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High Level Disinfection Guidelines


Both HICPAC (Healthcare Infection Control Practices Advisory Committee) and CDC (Center for Disease Control and Prevention) offer guidelines on the disinfection of patient-care equipment. Any instrument which comes in contact with mucous membranes is a semi-critical device and requires a high level disinfection after each use. Therefore, endocavity probes such as vaginal/rectal probes and TEE probes must undergo a high-level disinfection with a high-level disinfectant. T-Spray and other topical sprays and wipes are not FDA approved for high-level disinfection. The list of FDA approved disinfectants are found on the following link: http://www.fda.gov/cdrh/ode/germlab.html

Publications and Links

1. HICPAC Guideline for Environmental Infection Control in Health-Care Facilities, 2003
http://www.cdc.gov/ncidod/dhqp/gl_environinfection.html
  • Pg 71: Chapter of Interest: E. Environmental Services 1. Principles of Cleaning and Disinfecting Environmental Surfaces.
  • Pg 72-73: The process of high-level disinfection, an appropriate standard of treatment for heat-sensitive, semicritical medical instruments inactivates all vegetative bacteria, mycobacteria, viruses, fungi, and some bacterial spores. High-level disinfection is accomplished with powerful, sporicidal chemicals (e.g., glutaraldehyde, peracetic acid, and hydrogen peroxide) that are not appropriate for use on housekeeping surfaces. These liquid chemical sterilants/high-level disinfectants are highly toxic. Use of these chemicals for applications other than those indicated in their label instructions (i.e., as immersion chemicals for treating heat-sensitive medical instruments) is not appropriate.
  • Pg 208: Semicritical devices: medical devices that come into contact with mucous membranes or non-intact skin.
  • Pg 208: Spaulding Classification: the categorization of inanimate medical device surfaces in the medical environment as proposed in 1972 by Dr. Earle Spaulding. Surfaces are divided into three general categories, based on the theoretical risk of infection if the surfaces are contaminated at time of use. The categories are "critical," "semicritical," and "noncritical."


2. The Center for Disease Control and Prevention Sterilization and of Medical Devices
http://www.cdc.gov/ncidod/dhqp/bp_sterilization_medDevices.html
  • Reusable devices or items that touch mucous membranes should, at a minimum, receive high-level disinfection between patients.


3. FDA-Cleared Sterilants and High Level Disinfectants
http://www.fda.gov/cdrh/ode/germlab.html
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