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.

1. Current Regulatory Thinking in Reprocessing
Steven J. Elliott
Principal Medical Research Manager
NAMSA

2. 2
Overview
 Standards and Guidance
 FDA Draft Guidance
 Insights into the development and validation process
 Managing new validation studies

3. 3
Standards and Guidance

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
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
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
Draft Guidance for Industry and FDA Staff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
FDA Draft Guidance

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it comes to the draft guidance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
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comprehensive instructions in the draft guidance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
Disinfection
 It is important to understand the Spaulding Classification
of your device when worst-case use or foreseeable
misuse is considered

12. 12
Sterilization
 It is important to know the FDA-cleared cycles,
including the specified dry times

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
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
 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 clientcare@namsa.com.