Putting the Patient at the Center of the Device Recall

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.

4 responses to “Putting the Patient at the Center of the Device Recall

  1. Dr. Campbell,
    I appreciate your intent, but I do not agree with your point of view. “Rhetoric put forth in the New York Times”? Seriously?

    In a world in which physicians’ views are sometimes marred by speaking fees and consulting arrangements with medical device companies, patients must rely on the media for information about recalls.

    This case is not at all about the sensationalization of a medical device recall. This is about the unprecedented request by St. Jude for the retraction of Dr. Hauser’s paper and failed attempt to discredit his work by dragging a competitor down with them.

    This is about the Class 1 recall of a lead that’s been implanted in 79,000 U.S. patients. These are people who, like me, were told the device would be there to save their lives in case they ever needed it, and who are now learning that this might not be the case.

    This is about how poorly the “the guys in the suits” have handled this crisis so far: defensively and arrogantly. And how it reflects on their company’s image and reputation.

    Doctors and medical device companies should realize that a new world has emerged. It is a world in which patients are more empowered, equipped with information and engaged in their care. We are connected through social media like never before and we are talking. We’re talking about doctors, therapies, brands of devices and even recalls.

    You can no longer control the message. Patients have the right to know. After all, we are the ones living with heart disease. That’s how WE put ourselves at the center of a device recall.
    Hugo Campos

    • Mr Campos,
      Thanks so much for your thoughtful response. I would like to say that the point of the blog post was not to minimize the patient impact of a device recall in any way. In fact, the point of the post was to make sure that my EP colleagues are actively putting patient issues FIRST. It is easy to be distracted by the press and the bickering that is going on between the industry leaders. In no way am I suggesting that their behavior is justified or their response correct. I want to ensure that my patients who do have devices or lead affected by a recall are being cared for in the best possible way. Many of us in EP are collaborating to develop a strategy to deal with the current issues with Riata and will do our very best to develop recommendations for the management of this lead.

      I am so glad that patients like yourself are available on Twitter and other social media sites so that we as physicians can have a better understanding of the challenges you face everyday.

      Best,
      Kevin

  2. Bonnie Hardin

    Dr Campbell–
    Addressing patient issues first and in person as much as possible is the correct way to continue being a compassionate provider. EP is scary & confusing for so many patients and families and rife with misunderstanding. You have your work cut out for you in disabusing your patients of the notion that doctors are not the “man behind the curtain”. Kudos to you for starting the conversation.
    Bonnie Hardin, RN

    • Ms Hardin,
      Thanks so much for your thoughtful comments. You are absolutely correct–the most challenging part of my job is making sure that my patients and I are able to “connect”. We all must work very hard every day to put our patients first!
      Best regards,
      Kevin

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