The FDA permits some devicemakers to file reports on device-related injuries and malfunctions in a discreet database that is not accessible to physicians or the general public, according to an investigation from Kaiser Health News.
Physicians often turn to a public FDA database to learn of device issues that could threaten patient safety. However, devicemakers can apply for an FDA exemption to prevent specific incidents from going on the public database. KHN found at least 1.1 million device incidents have been reported to an "alternative summary reporting" FDA database since 2016.
The database contains incident reports for about 100 medical devices, including surgical staplers, balloon pumps and mechanical breathing machines. In 2017, more than 480,000 injuries or device malfunctions were reported through the alternative database, according to agency documents obtained by KHN.
The FDA created the alternative summary reporting program in 1997 to collect "summary reports of certain adverse events that are well-known and well-documented with the agency," an FDA spokesperson told Becker's. She noted the program was updated in 2017 to promote greater public transparency and said only low-risk products are elgible for the alternative reporting method.
"The public has a right to know about this," S. Lori Brown, PhD, a former FDA official and researcher who's accessed the database, told KHN. She noted physicians who only refer to the public FDA database could be missing important information on device safety.
To view KHN's full report, click here.