FDA requirements for Servicing and Refurbishment of Medical Devices

[Ronen E]

There is a gray line between "refurbisher" and "remanufacturer". My understanding is that FDA in practice considers the former term to apply to a company that obtains used equipment, cleans it up and re-markets it to a new user; with the latter applying to a company that performs repairs to equipment that is significantly out of original performance or safety specs, so as to bring it into those original specs, or new specs that make it clinically safe and effective in some different manner.

If your role will fit the "remanufacturer" definition, then very generally in the absence of further information about your company, your responsibilities will be:

1. Register.
2. List all the devices you will work on.
3. Set up and maintain a QMS, including all of the actions needed for your organization under that QMS to be conforming.
4. If the devices you work on are radiation emitting, file the appropriate reports.

To make things just a bit murkier, FDA has another type of activity - "reconditioning" - which in my understanding corresponds with "repair" or "fixing" in everyday language. The way I understand the (long standing) status-quo, this type of activity is generally not overseen by FDA.

 

[somashekar]

On March 12th, the FDA published a final guidance on reprocessing reusable medical devices. This guidance is a step toward further reducing the risk of patient infection by providing manufacturers with recommendations to validate their reprocessing instructions to ensure devices remain safe and effective for reuse.

 

[MIREGMGR]

To make things just a bit murkier, FDA has another type of activity - "reconditioning" - which in my understanding corresponds with "repair" or "fixing" in everyday language. The way I understand the (long standing) status-quo, this type of activity is generally not overseen by FDA.

The word "reconditioning" does not appear on the FDA "Who Must Register, List and Pay the Fee" page. I haven't had to interact with uses of that term in the device area other than in regard to customs detention where it has an odd legalistic meaning...the term however is used in pharma and food regulation. My understanding is that that term, if used on the device side, would be equivalent to "refurbisher", whatever you think the definition should be of that latter term.

FDA provided a good discussion of all of the terms we're using here as part of a proposal for regulation of refurbishing and remanufacturing back in 1997. That discussion is formally obsolete, but my expectation would be that the terms-definitions implicitly presented in it are still valid.

 

[Mark Meer]

Thanks MIREGMGR.

I was only familiar with the terms on the FDA's "Who Must Register, List and Pay the Fee" page, so have never heard of "reconditioning".

I strongly suggest the original poster (if they haven't already), check out the page here.

It's interesting that while "Refurbishers" is listed under "domestic establishments" (with no obligations to register or list), there is no equivalent under "foreign establishments"...

Also, as pointed out by MIREGMGR, I can see how the line between "refurbish" and "remanufacture" could be pretty murky. I would imagine that in practice "significantly changes the finished device's performance or safety specifications" would be a similar decision process to their guidance Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1).

 

[Ronen E]

The word "reconditioning" does not appear on the FDA "Who Must Register, List and Pay the Fee" page. I haven't had to interact with uses of that term in the device area other than in regard to customs detention where it has an odd legalistic meaning...the term however is used in pharma and food regulation. My understanding is that that term, if used on the device side, would be equivalent to "refurbisher", whatever you think the definition should be of that latter term.

FDA provided a good discussion of all of the terms we're using here as part of a proposal for regulation of refurbishing and remanufacturing back in 1997. That discussion is formally obsolete, but my expectation would be that the terms-definitions implicitly presented in it are still valid.

It makes sense, because as I stated above (and in several past threads) reconditioning, in the meaning I'm talking about, is not overseen by FDA. It is an intentional policy for at least 10 years now. If you widen your search you will see that this field is subject to sorts of voluntary or semi-voluntary industry codes. Read here for example.

Understanding whether one is a reconditioner is not about identifying FDA regulations or guidance that one must meet; rather, it's about identifying a scope that the FDA intentionally excludes. Whether or not to follow other (voluntary?) frameworks is a separate issue.

The term "Refurbish" is tricky. The way I understand it to be practiced by leading regulators, it requires the following as a minimum:
1. Back purchase of the used device/devices that will serve as a starting point.
2. Stripping the device(s) back to components level.
3. Identifying non-disposable "bad" parts - broken, malfunctioning, worn out etc.
4. Replacing all bad parts with good ones - either new or tested, used ones.
5. Assembling at least one complete device, to the original specs (or updated revision thereof), from "good" - used or new - parts. Disposable elements are all new or reprocessed.

