As most of the EP community is aware, device and lead recalls are a reality in today’s EP practice. In the last 5 years, both Medtronic and St Jude medical have had significant lead failure issues. The public responses to these recalls have been varied and quite different. As physicians who care for device patients, we must learn to quickly sort through the rhetoric put forth in the New York Times and other media outlets and focus on what is most important–our patients. Certainly, for-profit companies are going to have strategies for handling the “business” aspect of the recalls and we as clinicians must not be distracted by any of the battles we may see in the press. Our job is to provide superior care for our patients. We must analyze the available data and collaborate with industry and the FDA to determine what actions must be taken to keep our patients safe in face of lead or device recalls or advisories.
Recalls and advisories may affect our patients in many ways. Certainly there is the obvious direct biologic and medical risks and complications associated with a particular advisory. However, there is a great deal beyond the concrete medical complications. There is a growing body of published medical literature that examines the psychosocial and emotional effects of device therapy. One of my colleagues, Dr Sam Sears is one of the most well published in this arena. We must consider the emotional and psychosocial effects that these recalls and advisories may have on our patients. Many of these issues may need to be addressed with counseling sessions, support groups and psychotherapy. We must not underestimate the impact that emotional stressors can have on our patient’s overall health.
So, we know that recalls and advisories are a reality. We know that different industry leaders are going to have different responses and that the press is going to sensationalize the stories. The industry response is likely what the particular CEO or executive leadership team feels is in the best interest of their company and their shareholders. To us as physicians caring for patients, that response should not even be relevant. WE must respond in a way that puts our patients first. WE must address both the immediate medical issues as well as the potential longer lasting emotional and psychological needs in a patient-centered manner. WE must put the patient at the center of any device recall and let the guys in the suits on wall street manage their company and their own recall response.