FDA Releases Guidance for Reprocessing Medical Devices

On March 17th, the FDA announced the release of “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling’’ Guidance in the Federal Register.  This was followed by a webinar on March 24th by Elaine Mayhall, PhD and Geetha Jayan, PhD.

The Introduction notes:

This guidance provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable medical devices. This guidance document also provides recommendations for the content and review of premarket notification submissions [510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests and investigational device exemption (IDE) applications, concerning the labeling instructions for reprocessing reusable medical devices. (p. 1)

Moreover, it continues that:

…the focus of this document is to provide guidance to medical device manufacturers in the complex activities involved in crafting and validating reprocessing instructions that ensure that the device can be used safely and for the purpose for which it is intended. (p. 1)

Among other things, the Guidance outlines human factors-specific activities that should be performed during development of reprocessing instructions.  Specifically, it states medical device manufacturers should:

1. “…develop consistent reprocessing instructions across each of your product lines.” (p. 7)
2. “…address any known post-market human factors issues known to exist for reprocessing your device or similar devices.” (p. 7)
3. “…validate your reprocessing instructions to insure that users will be able to successfully understand and follow them.” (p. 7)

For the latter, the guidance provides five recommendations (Note: it’s actually six; the last recommendation is actually two distinct steps) that follow the later stages of a typical human factors design and development process.  They include:

1. “…validation study participants should be representative of the professional staff that would perform these actual reprocessing procedures.” (p. 8)
2. “Participants may use the instructions to perform an actual or simulated reprocessing procedure or verbally describe what they would do as they read the instructions.” (p. 8)
3. “If attributes of the use environment might affect use of the instructions and reprocessing of the device, they should be represented in the study.” (p. 8)
4. “Observing and documenting participant behavior during testing will allow you to assess the participants’ adherence to the instructions and to identify and understand the nature of any errors or problems that occur.” (p. 8)
5. “After using the instructions independently, you should ask the participants if they had difficulty in performing the reprocessing, and allow them to describe their experience.” (p. 8)
6. “If you make significant changes to the instructions after testing them, you should validate the success of the changes at eliminating or reducing the problems previously identified.” (p. 8)