This week's report that 80% of medical devices so dangerous that they had to be recalled had been cleared for use under a flawed, federal process (and others were barely reviewed at all) points a damning finger at the U.S. Food and Drug Administration.
Nevertheless, doctors and hospitals should absorb some of the responsibility, too.
These were Class I recalls, the most serious kind, necessary because "there is a reasonable probability that the use of or exposure to a violative (harmful) product will cause serious adverse health consequences or death," according to the FDA definition.
The largest category of these recalls involved 35 devices for cardiac patients, two-thirds of which were approved under the FDA's 510(k) process. That The 510(k) speeds approval for devices considered "substantially equivalent" to other devices approved under the more rigorous, premarket approval process (PMA) and requires little safety documentation and no clinical trials, according to a research paper published this week in the Archives of Internal Medicine.
These are devices classified by the FDA as the most dangerous kind, the type that "pose the greatest potential risk and include such items as implantable pacemakers, stents, heart valves, and human immunodeficiency virus diagnostic tests," wrote the researchers, Diana Zuckerman and Paul Brown of the National Research Center for Women & Families and Steven Nissen, MD, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic.
One such device is the LIFEPAK CR Plus automated external defibrillator. It was recalled on July 31, 2009 because, the FDA said, "An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy."
Other 510(k)-approved but now recalled devices included another 20 "general hospital" products, including an infant warmer used in hospitals, insulin pumps, intravenous infusion devices and patient lifts. Also approved by the 510(k) process, or slipped through with no review at all, were 10 now-recalled anesthesiology devices, such as mechanical ventilators.
Nissen says that during the 2005-2009 period of their review, 112 million medical devices were recalled, but not before 2,000 people a year died because of their failures.
This gives me cause to ask, Where are the doctors who are seeing this on the front lines, and why aren't they speaking out?
These are their patients that in many cases must undergo repeat procedures to remove and replace devices, re-enduring the risk of infection and other complications. Moreover, as an aside, it's unclear who pays for the added care required in a patient unfortunate enough to be a guinea pig.
Over time, the researchers wrote, the FDA's categorization of such devices has been modified to become even more lenient; now devices approved under the 510(k) process are increasingly less "substantially equivalent" than the ones that paved their way.
These standards have eroded so that devices approved under 510(k) criteria included those made from different materials, with different mechanisms of action than the parent product they were supposed to be substantially equivalent to.
Lifesaving devices need to work, and they need to undergo clinical trial scrutiny. And doctors and hospitals need to pay attention, and get upset and even angry when their patients get harmed by them. Yes, doctors want to provide their patients with the next best thing. And no one wants to tamp innovation; but safety should be a greater concern.
In a phone interview this week, I asked Nissen if it's all the FDA's fault, or whether physicians and hospitals should bear some responsibility for letting these products slip through the cracks.
"There's lots of blame to go around," he says. He and his co-authors put some of the blame on AdvaMed, the manufacturers' advocacy group, for successfully blocking recent efforts to strengthen FDA's purview over these devices. FDA wanted to require clinical trials in more 510(k) reviews, have more premarket inspections and postmarket studies. But "AdvaMed, the largest association representing medical device manufacturers, opposes these changes," Nissen and his co-authors wrote.
Nissen also blames physicians who design and test these devices, and then own a share of the stock, as well as the doctors who flock to use the latest new thing, knowing it didn't have to go through a clinical trial and may not yet be totally safe.
"The conflict of interest for physicians in the device world is even worse than in the pharma world," he says. "They promote them, get royalties from them and become advocates for these devices that they're involved with and earn equity from. In the orthopedic world, they're out there writing guidelines when they actually own equity in the devices they're recommending their colleagues use," Nissen tells me.
Nissen says the problem is especially acute in his own field of cardiology, which is why he got involved. "A single group of cardiologists dominate device-related research, and it's an enormous problem in orthopedics where there are so many entrepreneurs and investors," he says.
Other surgeons and interventionalists flock to use them without thinking about how new they are. "It's imprudent. Instead of looking at these devices as unproven, they flock to them as the 'latest and greatest,' when the devices that have a long-term track record might be a better choice."
Nissen says hospitals share some blame as well because they stock the devices that doctors want. "It's harder to put the blame on them, but they certainly should be asking more questions."
Healthcare reform may help mitigate the problem, because it is putting the squeeze on hospitals to reduce costs. That may result in hospitals buying fewer brands that are older and more "tried and true," enabling them to get volume discounts rather than purchasing dozens of brands to meet each physician's preference.
That might mean the same operators would be using the same devices repeatedly, and problems with the devices noticed more quickly.
However, Nissen insists FDA's rules need to be changed so that many of these dangerous, life-sustaining or life-saving devices will get more scrutiny.
AdvaMed struck back this week calling the Archives study "seriously flawed," inaccurate and misleading, and said the bulk of 510(k) devices are safe and have not been recalled. The organization said "the real problem at FDA is growing delays and inconsistency in product reviews, which is denying patients access to safe and effective diagnostics and treatment.
"Today, because of FDA delays and inefficiency, foreign patients benefit from new treatments two to three years sooner than American patients," even when those products are manufactured in the U.S., the group said.
The volume on this controversy is certain to be turned up on this issue today, as the Health subcommittee of the House Committee on Energy and Commerce convenes to hear the issue.
Nissen attended, telling the lawmakers that "it is no longer reasonable to compare modern medical products with devices marketed as long as 35 years ago."
Co-author Zuckerman agrees. "You have to understand how obvious a problem with one of these devices has to be before it is recognized and a device is recalled," she tells me. "If a 75-year-old person has a heart valve, and they die years later, that's just recorded as a death from heart disease. If there is no autopsy, no one will know if it was caused by a defective heart valve. But these less obvious problems would show up in well-designed clinical trials."