ISO 13485 production cleaning requirements of reusable devices

D

d.conroy

#1
We are a surgical instrument (class 1) reusable medical device developer/manufacturer.
The instrument is machined in a manufacturing environment, passivated, cleaned and then packed. The device is cleaned and sterilized in the hospital before each use. The cleaning and sterilization process that we instruct the hospital to complete is validated.

From reading iso 13485 I think section b) of 7.5.2 applies to our device but I'm not sure what level of cleanliness we require and the subsequent validation requirements of our factory cleaning process.

My opinion is that the device is cleaned by the user and that the factory cleaning process is not critical.
I could specify a required cleanness level as " free from visual particulate and contamination under x2 magnification". This would mean we could 100% verify the parts and not complete any validation of our factory cleaning process.

Will this be accepted? Any hep?
 
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somashekar

Staff member
Admin
#2
We are a surgical instrument (class 1) reusable medical device developer/manufacturer.
The instrument is machined in a manufacturing environment, passivated, cleaned and then packed. The device is cleaned and sterilized in the hospital before each use. The cleaning and sterilization process that we instruct the hospital to complete is validated.

From reading iso 13485 I think section b) of 7.5.2 applies to our device but I'm not sure what level of cleanliness we require and the subsequent validation requirements of our factory cleaning process.

My opinion is that the device is cleaned by the user and that the factory cleaning process is not critical.
I could specify a required cleanness level as " free from visual particulate and contamination under x2 magnification". This would mean we could 100% verify the parts and not complete any validation of our factory cleaning process.

Will this be accepted? Any hep?
Hi.. This is where you have to apply the risk based approach.
When you say
The cleaning and sterilization process that we instruct the hospital to complete is validated.
.... what was the input cleanliness consideration for the instrument in that validation ? Hope you have it.....
If not.,
There is an other catchy word called "Clinically clean" which you can use to your requirement. Dont look to see for particles, instead work under controlled conditions, someting like your processes are done under a laminar hood, with people wearing suitable PPE and using pure IPA to wipe out and pure N2 blow to dry and then pack.
Establish with such cleaning (Clinically clean) that the suggested sterilization process instructed to hospitals stands valid. Record your inprocess cleaning and continue to use same and maintain.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
Having been in that same situation not so long ago I will also say that you should take the risk based approach.

consider what clean is from the perspective of what the product is contacting throughout the manufacturing process, is any of that harmful, and how do prove that you remove it?

I had an FMEA that listed processing agents throughout the process (lubricants, cleaners, etc) and then did testing on final product to demonstrate that anything harmful has been removed (usually cytotoxicity and endotoxicity tests satisfied our customers - as well as visual inspection for particulate) As I remember we did that testing annually to show nothing changed.

Our products also went through sterility validation but that was a function of design - not manufacturing process.
 
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