Dive Brief:

• A medtech group that advises the European Commission published guidance on the regulatory status of ethylene oxide (EtO) for the sterilization of single-use medical devices.
• The Medical Device Coordination Group (MDCG), which shared the guidance on Tuesday, used the document to clarify that EtO falls within the scope of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).
• While EtO does not meet the definition of a device or device accessory, it is used in sterilization and validation processes that are subject to the MDR or IVDR conformity assessment procedure.

Dive Insight:

The use of EtO in the sterilization of medical devices has become a contentious issue in the U.S., where concerns about the health risks of exposure to the carcinogenic chemical have informed a rule from the Environmental Protection Agency that limits emissions from facilities. The restrictions have triggered a race to find alternatives to a chemical that is used to sterilize tens of billions of medical devices every year. 

The MDCG document has a different focus. In the three-page document, the expert group discusses the regulatory status of EtO when used to sterilize medical devices during the manufacturing process and by health institutions.

Several sections of the MDR and IVDR specifically address sterilization. An annex that discusses general safety and performance requirements says “devices labeled as sterile shall be processed, manufactured, packaged and sterilized by means of appropriate, validated methods.” The MDCG identified international standards on sterilization and EtO that provide more information on the requirements.

The group concluded that “EtO used for sterilization during the manufacturing of medical devices and IVDs is used for a process that falls within the regulatory obligations imposed by the MDR and IVDR.” As such, the MDCG’s position is that the use of EtO to sterilize devices is in scope of the MDR and IVDR even though the chemical does not meet the definitions of medical device or accessory for a medical device.

When used during device and diagnostic production, the chemical is controlled as part of the manufacturer’s sterilization and validation processes, the MDCG said. The processes are subject to the sterilized device’s MDR or IVDR conformity assessment procedure. EtO itself is not subject to additional conformity assessments.

The MDCG document contains no references to the carcinogenic properties of EtO or emissions of the chemical from sterilization plants.

The European Chemicals Agency has previously covered those topics, including in a 2020 assessment by its Biocidal Products Committee. The committee said no monitoring data from the surroundings of European sterilization plants are available but several studies have been done in the U.S.

“Although significant variation is seen in the monitoring studies, both with regards to the possible atmospheric background levels of ethylene oxide and the air concentrations caused by emissions from the sterilisation plants, these studies clearly indicate a need for EU monitoring data, particularly where the sterilisation plants are located close to residential areas or in urban areas,” the committee wrote.