Reuse of devices in the developing world

Some bioethicists argue that it is not ethically justifiable to offer reused pacemakers overseas since these are not approved for use in the United States, but “this goes on every day in the developing world,” says James N. Kirkpatrick, MD, an assistant professor of medicine at the Hospital of the University of Pennsylvania. Of 334 autopsies preformed between February 2009 and July 2011, 27 pacemakers and implantable cardioverter defibrillators were recovered, according to a study from the University of Pennsylvania. Of those, eight devices had at least four years of battery life remaining, and all but two of 40 patients who received used pacemakers reported improved health.1

“Reused devices may not be up to the standards we have set for ourselves in the United States in 2012, but they are up to the standards that Sweden set for itself in the 1990s, when they implanted reused devices in up to 14% of their primary implants,” notes Kirkpatrick, adding that most of the studies done on reuse have shown no significant differences in infection risk, although there have been differences in device failure.2

“These differences are small and still amount to a very low risk of malfunction, which should be even less for newer devices,” says Kirkpatrick. “It would be a different story if there was a large, demonstrated quality gap between new and reused devices. As always, we have to balance risk versus benefit. The data, so far, seem to indicate that the risk is small.”

In most cases, pacemakers and defibrillators are implanted either to dramatically improve quality of life or to save lives, notes Kirkpatrick. “We’re not talking about a brand name medication to treat upset stomach when a generic is available in the developing country, or cosmetic Botox injections,” he says.

Cardiology and electrophysiology professional societies stated in a 2002 guideline, “reuse of explanted pacemakers, not currently performed to any extent in the United States, may eventually add significantly to the cost-effectiveness of cardiac pacing.”3 “It may not be too long before we in the United States are considering ‘second-best’ treatments in order to save money,” says Kirkpatrick.

Double standard?

“In every country, there are clearly people who will die without a device. For that reason, even if one or two devices make it into such a country every year, ethically it makes sense to try and help,” says David L. Hayes, MD, professor of medicine in the Division of Cardiovascular Disease at Mayo Clinic College of Medicine in Rochester, MN.

U.S. government agencies have been opposed to sending these devices out of country, and some other countries don’t want cast-offs, notes Hayes. “However, those countries that self-identify as being open to whatever guidelines are established for the reuse of devices should be considered, and then available devices distributed by need and/or normalized to the population,” he says.

If the devices have been removed because they are infected, even though there are good data to demonstrate they can be safely and completely sterilized and could serve another patient for years, most countries would likely balk at the reuse of such devices, says Hayes. Devices that become contaminated but are non-infected could and should be resterilized and used, he says.

“Devices in the U.S. have a ‘use by’ date, but are still fine for use after that date,” says Hayes. “From a supply chain standpoint, most hospitals are very vigilant about not allowing outdating of a device because they don’t implant by a certain date. However, I believe the manufacturers would have such devices that could and should be used.”

The Food and Drug Administration (FDA) has a responsibility to make sure that devices are safe when used in the United States, and the argument can be made that it has a moral responsibility to make sure devices coming from the United States are safe for overseas use as well, says Kirkpatrick. “If there is to be large numbers of devices exported en mass from U.S. companies which are responsible for the quality and sterility of devices, the FDA should play a role,” he says. “It is less clear what oversight it should have over small numbers of devices carried overseas by private parties to be sterilized overseas prior to implant.”

Scarce resources

Understandably, lower-middle income countries have not allocated scarce resources to expensive pacemakers and defibrillators for their populations, notes Kirkpatrick. “Their health care budgets are much more wisely spent on prevention, since their primary duty is to the health of the population,” he says. That is why the need that exists in these countries for these devices cannot and should not be met by the governments purchasing new devices, says Kirkpatrick, and can only be met by donation of expired new devices or reused devices.

“The cost of implanting these devices, although far below the cost of a new device, is not trivial,” he adds. “There is a valid argument that this money could be better allocated to preventative measures.”

When the issue is examined not from a population perspective but an individual perspective, the donation and implantation of a used device can make a large difference for the individual and, perhaps, the individual’s family, argues Kirkpatrick. “In the United States, of course, we routinely make health care decisions that favor the individual over society,” he says. “One could argue that we can afford to do so, at least right now, whereas lower-middle income countries cannot, but we still have to acknowledge the double standard.”

Pacemaker implantation has effects beyond the health and well being of an individual, adds Kirkpatrick, because cardiovascular disease strikes patients much earlier in the developing world and keeps young people from being productive members of society. “A pacemaker can dramatically improve the quality of life of these patients, allowing them to return to work and contribute to their families, instead of being a burden,” he says. “Defibrillators, of course, save lives — important for young patients in southeast Asia, where sudden unexplained death syndrome is the number one cause of death of young, otherwise healthy men.”

References

  1. Zamani P, Kirkpatrick JN, Litzky LA, et al. Longevity of implantable electrophysiology devices explanted from patients having autopsy in hospitals. Am J Cardiol. 2012:110;1643-1645.
  2. Linde CL, Bocray A, Jonsson H, et al. Re-used pacemakers: As safe as new? A retrospective case control study. Eur Heart J. 1998; 19:154-157.
  3. Gregoratos G, Abrams J, Epstein AE, et al. ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices: Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee to Update the 1998 Pacemaker Guidelines). Circulation 2002; 106:2145–2161.

Sources

  • Thomas Crawford, MD, Assistant Professor of Medicine, Cardiovascular Center, University of Michigan School of Medicine, Ann Arbor, MI. Phone: (734) 936-6859. E-mail: thomcraw@med.umich.edu.
  • David L. Hayes, MD, Professor of Medicine, Division of Cardiovascular Disease, Mayo Clinic College of Medicine, Rochester, MN. E-mail: dhayes@mayo.edu.
  • James N. Kirkpatrick, MD, Assistant Professor of Medicine at the Hospital of the University of Pennsylvania. Phone: (215) 662-7726. E-mail: James.Kirkpatrick@uphs.upenn.edu.