A manufacturer of medical equipment that costs hundreds of millions of yen to repair has announced that it will no longer allow hospitals to make repairs without permission, sparking controversy over the company's right to repair.
It has been discovered that
Medical Device Company Tells Hospitals They're No Longer Allowed to Fix Machine That Costs Six Figures
https://www.404media.co/medical-device-company-tells-hospitals-theyre-no-longer-allowed-to-fix-machine-that-costs-six-figures/
Hospitals hire their own repair technicians and contractors to repair medical equipment within the hospital. Terumo provides these technicians with certification to repair its own medical equipment, and the Advanced Perfusion System 1 Heart Lung Machine was one of the devices that required certification to be repaired.
According to foreign media 404 Media, the certification renewal for the above equipment has ended, and technicians who are already certified will be able to work on repairs until the expiration date, but will no longer be able to carry out repairs after the expiration date.
The following is a message sent to hospitals: 'Terumo Cardiovascular will no longer offer certification for repair and maintenance of the Advanced Perfusion System 1 Heart Lung Machine. We recognize the value this certification has provided and the decision to discontinue offering it was made after careful consideration. Direct service of equipment and components will remain available.'
In a statement to 404 Media, Terumo said it had 'experienced a decline in participation in our certification program and decided that the best way to properly verify that equipment is being properly maintained is to require servicing by Terumo's in-house team.'
This change means hospitals will have to enter into repair contracts directly with Terumo.
404 Media points out that while this may seem like a reasonable change, it could end up driving up health care costs in the long run.
The Advanced Perfusion System 1 Heart Lung Machine is an advanced medical device used to recirculate blood during open-heart surgery, and 404 Media says that repairs would cost hundreds of millions of yen. However, when repairing such equipment, relying on official support rather than an outside technician can be two to three times more expensive, so the reduced options for repairs could lead to major problems.
'One of my fears is that if a device breaks down, the repair could be delayed depending on the convenience of the manufacturer's engineers,' said a source who repairs medical equipment at a hospital. 'If someone is waiting for open-heart surgery, we have to tell them, 'The machine's broken, so we're going to postpone it.' That's a disservice to patients who are facing life-altering circumstances.'
A source familiar with Terumo machine repairs added, 'Just because a technician is wearing a Terumo shirt doesn't mean he's more competent than an in-house technician. The cost of a service contract with the manufacturer is probably 10 times more expensive than a third party. A contract for one piece of equipment isn't a big deal, but when it spans many pieces of equipment, it adds up. It's no secret that the American healthcare system is one of the most expensive in the world, and these repair costs are one of the reasons that healthcare costs are rising.'
404 Media points out that this case goes against the 'right to repair.' The right to repair is the right of consumers to demand that they be able to repair their own devices themselves or through third parties without relying on the manufacturer. The right to repair is being sought to be expanded primarily in the United States to avoid the problem of manufacturers monopolizing repair methods, which tends to lead to high repair costs.
In the United States, the right to repair has been a hot topic, especially when it comes to agricultural machinery, with reports of farmers losing their crops during critical harvest periods because repair options for agricultural machinery are limited and can take days to complete. In January 2025, agricultural machinery manufacturer John Deere was sued by the Federal Trade Commission for monopolistic repair practices.
FTC sues farm machinery manufacturer for unfairly raising repair costs by limiting access to repair software tools to authorized dealers - GIGAZINE
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