A 'recall' by any other name: FDA urged to change misnomer that scares patients

June 01, 2006

Boston, MA - At least one seemingly small issue addressed by the implantable-device performance-oversight guidelines recently proposed by the Heart Rhythm Society (HRS) [1] seems to strike a nerve with both doctors and patients.

The HRS document asks the US Food and Drug Administration (FDA) to "establish a simple and more intuitive nomenclature to communicate important information about device malfunction or failure of a device. . . ." But there is one word the society singled out as a special problem.

"The FDA should eliminate the term recall and use in its place terms such as advisory notice or safety notice," said Dr Mark D Carlson (Case Western Reserve University, Cleveland, OH) when summarizing the proposed recommendations at a Town Hall Meeting conducted at the recent HRS 2006 Scientific Sessions. The meeting featured authors of the group's draft document, clinicians in practice, and representatives of patients, industry, and the FDA. Carlson chaired the HRS task force that developed the recommendations.

"I think we should banish the word," task-force member Dr Robert G Hauser (Minneapolis Heart Institute, MN) said at the meeting. "And we should begin to do so by educating our membership [and] eliminating the word from our manuscripts and abstracts and other presentations"—something he has done already, he said.

These people were frozen in fear because of the word 'recall,' because of the thought that the device in their chest wasn't going to do what it needed to do.

The issue is that currently, a device with almost any problem can be "recalled" without an implied need for explantation; device reprogramming or watchful waiting is often all that's needed. The word, according to many, is a bureaucratic misnomer in a consumer society trained to hear it as a call to return a product to the store for an exchange. So when the product is a life-sustaining implantable cardioverter defibrillator (ICD), patients and many clinicians tend to go with the word's familiar meaning.

"Recalls occur when a device is defective or could constitute a risk to health," HRS-document coauthor D r Leslie A Saxon (University of Southern California, Los Angeles) said at the Town Hall Meeting. "The term recall used in this setting, as we've heard from the FDA, is not meant to reflect the 'clinical acuity,' if you will, of a specific advisory notification. That's not always easy to understand when one looks at the FDA's definition of recalls."

Current FDA wording

From the Heart Rhythm Society Draft Recommendations Report, page 16, April 26, 2006:

  • Class I recalls: "Reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

  • Class II recalls: "The use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or in which the probability of serious adverse health consequences is remote."

  • Class III recall: "Situations in which the use of or exposure to a violative product is not likely to cause adverse health consequences."

In fact, Saxon later explained, the task force considered that many clinicians act on recall advisories as if they do reflect clinical acuity, even when a wait-and-see approach may be best. Such potential misinterpretations could prompt the replacement of a huge proportion of "recalled" devices. "That's what we were trying to avoid." Usually, she emphasized, whether explantation is the answer depends on each patient's clinical picture. "Twenty thousand or so" ICDs were subject to a recall in the past year and a half, she observed, but in general the low malfunction rates didn't necessarily create a broad need for device replacement.

If clinicians don't always grasp the FDA's meaning of the word, how well do patients understand it?

"You say the word 'recall,' and I think someone's coming at me with a scalpel," Lisa Salberg said into a microphone from the audience during the meeting. "That's the way the word is perceived." Salberg is founder and president of the Hypertrophic Cardiomyopathy Association (HCMA, Hibernia, NJ), a nonprofit advocacy group and resource for patients with the familial disorder and their families and healthcare providers.

Later interviewed by heart wire , Salberg—who has HCM herself and is on her fourth implantable device—said when the series of ICD recalls started last year, the families her organization serves flooded the HCMA office with inquiries. "For three months, almost every phone call we took was device related," she said. "These people were frozen in fear because of the word 'recall,' because of the thought that the device in their chest wasn't going to do what it needed to do."

Even if the agency wanted to change the word tomorrow, do we really know what system should be utilized instead?

Despite HCMA's advice to "talk to your doctor" about how to respond to the recalls, "every person we talked to who had a device in question just wanted it out because they thought they were misled," according to Salberg. "People need to be able to trust their devices. You can't understand that unless you live with one."

