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If your company’s high-level disinfectant research and development phase is complete and you have finished all of the GLP in vitro efficacy tests required by FDA, then you are ready to conduct the final test, the clinical “in-use” test. Passing this test proves that your product will perform under the rigors and stresses of clinical use.

The U.S. Food and Drug Administration realizes there are numerous challenges not addressed by in vitro testing that can alter the efficacy of a high level disinfectant product. The clinical in-use test provides a way to confirm the efficacy of high-level disinfectant products safely in real-world applications.

Clinical in-use tests expose high-level disinfectants to challenges including worn or rough endoscopes, blood, mucus, and wild-type microorganisms.  In addition, scopes that have been used for years in clinical practice may have developed biofilms, which are notoriously difficult to disinfect.  Success criteria for the Clinical In-Use test is zero recovery of vegetative bacteria and fungi after exposure to the test product following instructions for use.

There are many high-level disinfectant and sterilant products that are marketed for the purpose of endoscope or probe disinfection and sterilization. In order for these machines and disinfectants to be on the market, they had to go through clinical in-use testing. The FDA requires testing to be done per each disinfectant per disinfector. In other words, just because a machine and disinfectant are approved by the FDA does not mean they are approved to work together.

Clinical testing is conducted by the laboratory as follows:

  •  Laboratory staff travel to hospitals or clinics that perform procedures with the specific devices required for testing.
  •  After the medical device is used in a procedure, it is swabbed (recovered) for microbial presence, disinfected with the test product, and then swabbed for any remaining microorganisms.
  •  After this testing portion is complete, the medical device is sterilized per the facility’s standard operating procedure.

The parameters for clinical in-use testing can vary depending on the product’s intended use and can be a lengthy process.  Microchem is one of the few laboratories in the United States to offer clinical in-use testing for high-level disinfectants.  For comprehensive guidelines on FDA 510(k) submission requirements, check out this section of the FDA website.