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Reprocessing Validation for Medical devices

The importance of ensuring your products and instruments are clean and sterile every time they come into contact with a patient or end user cannot be overstated. The burden of responsibility falls on the manufacturers of finished medical devices to provide clear, understandable and reproducible cleaning and sterilization protocols that have been validated to be effective.


U. S. Food and Drug administration updated last year its guidance on reprocessing medical devices in health care settings.

The guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” was issued in 2015 and the update affected Appendix E “Devices for which a 510(k) Should Contain Data to Validate Reprocessing Instructions”.

Reprocessing is defined as validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use. These processes are designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization.

FDA defined six criteria for reprocessing instructions:

1)  Labeling should reflect the intended use of the device;

2) Reprocessing instructions for reusable devices should advise users to thoroughly clean the device;

3) Reprocessing instructions should indicate the appropriate microbicidal process for the device;

4)  Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed;

5) Reprocessing instructions should be comprehensive;

6) Reprocessing instructions should be understandable.

FDA will review the reprocessing instructions included in the labeling during the review of premarket submissions for reusable medical devices and requires that the reprocessing instructions should reflect the validated methods.


With more than 30 years of experience in this field, Eurofins Medical Device Testing offers a broad range of microbiological, bio-/chemical and toxicological testing to examine products for the intended reprocessing procedures according to current industry

standards and expectations to validate procedures for manual and automatic cleaning, disinfection and sterilization.