CDU Washington Editor
The Heart Rhythm Society (HRS; Washington) last month issued its long-awaited list of recommendations for reporting malfunctions and adverse events for cardiac rhythm management devices, with a considerable level of detail for physicians, industry and the FDA. While there were few surprises among the recommendations, those that target the agency and what it should do would demand more resources, something it is so notoriously short of, as emphasized recently by a variety of voices.
Whether any of the guidelines will create broad changes by — or pushback from — the industry remains to be seen. But at least one recommendation, that of deep-sixing the word "recall" for less confusing terms, will certainly be a source of debate in the cardio rhythm management sector.
Or at least it will raise some important questions: What is a better term? Should there be a variety of terms for a variety of the different actions, from simple warnings to actual recalls?
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.
Needed: post-mortems and experts sans ties
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. This is being called for since it is assumed that many device failures are not reported if such post-mortems and interrogations are carried out. (At least one case has been reported — that case generating a lawsuit — of an implantable device signaling failure from a body inside a casket.)
The guidelines call for "experts who are not full-time employees of industry or the FDA" to analyze device performance data, but without indicating what sort of compensation schedule would be appropriate, nor how the Center for Devices and Radiological Health (CDRH) would come up with the money to hire these 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 Cardiovascular Device Update 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 (R-Iowa), 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.
How to recall ‘recall'
HRS recommends that the FDA term "recall" should be eliminated from 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 told CDU. 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 what has been billed as a recall, HRS is not taking the position that a metric should be developed as a trigger. 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 should develop 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 said it prefers to leave the definition of what constitutes "good faith" up to the FDA and industry "according to guidelines already in place for advisory communications."
Defining malfunction information
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." And 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."
Reynolds cautioned: "It's not that we think that industry has suddenly tanked [on product quality]," but 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 CPA — or even some analysts — 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 ... 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.
Language ambiguity and legal clarity
In response to the HRS recommendation to dump the word "recall" in notifications of device malfunctions, the FDA said it will look into whether the term creates more problems than it solves. Reynolds said "recall" has resulted in the explantation of perfectly serviceable rhythm devices from patients.
By some accounts, the agency has issued alerts and notifications of various kinds for more than 300,000 defibrillators and pacemakers since 1990, but the rate of replacement of pacemakers due to malfunctions has been less than 5 per 1,000 and 21 per 1,000 for defibrillators. However, given that doctors implanted roughly a quarter of a million defibrillators in 2005, the need for a recall by one name or another is not likely to vanish any time soon, regardless of the approach the agency takes.
Yet to be answered is the question of whether the agency can legally do this without help from Congress. However, at least one association and one Capitol Hill staffer say that any such change can be dealt with via regulations and requires no statutory address. Amy Melnick, vice president for health policy at HRS, told CDU, "[w]e had an attorney look at this, and the opinion we received was that FDA can do this without Congressional approval."
Challenging but doable
To make the change, she said, "there are challenges, but it can be done." Melnick nonetheless noted that Congressional input would help, saying, "It might be appropriate to put this change into MDUFMA," the reauthorization of the Medical Device User Fee Modernization Act of 2002 which Congress must take care of next year.
She added: "FDA is doing their due diligence and have acknowledged privately and publicly that the word has caused unnecessary surgeries," but that HRS is nonetheless of the opinion that "it's imperative that Congress take an interest in this."
HRS's interest in this verbiage is restricted to implantable rhythm devices, and it does not say that the agency would have to implement a similar change of wording across all the products it regulates.
Melnick said that in HRS's talks with the agency, "they did not raise the issue of other products." She made the case that any fix, regulatory or statutory, "can be written narrowly" to apply to a particular range of products.
When asked if a different terminology for different products and/or classes of products might sow confusion in the public mind, Melnick said that this would not be a problem "from an HRS perspective."
Kevin Schweers, a member of the staff at the House Energy and Commerce Committee told CDU: "At first glance, it seems like FDA has enough flexibility to make these sorts of decisions.”