Medical Device Company Tells Hospitals They're No Longer Allowed to Fix Machine That Costs Six Figures

The manufacturer of a machine that costs six figures used during heart surgery has told hospitals that it will no longer allow hospitals’ repair technicians to maintain or fix the devices and that all repairs must now be done by the manufacturer itself, according to a letter obtained by 404 Media. The change will require hospitals to enter into repair contracts with the manufacturer, which will ultimately drive up medical costs, a person familiar with the devices said. 

The company, Terumo Cardiovascular, makes a device called the Advanced Perfusion System 1 Heart Lung Machine, which is used to reroute blood during open-heart surgeries and essentially keeps a patient alive during the surgery. Last month, the company sent hospitals a letter alerting them to the “discontinuation of certification classes,” meaning it “will no longer offer certification classes for the repair and/or preventative maintenance of the System 1 and its components.” 

This means it will no longer teach hospital repair techs how to maintain and fix the devices, and will no longer certify in-house hospital repair technicians. Instead, the company “will continue to provide direct servicing for the System 1 and its components.” 

On the surface, this may sound like a reasonable change, but it is one that is emblematic of a larger trend in hospitals. Medical device manufacturers are increasingly trying to prevent hospitals' own in-house staff from maintaining and repairing broken equipment, even when they are entirely qualified to do so. And in some cases, technicians who know how to repair specific devices are being prevented from doing so because manufacturers are revoking certifications or refusing to provide ongoing training that they once offered. Terumo certifications usually last for two years. It told hospitals that “your current certification will remain valid through its expiration date but will not be renewed once it expires.”

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