Sterility is a state of being free from viable microorganisms
Medical devices are
produced as per medical device quality requirements are also may have low
number of microorganisms prior to sterilisation .These products are called
nonsterile products.
Products are
sterilized to inactivate the microorganisms to transform nonsterile
products to sterile products. Sterile products are free from viable
microorganisms.
A strategy for sterilization or disinfection of inanimate objects and
surfaces based on the degree of risk involved in their use.
EH Spaulding provided a strategy for sterilization or disinfection
of the device based on their intended use .
|
Classification |
Type of contact |
Sterilization/Disinfection |
|
Critical |
Sterile tissue or the vascular system |
Sterilization |
|
Semi‐critical |
Contact mucous membranes or non‐intact skin |
High‐level disinfection |
|
Non‐critical |
Contact intact skin but not mucous membranes |
Low‐level disinfection |
Medica devices are either
terminally sterilized or aseptic processing
|
S.No |
Terminal sterilization |
Aseptic processing |
|
1 |
it is a condition of a medical device which has been
exposed to a sterilization process in a packaged or assembled form that
maintains the sterility of the medical device or a defined portion thereof. |
Medical device components are sterilized individually
and then assembled in clean room |
|
2 |
Risk of contamination is low because product is
fully sealed |
Risk of contamination is high |
|
3 |
State of sterility for terminally sterilized medical
devices is defined using sterility
assurance level (SAL) of 10−6 or less (e.g. 10−7) .Probability
of there being a viable microorganisms present on/in the device shall be equal
to or less 10−6 |
Difficult to achieve the SAL f 10−6 or
less (e.g. 10−7) as
accidental contamination caused by inadequate technique cannot be reliably
eliminated |
|
4 |
Physical methods: --Steam,dry heat --Radiation Chemical methods: Ethylene oxide, Hydrogen perioxise |
Filtration |
.
References:
https://basicmedicalkey.com/sterilization-in-practice/
BSI whitepaper Sterilization
– Regulatory requirements and supporting standards
