Inside AAMI

Abstract

Are you looking for an opportunity to interact with FDA officials and stay up-to-date on medical device standards and regulations? Mark your calendar. The 20th Annual AAMI/FDA 2010 International Conference on Medical Device Standards and Regulation, which will be held on March 9–10 in Reston, VA, just outside of Washington, D.C.The conference will provide detailed information about the latest standards and regulatory initiatives for both the United States and overseas; and offer attendees a unique opportunity to interact with FDA and standards committee authors and leaders.FDA officials often unveil the latest regulatory initiatives at the conference as well. The conference focuses not only on the latest U.S. regulations, but also international regulatory initiatives—which attracts attendees from around the world.For more information about the 2010 conference, including up-to-date speaker and topic information, visit www.aami.org/meetings/isc, or contact Chris Dinegar at (703) 525-4890, ext. 210, or e-mail cdinegar@aami.org.Applications are now being accepted for the AAMI Foundation's new Michael J. Miller Scholarship Program, which aims to provide scholarships to students pursuing careers in medical technology.Fundraising efforts also have ramped up with a goal of raising $500,000 to endow the scholarship program that was created last year to honor Michael J. Miller, AAMI's longtime president who retired in 2009 after 40 years of service.The program will award an annual $2,500 scholarship to a clinical engineering student and $2,500 to a biomedical equipment technician (BMET) student. A task force has developed eligibility requirements and set the scholarship limits based on the amount members determined could help make a difference in a recipient's life, says task force leader Marcy Petrini, PhD, professor at the University of Mississippi Medical Center. “There aren't a lot of opportunities for financial aid for needy students.”For more information on the requirements or to apply for the scholarship, visit www.aami.org/foundation/scholarship.To donate, send a tax-deductible contribution to AAMI Foundation, c/o The Michael J. Miller Scholarship Program, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201. Donations can also be made online at www.aami.org/foundation/scholarship.AAMI has joined three standards organizations to deliver unprecedented access to more than 2,000 standards and regulations through a convenient online clearinghouse.The Medical Device Standards Portal allows users online access to standards from AAMI, ASTM International, the American National Standards Institute (ANSI), and the German Institute for Standardization (DIN). This new portal also offers regulations from the U.S. Food and Drug Administration (FDA), and international standards and regulations from the International Electrotechnical Commission (IEC), International Organization for Standardization (ISO), and more.Currently, all of the documents in the portal are available in a PDF format that can be easily downloaded. By the end of the second quarter of 2010, it is anticipated that all of the documents also will be available in an HTML format, which provides greater functionality. Also, users will be able to add comments and attachments directly into the standards and share them with others. Users could also integrate company practices alongside the standards. The standards and regulations are updated throughout the year. The portal includes a red-line feature which outlines in red all of the changes that have been made to a standard or regulation.The portal is available for an annual subscription of $19,500 for a single site network, although the product can be customized for wide area networks. Some companies spend more than double that amount a year on standards.For more information about the Medical Device Standards Portal, visit www.medicaldevicestandards.com or call Jim Thomas at ASTM at 215-431-2411 or Mark Brown at ANSI at 212-642-4935.