In an effort to address triple-digit increases in errors related to device use, the Biomedical Research & Education Foundation (BREF) has 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 orthopedic 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.
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.
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