As Medical Device Use Rises, Unapproved Tools Find Their Way Into Patient Care
Also, WBUR examines workplace wellness and healthy rewards programs encouraging good employee health habits.
ProPublica/The New York Times:
Knee Replacement Device Unapproved, But Used In Surgery
Carla Muss-Jacobs didn’t give much thought to the tools her surgeon would use to replace her knee. Like most patients, she just wanted to feel better and trusted that any devices in the operating room would be safe. In her case, the surgeon sliced open her leg and positioned special cutting guides, like carpentry jigs, over her thigh and shin bones to line up his bone saw precisely. The device, called the OtisKnee, was supposed to speed the surgery and the recovery. ... As it turned out, the OtisMed Corporation, the maker of the OtisKnee, did not seek clearance from the Food and Drug Administration for its OtisKnee guides before it started selling them. When the company did apply for F.D.A. review, its application was rejected because, the agency said, the company failed to show that the product was safe and effective. (Allen and Pierce, 2/6)
WBUR:
As Health Incentives Rise, Many Get Paid To Work Out And Eat Kale
Rewards like gift cards, a preferred parking spot or a certificate of recognition aren’t working. Enrollment in wellness or healthy rewards programs hovers around 20 percent. So more and more insurers and employers are turning to cash — albeit modest amounts so far, like Smith’s $20. (Bebinger, 2/9)