Ethics and the Cardiac Pacemaker: More Than Just End-of-life Issues

Katrina Hutchison; Robert Sparrow


Europace. 2018;20(5):739-746. 

In This Article

Conflicts of Interest for IEAPs

IEAPs play an important role in the maintenance of pacemakers, including supporting cardiologists during implantation and with follow-up and programming. Despite being a significant point of interaction between industry and clinical staff, there has been little attention paid to risks of conflict of interest that arise in these relationships. IEAPs must balance the expectations of three separate groups: their employers, the health professionals they work with, and the patients whose treatment they support. Often these interests align—everyone wants patients to have good outcomes and for problems that arise with a device to be resolved efficiently without adverse events. Nevertheless, manufacturers stand to gain financially from the use of their company's devices. When it comes to recommendations about device selection, the interests of the patient and manufacturer are not always aligned. In the past, pacemakers have sometimes been implanted and replaced unnecessarily.[19] Questions of trust and disclosure also arise when patients are unaware that they are being attended by an IEAP.[10,12]

In recognition of the expanding and potentially conflicted role of IEAPs, the North American Society of Pacing and Electrophysiology has developed consensus recommendations for these roles.[12,25] These have also been incorporated into recommendations in Europe, where involvement of IEAPs appears to be more limited in scope.[26,27] However, these consensus recommendations are not always followed. For example, whereas the recommendations stress that responsibility for clinical decisions lies with physicians rather than IEAPs, recent qualitative research suggests that clinicians may look to IEAPs for significant clinical guidance.[10] The same study also found that IEAPs are sometimes asked to provide services (including device deactivations) when clinicians are not nearby, which is inconsistent with the recommendation that IEAPs should give technical support in close proximity to physicians. Competition between device companies and infelicitous requests by clinicians have been identified as factors that influence IEAPs to overstep their role.[10,19]

Institutional Conflicts of Interest

Institutions can also benefit from relationships with pacemaker manufacturers that go beyond the mere provision of devices at a price. Many hospitals rely on free training provided by industry representatives for the education of nurses, technicians and allied health professionals. Clinical colleges such as the American College of Cardiology have policies governing the involvement of industry in college-recognised continuing medical education.[28] However, in-hospital device-specific training provided by manufacturers is not governed by these policies. While training provided by manufacturers is an efficient way to ensure that health professionals are proficient with devices they are expected to use in their roles, these training sessions sometimes also function as sales and advertising events.[29] Stronger oversight by hospitals and regulators of what counts as 'training' as opposed to 'marketing' is desirable. This could include, for example, requirements that the manufacturers' employees who provide training are not directly answerable to the sales department or receiving commissions.

Another source of conflict for hospitals is the free provision of pacemaker programmers and other equipment that facilitates the use of a particular manufacturer's devices. This equipment may be proprietary and expensive to purchase. Previously acknowledged as a sales strategy,[19] our conversations with cardiologists, health purchasing bodies and device industry employees in Australia suggest that these strategies are still practised and influence patterns of device choice by administrators.

Conflicts of Interests and Clinical Leadership

In Table 2, we suggest a number of key questions to guide clinicians and other stakeholders in identifying possible sources of conflicts of interest in their team and clinic. There are now numerous requirements on clinicians for transparency and disclosure in relation to conflicts of interest. Regulations apply, especially to published research and when clinicians are using products for which they receive a royalty or other direct financial benefit. However, regulation does not apply to everything that patients or the public may find inappropriate so it is important to consider the spirit—and not just the letter—of these regulations and guidelines. There is more to be done concerning the way conflicts of interest are handled in hospitals and in clinics, and the potential for conflicts of interest to arise for IEAPs. Leadership from clinicians will be an important factor in addressing these challenges.