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Ethylene Oxide (EtO or EO) is a colorless gas used commercially in a wide variety of ways, including the production of textiles, personal care items, and the sterilization of medical devices, cosmetics, and spices. EtO is one of the most common methods used to sterilize medical devices, which is crucial for preventing infections in patients undergoing surgical procedures and other medical treatments.
Approximately 50 percent of all medical devices are sterilized with EtO, and for many of them, it is the only known option in modern science.
Hundreds of thousands of medical, hospital, and laboratory processes rely on EtO to sterilize devices and equipment, protecting millions of patients from the real risks of infectious diseases caused by bacteria, viruses, and fungi. EtO sterilization is often the most effective, efficient, and sometimes the only viable technology for sterilizing many critical medical technologies and devices that would otherwise be destroyed or rendered unusable by other sterilization methods.<img src="https://us1.yofishseo.com/file/2/新建项目-(40).png" alt="新建项目 (40).png">
There are several reasons why many medical devices require<a href="https://www.hzbocon.com/product-list/ethylene-oxide-sterilizer"> EtO sterilization</a>:
<ol>
<li>Gamma and e-beam radiation can make plastics brittle or cause certain non-woven materials to disintegrate.</li>
<li>Steam is high temperature and can melt plastics or damage products sensitive to heat and moisture.</li>
<li>Hydrogen peroxide and gas plasma are intended for small-scale, surface sterilization only and cannot penetrate devices with interior chambers or two surfaces in contact with each other (e.g., a syringe's piston and barrel).</li>
<li>EtO has the unique ability to penetrate packaging and plastic without damaging them, effectively sterilizing otherwise hard-to-sterilize product configurations (e.g., inside tubing or products with two touching surfaces).</li>
</ol>
Medical devices that commonly require EtO sterilization include fiberoptic endoscopes, specula, surgical kits, syringes, sutures, catheters, IV sets, plastic tubing, inhalation therapy supplies, surgical telescopes, anesthesia masks and circuits, renal peritoneal dialysis sets, renal hemodialysis sets, tubing sets/bloodlines, gowns and drapes, heart valves, pacemakers, surgical drills, pumps, respirators, electrical equipment, uterine monitors, surgical staplers, and diagnostic electrode catheters.
EtO is highly compatible with a wide variety of medical device materials, enabling the manufacturing of devices that would not be possible without it. The high level of performance and effectiveness of medical devices when sterilized by EtO is well understood. If EtO could not be used for sterilization, there would be significant adverse public health consequences, including increased morbidity and mortality.
The use of EtO in sterilization is strictly regulated by government agencies. The U.S. Food and Drug Administration (FDA) and other global regulators ensure that manufacturers' sterilization methods are properly validated. Manufacturers must comply with FDA's Quality Systems Regulation (QSR) and international standards, conduct exhaustive studies to demonstrate sterility assurance levels, and ensure the process does not affect the device's performance, safety, or effectiveness.
The U.S. Environmental Protection Agency (EPA) sets emission standards for EtO under the National Emission Standards for Hazardous Air Pollutants (NESHAP) rule, and the U.S. Occupational Safety and Health Administration (OSHA) sets permissible EtO exposure limits for workers.
Manufacturers must also meet global standards for device biocompatibility testing and assessment of EtO residuals remaining on the finished product post-sterilization. These requirements ensure that patients and healthcare providers are not exposed to unacceptable levels of chemical residues.
It is important to note that everyday items such as school buses, SUVs, lawnmowers, fire pits, charcoal grills, and gas generators emit EtO above the EPA's benchmark. However, the emissions from these sources are not related to the controlled and regulated use of EtO in medical device sterilization.
In summary, EtO plays a critical role in sterilizing medical devices, preventing infections, and maintaining the healthcare supply chain. It is a highly effective and necessary sterilization method for many medical devices that cannot be sterilized by alternative methods without compromising safety and effectiveness.

Ethylene Oxide Sterilization’s Invaluable Role In Protecting Public Health

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Ethylene Oxide  is a colorless gas used commercially in a wide variety of ways, including the production of textiles, personal care items, and the sterilization of medical devices, cosmetics, and spices

Ethylene Oxide Sterilization’s Invaluable Role In Protecting Public Health

Publish Time：2024-05-22