Bad Press Moves Industry to Massive Recalls of Cardiac Defibrillators

Bad Press Moves Industry to Massive Recalls of Cardiac Defibrillators

By Rebekah McCallister

Bad press can sometimes lead to positive outcomes. It was after The New York Times published an article (May 24, 2005) about 21-year-old Joshua Oukrop, who died after the Ventak Prizm 2 Model 1661 defibrillator device that had been implanted in him to save his life malfunctioned, that the medical device industry and the FDA sat up and took notice.

The malfunction that is believed to have led to Mr Oukrop’s death was known to the manufacturer of the device, Guidant Corporation of Indianapolis, Ind, for 3 years before the incident occurred. However, the company had not deemed the risk high enough to warrant sending out warnings to patients, physicians, or the FDA.

Since the publication of the Times article, however, the situation has taken a drastically different turn. Guidant and other medical device manufactures (eg, Medtronic, St. Jude Medical) have issued recalls and safety warnings for several devices. And in July 2005, Guidant established an independent counsel of experts to recommend guidelines for when information should be disseminated to physicians and patients about medical device compilations.

In addition, the Heart Rhythm Society hosted the recent “Policy Conference on Pacemaker and ICD performance,” in Washington, DC, where clinicians, FDA medical and scientific staff, and other stakeholders met to discuss ways in which information about the safe and effective use of implantable cardioverter defibrillators (ICDs) and pacemakers is made available to physicians and patients.

Data released at the meeting revealed that from 1990 to 2002 there were approximately 2.25 million pacemakers and 416,000 ICDs implanted in patients in the United States. During the same time, 17,323 devices (8834 pacemakers and 8489 ICDs) were removed from patients because of a confirmed device malfunction. The annual ICD malfunction replacement rate was significantly higher than the pacemaker malfunction replacement rate (20.7 vs 4.6 replacements per 1000 implants; P <.001). And although the pacemaker malfunction rate decreased during the study, the ICD malfunction replacement rate, while trending down during the first half of the 1990s, increased significantly during the latter half of the study, with more than 50% of the ICD malfunctions occurring between 2000 and 2002. A total of 61 deaths were confirmed to have been directly related to ICD or pacemaker malfunction during that period.

Conference Chair Mark Carlson, MD, MA, of Case Western Reserve University School of Medicine, Cleveland, Ohio, pointed out that the whole situation surrounding the device recalls needs to be put into perspective, “as they account for a very small percentage of manufactured devices, and that presently, devices save thousands, if not hundreds of thousands, of lives.”

“It is important to remember that this conference provided a unique and unprecedented opportunity for the FDA, industry, physicians, and patients to share information and opinions,” he told IMWR. “As a result, we have a better understanding of what challenges exist and where opportunities for improvement exist.”

Echoing Dr Carlson’s comments was Leslie A. Saxon, MD, of USC University Hospital, Los Angeles, Calif, who told IMWR “ICDs offer very effective therapy. Physicians and patients need to have confidence in this therapy.”

Dr Saxon said that one of the things discussed at the meeting was how to standardize the way the health care industry understands device malfunction and how such malfunctions should be communicated in the future. “Patients can expect improvement in assessment of risk and expect timely issuance of data that are reliable and accurate. At the end of the day, we do not want to release data too early that are not completely accurate,” she said.

According to Dr Saxon, the Times article “scared a lot of patients,” and made the medical industry aware of the need to disseminate correct information in an appropriate manner. “We discussed ways for patients to get information that isn’t related to the lay press—to the New York Times,” she said.

Another topic discussed at the meeting, according to Dr Carlson, was the importance of precise terminology and uniform definitions. “It was noted that the term ‘recall’ has strong implications for many people that, in some cases, may not match the intended meaning,” he said.

When asked to describe the purpose of postmarket surveillance of pacemakers and ICDs, Dr Carlson said that “the primary goal of postmarket surveillance is to monitor and determine expected device performance and to identify potential and recurring device malfunctions.”

However, Dr Carlson acknowledged that there are many barriers related to data collection of postmarket device surveillance, noting that “devices are often interred with patients, particularly when they die at a site remote from their cardiac electrophysiologist. Some physicians and patients may not be aware of the importance of returning devices for analysis. The importance of patient and physician education regarding the importance of returning devices was noted. It was noted also that some countries provide strong incentives to return devices for analysis. Incentives of this sort in the United States would require significant policy changes.”

According to Dr Saxon, current industry and FDA advisory communications have significant differences, which reflect the distinctive nature of each advisory and the medical, legal, and patient safety issues inherent in an implanted device advisory. Standardization of advisory communications to physicians to supplement industry and FDA communications is needed, she noted, providing physicians with:

• Concise clinical information to facilitate rational patient communication and better-informed clinical action
• Objective information
• Information that can be easily referenced and subject to updates.

When asked what she tells patients who are worried about advisories related to specific ICDs or pacemakers Dr Saxon said, “I have over 600 patients with devices right now. Advisories are fluid, and I follow the advice [in the advisories] and am open to what kind of information develops around it. In general, the advisories that have come out in the past 6 months have been low. And truthfully it’s hard to take a new device out of the box and be able to ensure that it’s not going to have any malfunction. Current ICDs have a very good track record—they would have to.”

In October 2005, the Heart Rhythm Society put together a task force to draft public policy recommendations to improve the pacemaker and ICD postmarket surveillance system and related communications between device manufacturers, the federal government, clinicians, and patients, as well as to develop comprehensive clinician guidelines. The 14-member task force, which includes Drs Carlson and Saxon, plans to have the recommendations ready for public comment by May 2006. Development of the clinician guidelines is expected to take 9 to 12 months.

“This was a positive first step,” Dr Saxon said.

According to a New York Times article (October 26, 2005), the Department of Justice issued subpoenas to Guidant, Medtronic, and St. Jude Medical as part of a new investigation that is looking into allegations concerning any illegal payments or other incentives any of these companies may have offered to physicians to use their products.