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 ABOUT THE EVENT

A Workshop on Medical Devices Metrology and Standards Needs, sponsored by ASTM Committee F04 on Medical and Surgical Implants, the U. S. Food and Drug Administration (FDA), the National Cancer Institute (NCI), the University of Texas at Arlington (UTA), the National Institute of Standards and Technology (NIST) will be held Tuesday, November 14, 2006. The workshop will be held at the Hyatt Regency Atlanta, Atlanta, Georgia, in conjunction with the November 13-17, 2006 standards development meetings of ASTM Committee F04.

The sponsoring organizations have agreed to collaborate in order to document and prioritize the measurement and measurement-related standards needs of a few categories of medical devices in cooperation with other government agencies, private industries and universities (http://www.usms.nist.gov). The ultimate goal of this identification initiative is to help direct NIST resources, or to create partnerships, in order to provide solutions to these needs.

Discoveries and technology developments during the 20th century made possible the development of a significant number of medical devices, which have radically transformed the way medical care is delivered today. These include the Computed Axial Tomography (CAT) machine in 1972, the Magnetic Resonance Imaging (MRI) machine in 1977, the Positron Emission Tomography (PET) machine, the implantable defibrillator in 1980, the artificial heart in 1982, the cochlear implant in 1985, Lasik eye surgery in 1990, Computer Assisted Surgery systems in 1986, Surgical Robots in 1990, Diagnostic Imaging Endoscopy Capsules in 2001, etc. Despite the tremendous progress, many problems exist in performance, standards, sensors and reliability.

This workshop will bring together experts in the fields of medical devices, metrology and standards in order to discuss and document the metrology and standards needs of a few categories of medical devices. Before the conclusion of the workshop, these needs will be listed and ranked according to their importance.

This workshop will not cover Medical Imaging as a Biomarker and Active Implantable Medical Devices Reliability, which have been the subjects of other NIST USMS needs workshops.

The scope of this workshop is focused on the metrology and standards needs of medical devices. Suggested topics for discussion are:

• Anthropomorphic Phantom Devices
• Computer Assisted Navigation and Surgery
• Drug-delivery Devices
• Image-Guided Therapies Devices
• Multi-modality Imaging Devices (e.g., PET/CT)
• Simulation Devices
• Surgical Robots
• Thermal Ablation Technologies Devices (Radio frequency generators, lasers, high-intensity focused ultrasound (HIFU), cryo-, etc.)

Workshop participants should address the following questions with respect to the above topics:

• What technological innovations are at stake?
• What is the economic significance of the innovations?
• What technical barriers to the innovations impede progress to the marketplace?
• At what stages of innovation do the technical barriers appear?
• What parts of the technical barriers are measurement science or standards development?
• What are the potential solutions to the measurement and standards development problems?
• Who are potential providers of solutions?
• Are there critical roles for agencies of the federal government?

To view the technical program, which includes presentation titles and times, click on http://myastm.astm.org/MEETINGS/WORKSHOPPROGRAMS/F04ID876.pdf

 REGISTRATION INFORMATION

Online registration opens approximately 8 weeks before the workshop and
closes November 8, 2006. There are no fees to attend the workshop, but registration is required. 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 submit your registration by the closing date, then you must register upon arrival at the workshop. All preregistrants must check in at the ASTM registration desk upon arrival at workshop.

If you have questions concerning online registration, please contact Hannah Sparks in Symposia Operations at mailto: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).

Online

On Site

 CONTINUING EDUCATION UNITS

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.

  TECHNICAL CHAIR CONTACT INFORMATION

For more information about this workshop, contact Workshop Chair Nicholas Dagalakis, NIST, Gaithersburg, MD, mailto:nicholas.dagalakis@nist.gov tel.: 301-975-5845

 STANDARDS DEVELOPMENT MEETINGS

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

 FUTURE MEETING DATES

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 above, and click on Future meetings.

 HOTEL INFORMATION

Reservations may be made by telephoning the hotel directly at 888-421-1442. To make your hotel reservation on-line, please visit resweb.passkey.com/Resweb.do?mode=welcome_ei_new&eventID=32113. Select your dates and proceed as instructed. Call the hotel directly at 888-421-1442 if you are unable to get your desired bed or room type.

Group rate is available until October 13, 2006 or when the ASTM Block is full: ASTM rates are $139 Single/Double, plus 15% tax (must mention ASTM November Meeting to receive group rate). You may be charged a higher rate if reservations are received after this date.

Internet Services: Hyatt Regency Atlanta offers a wireless Wi/Fi Internet Solution. If your laptop is equipped with an 802.11b wireless network interface card (NIC), then you have access to high-speed internet. Just set your SSID to "hyatt" and disable WEP. The cost of this service is $9.95 per day.

Members Office: ASTM is providing computers with an internet connection in the Members Office. This room will also be wireless for your laptop computer. You may visit the ASTM website, apply or renew your membership, order publications or check your email.

U.S. Government Rates: The Hyatt Regency Atlanta has a limited number of rooms at the Government per diem rate of $124. To obtain a government rate call the hotel directly at 888-421-1442 to make your reservation.

Advance Deposit: The Hyatt Regency Atlanta requires a credit card to guarantee the reservation.

Confirmation Notices: The Hyatt Regency Atlanta Reservations Center sends confirmation notices upon request.

Cancellation/Changes Policy: At the Hyatt Regency Atlanta, notice of cancellation must be received by 3:00pm, 72 hours prior to arrival date in order to avoid penalty.

 HEADQUARTERS AND TRANSPORTATION

All meetings will be held at the Hyatt Regency Atlanta, 265 Peachtree Street, NE, Atlanta, GA 30303. The hotel is located approximately 10 miles/20 minutes from Hartsfield International Airport. Their phone number is 404-577-1234, the general fax number is 404-588-4137.

For additional hotel information, visit their website at www.atlantaregency.hyatt.com/hyatt/hotels/index.jsp.

The Hyatt Regency Atlanta is located in the heart of downtown Atlanta, with shopping and dining in adjoining Peachtree Center, near Atlanta Market Center, Georgia World Congress Centre, Georgia Dome, Underground Atlanta and Centennial Olympic Park.

Airport Shuttle Service - Link Airport Shuttle Service is available at the baggage claim terminal. The cost is $16 per person one-way and $28 round trip. Taxis cost approximately $30.

MARTA (Metropolitan Atlanta Rapid Transit Authority) - From inside Hartsfield International Airport, you can travel directly to the Hyatt Regency Hotel, Downtown, Midtown, and Buckhead. MARTA also connects to the Georgia World Congress Center, Georgia Dome, Peachtree Center shopping, Atlanta's fine dining, and numerous attractions around town - all for jus $1.75.

Parking: Hotel parking (indoor valet) with in/out privileges is $22 a day. Non-Hyatt parking is located in the Suntrust building, 1/2 block from the hotel, the cost is $15 a day with NO in/out privileges.

 FLIGHT RESERVATION

If you need the assistance of a travel agent, you are welcome to use ASTM's Travel Agent - Uniglobe Wings Travel at (800) 243-4370 or 215-628-3322 or travel@wingsgt.com. PLEASE NOTE: Uniglobe Wings Travel charges a $30 service fee per domestic ticket and $50 for an international ticket.

 MISCELLANEOUS

Members have the option to determine their dress at ASTM meetings. Business casual attire is acceptable at this meeting and appropriate for Atlanta. The average temperatures in November range from a high of 63 degrees to a low of 41 degrees.

Special Needs
Several committees hold planned banquet events. You now have the ability to purchase your tickets on-line in advance on the preregistration page. Your tickets will be available at the Meeting Services Desk.