Learn the key criteria for selecting an analytical provider for EtO testing in medical devices
Ethylene oxide (EtO) sterilization is widely used in the medical device industry for its effectiveness in eliminating microorganisms without affecting delicate materials. However, after the sterilization process, it is essential to perform EtO testing on medical devices to ensure that EtO residues and its byproducts, such as 2-chloroethanol (ECH), remain within the safety limits established by international regulations, such as ISO 10993-7.
Selecting a vendor for EtO testing on medical devices should not be based solely on cost or delivery times. There are key technical criteria that directly impact the safety of the final product.
Criteria for selecting an EtO testing provider
1. Analytical capabilities and method validation
A reliable supplier must have validated analytical methods that guarantee precision, accuracy and repeatability in the results. The most commonly used techniques for the detection of EtO and ECH are gas chromatography with specific detectors, which allow reliable quantification of residues at traceable levels.
In addition, it is important that the laboratory has the capacity to perform different types of extraction:
- Simulated extraction: imitates the conditions of use of the device.
- Exhaustive extraction: removes as much residue as possible to identify maximum concentrations.
- Fluid Path Assessment: Specific for devices with internal channels where debris can accumulate.
2. Regulatory compliance and accreditations
A supplier whose EtO residue testing falls within the scope of ISO 17025 accreditation offers greater assurance in meeting regulatory requirements. Accreditations under international standards not only demonstrate technical competence, but also facilitate audit and approval processes by regulatory bodies.
3. Response times and specialized technical support
EtO testing is critical throughout the product lifecycle, especially during the launch of new devices or revalidation processes. Having a provider that offers fast results and specialized technical support to interpret data and optimize processes can make all the difference.
Why choose MCI as your EtO testing provider?
At MCI we combine technical rigor with a deep understanding of the needs of the medical device industry.
- Validated and accredited methods for the detection of EtO and ECH, in compliance with ISO 10993-7.
- Ability to test devices that require water as an extraction solvent, applying immersion and fluid path techniques.
- Optimized logistics thanks to our strategic location in Costa Rica, eliminating the need to send samples abroad, which reduces costs and delivery times.
- Specialized technical support to help you interpret results and make critical decisions.
With MCI you get not only reliable results, but also a partner committed to the safety and quality of your products.
