National Medical Device Registry Fact Sheet

Growth in Device Use and Need for Registry • In the past decade, the number of medical technology patents more than doubled. • From 1994 to 2004, the number of knee and hip replacements in the U.S. approximately doubled, from 209,000 to 478,000 and from 124,000 to 234,000, respectively. • Reports of adverse events related to medical products increased from 75,000 to 250,000 per year in the 1990s. • Over 400 people are seriously injured or killed each year due to an adverse event associated with a medical device. • An aging population, increased obesity, and improvements in medical technology are all expected to contribute to more widespread use of devices. • By 2030, the number of knee replacements in the U.S. is expected to increase 673 percent to 3.48 million and hip replacements are expected to grow 174 percent to 572,000. • In 2005, worldwide revenues for orthopaedic devices were $22.1 billion and for cardiovascular devices were $19.2 billion, with a six-year capacity growth rate of 11 percent and 9 percent, respectively. Related Food and Drug Administration Actions • The F.D.A. is seeking public comment until November 9 on the need for a unique identifier system for medical devices. It is holding a public meeting on the subject on October 25. • Currently, monitoring of new devices by the F.D.A. rarely extends beyond three years, even though most are designed to be used for much longer. • The F.D.A. has required reporting of medical device problems since the inception of the Safe Medical Devices Act of 1990 and subsequent introduction of MedWatch in 1993. However, current data is criticized for not being complete, timely or easily accessible. • In 2004, the F.D.A. adopted a bar code system for identifying drugs and biological agents such as vaccines, but did not include devices. • In August 2006, Daniel Schultz, M.D., F.D.A. Director of the Center for Devices and Radiological Health, said “Much like the bar code rule for drugs and biological products, unique identifiers for medical devices could have many potential benefits for improving the quality of care for patients. A unique identifier system could have broad applications in reducing medical errors, facilitating device recalls, improving medical device adverse event reporting and encouraging cost effectiveness by improving delivery and supply chain efficiency.” BREF Registry Development • BREF is conducting ongoing reviews of o medical device registries currently in use or under development in countries including Australia, Denmark, England, Finland, Hungary, New Zealand, Norway and Sweden. o analogous systems in the U.S., including meetings with the National Highway Traffic Safety Administration. • June 2006 – BREF sponsored a symposium hosted by the University of Pennsylvania that looked at how devices are monitored, evaluated and followed in recipients. Attendees included medical practitioners and representatives from major hospitals, universities and medical associations. They met with leaders from government regulatory organizations, manufacturers and technology providers and discussed how a medical device registry could improve patient care. • October 2006 – BREF announced the formation of a National Committee to develop a National Medical Device Registry. Founding partners include the University of Pennsylvania School of Medicine and the Cleveland Clinic Foundation. • January 2007 – Symposium to be held at the Cleveland Clinic. Information Sources • AdvaMed • American Academy of Orthopaedic Surgeons • National Hospital Discharge Survey, 1991-2004; U.S. Department of Health and Human Services; Centers for Disease Control and Prevention; National Center for Health Statistics • The Journal of Bone and Joint Surgery, 83:1582-1585, 2001, “National Joint Replacement Registries: Has the Time Come?” William J. Maloney, MD