title: An assessment of the effectiveness of the revised FDA checklist.
abstract: In 1978, the Food and Drug Administration (FDA), developed a generic anesthesia equipment preuse checklist. The checklist was first released by the FDA in August 1986 and endorsed by the American Association of Nurse Anesthetists on October 18, 1986. The FDA checklist was revised in 1992 to improve the abilities of anesthesia providers to detect machine faults. In the present study, the investigators attempted to determine the effectiveness of the revised FDA checklist in detection of anesthesia machine faults as compared to providers' usual methods. Whereas no published study of preanesthesia safety inspection had been performed since the revision of the FDA checklist, the authors compared the detection abilities of anesthesia providers before and after inclusion of the revised FDA checklist. Twenty-two anesthesia providers were tested to compare the number of prearranged anesthesia machine faults that could be detected with (1) their usual checkout methods, and (2) with the revised FDA checklist. Data describing the subjects' fault detection abilities were analyzed using the t test for paired observation (P value < 0.05 considered significant). Statistical analysis revealed no significant difference (P = 0.479) when subjects used the FDA checklist and when they used their usual method. Use of the FDA machine checklist was no more effective than the provider's usual method in discovering machine faults. When using their normal method, 54.5% of providers did not discover more than 50% of programmed faults. Approximately 40.9% of providers who used the revised FDA checklist did not discover over 50% of programmed faults.
authors.affiliation: Alaska Native Medical Center, Anchorage, USA.
authors.forename: R
authors.initials: R
authors.lastname: Manley
authors.forename: J D
authors.initials: JD
authors.lastname: Cuddeford
mesh_terms: D000776:Anesthesiology / Q000295:instrumentation* / Q000592:standards*; D004868:Equipment Failure; D004869:Equipment Safety; D017408:Guidelines as Topic; D006801:Humans; D009719:Nurse Anesthetists; D014481:United States; D014486:United States Food and Drug Administration