Medical devices sterilization validation is a basic requirement for intrusive sterile medical products such as reusable surgical implants as well as implants.
There are several methods of sterilization, and among them, the most commonly used methods are irradiation, heat, radiation, steam, and also ethylene oxide. Predetermined protocols are followed and there is a lot of focus on disinfection while following the procedures of proper sterilization.
All the bacteria, microbes such as bacteria or any other disease-causing microorganisms are removed or destroyed when the proper medical device sterilization methods are used. The method chosen for sterilizing will depend on the type of material with which the device has been made, the classification of the device, the availability of each sterilization method, and also the number of potential microorganisms that are involved.
Before sterilizing any instrument or device, it has to be cleaned properly. All the dirt, oil, or any other substance that could shield or block any kind of hidden microorganisms is removed by cleaning the medical equipment before sterilizing. When you make proper storage of sterilized equipment, it minimizes the chances of the device to become contaminated from moisture, dust, or any such factors after the device has been sterilized.
Sterilization through Steam
An autoclave is used to perform sterilization through heat and steam. It is a similar process to a pressure cooker where we make use of high-temperature steam to destroy all the microorganisms inside. This process takes nearly 15-60 minutes.
Sterilization through Chemical
For chemical sterilization, chemicals such as ethylene oxide are used. This process is usually undertaken for those devices that cannot be autoclaved. The objects have to be soaked in the solution for undertaking this sterilization method. This process can even take days for completion.
Sterilization through Radiation
The sterilization process of medical devices through radiation is conducted by placing the items that have to be sterilized on a conveyor belt. These items are hit by strong gamma radiations after transporting them to a different area through a conveyor belt.
The radiation emitted from the rays helps in creating free radicals that damage DNA and enzymes which results in cell death. The most significant benefit of sterilization through radiation is that it is faster than chemical and physical methods of sterilization.
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