We have been talking about a Consumer Reports investigation into medical devices and Food and Drug Administration approval processes. The investigation turns up some disturbing facts about the process as well as stories of how manufacturers have taken advantage of at least one loophole. The result is that manufacturers continue to market dangerous devices that put consumers at great risk of severe, life-changing injuries.
The report includes recommendations from Consumers Union, CR's advocacy arm. From the report, it looks as if there is a lot of work to be done.
First, testing on medical devices -- especially implantable devices -- should be at least as rigorous as it is for drugs. Again, the problem is not that the manufacturers are not complying with the regulations; the regulations are just not strict enough.
Second, the "substantially equivalent" standard, also referred to as "grandfathering," should be abandoned for high-risk and life-sustaining medical devices.
Third, institute a "unique identifier system" for implantable devices. This will allow regulators and manufacturers to notify consumers if a safety issue comes up. Such a system would make recalls much easier and much more effective.
Fourth, the FDA should create a national registry of devices to support the unique identifier system. Notifying consumers of a safety risk associated with something implanted in their bodies should be a comprehensive and simple process.
Finally, the user fees are too low to sustain a robust regulatory system. Manufacturers should pay more if the FDA is to do its job.
For patients, the challenge is to learn as much as possible about a device or procedure before agreeing to it. Get a second opinion, and keep records of the device's make and model. And, as with everything, be alert to health reports. The more information, the better.
Source: Consumer Reports, "CR Investigates: Dangerous medical devices," May 2012