Cardiovascular Devices Make Up Largest Class of FDA Device Recalls Since 2005

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While the overall percentage of medical devices approved and recalled by the US Food and Drug Administration (FDA) is relatively low, the recent increase in recalls for devices approved via the 510(k) process compared with the premarket approval (PMA) process raises a red flag, according to a study published online March 19, 2014, ahead of print in the American Journal of Cardiology. Additionally, the authors note, cardiovascular devices make up the largest proportion of recalls.

The FDA offers 2 pathways by which new devices can obtain approval:

• PMA: requires clinical trials to evaluate safety and effectiveness
• 510(k): if the manufacturer can show that its device is substantially equivalent to a predicate, additional clinical data are usually not required

John C. Somberg, MD, of Rush University (Chicago, IL), and colleagues conducted a retrospective review of all medical devices recalled by the FDA from 2005 to 2012. Of the 30,002 devices approved during that period, most (81%) were cleared using the 510(k) process.

Over 8 years, 249 devices were recalled (0.45% of all PMA-approved devices and 0.92% of all 510(k)-approved devices; P = 0.0004). The percentage of PMA-approved devices recalled remained steady over the study period, however, the same percentage of recalled 510(k)-approved devices rose after 2010 (table 1).

Table 1. All Device Recalls by Approval Pathway

A total of 5,437 cardiovascular devices were approved over the study period (18% of all device approvals), with almost half (46%) approved via the PMA process. Cardiovascular devices represented the highest percentage of recalls overall (27%) with 66 ‘serious recalls’ (0.48% of all PMA-approved and 1.83% of all 510(k)-approved cardiovascular devices; P < 0.001).

The trends in recalls for cardiovascular devices were similar to the overall numbers, with the percentage of 510(k) recalls spiking in 2009 (2.28%), 2010 (3.44%), and 2011 (2.82%). However, the rate of recalls in this category dramatically fell in 2012 (0.73%). Additionally, while the percentages of PMA recalls were similar for cardiovascular and all medical devices, there was a doubling of the rate of recall for 510(k)-approved cardiovascular devices (1.8% vs 0.9%; P < 0.001).

The researchers also examined device time on the market pre-recall in 91% of all recalled devices. While there were no differences seen between PMA and 510(k) devices before 2009, the time on market was longer for PMA- than for 510(k)-cleared devices in 2010 and 2011 (34 ± 44 months; P < 0.001). Moreover, 42% of recalled 510(k)-approved and 33.3% of PMA-approved devices were recalled during the first year.

510(k) Recalls ‘Raises Serious Concern’

Dr. Somberg and colleagues write that the overall low rate of recall for all devices “argues against scrapping the 510(k) process.” However, the fact that there are more recalls of 510(k)-approved devices “raises serious concern,” they add.

Problems could be due to “inadequate preclinical testing, performance standards, or a lack of clinical exposure for 510(k)-cleared devices,” they say, adding that the “FDA needs to review the performance testing standards that 510(k) devices undergo, especially those for Class III devices.” They advocate that while a large, randomized study for efficacy might not be necessary in every case, perhaps a 2-year registry to identify risks associated with the device might be warranted.

In a telephone interview with TCTMD, John Petersen, MD, MHS, of Swedish Medical Center (Seattle, WA), pointed out that “there is already a delay in getting things through the regulatory process at the FDA,” explaining that there is a balance of safety and the time it takes to do rigorous testing. “There is also the issue of [potentially] stifling innovation through the regulatory process,” he said.

Dr. Petersen said he does not think the 510(k) process is fundamentally flawed, although it could certainly be modified. “Even with the most rigorous sorts of evaluations, you may not pick up on things that you didn’t anticipate,” he commented. “But if you look overall, frankly the process works most of the time. We don’t want to throw the baby out with the bathwater here in terms of a process that seems to be in general doing a good job.”

In terms of the cardiovascular device market, Dr. Petersen said the field is incredibly competitive and potentially has a higher degree of innovation compared with other markets. “When you look at the total number of recalls, that’s something you have to understand,” he explained.

Taking a Cue from the Europeans

Cost is a huge issue when it comes to the approval process, Dr. Petersen continued. “The expense of more regulation always translates to higher costs for developing [technology]” and higher hurdles for industry to clear, he said. Instead of performing a large, expensive, randomized study for every device, he suggested utilizing simulated procedures or cadaver models.

“Perhaps that process should be looked at [with] scrutiny to understand where [it] might need to be revised… but basically to re-legislate the whole process… would be a mistake,” he commented.

In a telephone interview, Sorin J. Brener, MD, of Weill Cornell Medical College (New York, NY), observed that the European model of approvals moves much faster. “Most of [the approvals] are similar to the 510(k), meaning that there is really no PMA there, and they seem to be doing okay. They probably have the same rate of recall as we do,” he said, adding that their primary focus is on safety, not efficacy.

“If it seems to be safe then they let it go, and efficacy-wise the market will decide,” he continued. “If it’s good, people will use it.”

While he agreed that the FDA process does not need an overhaul, Dr. Brener said it should be open to evaluating “data that has been approved in other settings. We don’t need to reinvent the wheel every single time. If [a device] works in 50,000 Europeans, there is no reason why it wouldn’t work in 50,000 Americans.”

 

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Source:
Somberg JC, McEwen P, Molnar J. Assessment of cardiovascular and non cardiovascular medical device recalls. Am J Cardiol. 2014;Epub ahead of print.

 

 

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