David Hilzenrath reports for KFFHealth News on how defective medical devices end up remaining in use. Even when the FDA sends out notices about medical devices that can cause serious injuries or even death, physicians might be using them. Inexplicably, manufacturers and the FDA do not end their use or effectively recall them from use.
In most cases, when an agency recalls a product, be it food or an automobile or a crib, it asks that customers return the product to its place of purchase for repair or to discard it. But, an FDA medical device recall does not mean that the product is actually recalled. Rather, a recall could mean something other than an end to a product’s use. It can mean a fix of some sort, be it a repair or adjustment or inspection of a device.
In one case, Abbot, a medical device manufacturer, explained that instead of removing a defective implanted medical product from the market, it changed instructions on how to use it and required physicians to get training before implanting it.
Of 338 medical device recalls between 2019 and 2034, 164 were “corrections.” Only 174 products were actually taken off the market. When it does not remove a medical device from the market, the FDA says it is because the frequency or severity of the bad consequences from the product is not great or that the fix is effective and the benefits to patients are greater than the loss of the product. To be sure, there are risks from removing implanted devices from patients.
The takeaway: Be sure to look into any medical device your doctor recommends before agreeing to it. I have reported several times, including here and here and here, on dangerous medical devices that the FDA has failed to remove from the market, to the detriment of patients, allowing manufacturers the ability to “fix” the defects at some risk to patients.
Here’s more from Just Care:
- Dr. Oz’s heart valve: A cautionary tale about medical devices
- Medical device corporations and physicians harm patients through artherectomies and gouge Medicare
- Why aren’t medical devices tested against placebos?
- Beware of faulty medical devices
- Medical device company gouges hospitals that use its surgical robot
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