ASTM Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices
November 16, 2010
Grand Hyatt San Antonio
San Antonio, TX
Workshop Co-Chairs:
Reto Luginbuehl, Robert Mathys Foundation, Bettlach, Switzerland
Stephen Spiegelberg, Cambridge Polymer Group, Boston, MA
Terry Woods, FDA, Silver Spring, MD
TUESDAY, NOVEMBER 16, 2010
Opening Remarks
Reto Luginbuehl, Robert Mathys Foundation, Bettlach, Switzerland
Stephen Spiegelberg, Cambridge Polymer Group, Boston, MA
Terry Woods, FDA, Silver Spring, MD
SESSION 1: FDA AND LEGAL IMPLICATIONS
Reprocessing of Reusable Medical Devices: an FDA Perspective
Pamela Scott, Daniel McGunagle, FDA, Silver Spring, MD
The Legal Implications of Medical Device Cleanliness Standards
Steve Bennett, John Schlafer, Baker & Daniels, LLP, Fort Wayne, IN
SESSION 2: CLEANING AND TESTING, PART 1
Exploring Methods of Optimizing Surgical Instrument Reprocessing Operations
Jahan Azizi, Linda Lavey, CBET, University of Michigan, Dearborn, MI
Validation Strategy for an Automated Endoscope Reprocessor
Bradley Catalone, Thomas Gilmore, David Barlow, Olympus America, Center Valley, PA
Ray Gsell, Zimmer, Warsaw, IN
Marcia Frieze, Case Medical, South Hackensack, NJ
SESSION 3: CLEANING AND TESTING, PART 2
Cleaning and Testing for Debris in Reusable Medical Devices
Shani Haugen, Vicki Hitchins, FDA, Silver Springs, MD
Boopathy Dhanapal, Zimmer, Warsaw, IN
Two-phase Flow Cleaning of Endoscope Channels
Mohamed Labib, Stanislav Dukhin, Joseph Murawski, Yacoob Tabani, Richard Lai, Michelle Alfa, Novaflux Technologies, Princeton, NJ
Assessment of Organic Residues on Medical Devices
Boopathy Dhanapal, Zimmer, Warsaw, IN
SESSION 4: ESTABLISHING CLEANING LIMITS
Establishing and Justifying Limit Values for Residual Analysis
Kierstan Andrascik, QVET Consulting, Layton, UT
Residual Soil on Reusable Medical Devices: How to Determine Limits?
Steve Goldstein, Steve Goldstein Consultants, Albuquerque, NM
A PDF copy of the whole workshop can be download here (6.6 MB)