Component Lot Number Traceability - Class I reusable and "resposable" Medical Devices

#1
Hello All,

I work at a start up company that is working on trying to streamline our processes. One thing that seems to take a lot of time is the recording of lot numbers on our Class I reusable and "resposable" devices. Is there a requirement that ALL these lot numbers be recorded for all components that make up the instrument (one has 17 tiny components) or can this be based on risk (example: only the parts that have human contact)?

I understand that if one of the components fails that we do not have traceability on, we would have to recall the whole instrument line which is a business decision. But besides the business aspect, are there any quality requirements that say that I must trace all components?
:thanx:
 
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normzone

Trusted Information Resource
#2
Re: Component Lot Number Traceability

Funny you should bring this up. I'm beginning to see more customers requiring seven year traceability of COTS components in their Terms and Conditions - I'm assuming it's all driven by the counterfeits concerns.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: Component Lot Number Traceability

Hello All,

I work at a start up company that is working on trying to streamline our processes. One thing that seems to take a lot of time is the recording of lot numbers on our Class I reusable and "resposable" devices. Is there a requirement that ALL these lot numbers be recorded for all components that make up the instrument (one has 17 tiny components) or can this be based on risk (example: only the parts that have human contact)?

I understand that if one of the components fails that we do not have traceability on, we would have to recall the whole instrument line which is a business decision. But besides the business aspect, are there any quality requirements that say that I must trace all components?
:thanx:
Hello and welcome to (posting on) the Cove :bigwave:

I'm not aware of such a regulatory requirement for class 1 devices (BTW, I didn't understand what you meant by "resposable").

IMO it comes down to managing the risks, both clinical and business.

Cheers,
Ronen.
 
M

MIREGMGR

#4
Re: Component Lot Number Traceability - Class I reusable and "resposable" Medical Dev

I hate the term "resposable". I regard it as a shirking of the responsibility of the device maker to define how the device is to be safely and effectively used throughout its lifecycle.

I don't think there are any devices that are equally suited to be single-use disposed, or reprocessed and re-used. That is not a decision that the end user should make. Thus there are no devices for which the word "resposable" properly would apply.

If my device is single use because of its inherent nature, i.e. it's been engineering to be safe and effective once and to have minimum first cost instead of to be reprocessable, I'm going to say so on the labeling. If someone downstream from me chooses to reprocess it anyway, I'm not going to share the responsibility for their bad decision by describing the product as "resposable".

If on the other hand the device was engineered to be reprocessed, then it should be labeled as such.

Beyond that, it's always dumb to use a recently coined word in labeling and marketing communications that doesn't translate readily and may be misunderstood by users, particularly those for whom English isn't a first language.
 
V

Vthouta

#5
Re: Component Lot Number Traceability - Class I reusable and "resposable" Medical Dev

Now-a-days, medical OEM's are pushing to have Component Lot Number Traceability level 1 traceability. This is partly due to counterfeit issues and it will help to save lot of time during product recall and for medical customer when they have field failures. It is been used most extensively for field failures to know what exactly happened at that point of time and helps in deducing root causes effectively.

Having component lot number traceability helps in long run.
 
M

MIREGMGR

#6
Re: Component Lot Number Traceability - Class I reusable and "resposable" Medical Dev

I agree with Ronen:

...are there any quality requirements that say that I must trace all components?
Substituting "US, Canada or EU regulatory" for "quality" in the question:

No.
 
#7
Re: Component Lot Number Traceability - Class I reusable and "resposable" Medical Dev

Thank you all for your helpful comments. Being a small business, we are trying to get our time that it takes us to kit product down so knowing these requirements helps.

Now my question is for sterile product. From a business stand point, it doesn't make any sense to not track the lot numbers of the sterile pouches that are used for the product and components like that. But is there any FDA, EU or Canadian requirement that requires you to have FULL component lot traceability for Class Is/II products (EU classification), Class I/II products (FDA) and Class II (HC classification).
 

phoenix2368

Starting to get Involved
#8
Re: Component Lot Number Traceability - Class I reusable and "resposable" Medical Dev

Regarding Resposable, I wonder how even one can even record a lot number, unless your company issue a new lot number to the useable items it is buying from the different sources and allocating some specific lot number per source and it is assumed that the device's previous record archived or retained with the source.
When you guys get these devices , do you also collect the manufacturing, purchasing, previous inspection, testing & receiving records too, If you do then you have to use the original lot # which was generated by the manufacturer but if you are sourcing it (e.g. previously used item from a hospital) and not getting any records , the hospital would be considered as the primary source and as you reprocessed these, you would be considered a manufacturer.
In this case you should allocate a lot # which you can trace to your primary source (i.e. The Hospital) and the burden of proof for previous Device History records is on the Hospital. In case the device cause some injury or fails during a critical procedure , it can be tracked and traced back to Hospital.
As now reprocessed market is gaining momentum, companies are forced to keep records for 15-30 years ( I recently got emails and record retention requests from some of the major companies in US)
If you can explain which instrument it is , may be i can be more helpful too, Is it Brook Walter Universal Retractor System?
 
#9
Re: Component Lot Number Traceability - Class I reusable and "resposable" Medical Dev

So for my company, our "resposable" line is a line that we say the customer can use about 50 times and then it will need to be thrown out. We give the account a special tray we suggest they autoclave the instrument in so that the integrity is kept as well as a special tip protector.

We etch all of these instruments with a serial number so that we are able to keep track of how long these instruments have been at the account.

This is not a retractor system, it is a microsurgical instrument.

Please see my post about sterile product lot number traceability. Thanks.

MIREGMGR, thank you for your input on "resposable." We make sure that the proper training is done for our international distributors and do our best to make sure that the account takes care of the instruments to get the most uses out of them. I'm sorry that you feel that this is a "cop out."
 
M

MIREGMGR

#10
Re: Component Lot Number Traceability - Class I reusable and "resposable" Medical Dev

I'm not criticizing your device's intended use and post-use handling. I'm sure your distribution and marketing is appropriate for safety and effectiveness. My critique was because the neologism "resposable" can easily be misunderstood to have a meaning other than the one you intend. Every previous use of the word I've seen has had a different meaning than how you use it.

The mere fact of the need for this discussion to clarify what you mean by the word, i.e. a device that may be reprocessed about fifty times and then is to be disposed, seems to me to be indicative that there may be potential for a problem...especially for global labeling.

The term I'd prefer to see for a device of the same intended use as yours is "up to fifty cycle reprocessable". I think everyone in the medical device user community likely would have the same understanding of that term, in English or as translated.
 
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