A white paper by Patrick Kenny
The cost associated with the medical devices utilized in healthcare facilities has led them to be reused many times during their lifetimes. A validation of the cleaning procedure to remove residual patient soil must be completed by the device manufacturer prior to submission to the FDA.
Government regulations state that a reusable medical device must have both adequate directions for use and for processing prior to application on the next patient. Guidance documents that are available for review now indicate that the traditional method of cleaning validation, spore log reduction, will no longer be acceptable and that analytical assays capable of providing quantitative results will be the requirement. Although a new requirement for reusable medical devices, these tests are traditional analytical assays that are performed routinely on other types of samples.
This paper reviews how an effective protocol and report that include justifications for the test soil and assays chosen, as well as thorough documentation of all parameters used in the validation, will help ensure success for your reusable medical device submission.