BREF and Leading Medical Institutions Announce Medical Device Registry to Help Improve Patient Care

PHILADELPHIA, PA, October 24, 2006 – In an effort to address triple-digit increases in errors related to device use, the Biomedical Research & Education Foundation (BREF) today announced that it has formed a National Committee to develop a National Medical Device Registry. Founding partners are the University of Pennsylvania School of Medicine and the Cleveland Clinic Foundation. The first phase of development will focus on monitoring and tracking the use of orthopaedic devices. In the past decade, the number of medical technology patents and knee and hip replacements approximately doubled. Reports of adverse events related to medical products increased from 75,000 to 250,000 per year in the 1990s. "With the increase in complexity and number of implanted medical devices, patients and physicians need a full understanding of the devices as well as any potential complications,” said Robert L. Wilensky, M.D., Director, Experimental Interventional Cardiology and Associate Professor of Medicine, University of Pennsylvania School of Medicine. “The National Device Registry will be a start in improving patient outcomes as well as the flow of information between patients, physicians and members of the medical community." The Committee is open to all medical centers, professional associations, relevant government agencies and industry participants. Interested organizations should contact BREF. By participating, institutions will be able to have significant input in system development and prepare for anticipated regulations requiring increased device identification and monitoring procedures. Inquiries should be forwarded by February 1, 2007 to Aaron Moskowitz, moskowitz@brefnet.org; BREF, 3701 Market St. Suite 340, Philadelphia, PA 19104; 215-966-6237. A device registry could allow for longer-term monitoring, facilitate more successful recall programs, increase reporting of adverse events and allow for quality and cost comparisons. In addition, it could provide medical professionals with critical information regarding device use, sterilization needs, compatibility with other devices and procedures, and allergy risks. The need for a medical device registry is expected to continue growing. An aging population, increased obesity, and improvements in medical technology will all contribute to more widespread use of devices. “While the tremendous diversity and long lifespan of most devices make development of a registry difficult, the growing need for one is overwhelming,” said Wael Barsoum, MD, Vice Chairman, Department of Orthopaedic Surgery, Cleveland Clinic Foundation. “We are confident that by starting out focused on one specialty and incorporating the expertise of top medical facilities, we will develop a prototype that can ultimately be used across the country to track devices and improve patient care in all medical areas.” About BREF The Biomedical Research and Education Foundation was founded in November 2003 to provide independent objective reviews of medical technology. Its publications include the Biomedical Review Letter, Biomedical Review Letter: Market Edition; and the Drug Monographs Prepared by the University of Pennsylvania. BREF is a non-profit organization and does not accept funding or advertising from commercial organizations. It is committed to building ties among medical centers, professional medical associations, business schools and government agencies. About the Founding Partners • The Cleveland Clinic is a not-for-profit multispecialty academic medical center. U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. Approximately 1,500 full-time salaried physicians at Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specialties and subspecialties. Patients came from every state and more than 80 countries. For more information, visit The Cleveland Clinic. • The University of Pennsylvania School of Medicine was founded in 1765 as the nation's first medical school. It is ranked #2 in the nation for receipt of NIH research funds; and ranked #3 in the nation in U.S. News & World Report's most recent ranking of top research-oriented medical schools. Supporting 1,400 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine. For more information, visit Penn Health.