San Francisco, CA - When confronted with what the FDA terms a "recall" of their implantable cardioverter defibrillator (ICD) or pacemaker, most patients would be willing to go along with the course of action recommended by their physicians. On the other hand, about one in 20 would insist that the device be explanted and replaced, regardless of whether a far less invasive measure is all that's needed. But only half that many would insist on a device change-out if the regulatory action were called a "safety advisory."

Dr Christina M Murray

That's according to a survey of 165 randomly chosen device recipients at a major referral center, in which most also showed undue confidence that they wouldn't themselves be subject to such a recall or safety advisory [1].

Regardless of which term is used, patients who would demand a device change-out are "clearly outliers" compared with the majority who would trust their doctors' decision, observed Dr Christina M Murray (University of Oklahoma, Oklahoma City) for heartwire. But replacement of implanted devices, and especially their leads, entails well-recognized risks of infection and other complications, she noted, many of which could apparently be prevented if device recalls were always referred to as advisories.

Murray reported the survey results here today at the Heart Rhythm Society [HRS] 2008 Scientific Sessions. They support several years of so-far-unsuccessful effort by the organization to convince the FDA to change the terminology it uses to inform doctors and patients about device failures and advise them on how to respond, especially the word recall.

Recall vs advisory: The HRS and FDA collide

In a Town Hall Meeting conducted at the HRS sessions two years ago, heartwire then reported, Dr Mark D Carlson (Case Western Reserve University, Cleveland, OH) described what the society was asking federal regulators to do about the word in a broad and far-reaching set of guidelines for the oversight of ICD and pacemaker performance [2]. "The FDA should eliminate the term recall and use in its place terms such as advisory notice or safety notice," he had said.

The FDA's position at that time, as stated by agency spokesperson Dr Bram Zuckerman, was that the word is "currently an important part of FDA regulations and operations and cannot be changed quickly due to broad policy ramifications. The FDA is currently committed to more clearly explaining and communicating the current terminology and system to the public and physician community."

At a similar Town Hall Meeting at this year's sessions, Dr Dwight W Reynolds (University of Oklahoma), HRS immediate past president and a coauthor of Murray's analysis, said that the society formally resubmitted the recommendation to the FDA in February 2008.

"We advised the FDA-regulated manufacturers and the FDA to use identical terminology when classifying device malfunctions," he said, and "We reiterated that we recommend to the FDA that they eliminate the term recall for all public communications regarding implanted devices, and once again we recommended that they change the word to advisory notice or safety alert."

Added HRS president-elect Dr NA Mark Estes III (Tufts University-New England Medical Center, Boston, MA), "The word recall to a patient means something very different from what it does to a regulator." In general, he said, industry and the FDA have done well at adopting the recommendations in the society's 2006 document. "But this word recall is still there." To FDA representatives who were also at the Town Hall Meeting, Estes said, "What's it going to take to have the regulatory agencies understand the major impact it has on our patients?"

Megan Moynahan

With her response in 2008 echoing Zuckerman's in 2006, Megan Moynahan of the FDA's Center for Devices and Radiological Health said, "We've heard that message loud and clear. . . . But it's also important to remember that one reason we get worked up about the word recall is because many physicians equate the word with explantation. And we really want the message to get out that 'recall' does not mean explantation."

From the audience, Dr G Frank O Tyers (University of British Columbia, Vancouver) offered other reasons to keep the current terminology. "I don't think we should get rid of recall. Something like that could be [seen as] attempting to whitewash the problem. Recall is used across all industries, and recall means to me that the manufacturer actually went out and took the product back from the field, [ones] that hadn't been implanted. It's not such a bad word," he said. "I think the critical issue is that this still requires physician judgment. Not every recalled device should be explanted."

Whereupon audience member Dr Peter N Smith (Marshfield Clinic, WI) said, "The word recall has different connotations in different industries. Recall is why I have never bought a set of tires for my truck. I've gotten free tires twice. Recall to a patient with an ICD evokes all kinds of anxiety."

Show me the data

Dr Peter N Smith

According to Murray, the survey goes a long way toward giving the HRS efforts some teeth—that is, hard evidence that the word recall has an adverse effect on patients and that using safety advisory instead might have measurable clinical benefits.

The 45 patients with conventional pacemakers, one with a resynchronization pacemaker, and 119 with ICDs were asked a number of questions, including, "If you were told there was a safety advisory on your device, what would you want?" Of the patients, 2.5% responded they "would want the device removed no matter what." But 5% (p=0.01) gave that answer to the same question with recall substituted for safety advisory, Murray said.

In an analysis of how the 2.5% difference in the number of patients insisting on change-outs would have played out hypothetically last year, when—as covered at the time by heartwire —Medtronic issued a recall of its popular Sprint Fidelis ICD leads due to what it saw as an increased failure risk, calling it a "safety advisory" would have prevented about 300 major change-out-related complications and about 26 deaths, Murray said. "We think these are powerful data, actually, to support a change in terminology."

Survey responses also showed that 77% of the group understood that their generator might fail and need replacing; 71% understood that about their leads. But when they were asked what they believed their chances were of experiencing a safety advisory or a recall, 30.6% responded 1 in 100 000, the same percentage said 1 in 10 000, 14.3% said 1 in 1000, and 17.7% said 1 in 100. So just over 75% had "clearly very unrealistic expectations of device performance," Murray said, adding that the true risk is "somewhere between 1 in 10 and 1 in 100."

The finding suggests that physicians need to educate their patients better on the risks of implanted devices, she said. Indeed, asked whether they had received enough education on the risk that their device would malfunction, 67% of the patients replied yes; 58% replied yes when asked if they'd had adequate education on the risk of a "recall" or "safety advisory."