Ethylene oxide has been used as a primary low-temperature sterilization technology for heat and moisture sensitive items since the 1950's. In the United States, more than 56% of medical devices are sterilized by ethylene oxide. In the United States, according to the total amount of sterilization and including industrial sterilization, more than 56% of medical devices are sterilized by ethylene oxide, and the proportion is still increasing year by year. To date, according to incomplete statistics, there are about 4,000 ethylene oxide sterilizers in healthcare facilities in the United States*** and 11,000 in healthcare facilities worldwide***. 3M, as a pioneer in low-temperature ethylene oxide sterilization technology, has provided the market with the Steri-Vac series of ethylene oxide sterilizers and related products and services as early as the 1960's. The 3M Steri-Vac ethylene oxide sterilizers include the 5XL and the 5XL, and the 3M Steri-Vac ethylene oxide sterilizers include the 5XL and the 5XL. The 3M Steri-Vac Ethylene Oxide Sterilizers include two models, 5XL and 8XL, with corresponding chamber volumes of 136L and 223L. The main features are as follows:
1. International safety certification: 3M Steri-Vac Ethylene Oxide Sterilizers have an excellent record of safe use by users during nearly half a century of worldwide sales, and have obtained UL certification in the United States and Canada, as well as CSA certification in Canada.
2. Single Dose Sterilization Gas Canisters: Individually packaged, small-dose ethylene oxide gas canisters for use with the 5XL and 8XL eliminate the need for additional connecting cables and filters, and allow for the direct, safe release of ethylene oxide gas directly into the sterilizer chamber. Before the sterilization process actually starts, the 3M Steri-Vac Series sterilizers perform a self-test of the prevailing sterilization conditions, and when the conditions are met, the sterilizer automatically punctures the gas canister to release the sterilant. At the end of the sterilization process, the gas canister is vented with other post-sterilization items and can be disposed of as ordinary medical waste, conveniently and safely.
3. 100% Pure Ethylene Oxide System: The sterilizing gas is 100% pure ethylene oxide gas, which does not contain environmentally destructive substances CFC (Freon) and HCFC (Hydrogenated Freon), and does not damage the atmosphere. The final environmental decomposition products of the sterilizing agent are carbon dioxide and water, which are friendly to the environment.
4. Negative Pressure Sterilization Procedure: 3M Steri-Vac series sterilizers are designed with a unique ventilated pump, which makes the sterilization process in a negative pressure state throughout the entire process, completely avoiding the leakage of ethylene oxide from the sterilizer, and avoiding the exposure of staff to ethylene oxide gas. The negative-pressure sterilization process, together with the small-dose gas tank and precise mechanical ratio of the sterilization chamber design, also greatly reduces the risk of ethylene oxide combustion and explosion.
5. Control or monitoring of relative humidity: 3M Steri-Vac has the ability to control or monitor relative humidity, effectively improving or reflecting one of the most important sterilization parameters in the sterilization process. The 8XL controls relative humidity at the pretreatment stage to ensure that optimal humidity levels are achieved before the sterilization process is initiated; the 5XL monitors and reflects relative humidity, but does not adjust humidity.
6. Safety door lock: Once the sterilization process starts, the sterilizer chamber is mechanically and electronically double locked. Sterilization and aeration process of the vacuum state also makes the sterilizer chamber door in a tight state. Only after ethylene oxide is effectively discharged from the sterilizer cavity, and the air pressure in the cavity is restored to normal pressure, the door of the sterilizer can be opened, which ensures that there is no leakage of ethylene oxide gas and no operation of the personnel during the sterilization process.
7. Gas leakage pre-check/interruption performance: When the sterilization program starts, the sterilization system automatically monitors the air pressure level in the sterilization chamber to ensure that the air pressure meets the requirements. If it can not reach the effective negative pressure state, will not enter the sterilizer cavity, and the program will automatically terminate and report errors.
