ISO17664:2017[1] states that, where applicable, the following information with regards to the cleaning agent(s) should be included in the IFU; the “identification and concentration of chemicals required” and the “contact time of any cleaning agent used.” It also states that “the medical device manufacturer’s instructions for use can direct the processor to refer to the detergent manufacture’s IFU with reference to concentration, temperature and contact time.” The FDA guidance for reprocessing medical devices[2] further states that “instructions should recommend only cleaning agents or classes of agents that were used during the cleaning validation studies, that have been demonstrated to be compatible with the device, and are effective in cleaning the device.”
Consequently, either a specific detergent that was validated or the class of detergents to which this detergent belongs should be included in the IFU. Detergents are classified based on their characteristics e.g. alkaline detergents, enzymatic detergents, neutral pH detergents, etc. Specifying the detergent class, but not a specific detergent, will give the user more options to perform the cleaning at their facility with the cleaning agents at hand. However, we do recommend including the specific detergent that was used for the validation in the IFU; for example, by indicating this in a separate “validation parameters” section or by mentioning the detergent in parentheses following the detergent class.
In addition to mentioning the detergent or detergent class that was validated in the IFU, it is important to note that as a device manufacturer you should also provide the generic name or general category of cleaning agents and procedures that should not be used because they are incompatible with the medical device, if such incompatibilities are known1,[3]. For example, detergents or detergent classes that are known to damage device materials or affect the device’s biocompatibility should be mentioned in the IFU to instruct users to avoid these products.
[1] ANSI/AAMI/ISO17664-2017 Processing of health care products – information to be provided by the medical device manufacturer for the processing of medical devices
[2] FDA guidance on Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling – March 17, 2015, Revised 2017
[3] TIR12:2020
