Better Medical Device Registry Needed
By Katie Wike, contributing writer
Three groups have asked the FDA to improve its efforts in creating a better registry to track the performance of medical devices.
The Food and Drug Administration (FDA) is being urged to implement a better version of medical device registry in order to improve care and more easily track devices. According to iHealth Beat, The Blue Cross and Blue Shield Association, The Pew Charitable Trusts, and The Science Infrastructure Center issued a report to the FDA recently outlining their recommendations for improving medical device data.
“Patients rely on the Food and Drug Administration to ensure the safety and efficacy of new medical devices. However, recent high-profile failures of these technologies, including metal-on-metal hips and implantable cardiac defibrillators, are a reminder that this country lacks a robust system for assessing the safety and effectiveness of medical devices once they enter the market,” notes the report.
Modern Healthcare reports device registries gather information about how patients respond to devices after they are implanted. Registries also help compare the performance of products and even identify problem devices.
“It's taken us too long to figure out these devices have serious and unexpected safety problems,” said Dr. Josh Rising, Pew's director of medical devices. “There's no reason that we shouldn't be able to identify these problems in the United States.”
The report explains, “Registries can support patient care decisions and improve outcomes by providing health care professionals with reliable information on the performance of a technology, and can highlight factors that affect the data collected, such as patient selection or operator experience. Registries can also go further than the premarket trials necessary for FDA approval by allowing for the evaluation of devices in wider populations and practice settings.”
The groups advise the FDA to take into consideration the recommendations outlined in the report and implement them as soon as possible. “Only then will registries play a central role in a robust national surveillance system that quickly identifies poorly performing devices, provides information to patients and clinicians for shared decision-making, and supports device innovation.”