Resterilization of Disposable Medical Devices by a Distributor

[sherley13]

Dear All,

The Disposable devices packed in Tyvek pouch and sterilized by Ethylene Oxide and this device is sterilized original manufacturer. Can distributor do Re-sterilization of this product again. The product is supplied from ASIAN continent and distributed in US counter parts. Please advise

Thank you.

Regards
Sherley13

 

[Ronen E]

No resterilization is to be done unless that exact process has been adequately validated.

Cheers,
Ronen.

 

[planB]

Sherley,

have to concur with Ronen. Sterilization is a manufacturing process and thus, the distributor would become a manufacturer.

FDA is concerned about the growing re-use trend and says:"FDA now requires hospitals and companies that reprocess SUDs to meet the same manufacturing standards used by the original manufacturer. In other words, they will have to ensure that the reprocessed SUD is as safe and as effective as it was when originally manufactured." (from here: https://www.fda.gov/MedicalDevices/...ReprocessingofSingle-UseDevices/ucm121465.htm)

HTH,

Gerhard

 

[blargon]

Absolutely not.

Unless its cost-effective to consider validating a resterilization protocol. Or they want to use the devices as demos / test units and the sterilization doesn't compromise / alter the properties of the devices. Why does the distributor want to resterilize the batches?

 

[sherley13]

Thank you for your response.

If the Disposable sterile device is opened from the pouch and put in the Kit. Does the device require Re-sterilization? .

 

[Ronen E]

Thank you for your response.

If the Disposable sterile device is opened from the pouch and put in the Kit. Does the device require Re-sterilization? .

Yes, if its role in the kit is such that requires it to be delivered in sterile state (assuming of course that the it is put in another sterile barrier). Such a process of repackaging and resterilization post the initial ones would have to be validated.

Cheers,
Ronen.