Medical Device Daily

Timing is everything, they say.

And the timing of a recent report from the FDA's Center for Devices and Radiological Health (CDRH), outlining a proposed increased emphasis on postmarket evaluation of medical devices, issued Monday (Medical Device Daily, Jan. 24, 2006), seems, well, timely.

It could easily be interpreted as a very direct response to the device problems that have bedeviled Guidant (Indianapolis), as well as other manufacturers of implanted medical devices, over the past year.

Not so, said Daniel Schultz, MD, director of CDRH, in an interview yesterday with Medical Device Daily.

“I don't want people to take away that we looked specifically at Guidant, or at any one recall or any particular action, and then said, 'Aha, we've got a problem,“ Schultz said.

Rather, he said that CDRH began focusing on the issue of postmarket surveillance and reporting “about a year ago,“ and a group was then established “to look at all of our safety programs“ to determine ways of improving these programs. “So the reality is that those discussions predated anything having to do with Guidant.“

But Schultz acknowledged that these events were “factored in“ to this discussion and that the recalls of “ICDs and pacemakers and some of the other problems that we've seen reconfirmed my impression, and a lot of our impressions, that this is an effort that is certainly needed.“

And he noted that while the center has previously looked at “specific areas, we really had not taken the overall look at the [postmarket] program to see where all these pieces fit together.“

Schultz also laid out two important timeline events in following through on the new report, Ensuring the Safety of Marketed Medical Devices: CDRH's Medical Device Post-market Safety Program:

• Feb. 8 and 9: CDRH and the Advance Medical Technology Association (AdvaMed; Washington), will hold a meeting in Bethesda, Maryland, focused on postmarketing issues.

Schultz noted that AdvaMed has regularly sponsored premarket submission workshops, “but never a workshop focused on postmarket issues, like adverse event reporting, inspections, annual reports.“ (MDD will provide further specifics concerning this workshop next week.)

• Sometime in June: What Schulz described as a “senior-level team“ has been established and given the task “in about four months“ of presenting recommendations concerning improving the center's surveillance and reporting of postmarket medical device problems.

He said that this group met in their “first official meeting“ last Friday and were “tasked“ with their instructions and the “aggressive timeline“ they must meet.

The group “includes all of the office directors within the center, including myself“; Lillian Jill, senior associate director of CDRH; and two consultants, Liz Jacobsen, now with AdvaMed but previously a deputy center director, and Jeff Brinker, MD, a cardiologist at Johns Hopkins Medical Center (Baltimore).

“I wanted to have a combination of people,“ Schultz said, “who understand the individual processes“ and so are able to provide a comprehensive view of postmarket issues.

A rather large and critical key to the center's improvement of postmarket surveillance – as defined in the new report – is to develop a system for giving “unique identifiers“ to medical devices in order to make adverse event reporting more doable and more exact.

Schultz was clearly careful to note that the center isn't poised to say, at this point, what that system will be.

“What we want to do is begin the dialogue with the industry to figure out how best to do this, in order for us to make better sense of the reports that we're getting in. We need to know which devices are being referred to in a much more clear, precise way then we presently do.“

How to do this won't be “a one-size-fits-all answer,“ he said. “It's something we need to begin to explore. And we can't say, 'It's too hard, and we can't do this.'“

He added: “We're not looking to be overly prescriptive, other than to say we need to work with device manufacturers and individual companies to figure out a system that will allow both them and us to identify these devices.“

Schultz also addressed two other major questions that serve as obvious barriers to reporting of adverse events caused by devices.

• How to get clinicians to report such events?

“We're not going to start passing out $100 bills [to encourage adverse event reporting]. What we can do is identify some of the disincentives by making it as simple and as easy to provide reports and provide reports that are meaningful. A unique identifier would allow someone to identify the device we're talking about.“

And he said that an electronic system for making these event reports “would remove one of the disincentives to get better feedback to the public on what we're seeing. I think there are a number of things that we can do to make the system more appealing.“

Schultz said he was well aware of the need to reduce the inherent liability/litigation issues but candidly admitted: “I'm not an attorney. The issue of tort reform is more than I'm capable of fixing.“

• How to get manufacturers to report device adverse events?

“We absolutely need to engage the medical device industry in this effort, at least initial discussions,“ Schultz said, and that, thus far, he has gotten “buy-in“ from manufacturers.

“They understand the need to make this happen, and they are very anxious to make it happen in a way that is both meaningful and also something that meets their needs as well as ours.“

As to the actual size of the problem presented by device adverse events, or any comparison with adverse drug events, Schultz readily acknowledged the intrinsic difficulties – and by extension the tough task that lies ahead for the center and the postmarket challenges.

“It's hard,“ he said. “Trying to define and trying to compare rates of device vs. device events is incredibly difficult. It depends on how you define an adverse event, how you look for it, who asks the question, whether you include user problems or just problems related to specifically a device malfunction – it is very, very difficult to precisely compare.“

As of now, Schultz said, the best the center can do is “get an overall impression, and we get signals that allow us to follow up in certain areas – but it's difficult.“