Press Release

STEMart, a US-based provider of comprehensive services for all phases of medical device development, recently announced the launch of new Ethylene Oxide Sterilant Residual Testing services. The new services will help manufacturers and healthcare providers ensure the safety of EO-sterilized medical devices by determining accepted residual limits.

Ethylene oxide (EO) is a colorless gas that is used to sterilize medical equipment and supplies. EO is known to exhibit a number of biological effects including irritation (e.g., skin irritation, erythema, eye irritation, blistering, and burns), organ damage (e.g., bronchitis, pulmonary edema, and headaches), mutagenicity, cancer in animals and humans, and reproductive effects in animals.

STEMart now offers EO Sterilant Residual Testing Services to the medical device industry to ensure product and patient safety under the guidance of "Ethylene Oxide Sterilization Residuals", Part Seven of the Biological Evaluation of Medical Devices Standards (ISO 10993-7). It outlines the general considerations that should be taken into account when evaluating the levels of EO and ethylene chlorohydrin (ECH) that may remain on medical devices, and specifies acceptable limits and compliance methods for residual EO and ECH in individual EO-sterilized medical devices. It also describes the specific limits of EO and ECH that must not be exceeded to ensure product and patient safety.

Ethylene Oxide Residual Analysis can identify and quantify EO and ECH by gas chromatography. This test demonstrates the safety of medical devices sterilized with EO by determining compliance with accepted residual limits. General procedures include determining patient exposure, selecting appropriate test methods, preparing samples for testing, sterilizing the product, and performing the test. Specifically, samples are prepared according to the applicable pre-use instructions on the product label unless otherwise specified in the sponsor's extraction instructions.

There are two product extraction methods for residual EO analysis based on the intended use of the medical device, exhaustive extraction and simulated-use extraction. If all residual ethylene oxide is potentially accessible to the user, exhaustive extraction is used. In this method, the device must be incrementally extracted until no significant increase in cumulative residual level is detected upon re-extraction, or until the amount extracted is less than 10% of the amount detected in the first extraction. Meanwhile, limited use extractions are performed to duplicate the patient/user exposure to the device. During normal use of the device, the patient or user is exposed to only a portion of the residual ethylene oxide.

If you have any questions about Ethylene Oxide Sterilant Residual Testing or would like to learn more about medical device testing services, please visit https://www.ste-mart.com/ethylene-oxide-sterilant-residual-tests.htm.

About STEMart

STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols in order to access better health worldwide.

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