Also, Better Post-Market Surveillance
Gottlieb’s FDA is piloting what it hopes will be a faster, more real-world post-market adverse event reporting system. The new system, called the National Evaluation System for Health Technology (NEST), is run by an independent governing body, the NEST Coordinating Council (NESTcc).
“To date,” Gottlieb and Shuren said in another posted commentary on November 20, “the NESTcc has entered into agreements this year with 12 organizations that represent more than 195 hospitals and almost 4,000 outpatient clinics with access to more than 495 million patient records—which will all be a part of the early data network.”
In September, FDA added $3 million to the seed funding for NEST, and asked Congress for an additional $46 million in fiscal year 2019 to build up NEST and to investigate post-market problems with individual devices. As of December 12, that additional $6 million is uncertain; FDA’s budget is caught in the middle of the President’s tug-of-war with Congress over the Mexican border wall.
Dumping MAUDE
NEST may seem like “Oh, well, yet another government database nobody looks at.” However, it may be different. Harm from medical devices is a hot button with the public.
On the very same day Gottlieb announced his intention to overhaul the 510(k) system, the Associated Press and NBC were publishing the results of a year-long medical device investigation conducted by the International Consortium of Investigative Journalists and more than 50 other media partners around the world.
One of those stories described how six medical devices (two of them orthopedic—spinal cord stimulators and hip prosthesis) out of more than 190,000 were responsible for a quarter of all the medical-device-related injuries and deaths reported to the Food and Drug Administration (FDA) from 2008 to 2017.
