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Bioburden monitoring for surgical instrument provided non-sterile

#1
Hi all,

Is bioburden monitoring required for a single use surgical instrument that is provided non-sterile? The instrument is processed at the hospital before being used during surgery. This means that the instruments is cleaned and steam sterilized at the hospital according to the instructions in the instructions for use (IFU).

The steam sterilization cycle mentioned in the IFU was validated using the overkill method described in annex D of ISO 17665-1. This standard mentions that this method should be used when "the challenge to the sterilization process is difficult to define and pre-sterilization treatments (such as cleaning) are difficult to validate and control". As the bioburden on the device before sterilization is mainly depended on the cleaning/handling at the hospital, this seems appropriate. Annex D of ISO 17665-1 also does not mention that ongoing monitoring is required, while it does mention this explicitly when another method (the one of Annex B) is used.

Are we now required to perform bioburden monitoring on the surgical instrument before they are being shipped to the customer? In case of yes, can you point me to the applicable regulation or standard that is requiring this? Also in case of yes, is an acceptance criterion of <10^6 CFU/device appropriate as the overkill method used this amount of spores?

In my opinion this makes little sense to perform this monitoring as there is limited relation between the bioburden level at the time of shipment at our facilities and the level before sterilization at the hospital, but maybe I am forgetting something?

KR
 
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indubioush

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#2
ISO 13485:2016:
7.5.2 Cleanliness of product
The organization shall document requirements for cleanliness of product or contamination control of product if:

b) product is supplied non-sterile and is to be subjected to a cleaning process prior to sterilization or its use;
 

planB

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#3
BioCPS,

no, you are typically not required to monitor the bioburden of your surgical tool prior to shipping in case you label a pretty standard (i.e. commonly used) cleaning, disinfection and sterilisation process. Make sure that the protective packaging used for your shipping configuration protects the device from excessive soiling.

HTH,

Gerhard
 
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