Hospital Sterilants: Insufficient FDA Regulation May Pose a Public Health Risk

FDA has taken no action to respond to the report. FDA informed GAO that as of January 31, 1993, it had identified all manufacturers registered with EPA that should be registered with FDA. EPA informed FDA of 25 companies registered with EPA that manufacture sterilants. On June 4, 1993, FDA and EPA signed a memorandum of understanding (MOU) which defined both agencies' responsibilities. Under the MOU, FDA will have primary responsibility for premarket review of safety and efficacy requirements for liquid chemical germicides that are sterilants intended for use on critical and semi-critical devices. Each agency will assist the other through the use of their registration processes in identifying manufacturers of sterilants and disinfectants.

FDA has taken no action to respond to the report. On June 30, 1994, FDA began requiring that manufacturers of sterilants and disinfectants on the market prior to the FDA-EPA MOU submit premarket notifications and obtain FDA clearance. FDA has employed a variety of regulatory actions to ensure compliance by manufacturerrs of sterilants and disinfectants subject to regulation by FDA. FDA cooperative efforts with EPA have led to seizures, recalls, and warning letters. Premarket notifications have either been submitted for all products identified as requiring 510(k) clearance, or those products have been withdrawn from the market. Formal notification to the industry has been given through publication of the notice of the MOU public meeting in the June 17, 1993 Federal Register. In addition, all manufacturers of sterilants and disinfectants known to FDA were notified of the requirement by letter from FDA. The new requirements were repeatedly brought out by FDA representatives at conference.

FDA has taken no action to respond to the report. On June 4, 1993, FDA and EPA signed a MOU which defined both agencies' responsibilities relevant to disinfectants and sterilants. Under the MOU, EPA is responsible for sampling and efficacy testing of general purpose chemical germicides that are intended for sampling and efficacy testing of sterilants intended for use on devices other than critical and semi-critical devices. FDA is responsible for sampling and efficacy testing of sterilants intended for use on critical and semi-critical devices. Both agencies will share safety and efficacy test results that are of interest to the other agency.