Three U.S. senators have proposed a bill calling for stricter medical device regulations. This was published last December 14, 2011 on the New York Times. The three senators were Charles E. Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI). These lawmakers are throwing bipartisan support for a "wave of medical device industry-friendly" bills that would further streamline Food and Drug Administration (FDA) regulations, allowing more stringent product clearances.
Apart from proposing the bill, they also gave out letters to five major manufacturers of medical devices, asking about how they determine product safety and recall devices. The manufacturers were Johnson & Johnson, an artificial joint maker; Zimmer Holdings, another producer of artificial joints; Medtronic, a heart and spinal implant producer; Boston Scientific, a heart device maker, and C. R. Bard, a surgical implant maker.
Particularly in the case of Johnson& Johnson, with approximately 93,000 recipients worldwide, the ASR XL Acetabular System and the ASR Hip Resurfacing System were recalled after data revealed that the devices had failed prematurely in one out of eight people who have them. Factory production and sale of the two prosthetic items started in 2003. In August 2010, DePuy carried out a worldwide recall.
No comments:
Post a Comment