Sampling Plan for for Chemical Analysis Testing of Medical Devices

M

mhyczelle

#1
Hi,

I urgently need help. Is there any standard frequency for chemical testing of medical device?

Thank you
 
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Bev D

Heretical Statistician
Staff member
Super Moderator
#2
Welcome to the cove! :bigwave:

It really depends on your regulatory standards and the specific product. Generally there are requirements (stated and/or standard practice) to sample from every lot or batch or if the 'device' is a large instrument then each instrument might be tested. Of course the nature of the test itself also matters as a destruct test would never be 100% of the product and a simple non destruct measurement (such as an automated vision inspection, or a single run of an analyzer) might be 100%.

Can you provide more information on your situation?
 
M

mhyczelle

#3
The product is a dental cleaning powder and this is for 93/42/EEC.
One batch is around 60 tons, currently we are testing chemical analysis 1 bag/per batch only.
Is this sufficient?

Thanks for your reply.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
The product is a dental cleaning powder and this is for 93/42/EEC.
One batch is around 60 tons, currently we are testing chemical analysis 1 bag/per batch only.
Is this sufficient?

Thanks for your reply.
Hi,

From a process control perspective it seems a bit too low to me, but I'd be curious to see what the statistics experts would say. I'd expect at least 3 samples from the batch - somewhere at the start, somewhere in the middle and somewhere towards the end.

From a regulatory perspective, the MDD essential requirements say:

7 Chemical, physical and biological properties

(...)

7.2. The devices must be designed, manufactured and packed in such a way as to minimize the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to the patients, taking account of the intended purpose of the product. Particular attention must be paid to the tissues exposed and to the dura-tion and frequency of exposure.
"Manufactured" includes in-process monitoring & testing.

Since the requirement is quite general, it's up to you to show how your process complies. If there's a vertical standard covering this type of device, it might have something about testing or quality control (this specific area is not my expertise so I don't know if such a standard exists). Either way, you should address the issue in your risk management file (ie what is the risk level imposed by the current sampling / testing practice). At the end of the day it's really down to the details of the device, intended use and the manufacturing process.

Cheers,
Ronen.
 
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