ByDr. Tim Sandle
SCIENCE EDITOR
DIGITAL JOURNAL
September 20, 2025
A team of surgeons transplanting a pig kidney into a brain dead patient, part of a growing field of research aimed at advancing cross-species transplants and closing the organ donor gap - Copyright NYU Langone Health/AFP Joe Carrotta
Most medical devices need to ‘sterile’ and the main mechanisms for doing so are the use of ethylene oxide or a type of irradiation (gamma, electron beam, or X-ray). For many years there have been concerns about ethylene oxide (not least since the residues, if present, act as a mutagen).
While moves were in place to reduce ethylene oxide use, the U.S. government has reversed a policy that was driving this reduction forwards.
President Donald Trump has issued an executive order granting a two-year extension for medical device sterilization facilities to comply with the new limits for ethylene oxide (EtO). This decision impacts 39 specifically named facilities and reflects the governmental position that required emissions-control technology is not commercially viable.
Mutagens are agents that can induce mutations in DNA, leading to genetic alterations. This can include triggering cancer.
EtO is a dangerous chemical, with mutagenic properties. Throughout Europe its use has declined, primarily driven by regulatory requirements. Inhalation of ethylene oxide can cause irritation of the eyes and nose, coughing, burning sensation in the mouth and breathlessness. In severe cases lung damage can occur. Ethylene oxide can be absorbed into the body via inhalation or skin contact causing headache, stomach upset, fitting, coma and heart problems.
The use of EtO as a sterilant has also been questioned in terms of its suitability. The UK medicines regulator, the MHRA has long expressed concerns about residuals posing a risk to human health. Other forms of sterilisation, such as gamma radiation, are preferred.
Such factors make the U.S. move surprising. Ethylene oxide is a regulated substance, and its use in medical devices is governed by international standards like ISO 10993-7 and ISO 11135, which set limits for residual EtO levels and the EPA’s decision is aligned with these international standards.
The Trump order extends compliance deadlines for facilities listed I by two years beyond the U.S. Environmental Protection Agency (EPA) rule’s original requirements. During the extension period, these facilities will remain subject to the emissions and compliance obligations that were in effect before the EPA’s EtO rule, as The FDA Group reports.
For the past year or so, medical device trade groups have been lobbying the government, warning about potential supply chain disruptions and implementation challenges. Sauch groups have logistical and economic motivations for doing so.
The order invokes section 112(i)(4) of the Clean Air Act, which provides backstop authority allowing the President to grant compliance exemptions under specific circumstances. The executive order cites two specific determinations: “The technology to implement the EtO Rule is not available. Such technology does not exist in a commercially viable form sufficient to allow implementation of and compliance with the EtO Rule by the compliance dates.”
September 20, 2025
A team of surgeons transplanting a pig kidney into a brain dead patient, part of a growing field of research aimed at advancing cross-species transplants and closing the organ donor gap - Copyright NYU Langone Health/AFP Joe Carrotta
Most medical devices need to ‘sterile’ and the main mechanisms for doing so are the use of ethylene oxide or a type of irradiation (gamma, electron beam, or X-ray). For many years there have been concerns about ethylene oxide (not least since the residues, if present, act as a mutagen).
While moves were in place to reduce ethylene oxide use, the U.S. government has reversed a policy that was driving this reduction forwards.
President Donald Trump has issued an executive order granting a two-year extension for medical device sterilization facilities to comply with the new limits for ethylene oxide (EtO). This decision impacts 39 specifically named facilities and reflects the governmental position that required emissions-control technology is not commercially viable.
Mutagens are agents that can induce mutations in DNA, leading to genetic alterations. This can include triggering cancer.
EtO is a dangerous chemical, with mutagenic properties. Throughout Europe its use has declined, primarily driven by regulatory requirements. Inhalation of ethylene oxide can cause irritation of the eyes and nose, coughing, burning sensation in the mouth and breathlessness. In severe cases lung damage can occur. Ethylene oxide can be absorbed into the body via inhalation or skin contact causing headache, stomach upset, fitting, coma and heart problems.
The use of EtO as a sterilant has also been questioned in terms of its suitability. The UK medicines regulator, the MHRA has long expressed concerns about residuals posing a risk to human health. Other forms of sterilisation, such as gamma radiation, are preferred.
Such factors make the U.S. move surprising. Ethylene oxide is a regulated substance, and its use in medical devices is governed by international standards like ISO 10993-7 and ISO 11135, which set limits for residual EtO levels and the EPA’s decision is aligned with these international standards.
The Trump order extends compliance deadlines for facilities listed I by two years beyond the U.S. Environmental Protection Agency (EPA) rule’s original requirements. During the extension period, these facilities will remain subject to the emissions and compliance obligations that were in effect before the EPA’s EtO rule, as The FDA Group reports.
For the past year or so, medical device trade groups have been lobbying the government, warning about potential supply chain disruptions and implementation challenges. Sauch groups have logistical and economic motivations for doing so.
The order invokes section 112(i)(4) of the Clean Air Act, which provides backstop authority allowing the President to grant compliance exemptions under specific circumstances. The executive order cites two specific determinations: “The technology to implement the EtO Rule is not available. Such technology does not exist in a commercially viable form sufficient to allow implementation of and compliance with the EtO Rule by the compliance dates.”
The exemption is “in the national security interests of the United States.”
It was back in March 2024 that the Environmental Protection Agency issued ‘a final rule’ updating National Emission Standards for Hazardous Air Pollutants for commercial sterilization facilities. The rule was designed to reduce EtO emissions by more than 90% through installation of air pollution controls.
The EPA rule affects nearly 90 commercial sterilizer facilities operated by approximately 50 companies throughout the U.S. This set out new rules for building leaks, chamber exhaust vents, and requires continuous emissions monitoring.
The proclamation emphasizes that about 50% of all sterile medical devices in the United States are sterilized with ethylene oxide, and sterilization with EtO may be the only method of sterilizing many medical devices without damaging them
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