TY - JOUR
AU - 
AB - BSS02.qxd:Layout 1 1/3/08 7:19 PM Page 9 Biomedical Safety & Standards Concise, accurate news repor ts for medical device safety professionals BS&S FEATURE February 1, 2008 Volume 38 FDA Petitioned on Direct-to-Consumer Number 2 Medical Device Ads IN THIS ISSUE The publisher of Consumer Reports, the Consumers Union (Yonkers, NY), has filed a petition with the FDA regarding direct-to-consumer (DTC) advertis- Recalls & Field Corrections ing of medical devices. Specifically, the organization wants the FDA to Luer Connector; Risk of require DTC ads for implantable devices to carry stronger warnings regard- Leakage ........................11 ing the potential for severe infection or failure after implantation. Electrolyte Analyzer for There has been a great deal of publicity recently on the ethical issues sur- Incorrect Results..........11 rounding physician relationships with manufacturers. In late 2007, five mak- X-Ray Systems, for ers of hip- and knee-implantation devices settled claims that they paid kick- Unexpected backs to surgeons who used their products; it was disclosed that some physi- Shut Downs ..................11 cians and organizations were paid $1 million or more. Bone Pressurizer; Yet, device makers have not yet used DTC advertising at the same level as Compromised pharmaceutical companies to take their advertising message to the 
TI - 100,000+ Skin Cleaning Devices Recalled
JF - Biomedical Safety & Standards
DO - 10.1097/01.BMSAS.0000310456.83586.c8
DA - 2008-02-01
UR - https://www.deepdyve.com/lp/wolters-kluwer-health/100-comma-000-plus-skin-cleaning-devices-recalled-DQI32RnvFb
SP - 13
EP - 13
VL - 38
IS - 2
DP - DeepDyve
ER -