Medical Device Registries
Medical device registries collect data on a group of patients treated with a particular device to assess the safety and effectiveness of the technology. Registries can be especially helpful in tracking experiences of broader patient populations over longer periods of time, in comparison to premarket clinical trials. For example, hip implants are expected to last for 15 to 20 years but typically require only two years of clinical data for FDA approval.
Registries in use across the United States and abroad have provided valuable information about the safety and effectiveness of medical devices; in recent years, registry data have helped signal issues with metal-on-metal hip prostheses and demonstrate the safety of implantable cardiac defibrillators in athletes. These registries, as FDA has articulated in its national plan to improve device surveillance, have the potential to improve the data available on the safety and effectiveness of new technologies.
Yet most device registries used today in the United States do not provide early and actionable safety information to physicians and the public.
Pew is working to develop best practices for medical device registries in the United States to help provide patients, doctors and regulators with better information on the performance of medical devices used in care.