Medical Device Daily Associate

The Heart Rhythm Society (HRS; Washington), the primary group representing cardiac arrhythmia specialists, reported that it has formed a task force to begin drafting recommendations for uniform notification standards to inform physicians and patients about safety alerts and recalls of implantable cardioverter defibrillators (ICDs).

The task force on device performance will finalize the standards – including recommendations for physicians on when to replace an ICD – at a public policy conference in Washington in the fall, HRS said. The meeting will include representation from the FDA, clinicians, media, manufacturers, and cardiac and patient organizations.

The society’s announcement comes less than a week after major ICD player Guidant (Indianapolis) said that it was recalling nearly 50,000 ICDs (Medical Device Daily, June 21, 2005), and less than a month since the company reported that it failed to alert customers to the danger of one of the recalled devices for nearly three years after it was aware of the problem. And according to The New York Times, the company continued to sell older versions of the system even after developing an improved model of the device that was not prone to short-circuiting (MDD, May 25, 2005).

According to HRS President-elect Dwight Reynolds, MD, professor of medicine and chief of cardiology at the University of Oklahoma Health Sciences Center (Oklahoma City), the timing of the HRS announcement is not coincidental only to the recent problems that Guidant and other companies are reporting concerning their ICDs.

“It is a response to the combination of multiple manufacturers’ issues and recalls that have occurred over the past six months,” Reynolds told Medical Device Daily.

“It’s triggered immediately by the most recent situation with Guidant, but it’s clear that the issue looms large with multiple manufacturers of these implantable devices,” he said.

“These new guidelines will focus on what is always our first priority: patient safety,” Anne Curtis, MD, president of HRS, said in a statement. “We’re taking the lead in developing these guidelines, just as we’ve been the industry leader in establishing universal standards of care for heart rhythm disorders for 25 years.”

In a statement disclosing the recall, Guidant CEO Ronald Dollens said the purpose of the company’s recent communications was to share information with physicians and patients about problems in what he termed a “small subset” of Guidant devices.

It appears – at least from Guidant’s point of view – that the failure rate associated with its recalled ICDs falls below 0.1%, the generally accepted threshold for reporting problems. But some have questioned where one draws the line in reporting adverse events with a device, even in a “small subset,” when those events may result in fatality.

Dollens expressed a willingness to work with all parties that could potentially be impacted, by reporting decisions to establish a standard industry protocol, apparently anticipating the formation of the HRS task force.

“We will work with physicians as they decide how best to treat their patients,” he said in last week’s statement reporting the recall, adding that Guidant is committed to establishing industry guidelines and processes to determine when, how and under what circumstances adverse events should be communicated to doctors and patients.

“Guidant hopes to work with FDA, other regulatory agencies and physicians to convene a panel to assist the medical device industry in establishing clear guidelines,” Dollens said.

Reynolds told MDD he believes everyone involved in healthcare, including manufacturers, understand their role in protecting the public. “My sense is, when mistakes are made, it’s uncommon for them to be made maliciously.” Rather, he said he believes that someone has exercised “poor judgment.”

While citing “overly aggressive reactions” to some of the recent physician and patient notifications concerning ICDs, Reynolds blamed a “lack of clarity or the lack of guidelines for companies in this regard.” But he added: “Most of us as physicians and most of us as patients in this day and age expect fairly comprehensive disclosure in a timely fashion” if there is a problem.

There is no “hard and fast threshold within companies,” for reporting, according to a representative of another major company that makes ICDS, declining to be named. “On the other hand,” the source told Medical Device Daily, “I do think that companies tend to look [closely] at the complication rate” when making their reporting decisions. Ultimately, the decision to report an event “is made by individual companies.”

One generally accepted international standard that sets guidelines for the medical device industry that would probably be incorporated into the HSR ICD recall protocols is ISO 14971:2000, developed by the Organization for Standardization (Geneva, Switzerland).

The purpose of that document is to provide an international regulatory framework for identification, estimation, evaluation and reduction of risk. Risk reduction measures specified by the standard include: design to eliminate hazardous situations; providing safety mechanisms; providing warning mechanisms and control with labeling and training.

“That is the written document that the decision [whether something remains an advisory or becomes a recall] is made on,” said Reynolds.

He added that the multi-person task force that HRS is putting together, along with the more inclusive policy conference this fall, should put together “a fairly strong set of specific recommendations that FDA hopefully will codify.”

The FDA said it had classified problems with the Guidant devices as a recall, but recommended that replacement decisions be made via patient-physician consultation.

The Heart Rhythm Society said that, while its guidelines are being developed, it concurs with the FDA in recommending that patients affected by recalls seek the medical advice of their heart rhythm specialists.

“Patients need to discuss the variety of treatment options available with the heart rhythm specialist overseeing their care,” Curtis said. “Each patient is unique and the decision regarding ICD treatment based on recall information from the manufacturer and the FDA will depend on the patient’s specific medical condition.”

Curtis said also that those needing ICDs should not automatically reject getting them because of all the negative attention by the media.

“Despite recent device recalls, the benefits of sudden cardiac arrest prevention conveyed by the ICD far outweigh the risk of device failure,” she said.