ICD Re-use: More Clinical Evidence To Fuel More Debate

In short

It’s never likely to be a practice that turns the device world on its head, but the debate continues to develop as to whether recycling of implantable cardioverter/defibrillators from first deceased westerners to the poor and needy of countries such as India. Now a further paper has been published, supporting the argument that at least from a clinical perspective this is a valid and justifiable practice.

Background

The arguments are fairly well characterised by now, not least on our own pages. When faced with the bare facts of the matter it looks like a pretty compelling argument, that ICDs in people who have sadly expired can be explanted, checked, cleaned, sterilised and shipped through charitable routes to Indian people in need of ICD therapy yet for whom financial circumstances would otherwise prevent them receiving the devices. Often these explanted devices have quite a lot of battery life left in them, making it entirely possible that three years of effective treatment can be delivered, funded entirely by the generous donation of the device according to their wishes, coupled with charitable support for the explantation procedure, device reprocessing, shipping and implantation.

Arguments against the process are being thrown around too though, not to mention the practicalities of the process. From a legal perspective, questions such as who actually owns the explanted device have been resolved in some countries but not in others. Then there’s a host of regulatory complications, the practice not exactly gaining encouragement from the U.S. FDA who’s own compliance manual calls it “an objectionable practice”. And what about the legal protection of the neoimplantee? What protection could possibly be enforced here. And what about upgrades and obsolescence. Should it be that if a device is working it is considered usable, or should somebody be checking for software changes, recalls, or a variety of other factors that would render the device “as new”. It’s certainly unlikely that the original manufacturer would sanction re-use and as such get involved in this revalidation process. Indeed some have  come out strongly against the practice, citing their own commitment to low to middle income countries in the form of donating free of charge new goods each year, although in what quantity is not entirely clear.

If you want more detailed coverage of the issues, you could do worse than read this article, published by a U.S. research group in 2010.

Anyway, ethical issue aside, a recent paper has returned to the practicality of the process, by reviewing the real world situation in which 81 consecutive patients received explanted ICDs. The report can be found on pubmed here, and it concludes that “explanted ICDs with 3 or more years of estimated remaining battery life can be reused after they are cleaned and resterilised. These devices functioned normally and delivered life-saving therapies, without an increased risk for complications. These preliminary data deserve further validation and, if confirmed, could have important societal and economic implications.”

The paper provides plenty of room for ICD manufacturers and other objectors to counter-argue.  This is after all a retrospective report of a single-centre experience with a modest number of patients and devices, missing follow-up data, no records of the number of devices obtained through postmortem versus antemortem explantation or whether explantation was due to infection or upgrade.

Furthermore complete data were not available on exact battery voltage at the time of reimplantation, left ventricular ejection fraction, or number of inappropriate shocks, and a control group was not possible.

The debate will continue.

Source: Annals of Internal Medicine, Pubmed