Nearly ten years ago, the Food and Drug Administration (FDA) began a breakthrough device program with a goal of speedily approving innovative medical devices in order to help patients in need. More than one hundred of these devices are now on the market, but are they safe or effective? Katie Palmer reports for Stat News.
Medical device manufacturers are lobbying to ensure Medicare pays for their devices as soon as the FDA approves them. They want the payback on their innovations as quickly as possible. And, the FDA Commissioner says he would like that to happen.
But, perhaps Medicare should not be so quick to approve these new devices for coverage. Are these really breakthrough devices and are they safe? Researchers believe that the breakthrough device program is conducting faster reviews of new medical devices. But, they do not see the evidence that would confirm that these devices would actually benefit patients.
When new devices are intended to meet unmet health care needs, they should be subject to clinical testing. The FDA allows some “substantially equivalent” devices to circumvent this testing; but, there have been serious safety issues with some of these devices.
Of 75 medical devices intended to be therapeutic in the breakthrough device program, 67 underwent clinical tests, and half of them were high-risk. Of course, it’s important to consider their benefits as well as risks. But, these devices should not fail their clinical testing on safety and efficacy.
It would be easier to accept bringing speedy new devices to market if they were subject to greater market oversight. But, that does not always happen. The researchers found that many of the breakthrough devices are not getting the post-market oversight needed to confirm their safety and efficacy.
For sure, manufacturers are benefiting from the breakthrough device program. But, should their devices be covered automatically as they would like? It would increase Medicare spending by billions without any assurances that it would benefit patients, let alone not harm them.
Here’s more from Just Care:
- Why aren’t medical devices tested against placebos?
- Beware of faulty medical devices
- FDA approved medical devices may not be safe
- FDA hides data on medical device malfunctions and injuries
- A medical device may make heart surgery even riskier
