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What Is EtO Sterilization?

In the healthcare field, it is vital to ensure that medical devices and instruments can be sterilized properly. Neglecting this process constitutes a major breach of acceptable professional conduct, as well as being a serious health risk to patients who are exposed to potentially unsafe instruments. There are a variety of sterilants used in the medical field, however, not all products can withstand high temperatures and humidity that processes such as steam sterilization and depyrogenation rely on. For these cases, ethylene oxide sterilization methods are employed. Ethylene oxide (also referred to as EtO) is a colorless gas routinely used to sterilize a number of surgical devices, including surgical telescopes, syringes, sutures, and catheters. What differentiates ethylene oxide from other sterilants utilized in the medical sector? It’s a question that deserves a closer look.

Why Use Ethylene Oxide?

Ethylene oxide has been used in the medical field since the 1950’s and, despite decades of technological advances since that era, the gas remains a viable choice for sterilizing sensitive materials. Alternative sterilization methods are in use today, such as radiation, dry heat, and steam sterilization, however, EtO remains unequaled in its ability to sterilize heat and moisture sensitive materials. Unlike competing methods, EtO sterilization can be safely used on virtually any kind of medical device.

The EtO Sterilization Process

The EtO sterilization cycle is divided into five stages. First, the items being sterilized are placed inside a vacuum chamber and go through basic air washes. The ethylene oxide is then pumped into the compartment, and the exposure occurs for upwards of three hours, depending on the temperature, humidity, and concentration of the gas. Next, the gas is evacuated and another round of air washes occurs, allowing residual EtO to desorb from the treated materials. This stage is essential because EtO has potentially toxic properties.

EtO Must Be Used With Caution

Ethylene oxide is both flammable and explosive, which, for obvious reasons, means that proper handling procedures must be in place. In addition, EtO is considered a carcinogen and can be highly toxic to humans, causing a wide range of unpleasant physical effects, including headaches, nausea, dizziness, and vomiting. However, when properly deployed and monitored, ethylene oxide provides a safe and powerful sterilization method for heat and moisture sensitive materials.

The Function of Data Loggers

The EtO sterilization process is regulated by the Food and Drug Administration (FDA) to promote optimal safety. Specifically, the FDA requires the relevant supervisor to monitor the temperature and relative humidity of the chamber at various intervals during the entire sterilization cycle. Luckily, there are a number of data loggers on the market that are designed to monitor and record this data to ensure compliance with FDA regulations. Furthermore, data loggers made for EtO sterilization are approved as intrinsically safe, which is to say that they have been engineered with fewer electrical currents to function safely (without sacrificing reliably) in environments where hazardous and flammable materials—such as ethylene oxide—are present.


Company Bio

Founded in 1996, MadgeTech, Inc. is dedicated to the development and manufacture of high-quality data loggers and related accessories. Distributed worldwide, the company’s line of products includes temperature, humidity, motion, voltage, water level, and wind loggers, among others. MadgeTech is based in Warner, New Hampshire.

Sources

http://www.madgetech.com/data-loggers/applications/eto-sterilization.html

http://www.cdc.gov/hicpac/Disinfection_Sterilization/13_02sterilization.html

http://www.eosa.org/

http://www.epa.gov/ttnatw01/eo/eoguide.pdf

http://www.esb.ucp.pt/sites/default/files/files/Biotecnologia/investigacao/562crisluirev.pdf