The Heart Rhythm Society, a professional organization for cardiac arrhythmia specialists, is lobbying the FDA to change the guidelines surrounding recalls of implanted cardiac devices. This move is in response to patient confusion about recalls and the devastating business effects surrounding major recalls of potentially faulty pacemakers and defibrillators from Medtronic and Guidant (now owned by Boston Scientific) in 2005 and early 2006.
The Society claims that some words cause undue distress among consumers, especially when a patient must replace potentially faulty cardiac devices. Such procedures could be just as damaging to a patient’s heath — replacement operations have a high risk of fatal infection and other health issues — as a malfunctioning defibrillator or pacemaker. They suggest the FDA adopt less stark words, but still use “safety advisory” or “safety alert” instead.
Some skeptics, not surprisingly, see this move as a way to pull the wool over the eyes of consumers. In their minds, the FDA should not sugar coat the news that a pacemaker might fail. Additionally, they feel consumers may be confused by the change in terminology, or that they may not understand the urgency of the situation if recalls are not plainly stated as such.
The FDA has acknowledged, in its bureaucratic way, the receipt of these recommendations, and is already working to improving communications between device manufacturers and consumers — but has argued in the past that changing use of the term ‘recall’ will require legislative action. It is implementing focus group research to study consumer reactions to word choices.
Meanwhile, big industry players like Boston Scientific, Medtronic, and St. Jude Medical — among others — have already agreed to communicate device performance more effectively, appoint external review panels to evaluate after-market performance of their devices, and develop wireless monitoring systems for patients and doctors.
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