The Houston medical device injury lawyers at Denena & Points note that the FDA has proposed a new medical device tracking system in an effort to help the agency keep watch over patients’ safety and medical device effects on that safety. The new medical device tracking system responds to concerns raised over the past several years regarding adverse effects caused by widely used medical devices in the United States.
The types of medical devices affected by the proposed rule would include some of those life-saving innovations upon which so many are dependent: artificial hips, knees, and other joints, pacemakers and cardiac stents, scanners, and radiotherapy machines. The U.S. remains the global leader in medical device technology. The medical device industry shows a net trade surplus in the U.S. and employs about 2.5 million workers within the U.S.
Our Houston medical device injury lawyers emphasize that the real economic benefits of the medical device industry to the United States should not blind us to the dangers posed by lack of product testing. Medical devices generally are not subject to the rigorous testing or clinical trials that new drugs must sometimes undergo.
Certain classes of medical devices are exempt altogether and others are “grandfathered” into FDA approval if manufacturers can show that they are a descendant product that is substantially equivalent to another product that has already garnered FDA approval. And don’t forget that medical device products that already existed at the time of the FDA’s advent in the 1970s received automatic approval with no testing and no questions asked. Our Houston medical device injury lawyers hope that you might see from this brief outline some of the serious safety gaps in the FDA approval process that lead to defective and dangerous medical devices that cause adverse health consequences to patients.
A prominent example of medical device failure causing widespread harm focuses on the metal-on-metal hip implants that quickly failed in a majority of recipients and led to dangerous repeat surgeries. Among the brand names associated with the metal-on-metal hip implant failures are the Depuy ASR, the Stryker Rejuvenate, the Biomet M2A-Magnum, and the Zimmer Durom Cup. (Source: Eric Chaffin, The Legal Examiner, 7.19.2012) Around 150,000 U.S. patients are thought to have received the dangerous hip implants, but the identities of only a few thousand of those patients are known to the FDA.
The FDA has received strong criticism for approving these medical devices without clinical testing. The agency has also been blamed for failing to respond quickly or strongly enough to the many reports of the medical devices failures and adverse consequences in the patients that received the metal-on-metal hip implants.
The FDA responds by saying that its proposed new medical device tracking system should make it easier for the agency to track performance of medical devices once they reach the market, identify problems in the devices, and respond more quickly with product recalls when needed.
The tracking system would apply a unique alphanumeric identifier, similar to a bar code, to each device. Our Houston medical device injury lawyers understand that the ID number would contain information like the manufacturer’s name, type of device, serial number, batch or lot number, and expiration date. The information in the ID code would also be placed into a publicly available database to enable easier tracking of individual medical devices.
The proposed tracking system comes as a response to a law passed by Congress in 2007 that instructed the FDA to develop a Unique Device Identification (UDI) medical device tracking system. Another law passed by Congress in this year set a final deadline for enactment of the UDI system within the year.
The FDA has provided 120 days for the healthcare and manufacturing industries to comment on the proposal. After the comment period, The FDA will have 6 months to finalize and issue the UDI medical device tracking rules. And the new rules will then be phased in over the following 7 years. The rules will apply first to those medical devices the agency deems most dangerous or highest risk.
Our Houston medical device injury lawyers believe that the proposed UDI medical device tracking system will provide some improvements to patient safeguards and safety oversight of new medical devices. But we wouldn’t argue that the proposed system even begins to address the potential problems caused by medical device exemptions from safety testing and clinical trials under the FDA. Learn more about the substantial safety gaps in the existing FDA approval process in our Houston medical device injury lawyers’ linked article on the topic.