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

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Report Type Reports and Testimonies
Report Date June 14, 1993
Report No. HRD-93-79
Subject
Summary:

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.

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