Deciding if a medical device shall be supplied sterile or not

[RA Lille]

Has anyone got a good rationale, a decision tree or a list of questions that could be used to help DnD engineers to decide if a medical device shall be supplied sterile or not ?
I'm aware of the Spaulding classification, but it's more applied for retreating/reuse of MD.
Here the point is, as a manufacturer how could we decide that a MD shall be sterilized or not ?

lots of factors play an essential role : impact of the method of sterilization (discoloration, temperature,...) impact of the manufacturing flow (environment or not), compatbility of materials…

For example, a gastroscope should be disinfected before being used on a patient. But shall a single used device used in the digestive tract be sterile ? it will be in contact with food and so on… so, physicians say, give it non sterile… the point is, is there any constructive justification of this ? how could I incorporate such rationale in a technical file ? in a sterilization procedure (let's say "choose of sterilization" procedure) that would be defended in a microbiological audit ?

I'm sure I'm clear,
any idea/info is welcome,
thanks !

 

[J0anne]

I wouldn't ask a physician and I wouldn't want a non-sterile gastroscope anywhere near me, would you?

This will be determined in your risk assessment.

You can market it non-sterile, but you'll still have to validate the sterilisation/cleaning method so that you can tell the user how to sterilise/clean it safely before use and to ensure the sterilisation/cleaning method doesn't impact the device's safety and efficacy.

When you say it's single use, is it going to be used once and discarded?

Or will it be reused?

Reuse and resterilisation/cleaning also has to be validated to determine how many times it can be reused safety and effectively.

 

[RA Lille]

dear J0anne,

thanks for your answer.
You know, most of gastroscopes used in endoscopy are not sterile, they're disinfected… not sterilized… anyway, it's not the point.

I was initially wondering whether there is any simple decision tree or questions (as part of a risk assessment) that could be used to discuss and debate with RnD engineers. Something to help them to decide if the device should be sterile or not, if it should be sterilized prior use or simply disinfected… .

single use is single use, i.e. used then discarded.
reuse means reprocessing.

Even if the debate about reuse/reprocessing (means cleaning + disinfection or cleaning+disinfection + sterilization) is really interesting, the point of my wondering came earlier : how could an engineer decide or choose if the device he is designing shall be single used, sterile or not, reusable or not. I'm microbiologist and QA/RA, I'm not the engineer… i'm looking for Tools to help risk assessment during RnD process.

 

[somashekar]

Just throwing in my hat .... If the device is going to come in contact with blood (Vascular system), then the risk of infection leads you to think sterilization. Otherwise as you mentioned about gastroscopes, they are cleaned and disinfected following a laid out method. (Clinically clean)
You must also look at the pyrogen levels apart from sterilization in your risk assessment.

 

[RA Lille]

Dear Somashekar,
i agree with you, when you're QA or microbiologist or both, you could easily think about infection risks.
Indeed, pyrogen levels should also looked at.
I'm looking for something more systematic, as a list of questions or a list of imputs that mechanical engineers could use to check if they'd thought at all risks to define the status of the device they're designing, and also the choice of the method of sterilization (if needed) they could use…

a bit as
which tissues will your device be in contact with ? blood, mucuous tissue, bone, skin….
is your device entering into the body ?

Is your device resistant to high temperature (>120°C) Yes/ No. if Yes, is it resistant to pressure ?
Could your device be discolored ?
is your device containing lots of tubes, inner parts…
does your device contain ambient air ?

I'm looking to draw up a kind of systematic review of risks and sterilization issues to help engineers to manage the risks at the beginning, from the conception.

 

[J0anne]

I understand. My personal preference would be for it to be supplied for use as sterile.

As for tools, the best tool you have is your risk management procedure.