US President Trump extends Transition Period for EtO Sterilisation

Sterilisation with ethylene oxide (EtO) is widely used in the medical device sector, although the technology is controversial for environmental reasons. There is an extraordinary measure in the USA to achieve an extension of the status quo for medical device sterilisation companies and thus circumvent stricter environmental regulations. The initiator is US President Trump. What does Trump have in mind?

Ethylene oxide sterilisation and its emissions are regulated in the USA by the Environmental Protection Agency (EPA), among others. A recently published and very comprehensive document entitled 'National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilisation Facilities Residual Risk and Technology Review' sets the course for the future. The plan is to provide greater protection for the population from EtO emissions, which in turn would also lead to significant investments by EtO sterilisation companies.

This is precisely how President Trump sees it. Around 50 per cent of all sterile medical devices in the United States are sterilised with ethylene oxide. In some cases, it is the only method of sterilising medical devices without damaging them. By requiring compliance with standards, the EtO regulation carries the risk that important sterile medical devices will no longer be available for care. A supply bottleneck is looming.

President Trump's measure

President Trump has issued a proclamation entitled 'REGULATORY RELIEF FOR CERTAIN STATIONARY SOURCES TO PROMOTE AMERICAN SECURITY WITH RESPECT TO STERILE MEDICAL EQUIPMENT'. It once again points out the danger of a supply bottleneck for medical devices and therefore grants a two-year deferral as an exemption for various sterilisation companies listed in Annex I.

Conclusion: With this exemption, US President Trump is allowing certain EtO sterilisation companies to continue with their current procedures for two years and not have to comply with the stricter environmental regulations. He believes that this measure will prevent a supply shortage of sterile medical devices in the US. The measure also demonstrates President Trump's industry-friendly stance towards domestic industry.