Does anyone have experience with EN ISO 17664 ?

zeypzeyn

Starting to get Involved
#1
To comply with 17664,

Do we need to validate each process (manual/automated cleaning, disinfection, sterilization) individually? Or, is it enough to apply all the cleaning and sterilization processes on IFU and then test for sterility ?

There are not any laboratuary in Turkey that have experience on that. (The market is mainly focused on sterile packaged instruments)

PS: The products are reusable scissors, aspiration tips. etc.

I hope the question is clear. If not, please ask, any help is apprecited :)
 
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planB

Super Moderator
#2
zeypzeyn,

each sub-process requires validation on its own merits (except disinfection if the washer disinfector complies to the ISO 15883 series, capable of achieving an A0 of 3000). There are numerous accredited labs, e.g. in the EU or US, that offer corresponding validation services.

HTH,
 

chris1price

Trusted Information Resource
#3
As HTH says, you need to treat each process separately. In order to validate the sterilisation, you will need to establish a known and consistent level of initial bioburden. To do that, you need to validate the cleaning and/or disinfection first.
 

zeypzeyn

Starting to get Involved
#4
As HTH says, you need to treat each process separately. In order to validate the sterilisation, you will need to establish a known and consistent level of initial bioburden. To do that, you need to validate the cleaning and/or disinfection first.
The problem is, our notified body wants a "used device" to be tested for validation. But how can we take an unsterilised device out of the sterilization unit. There is a risk to someone get infected.
 

zeypzeyn

Starting to get Involved
#5
zeypzeyn,

each sub-process requires validation on its own merits (except disinfection if the washer disinfector complies to the ISO 15883 series, capable of achieving an A0 of 3000). There are numerous accredited labs, e.g. in the EU or US, that offer corresponding validation services.

HTH,
Do you mean we can recommend to use a washer/ disinfector that complies to the ISO 15883 series and omit the automated cleaning validation ?
 

chris1price

Trusted Information Resource
#6
The best sources of information on the subject I have come across are:

AAMI TIR 12 (Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers).
AAMI TIR 30 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices)

These will describe how to contaminate the device in a consistent manner to simulate the Used Device that your NB want.
 

planB

Super Moderator
#7
Do you mean we can recommend to use a washer/ disinfector that complies to the ISO 15883 series and omit the automated cleaning validation ?
No, you _do_ have to validate your labelled (automated) cleaning process. You may omit disinfection validation if the washer / disinfector complies to the ISO 15883 series, capable of achieving an A0 of 3000.
 
#8
zeypzeyn,

each sub-process requires validation on its own merits (except disinfection if the washer disinfector complies to the ISO 15883 series, capable of achieving an A0 of 3000). There are numerous accredited labs, e.g. in the EU or US, that offer corresponding validation services.

HTH,
Hi, could you share some of the information about these labs? I've been looking for labs to do VHP sterilization validation for some time. But it seems there aren't many labs can do the test.
 

monoj mon

Quite Involved in Discussions
#10
Alice,

this (sponsored) article contains the name of one big player in this field, both in terms of equipment and offered (validation) services.

Hope this helps,
On a different note, thank you for providing the link to this article. I was looking for literature to enhance my understanding about sterilization of medical device. This article is helpful with their simplistic approach to explain it.
 
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