Hospital Sterilants:

Insufficient FDA Regulation May Pose a Public Health Risk

HRD-93-79: Published: Jun 14, 1993. Publicly Released: Jun 24, 1993.

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Pursuant to a congressional request, GAO reviewed the regulatory actions of the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the Federal Trade Commission (FTC) that resulted in the termination of sales of a manufacturer's sterilants and disinfectants.

GAO found that: (1) in response to a competitor's complaint, FTC reviewed the manufacturer's advertisements and marketing material for one of its products and determined that the manufacturer falsely advertised the product's effectiveness; (2) in response to FTC findings, FDA and EPA have investigated the manufacturer's products and found them ineffective when used as labelled; (3) FDA has found that the products were not manufactured according to its standards; (4) the manufacturer believed the agencies were not justified in taking regulatory action; (5) the manufacturer obtained premarketing authorization for only one product for limited medical use and contended that its product registrations with EPA gave it marketing authorization for its other products; (6) FDA regulation of hospital sterilants and disinfectants is inadequate, since it does not ensure that products are safe and effective before they are marketed; (7) FDA has allowed manufacturers to market their products without authorization because it does not have sufficient staff to review them; (8) FDA did not begin inspecting manufacturers' facilities until 1990, at which time it found that more than 50 percent of them had deficiencies; (9) the inspections resulted in the seizure of two manufacturers' products, the recommended seizure of four other manufacturers' products, two voluntary discontinuances of product marketing, and four warning letters; (10) coordination of FDA and EPA testing could result in more efficient use of resources; (11) FDA has developed a strategy to inspect manufacturing facilities, test hospital sterilants' and some disinfectants' efficacy, and enforce compliance with premarketing notifications; and (12) FDA does not plan to review 1,200 EPA-registered disinfectants to see if they have medical uses, and has not developed a strategy to ensure that future sterilant and disinfectant manufacturers obtain premarketing authorization.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: 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.

    Recommendation: The Commissioner, FDA, should develop a plan to identify all manufacturers of sterilants and disinfectants and ensure that they comply with the law.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  2. Status: Closed - Implemented

    Comments: 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.

    Recommendation: The Commissioner, FDA, should devise a strategy to ensure that in the future sterilants and disinfectants are not marketed without prior FDA authorization.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  3. Status: Closed - Implemented

    Comments: 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.

    Recommendation: The Commissioner, FDA, should develop procedures, in coordination with EPA, that would satisfy the requirements of both agencies for testing hospital sterilants and disinfectants to avoid unnecessary duplication of product testing.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

 

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