Mesh Medical Device News Desk, June 5, 2021~ MND Podcast with Madris Tomes-Kinard on the FDA and whether it has what it needs to do an adequate job of patient safety.
Just who is in charge? And how can citizens mobilize to bring attention to their troubling medical device?
Madris Tomes Kinard is a former FDA IT project manager who left the agency to focus on patient safety and medical devices.
Kinard is the system architect of Device Events, a database she created to make FDA adverse event reports much more accessible to the public and consumers, the media, hospitals, doctors, and lawyers.
With more than 11 million adverse event reports collected by the FDA, the agency has trouble identifying any early warning signs of trouble. The problem is simple - there are more devices are on the market while there are fewer eyes to watch them.
For example, Australia saw the problems with metal-on-metal hips long before the U.S. did, meaning patients were needlessly injured because we are not paying attention.
"There are a lot more devices on the market now they haven’t matched that with post-market funding from Congress. The FDA doesn’t have enough people to read these reports coming in. When we spoke 5 yr. about 65k a month and that has doubled. The FDA has 11.1 million ae reports and not enough analysts to read and act on them" ~ Madris Kinard