Tougher oversight needed on harms of medical devices

Problems with medical devices contribute to 3,000 Americans’ deaths annually, research shows, and fixing any one of the problem devices can cost hundreds of millions. So why aren’t government officials doing more and better in regulating them and protecting the public, a New York Times health policy columnist has asked.

This health economist, Austin Frakt, also has zeroed in on possible solutions, some of which have surfaced after a scandal involving diagnostic scopes used in gastroenterological procedures. Those defective and dirty scopes caused infections that have killed at least 21 and sickened dozens at hospitals nationwide, U.S. Senate investigators confirmed in January.

Experts are starting to think that medical devices each must carry distinctive numbers and tags of some kind, and that this information needs to be recorded in health records each time a device is implanted or used. Such a system exists now for medications. It has helped researchers analyze and find problems in drug prescribing.

But opponents fear that creating it for medical devices could be costly (amounting to $50 million annually) and time consuming. The system might be cumbersome, as some procedures require many items that might each carry distinctive tagging, such for hip or back surgeries where there might be multiple plates, screws, and other hardware. And it isn’t clear exactly where the information would be recorded (since not all electronic health records are interchangeable among various hospitals), and who would analyze it and how.

Still, similar systems elsewhere (Australia, England, Wales, and Sweden) have surfaced flaws faster than occurred in the U.S. with devices, including hip joints and heart stents.

The American lack of a system also clearly cannot suffice. Defective defibrillators affected more than 200,000 patients, and cost Medicare $287 million, the Times columnist notes.

Patients, physicians, and hospitals now also are part of a clearly unworkable, largely self-reporting, and lethargic system that, at least in the scopes case, failed badly. A Senate committee assailed inaction and ineptitude by hospitals, regulators, and the manufacturer for allowing the defective devices to kill and sicken patients for such a long time; the crisis worsened, partly because the manufacturer failed to inform scattered users of problems with the devices. Hospitals didn’t file required incident reports. Regulators didn’t detect the pattern of problems until they were pointed out in news reports.

In fact, new stories now say the manufacturer─which also has settled out with federal prosecutors by agreeing to pay record-breaking fines for kicbacks─sought to charge hospitals troubled with scope-related infections more for replacement devices. Investigators also have upped the number of afflicted patients in a recent five-year period to as many as 350 in more than 40 facilities worldwide.

The bottom line? The columnist says of information that might be produced by more aggressive oversight of medical devices:

Statistical techniques can increase confidence that correlations from surveillance systems imply a causal relationship (when they really do) or cast doubt (when they don’t). Medical devices are intended to cure, but some may cause harm. We’re not collecting the data that would help us know the difference.

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