Lack Of Tracking Of Medical Devices' Performance Raises Questions About Safety And Efficacy

The New York Times reports on a dispute between a surgeon and the medical device company he once worked for and promoted. "For years, Dr. Richard A. Berger designed surgical tools and artificial joints for Zimmer Holdings, trained hundreds of doctors to use its products and talked it up wherever he went. In return, Zimmer, an orthopedic implant maker, helped enrich Dr. Berger, portraying him as a master surgeon and paying him more than $8 million over a decade" But then "Dr. Berger started complaining to Zimmer a while back that one of its artificial-knee models was failing prematurely, and he went public recently with a study that he says proves it." The company told Berger that the problem was his technique not the product and did not renew his contract last year.

"Amid the booming use of artificial joints in the United States, the breakup between Dr. Berger and Zimmer highlights what experts say is a troubling situation for patients and doctors: when disputes arise about orthopedic implant safety, there are no independent referees or sources of information because no one tracks the performance of the devices. ... While producers of implanted heart devices have a voluntary system in which outside panels investigate problems, American makers of orthopedic devices do not. Many of the artificial joints that surgeons like Dr. Berger use, including the Zimmer knee at issue, are cleared under law by the Food and Drug Administration for sale without testing in patients" (Meier, 6/18).

Meanwhile, The Wall Street Journal reports on Paro, a Japanese robotic seal pup used to "lift the spirits of millions of elderly adults." The device "never quite caught on" in Japan but is now coming to the U.S. with some controversy. "Nursing-home workers and academics who study human-robot interaction are trying to figure out whether the $6,000 seal, cleared last fall by U.S. regulators as a Class 2 medical device (a category that includes powered wheelchairs) represents a disturbing turn in our treatment of the elderly or the best caregiving gadget since the Clapper."

Bill Thomas, "founder of the Green House Project, a campaign to make nursing homes smaller and more like regular houses," believes "it's inhumane to entrust the task of emotional support to a gadget." But "In several countries, robots are starting to play a role in elder care. In Japan—where 22.3% of the population is over 65—robots handle such tasks as feeding patients and helping disabled people move their limbs. Also planned are wheelchairs with robot arms and robotic diet-and-exercise coaches." Paro, however, "isn't a mechanical aid. It serves as a low-maintenance alternative to the cats and dogs many nursing homes import for 'pet therapy' visits" (Tergesen and Inada, 6/21).

This is part of Kaiser Health News' Daily Report - a summary of health policy coverage from major news organizations. The full summary of the day's news can be found here and you can sign up for e-mail subscriptions to the Daily Report here. In addition, our staff of reporters and correspondents file original stories each day, which you can find on our home page.