Late last week a group of four U.S. Senators introduced a bill that targets the safety of medical devices used in surgical procedures. Mass Device explained that Democrats Jeff Merkley, Michael Bennet, and Herb Kohl, along with Republican Chuck Grassley put forward the Ensuring Safe Medical Devices for Patient’s Act. The underlying purpose of the proposal is to enhance the oversight provided by the U.S. Food and Drug Administration (FDA) of these devices. Our Illinois elder care lawyers believe that this represents good news for local seniors-many of whom need medical devices implanted to help with various issues. The DePuy hip recall is perhaps the most high-profile example of mass device breakdowns affecting thousands of seniors, both in our area and around the country.
Understanding the need not to rush into approval of any devices which may pose risks to unsuspecting patients, many different advocacy groups are applauding the spirit of this latest legislative proposal. One part of the bill would add medical devices to the “Sentinel post-market surveillance initiative.” The initiative is a program, first started in 2008, that monitors prescription drugs. Inclusion of medical devices would essentially add a range of oversight features which would hopefully act as an important check to identify problematic devices before they cause serious harm.
In addition, a second component of the bill would force the FDA to issue final rules on the Unique Device Identifier program. That program is now nearly five years old and was created to track medical implants. The tracking itself enables regulators to identify trends in the devices quickly. For example, some have argued that if tracking was used in the recent metal-on-metal hip problem, then the devices could have been stopped well before the official DePuy hip recall. Potentially thousands of patients might have been spared the need for revision surgery.
Summarizing the concerns often voiced by our elder law attorneys on the issue, Senator Merkley noted that, “When seniors undergo hip replacement surgery or heart patients need a cardiac stent, they shouldn’t have to worry that the device that is supposed to improve their health could actually make them sicker.”
Two of the Senators leading the efforts, Sens. Grassley and Kohl, have been investigating medical device safety for years. A report released by the pair of bi-partisan legislators last year systematically detailed problems with the current oversight system. Even then the two had called for better oversight and more comprehensive review of medical device trends in an effort to keep consumers safe.
This latest bill is similar to one that was introduced last December-Medical Device Patient Safety Act. That former bill sought to increase FDA safety regulations. Specifically, the measure would have allowed the FDA to study devices even after they had been approved and to grant conditional approvals which would then be contingent on successful completions of further trials.
Senator Grassley has been particularly vigilant about this problem. In addition to co-sponsoring these two medical device bills, he has also looked into claims of intimidation by those involved in approving the devices. He has previously launched an investigation into claims by whistleblowers at the FDA who claim that the agency was overly aggressive with employees who challenged the devices that had already been cleared for market use.
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