FDA to Replace Current Medical Device Approval System

The FDA recently announced plans to overhaul its dated medical device approval system. The system, which has been in place since the 1970s, has been criticized for years due to its approval of over 95 percent of medical devices to be put on the U.S. market; unlike pharmaceutical drugs, medical devices do not always undergo extensive testing to ensure that they are safe enough for public use.

The news of the system reboot came just one day after an expansive investigation released by 50 media organizations revealed that 1.7 million injuries and almost 83,000 medical implant-related deaths have been reported to the FDA in the past 10 years.

Two of the most high-profile approved medical devices that were later proven to be high-risk are metal hip replacements and surgical mesh. Hip replacements have failed almost instantly in thousands of customers, while surgical mesh has caused bleeding, severe pain, and even worked to spread uterine cancer in some patients.

Today, there is a passive reporting system in place that allows healthcare providers to post medical device complications to a FDA database; reporting, however, is often under-done or not completed in a timely manner. With this in mind, the overhaul will consist of a more active surveillance system, known as the National Evaluation System for Health Technology (NEST), so that the risks and benefits of each prospective medical device can be weighed more carefully.

Here are some of the major objectives that NEST is striving to achieve:

• Increase efficiency in generating better evidence and regulatory decision-making
• Apply advanced analysis to real-world data to identify which devices may be causing problems in a timely manner
• Link data from multiple sources (i. e., clinical registries, electronic health records, and medical building claims) so that a wider breadth of data is being examined
• Help health officials make more informed decisions about medical device decisions to enhance patient safety

As of now, it could still be years before NEST is fully implemented by the FDA. This is largely due to the need for additional funding — just recently,  an additional $46 million of the President’s 2019 budget was recently requested to support NEST. Unfortunately, this delay makes it likely that unsafe medical devices will be approved for public use for years to come, potentially injuring or killing many more individuals.

Our law firm of Childers, Schlueter & Smith is well-versed in drug and medical device litigation and might be able to help you or a family member who is suffering due to this lacking process of the FDA. If you have questions, please give us a call at 800-641-0098. All initial inquiries are free of charge and without obligation.