Ethylene oxide: risk-free sterilization for medical devices
Patient safety is guaranteed through perfect sterilization of medical devices. Ethylene oxide (EO) is one of the most commonly used chemical substances for sterilization, because it has been proven to remove all potentially hazardous micro-organisms.
However, over the last few years, concerns have been raised about the presence of residual traces of ethylene oxide on medical devices. These traces, sometimes found in minute quantities, pose no risk to human health.
Patient safety is guaranteed through perfect sterilization of medical devices. Ethylene oxide (EO) is one of the most commonly used chemical substances for sterilization, because it has been proven to remove all potentially hazardous micro-organisms.
However, over the last few years, concerns have been raised about the presence of residual traces of ethylene oxide on medical devices. These traces, sometimes found in minute quantities, pose no risk to human health.
Ethylene oxide: effective sterilization
Highly effective, ethylene oxide is able to penetrate the most complex devices, and devices with hard-to-reach parts. It effectively removes most viruses, bacteria and all kinds of microbial spores. This method is so effective because it even eliminates most micro-organisms on devices that are sensitive to heat, humidity or high pressure.
Concerns about residual levels
Ethylene oxide is a CMR substance (carcinogenic, mutagenic or toxic for reproduction). All medical device manufacturers must therefore make absolutely sure they reduce residual traces to below a specific limit not to be exceeded after sterilization, as set out in the standards, so as to limit patient exposure when the medical device is used.
In 2015, after a study of 24 catheters, ANSM (the French agency for the safety of health products) found that not all manufacturers complied scrupulously with the protocol, since 60 % of the medical devices analysed exceeded the recommended standards. The national health agency therefore issued a warning to manufacturers.
Detailed legislation
“Given that standard NF EN ISO 10993-7 specifies that calculation of the permissible limits for residual traces is based on:
- the patient’s body weight on the one hand;
- and on the other, the simultaneous use of other devices sterilized with ethylene oxide”
Remember that manufacturers, of which we are one, take care to keep ethylene oxide trace levels as low as possible, well below the permissible limits defined by law. Technological progress and modern sterilization processes aim to achieve minimum ethylene oxide trace levels, without compromising effective sterilization.
Ethylene oxide sterilization: benefits and drawbacks
Benefits
Unlike other sterilization methods, ethylene oxide molecules are smaller than those of water and are able to penetrate breathable packaging, so large-scale sterilization is possible, for example entire pallets of products in a single operation.
Ethylene oxide is highly effective against viruses, fungi and bacteria, and kills micro-organisms chemically, by alkylation.
It does not deform or alter heat-sensitive materials, because it can be used for low-temperature sterilization, often in the region of 37 to 63 °C.
Drawbacks
Ethylene oxide sterilization is a longer process than heat sterilization, and the toxic nature of the chemical requires post-sterilization aeration for several hours and checking of any deposits afterwards.
All medical device manufacturers must calculate the trace levels on their devices, to allow health workers to assess the potential exposure of patients, especially in the case of newborns.
Ethylene oxide sterilization is a longer process than heat sterilization, and the toxic nature of the chemical requires post-sterilization aeration for several hours and checking of any deposits afterwards.
All medical device manufacturers must calculate the trace levels on their devices, to allow health workers to assess the potential exposure of patients, especially in the case of newborns.
Ethylene oxide sterilization: a tried-and-tested technique
Given that patient safety is the absolute top priority, using ethylene oxide to sterilize medical devices is a safe, tried-and-tested method which is perfectly suited to the highest safety standards.
Any minute traces of ethylene oxide are well below levels that would give cause for concern, and do not lead to health problems for patients. It is reassuring to know that healthcare professionals and the medical industry take stringent measures to guarantee that medical devices are sterilized in absolute compliance with patient safety and well-being.
