New system in the works to better track faulty medical devices

Artificial hips that shed bits of metal, stents that fail to open arteries and many other medical devices have been recalled after they caused patients harm, sometimes years after they were sold to the public.

The U.S. Food and Drug Administration now says it's a priority to more quickly share information about faulty products within the medical community and with the public.


The agency is working with the University of Maryland and other institutions to develop an easily accessible system that will begin collecting and analyzing real-time data as soon as devices hit the market. The effort aims to not only help protect patients from harmful products but steer them to innovations showing unexpected or special benefits.

"There are a lot of things we don't know when a technology comes on the market," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. "We get a lot of data from clinical practice... How do we better leverage real-world data?"


Dr. Shuren was among several researchers and government regulators who spoke Thursday during a symposium at the University of Maryland School of Pharmacy to outline a new evaluation system.

Much of the data on the $133 billion medical device industry already is being collected by industry, insurers, health systems and other private networks but the information isn't linked or widely available. Planning for the new public-private effort to connect it began in 2014 and officials now hope to design a system to monitor every medical device regulators approve for use.

Such a system is vitally important given that millions of people now have implanted heart, orthopedic, contraceptive and other devices, and more people are getting them while they are relatively young, said Fadia Tohme-Shaya, a Maryland professor who is helping lead the effort through the Maryland Center of Excellence in Regulatory Science and Innovation. The center is an FDA-funded collaboration between the University of Maryland campuses in Baltimore and College Park.

Doctors today are replacing joints in people in their 30s or 40s, wrecked from activity rather than age, making the durability of devices more important, especially as people live longer, she said.

Despite arduous testing before devices gain approval, Tohme-Shaya said it remains difficult to determine what device may be best for a patient because the available information is limited. Problems and questions often aren't apparent until after hundreds or thousands of devices have been implanted.

"Most everyone knows someone living with a device like a pacemaker, a hip or a stent, and they themselves might be living with one," said Tohme-Shaya, professor and vice-chair for academic affairs and associate director of the Center on Drugs and Public Policy in the Maryland School of Pharmacy. "Unlike with drugs, it's hard to switch to a new device. When something goes wrong it's rarely an option for the patient to have it removed."

The collaborative database could help catch device defects or unintended consequences in patients earlier, allowing for tweaks or advice to doctors and limiting major recalls, she said.

The FDA has issued about a dozen top-level recalls so far this year, meaning those products could cause serious injury or death. Many more less serious recalls occur annually.

The system also could pinpoint who is benefiting the most from devices, allowing manufacturers to market more effectively or even customize products. That could tell doctors which artificial joints work best in runners, for example, or which stents are safest for certain heart patients, said Dr. Matthew Brennan, a cardiologist and co-director of the STS Analytical Center at Duke University's Clinical Research Center.

He cited a recently approved kind of stent that is made of a polymer that the body absorbs. While it could "revolutionize the market" by eliminating complications from implanting metal, it now appears to createscar tissue that can cause new blockages. And polymer stents coated in medication to prevent the scarring may lead to more dangerous blood clots

"The polymer ones are supposed to prop open an artery and then go away," Brennan said. "The question now is what is the real-world outcome. I won't have to wait four years, after millions have been placed, to see which patients benefit. There also may be a downside that didn't come to light in trials."

Others at the symposium said the biggest challenge with building a new system is getting everyone to share information, though public, industry and health groups are now at the table, FDA officials and researchers said.


Other issues will be technical, such as a separate but intertwined effort to label each device manufactured. That specific data could help quickly identify what happened to a defective batch of devices, for example, but pose other problems, such as added cost, said Dr. Andrew N. Pollak, chair of the University of Maryland School of Medicine's department of orthopedics.

The FDA already has begun requiring unique identifiers for devices.

While a national evaluation system has tremendous potential to provide doctors with important information about devices, Pollak said it will be important to insure the data isn't skewed. Some failures are not due to the devices but because of a patient's behavior or circumstances, such as when a car crash victim's fractures become infected, he said.

A big issue for manufacturers might be "signals" given off by a device that erroneously indicates a problem, said Theodore Heise, vice president for regulatory scientific affairs at Cook Medical, a Bloomington, Ind.-based device maker. That could put off doctors, scare patients and even lead to litigation, while denying some patients a needed medical advance, he said.

Still Heise sees many positive possibilities with sharing information, including the ability to quickly add or change features to benefit more patients, and avoiding or minimizing recalls.

"Our concern," he said, "would be that a device is not completely evaluated."

The FDA's Shuren said ensuring quality data goes into the system and proper analysis would be critical to handling such signals. Pushing the data out to doctors in a timely way also would be necessary to make sure patients have information on the products, a concern of consumer advocates.

The task now, Shuren said, is to work out the details.

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