The Brits do it. The Australians do it. So why does the U.S. trail in tracking the performance of medical devices through registries? Organizations such as the Pew Charitable Trust, Blue Cross and Blue Shield and the Science Infrastructure Center run by Weill Cornell Medical College’s Medical Device Epidemiology Network are leaning on the Food and Drug Administration to catch up.
Jaimy Lee, writing for Modern Healthcare, points out that “device registries gather information about how patients respond after devices are used or implanted.” He noted that a carefully kept registry can compare older, less costly devices with newer products. Too often clinical trials involve a small number of patients over a short period of time and so do not provide the needed long term data about how those devices work over the long haul in patients.
Those calling for a federally run registry refer to Johnson & Johnson’s recall in 2010 of metal on metal implants. Clinicians tracking outcomes of the implants in registries in Australia and the United Kingdom were the first to identify the higher failure rates of these hip implants compared with older devices that had been on the market for years. J&J eventually recalled 93, 000 hip implants, Lee wrote.
“It’s taken us too long to figure out these devices have serious and unexpected safety problems, ” Josh Rising, M.D. Pew’s director of medical devices, told Lee. “There’s no reason that we shouldn’t be able to identify these problems in the United States.”
Lee noted that “many private organizations have developed their own registries to improve clinical and purchasing decision-making.” Among those organizations are Kaiser Permanente, the Cleveland Clinic and the Veterans Affairs Department. However the data collected is private, the property of these organizations. Those arguing for the establishment of a federal registry believe the data should be publically available.
