Marianne Matthews

As some 62,000 industry professionals head to RSNA, the world’s largest medical meeting, and more than 700 manufacturers plan to unveil new equipment and technologies, questions of readiness dance in my head.

For example, is the molecular imaging community poised to tackle tough challenges like the shortage of medical isotopes due to the recent closure of a nuclear reactor plant in the Netherlands? Faced with a weakening economy and rising prices, will acute care and community hospitals across the country be ready, willing, and able to invest in the latest and greatest advancements?

But a key question of readiness concerns new technologies themselves. Is the larger world of patients, caregivers, and advocacy groups ready to accept the innovations so many of us in the industry are quick to embrace?

A recent cover article in The New York Times (October 27, 2008) examines the pros and cons of the 510(k) review process. Titled “Quickly Vetted, Treatment Is Offered to Cancer Patients,” the article examines how MammoSite was brought to market. A form of breast cancer treatment where radioactive “seeds” are inserted in the tumor site, the Times reporter states, “The MammoSite system is among the thousands of devices the FDA lets onto the market each year after only cursory review and with no clear evidence that they help patients.” According to the report, the FDA approved MammoSite on the basis of a study involving “only 25 women that did not answer the fundamental question of how effective it is against breast cancer.”

While the article cites several groups who criticize the 510(k) process and push for tougher scrutiny of new devices—the nonprofit ECRI Institute and the Washington advocacy group National Research Center for Women and Families, for example—it also quotes an FDA spokesperson as well as both physicians and patients, who applaud the process and are grateful for advanced alternative treatments. According to the article, Bradley R. Prestidge, MD, chief executive of the Texas Cancer Clinic, has performed more than 600 MammoSite treatments—the most in the country—and only three women have had a cancer recurrence.

The 510(k) process made headlines this past spring as well when the FDA proposed to reclassify full-field digital mammography (FFDM) systems from class III devices, which require premarket approval applications, to class II, which call for the less complicated 510(k) process. The upshot for the industry? A quicker, easier process for vendors because there would be less need to conduct large, multicase clinical trials prior to submitting clearance applications. The result could mean lower prices for health care organizations that purchase FFDM equipment in the future.

Looking at the issue as a health care consumer, I am hard-pressed to find any cancer patient I have ever known who does not want every possible available option—from participation in new clinical drug trials to access to newly released 510(k)-approved medical devices.

Even so, The Times raises important questions. What should be the measures of quality, effectiveness, and performance before new technologies come to market? Just how long should new medical devices wait in the wings before they debut on vulnerable patients?

Scrutiny is a good thing, particularly when it concerns life and death. The RSNA curtain is ready to rise. But it is our industry professionals—not technology—who must rise to the occasion. We are charged with meeting unprecedented market challenges while always keeping the best interest of patients at heart. Get ready, because the show is about to begin.

Marianne Matthews, editor