Title: Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Dates: Tuesday November 16 2010
Location: Grand Hyatt San Antonio; San Antonio, TX
Event Name: November 2010 Committee Week

About The Event
Technical Program
Registration Information
Continuing Education Units
Technical Chair Contact Information
Hotel Information
Standards Development Meetings
Future Meeting Dates

• Printer Friendly Version
• Receive Emails When New Papers Are Available
• Return to Previous Page

A Workshop on Medical Device Cleanliness: How Clean is Clean Enough?, sponsored by ASTM Committee F04 on Medical and Surgical Implants and Materials, will be held Tuesday, November 16, 2010 from 9:00am to 6:00pm. The workshop will be held at the Grand Hyatt San Antonio in San Antonio, Texas, in conjunction with the November 16-19 standards development meetings of Committee F04.

Objectives
This workshop will address two key issues that came out of the Committee F04 previous workshop and symposium on the cleanliness of medical devices: (1) How should reusable devices be cleaned and validated; (2) what are acceptable residue limits for implants and other medical devices? Currently, there are no standards that address either subject, and a discussion amongst the leaders in these areas will help frame a path forward for drafting said standards. Currently, device manufacturers either do not have residue limits, or have an inconsistent method of determining residue limits. Similarly, the U.S. Food and Drug Administration (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 (for example, cannulated devices like arthroscopic/endoscopic devices from which it is difficult to remove retained tissue.)

Solicitation of Presentations
Presentations are sought on the topics below. Interested participants must submit a 300-500 word abstract before August 31, 2010 by e-mail to:

Reto Luginbuehl, RMS-Foundation - reto.luginbuehl@rms-foundation.ch
Stephen Spiegelberg, Cambridge Polymer Group - stephen.spiegelberg@campoly.com
Terry Woods, U.S. Food and Drug Administration - terry.woods@fda.hhs.gov

Cleaning:

• What are the state-of-the-art cleaning procedures for both implants and reusable devices?
• How can we validate variable cleaning processes?
• Can we engineer and design devices for low risk of contamination and for cleanability?
• Can we develop a standard guide or practice for cleaning and processing reusable devices for subsequent uses, particularly cannulated medical devices?

Testing:

• How can we test for residues?
• What biological assays can we perform to establish limits?

Limit Values:

• What are the effects of inorganic, organic and biological alteration of surfaces on the surrounding tissues?
• What are the clinical consequences of residues on devices, specifically addressing biocompatibility and toxicity?
• How do we determine acceptable residue levels?
• What are the legal implications of defining or not defining residue limit values, or of omitting testing for specific residues? (incomplete testing)
• Can we make guidelines for setting limit values for residues on both implants and reusable devices?

A technical program (which includes presentation times, paper titles, and presenters' names), will be posted on the ASTM website by end September 2009.

Online registration opens approximately 8 weeks before the workshop and closes November 10, 2010. The fees to attend this workshop are listed below.

All attendees, including presenters and ASTM members, are urged to register online for this event so that space requirements can be accommodated. If you do not register online by the closing date, then you must register upon arrival at the workshop.

All attendees must check in at the ASTM registration desk upon arrival at workshop.

Cancellation
A refund of the workshop fee will be honored only if requested at least 7 business days prior to the workshop. To cancel your registration and request a refund, please contact Hannah Sparks at hsparks@astm.org or 610-832-9677.

If you have questions concerning online registration, please contact Hannah Sparks in Symposia Operations at hsparks@astm.org, Tel: 610/832-9677, or ASTM Technical Support at support@astm.org, or 1-800-262-1373 (domestic) or 610-832-9578 (international).

Workshop attendees interested in receiving 0.7 Continuing Education Units (CEUs) should complete a CEU application form at the adjournment of the workshop, and then submit it to the ASTM staff member on site. A certificate will be sent to the attendee approximately 4 to 6 weeks after the workshop.

Additional information about the workshop is available from Workshop Co-Chairs Reto Luginbuehl, RMS-Foundation, Bischmattstrasse, Switzerland, reto.luginbuehl@rms-foundation.ch, tel: 011 32 644 1416; Stephen H. Spiegelberg, Cambridge Polymer Group, Inc., Boston, MA, USA, stephen.spiegelberg@campoly.com, tel: 617-629-4400; or Terry O. Woods, U.S. Food and Drug Administration, Silver Spring, MD, USA, terry.woods@fda.hhs.gov, tel: 301-796-2503.

The workshop will be held at the Grand Hyatt San Antonio. Hotel registration information will be posted at the ASTM website approximately 8 weeks before the workshop.

Meeting schedules of Committee F04 are posted on the ASTM web site at www.astm.org/COMMIT/COMMITTEE/F04.htm or contact the ASTM staff manager, Dan Schultz, at dschultz@astm.org or tel: 610-832-9716.

Committee F04 invites you to attend their future standards development meetings. There is no fee to attend these meetings, and membership in ASTM International is not required. For more information, visit the web page listed immediately above, and click on "Future Meetings".