Current Regulatory Thinking In Reprocessing


Published on

The Current Regulatory Thinking in Reprocessing seminar discusses standards and guidance for reprocessing and reusable medical devices as well as insights into the development and validation process.

  • Be the first to comment

  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

Current Regulatory Thinking In Reprocessing

  1. 1. Current Regulatory Thinking in Reprocessing Steven J. Elliott Principal Medical Research Manager NAMSA
  2. 2. 2 Overview  Standards and Guidance  FDA Draft Guidance  Insights into the development and validation process  Managing new validation studies
  3. 3. 3 Standards and Guidance
  4. 4. 4 AAMI TIR 12:2010  Designing, testing and labeling reusable medical devices for reprocessing in healthcare facilities: A guide for medical device manufacturers AAMI TIR 30:2011  A compendium of processes, materials, test methods, and acceptance criteria for cleaning medical devices These two guidances are critical with reusable medical devices. They offer great direction and insight to the available processes and procedures you could use.
  5. 5. 5 ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012  Comprehensive guide to steam sterilization and sterility assurance in health care facilities  Offers insight on what you should anticipate when it comes to the use of your medical device(s) in the actual health care facility.
  6. 6. 6 ANSI/AAMI ST81:2004/(R)2010  Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices, 1ed  U.S. version of ISO 17664
  7. 7. 7 Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling  When finalized, this document will supersede “Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance”  Guides how FDA reviewers and inspectors/investigators are looking at reprocessing and reusable devices  Understanding and following this guidance will be critical to your success with FDA submissions and reviews on processed/reprocessed medical devices
  8. 8. 8 FDA Draft Guidance
  9. 9. 9 Validation Process – One important thing to recognize and understand about each processing/reprocessing step when it comes to the draft guidance
  10. 10. 10 Cleaning  It is important to recognize that the most comprehensive instructions in the draft guidance for validation of a process is for cleaning efficacy
  11. 11. 11 Disinfection  It is important to understand the Spaulding Classification of your device when worst-case use or foreseeable misuse is considered
  12. 12. 12 Sterilization  It is important to know the FDA-cleared cycles, including the specified dry times
  13. 13. 13 All validations of processing/reprocessing instructions provided to the end-user by the manufacturer should be conducted under the direction of a comprehensive validation protocol
  14. 14. 14 All validations, in their own way, must address “worst-case” conditions when determining the challenge that will be presented to the processing/reprocessing procedures and the parameters of the study that will be conducted to validate those procedures
  15. 15. 15  To view the full series about Current Regulatory Thinking in Reprocessing  Visit NAMSA Seminars  For information about the regulatory services NAMSA offers or our processing/reprocessing services  Check out our service page on Regulatory and Consulting  View our Post-Market Support page  Download our brochure on Processing/Reprocessing Validations for Medical Devices  If you have any questions or would like to request a quote  Contact us at