FDA Med Device Action

The FDA’s New Medical Device Safety Action Plan Throughout history, protecting patients from harm has been a primary goal of all healthcare providers. This task has become increasingly more difficult over the past several decades due to the virtual explosion of new medical devices. With all of these new medical devices and innovations comes the ever present risk of patient harm due to a problem with the device that is not discovered during the premarket testing and approval phases. In April of this year, the FDA proposed steps to improve the government's system for overseeing medical device safety and new product/device innovation - see our blog on this here. For years the FDA has been criticized for failing to catch problems with high risk implants and complex/difficult to clean medical instruments. This new plan is designed to address and correct these problems.¹ In announcing the new plan last April, FDA Commissioner Scott Gottlieb, M.D., said “My colleagues in the FDA’s Center for Devices and Radiological Health (CDRH), led by Dr. Jeffrey Shuren, have been advancing new policies to drive innovation in medical product development by taking novel approaches to regulation, including the use of real world evidence to support iterative improvements in device performance and establishing a balanced framework for health devices that improves the lives of patients. Although medical devices provide great benefits to patients, they also present risks. And we are focusing equal attention on advancing new frameworks for identifying risks and protecting consumers.”² Over the past decade, the FDA has been frequently forced to issue safety alerts over problems with products/devices that only appeared years after they were approved for use in patients. Those safety alerts have included hip replacements that failed prematurely: faulty wiring in implanted defibrillators, surgical mesh and a surgical instrument that inadvertently spread uterine cancer. According to a November 20, 2018 joint statement by FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren, the goal of the new medical device safety plan is to ensure that “the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.”³ In order to achieve their new goal, the FDA will need to significantly increase its investment in the National Evaluation System for Health Technology (NEST). This increased investment will be necessary to help FDA staff collect and analyze data on medical devices that are in use daily in healthcare facilities and in home care settings as well. Armed with this real-time data from the field, FDA staff will be able to quickly identify medical device safety and performance issues. Once identified, FDA staff will be able to work with the manufacturers to take corrective action. “We’re evolving beyond our current postmarket surveillance system—which is largely passive and relies on device users to report problems to us, sometimes resulting in underreporting. We’re moving to an active surveillance system that relies on real-world evidence and timely receipt of robust safety information,” Gottlieb and Shuren said.⁴ Achievement of the FDA’s new goal of an active surveillance system is a massive undertaking that will require a lot of staff effort and additional Congressional funding. Presently, the FDA grants authorization for a dozen or more new medical devices every day. This is on top of the over 190,000 devices that it already has regulatory responsibility for. Making the problem even more complicated is the fact that all of these devices are manufactured by over 18,000 different companies that require regulation and surveillance (FDA facility audits, plant inspections, etc). While products are thoroughly tested and evaluated prior to their receiving 510(k) approval for sale and distribution, the real testing and learning about any potential risks comes once the product is in wide-spread use. The primary goal of the FDA’s new program is to have better tools for detecting issues that occur post-approval once new devices are in the hands of clinicians and are being used in diverse patient populations. The secondary goal is to develop better policies to quickly intervene and better inform patients and providers if adverse events are detected. “Access to robust and timely data, including more extensive and informative post-market data and real-world evidence, is central to empowering the FDA to identify, communicate and act on new or increased medical device safety concerns. Such data serves as the foundation of our commitment to improving our nation’s post-market medical device surveillance. It’s one of the core pillars of our safety plan.”⁵ Like the FDA, your facility is committed to protecting your patients from harm by minimizing avoidable risks. When it comes to reducing the risk of a surgical infection from a contaminated instrument, a simple, inexpensive step that you can take immediately is to seek out companies that have validated their cleaning IFUs. 1. FDA Press Release April 17, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604672.htm 2. FDA Op. Cite. 3. FDA Press Release November 20, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626286.htm 4. FDA Op. Cite. 5. FDA Op. Cite.