From the Editors
Problems have plagued cardio device manufacturers recently. Particularly noteworthy was Guidant's failure to promptly disclose defects. Now, the Heart Rhythm Society (HRS) has weighed in. The physician group released a comprehensive list of recommendations for the reporting of pacemaker and implantable cardioverter-defibrillator (ICD) malfunctions. The draft guidelines were released April 26.
The recommendations are well intentioned, calling for a coordinated and cooperative approach from industry, FDA, and physicians. This is a great goal. The end result, of course, is to provide heart patients with clearer, timelier, and more-consistent information about the recall process.
However, it is not necessarily feasible to expect that companies can extrapolate a potential problem from a single event. Nevertheless, Boston Scientific—which recently purchased Guidant and all of its inherent woes—has already announced that it plans to implement all of the recommendations in the draft report. Medtronic, however, is being more cautious, stating in its release that it looks forward to working with HRS, FDA, and others to adopt final recommendations for addressing the problem.
Stephen Mahle, president of Medtronic's cardiac rhythm disease management business, released this comment on the draft guidelines: “We are pleased to note that the majority of the recommendations in the HRS proposal have been Medtronic standard practice for many years.”
Boston Scientific's president and CEO, Jim Tobin, said, “This is a sound and constructive report whose recommendations can and must be implemented.” In a press release, Tobin singled out the society's recommendation for independent oversight. “In particular, we believe an industrywide, independent committee of outside experts should be established,” he said. Tobin praised Guidant for “demonstrating early leadership and already implementing a number of the measures recommended by HRS.”
The report's key recommendations for manufacturers include the following:
• Use wireless and remote monitoring technologies to identify abnormal devices earlier and automatically.
• Establish independent, standing committees of outside experts to analyze device performance reports and to recommend appropriate action.
• Communicate with patients directly using standardized forms to notify them regarding potential malfunctions.
The recommendations stress the need to provide a standardized format for reporting pertinent device information. The report emphasizes identifying abnormal device behavior earlier than is done now and improving the accuracy of reported malfunctions. These are good suggestions, but they don't account for certain nuances.
Mahle said that Medtronic supports HRS's recommendation that manufacturers notify patients directly, but he cautioned that “a field action does not necessarily mean patients need to have their devices removed,” noting that the term recall can be confusing for patients because it can incorrectly imply the need for device removal.
What the industry does not need is a system that incites the media—and thus patients—to panic. The final guidelines are expected to be published in the October 2006 issue of the Heart Rhythm Journal.
Sherrie Conroy for the Editors