Using five years of FDA data, researchers examined all high-risk medical device recalls to determine what level of approval process had been used for clearance. According to the study, which appeared online Feb. 14 in the Archives of Internal Medicine, 71% of the 113 high-risk recalls that took place from 2005 to 2009 had gone through the agency's expedited review process, known as 510(k), while only 19% had gone through the more stringent premarket approval process involving clinical trials.
The study was published a week after the FDA took a new step to ease the approval process for medical devices. The initiative, called the Innovation Pathway, would speed the clearance process for certain devices, a move the FDA says will spur development and help patients get the care they need.
Those priorities were the subject of a Feb. 17 House subcommittee hearing focused on the impact of medical device regulation on the economy and on patients, an event attended by authors of the study.
“I have nothing against innovation,” said lead author Diana Zuckerman, president of the not-for-profit National Research Center for Women & Families. “But we hear from patients who chose a top hospital and a great doctor and ended up with a device that has never been tested.”
Created in 1976, when the FDA was given regulatory authority over medical devices, the 510(k) program was conceived as a way to provide a faster, easier path to approval for devices that were similar to others already on the market.
Zuckerman says the original intent of the 510(k) designation has been stretched far beyond what it was originally intended to address.
“The idea made sense then, but the understanding was that the provision would fade away because devices would be less and less similar to each other,” Zuckerman said. “But it went in the opposite direction. Instead of making sure high-risk devices were held to a higher standard, soon practically nothing was being held to that higher standard.”
Nearly a third of the recalls during the five-year period were cardiovascular devices and 23 of those had been cleared through the 510(k) process, the study found. Also, 13 of those 510(k) devices—many of which were external cardiac defibrillators used to resuscitate patients in distress—were designated as class III devices, a classification that mandates clearance through the more rigorous premarket approval process, Zuckerman said.
“High-risk recalls are defined by the FDA as having the potential to cause death or serious injury,” she said. “Since the devices that go through 510(k) process are supposed to be low or moderate risk, there shouldn't be any high-risk recalls in that group.”
Not so fast, said officials from the Advanced Medical Technology Association, or AdvaMed, a medical device industry group. They called the paper “fundamentally flawed,” arguing the FDA has an excellent record of safety. They also said the review process needs to be shorter—not longer—to support innovation and competitiveness.
In a statement, Stephen Ubl, AdvaMed's president and CEO, said Zuckerman's research contained faulty analysis. He contrasted it with three previous studies, all of which used the same data set and found the 510(k) process to be safe.
Zuckerman responded by pointing to previous studies' authors ties to industry and by noting that her study and the others contained similar analyses.
“The bottom line is that these three studies all agree that only a small percentage of devices cleared through the 510(k) process are recalled,” she said. “We agree with that. But we disagree with any conclusions by AdvaMed or industry consultants that this means the 510(k) process shouldn't be improved.”
One of main flaws in Zuckerman's study, according to David Nexon, AdvaMed's senior executive vice president, is that it equates a serious recall with a high-risk device.
“One recalled product was a teething ring, and there was a sterilization issue with one of the lots,” Nexon said. “You want to strive for zero events, but surely no one would think a teething ring should be subject to a clinical trial.”
Expanding the premarket approval process would have a devastating effect on innovation, Nexon countered, because that process takes much more time and money.
If a product requires premarket approval, it should get it, he said. But if similar products have been shown to work safely, 510(k) is the way to go.
The FDA also fired back at Zuckerman's analysis in its own statement, saying the 80 recalls, while troubling, still represented a very small percentage of the more than 19,000 devices cleared through the 510(k) process between 2005 and 2009. In addition, the agency said, 13 of those 80 devices are already being considered for reclassification.
The FDA also highlighted its recent external defibrillator initiative, an effort the agency said will involve consideration for reclassification.
Officials said the number of recalled 510(k) cases was a product of probability.
“More than 90% of the devices (that require premarket review) are cleared via the 510(k) pathway,” according to the FDA. “It's not surprising that the majority of devices are 510(k).”
The agency has taken some steps to address criticism of its expedited review process. In August 2010, the FDA's 510(k) Working Group released a preliminary report outlining suggested changes such as increased use of clinical trials.
But when the FDA released its final, 25-item action plan in January, the agency had eschewed many of the patient-safety-driven changes in favor of industry-favored changes such as more streamlined review, Zuckerman said.
