How Safe are Resterilized Pacemakers and Defibrillators?

Access to pacemakers and implantable cardioverter-defibrillators (ICDs) in developed countries is widespread for patients with cardiac rhythm abnormalities. However, these devices are in short supply in low-to-middle income countries. How safe is it to resterilize and reuse these devices? 

Pacemakers and ICDs are removed from patients after death because they can cause explosions during cremation. If these devices are in good condition with adequate battery life after removal, they can be reused after resterilization. The Montreal Health Initiative established and later expanded a citywide effort to send tested and resterilized pacemakers and ICDs to underserved nations for reuse. 

A prospective registry was created in 2003 to track outcomes of this program and the results were recently published in NEJM. Resterilized devices were implanted in 1051 patients in Mexico, the Dominican Republic, Guatemala, and Honduras. No device-related deaths were reported and the 2% incidence of infections at 2 years was not significantly different than the incidence in matched controls with new devices in Canada. These data address some of the uncertainties regarding the safety of reusing pacemakers and ICDs.

The following NEJM Journal Watch summary explains the study in more detail.

Mark S. Link, MD reviewing Khairy TF et al. N Engl J Med 2020 May 7

Permanent pacemakers (PPMs) and implantable cardioverter–defibrillators (ICDs) are often explanted at the time of burial or cremation and, not uncommonly, have many years of battery life remaining. While reusing these devices in highly developed countries is currently implausible, reuse in less-developed counties has been occurring for decades. Small studies have shown that this practice is probably safe. Researchers have now published the largest report of this practice, relying on registry data on 1051 patients who were implanted with resterilized devices — 85% were PPMs and 15% were ICDs — through a program run by the Montreal Heart Institute.

Participating countries were Mexico, Dominican Republic, Guatemala, and Honduras. The patients were matched in a 1:3 ratio to patients receiving new devices at the Montreal Heart Institute. Data were collected retrospectively. At 2 years postimplantation, infections were present in 2.0% of patients with resterilized devices and 1.2% of patients with new devices (hazard ratio, 1.66; 95% CI, 0.97– 2.83; P=0.06). Staphylococcus aureus and S. epidermidis accounted for most infections. Infections with resterilized devices occurred a median of 66 days after implantation. 

Comment: Although the between-group difference was close to being statistically significant, the infection rate of resterilized devices was quite low at 2 years. This is remarkable considering the differences in healthcare systems. While probably not a realistic option for developed countries, the practice of donating and resterilizing devices for developing countries has merit. However, this practice will still have associated costs, for example from the procuring of new leads because used leads cannot be explanted without damage.

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Ken is a 2019-2020 NEJM Editorial Fellow and a paediatrician working in the National Health Service of the United Kingdom. He graduated from Imperial College School of Medicine and is training in general paediatrics in London.