Changes necessary to make device registries work
Regarding “Groups press FDA to encourage medical-device registries” (ModernHealthcare.com, Sept. 3), device registries are challenged by their inability to track patients over time. Unlike drugs, devices aren’t generally “renewed/refilled,” so tracking them with ongoing claims is not possible. Also, the relationship between the implanting surgeon and the patient is often transient. Until a device’s Unique Device Identification number is a required field in the electronic health record and provided on behalf of the patient for longitudinal followup, institutional-based registries will have limited abilities to track devices and essentially no ability to notify all device recipients in the event of a recall/problem.
Dr. Edward Fotsch Sausalito, Calif.