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ASTM Workshop addresses medical device cleanliness.

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July 14, 2010 - Medical Device Cleanliness: How Clean is Clean Enough? will be held on November 16, 2010 in San Antonio, TX. Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices, workshop will address how reusable devices should be cleaned and validated as well as acceptable residue limits for implants and other medical devices. Presentations are invited on cleaning, testing, and limit values; interested participants must submit 300-500 word abstract before August 31.

ASTM International Sponsors Workshop on Medical Device Cleanliness


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ASTM International
100 Barr Harbor Dr., Box C700
West Conshohocken, PA, 19428-2959
USA



Press release date: July 12, 2010

W. CONSHOHOCKEN, Pa.-A workshop on Medical Device Cleanliness: How Clean is Clean Enough? will be held on Nov. 16, 2010, at the Grand Hyatt San Antonio in San Antonio, Texas. The workshop is sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices, and will be held in conjunction with the Nov. 16-19 standards development meetings of the committee.

This workshop will address two key issues that came out of previous F04 workshops and symposia on the cleanliness of medical devices: 1) how should reusable devices be cleaned and validated; and 2) what are acceptable residue limits for implants and other medical devices? Currently, device manufacturers either do not have residue limits, or have an inconsistent method of determining residue limits. Similarly, the FDA has concerns about reprocessing of some reusable devices, and would like a discussion on re-processing and validation.

The intent is to examine ongoing issues of cleaning medical devices, including new implants and reusable devices (e.g., cannulated devices like arthroscopic/endoscopic devices from which it is difficult to remove retained tissue). Presentations are invited on cleaning, testing and limit values (see detailed information at www.astm.org/F04work1110.htm). Interested participants must submit a 300-500 word abstract before Aug. 31 via e-mail to one of the workshop chairs listed below.

Online registration opens approximately eight weeks before the workshop and closes Nov. 10. The fee for ASTM members and non-members is $50 USD for online registration and $75 USD for on-site registration. The fee is waived for presenters and students with a valid I.D. For more information, visit www.astm.org/F04work1110.htm.

Additional technical information is available from workshop co-chairs Reto Luginbuehl, RMS-Foundation, Bischmattstrasse, Switzerland (phone: +011 32 644 1416; reto.luginbuehl@rms-foundation.ch); Stephen H. Spiegelberg, Cambridge Polymer Group Inc., Boston, Mass. (phone: 617-629-4400; stephen.spiegelberg@campoly.com); or Terry O. Woods, U.S. Food and Drug Administration, Silver Spring, Md. (phone: 301-796-2503; terry.woods@fda.hhs.gov).

ASTM International is one of the largest international standards development and delivery systems in the world. ASTM International meets the World Trade Organization (WTO) principles for the development of international standards: coherence, consensus, development dimension, effectiveness, impartiality, openness, relevance and transparency. ASTM standards are accepted and used in research and development, product testing, quality systems and commercial transactions.

ASTM Staff Contact: Hannah Sparks, Phone: 610-832-9677; hsparks@astm.org
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