Bioburden Requirements on Device used on Unbroken Skin

Q

Quarma

#1
Product: a single use neutral electrode for electrocautery (HF-cutting surgical equipment used to still bleeding and cutting in Operation theater). The electrode is adhesive and is attached to unbroken skin of the patient.
it is used in the operation theater but not in sterile areas.
it is used on unbroken skin.
burns underneath are a "rare" side effect - should not happen

Question:
What cleanlyness requirements would you expect ?
any bioburden requirements ?
do i need to control the environment during production ?


if you have any experience in comparable products i would be glad if you would share them.
 
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A

arios

#2
Re: bioburden requirements on device used on unbroken skin ?

Do you intend to place your product in the market in sterile condition?
 
M

MIREGMGR

#3
Re: bioburden requirements on device used on unbroken skin ?

"Bioburden", per se, is only relevant to a device that is to be sterilized. The bioburden on a non-sterile device is not regulated.

What matters most to a patient contact device is biocompatibility. Every device that has more-than-ephemeral patient contact must have proven biocompatibility. I'd guess that a device that may result in burns at its area of contact may require special biocompatibility qualification.

If your device is provided in sterile form, production-environmental cleanliness is exceedingly important. It is very difficult to consistently achieve sterility and meet applicable standards without a rigorously controlled production environment.

If your device is not provided in sterile form, production-environmental cleanliness is still relevant for two reasons:

1. Any contaminants that are identifiably present in your production environment and therefore might be present on your product must themselves be proven biocompatible, since they may in effect be part of your product.

2. Your product may be detectably contaminated when received by a customer. Medical device users really don't like that.
 
Q

Quarma

#4
will be placed on market non-sterile and is not intended to be sterilized.
Market also includes Europe.
biocompatibility is assured according to ISO 10993
 
V

Vincnet

#5
I agree with MIREGMGR,

and I would add the following :

you need to consider the issue in you Risk Management
and address in your process validation how you ensure that the level of "comtamination" is compatible with the use of the device and how you make sure that this level is kept in the tolerance zone.

After that it is your Post-Marketing Surveillance that should demonstrate that you are ok

V
 
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