According to Mass Device, a group of legislators have introduced another bill that seeks to keep medical patients safe from unsuspecting medical device errors. The latest measure was spurred in large part by a spate of medical device failures that have harmed countless residents in our area and throughout the country. Perhaps the most high-profile of those errors involve defective hip implants which spurred the Johnson & Johnson DePuy Orthopaedics ASR hip implant recall. Our DePuy hip recall lawyers understand that many local residents have faced serious problems as a result of these failures. Designs flaws in the hips can lead to release of metallic particles in the body. The product can cause significant pain and swelling, making it difficult to walk. Costly and risky revision surgery is often required.
To help avoid more device failures and keep patients safe, a bipartisan group of Senators are hoping to beef up U.S. Food and Drug Administration (FDA) oversight to prevent dangerous products from being used and to catch defective products that slip through the cracks. The latest proposal, introduced late last week, is known as the Ensuring Safe Medical Devices for Patients Act. It is being sponsored by three Democrats (Senators Jeff Merkley, Michael Bennet, and Herb Kohl) and one Republican (Senator Chuck Grassley).
After introduced the bill, one of the Senators noted that there is a balance that needs to be observed between taking advantage of technological changes to potentially improve medical care and ensuring that those devices first “do no harm.” That balancing act between proper use of innovation and patient safety is something that our Illinois medical malpractice lawyers intimately understand.
The new bill would essentially have two main components. The first would require the FDA to issue a final rule on a project known as the Unique Device Identifier program. The program is five years old and was intended to systematically track medical devices. Tracking is important, because it allows regulators to catch higher-than-allowable rates of failure in those devices. As soon as they are caught, the product can be pulled from the market, ensuring that fewer patients are exposed to the unnecessarily high risks. Failure to track, as in the case of the DePuy hip recall, often means dangerous products are still used until the total number of affected patients is staggeringly high.
The second part of the new proposed measure would add medical devices to the Sentinel post-market surveillance initiative. Similar to the Unique Device Identifier program, this Sentinel initiative involves monitoring products and devices after they are on the market. Right now the program is limited just to prescription drugs.
Our Chicago medical malpractice lawyers know that this bill comes on the heels of another measure proposed last December which similarly seeks to keep medical devices safe. That bill, the Medical Device Patient Safety Act, would increase FDA power during the approval process. Specifically, the legislation seeks to provide the FDA with more flexibility. If passed the agency would be able to offer conditional approval to certain devices, allowing full approval to hinge on successful completion of more patient safety trials.
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