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Decontamination of Customer Returned Product - Seeking sample procedure

S

sardonyx

#1
Is there anyone out there that can give me a sample procedure on how to decontaminate a customer returned product. Any sample will do I just want to have an idea on how do you handle this. Or do we need to have a procedure for that? Thanks!
 
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G

Gert Sorensen

#2
What kind of products are you producing? The procedure would be different depending on the product, and the possible contamination.
 
R

RA Princess

#3
Hi everyone

I am puzzling over the same thing at the moment. :confused:

We manufacture long term implantables that come into contact with the central nervous system. Can anyone offer any advice please?
 

SteelMaiden

Super Moderator
Super Moderator
#4
What do you actually do, now? just document what you are doing, along with any improvements to the process you would like to see.

Obviously, you know that you have things to do with returns, so the best thing you can do is document it. None of us are as well versed with your particular product as you are.
 
R

RA Princess

#5
Thanks for the reply. Sorry I should have explained a little better. This is our first product we are looking at taking to market. We are currently implementing ISO 13485 and are looking to CE-Mark for sale in Europe. So unfortunately at the moment we dont do anything. :(
 
R

RobRoy

#6
Not sure If I'm on the right track here, is it a Return Authorisation procedure you are looking for?. If so I have attached one which you can customise.
If on the other hand these "Devices" are contaminated with body or spinal
fluids , then you can't just mail them through the post.In the NHS in the UK
the Trusts have procedures to decontaminate and mark material that needs to be maintained,repaired or returned to the manufacturer and must fill in a decontamination declaration(see attached example).This is all explained in the MDA bulletin DB2003(05) which is also attached.
This alone though is only a small part of your Material Control Process and
won't be much use on its own.If you need to know a specific Sterilisation procedure then contact me.I have a lot of info.


Hope this helps
Roy
 

Attachments

V

victoriab65

#7
For used devices, especially those in contact with central nervous system, you need to be aware of the risk of prions. The WHO Infection Control Guidelines (attached) outline the latest thinking in prion decontamination for surgical instruments. It is also available freely at their website:
http://www.who.int/csr/resources/publications/bse/WHO_CDS_CSR_APH_2000_3/en/

Undiluted bleach for one hour is probably the easiest method, if your device can handle it.

The standard practice followed by med device manufacturers for decontamination of used devices has been glutaraldehyde (e.g. Cidex). Please note that glutaraldehyde (e.g. Cidex) preserves prion infectivity.
 

Attachments

R

RosieA

#8
Why not require that any returned material be cleaned and (if necessary) sterilized prior to being returned? Put the onus on the customer for protecting everyone in the chain!

In a past life I worked for a medical devices company and we put this policy in place after receiving a device back that scared the poop out of our Returns Coordinator. The device is designed to come in contact with blood and tissue during surgery. When we opened the box, there was our device, bloody, along used needles and a half used bottle of Heperin. Obviously it came right from the surgical suite. :mg:

After that we insisted on cleaned and sterilized product. Our Returns Coordinator also was required to get the Hepatitis vaccine.

In my present job, which is as far away as you can get from medical devices, we got some product back from a meat packing plant that had pig hair and guts attached to it. No hesitation on my part: we rejected it back to the customer and required that it be cleaned before we'd touch it. Animals can transmit disease too.

You have to protect your people and everyone in the transportation chain!
 
#9
I am working in a medical device company and we often receive samples for investigation; we face the problem with contaminated products -administration sets- which are coming from the hospitals and sometimes contain blood as they are in direct contact with the patient. The issue here is, who's responsible to clean/decontaminate samples before shipping back for investigation? And what if those samples contain medicine fluids or drags for chemotherapy as well; Transportation companies also deny to carry out these samples containing drugs.

Any feedback on this is more than welcome and thank you in advance,

Kind regards,
Thanos
 
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