March 28, 2008

Pacemaker Recycling

Stupid Question ™
Sept. 8, 2003
By John Ruch
© 2003

Q: When pacemakers are removed, are they recycled or reused in another patient?
—anonymous, Columbus, Ohio

A: In the US, these invaluable devices that keep a diseased heart beating at a normal rate typically end up on the junk heap when their users die.

“Most of the time the device is scrapped,” Scott Papillon of Minneapolis-based Medtronic, a premiere pacemaker manufacturer, told me. Not even the parts are reused.

But pacemakers certainly can be reused. They were in this country from their modern debut in 1960 until 1976, when the Food and Drug Administration (FDA) put a stop to it. And they still are reused in patients in many countries around the world, from China to Israel, Australia to Canada.

The one place they’re reused in the US is in pets—a rising field in veterinary medicine thanks to donations from the families of dead pacemaker users.

While aging pacemakers aren’t good enough for you and me, they’re apparently good enough for the rest of the world. With FDA approval, Heartbeat International of Tampa, Florida donates oodles of devices to “pacemaker banks” (there are about three dozen around the world) which offer them to poor patients. (Heartbeat uses only old-model devices taken from manufacturers’ inventory, not from corpses.)

The FDA regulation barring reuse in humans cites worries about the difficulty of sterilizing the devices, which are too fragile for hardcore germ-killing. More recently, the FDA has cited concerns about battery life and product testing.

For a variety of reasons, nobody takes the sterilization worries too seriously anymore. The quality control issue is still debated.

International experience and many studies have shown that reused pacemakers (cycled through as many as six patients) have no more primary complications or failures than brand new devices. In fact, they typically get an even better inspection and obviously have the advantage of a proven track record.

The bigger reasons behind the US no-reuse policy are industry profitability and potential lawsuits in our especially litigious society.

In the US, it’s extremely easy to sue a manufacturer for product failure and win. A used pacemaker market could be a legal nightmare. It just sounds bad.

Pacemaker companies have said they don’t want to undercut their own market with used sales, and worry that reconditioning used devices could be expensive.

Many of the pro-reuse countries have socialized medicine, under which the government owns the pacemaker after the patient dies, and can therefore reclaim it easily for reuse. But in the private-ownership US, the patient’s family owns it. Getting pacemakers back for a regular reuse program could lead to a pricey buy-back market.

If this all sounds cynically profit-driven, keep in mind that the reuse debate in the US has typically been framed, especially during a mid-1980s Congressional hearing, as lowering the price of pacemakers, not as a donation program or a more efficient use of resources.

As things stand, Papillon said Medtronic tries to get pacemakers back for “evaluation” and will provide a “return kit” for that purpose. Other times, the pacemaker just stays in the body—though the titanium casing and lithium-based battery are a no-no for cremation.

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