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Using Suture materials after their expiry date

A

Ahmed Morgan

#1
Dear All,

I was advised by a manufacturer we deal with at our company ( A surgical suture manufacturer) that we can use an Expired Absorbable suture reel & use it normally despite the fact that it passed it's expiry date.

Personally, I wasn't able to comprehend the manufacturer's recommendation, but i'm requested to build a case for my Quality director whether to use it or not.

I was hoping you can help me as I'm a bit new to the medical devices manufacturing sector...

Can you tell me the reference(s) that mentions the use of the Raw materials? & whether what was recommended by manufacturer is correct or not?

Thank you very much in advance :)
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello Ahmed and welcome to the Cove :bigwave:

I am not aware of any regulation or guidance allowing that.

To extend the shelf life the manufacturer would have had to validate the extension, then relabel the specific unit. Otherwise, you might be liable for using an expired ingredient. Do you have an official letter from the manufacturer stating that expiry has been extended (to another date, I presume)?

Cheers,
Ronen.
 
Last edited:

Statistical Steven

Statistician
Staff member
Super Moderator
#3
What is not clear is what is the additional processing you are doing with the suture material. The suture reel is a raw material, like any expired raw material that has expired, if you used it, it would require a deviation. Upon the proper risk analysis, can it be used with low risk to the patient? For example, since it's an absorbable material, you could do tensile strength or in-vivo testing to show that the product still have sufficient strength for the intended purpose (which might be lower than the suture requirement as a suture). It's all about the intended use of the material in your device. But with a justification and risk analysis it can be done.


Dear All,

I was advised by a manufacturer we deal with at our company ( A surgical suture manufacturer) that we can use an Expired Absorbable suture reel & use it normally despite the fact that it passed it's expiry date.

Personally, I wasn't able to comprehend the manufacturer's recommendation, but i'm requested to build a case for my Quality director whether to use it or not.

I was hoping you can help me as I'm a bit new to the medical devices manufacturing sector...

Can you tell me the reference(s) that mentions the use of the Raw materials? & whether what was recommended by manufacturer is correct or not?

Thank you very much in advance :)
 
A

Ahmed Morgan

#4
Hi Ronen... Thank you very much :)

I contacted the manufacturer via e-mail & they replied back via an e-mil as well. But when i requested any supporting documents they told me they have none.
 
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