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
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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