ClickCease Focus: developments on labeling/tracking of medical devices

Focus: developments on labeling/tracking of medical devices

As we have previously noted for readers, whether the latest product is a drug or device, approval by the Food and Drug Administration to market and sell a pharmaceutical or medical device hardly ensures the safety OR performance of that product going forward.

There has been a steady parade over the last 30 years of defective medical products that have cleared regulatory hurdles and subsequently visited dire — and, far too often, deadly — consequences on consumers in California and elsewhere across the country.

Our firm has provided vigorous and effective representation to clients injured by a wide spectrum of drug and device offerings. From L-Tryptophan to the Copper -7 IUD’s; DES to Sulzer hip prostheses; Dalkon Shield birth control devices to Vioxx; Defective pacemakers to drug eluting stents; metal on metal hip-replacement products to Infuse morphogenic bone compound, the walkup Melodia firm has been at “ground zero” of consumer protection.

A recent FDA announcement concerning more accurate information on medical devices once they are in the marketplace speaks to the very deep agency concerns with product irregularities and the need for enhanced safety.

Late last month, the FDA released guidance on the so-called Global Unique Device Identification Database (GUDID), a system the agency has long been working on to better label and track devices deemed problematic and/or subject to a safety recall.

It is ultimately envisioned that targeted medical devices will be able to be immediately tracked and located pursuant to a scanning process that is undertaken prior their implantation in a patient.

To the extent that such a system is effective, it will truly promote health safety.

It will not, however, rid the marketplace of drugs and devices that leave their manufacturing source in a flatly dangerous or otherwise defective state.

Defective medical products continue to injure and kill unsuspecting consumers. Without adequate staffing, oversight and independence from the influence of Big Pharma the FDA will never provide protection from injury. Until that happens, it remains the job of experienced product liability lawyers acting on behalf of injured victims and their families to protect the American public.

Source: Injury Lawyer News, “FDA finalizes guidelines for medical device tracking system,” Ava Lawson, July 8, 2014

Category: Defective medical devices … (anchor/deep link test “defective medical products” taken from client’s Defective Medical Devices and Drugs practice page).