8. Ethylene Oxide Mechanical and Electronic Interlocking Puncture Device: When the gas canister is placed in the sterilizer chamber, the device is punctured by an air valve that works only when a predetermined vacuum condition is reached. Only when the gas canister is correctly placed in the sterilizer cavity, the interlock device is ready, and at the same time the sterilizer cavity to reach the effective negative pressure, the gas canister can be punctured, and any mechanical failure will not affect the effectiveness of this function and play.
9. Continuous Gas Leak Detection: The 3M Steri-Vac Sterilization System is equipped with a special ventilated pump that keeps the entire sterilization process under negative pressure (as opposed to the half-mixed ethylene oxide gas sterilization system that is under positive pressure). If a leak occurs in the sterilizer chamber during the sterilization process and air flows into the chamber, a continuous gas leakage detection device can acutely monitor the air pressure change in the chamber, automatically interrupting the sterilization process and advancing into the residue removal procedure to maximize the safety of use and avoid the risk of ethylene oxide exposure.
10. Built-in type ventilation design: After the gas exposure stage, the control system also detects the safety and effectiveness of the ventilation stage through the vacuum level. If the vacuum level is not up to standard, the program is automatically interrupted and the sterilizer door locks. The chamber door will not be opened until the fault is removed and the sterilizer can be gassed normally. The built-in venting design also avoids ethylene oxide gas exposure that can occur during the handling of sterilized items that have not been fully vented to a separate ventilator.
11. Program Error Codes/Human-Machine Interface: The sterilization control system displays error messages when it detects any incorrect condition. These error messages not only indicate the cause of the malfunction, but also provide a clear indication of whether proper precautions need to be taken or whether mechanical repairs and corrections must be made. Ethylene oxide is a highly effective gaseous sterilizing agent that has been widely used since the 1950s to sterilize heat and moisture sensitive medical devices. Its liquid and gas state have sterilization effect, but the gas state is more effective, so the actual use of its gas state as a sterilization medium. The powerful sterilization effect of ethylene oxide is mainly through its non-specific alkylation with proteins, DNA/RNA and other genetic material in microorganisms, resulting in the denaturation of proteins and genetic material, and ultimately leading to the death of microorganisms due to the blockage of their metabolism. Ethylene oxide can also be converted to ethylene glycol when it undergoes hydrolysis. Ethylene glycol also has a certain bactericidal effect. Ethylene oxide as a sterilizing agent has its own characteristics as follows:
1. Excellent penetration performance: the penetration performance of the sterilizing agent is very important for the sterilization process, especially for the treatment of complex medical devices. Ethylene oxide has a boiling point of 10.7℃ and a vapor pressure of 1094mmHg/20℃. These physical properties make ethylene oxide has very good penetration ability, can effectively contact every surface of the items to be sterilized, and then inactivate microorganisms.
2. Stability: Ethylene oxide gas molecules have good stability in the sterilization process. This makes ethylene oxide gas in the penetration of the items to be sterilized, its own decomposition or degradation will not occur, can effectively ensure that each surface to be sterilized gas concentration, and thus guarantee the quality of sterilization.
3. Strong compatibility: Ethylene oxide is compatible with almost all medical devices, including most of the packaging materials used in medical institutions. As a basic equipment for low temperature sterilization, it is convenient for daily work and economical to use.
4. Perfect quality control: Ethylene oxide has been used in a large number of medical institutions for nearly 50 years, in the process, the technology has accumulated a lot of experience, quality monitoring and control of a lot of innovations, the international community has a mature and recognized sterilization quality monitoring system. 3M Steri-Vac Ethylene Oxide Sterilizers are recognized by a wide range of international standards, including UL, cUL, CSA, CE, and others.
*UL: Underwriters Laboratories, Inc. is the most authoritative in the United States and one of the largest organizations in the world engaged in safety testing and qualification
UL is an internationally recognized safety testing and authorization body for the UL Mark.
CSA: Canadian Standards Association, Canada's largest safety certification body and one of the world's most recognized
safety certification bodies, the CSA Mark is one of the world's most recognizable product safety approval marks.