Medical Diagnostic Equipment Control Computer Repair

M

mfreff

#1
I work for a computer repair company that has been asked to repair several computers that are used to control medical diagnostic equipment, and so the diagnostic equipment falls under FDA approval. The repair involves replacing capacitors on the motherboard, however the exact part number for this specific capacitor is no longer available. Can I replace the capacitors with another part that has the same or improved specifications? Where can I find information on the FDA requirements for repairs of this sort?
I apologize if this is not the proper forum for this question. I am new to both the forum and to FDA regulation in general.
Thank you.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
I work for a computer repair company that has been asked to repair several computers that are used to control medical diagnostic equipment, and so the diagnostic equipment falls under FDA approval. The repair involves replacing capacitors on the motherboard, however the exact part number for this specific capacitor is no longer available. Can I replace the capacitors with another part that has the same or improved specifications? Where can I find information on the FDA requirements for repairs of this sort?
I apologize if this is not the proper forum for this question. I am new to both the forum and to FDA regulation in general.
Thank you.
Hi,

I think that the regulatory situation in your case requires some clarification.

First, are these computers integrated in the diagnostic equipment, i.e. formed an integral part when this equipment was first sold, or are they general purpose stand-alone computers, purchased in parallel (or afterwards) and put to work with the diagnostic equipment?

Second, who exactly hired your company to fix them? Is it the original manufacturer who first made the diagnostic equipment, or the facility using it? If the latter, what are the circumstances that led them to approach a different company than the original manufacturer?

If you could answer these questions, there would be a much higher chance the applicable requirements, and best course of action, could be defined.

Cheers,
Ronen.
 
M

mfreff

#3
The computers are off-the-shelf IBM computers that are inserted whole into the diagnostic equipment. We are providing service to the original "manufacturer" of the diagnostic equipment, but up to this point, we have been simply cannibalizing parts to repair. We have depleted the supply of donor units, but have identified the capacitors as a common point of failure. Replacing these caps can allow us to continue on with repairs for some time. We are an authorized IBM repair center, but this is technically not an "authorized" repair. The units are out of warranty, so we would typically just replace the caps, but with the FDA thing... We just don't want to do anything unethical or illegal.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
The computers are off-the-shelf IBM computers that are inserted whole into the diagnostic equipment. We are providing service to the original "manufacturer" of the diagnostic equipment, but up to this point, we have been simply cannibalizing parts to repair. We have depleted the supply of donor units, but have identified the capacitors as a common point of failure. Replacing these caps can allow us to continue on with repairs for some time. We are an authorized IBM repair center, but this is technically not an "authorized" repair. The units are out of warranty, so we would typically just replace the caps, but with the FDA thing... We just don't want to do anything unethical or illegal.
Hi,

Thanks for clarifying.

So, I understand that these computers form an integral part of the diagnostic equipment, supplied to the user by the original manufacturer. If not, then the rest of this answer is irrelevant.

First off, I reckon that from the FDA viewpoint, the overall regulatory responsibility for the repair would lie with the original diagnostic equipment manufacturer (the company that hired you to do the repair). So, whatever you do, make sure to document it in detail and get their written consent. Since they (I guess) don't have the specific technical expertise, make sure to capture the details and rationale, and if required take the time to help them understand and become comfortable with what you're doing. They should already be aware that they carry the regulatory responsibility, however you could mention that as well if you feel they're not.

With regards to the technical specifics, I would approach IBM and ask for their advice, since they are the ones who designed and specified this part of the device in the first place. Once you got the details from them, include these in the document you take to your customer for approval. You can also attach any relevant correspondence from IBM as appendix.

I reckon if you achieve the above then you will be pretty much covered both ethically and regulatorily.

The above only represents my own opinions and is not to be taken as legal advice.

All the best,
Ronen.
 
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