Hidden Device Reports to be Made Available: Gottlieb
FDA Commissioner Scott Gottlieb has reversed course on certain device summary reporting about adverse events that are hidden to the public and researchers, and now says the agency will make such reports received prior to 2017 more easily accessible. “I think that the imperative of the agency is to make as much of this information available to the public as possible,” Gottlieb told Kaiser Health News. “I think these databases by and large should be searchable to the public.”
Earlier this month, a lengthy Kaiser Health News investigative report said FDA was allowing medical device manufacturers to submit summary adverse event reports to databases that are kept from public view, hindering doctors and researchers who are trying to stay aware of issues with the devices. The report detailed issues with surgical staplers and other devices and included interviews with doctors, patients, researchers, and former FDA officials, including former commissioner Robert Califf, who said he had never heard of the secret databases.
“Since 2016, at least 1.1 million incidents have flowed into the ‘alternative summary reporting’ repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could place patients in jeopardy,” Kaiser said at the time. “Deaths must still be reported in MAUDE. But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to FDA, many implanted in patients or used in countless surgeries. They have included surgical staplers, balloon pumps snaked into vessels to circulation, and mechanical breathing machines.”
A 3/27 follow-up report from Kaiser notes that medical device safety researchers are now calling on FDA to release hundreds of thousands of hidden injury and malfunction reports related to about 100 medical devices. In response, Gottlieb said in a Twitter post that the summary reports are in an “old database where historical information wasn't easily accessible electronically owing to the system’s age. But it's imperative that all safety information be available to the public. We're now prioritizing making ALL of this data available.”
Meanwhile, Washington-based online news service Politico reported 3/28 that the Drug Enforcement Administration’s inspector general criticized that agency’s similar maintenance of a secret data base, this one comprising telephone records it has been bulk-collecting without sufficient legal justification since 1992 and shared with other agencies.