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The New Stringent Medical Device Clearance Sought

by:Zhiyuan     2020-06-02
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. Because of the numerous complaints against the DePuy hip system, the British Hip Society has pushed for an informal metal-on-metal hip replacement ban. After information saying that the devices have defects in one out of eight clients, the ASR XL Acetabular System and the ASR Hip Resurfacing System were withdrawn. There are about 93,000 recipients of these products worldwide. Design problems with metal-on-metal hip implants, particularly the DePuy ASR hip devices, may cause the metal components to rub against each other and shed microscopic metal particles into the body. The amount of certain metals in the blood, like chromium and cobalt, may be augmented by the metal bits transported from the implant device. Cancer and tumor may also be developed due to the presence of chromium and cobalt in the blood. '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,' adds Markey. Additionally, on December 14, 2011, the New York Times published an article saying that three U.S. senators proposed a bill reinforcing medical device regulations. 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. Furthermore, the Times said these lawmakers have proposed a 'wave' of medical device industry-friendly bills that would further 'streamline' FDA regulations, allowing more product clearances. This effort from a group of lawmakers demonstrates that policymakers are listening to patients, companies, and consumers about their concerns for potential negative consequences from a stricter medical device regulatory regime, legal observers say. It also shows that senators are recognizing the important role industry plays in improving health care and outcomes for patients. There are many other pharmaceutical companies, not only DePuy, which will be affected by these forthcoming law. Beginning in 2008, the Food and Drug Administration (FDA) had received nearly 400 reports of patients who encountered problems with DePuy hip device. Presently, numerous clients have pursued legal complaints against DePuy Orthopaedics Inc. and its mother company, Johnson & Johnson.These lawsuits claim that the company was deferring the implementation of DePuy hip recall although it is aware of the problems of the devices. To facilitate medical attention for men and women who had bought the devices from it, DePuy should provide wide-ranging information dissemination on the flawed hip replacement symptoms.
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