Streamlining of Medical Device Approval Proposed by Legislators
Senators among US Democrats have proposed a bill to hinder approval of medical devices with
safety issues , as reported by Bloomberg. They talked about untoward results brought about by
medical products of Johnson & Johnson.
There are around 93,000 recipients of the ASR XL Acetabular System and the ASR Hip
Resurfacing System worldwide. After the release of data presenting defectiveness in one out of
eight patients to whom they were implanted, the two devices were pulled back.
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 may lead to metallosis, a
type of blood poisoning, and genotoxicity, which comprises genetic damage.
“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,” says Representative Edward Markey of Massachusetts in a statement issued
to reporters.
“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,”
explains Markey.
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 The authors of the bill
were Richard Blumenthal (D-CT), Herb Kohl (D-WI), and Charles E. Grassley (R-IA).
According to Senator Blumenthal, “there is clearly a need for scrutiny once products are
implanted or used on patients.”
According to the Times, “these lawmakers have proposed a wave of medical device industry-
friendly bills that would further streamline FDA regulations, allowing more product clearances.”
This coordinated effort from a significant and different group of
legislators displays that the government are listening to the
public about their concerns onr the probable negative
consequences from a lenient medical device regulation.
Additionally, legal observers say that thiseffort exhibits the
concern of the lawmakers to the citizen’s need for better health
and medical care. Aside from DePuy, there are several other
manufacturers who will be affected by these impending bill.