A med-tech rep says current approval system serves patients well.
On Wednesday, Consumer Reports released recommendations to slow it down -- in the name of safety.
While tens of millions of Americans live with medical devices implanted in their bodies, the report says that many of these implants have never been tested for safety. In fact, according to Consumer Reports, manufacturers often are required to do nothing more than file paperwork and pay a user fee before bringing their products to market.
An advocate for the medical technology industry, however, said Consumer Reports "dramatically" mischaracterized the U.S. Food and Drug Administration approval process and that the current system "serves patients extremely well."
"On numerous occasions over the years, FDA officials and outside experts have stressed the system's rigor and effectiveness, and its basic structure is sound," said Janet Trunzo, executive vice president, technology and regulatory affairs, for the Advanced Medical Technology Association.
Consumer Reports highlights several devices that it says have had significant problems over the years, yet were not subject to extensive testing before going on the market.
In particular, the story pointed to the FDA's 510(k) approval process. Under that process, which is similar to the way generic drugs are approved, medical device makers can get clearance to market a device that is "substantially equivalent" in safety and effectiveness to another lawfully marketed device when used for the same intended purpose.
Consumers Union, the advocacy arm of Consumer Reports, recommends that Congress make the FDA require that implants and other "life-sustaining" devices be tested at least as rigorously as drugs.
Consumers Union also advocates ending the practice of "grandfathering" high-risk new implants and life-sustaining devices, as well as creating a "unique identifier system" for implants, so that patients can be quickly notified about recalls and safety problems.
The full report is online at www.ConsumerReports.org.
Dr. Robert Hauser, a cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, said he agrees with much of what Consumers Union recommends.
Hauser has for years advocated stronger oversight of medical device approval and better surveillance of how devices perform after they have been implanted. "The bottom line is that new devices, particularly [the most complex] lifesaving devices, need to be tested before they are put in people," he said.
But Denise Kaigler, a senior vice president for corporate communications for device-maker Boston Scientific, said the 510(k) process has allowed thousands of lifesaving devices to enter the U.S. market over the past 35 years.
"The 510(k) process is grounded in science, and the FDA routinely requires the submission of extensive testing results and scientific data," she said. "We look forward to working with the FDA and others to make the review process more efficient and predictable, while ensuring that patients have timely access to our latest products and therapies."
Officials from Fridley-based Medtronic and Little Canada-based St. Jude declined to comment.
Sen. Amy Klobuchar and Rep. Erik Paulsen, Minnesota members of Congress who have led efforts to improve the approval process, said it is possible to boost both efficiency and patient safety.
"I will continue to work to ensure we have the processes in place to promote safe, pioneering technologies that help save lives, and create good jobs in Minnesota," said Klobuchar, a Democrat.
Said Republican Paulsen: "Above all else, we must ensure that medical devices are safe -- period. I am confident that we can improve the efficiency and effectiveness of the medical device approval process as well as solidify our nation's position as a global leader in innovation."
James Walsh • 612-673-7428