Sterilants and High-Level Disinfectants

Which federal agency regulates liquid chemical sterilants and high-level disinfectants ... 

Equipment used in medical practice for disease diagnosis, which come into contact with the body, must be sterilized. Nonsterilizations can cause transmission of infection from one person to other. Commonly, 2% glutaraldehyde solution is used. Instruments must be kept in the solution for at least 3 hours, but high-level disinfection is achieved in 20 to 30 minutes for most. Glutaraldehyde is an irritant and may cause sensitization. Alternatively, paracetic acid, chlorine dioxide, and superoxidized water are used for this purpose. 

The safety and biocidal efficacy of glutaral has led to its endorsement by the CDC and WHO as a substitute for formaldehyde in high-level disinfection and cold sterilization (1,2). Glutaral is used in a 2% aqueous solution buffered to a pH of about 8 for sterilization of endoscopic and dental equipment and for other equipment that cannot be sterilized by heat. 

Critical instruments come into direct contact with the patient s bloodstream or other sterile areas of the body. Examples of critical instruments include needles, surgical instruments used within the body, IV catheters, peritoneal endoscopes, and kidney dialysis membranes. Semicritical instruments must be free of pathogenic organisms. Examples of semicritical instruments are gastrointestinal endoscopes, bronchoscopes, vaginal speculums, respiratory care devices, and anesthesia equipment. Semicritical instruments must, at a minimum, require high-level disinfecting. 

Food and Drug Administration. Guidance for Industry and FDA Reviewers Content and Format of Premarket Notification [5I0(k)] Submission Chemical Sterilants/High Level Disinfectants. Rockville, MD US Department of Health and Human Services, Food and Drug Administration, 2000. 

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