The FDA is building a postmarket surveillance program for medical devices.
The agency will look for medical device-related safety issues reported in EHRs, billing claims and pharmacy data, according to a U.S. Government Accountability Office report released Aug. 15.
The program will begin surveillance of two medical devices by December, with plans to increase the number of devices under investigation each year over the next five years.
There were more than 1.7 million injuries and 83,000 deaths linked to medical device safety issues over a 10-year period, according to FDA data from 2018, the report said.