How often do we depend on customer reviews when shopping online, considering a restaurant, or making movie plans? We don’t even think about how Yelp and Rotten Tomatoes have changed the way we plan “dinner and a movie.”
But if you’re suddenly in the market for a pacemaker, hip replacement, or other medical devices, it isn’t so easy to check the reviews. And there are millions of “bad reviews” for medical devices out there.
They’re called “adverse event reports” — stories of device failures, injuries, and even deaths. They’re filed by manufacturers, doctors, and patients who witness or experience a problem. The reports live in a U.S. Food and Drug Administration database. More than 2,000 new reports are added every day. But they can be so difficult to access, and so nearly impossible to put in perspective, that FDA regulators themselves are often unaware of the full stories they tell.
What's worse, only a fraction of problems — one study says as few as 1 percent — actually end up in the database. This is what medical journalist Jeanne Lenzer, author of The Danger Within Us, said in a recent NPR.org interview.
"Loose oversight of devices poses a threat to public health," Lenzer wrote in a recent column for the New York Times.
The Manufacturer and User Facility Device Experience, or MAUDE, database is meant, in part, to be an early warning system. It is intended to spot trends when a particular model of medical device fails or causes the same injury over and over. At best, it’s a clunky public service.
For instance, try looking for medical devices made by one specific company, let’s say Medtronic PLC, on the MAUDE database. You’ll quickly find out what a nightmare it is to navigate.
“With Medtronic, you have 1,397 variations of the company name in the system,” said Madris Tomes, who managed the FDA’s adverse-event reporting system from 2012 to 2014. “You have to type in each variation to find all the reports.”
Tomes left the FDA in 2014 to start her own company, Device Events, which allows users to search the FDA’s medical device adverse events based on keywords — much as you would do a Google search. (In full disclosure, Tomes is also a paid contributor to my employer.)
Her clients are insurance companies, hospitals, and other large institutions. Consumers should expect a similar common-sense approach from their government.
The FDA promised in 2012 to “modernize adverse event reporting and analysis.” Since then, high-profile cases have only highlighted the agency’s shortcomings in doing so.
In 2017, the Government Accountability Office detailed how the FDA managed to miss — for nearly 20 years — the fact that power morcellators used in hysterectomies were spreading cancer in patients. In 2016, a U.S. Senate committee investigated why it took the agency three years to respond after another medical device caused “superbug” outbreaks at U.S. hospitals.
Dr. Josh Rising, director of the Pew Charitable Trusts healthcare programs, told the Los Angeles Times at the time that gaps in early detection could “compromise the safety of millions of Americans.”
This is not an impossible fix. The FDA has already done it with the agency’s similar database for drugs. In September, the FDA unveiled its new FDA Adverse Events Reporting System, or FAERS, public dashboard, featuring every report dating back to 1968. You can use keyword searches much like you would on Google to look for specific medicines or side effects. The results don’t point directly to conclusions and the dashboard is rife with disclaimers, but this kind of information can help consumers and healthcare professionals better understand what others are experiencing with a given medication.
FAERS and MAUDE are essentially meant to provide the same consumer service for different medical products. But they are light years apart in the service each provides.
The federal government is often slow or inept when it comes to applying common-sense technology. Consider, for example, the disastrous debut of healthcare.gov, which inconvenienced so many. Unfortunately, failure to adopt new technology on medical devices could have much more serious consequences, needlessly costing people their lives.
Terry Turner is a medical writer who covers drugs and medical devices, their health complications and legal implications, for Drugwatch.
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