Advisory Advice April 12, 2010

I can summarize my desires for dealing with device “recalls” in one word: transparency. When making medical decisions with patients, the benefits and risks surrounding a treatment choice must be weighed against those of alternate options. Whether discussing new device implantation or possible replacement of an advisory device, health care providers must be able to understand, as fully as possible, what is the frequency and nature of device failure, how might it manifest, and how does the risk change over time? In other words, we must understand the nature and magnitude of the risk in order to have proper discussions with our patients and help them make intelligent decisions.

Fortunately, when advisories have been issued in recent years for a particular pacemaker, ICD, or lead, the failure rate in that model has been in the range of 0.01% up to a few percent (usually less than 1% of devices are affected). And many of these failures can be detected before there are clinical repercussions. With regard to new device implants, which clearly would not include advisory devices, the risk of random component failure or future device recall is far outweighed by the benefits that these devices afford. And so, while the informed consent process should involve a discussion about the small risk for device failure, this risk should almost never sway the decision of whether or not to implant. The decision of whether to replace an advisory device is complex and should be made on a case-by-case basis. A few elegant decision analysis models have been developed that give perspective to this question (including Amin et al, JAMA 2006 and Priori et al, JCE 2009, which demonstrate that device replacement is generally associated with greater risk than simple monitoring for failure (except when the failure rate is high or in pacemaker-dependent patients).

But the purpose of this entry is to articulate my firm stance that health care providers must be provided with prompt, complete, up-to-date information about device advisories so that appropriate conversations and decisions can be made with our patients. When information is released in a guarded, sequential, piecemeal fashion, it can garner skepticism and erode trust. I do appreciate the medico-legal concerns that might impede full disclosure, as well as the desire to avoid giving hasty, incomplete data that later require revision. I am a bit less understanding of the concept of withholding data under the notion of protecting proprietary information. (more…)