Medical Device Safety Concerns Rheumatologists

“With these resources, we can very quickly sift through large populations and get information on where there might be a problem,” says Dr. Challoner. “Opportunities for feedback from the clinical environment to the manufactures and the FDA are there. So far, the manufacturers have not been enthusiastic.”

There is evidence from other parts of the world that large-scale registries can prove useful. Indeed, the first indications of problems with the metal-on-metal hip replacement came from overseas.

“The Scandinavian countries and Australia both have registries,” says Dr. Kraay. “They get good numbers of patients and have good follow-up reporting. Inferior devices have definitely shown up earlier than if this type of surveillance was not performed.”

What’s Next?

The release of the committee’s report was met with differing opinions. Some representatives of the medical device industry were not in favor of the suggestions, while some patient advocacy groups said the findings did not go far enough.

Multiple requests to the FDA for input on this article were not acknowledged. However, a news release sent out after the IOM report was released included a quote from Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, saying that the FDA “believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.”⁴

There is agreement among the experts interviewed that medical devices are not likely to be regulated to the level of pharmaceuticals. The economics of the industry would not support full-scale trials because engineers or physicians in their garages put many of the devices together. They also point to the impossible nature of doing many randomized, blinded, placebo-controlled trials, especially where surgery or another invasive procedures are required.

In addition, much of the innovation has been incremental in nature. Most of the newer devices are improvements on older versions. So, it is a fair question to ask if there is a need for a very rigorous approval processes. “For instance, consider total hip replacements,” says Dr. MacKenzie. “The original system by Charnley was really the major innovative leap. One wonders how much more slowly this remarkable therapy would have presented in a more highly regulated environment.”

FDA Balancing Act

Going forward, the FDA has a balancing act that they have to perform. On one hand is the demand from the public (and some rumblings from Congress) that medical devices be safe and effective. On the other is the need to not unnecessarily stifle creativity.