ASTM Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Committee F04 on Medical and Surgical Materials sponsored a workshop on medical device cleanliness at the November 16th ASTM meeting in San Antonio, TX.
Chairmen: Reto Luginbuehl, Robert Mathys Foundation, Bettlach, Switzerland
Stephen Spiegelberg, Cambridge Polymer Group, Boston , MA
Terry Woods, FDA, Silver Spring, MD
- Opening remarks and current ASTM work on medical device cleanliness Stephen Spiegelberg, Cambridge Polymer Group, Inc., Boston, MA
- 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
- 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
- Effects of Non-Aqueous Vapor Degreasing Solvent Cleaning on Ultra-High Molecular Weight Polyethylene (UHMWPE) Ray Gsell, Zimmer, Warsaw, IN
- Breaking the myth that caustic surgical instrument cleaners are necessary for safe and effective decontamination of medical devices Marcia Frieze, Case Medical, South Hackensack, NJ
- 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
- 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 Goldstine, Steve Goldstine Consultants, Albuquerque, NM