Bioburden Testing requirements for Non-Sterile Dental Products

F

fishtruk

#1
Hello,
We make consumables for dental use. Our product is put in the mouth for one to approx. 20 days. Our previous auditing co. in Europe did not require bioburden testing. they "went out of business" and our new auditing company requires bioburden testing.
this company is very bad in working with us to make the process easier. We will be changing from this to another company soon.

My question is, we're setting up bioburden testing and how can we know if "the rules are going to change" next week? ie, frequency of testing etc. Bioburden testing is not cheap and we need to know the rules to plan for the future, too simple, right?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
they "went out of business" and our new auditing company requires bioburden testing.
this company is very bad in working with us to make the process easier.
I'm assuming you are referring to Notified Bodies. Your previous NB probably didn't "go out of business" per se, but rather either its notification was withdrawn because it wasn't up to the required standard, or it got out of this business voluntarily because it realised it can't keep up with the required standard and stay profitable at the same time. There have been known cases where "easy going" NBs went "out of business" in this manner, in the last few years, as the Competent Authorities have been trying to raise the bar (and not without some reasons).

Your current NB is not "making the process easier" - perhaps they're simply doing their job, as originally meant to be. Given the current trend, I'm not sure you will easily find another NB that will be "very good at making the process easier" for you.

The MDD ER 8.1 says:
The devices and manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patient, user and third parties.
(Manufacturing processes include in process monitoring and controls)

There are no specific bioburden testing requirements, but unless you can confidently establish that you can "eliminate or reduce as far as possible the risk of infection to the patient" without sterilization and bioburden testing, I think the NB's requirement is not out of place.

My question is, we're setting up bioburden testing and how can we know if "the rules are going to change" next week? ie, frequency of testing etc. Bioburden testing is not cheap and we need to know the rules to plan for the future, too simple, right?
The rules won't "change next week" because there are no hard and fast rules spelled out in the regulations. It is your job to establish and rationalise your testing regime. Bioburden testing is about control over your production environment and process and about stability. I would recommend testing every batch for the first 3 to 6 months (depends on how many batches you make during that period), then start to relax (every other batch, once a month, once every 3 months etc.) based on good results and a stable trend. Thereafter you need to monitor bioburden at a frequency deemed sufficient to alert you if anything starts to deteriorate (eg 1, 2, 4 times a year, depending on the specifics).

Don't forget that bioburden is not only about the numbers of CFU found, but also about their types.

You may further consult EN ISO 11737.
 
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F

fishtruk

#3
The MDD ER 8.1 says:

Quote:
The devices and manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patient, user and third parties.

Do you see any nebulosity in this? The word "possible" is the hinge. It is quite possible to eliminate the risks. The only question is how much money will be wasted in efforts to sterilize products which do not need such treatment. eg, toothbrush, toothpick, floss, etc. I am only speaking of the quote above here.
I take this to mean that as far as possible is necessarily limited by the cost/criticality of the product in question.

The "NB" in our case is flying by the seat of their pants. Perhaps the regulations they, and we are using are as poetic as any religious tome and thus subject to interpretation - a protocol I see having no place in healthcare.

Sorry, thanks for your reply, just venting. Regulations are a good thing if done fairly, with no ulterior motivation, and with no room for interpretation.
 
F

fishtruk

#4
I suppose the problem is that the NB must be liable in an unfortunate event? I would hope this is so since different NB's have different interpretations.

Templates accessible by manufacturers for regulation are absent from this arena, we have searched. How else can we interpret this as providing steady work for some? Laws must be stated before they can be followed or ignored.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
It is quite possible to eliminate the risks. The only question is how much money will be wasted in efforts to sterilize products which do not need such treatment.
You are correct, the goal is to eliminate risks. I didn't say anything about sterilization (and as much as I understood from you, neither did your current NB). It is up to you to determine and rationalise the way in which you eliminate the risk. If you can do it through a rationalised bioburden programme, that's good. It seems that this is your current NB's thinking. If you can otherwise do it in a solid way without bioburden testing - even better.

I take this to mean that as far as possible is necessarily limited by the cost/criticality of the product in question.
This has been debated thoroughly during the last 5 years (at least), and unfortunately what you express above is not currently a widely accepted thinking among regulating authorities.

