Diagnostics & Imaging Week Washington Editor

WASHINGTON — The Heart Rhythm Society (HRS; Washington) has compiled its list of recommendations for reporting malfunctions and adverse events for cardiac rhythm management devices, with quite a level of detail for physicians, industry and the FDA.

While there are few surprises among the recommendations, those written for the agency would demand more resources — something it is so notoriously short of that two groups recently have been formed to address this with Congress and the White House.

Whether any of the guidelines will rile the industry remains to be seen, but at least one recommendation — that of deep-sixing the word "recall" for less confusing terms – may find a welcoming audience among those who manufacture pacemakers and implantable cardioverter defibrillators (ICDs).

The guidelines call for return of devices that are explanted for replacement, even if the replacement is simply for a depleted battery. This is no surprise since the notion has been making the rounds for several months.

HRS also recommends that patients be asked for consent for removal and interrogation procedures at post-mortem and that coroners make a request for such privileges of the next of kin.

The guidelines call for "experts who are not full-time employees of industry or the FDA" to analyze device performance data, but does not suggest what sort of compensation schedule would be appropriate, nor how the Center for Device and Radiological Health (CDRH) would come up with the money for those experts.

One way of staffing such a panel would be to extend "the scope of the circulatory devices panel to the post-marketing period," according to the HRS document.

Dwight Reynolds, MD, president of HRS, told Diagnostics & Imaging Week that HRS has discussed some of the funding dilemmas at the FDA with Sen. Robert Bennett (R-Utah), who chairs the agriculture subcommittee for the Senate appropriations committee, and Sen. Chuck Grassley, chairman of the finance committee. However, he declined to comment on the idea that such a boost in funding for this surveillance program might amount to a "rob-Peter-to-pay-Paul" scenario in an agency-wide flat-funding environment.

HRS recommends that the FDA eliminate the term "recall" in public communications regarding implanted devices. The recommended alternative is to use the term "Class I advisory notice" or "Class I safety alert" for actions currently described as Class I recalls. Class II and III recalls would also be re-christened "advisory notices" or "safety alerts."

"We know that very good physicians have explanted devices due to the use of the word 'recall' when explantation might not have been necessary," Reynolds said. He said that device makers encounter "significant pushback from patients and physicians waiting for the dust to settle" when recalls are announced, even when the action is for a minor reason. "We think that the term recall is pejorative," Reynolds added.

As for the threshold of a recall, HRS is not taking the position that a metric should be developed to trigger a recall. The HRS document states that it would be "inadvisable to determine a fixed percentage of device malfunctions or to attempt to classify all of the particular types of malfunctions that would automatically trigger a notification or advisory." The association prefers to leave the question of an advisory up to "the committees … to determine when a pattern of inadequate device performance exists."

Another recommendation is that manufacturers come up with a standard format for notification of patients and physicians and the use of the manufacturer's web site to post such material, along with links to the HRS and FDA web sites.

HRS also suggests that manufacturers make a "good faith effort to contact affected patients using the patient's registration information obtained at the implant center," as well as the use of e-mail as a conduit for notifications. The association would prefer to leave the definition of what constitutes "good faith" up to the FDA and industry "according to guidelines already in place for advisory communications."

One of the elements of the guidelines suggests that doctors inform patients of "potential malfunction rates," but how a doctor might describe this for a new ICD/pacemaker design or with a unit that has a new component is not totally clear.

"You have to have some trust in the manufacturer as well as the device," Reynolds said, "but some of that is based on experience. It's not to say that any given product will at some point have a problem." But the patient needs to know that these devices are not infallible, he noted also.

"We feel that the process that highlights device performance has been broken," he said. And he urged a "greater sense of transparency" as well as "better tracking by industry, FDA and physicians and physician organizations."

"It's not that we think that industry has suddenly tanked [on product quality]," Reynolds cautioned, just that industry should get the word out regarding problems "in a format that's standardized."

Communicating complex information to patients can be especially tricky, given that doctors, manufacturers and the FDA are all well versed in such subjects, and that the typical waiter or CPA is not so savvy about pacemakers and ICDs. Nonetheless, Reynolds insisted that patients "need to be directly notified just after the physician has been notified."

"We strongly believe that concise information should be conveyed to the patient because that combination &ehllip; is needed to appropriately decide what to do." He alluded to the idea that timing is everything in remarking that "it's critical that this occurs early enough that patients don't feel that they're the last to know … and getting it from wrong sources or groups that are preparing to file class-action suits."

However, he was less concerned about the level of detail than about the language of such information.

"I don't think it's [likely to be] too much information, but the perception that the information was incomplete and that there was some spin" creates problems.

"I think that every patient who is of sound mind for their age is capable of understanding information that is couched in appropriate language," Reynolds said.

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