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Qualification of sterilization indicators as medical devices with the EU MDR 2017/745

xcanals_tecno-med.es

Involved In Discussions
#1
Dear all
as you know the EU definition of medical device is changed in the MDR 2017/745 and include now "products specifically intended for the cleaning, disinfection or sterilization of devices" as for example sterilizers.
As indicated in the last version of the MANUAL ON BORDERLINE AND CLASSIFICATION version 1.22 (05-2019) for the MDD "these do not fulfil teh definition of medical device or accesory".
Do you think that now does not fulfil the definition of accessory of a STERILIZER ?
‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);
I see that no manufacturers are until now commercializating sterilization controls as BI, BowieDick, ... with CE mark, are all waiting the application date 26 may 2020?
 
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Jane_S

Starting to get Involved
#2
Well I wouldn't say the BI's are intended for cleaning or sterilising a device, but to control the process, which is different, BIs don't ensure the sterility/cleanliness of the product by themselves. I am more concerned about the manufacturers of sterilisation chambers, as I got a chance to speak with QM from one and they were completely oblivious to this change.

There are additional controls possible (excluding) BIs. But the manufacturers of sterilisation chambers are a real concern.
 

xcanals_tecno-med.es

Involved In Discussions
#4
Which entry are you looking at in the Manual?
The manual is https://ec.europa.eu/docsroom/documents/35582/attachments/1/translations/en/renditions/native and is related to MDD
and the entry
"...
7.4. Sterilization indicators
- Background
The sterilization procedure is monitored routinely by using chemical and biological indicators to evaluate the sterilizing conditions and indirectly the microbiologic status of the processed items.
- Outcome
Sterilization indicators monitor the performance of the sterilizer. They do not affect the sterilization procedure and only provide additional information to the user. Sterilization indicators do not fulfil either the definition of a medical device laid down in Article 1(2)a of Directive 93/42/EEC or the definition of an accessory laid down in Article 1(2)b of Directive 93/42/EEC as they are not intended specifically to be used together with a device to enable it to be used in accordance with its stated use.
..."
AS THE STERILIZER IS A MEDICAL DEVICE ACCORDING THE MDR DEFINITION, THE LAST SENTENCE UPDATED TO MDR WILL BE :
"...
- Outcome
Sterilization indicators monitor the performance of the sterilizer. They do not affect the sterilization procedure and only provide additional information to the user. Sterilization indicators do not fulfil the definition of a medical device laid down in Article 2(1) of MDR but they fulfill the definition of an accessory laid down in Article 2(2) of MDR as they are intended specifically to be used together with a device (the sterilizer) to enable it to be used in accordance with its stated use.
.."

Regards
Xavier Canals
 

pkost

Trusted Information Resource
#5
I disagree that the indicator enables the steriliser to be used in accordance with it's stated use - the lack of indicator does not affect the sterilisation and it is not intended to be used to to demonstrate that sterilisation has been successful to the user of the steriliser (other methods are used for this e.g. temperature, dose, duration etc).

The indicator should only be used to show that the item has gone through the process, not that it is sterile and that the process was effective.
 

dgrainger

Trusted Information Resource
#6
The Borderline entries apply specifically to the MDD/IVDMDD. You can't assume that they will apply to the MDR/IVDMDR.
However, the definition of accessory has changed. The manufacturer of the steriliser would have to identify the sterilization indicator as an accessory in the IFU/technical file though!
 
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