What criteria decides Sterilization of a Medical Device?

somashekar

Staff member
Super Moderator
#1
What are the criterias that one has to consider to decide sterilization as a design and development input requirement for a medical device ... ?
 
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pkost

Trusted Information Resource
#2
Re: What criteria decides sterilization of a medical device ?

Do you mean a decision as to whether a device should be terminally sterile? or whether it just needs to be sterilisable by the end user? or do you mean the sterilisation process to use?

A device needs to be sterilised if it's use in a non sterile form could cause infection in the patient. Therefore all implantables and invasive devices need to be sterile. Additionally devices which contact open wounds need to be sterile. I believe there is some debate with endoscopes as to whether they need to be sterile or just decontaminated - I seem to remember a discussion about that on this forum - there was some FDA guidance or something.

With regards to terminally sterilising a device there are no specific requirements to do this as far as I am aware other than market demands. Obviously with reusable devices there is not much point in providing them terminally sterilised. Implants are another matter, there is an increasing trend for single use devices, especially implants, to be provided in a sterile form.

With regards to the type of sterilisation - EtO, gamma, e-beam, steam etc, this is entirely dependant on the device and the effect each process would have on them
 

somashekar

Staff member
Super Moderator
#3
Re: What criteria decides sterilization of a medical device ?

Do you mean a decision as to whether a device should be terminally sterile? or whether it just needs to be sterilisable by the end user? or do you mean the sterilisation process to use?

A device needs to be sterilised if it's use in a non sterile form could cause infection in the patient. Therefore all implantables and invasive devices need to be sterile. Additionally devices which contact open wounds need to be sterile. I believe there is some debate with endoscopes as to whether they need to be sterile or just decontaminated - I seem to remember a discussion about that on this forum - there was some FDA guidance or something.

With regards to terminally sterilising a device there are no specific requirements to do this as far as I am aware other than market demands. Obviously with reusable devices there is not much point in providing them terminally sterilised. Implants are another matter, there is an increasing trend for single use devices, especially implants, to be provided in a sterile form.

With regards to the type of sterilisation - EtO, gamma, e-beam, steam etc, this is entirely dependant on the device and the effect each process would have on them
A device needs to be sterilised if it's use in a non sterile form could cause infection in the patient. Therefore all implantables and invasive devices need to be sterile.
While I agree with the first statement., where does this in bold above come from ?
Can I say that an invasive device through a natural body orifice not getting into direct contact with the circulatory system could be Clinically clean and need not be sterilized as an input requirement at my design stage ?
 
Last edited:

pkost

Trusted Information Resource
#4
Re: What criteria decides sterilization of a medical device ?

Sorry, perhaps I was letting my own bias get in the way with a bit of over-exuberance.... You may want to look at http://elsmar.com/Forums/archive/index.php/t-48610.html which discusses hospital sterilisation and the spaulding classification.

As far as I'm aware there are no direct requirements for any device to be sterile, it is a risk based decision on the part of the manufacturer.
 
M

MIREGMGR

#5
Re: What criteria decides sterilization of a medical device ?

Can I say that an invasive device through a natural body orifice not getting into direct contact with the circulatory system could be Clinically clean and need not be sterilized as an input requirement at my design stage ?
If your product were a tongue depressor, or a menstrual supply, or various dental items, yes you could.
 

Michael Malis

Quite Involved in Discussions
#8
Re: What criteria decides sterilization of a medical device ?

While I agree with the first statement., where does this in bold above come from ?
Can I say that an invasive device through a natural body orifice not getting into direct contact with the circulatory system could be Clinically clean and need not be sterilized as an input requirement at my design stage ?


Somashekar,

We can't just decide from design process that invasive device could be just clean...
Sterilization is the only process that eliminates all forms of microbial life!

How can you do this with "just clean device"? What did you do to eliminate all forms of microbial life without sterilization?
Please provide any example of non-sterile invasive device by your definition, because menstrual supply is not an invasive product.

Regards,
Michael
 
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