Disinfectant Concentrations and Contact Times for EPA's List of Products Effective against Mycobacterium tuberculosis, Human HIV-1, and Hepatitis B Virus (List E)
March 1, 2023 | Evaluations & Guidance
FDA's 2015 guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling states that "items contaminated with blood or body fluids, which may contain blood-borne pathogens, should be cleaned and then receive intermediate level disinfection with a product having an EPA-registered claim for activity against hepatitis B." Antimicrobial products in the US Environmental Protection Agency's List E are effective in killing Mycobacterium tuberculosis, human HIV-1, and hepatitis B virus. Manufacturers of reusable medical devices may recommend the use of certain generic disinfectants (e.g., isopropyl alcohol) at certain concentrations. But List E contains just EPA registration numbers, product brand names, and company names; it does not include concentrations or required contact times.
To help you more easily determine whether any products on List E match medical device manufacturer disinfectant recommendations, we've created a table listing the...