Help with ISO 13485 Clause 6.4 as it applies to Medical Device Servicing

X

XeniAnnoula

#1
Greetings, brand new here, hoping someone can offer useful opinions on the applicability of section 6.4 to the provision of service of medical devices.

Specifically, our business is sales and service of several medical devices (hospital CSSD sterilizers and washers, O.R. tables and lights) and we're now in the midst of preparing for certification against 13485 (we've had 9001 for almost a decade). I am our company's QM.

While I understand that the term product in this standard can -- key word -- apply to [the provision of] service, I interpret section 6.4 to be intended for medical device manufacturers.

Our ISO advisor is construing this section to apply to us providing service as well, with the 'product' referred to in "...the quality of the product" under (a) being 'the provision of service'. Further, she construes the 'contaminated product' referred to in (d) to include our personnel (as a part of "service").

I'm afraid I feel these are both mis-interpretations, not to mention far-fetched. FYI, while we have a fair amount of control over our employees' behavior in the hospital environment and train to ensure that they are 'gowned and bootied' and do not enter the hospital ill, we otherwise have no control whatsoever over the environments in which we provide service (always in-house at the hospital).

Any thoughts on this? I'd appreciate whatever anyone might have to offer, in agreement or not! I'd like to agree with our consultant as after all, we're paying her for her expertise, but honestly in these two cases so far I simply can't see it. :confused:

Thanks very much!
 
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somashekar

Staff member
Admin
#2
Greetings, brand new here, hoping someone can offer useful opinions on the applicability of section 6.4 to the provision of service of medical devices.

Specifically, our business is sales and service of several medical devices (hospital CSSD sterilizers and washers, O.R. tables and lights) and we're now in the midst of preparing for certification against 13485 (we've had 9001 for almost a decade). I am our company's QM.

While I understand that the term product in this standard can -- key word -- apply to [the provision of] service, I interpret section 6.4 to be intended for medical device manufacturers.

Our ISO advisor is construing this section to apply to us providing service as well, with the 'product' referred to in "...the quality of the product" under (a) being 'the provision of service'. Further, she construes the 'contaminated product' referred to in (d) to include our personnel (as a part of "service").

I'm afraid I feel these are both mis-interpretations, not to mention far-fetched. FYI, while we have a fair amount of control over our employees' behavior in the hospital environment and train to ensure that they are 'gowned and bootied' and do not enter the hospital ill, we otherwise have no control whatsoever over the environments in which we provide service (always in-house at the hospital).

Any thoughts on this? I'd appreciate whatever anyone might have to offer, in agreement or not! I'd like to agree with our consultant as after all, we're paying her for her expertise, but honestly in these two cases so far I'm simply can't see it. :confused:

Thanks very much!
Look at 6.4 closely.
There is a) b) c) and d)
a) b) and d) have an "If"
c) has mention of special environmental condition, within your work environment (Ex. A clean room within your work space)
Respond to yourself about the "If" by making an assessment and you will have the requirement that will apply to you.
Do you have any special environmental condition, defined for your activity ?
If so, then appropriately train all the personnel who have to enter that zone on the do's and don't as well as have that zone superviser trained well, who can direct any person coming into that zone. Maintain records of training appropriately.
Else simply determine and manage the work environment needed to achieve conformity to product requirements, as you do within the ISO9001 requirement.
So as you can see, this clause applies to you as a minimum like the ISO9001 requirement OR further more based upon your determination on the a) b) c) and d) of 6.4; ISO13485.
 
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X

XeniAnnoula

#3
Somashekar, thank you for your speedy input. I think, however, that I may have not made myself clear. You are of course correct that (a), (b), and (d) have an "if" with which I could assess the applicability of the clause, but it's not quite that easy. The interpretation of the scope of the words used still play a major role in determining applicability.

But let me run through what you've outlined: do we have any special environmental conditions defined for our activity? No, for servicing our equipment within these hospital departments, we do not require special conditions. However, for the primary intended use of these rooms (operating room and central sterilization) there would be 'special environmental conditions' which apply. They are not our responsibility to achieve, however (the disinfection of the O.R. prior to surgery).

Do we train our personnel to respect the departments in which they are to work? Yes, we do. Do we train the zone supervisor? No, we do not: he or she is not our employee, and our workplace is not our property. We cannot 'manage' a work environment which does not belong to us.

