TechNation is proud to support and be an advocate for the Right to Repair movement in the healthcare technology management and health care community. A new web form specifically allows biomeds everywhere to report incidents when an original equipment manufacturer (OEM) declines to provide parts, technical assistance, keys or other support needed to repair or maintain a device.

The goal is to provide biomeds a place to share their experiences to help others as well as collect data regarding right to repair issues that can be shared within the industry and with regulatory organizations, including the FDA.

Share a right to repair issue today.

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VIEW REPORTED INCIDENTS

Bausch and Lomb - 11/11/2021


Manufacturer: Bausch and Lomb
Equipment: Phacoemulsifier
Model/ID Number: ELITE BL15455

An HTM technician at my facility attended a technical training course to perform maintenance on a phacoemulsifier used in our Surgery department. When she returned, we had an issue and called Bausch and Lomb to order the replacement part. They would not sell the part even though the technician went through training. We were told that we could only do the PM and any repair inside of the unit had to be done by a field engineer employed by Bausch and Lomb. We could have had the part on order on 11/11. It is now 11/15. We requested field service, but we have not heard back or had a field engineer show up yet. This will increase our downtime and cause us to reschedule additional procedures. If we were able to purchase the part and perform the repair ourselves, the device would be back in service sooner.

Mizuho - 10/19/2021


Manufacturer: Mizuho
Equipment: Surgical Table
Model/ID Number: Hana

Mizuho will not sell parts to anyone not factory trained on equipment. Was forced to pay $4000 in labor.

Integra Life Sciences - 10/11/2021


Manufacturer: Integra Life Sciences
Equipment: Headlight System
Model/ID Number: 90500

Integra won’t provide parts for simple headlight system. Was told by tech support this is mandated by the FDA. I politely explained that GE is able to provide parts for life support equipment, how is it the FDA restricts parts purchase on simple headlights? The answer was no parts are available for purchase.

Stryker - 10/11/2021


Manufacturer: Stryker
Equipment: Insufflator
Model/ID Number: Pneumclear Plus CO2

Stryker won’t provide basic functional test procedures to verify system performance. Documentation needed to verify performance periodically or due to an incident.

Cardinal Health - 10/1/2021


Manufacturer: Cardinal Health
Equipment: Enteral Feeding Pump
Model/ID Number: ePump

These devices utilize a gearbox. These gearboxes often break or wear down to the point that the device will not pass a re-certification test. Cardinal Health will not sell these parts unless it’s a franchise with permission to repair the units. The only way to get the units back into working condition is to send them out for a flat rate repair costing $150. The turn around time is anywhere from 2-4 weeks. If we were able to order these parts, we’d be able to get them back into service with a simple replacement and re-certification test.

Medtronic - 9/9/2021


Manufacturer: Medtronic
Equipment: ESU
Model/ID Number: FT10

No parts are for sale on this unit. Not a single one after at least 5 years on the market. You can’t even change the date.

Stryker - 8/18/2021


Manufacturer: Stryker
Equipment: Generator
Model/ID Number: MALIS

Anything that needs to be fix / replaced has to be sent in for a flat rate repair of $4490.80. The turn around time is 6 to 8 weeks.

Skytron - 8/9/2021


Manufacturer: Skytron
Equipment: Skytron 6700 OR Table
Model/ID Number: 6700

Skytron refused to sell us the parts needed to repair this table because we were not the end user.

Skytron - 8/9/2021


Manufacturer: Skytron
Equipment: Sktron 6700
Model/ID Number: 6700

Could not get parts sent directly to us.

Fukuda Denshi US - 8/6/2021


Manufacturer: Fukuda Denshi US
Equipment: Central Station
Model/ID Number: DYNASCOPE DS7700

Power outage caused Central Station to not power on. Issue resulted in board failure and software reload. Entire facility unable to monitor patients at Bedside for 3 weeks as Fukuda does not allow biomeds to service in field nor allow software to reload.

OLYMPUS - 8/6/2021


Manufacturer: OLYMPUS
Equipment: LIGHT SOURCE
Model/ID Number: CLV-400S

The manufacture would not sell guide port connector. which cost us triple amount of money to repair.

iNTEGRA lifesciences - 8/5/2021


Manufacturer: iNTEGRA lifesciences
Equipment: Head Lamp
Model/ID Number: 90500

No parts sold, only OEM flat rate repair $1800.

All I need is a rear plastic case . . . .

Olympus - 8/5/2021


Manufacturer: Olympus
Equipment: Video processors
Model/ID Number: CV190

I have been looking to obtain a front connector for Olympus video connector for a while. In past, I was able to obtain the connector for different CV180 processor for about $350. Now, they have stopped selling any parts for the newer model and charge ridiculous amount which is at least 8 to 10 times more for it.

The service report when the equipment is received has no description of what was done for repair beside ” Level X” repair, where X is 1,2,3,4,5..

Even dealing with Olympus for video recorder (Medicapture USB 300) has been been extremely frustrating. They supply no parts for repair and the repair has no description of what has been done.

There are hardly any service manuals are provided for anything that made by Olympus. As biomed, they have turned us into glorified shipper and and receivers when it comes to dealing with Olympus equipment. It increases our downtime for equipment and is very inconvenient to end users.

Medtronic - 7/26/2021


Manufacturer: Medtronic
Equipment: O-Arm
Model/ID Number: All

Medtronic has refused to sell any parts or provide any service manuals. I included recent info on the right to repair and sent to the service manager and here is his response. “Medtronic’s position has remained the same, we do not sell parts or provide service manuals.”

I put in a complaint to the FDA two years ago and did not hear anything. So far no one is doing anything about this.

Stryker - 7/23/2021


Manufacturer: Stryker
Equipment: Defibrillator
Model/ID Number: LIFEPAK 15

Called Stryker service for Test equipment, P/N 3305682. A device needed to complete electrical safety checks on the device. I was told the part will not be sold to any Biomeds that are not employed by Stryker. I then requested schematics to make the part and was told if I want the machines safety checked I needed to hire their tech. I then requested an email stating what had been said to me but I have yet to see that.

Philips - 7/22/2021


Manufacturer: Philips
Equipment: Patient Monitor
Model/ID Number: IntelliVue MP5

Tried to fix this and Philips won’t send the part.

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