Requirement for Updating Medical Device Software (Firmware) in the Field

B

bjarket

#1
Hello!
Are we allowed to update software on released medical devices in the field, or are we only allowed to ship the new software with the new devices from factory?

Thanks!
 
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B

bjarket

#3
Yes, it would be great with some advice on this...
We follow the obvious standards, 60601-1, 13485, 14971...
Thanks,
/B
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#5
Yes you can update in the field.
Could you possibly expand upon that a bit? Any standards which can be referenced/cited? Other "requirements"? I would personally appreciate it. I'm in "learning mode" myself. Any help in the Medical Device field is appreciated!
 
B

bjarket

#6
From my point of view, a software update in the field should be considered as a replacement of a component, and therefore go through the same QA procedure as any other component (e.g. hardware). However, I have no data or real life experience of this to back it up...
Could anyone confirm this principle, or maybe not if special rules apply?
Thanks,
 
#7
My feeling would be that this is (yet) another situation where risk analysis determines the acceptability of the upgrade.

FDA often quotes the fact that for devices being subject to recall, where software has played a part, 80% of these instances are caused by changes to the software after release. So, I would suggest, only an upgrade that has been very carefully validated and regression tested should go ahead. This is bearing in mind that testing the device in the field is likely to be rather less stringent than in the laboratory.

If you have a well tested update, tested on ALL possible field versions, then I would conduct a risk analysis on the difference between doing it in the field and doing it at the manufacturers site. What could go wrong? Is it possible a fault could be introduced that will not be obvious?

There is also the requirement for configuration management. How will you keep track of the software version in each device?
 
Q

QSMLauren

#8
There are a couple of threads in this forum that have more information. If I knew how to link them I would. Search under "iec 62304" and "software validation" . The link inserted is an article from Quality Digest.

References: IEC 62304 - Medical Device Software, Software Development Lifecycle Procesess (SDLC)

Principles of Sofware Validation - Guidance for Industry.

http://www.qualitydigest.com/print/7640

Suggested Steps:
1. Identify the risk that the software has on the performance of the device. (Iso 14971 and IEC 62304).
2. The release of the update/fix is in the Maintenance phase of an SDLC, but it still needs to follow the product realization processes as someone suggested above. (21 CFR Part 820/iso 13485) A new version# or some other sort of identification # should be assigned.
3. For the field updates, keep track of the serial# of the device and the new version/or identifyer #. (21 CFR Part 820.160)
4. The user should document this change and retest the device in their environment before using, and documentating per their own change control and/or validation requirements.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
There are a couple of threads in this forum that have more information. If I knew how to link them I would. Search under "iec 62304" and "software validation" . The link inserted is an article from Quality Digest.

References: IEC 62304 - Medical Device Software, Software Development Lifecycle Procesess (SDLC)

Principles of Sofware Validation - Guidance for Industry.

http://www.qualitydigest.com/print/7640

Suggested Steps:
1. Identify the risk that the software has on the performance of the device. (Iso 14971 and IEC 62304).
2. The release of the update/fix is in the Maintenance phase of an SDLC, but it still needs to follow the product realization processes as someone suggested above. (21 CFR Part 820/iso 13485) A new version# or some other sort of identification # should be assigned.
3. For the field updates, keep track of the serial# of the device and the new version/or identifyer #. (21 CFR Part 820.160)
4. The user should document this change and retest the device in their environment before using, and documentating per their own change control and/or validation requirements.
Hi,

Reading this and other posts above, I have a disturbing feeling.

I'm trying to make an analogy with a mechanical hardware part. Let's assume a manufacturer identifies a deficiency (or opportunity for improvement), designs, makes and validates such a new replacement part, then introduces it to equipment already in service.

As far as I understand, this could fall (in the USA) under "servicing" of multi-use devices. This area's regulation hasn't been finalized by the FDA (AFAIK) for the last 10 years or so, and is probably only covered by an industry voluntary compliance plan. So, if I got it right, the FDA doesn't pose any formal requirements on the actual replacement, its documentation, config control etc.

I wonder why should software be treated different to a tangible part.

Cheers,
Ronen.
 
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