No increased risk of infection with recycled pacemakers and defibrillators
In areas with limited resources, healthcare providers often receive medical devices that have been used and resterilized—but is there an added risk of infection with those devices?
Researchers studied data from 1,051 patients who received resterilized pacemakers and defibrillators from a large multinational program, sharing their findings in the New England Journal of Medicine. The patients who received resterilized devices were compared to a control group of patients that received new devices.
Overall, after two years, infections occurred in 2% of patients with used and resterilized devices—the number was 1.2% for patients with new devices. No device-related deaths were reported.
“Surveys indicate that most physicians and device recipients are receptive to resterilization and reuse programs,” wrote lead author Thomas F. Khairy, Montreal Heart Institute, and colleagues. “Nevertheless, a common reservation expressed is the uncertain risk of infection. In our study, we found a reassuringly low incidence of infection among more than 1,000 patients with reused devices from four participating resource-limited countries—the Dominican Republic, Guatemala, Honduras, and Mexico.”
Khairy et al. also noted that policies surrounding these devices after a person’s death vary throughout the world.
“Depending on local jurisdictions, explanting a pacemaker or ICD may or may not be legally required,” they wrote. “For example, in Sweden, postmortem retrieval is required by health authorities and cannot be refused by patients. In the United States, there are no federal statutes specific to ownership of medical devices after death. In Canada, devices have historically been considered the property of patients or their next of kin. A survey of funeral directors in Michigan indicated that in 85% of cases, cardiac implantable electronic devices are buried with the patient.”
The FDA, the authors added, “consider pacemaker reuse to be ‘an objectionable practice.’”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.