Category: Medical Devices

‘An Arm And A Leg’: Journalist Learns The Hard Way That CPAP Compliance Pays

Check the fine print. When you get a prescription for expensive medical equipment, you may need to follow the doctor’s orders — to the letter — to get your health insurance company to pay up.

Five Things We Found In The FDA’s Hidden Device Database

The Food and Drug Administration released two decades of previously hidden data containing millions of injuries or malfunctions by medical devices. Here’s what we’ve learned so far.

More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database

The FDA reveals that 56,000 malfunctions associated with surgical staplers weren’t reported through its traditional public reporting system.

Hidden Reports Masked The Scope Of Widespread Harm From Faulty Heart Device

The Food and Drug Administration allowed one company to send 50,000 reports of harm or malfunctions to an internal database even as patients worried about faulty defibrillators lodged in their hearts.

FDA To End Program That Hid Millions Of Reports On Faulty Medical Devices

In the wake of a KHN investigation, the agency will no longer let device makers file reports of harm outside a widely used public database.

FDA Chief Calls For Release Of All Data Tracking Problems With Medical Devices

In the wake of a KHN investigation, Scott Gottlieb says releasing the records is in the public interest.

Device-Safety Experts To FDA: Make Data Public

For almost two decades, device makers have sent reports of incidents to databases hidden from public view.

FDA Announces Sweeping Plan To Review Safety Of Surgical Staplers

The FDA said it might reclassify the widely used devices featured in a recent Kaiser Health News investigation.

Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices

The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, leaving doctors and medical sleuths in the dark.

Podcast: KHN’s ‘What The Health?’ New Year, New Health Proposals

Democratic governors and mayors are unveiling new ideas to control costs and expand coverage. The federal government shutdown has spared most health agencies, but not all. And learn the latest on that lawsuit out of Texas, which is threatening the Affordable Care Act once again. Margot Sanger-Katz of The New York Times, Anna Edney of Bloomberg News and Rebecca Adams of CQ Roll Call join KHN’s Julie Rovner to discuss these issues and, for “extra credit,” provide their favorite health policy stories of the week. Rovner also interviews KHN’s Jordan Rau about the latest “Bill of the Month.”