ASTM Workshop Programm:

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 3: Cleaning and Testing, Part 2

Cleaning and Testing for Debris in Reusable Medical Devices
Shani Haugen, Vicki Hitchins, FDA, Silver Springs, MD

Evaluation of the Cleaning Efficiency of a Aqueous Based Detergent System for Cleaning Metallic Medical Devices
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

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