Stringent Medical Device Clearance Sought by Senators
Legislators from leading US Democrats aim to prevent approval of unsafe medical products , through a landmark legislation, says Bloomberg They stated cases from defective devices 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 fail prematurely in one out of eight people who have them.
Transporting of microscopic metal parts into the body due to metal components rubbing against each other is one effect of design problems with metal-on-metal hip implant devices, like the DePuy. The amount of certain metals in the blood, like chromium and cobalt, may be augmented by the metal bits transported from the implant device. This condition may result in genetic damage (genotoxicity) and blood poisoning (metallosis). (Chromium and cobalt have also been linked to cancer, and might lead to the development of tumors.
'A bill introduced this week before the lower house of Congress would close a loophole that allowed devices to win approval even when these are similar to a product already pulled out from the market,' as stated by Representative Edward Markey of Massachusetts in a statement released to the media.
'If an automobile is recalled for a major safety problem, we wouldn't allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies,' Markey said in the statement.
On a similar note, on December 14, 2011, the New York Times reported that three US senators proposed a new bill affecting medical device regulations as a response Theproponents were Herb Kohl (D-WI), Richard Blumenthal (D-CT), and Charles E. Grassley (R-IA).
'There is clearly a need for scrutiny once products are implanted or used on patients,' stated Senator Blumenthal.
The Times further noted that 'these lawmakers have proposed a wave of medical device industry-friendly bills that would further streamline FDA regulations, allowing more product clearances.'
This harmonized move from a varied group of lawmakers exhibits that they are giving attention to the consumers concerns on the possible negative risks from vague and lenient rules on medical device. According to legal observers, this move also demonstrates that the policymakers are acknowledging the significance of improving health care for the citizens. This bill at hand will take its effect not only on DePuy but also on the many other device manufacturers.