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Senators Medical Device Effectiveness Following FDA Approval

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The end of last week, Senators Grassley, Blumenthal and Kohl introduced legislation in the U.S. Senate which they say will help protect patients from unsafe medical devices and improve the management (and reduce the costs) of device recalls.  

The bi-partisan-sponsored measure, The Medical Device Patient Safety Act, would provide FDA vital "tools to discover problems with faulty medical devices sooner and to better manage recalls when problems do occur, without slowing down the approval process for new devices," according to the U.S. Senate’s press release.   

Also, under this legislation, if passed, the FDA could require post-market clinical studies for medical devices that FDA believes pose potential safety risks, if they were approved through the expedited 510(k) [fast track] review process, and could grant conditional approvals pending the result of ongoing trials. That would strengthen rules for products approved through the so-called 510(k) system, according to an article in Bloomberg News by Anna Edney and Alex Nussbaum, December 16, 2011.

If signed into law, the bill would also implement the General Accountability Office’s (GAO’s) recommendations to improve the recall process, and "give the FDA new authority to require conditional clearance pending safety studies for devices reviewed under the fast-track, 510(k) approval process." Senator Grassley hoped this legislation would become part of the reauthorization legislation of the medical device user fee law (which must occur by next October).

The proposed legislation gives the FDA a more teeth in the approval process and will likely speed the 510(k) process which had slowed in recent years. Grassley described the measure as helping to build a robust post-market surveillance operation in the FDA. Theoretically, the bill demands more consumer safeguards, improves recall management, helps to avoid expensive recalls, and helps prevent irreversible injury to patients. Senator Blumenthal said, "By removing unsafe devices from the market more quickly and efficiently, we're preserving a faster approval track for safe and effective products to reach patients."

At least Senators across political aisles agreed on something last week. But we wonder exactly how this will affect the consumer in the long run, e.g., the elderly man with a defective hip replacement (e.g., DePuy ASR hips recalled last year) or the woman with a faulty pacemaker? Once the hip joint is implanted and the pacemaker has failed, one might say the horse is already out of the barn and the burden falls to the consumer to pick up the pieces. One would like to believe, too, that a faster approval process and post-market safety studies would help the companies make better devices, but one wonders. A faster to-market process may actually incentivize manufacturers to cut corners in an effort to keep up competitively. Maybe the costs to industry of recalls will be less, but who does that protect? Big business, that's who. This writer is not sure the average end-user of a medical device is better off with this bill.

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  1. jane akre says:
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    Thank you for your well thought out comments.

    At the FDA expert panel convened in September, the discussion was that the FDA under Section 522 already had the authority to order postmarket surveillance for Class II and Class III medical devices if there were any complication reports and/or the device was intended to be implanted in the body for more than one year.

    Perhaps the word “conditional” approval is what’s new here.

    BTW- as News Editor of IB for three years I did a pretty comprehensive 4-part series on surgical mesh and the complications it causes:

    Suffering in Silence- Part one
    http://www.injuryboard.com/national-news/suffering-in-silence–medical-device-surgical-mesh.aspx?googleid=260038

    Really – an incredible example of the tail wagging the dog.

    Thanks again for your interest in raising awareness of this subject!