Perhaps the regulations they, and we are using are as poetic as any religious tome and thus subject to interpretation [...] Regulations are a good thing if done fairly, with no ulterior motivation, and with no room for interpretation.
Unfortunately, this is not how it really works. Regulations can't practically be detailed enough and prescriptive enough to cover all existing and future devices and all possible situations, therefore they are typically generic in nature and are subject to interpretation. Fortunately enough, some of the issues are recurring and thus already have been thoroughly debated with the results captured in published standards, official and semi-official guidance documents and the like.

I suppose the problem is that the NB must be liable in an unfortunate event?
Yes: PIP breast implants: French court tells TUV to pay damages - BBC News

Templates accessible by manufacturers for regulation are absent from this arena, we have searched. How else can we interpret this as providing steady work for some? Laws must be stated before they can be followed or ignored.
I completely lost you here. The regulations are available to all online and free of charge; likewise a lot of official and semi-official guidance, where the regulatory authorities and NBs state what they deem the "laws" to be.
 
F

fishtruk

#6
In Reply to Parent Post by fishtruk https://elsmar.com/Forums/eu-medical-device-regulations/70849-bioburden-testing-requirements-sterile-dental-products-post597604.html#post597604

Templates accessible by manufacturers for regulation are absent from this arena, we have searched. How else can we interpret this as providing steady work for some? Laws must be stated before they can be followed or ignored.
I completely lost you here. The regulations are available to all online and free of charge; likewise a lot of official and semi-official guidance, where the regulatory authorities and NBs state what they deem the "laws" to be.
Sorry I was not more clear. As I work in a support capacity here regarding this discussion, those who are doing the actual compliance here lament frequently the total lack of templates showing examples for different industries, of acceptable forms for fulfilling various agency's required compliance. For example... company X makes widgets which are class 2 med. dev. and click here to download the compliant forms they would use, etc.

Another issue is "critical" suppliers and unannounced audits. Our suppliers have been reticent in doing this, not covering anything up, but just the possibility that they could conceivably be deluged by these audits, by surprise. I imagine our suppliers think that, "we've got 35 customers. What happens during an audit? One or more people have to use their day for this purpose. Our suppliers looked into it, considered it, and they have respectfully declined since they haven't people to wait for an audit. Now we have to relieve them of the "critical" status by finding other sources for raw materials. Not impossible, but let's say the price would make our products too expensive? We would thus have to drop these products since negative profits die fast. Can we say a supplier is not critical because we will stop selling a product if the source of materials goes away?
 
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Ronen E

Problem Solver
Staff member
Moderator
#7
For example... company X makes widgets which are class 2 med. dev. and click here to download the compliant forms they would use, etc.
As explained, it doesn't work this way - the variety of devices and situations is too vast to cover in detail. Wherever practicable NBs and other involved bodies do provide some (generic) templates, though I agree it doesn't normally cover the majority of documentation / requirements. Some other resources are available online*, either free of charge or not, and the rest your org has to complete on its own.

*) Some even at Elsmar - check the "Post Attachment Files" tab at the top of this page; you are also always welcome to ask for something you need, though there's no guarantee you'll get it.

Another issue is "critical" suppliers and unannounced audits. Our suppliers have been reticent in doing this, not covering anything up, but just the possibility that they could conceivably be deluged by these audits, by surprise. I imagine our suppliers think that, "we've got 35 customers. What happens during an audit? One or more people have to use their day for this purpose. Our suppliers looked into it, considered it, and they have respectfully declined since they haven't people to wait for an audit. Now we have to relieve them of the "critical" status by finding other sources for raw materials. Not impossible, but let's say the price would make our products too expensive? We would thus have to drop these products since negative profits die fast. Can we say a supplier is not critical because we will stop selling a product if the source of materials goes away?
This is a little :topic: for this thread.

There have been other threads at Elsmar discussing those issues, including "criticality" of suppliers, unannounced audits and the lack of cooperation on supplier's part. I recommend you run a search in Elsmar ("Search Forum Discussions" tab at this page's top), using some relevant keywords, and read through those threads. If you still can't find meaningful answers, you're very welcome to start a new thread with the question(s) you will still have unanswered.

Cheers,
Ronen (member of the moderators team).
 
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