Hospital Sterilants

The Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) were justified in halting sales of a sterilizing solution and disinfectants produced by Sporicidin International, Inc. The sterilizing solution was found to do a poor job of cleaning medical instruments, putting patients at risk of serious infections. The company had been marketing its products without prior FDA authorization and had failed to register its products. FDA inspections at Sporicidin also uncovered significant violations of good manufacturing practices regarding cleanliness and recordkeeping. Although FDA took proper action against Sporicidin, its overall regulation of hospital sterilants and disinfectants has been shoddy, allowing manufacturers of hospital sterilants and disinfectants to market many products without first guaranteeing that they are safe and effective in killing harmful germs.

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

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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