To qualify as refurbishment the process has to involve a complete, systematic disassembly of the device and replacement of all bad parts. This is different from repair (reconditioning?) or service, in which disassembly is normally partial and extends only to necessity / a defined scope. Additionally, repair and service normally don't involve back-purchase and re-sale of the finished (good) device.

Cheers,
Ronen.

 

[Mark Meer]

The term "Refurbish" is tricky. The way I understand it to be practiced by leading regulators, it requires the following as a minimum:
1. Back purchase of the used device/devices that will serve as a starting point.
2. Stripping the device(s) back to components level.
3. Identifying non-disposable "bad" parts - broken, malfunctioning, worn out etc.
4. Replacing all bad parts with good ones - either new or tested, used ones.
5. Assembling at least one complete device, to the original specs (or updated revision thereof), from "good" - used or new - parts. Disposable elements are all new or reprocessed.

Tricky definitions to be sure...

I've always thought of "Refurbish" as either:
(a) any activities necessary to bring an old or used (but otherwise conforming) item back to "good-as-new" state; or
(b) any activities necessary to bring a previous version up to the state-of-the-art (i.e. current specifications).

I don't see why points 1 & 2 are necessary to qualify as "refurbishing".

The above makes a lot of sense as a definition for "Remanufacturer" (because that is exactly what it is describing).
...but then the FDA's already defined this, including the criteria that the activities "...significantly changes the finished device's performance or safety specifications, or intended use.", which isn't necessarily the case here.

 

[Ronen E]

Tricky definitions to be sure...

I've always thought of "Refurbish" as either:
(a) any activities necessary to bring an old or used (but otherwise conforming) item back to "good-as-new" state; or
(b) any activities necessary to bring a previous version up to the state-of-the-art (i.e. current specifications).

I don't see why points 1 & 2 are necessary to qualify as "refurbishing".

The above makes a lot of sense as a definition for "Remanufacturer" (because that is exactly what it is describing).
...but then the FDA's already defined this, including the criteria that the activities "...significantly changes the finished device's performance or safety specifications, or intended use.", which isn't necessarily the case here.

Without 1&2 it becomes plain repair / service. This is exactly what makes it refurbishing.

Your (a) & (b) sound to me like two variants of service.

 

[Mark Meer]

Without 1&2 it becomes plain repair / service. This is exactly what makes it refurbishing.
Your (a) & (b) sound to me like two variants of service.

In my (admittedly informal) use of the terms, the key difference is whether or not the item is intended to be (re)distributed as (basically) new, and, to a lesser extent, whether the device is non-conforming.

Manufacturers can take old inventory, demo/rental units, etc. that are otherwise conforming, and do what is necessary to make them "good-as-new", and I would consider this refurbishing. This does not necessarily entail a complete disassembly and reassembly, nor does this require a "back purchase".

Repair - again, to me - necessarily involves fixing something that is broken, or non-conforming.

Good discussion!

 

[fcowdery]

This is a great and very informative discussion. Since there is not a lot of detailed guidance available, all of your perspectives are appreciated.

I have a couple questions on the topic of refurbishment as well. We are an OEM.

Currently when a system fails, we replace the system with a new production system.

The failed system is then refurbished in our factory, relabeled with a new serial number and distributed as a new (like new) device.

1. Do we need to document a rationale explaining which parts were or were not replaced in the system to restore it to state of the art functionality?

2. For internal record keeping conveniences we issue a new serial number to the device during the refurbishment process. Is this necessary?

Thanks in advance

 

[Ronen E]

1. Do we need to document a rationale explaining which parts were or were not replaced in the system to restore it to state of the art functionality?

In my opinion, yes. If there are many parts you could document the decision rules / logic rather than a decision for each and every component. Added in edit: my comment relates to the rationale. Documenting which components were replaced (not why) seems to me absolutely necessary.

2. For internal record keeping conveniences we issue a new serial number to the device during the refurbishment process. Is this necessary?

In my opinion it's a good practice. If you "mix and match" parts from several individual units, it would be a must.