STAT+: Former FDA official lays out how to keep patients safe from risky medical devices
Former FDA official Madris Kinard built a database to help patients, doctors, and hospitals keep better track of risky medical devices.
Madris Kinard’s unlikely journey to becoming a champion for patient safety started in a fire station. As a fresh-faced college intern for a company insuring volunteer firefighters, she asked one of the firefighters if she could do something on every child’s bucket list: slide down the fire pole.
“They were like, you work for our insurance company,” Kinard said. “We’re not going to let you slide down the pole. And I thought, doesn’t that mean nobody should really be sliding down poles?”
That train of thought — calculating risks, eliminating threats — eventually led her to a job with the Food and Drug Administration in 2012 as a public health analyst. She was put in charge of developing a new online system for collecting reports of harmful device malfunctions. She quickly realized that the software was too old and clunky to identify report patterns that would help the agency shut down a product before hurting patients. Critical information, like unique device identifiers that help hospitals keep track of implants in patients, was often missing. Patients and doctors alike often knew very little about the safety record of their devices. Dispirited, she left in 2014 to work for consulting firm Avalere to build a device recall database. The company ultimately decided not to pursue this project and let Kinard buy the rights to the database.
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