Section (d) states: "if appropriate, special arrangements shall be established and documented for the control of contaminated or potentially contaminated product in order to prevent contamination of other product, the work environment or personnel". The applicability of this to us -- visiting the hospital to service a piece of equipment -- is not at all clear to me. What's the 'product' in question here?

Forgive me if I'm appearing thick -- this is a real mind-bender for me!
 

somashekar

Staff member
Admin
#4
Forgive me if I'm appearing thick -- this is a real mind-bender for me!
You are doing fine and really appreciated questions with great clarity in them .... :applause:
Do we train our personnel to respect the departments in which they are to work? Yes, we do.
6.4 c) is answered. maintain records. The hospital can be a great source to provide training and certify your list of servicing technicians who need to walk into such zones for servicing. If not, simple ask and get trained. It will be simple do's and don't and following a few typical behaviour while servicing and using of any gowning, gloves, etc etc.
We cannot 'manage' a work environment which does not belong to us.
You need not. If the medical device is operating in such a zone maintained by the hospital, and if you have to service within that zone, the manufacturer would have so recommended.
Section (d) states: "if appropriate, special arrangements shall be established and documented for the control of contaminated or potentially contaminated product in order to prevent contamination of other product, the work environment or personnel". The applicability of this to us -- visiting the hospital to service a piece of equipment -- is not at all clear to me. What's the 'product' in question here?
Ex. If you are to service a patient monitor sensor and the sensor is from the hospital that is stained, what and how you will do to first safely disinfect it (a documented activity) , such that during the servicing process the chances of cross contamination for one stained sensor to a serviced and cleaned sensor is definitely avoided, your servicing place is not contaminated, and your people as well. These can also potentially contaminate a medical device when being serviced without one being aware of it.
The product is "Servicing of medical device"
If my example lights up your thought, you have the answer.
 
X

XeniAnnoula

#5
Yet again, my thanks for your input. :)

Okay, I think I will agree with you that we have (c) covered since we do train our personnel to behave appropriately in the hospital conditions which might be classified as 'special environmental' conditions. We also document details of our training.

However, while one can claim exemption to certain sections of the standard if they do not apply, can one exempt themselves from parts of sections? I think not, and I'm not yet convinced that all of this applies to us.

But perhaps we have (b) covered as well? I agree that if servicing of our equipment required special environmental conditions the manufacturer would have been obligated to make this clear (and I know for a fact that it is not required) and, as well, as authorized distributors and service agents for this equipment, any special environmental conditions needed would have to be something we could reasonably be expected to provide. And that's also not the case.

Is (a) however, so easy? Basically it states that personnel shouldn't adversely affect "the quality of the product" through their actions. My problem here is that our ISO advisor suggests that "the product" in our case is not the equipment we service, but the very act of servicing itself. And so if that's the case, how could it be that the actions of the personnel could adversely affect ... our servicing efforts? :confused::confused::confused:

And on that tangle I must end these comments for today. Thank you again for your help. I will check in again tomorrow and continue as needed.

:thanks:
 
M

MIREGMGR

#6
I'd agree that your product is your service actions. I think that's a broadly accepted interpretation.

(d) seems to me to be easy enough to procedurize for compliance, as it's common sense. If you were servicing an item of equipment that is installed in a cleanroom lab facility, likely you'd move the equipment elsewhere to work on it, or make other arrangements to avoid the need for post-servicing re-validation of the cleanroom lab. If you were servicing a light, you wouldn't do so while the room contains a sterile field procedure. If you were servicing a sterilizer, you would follow procedures to avoid contamination of kinds that would defeat the sterilizer's purpose.

Actually, (a), (b) and (c) all seem to be common sense, too. It might be easier to embrace them, write up some procedures that capture what your people already know and do, and just get on with things instead of resisting.
 
X

XeniAnnoula

#7
Good morning MIREGMGR and thanks for chiming in here as well.

Please, however, don't misunderstand that I wish to 'resist' just for the entertainment value. Quite the opposite: I got through the writing of our 9001 QMS without a quibble and I'd love to do the same with this new standard, but sadly for me, I guess, I'm unable to write clear procedures for something I don't truly understand and/or I don't truly feel is applicable. I wish it were otherwise!

So I envy you for whom this is immediately common sense. But I'll try again. Bear with me.

