In a decision that could cost medical device manufacturers millions of dollars each year, the U.S. Food and Drug Administration said Tuesday that it has imposed a new rule requiring makers of implant devices to track patients who use their products.
The rule, spurred by controversies surrounding the Bjork-Shiley heart valve and Dow Corning silicone breast implants, also affects makers of ventilators, breathing monitors and heartbeat regulators designed for use at home, the FDA said.
“We need a system that will allow us to communicate quickly and effectively critical information about the safety and efficacy of implants and devices,” FDA Commissioner David A. Kessler said in a statement issued Tuesday afternoon. “Tracking will help save lives by making it possible to get in touch quickly with people who have faulty devices.”
The move was no surprise to medical device manufacturers: It was proposed in the Safe Medical Devices Act of 1990, FDA spokeswoman Sharon Snider said. It was implemented on Monday after almost three years of review and comment from companies, she said.
It affects makers of 17 categories of implantable devices, including heart valve, breast, throat, jaw, artery and penile implants; and five categories of devices, such as ventilators and implantable infusion pumps, that are used by patients of in-home nursing services.
The announcement was made three days after a U.S. Department of Veterans Affairs spokesman said that inspectors have not been able to locate as many as 40% of veterans fitted with Shiley heart valves between 1979, when the valves were first sold, and 1986, when they were discontinued.
Critics of the Shiley heart valve have noted that thousands of Shiley valve recipients still do not know that the devices may fracture at any time, killing them.
“Shiley is the prime example of why a law like this is needed,” Snider said.
Industry leaders, however, said that the new rule adds a layer of bureaucracy, though they conceded that it is probably overdue.
“It was inevitable that the industry, what with the Shiley issue and all, would be subjected to this new requirement,” said David Anast, publisher of the Biomedical Market Newsletter in Costa Mesa. “But in terms of cost, there are a lot of small companies in this industry, and it could cost them several millions of dollars per year per company.”
Don Earhart, president of infusion pump manufacturer I-Flow Corp. in Irvine, said he does not know yet what the new rule’s effect will be on his company. “It may be big,” he said.
He said his company is evaluating the regulation as well as trying to determine to what extent the company would be required to follow patients who use its pumps.
“It will be relatively difficult to track every pump with every patient who uses it,” he said.
Holly Glass, a spokeswoman for the Health Industry Manufacturers Assn., an industry lobby group in Washington, said that, at first glance, the new law appears to be overly complicated.
“We have some very serious concerns,” Glass said. Still, she said, the association will urge companies to “make every effort to comply.”
The FDA’s Snider said that medical device manufacturers will be required to establish systems to track their products from the warehouse to the patient. The tracking systems must be developed so that companies can provide accurate and complete data to the FDA within 10 days, she said.
The FDA will also have the right to audit companies periodically to ensure that tracking programs are up to date.
How the tracking systems will be designed is up to the companies, Snider said. She pointed out that companies can hire database firms to help out.
Shiley, for instance, has contracted with Medic Alert, an international nonprofit medical identification organization, to find all of the 83,000 Shiley heart valve recipients.
No one is sure how many recipients the organization has notified since the Shiley contract was signed under FDA orders in 1991, Shiley spokesman Robert Fauteux said. But the company is continuing efforts to locate them, he said.
James Capretz, attorney for a 54-year-old San Diego County woman who is suing Shiley for emotional distress over her artificial heart valve, applauded the FDA decision.
“I personally believe this is long overdue,” he said. “It will not only benefit implantees and health care providers, but manufacturers as well.”
The rule could also be a benefit to Medic Alert, which usually receives information only when patients phone it in, said spokeswoman Lisa Howard at the organization’s headquarters near Modesto. Shiley is the only company that contracts with Medic Alert.
That may change now, Howard said: “Hopefully, the manufacturers will come to us.”