FDA releases plan for improving medical device safety
The Food and Drug Administration (FDA) has released its “Medical Device Safety Action Plan,” a series of ideas and proposals on more quickly enforcing new safety requirements, encouraging manufacturers to make safer products and improving cybersecurity of devices.
“Although medical devices provide great benefits to patients, they also present risks,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “And we are focusing equal attention on advancing new frameworks for identifying risks and protecting consumers.”
The plan doesn’t propose immediate changes in guidelines or regulations surrounding devices and may also require additional money from Congress to implement. The FDA has been caught flat-footed in recent years when unexpected safety issues are identified in medical devices long after they’ve been approved by the agency.
Several of the greatest safety issues have arisen from women’s products. Power morcellators—a device to remove tissue via small incisions used during hysterectomies and removals of benign uterine tumors—had been approved by the FDA in 1991, but more than 20 years later, reports started streaming in that the devices had been spreading undetected cancers. A federal report blamed the FDA’s “passive” reporting system for adverse events for the problem not being addressed sooner.
Following those issues and other identified in the birth control implant Essure and vaginal mesh products, the FDA’s plan cites additional safeguards for women’s health devices as a priority in this new initiative. The plan also acknowledged the current reporting system “can take a long time” before identifying risks and safety concerns, so one of its goals will be to move the FDA to develop a public-private partnership called NEST (National Evaluation System for Health Technology) to engage in more active safety surveillance.
The proposals were praised in statements from the device industry, though with some caveats. The Advanced Medical Technology Association (AdvaMed) said its industry is “committed to patient safety” and ready to work with FDA, but it also said the “current regulatory framework has served the American public well,” while adding its open to improving processes.
Consumer advocates, however, didn’t see much to get excited about in the plan.
“FDA’s safety strategies for medical devices are still years away from effective implementation,” Diana Zuckerman, president of the National Center for Health Research, told the Associated Press.
John joined TriMed in 2016, focusing on healthcare policy and regulation. After graduating from Columbia College Chicago, he worked at FM News Chicago and Rivet News Radio, and worked on the state government and politics beat for the Illinois Radio Network. Outside of work, you may find him adding to his never-ending graphic novel collection.