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“Checking Safety of Old Devices”

There was an article on the New York Times website yesterday stating that the F.D.A. is to Check Safety of Old Devices. The article said ”Federal regulators said Wednesday that they would ask makers of some of the riskiest medical devices to prove their products were safe and effective — a step that critics have said was long overdue.”

The article did not specifically state which devices were under review, but the FDA did issue an Order on April 9, defining which Class III devices they wanted the safety data on. These devices were classified as Class III (transition devices) back in 1976 when the devices were originally classified.

It appears that in January, the Government Accountability Office issued a report scolding the FDA for failing for decades to fix its system for reviewing categories of devices that have been on the market since before the enactment of the medical device law in 1976.

Back in 1976, all legacy devices were allowed to remain on the market. These “legacy devices” were devices that the FDA was not sure of the safety and/or efficacy and included silicon breast implants, the Enhanced External Counter Pulsation device, artificial lung membranes, external defibrillators and various pacemaker components. Interesting enough, other manufacturers were able to use these Class III devices as substantially equivalency as a way to market via the 510(k) clearance. But, the F.D.A. was supposed to gradually reclassify these older devices and decide which ones needed extensive testing before approval of new versions and which ones did not. In other words, which of these devices were to be classified as a PMA Class III or put into the Class II 510(k) category. This was never done except for the silicon breast implants which had their problems back in the late ’80s and early ‘90s.

The article states that “for decades, the F.D.A. has approved devices in these categories for sale without demanding rigorous tests showing that they work safely.” This statement may have been true prior to 1992 but since the Safe Medical Device Act of 1992, the FDA has required for most 510(k) applications extensive safety testing and clinical trials for efficacy.

What the FDA has not done is use the law (sect. 519) that they have on the books and call in the safety data to review the safety and effectiveness of these devices. Though the MDR reporting requirements provide the FDA insight into the many of the possible issues that may arise from patient injuries and deaths associated with the use of these devices. So, for the most part this exercise is just a document exercise to use a regulatory requirement that had laid dormant for over 33 years.

The agency has already undertaken a review of two of these older device types, and it announced Wednesday that it was requiring makers of the other 25 types of devices to submit information to the agency within 120 days, detailing the products’ safety and effectiveness. The F.D.A. could not predict how long the reclassification process for the older devices would take. Industry groups predict that the F.D.A. will conclude that most of the products are not risky enough to warrant greater scrutiny. “The device types subject to the F.D.A. notice have already been thoroughly reviewed by the agency,” said Janet Trunzo, executive vice president of the Advanced Medical Technology Association.

“It’s great that the F.D.A. is finally going to look at pre-1976 devices, but the bigger problem is the low standards for approving any and all devices without clinical trials or any proof of safety or effectiveness,” said Diana Zuckerman, president of the National Research Center for Women and Families.

But consumer advocates argue that the agency’s entire process for approving medical devices needs overhauling. It would be interesting to see what this advocate group would like a company to do to get a 510(k) device to market that is not already being required by the FDA. Again, this may have been true prior to 1992 but not after. The cost and time to prove a substantially equivalent device, let alone a brand new medical device to be safe and effective is preventing many good improvements from reaching the consumer. For more information on this article, please email mdi at info@mdiconsultants.com

For more information on this article, please email mdi at info@mdiconsultants.com and reference checking safety.

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