Investigation of Anesthesia Machine Check Out Procedures - Anesthesia Gas Delivery Systems (AGDS). Final Report

摘要

In August 1987, the Consumer Protection Division of the Colorado Department of Health submitted a proposal to the Food and Drug Administration (FDA) in response to RFP Number 223-87-4222. The Division proposed to develop and conduct a program to determine, assess and review Anesthesia Gas Delivery Systems (AGDS) and associated monitoring equipment check-out procedures at medical institutions located in several Colorado front range communities during the contract period of performance September 30, 1987 to September 29, 1988. The specific performance objectives of the proposal were to: Determine if these check-out procedures exist; Determine if these check-out procedures are being conducted, by whom and the frequency; Determine if testing, calibration, servicing and maintenance procedures exist; Determine if testing, calibration, servicing and maintenance procedures are being conducted, by whom and the frequency; Determine if responsible individuals (users) are properly aware of procedures and if training is offered and attended; Determine if criteria and procedures for reporting, documenting and resolving AGDS and associated device failure exist; and Collect and report all information to the appropriate FDA offices.