Recommendations for Designing Studies for the Validation of Reprocessing Instructions

In FDA, Microbiology, Packaging & Stability by Staci DeMoss


With the recent release of the FDA guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff”1, the recent safety alert issued on “the complex design of duodenoscopes. . . causes challenges for cleaning and high-level disinfection [such that] effective cleaning of all areas of the duodenoscope may not be possible”2, and the recent article “FDA advisor panel recommends costly sterilization before reuse amid deadly superbug outbreaks”3, the requirements for validating device reprocessing instructions have become more rigorous for device manufacturers. The following factors are recommended for consideration when designing these reprocessing validation studies:

  1. Test samples provided for reprocessing validations (e.g., sterilization, cleaning, and disinfection) should be exposed to simulated use cycles including soiling, cleaning, and sterilization or disinfection, prior to use. Devices should not be tested as newly manufactured device.
  2. Validation protocols should include a side by side comparison of the Sponsor’s recommended reprocessing procedure and the protocol reprocessing procedure to allow for identification of worst case parameters (e.g., shortest times, lowest dilutions, etc.) selected for testing.
  3. The artificial test soil selected for cleaning validations shall consider the composition of actual materials exposed to the device during worst case clinical use. In addition, the soil should allow for a least two clinically relevant soil components to be quantified during testing. Note: The FDA does not recommend the use of bacterial spore log reduction testing to determine the effectiveness of the cleaning method.
  4. Cleaning validations should include multiple full use cycles to assess the accumulation of soil on the device over time. Multiple reprocessing cycles, including soiling, cleaning, sterilization or disinfection, should be considered when designing the accumulation cycles.
  5. Rinsing instructions for cleaning and disinfection studies should be validated to ensure that remaining cleaning and disinfection agent residuals are reduced to a non-toxic level and do not interfere with subsequent reprocessing steps. Consideration of the cleaning/disinfecting agent manufacturer’s instructions for rinsing recommendations should be made.
  6. Address reuse life of the device by either including the number of times the device can be reused, based on testing, or providing the user with a mechanism or method to determine whether the device has exceeded its use life.

Next Steps


1 Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Document issued on March 17, 2015, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluations.

2 Johnson, S. (February 19, 2015). FDA issues endoscope warning following superbug outbreak. Retrieved April 2, 2015, from

3 Crotti, N. (May 19, 2015). FDA Panel Deems Duodenoscopes to Be Unsafe. Retrieved May 20, 2015 from


Staci DeMoss received a B.S. degree in Chemical Engineering from Iowa State University. Since 2010 she has been at NAMSA and currently works as a Medical Research Scientist in Clinical and Consulting with primary focus on medical device reprocessing validations.