Group 1(1).png

导航栏

公司信息

公司介绍

<h2>What Medical Devices Can be Sterilized with Ethylene Oxide?</h2>
<p>Ethylene oxide (EO or ETO) is a gas commonly used to sterilize medical devices and products chemically. Due to its low-temperature conditions, ethylene oxide sterilization is well suited for medical devices with embedded electronics and medical devices that cannot withstand steam (autoclave) sterilization. Ethylene oxide is also used to sterilize the personal protective equipment and drapes used by doctors and healthcare workers. Medical device types that are sterilized with ethylene oxide range from external wound dressings to implantable stents. Other devices include heart valves, vessel closure devices, catheters, and guidewires. Products combining devices, drugs, and biologics within a single item may also be sterilized using ethylene oxide.</p>
<h2>How Does the United States Food and Drug Administration (FDA) Define Sterile?</h2>
<p>Under the strictest definition of sterility, an item or product is sterile when there is the complete absence of viable microorganisms (bacteria, yeasts, viruses, and molds). For regulatory purposes, sterility is defined by acceptance criteria based on calculated contamination probability. An acceptable level of contamination risk for most items is the probability of a single contaminated product out of a million manufactured products. However, sterility criteria may be more stringent or lax depending upon the intended use of the medical device or product.</p>
<h2>What are Ethylene Oxide and Sterilization by Ethylene Oxide?</h2>
<p>Ethylene oxide is a potent and highly penetrating alkylating agent. These characteristics make it an extremely effective sterilizing agent. However, at certain levels, ethylene oxide is also capable of causing cancer. Sterilization by ethylene oxide kills microorganisms through exposure to ethylene oxide gas under vacuum and humidity. EO is used either as one hundred percent EO or in combination with carbon dioxide.</p>
<h2>How Common is Ethylene Oxide Sterilization?</h2>
<p>Approximately 20 billion medical devices are sterilized with ethylene oxide each year, accounting for about half of sterilized medical supplies in the United States.</p>
<h2>What Items Cannot be Sterilized with Ethylene Oxide, or are Ethylene Oxide Resistant?</h2>
<p>Ethylene oxide is not recommended for medical devices with embedded batteries due to the vacuum used during sterilization. Ethylene oxide sterilization is not recommended for materials sensitive to temperatures ranging from 30&deg;C to 60&deg;C or for medical devices made with materials that are sensitive to humidity. Polymers that are resistant to ethylene oxide sterilization are polyolefin resins such as polypropylene (PP), high-density polyethylene (HDPE), and low-density polyethylene (LDPE).</p>
<h2>What are the Problems with Sterilization by Ethylene Oxide?</h2>
<p>The primary issue with using ethylene oxide for sterilization is its absorption into certain materials and its reaction with water or other material components to form toxic residual compounds (ethylene oxide, ethylene glycol, and ethylene chlorohydrin). These residual compounds are hazardous both to people and to the environment. Ethylene glycol is formed from the reaction between ethylene oxide and water, while ethylene chlorohydrin is formed from the interaction of ethylene oxide and chloride compounds. Products sterilized with ethylene oxide must meet strict ethylene oxide residual limits to ensure patient safety during medical device and product use. Current ISO 10993-7 ethylene oxide residual limits can be found here.</p>

What Medical Devices Can Be Sterilized With Ethylene Oxide?

文章内容

页脚map

Ethylene oxide (EO or ETO) is a gas commonly used to sterilize medical devices and products chemically.

What Medical Devices Can Be Sterilized With Ethylene Oxide?

Publish Time：2024-06-14