Ethics of postmortem implant explantation are overlooked

Consent forms often omit it

Explantation of battery-operated implants such as pacemakers involves pressing ethical issues but receives little attention, according to Katrina A. Bramstedt, PhD, a clinical ethicist and associate professor at Bond University School of Medicine in Australia, and former faculty in the Department of Bioethics at Cleveland Clinic Foundation, Cleveland, OH.1

"The focus when bringing these products to market is their safety and effectiveness," says Bramstedt. "End-of-life issues have been an afterthought for many clinicians, regulators, and manufacturers."

Bramstedt says that the "big picture" thinking for these technologies needs to reflect the many clinical and ethical possibilities that can happen after implantation. One ethical consideration is whether informed consent of postmortem explantation of battery-operated implants should occur at the time of the implant, or at the time of the explant.

"Many consent forms don't mention the topic of explant, only implant," says Bramstedt. "The consent discussion can also fail to include this matter as well, unless the cardiologist has it on his radar." Often, the topic of explant does not come up until after death when surrogates are approached for a decision.

Patients or families might consent to implant but refuse to consent to explant. "Should we require implant and explant consent as a conjoined consent that does not allow refusal for explant?" asks Bramstedt.

Bramstedt identifies these ethical issues involving explantation:

  • Failure to explant and analyze devices from the clinical setting allows product defects to be potentially hidden from patients, families, clinicians, manufacturers, and regulatory agencies.
  • Bodies buried with battery-operated implants potentially harm the environment.
  • Religious or philosophical objections to autopsy should not supersede the duty to explant and analyze battery-operated implants.

"In my view, the societal benefits of device analysis exceed any 'right' to refuse explant," says Bramstedt.

While it is very common for implanted pacemakers and defibrillators to be removed in the postmortem state if the patient is to be cremated, it is very uncommon for this to happen if the patient is to buried.2

If this were to become a common practice, then patients likely would be asked about this prospectively, as is the case with organ transplantation, says George Crossley, MD, FACC, a member of the American College of Cardiology Clinical Electrophysiology and Electrocardiography Committee and a cardiologist at Baptist Hospital in Nashville, TN.

"Even in organ transplantation, though, the formal informed consent comes from the patient's family members," he notes.

The process of evaluating devices in the postmortem state for quality improvement is certainly important, says Crossley, but most malfunctions of implanted pacemakers and defibrillators involve leads and not the pulse generators. "Catastrophic problems in the pulse generator can occur, and would certainly be picked up by the quality assessment done before using these devices," says Crossley. "If this practice becomes common, it will be very important for the reporting system to capture all devices that have electrical or mechanical problems."

Reuse of devices

Bramstedt says she doesn't think that the duty to explant also extends to a duty to donate to any specific philanthropic cause afterward. "I don't think they should be forced to consent to reuse in humans," she says. "They could consent to reuse in an animal if they wanted to, or they could simply consent to the explant and analysis of the device."

If reused devices are sold, they should be labeled as such and patients/surrogates informed of such, says Bramstedt. Studies should be conducted about patient safety, device efficacy, lifespan of devices, and limitations of devices when reused, she adds.

"Patients should be informed of any safety and performance differences between used and new devices, even if a country chooses to only offer reused devices to its residents," she says. "Patients should know what they are getting and not getting if they choose or are forced to accept a used device."

There is a great need for cardiac electrical implanted devices in the developing world, says Crossley, noting that he has obtained unused donated devices and shipped them to Romania and the former states of Yugoslavia.

Crossley says the most significant barrier to reusing devices is the concern over possible infection. "While a new device that does not have tissue or blood exposure is not difficult to sterilize, a 'dirty' device is fairly difficult to sterilize," he says. "The use of Q-tips or other devices up into the header to try to clean material away can be catastrophic for device function."

"Even if we manage to sterilize the device, DEA regulations really inhibit one's ability to ship them overseas," says Crossley. "There are reports in the 1990s of well-intentioned folks doing this for charity having serious legal consequences."

According to Benedict S. Maniscalco, MD, CEO and chairman of Heartbeat International Foundation, Inc., a Tampa, FL-based organization that provides cardiovascular implantable devices and treatment to the developing world, the biggest ethical issue involving reused devices in the developing world is whether restoring a patient to cardiovascular function is the priority. "Or do we make concerns about reuse and its potential complications override the concern for human life?" he asks. "In the developing world, ethical standards are quite different in many ways."

Physicians must ultimately make the decision regarding the reuse of a pacemaker if a new device is not available, in order to restore a patient to normal function or perhaps save a life, says Maniscalco.

"The problem is not one of the greatest good for the greatest number, but one made for an individual patient," he says. "There is no issue in my mind of fairness or equality. A patient is a patient."

References

  1. Bramstedt KA. Harms and responsibilities associated with battery-operated implants (BOI): Who controls post-mortem explantation? Pacing and Clinical Electrophysiology 2013;36:7-10.
  2. Baman TS, Kirkpatrick JN, Romero J, et al. Pacemaker reuse: An initiative to alleviate the burden of symptomatic bradyarrhythmia in impoverished nations around the world. Circulation 2010; 122:1649-1656.

Sources