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Federal Regulatory Action Against Sporicidin Cold Sterilizing Solution

The U.S. Environmental Protection Agency (EPA) has begun testing antimicrobial products registered for use as sterilants and sporicides to determine their effectiveness. The product Sporicidin Cold Sterilizing Solution (SCSS) (EPA Reg. No. 8383-5), registered as a sterilant to reprocess medical instruments that are reused, has failed standard registration efficacy tests. On December 13, 1991, EPA issued a "Stop Sale, Use or Removal Order" against the registrant of Sporicidin, Sporicidin Company of Rockville, Maryland. In addition, on December 13, the Food and Drug Administration (FDA) filed court actions to seize the following five products distributed by Sporicidin Company: SCSS, Sporicidin-HD, Sporicidin Brand Disinfectant Solution, Sporicidin Brand Disinfectant Spray, and Sporicidin Disinfectant Towelettes. The FDA also filed a cease-and-desist order involving SCSS and Sporicidin-HD, the first step toward a mandatory recall of these two products. The Federal Trade Commission filed a district court complaint for a preliminary injunction to prohibit false and misleading advertisement of SCSS.

CDC is not aware of the occurrence or transmission of disease associated with the use of SCSS. However, use of an ineffective sterilant/disinfectant could be associated with an increased risk for disease transmission, specifically as a result of the use of medical instruments that may retain patient material even after vigorous cleaning.

Standard sterilization and disinfection procedures are recommended for reprocessing of instruments, devices, or other items contaminated with blood or other body fluids from persons infected with bloodborne pathogens, including hepatitis B virus (HBV) and human immunodeficiency virus (HIV). HBV and HIV are not resistant to heat or germicidal chemicals; HIV is sensitive to a wide range of common chemical agents. CDC has published guidelines for sterilization and disinfection of reusable medical devices (1). Devices coming into contact with normally sterile areas of the body should be sterilized between uses. CDC recommends that, when possible, devices that come into contact with mucous membranes be sterilized; at a minimum however, such devices should receive high-level disinfection. CDC recommends that liquid chemical germicides registered by the EPA as "`sterilant/disinfectants" be used for high-level disinfection. Germicides that do not meet EPA criteria for a liquid chemical sterilant also do not meet the CDC criteria for a high-level disinfectant.

A number of formulations approved by the EPA as sterilant/disinfectants are commercially available in the United States; many of these products are widely available. Information on products that can be used is available from the EPA information hotline, (800) 858-7377.

Reports of cases of infections suspected of being associated with the use of Sporicidin or other sterilant/disinfectants should be reported through state health departments to the Hospital Infections Program, National Center for Infectious Diseases, CDC; telephone (404) 639-1550. Reported by: Environmental Protection Agency. Food and Drug Administration. Federal Trade Commission. Hospital Infections Program, National Center for Infectious Diseases, CDC.

References

  1. Garner JS, Favero MS. Guideline for handwashing and hospital environmental control, 1985. Atlanta: US Department of Health and Human Services, Public Health Service, CDC, 1985; HHS publication no. 99-1117.



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