Nelson Labs Advises Reusable Medical Device Manufacturers to Follow New FDA Guidance


Nelson Laboratories strongly recommends that reusable medical device manufacturers reevaluate their validation testing procedures following a growing trend of increased scrutiny by the Food and Drug Administration (FDA) of the currently accepted validations for cleaning, disinfection and sterilization methods for their devices.

"It is clear the FDA is recommending increased testing procedures that more closely simulate the actual and clinical use of reusable medical devices, says Alpa Patel, department scientist for hospital reprocessing at Nelson Laboratories. As indicated by recent responses, the FDA would like manufacturers to perform testing on three runs for cleaning validations. This is a change from previous practices and is catching many manufacturers by surprise.

Specifically, the FDA would like to see validations performed in worst-case scenarios, which include:

Using clinically relevant soils.
Performing more runs of the validation.
Performing an exhaustive extraction to obtain extraction efficiency.
Performing end of use life testing.
Manufacturers will need to use test soils during validation that simulate actual use and are clinically relevant. The FDA is also requesting testing of worst-case dwell times the time between patient use and actual cleaning of a reusable device.

Additionally, the FDA is increasingly requiring cleaning validation analysis using a series of assays such as protein, hemoglobin, carbohydrate, endotoxin and total organic carbon. A focus on these markers is a change over the old process, which focused on bioload reduction. The FDA would also like to see manufacturers validate their devices using the labeled dose and time recommendation of the detergent used during cleaning.

Based on our experience with multiple companies who have received FDA responses requesting additional testing, manufacturers should become familiar with the recently published FDA draft guidance document, says Patel. Failure to do so may increase risk and delays in product launches.

Nelson Laboratories is a leading provider of full, life-cycle microbiology testing services.

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