Re-sterilization yields low incidence of infection

The re-sterilization and reuse of implantable cardiac devices in underserved countries results in a “reassuringly” low incidence of infection, researchers found.

Furthermore, they determined that the infection rate among patients with reused devices was not significantly higher than the rate for control patients implanted with new devices in Canada.

Their study, led by Thomas F. Khairy, Montreal Heart Institute, Universitéde Montreal, Montreal, Quebec, was published in The New England Journal of Medicine.

The cost of implantable cardiac devices can be prohibitive, estimated to be $2,500 to $8,000 for pacemakers and $10,000 to $18,000 for implantable cardioverter–defibrillators (ICDs). Consequently, countries with limited resources have trouble accessing implantable cardiac devices. However, a possible strategy for dealing with this problem is the postmortem harvesting of devices that are in good condition and have adequate battery life remaining.

According to Khairy and colleagues, the concept of reusing these devices — once they’ve been re-sterilized — was introduced decades ago, but a lack of data on the risk of infection associated with these recycled devices has continued to be a concern.

In 1983, the Montreal Heart institute established a program in which it sent recycled pacemakers and ICDs to underserved nations for re-sterilization and reuse, setting up a registry in 2003 in order to enable the tracking of outcomes.

Here, in this study, the authors wanted to quantify the incidence of infection after implantation of a re-sterilized and reused pacemaker or ICD and identify factors associated with infections. The incidence of infection was to be compared with that of matched control patients with new devices in Canada.

Patients in underserved nations who received reused devices through the program were matched in a 1:3 ratio with control patients. The primary outcome was infection or device-related death, with mortality from other causes modeled as a competing risk.

Re-sterilized devices were implanted in 1,051 patients in four countries — Mexico (36.0%), the Dominican Republic (28.1%), Guatemala (26.6%), and Honduras (9.3%). Of those patients, 85% received pacemakers, while the remaining 15% received defibrillators.

Khairy and colleagues found that, over a two-year follow-up period, no device-related deaths occurred, while non–device-related deaths occurred in 4.0% of patients with reused devices and 3.9% of patients with new devices.

As for infections, during the follow-up period, 2.0% of patients with reused devices developed infections, compared to 1.2% of patients with new devices (hazard ratio, 1.66; 95% confidence interval [CI], 0.97-2.83). Infections occurred a median of 66 days after reused device implantation compared with 61 days after new device implantation.

The most common pathogens implicated in infection were:

  • Staphylococcus aureus (in 13 patients [61.9%] with infections involving reused devices and in 23 patients [60.5%] with infections involving new devices).
  • S. epidermidis (3 [14.3%] and 9 [23.7%], respectively).
  • Cutibacterium acnes (1 and 3 infections, respectively).
  • Pseudomonas aeruginosa (0 and 2 infections, respectively).

Despite these results, Khairy and colleagues suggested that there are practical and ethical issues to consider in establishing device reuse programs.

For example, they pointed out that the FDA questions whether reused pacemakers can be properly sterilized and therefore considers pacemaker reuse to be “an objectionable practice.” In addition, they noted that while the risk is low, there are concerns about the possibility of the transmission of infectious disease.

However, the restrictive regulatory regimen in developed countries “neither precludes nor sanctions the donation of devices after a person’s death to regions that have no viable alternatives,” Khairy and colleagues observed.

Thomas Crawford, MD, assistant Professor of Medicine at the University of Michigan, director and principal investigator for My Heart Your Heart, a pacemaker reconditioning and recycling program at the University of Michigan, told BreakingMED that, while previous studies have shown similar results, “this by far is the largest.”

“Its value is also derived from its prospective nature, and they had a control group that was reasonably selected,” Crawford said. “And, while the study does not completely prove there is no increased risk of infection with reconditioned devices, it certainly says that if the infection rate is higher with reconditioned devices, it is not significantly higher. Although the authors acknowledge it was not a randomized study, I think they were able to show the practice of reconditioning pacemakers, and reusing them in patients who have no other choice, is a very sound one.”

Crawford also noted that in addition to infection, the issue of device malfunction has also been a matter of concern when it comes to pacemaker reuse.

“When the devices are removed from patients and are reclaimed from funeral homes and crematories, there certainly is some worry that handing of the devices could impact the longevity of some of the components,” he said, and he pointed out that a recent meta-analysis his group wrote suggested that the risk of malfunction with reconditioned devices was about 5-fold greater than with new devices.

“But you have to remember that new devices are exceedingly reliable,” Crawford said. “So, a 5-fold increase is still a small risk. And, we certainly believe there is a way to reprocess the device in such a way that the risk of malfunction is not excessive.”

  1. Use of re-sterilized pacemakers and defibrillators in patients in underserved countries results in a low rate of infection.

  2. Recycling these devices may be a possible alternative to implanting new devices, which can be prohibitively expensive in low income countries.

Michael Bassett, Contributing Writer, BreakingMED™

Khairy had nothing to disclose.

Cat ID: 2

Topic ID: 74,2,730,2,306,308,5,914,192,925,159,492