ETO Sterilization

Ramanaik

Starting to get Involved
Dear Sir's,

We manufacture a single use ophthalmic medical devices and are packed in primary pack of Tyvek pouch & bulk packing in a carton boxes, sterilized by Ethylene Oxide from us (manufacturer) and labelled as a 'do not resterilize' (Single use). now one of my customer wants to purchase a sterile pack and he wants to put it in to custom kit pack and do the reserialization by ETO for my medical device.

My question is that, the distributor/ customer can do the Re-sterilization of my medical device product again and do the marketing.



Please advise:
Thanks in advance
 

planB

Super Moderator
Ramanaik,

in this case your distributor / customer becomes the manufacturer and takes full liability - if this reprocessing is not banned at all under the respective national law. E.g. in the EU, reprocessing of single use devices is principally allowed only under very tight conditions, but may also be banned by its member states on a national level.

HTH,
 

Ramanaik

Starting to get Involved
Thank you very much.

Since i am labelling my MD is do not re-sterile, so in the above case can we give the declaration on re-sterilization? please guide me . i am struck in between actually to declare.
 

planB

Super Moderator
Ramanaik,

are you in a contractual relationship with your distributor / customer where you agreed to take any liability for the what your distributor/customer intends to do? If no, I would not see any reason for you to declare whatsoever with regards to re-sterilization.

HTH,
 

Ramanaik

Starting to get Involved
Thank you HTH,

There is no contractual relationship,

We are OEM and product will be supply to OBL customer from EU, he wanted a sterile product from us and once again he re-sterilize with kit. so in this case shall i give a declaration for re-sterilization, because as per ISO15223, i will be stating that the my product is do not to re-sterilization, where already the products been supplied to another distributor in EU countries.

Hope i conveyed.
Please advice
 

mboynton

Starting to get Involved
In my opinion, the primary intent of the "do not re-sterilize" symbol on the label is directed at the user, that after having used the device once, not to attempt to re-sterilize/ re-process it, rather than about a business partner performing a second sterilization on the packaged device prior to putting it into use.

Given that the reason the user should not re-sterilize the device may not apply to the business partner (i.e., if there is no feasible way to clean the device after it has been exposed to the patient), it may be acceptable to have the symbol on the label, while simultaneously advising the business partner that it is OK to resterilize the device under their controlled conditions.

I think whether or not you can advise your partner that it is possible to resterilize, though, depends on if you have any data to support that sterilizing an unopened device twice is safe, including with respect to product functionality, packaging integrity, EO residuals, etc. Ultimately, however, it would be the business partner's responsibility to ensure that this is true, because they are the entity performing the second sterilization.

Would the business partner accept non-sterile product from you instead, since they will be sterilizing it anyway? There are provisions governing shipping non-sterile product already labeled as "STERILE" in the context of a business relationship.
 

Ramanaik

Starting to get Involved
Dear mboynton and HTH,

thank very much for advice and wonderful discussion. i got a answerer for my query.
 
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