FDA’s ‘flawed’ device pathway persists with industry backing
WASHINGTON (AP) — Roughly 3,000 medical devices enter the U.S. market every year through a system that generally requires little or no patient testing to verify safety and effectiveness.
Unlike new pharmaceuticals, most medical devices reviewed by the Food and Drug Administration are cleared based on similarities to already-approved devices, not specific clinical trial testing.
Insulin pumps have most reported problems in FDA database
DESTIN, Florida (AP) — When Polly Varnado's 9-year-old daughter was diagnosed with Type 1 diabetes, it didn't take long for the family to hear about insulin pumps.
In September 2012, the girl picked out a purple one — her favorite color.
Over the next seven months, she proceeded to be hospitalized four times in a McComb, Mississippi medical center with high blood sugar. But when Varnado asked about all her daughter's problems, she said, her doctor blamed user error.
Breast implants reveal problems in tracking device safety
WASHINGTON (AP) — To all the world, it looked like breast implants were safe. From 2008 to 2015, the U.S. Food and Drug Administration publicly reported 200 or so complaints annually — a tiny fraction of the hundreds of thousands of implant surgeries performed each year.
Then last fall, something strange happened: Thousands of problems with breast implants flooded the FDA's system. More than 4,000 injury reports filed in the last half of 2017. Another 8,000 in the first six months of 2018.
Improving medical device tracking a slow, imperfect process
WASHINGTON (AP) — For nearly two decades, health advocates have pushed to standardize the way medical devices are tracked and studied.
They eventually landed on a solution that others, including other parts of the medical industry, already had adopted — a unique code to help track the type, manufacturer and other key information about a device.
In 2007, Congress asked the U.S. Food and Drug Administration to create the system, and the FDA passed a final rule establishing it in 2013.