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Medical Device Sterilization

Monday, July 11, 2022

Keeping Workers Safe

Understanding the Medical Device Sterilization Process
When most people think of an implantable medical device, such as a pacemaker, they think of the incredible technology that goes into developing it and the operation for implanting it. Not many people realize there are numerous steps between the development and the implantation processes, including a sterilization step. Baseline Gas Analyzers help to ensure the safety of technicians at sterilization facilities.

The Solution to Safe Ethylene Oxide Usage
Before a medical device is distributed, it needs to be free of all contamination.

To do this, technicians fill a chamber with a sterilizing gas called ethylene oxide, which permeates through cardboard or plastic packaging and sterilizes the device. This process might be repeated a few times.

Ethylene oxide (EtO) is widely used because it’s effective, killing any bacteria that might be inside the packaging or on the device, but it’s also highly toxic to people. The Occupational Safety and Health Administration (OSHA), specifically outlines the exposure limit for employees working with EtO, but most companies aim for a level much lower than the maximum. That’s where AMETEK MOCON comes in. Our Gas Chromatographs constantly monitor the levels of EtO in areas surrounding the main chamber, alerting workers to the possibility of leaks and keeping the facility safe. To keep technicians as safe as possible, it’s important to have the capability to measure even small changes in gas levels.

Prioritizing Worker Safety
Even trace levels of toxic gases like ethylene oxide can be hazardous. With the Baseline 9100 Gas Chromatograph, process facilities can measure down to less than 1 part per billion of EtO, with minimal interference from other gases.

Our sampling system and fast measurements provide accurate, timely information to ensure safe environments for workers. This instrument also gives users the data to document gas levels, as well as set alert and alarm conditions so technicians can be confident it’s a safe environment for everyone.

Our instruments provide invaluable data that can be digitally collected directly from the analyzer. This allows for immediate action if gas levels change and simplifies easy digital data storage for compliance purposes. AMETEK MOCON has been at the forefront of sensor development for over 20 years, and we’ve designed industry-leading instruments for health, safety and medical applications. Our lower detection rates exceed the expectations and limits set by OSHA and the EPA, positioning us as industry experts when it comes to worker safety. With decades of experience in gas detection and analysis, you can trust our expertise to keep workers safe while using ethylene oxide to sterilize medical devices.