FDA Worried That Class I Recall Jump Reflects Industry Rush To Market

Article preview from "The Silver Sheet"- May 24, 2010

A recent spike in Class I medical device recalls has led FDA to question whether manufacturers are sacrificing quality to rush products to market.

"We're concerned because we have seen a substantial increase in the number of recalls over the last few years," Steve Silverman, senior advisor to the CDRH director, said May 5 at the MedCon medical device conference in Cincinnati.

FDA Worried That Class I Recall Jump Reflects Industry Rush To Market

Article preview from "The Silver Sheet" - May, 2010

 recent spike in Class I medical device recalls has led FDA to question whether manufacturers are sacrificing quality to rush products to market.

"We're concerned because we have seen a substantial increase in the number of recalls over the last few years," Steve Silverman, senior advisor to the CDRH director, said May 5 at the MedCon medical device conference in Cincinnati.

"Perhaps even more troubling is that there has been a major jump in Class I recalls," he added. "Since the beginning of this fiscal year [which began Oct. 1, 2009], we have designated almost 30 recalls as Class I. That is nearly as many Class I recalls as we saw in all of fiscal year 2009."

Class I is FDA's most serious recall category, reserved for situations where the agency believes patients face a reasonable probability of serious injury or death from use of the defective products.

Silverman said CDRH is trying to better understand why so many recalls are happening.

"There are a number of possible causes," he said. "Part of it is increased agency attention to this area, and holding firms more accountable for product problems more closely and more cautiously than we have in the past. Part of it may be a lack of understanding on the part of some manufacturers about our expectations."

However, it also "may be a lack of willingness on the part of firms to slow the process of bringing products to market in favor of making sure that those products, once marketed, will work in the manner in which they're designed to work," Silverman said.

"It's unacceptable to finish products in the marketplace. That's not the way the regulatory system works," he said.

Silverman noted that if FDA's Quality System Regulation could be modified "to help mitigate some of the concerns that we're seeing, then yes, that's absolutely a possibility that is on the table.

"Making regulatory changes is sometimes a difficult process and a slower process than we would like, so I can say pretty confidently that we wouldn't simply rely on regulatory changes," he continued. "We would want to find other venues to communicate with industry about what our expectations are."

In the past, agency staffers have speculated that rising numbers of recalls are due to increased numbers of new devices on the market.

Silverman says the agency has not done a formal analysis of that question. But he doesn't believe that the increase in recalls is due to more devices being in the marketplace.

"I think there are other factors at play here, and I think those factors may be a combination of a need for manufacturers to be a little more circumspect before putting devices into the marketplace, and the agency being more sensitive to device-related problems than it may have been in the past," he said.

The agency is currently mining recall data to see where recalls occur, the reasons for recalls and how they're classified, Silverman noted.

"Manufacturers have the principle duty to ensure the quality and the integrity of their products," he said. "This means active surveillance for problems and effective work to understand the problems' root causes.

"For manufacturers dealing with recall, after recall, after recall - those are not isolated incidents," Silverman added. "If this is a manufacturer's experience, then that manufacturer has a system-wide problem that it needs to understand and resolve.

"And if that manufacturer wants the space to fix those problems free from FDA oversight, then it needs to demonstrate to the agency that it understands that it's dealing with a system-wide problem and that it's proceeding accordingly."

- Shawn M. Schmitt

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