Industry seems to appreciate the word's impact and seldom uses it. Implantable-device-company representatives at the Town Hall Meeting were in complete support of replacing "recall" with less loaded, more accurate words.

"We prefer the term used to be similar to what the Heart Rhythm Society has recommended," according to Dr Dale Devries, vice president for Clinical and Regulatory Affairs at Guidant Corp (St Paul, MN). Physicians tell the company, he said, that the word 'recall' is "somewhat alarming."

Later at the meeting, panelist Timothy D Samsel, vice president of Cardiac Rhythm Device Regulatory Affairs for Medtronic Inc (Minneapolis, MN), confirmed support for the HRS position on behalf of AdvaMed (Washington, DC), a massive US medical-device-industry association. Samsel chairs its Pacemaker/ICD Working Group.

According to the lobbying organization's website, AdvaMed "is particularly encouraged by HRS's call for the FDA to cease use of the term recall in its public communications involving device malfunctions, as the term is often inappropriate and routinely misunderstood, especially as regards to implanted devices." [2]

The HRS recommendation

From the Heart Rhythm Society Draft Recommendations Report, page 15-16, April 26, 2006:

Directed at the FDA:

  • Eliminate the term recall in public communications regarding implanted devices.

  • Change the term "Class I recall" to "Class I advisory notice" or "Class I safety alert." Class I advisory notices would be those in which device replacement should be considered because of the reasonable probability that the malfunction could result in death or significant harm.

  • Change Class II and III recalls (non-life-threatening malfunctions or potential malfunctions) to "advisory notice" or "safety alerts."

But the FDA's representative at the meeting made it clear that the agency isn't inclined to "banish" the word soon. From the panel, HRS president Dr Anne B Curtis (University of South Florida, Sarasota) asked FDA spokesperson Dr Bram Zuckerman: "What would it really take to get rid of that word?"

"It's deeply embedded in our federal regulations, so it would take the work of some very good lawyers," Zuckerman replied. The agency is in favor of clarifying its terminology, he observed, but wants time to explore what changes might be most effective. That is more pertinent than any legislative challenges to eliminating the word "recall," he suggested. "Even if the agency wanted to change the word tomorrow, do we really know what system should be utilized instead?" Zuckerman directs the FDA's Division of Cardiovascular Devices at the Office of Device Evaluation, Center for Devices and Radiological Health.

During his formal presentation, he displayed the following statement from his agency: "The recall nomenclature is currently an important part of FDA regulations and operations and cannot be changed quickly due to broad policy ramifications. FDA is currently committed to more clearly explaining and communicating the current terminology and system to the public and physician community."

I think they're overcomplicating what should be a rather simple matter.

Later, Zuckerman said that if any immediate action is taken, it will be such public and physician education on the current system. That, he said, "is a work in progress."

Also at the Town Hall Meeting, Salberg appeared to suggest that the FDA could use some education itself. She proposed that focus groups consisting of "patients and the public," not simply clinicians and other professionals, should explore "how the word 'recall' affects them psychologically, physically, and in every other way."

To heart wire , Salberg said, "I think they're overcomplicating what should be a rather simple matter." She said she understands that the FDA is "steeped in tradition and terminology" and that they are trying to protect patients. But, "there comes a time when you have to look at the word and realize that it doesn't work anymore."

Regarding the agency's current preference for public education, Salberg observed, "We've done a really good job in this country of educating people on what the word 'recall' means—the Consumer Product Safety Commission has done that. We all know when a product is recalled that we need to act quickly and swiftly to correct the problem." Usually, she said, that means returning a car, playpen, or any other product people rely on to the manufacturer.

"If we're going to train people to have a different attitude about the word 'recall' when it comes to devices that are implanted in our bodies vs something we ride in or put our children in, we're fighting a battle that I don't think is winnable," according to Salberg. "When you say 'safety advisory' as opposed to 'recall,' it heightens people's awareness that they'd better get to their physician or call the physician and ask for information."


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