For (a) then: yes, I could write up a procedure which documents requirements for the behavior of our personnel to ensure that they do not adversely affect ... the work environment (including any equipment within). But that's not what this paragraph says! It says the personnel should not adversely affect the product! And although in a generic sense, outside of ISO, our 'product' does happen to be a piece of equipment that's in this particular environment ... for the purposes of this standard, our 'product' is our servicing efforts. And here is where I fail to see how the behavior of our personnel could adversely affect that.

As for (b), no matter how you shake it, I can't see how this could apply: our servicing efforts do not require specific environmental conditions (fine, we don't do well in hail ...), nor, for that matter, does our equipment, even if as I said above, that's not the 'product' to which we're referring in this standard.

So on to (c): again, I can mostly ignore the specifics of the way this paragraph is written and blithely write up something about how our personnel are to behave working, say, on the 'clean side' of a hospital central sterilization department. We cover this anyways in general training -- gown, booties, etc. Still, these departments are our work environment and in performing equipment service, we always work in these 'special environmental conditions' -- whereas the standard asks us to ensure that we train if personnel are required to work temporarily in these conditions within the work environment. Is this hair-splitting, or is this simply not applicable?

And finally (d): here I completely buy the common sense in your example. Problem is, that example doesn't apply to how we work. 98% of our equipment, for instance, is fixed in place within these departments. The 'post-servicing re-validation' of the -- for us -- operating room, not only isn't our responsibility, but is actually instead a rigorously standard 'pre-surgery' disinfection procedure, done before each and every operation irrespective of whether there have been equipment servicing activities in the room or not.

It goes without saying that we do not, of course, engage in service activities while the room is being used for a sterile procedure.

You come a bit closer when you talk about the sterilizer, however. Do we follow 'procedures to avoid contamination that would defeat the sterilizer's purpose'? May I ask you to think closely about that for a second? The 'sterilizer's purpose' is to eradicate contamination. The very nature of a sterilizer is that it regularly deals with contaminated items. No, we don't do anything to willfully add to that burden of contamination, but in the same sense, we don't go out of our way to avoid it -- why would we? The entire [central sterilization] department is all about processing of soiled, contaminated items. We service a series of equipment which deal with various levels of contamination: from bedpan washers on the wards through instrument and endoscope washers finally to sterilizers. What our personnel bring to this scenario is likely to be a good deal less harmful than the common contamination burden of this department.

Sorry to go on in such detail :eek: but I think it matters: (d) basically asks that we ensure that our 'product' is not contaminated so as to prevent cross-contamination. Again I emphasize that our product for the purposes of this standard is our equipment servicing efforts. I just don't see it that our 'product' in this case can extend to be our personnel. If the good folks at ISO intended for this paragraph of the standard to apply to personnel ... just why did they bother to write (a) which is specifically and clearly geared to personnel?

Wow, I'm so not enjoying working on this standard at this moment! But please forgive my obvious frustration. Still would so appreciate any help anyone can offer so that I can indeed write this up and move forward!
 
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X

XeniAnnoula

#8
A quick thought perhaps to help anyone reading understand why I think the authors of 6.4 had something else in mind:

Try envisioning the factory of a medical device manufacturer who makes a variety of devices among which are some implants -- heart valves let's say. Obviously at least part of the manufacturing process for these valves would have to be done under super-stringent conditions of sterility and perhaps temperature. So, accordingly, there's going to be a place within this factory [c] where these conditions are provided for the manufacture of these valves.

Now read the four paragraphs of section 6.4 with the above scenario in mind. Fits like a glove! Can't send dirty or ill employees in to the special sterile environment / can't let the sterile environment lose its sterility / can't just let any ol' employee wander into this special environment whenever and however they choose / and finally, you can't bring in just any old non-sterile product from another part of the factory because it might dirty the valves, the sterile room, or the clean personnel ...

Like a glove.

But try to fit the same paragraphs to the 'product' which is service? It's like trying to jam the glass slipper on to Cinderella's wicked stepsisters' feet. You can force it to fit -- maybe -- but ...
 
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somashekar

Staff member
Admin
#9
Again I emphasize that our product for the purposes of this standard is our equipment servicing efforts.
One of the output of your product (service) is the serviced medical device.
 
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X

XeniAnnoula

#10
Hi again Somashekar -- thanks for your comment. I don't debate that the output of our 'product' is the serviced medical device, but can you tell me please where you see that as relevant? (I'm sorry, but clearly these very nit-picking conversations are 'doing my head in' a bit!)
 
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