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Philadelphia, PA, Oct. 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, MD, 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.ÝInquiries 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.

ÝA 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.Ý Ý 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."

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 medical device registries currently in use or under development in countries including Australia, Denmark, England, Finland, Hungary, New Zealand, Norway and Sweden.

• 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

Source: Biomedical Research & Education Foundation