FDA: Pacemaker reuse "objectionable practice"
FDA: Pacemaker reuse “objectionable practice”
Devices could be exported for clinical trial
By refurbishing and repackaging pacemakers, “we are de facto creating a new product, which no longer adheres to the original specifications,” says Thomas Crawford, MD, an assistant professor of medicine in the Cardiovascular Division at the University of Michigan School of Medicine in Ann Arbor and co-chair of Project My Heart Your Heart, a program which collects used devices from patients and funeral directors to be someday donated to developing countries. So far, the project has collected more than 10,000 devices, and about 20% of them have more than four years of remaining battery life.
It is against Food and Drug Administration (FDA) regulations to ship adulterated medical devices across state lines and abroad. “We are working with the FDA to allow exportation of a limited number of devices for a clinical trial,” Crawford reports.
My Heart Your Heart’s survey of funeral homes in the Ann Arbor area found that only 4% returned devices to the manufacturers, which is currently recommended for quality improvement (QI). “The vast majority of pacemakers are never returned to the manufacturers, and end up buried with the deceased or fill the landfills,” he says. “It is possible to create a system where a certain number of devices are randomly selected and returned to the device manufacturers to allow for ongoing QI.”
The FDA considers pacemakers as class III devices, which are of “substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury.” “This designation requires the highest standard of safety,” says Crawford. “Many other medical devices, including catheters, are categorized as class II and do not require premarket approval.”
The FDA regulations do allow reprocessing of most catheters under strict protocols, says Crawford, noting that although technically possible, pacemaker reuse is specifically called “an objectionable practice” by the FDA compliance manual. “Currently, there are no developed standards for safe pacemaker re-implantation,” he says. The mission of My Heart Your Heart is to address this deficiency and to develop device evaluation protocols in terms of its functionality and sterility with appropriate validation, says Crawford.
A meta-analysis of data from 18 studies suggests that the risks of infection with pacemaker re-implantation are similar to the risks with brand new devices, although the risk of mechanical failure rate is six-fold higher with reused devices.1 “We believe this may be an acceptable level of risk, given that many patients in the low- and middle-income countries have no alternative way of receiving this potentially life-saving therapy,” says Crawford.
The World Health Organization’s Medical Device Regulations, which emphasize that the quality of devices should be equal, appeal to egalitarian principles, while the use of refurbished devices aims to improve equality of access and equality of health outcomes for people in low- and middle-income countries, notes Crawford.
“Refurbished pacemakers, we believe, are a reasonable response to a dramatic disparity in access to this therapy between the advanced economies and the low and middle-income counties,” says Crawford.
Cardiovascular disease remains a number one killer around the world, with the exception of sub-Saharan Africa, where acquired immunodeficiency syndrome and other communicable diseases claim more lives, notes Crawford. “It is estimated that one million people die each year because of lack of access to pacemakers, mostly due to economic constraints,” he says. “We agree that it would be inappropriate to ‘dump’ unwanted and unreliable devices for use in patients in low- and middle-income countries.”
However, the ethical principle of egalitarianism supports the concept of pacemaker reuse by emphasizing the equality of health outcomes, as without the donated pacemakers many deaths are likely to ensue, Crawford says. “Utilitarian conceptions of justice support reuse of pacemakers, provided that resources needed for such efforts were not better used elsewhere,” he says.
Reference
- Baman TS, Meier P, Romero J, et al. Safety of pacemaker reuse: A meta-analysis with implications for underserved nations. Circ Arrhythm Electrophysiol. 2011;4:318-323.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.