Cleaning Validations & IFU Development for Reusable Medical Devices

Validation of reusable medical devices is at the forefront of the FDA’s efforts to ensure patient safety. With contaminated endoscopes making headlines and FDA’s recent release of new guidance for reprocessing reusable medical devices, industry and regulatory attention have been refocused on IFU development.

Due to the development of more complex devices, the single biggest challenge for reprocessing staff is adequate cleaning and disinfection/sterilization of devices prior to reuse. Becoming more knowledgeable of the current trends in both methods and regulatory expectations will allow for a more efficient and effective path to regulatory approval.

Philip Nosel, Supervisor- Reusable Medical Device Testing at Accuratus Lab Services, shares what you need to know about current regulatory expectations for cleaning and reprocessing of reusable medical devices. Philip holds a B.S degree in Chemistry, an M.S. degree in Biochemistry, and has spent the past 25 years working in analytical, R&D, and QA manufacturing laboratories at various companies. Philip is a member of the American Chemical Society and AAMI Committee WG84, focused on developing Endoscope Reprocessing standards.

This webinar (recorded 6/24/2015) addresses the following “need to know” topics:

  • What are current regulatory expectations, guidelines and requirements for reusable medical device cleaning validations?
  • Top concerns and considerations when developing reprocessing instructions for use (IFU).
  • How to select the appropriate soils, inoculation locations and analytical endpoints to follow the new guidance.
  • Advantages and disadvantages of manual and automatic washer/disinfector reprocessing.
  • Lessons learned from the trenches conducting cleaning, disinfection, and sterilization validations of reusable medical devices.