Databases for Studying the Epidemiology of Implanted Medical Devices

The worldwide market for implanted medical devices continues to accelerate from $41.7 billion in 1993 to $56.7 billion in 1995 (1). Unlike epidemiological research for pharmaceuticals, which builds knowledge on clinical trials that are typically completed in several months, clinical trials for implanted medical devices require longer follow-up to determine safety and efficacy. Follow-up for the purpose of regulatory approval is usually complete in 1 or 2 years, but practitioners and patients are interested in the safety and efficacy of implants for the entire life span of patients. This was highlighted in the development of a National Institutes of Health (NIH) Technology Assessment Panel Consensus Statement on Implant Registries (2). The panel noted that 20 to 25 million US patients have had a medical device implanted. Device epidemiology provides a scientific method to contribute to this area of inquiry.