Medical devices that are sterilized with ethylene oxide (EO) must be tested for residues of EO and its degradation product ethylene chlorohydrin (ECH) to ensure patient safety.

Safety assessment of EO-sterilized medical devices

Ethylene oxide is a highly effective sterilizing agent that is used in particular for temperature-sensitive materials. At the same time, EO is a toxic, carcinogenic, mutagenic and reprotoxic substance that can remain in small quantities in the product material or packaging after sterilization. Ethylene chlorohydrin, which is produced by the reaction of EO with water, is also harmful to health and can be released from the product under certain conditions.

Testing for EO and ECH residues is therefore a central component of the biological safety assessment of medical devices. It is carried out on the basis of DIN EN ISO 10993-7, which defines permissible limit values for the daily intake of these residues by the patient. These limits vary depending on the type and duration of patient contact with the product. The aim of the residue analysis is to prove that the exposure to EO and ECH is so low that there are no health risks.

In addition to patient safety, regulatory requirements also play a decisive role. Both the European Medical Device Regulation (MDR) and international authorities such as the FDA require proof that no dangerous amounts of residues remain on the product after EO sterilization.

Testing for EO and ECH is therefore not only an important contribution to health protection, but also a prerequisite for the market approval of EO-sterilized products. It is also part of quality assurance and product liability: only an analytically validated residue test can ensure that medical devices can be used reliably and safely.

Guidelines:

    • DIN EN ISO 10993-7, -12

We are happy to support you with your questions about residual gas analysis of ethylene oxide sterilization residues at microbiology@gfps.de.