ISO 13485 justification for design and development exclusion for medical packaging

Swimming In The Soup

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#11
Assuming you are in the U.S. under FDA jurisdiction, this article may support your claim.

CPG Sec. 300.100 Inspection of Manufacturers of Device Components

What gives me pause are the components designed and exclusively supplied to a MD manufacturer as they could be considered a component of the device if primary packaging. Still, my understanding is that the medical device manufacturer is responsible for the suppliers quality as described in 7.4 and 7.5 of the standard. The attached powerpoint will give a sense of the requirements your customers need to comply to. Their requirements will likely influence your requirements if you want them as customers.

To target the question specifically, my understanding is that you can exclude (with justification) things from the scope of the 13485 certification and the exclusions would be listed on the cert. If your product is involved in a law suit, you would likely wish you included it.
 

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#12
Good call, I see the sterile barrier being a direct correlation to prevention of disease. We also validate for possible cross-contamination from packaging materials to any contained medical device. This too can be a prevention of disease.
 

Billy Milly

Involved In Discussions
#13
I see the debate became very fuitful.

FWIW, I checked the QM from one of our suppliers that I have access to. They supply us the packaging - films and pouches. Exclusions are installation, servicing, sterilization, sterilization and packaging validation, implantables. R&D is not excluded.

As others already pointed out, inclusion or exclusion for this specific case depends on the design owner. So it is possible to exclude R&D, but you will be less interesting for customers looking for a "development supplier".
 

Zero_yield

No cost too great...for Quality
#15
I disagree with the evaluation that a sterile barrier system is a product to "prevent disease." By that logic, is a set of matches or a Zippo lighter a medical device? In a pinch, they can be used to build fire to boil water, which prevents disease. However, no one buys a set of matches because they expect that the matches will provide some sort of therapeutic benefit to the user.

Similarly, no one claims that sterile barrier systems inherently have a curative effect, diagnose disease, improve the immune system, etc. Nobody's doctor is prescribing them 3 pouches a day. There aren't a bunch of empty pouches in a first aid kit or in an OR. Intended use is a critical step in determining whether something is a medical device.
 
#16
I disagree with the evaluation that a sterile barrier system is a product to "prevent disease." By that logic, is a set of matches or a Zippo lighter a medical device? In a pinch, they can be used to build fire to boil water, which prevents disease. However, no one buys a set of matches because they expect that the matches will provide some sort of therapeutic benefit to the user.

Similarly, no one claims that sterile barrier systems inherently have a curative effect, diagnose disease, improve the immune system, etc. Nobody's doctor is prescribing them 3 pouches a day. There aren't a bunch of empty pouches in a first aid kit or in an OR. Intended use is a critical step in determining whether something is a medical device.
Thank you for your opinion. I’m hoping to find references that I can use during an audit to support our position once we decide the path we will take.
 

Zero_yield

No cost too great...for Quality
#17

Zero_yield

No cost too great...for Quality
#18
I disagree with the evaluation that a sterile barrier system is a product to "prevent disease." By that logic, is a set of matches or a Zippo lighter a medical device? In a pinch, they can be used to build fire to boil water, which prevents disease. However, no one buys a set of matches because they expect that the matches will provide some sort of therapeutic benefit to the user.

Similarly, no one claims that sterile barrier systems inherently have a curative effect, diagnose disease, improve the immune system, etc. Nobody's doctor is prescribing them 3 pouches a day. There aren't a bunch of empty pouches in a first aid kit or in an OR. Intended use is a critical step in determining whether something is a medical device.
I'm also going to eat crow here and say that after doing a little more digging, I can say that some pouches are indeed used in hospitals and are medical devices. Not all pouches used for medical devices are medical devices themselves, but pouches can be medical devices when marketed as such.
 

EmiliaBedelia

Involved In Discussions
#19
Packaging on its own is most likely not a medical device at all. If you are only selling to manufacturers to use in packaging a sterile product, it is a component of those devices. As indicated above, the only way it would be a device is if you market the product as a standalone device that has its own intended use/medical purpose.

I'm not entirely clear, is your company compliant to ISO 13485 and trying to justify what clauses are relevant, or not compliant and wondering if you should be? Even if you decide you are not required to be compliant I think it is wise to understand the role that the packaging would have as part of a medical device, and recognize what controls a manufacturer would need in place, to understand what you would need to do as a supplier.

From my POV as a manufacturer of a sterile device, I need the package to:
1) last the lifetime of the device
2) be compatible with my desired sterilization method
3) not leave residues or particulates on my device
4) be physically rigorous enough to contain and protect the device before use
5) withstand transit/handling/storage
6) maintain sterility
7) be open-able by my intended user in the intended context
8) work within my intended packaging/manufacturing process
9) be reliable enough to produce an acceptable quality rate in manufacturing
10) ...whatever other requirements you can think of

All of this is determined in relation to my device's intended use.
I need to document these requirements within my documentation and provide evidence that the product that I choose will fulfill those requirements. If my supplier cannot sufficiently provide evidence that their packaging meets my requirements, I will not choose that supplier, because I will be on the hook if my device fails because of that packaging. I as the manufacturer are responsible for defining my requirements based on my device's intended use. You as the supplier are responsible for ensuring that the product you provide meets the specifications that it is claimed to.

If you ARE ISO 13485 certified, I would think you need some level of documentation to demonstrate that your product is designed to a certain specification and manufactured to consistently meet that specification. Where you would not be responsible is how those requirements relate to the patient's intended use, and the validation/surveillance that the device meets safety and performance requirements.
 
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