The process of cleaning and disinfecting the medical devices can be carried out by decontamination. This process is used so that these devices can be reused or can be tested by the engineers. The recently used devices must be decontaminated before they can be handled by anyone in order to ensure the safety of the staff. To complete such tasks, firms must have the necessary certification for the decontamination process and must follow the guidelines to reduce the risks alongside the exposure of bio-hazardous materials like blood, body, and tissue to the workers. If the corporation cannot conduct these tasks themselves then they must outsource this activity to the third-party vendors. The main three levels of decontamination are cleaning, disinfecting, and sterilization.
Cleaning
It is the first and most important step in the decontamination process. It involves the removal of both visible and non-visible substances from the medical device with water and detergent.
Decontamination
This is the next step in the process and is used to kill the non-spore forming bacteria on medical devices.
Some of the most commonly used disinfectants in the decontamination process are;
- Sodium Hypochlorite
- Liquinox
- Cidex (Glutaraldehyde)
- Isopropyl Alcohol Alconox
- Ethyl Alcohol
Sterilization
The application of high levels of heat to kill the highest level of microorganism along with getting rid of transmissible agents is called sterilization. In this, transmissible agents like spores and bacteria are eradicated. Sterilization methods mostly depend on the device’s ability to withstand the heat and extent of sterilization requirement. For example, devices with tubular openings require low steam level and other devices require high steam level.
Some of the common sterilization methods are;
Ethylene Oxide (ETO)
It is one of the most popular methods of sterilization. It involves the exposure of medical devices with ethylene oxide gas. This gas is an alkaline agent, infiltrate the packed medical device and kills microorganisms, thus achieving sterilization.
The process of ETO is toxic and flammable at low temperature and is used on products that cannot withstand the high-temperature process. This process is applied to
- Plastic packaging disclosed with irradiation
- Devices with electronic components
- Materials that get damage at high temperatures
- Custom kits
- Materials not compatible with gamma or steam sterilization.
Irradiation Methods (Gamma and E-beam)
These irradiation methods, gamma, and e-beam are radiation based sterilization techniques. The gamma one deals with the exposure of the product with high gamma rays continuously and the latter one uses the electron beams. Both these methods are effective; however, e-beam is more powerful than the gamma radiation. Reusable devices undergo audit after these radiation methods in order to ensure that they meet established standards and sterilization methods.
Steam Sterilization
This is the simplest, yet effective decontamination method. Sterilization is attained by exposing the devices in the saturated steam at high temperatures. The devices are placed in another device called autoclave and are heated through pressurized steam to eliminate the microorganisms including spores. Consequently, this method is not appropriate for many materials that cannot withstand high temperatures. Another point to be noted here is that there is a down time required, once the products are sterilized. The devices must be dry before being removed from the autoclave. Once removed, they must be must be allowed to cool down to ambient temperature, which can take several hours.
Dry Heat Sterilization
One of the easiest ways of sterilization is by using the dry heat method. As the name suggests, it uses hot air that is free from water and vapor, and where moisture plays no role in the process. The process is accomplished by conduction i.e. heat is absorbed by the external surface and is passed inward to the next layer. Eventually, the entire device reaches a certain temperature that is required to achieve sterilization. A major thing to note down here is that the instruments should be dry beforehand because water can interfere with the overall process.
Packaging and Transportation Guidelines
There are critical guidelines that need to be followed in packaging and transporting contaminated medical devices because of the involved bio-hazardous risk. Transport and Logistics companies insist on packaging and transporting diagnostic specimen and test samples, which must include the four basic components:
- Absorbent material
- Watertight primary receptacles
- Sturdy outer packaging
- Watertight secondary receptacles
Sterility Assurance Level (SAL)
The process of SAL can be defined as the probability of a single device being non-sterile after being subjected to the sterilization process. Once the device has been sterilized, tests can be conducted to determine if the desired level of sterility is attained or not.
If these medical devices are not decontaminated and cleaned between the users, these devices may transmit infectious agents between the units, patients, and can be brought with the patients from healthcare institutions. Hence, the increase in the hygienic quality of these devices to standard levels is a must requirement in the modern medical practice.
Source :-The 10 Most Advanced Medical Device Companies
