“The FDA finds itself in the middle,” says Dr. MacKenzie. “We, as a society, want to be sure systems exist to protect the patients. Yet, we also want assurances that the evolution of technology is not inhibited to the point it thwarts innovation and stops the public from enjoying its benefits.”
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He says the FDA is hunting for the proper equilibrium where devices not ready for human use are put on the market—but that you also don’t put up barriers to the good things, either. “If anything comes out of the IOM report, other than raising the problems of the clearance process to the attention of the public, it is the recommendation that postmarket surveillance is the key to managing the public health question of safety and efficacy,” says Dr. Challoner.
Still Confident Overall
All three physicians are unanimous in saying that, for the most part, medical devices can be recommended by rheumatologists with confidence.
“The committee said that we don’t think that there is a public health emergency,” says Dr. Challoner. “This is mainly because the noise level coming back from the patient and practitioner, except for isolated incidents, doesn’t indicate one.” He does stress that there is still a nagging concern that “the 510(k) Emperor has no safety and efficacy clothes.” In the long run, he doesn’t think this can be good for public health and might lead to low-incidence but high-impact complications.
Dr. Kraay agrees in principle but does have an added caveat: It may not always be necessary, or even advisable, to go with newest alternative. “Devices in use for a reasonable period of time and that have a good track record for performance are frequently safer than the latest alternative released to the marketplace,” he says. “Both patients and users need to understand that new is not always better.”
Dr. MacKenzie sums it up this way: “I don’t think that the recent problems with medical devices that have risen recently in respect to medical devices assault the fundamental and well-established value of the treatments in general. Very thoughtful people on all sides of the issue are now giving it careful consideration, and I take comfort in that.”
Kurt Ullman is a freelance journalist based in Indiana.
- Porucznik MA, Kennedy J. The 510(k) pathway: Changes may be coming. AAOS Now. www.aaos.org/news/aaosnow/dec09/reimbursement2.asp. Published December 2009. Accessed October 18, 2011.
- Challoner DR, Vodra WW. Medical devices and health—creating a new regulatory framework for moderate-risk devices. N Engl J Med. 2011;365:977-979.
- Medtronic, Inc. v. Lohr, 518 US. 470.
- U.S. Food and Drug Administration. FDA to seek public comment on IOM recommendations. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm265908.htm. Published July 29, 2011. Accessed October 18, 2011.