A Look at Updated Standards for Reusable Medical Devices

Nelson Laboratories delves into the impact of updated standards on IFU validations for reusable medical devices.

Bob Kronemyer

September 11, 2023

3 Min Read
Image Courtesy of Nelson Labs

As reusable medical devices continue to advance, the validations used to evaluate the reprocessing (cleaning, disinfection, and/or sterilization) procedures have had to advance as well. These advancements have resulted in numerous standards and guidance documents being either updated or created to ensure that reusable medical devices can be safely reprocessed. 

A session from MD&M Minneapolis, titled “The Impacts of Updated Standards on IFU Validations for Reusable Medical Devices” and presented Alpa Patel, BS, RM(NRCM), director of scientific improvement at Nelson Laboratories  in Salt Lake City, UT, will address the reusable device landscape. 

MD+DI: What are the recent major changes in guidance documents to ensure that reusable medical devices can be safely reprocessed?

Patel: In August 2022, the Association for the Advancement of Medical Instrumentation (AAMI) published the first document on cleaning validations for reusable medical devices. The document outlines test methodologies that should be considered during cleaning validations, including sample sizes, controls and interpretation of data.

A lot of other documents on reprocessing or cleaning validations for reusable medical device were revised between 2020 and 2023. There is definitely a push in this sector of the medical device industry to ensure patient and human factors are considered during validation plans. So now we are seeing the revisions and adjustments needed to guarantee that undermining factors are considered.

Another change we have seen is to consider end-of-life assessments of reusable medical devices. What this basically means is, how many times can you clean and sterilize a device before its functional properties are compromised, making it no longer safe to use? Clear guidance on this is not currently available in the industry because it is process dependent, so manufacturers have to determine this number for their own devices.

Currently, the standards allow manufacturers to specify in their instructions for use (IFU) the point at which the device is no longer usable and how that can be identified; however, without some testing of verification, these instructions would be difficult to develop. This is the reason standards and regulatory agencies are now looking at adding verification testing to the list of tests.

MD+DI: How are these changes impacting new and already completed reprocessing validations for reusable medical devices?

Patel: The biggest impact on reprocessing validations is in cleaning validations, because previously there were not clear guidelines about cleaning validations. Now reusable medical devices validated before 2015 must have their design history files validated to ensure their legacy products, worst-case devices or family grouping assessments are still in compliance with the current standards.

In 2015, FDA published the guidance document “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” which outlines some specifications for cleaning validations. But this document was recognized as containing only recommendations when it first came out, so it was generally overlooked until last year’s AAMI ST98 document was released.

MD+DI: Are there any challenges in incorporating these new changes?

Patel: Although the standards have left many parts up to the interpretation of the reviewer, they do provide enough information to design adequate validation plans.

MD+DI: What is the next step for reprocessing validations?

Patel: Reprocessing standards have a long way to go to identify key features of validations that are still unknown or not defined clearly. Meanwhile, we need to keep our eyes out for what regulatory will do next regarding end-of-life device testing, as this will change the paradigm for reprocessing validations.



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