by anesthesia professionals.

In an attempt to measure the use of the checkout recommendation, the FDA initiated a survey at medical institutions in four states, Alabama, Colorado, Iowa, and Washington in September of 1987. A total of 125 medical facilities were visited. The sample included 37 hospitals with less than 100 beds, 40 hospitals with 100-300 beds, 31 hospitals with more than 300 beds, and 17 ambulatory surgical centers. In total, 404,700 anesthesia procedures were performed at these facilities in 1987 (371,441 in the hospitals, and 33,259 at the ambulatory surgical centers).

A cross-sectional survey with face-to-face interviews was carried out in which participants were asked whether or not there was a documented AGM checkout procedure at their facility. Of the 125 facilities surveyed, 70 percent (87) responded yes. Of these, however, only 26 percent (32) reported that they used the FDA checklist for their checkout procedure.

Ninety-one (73 percent) of the facilities reported that a thorough AGM checkout was performed at the beginning of each day or shift even though some did not have a documented procedure for this. Only 74 (59 percent) reported that a partial checkout of some sort was consistently done between cases.

These results indicate that the AGM checklist issued by the FDA is not widely used. Sources of other checklists reported in the sample included the facility itself, the AGM manufacturer, and the anesthesia professional’s memory. While it is encouraging that the majority of facilities surveyed (70 percent) reported using some type of documented AGM checkout procedure, less than half of them (37 percent) used the FDA version.

An internal study of AGM-related death reports in the FDA Medical Device Reporting (MDR) data base covering the period of December, 1984 through December, 1988, revealed 86 reports of deaths which had occurred either during anesthesia, or within 24 hours of anesthesia, or were associated with anesthesia management. Thirty-seven of the 86 reports were judged to be anesthesia mishaps. Twenty-seven of these 37 mishaps were judged to be user error associated with the equipment. It should be pointed out that no equipment failures during anesthesia were noted in any of the reports. A further analysis of the 27 deaths judged to be due to user error related to anesthesia equipment indicated that 19 percent (5) of these deaths may have been avoided by a proper pre-use checkout.

The results of a George Washington University Medical Center/FDA study reported by March and Crowley at the October, 1990 ASA meeting indicate that anesthesiologists using the FDA checklist detected an average of one out of four intentionally created faults in a standard anesthesia machine. Preliminary results of another study suggest that a brief training period prior to testing resulted in almost 100 percent improvement in the subjects’ ability to find these faults. However, even after the training, the anesthesia professionals found about 50 percent of the faults.

FDA is in the process of expanding and improving the training materials for anesthesia machine checkout procedure. The agency is also examining and evaluating the existing checklist. It may be that the utility of certain checklist items, for instance, checking of the oxygen fail-safe system, may no longer be necessary, now that advanced monitoring systems such as oxygen analyzers and pulse oximetry have become standard in most operating rooms. (See accompanying article)

Ms. Withiam-Wilson is Nurse Consultant, Division of Technical Development, Office of Training and Assistance, Center for Devices and Radiologic Health, FDA.