In the medical device sterilization services industry, ethylene oxide remains the most widely used low-temperature sterilization method, accounting for 20 billion devices, or 50% of all medical devices sterilized. However, growing concerns about the cancer-causing emissions from ethylene oxide sterilization facilities have led to increased regulatory pressure. As a result, in March 2024, new EPA regulations now require facilities to reduce their emissions by 90%, creating significant compliance costs for those relying on ethylene oxide (EPA, 2024).
These new regulations come at a hefty price for existing facilities. It has been estimated that the industry will need to invest $220 million in one-time capital expenses and $86 million in annual operating expenses to comply with stricter emission standards (MedTech Dive, 2023a). With 86 commercial facilities across the U.S., this equates to approximately $2.6 million in capital expenses and $1 million in annual operating expenses for each facility.
The high compliance costs are forcing facilities to spend a significant amount of money on abatement methods, search for alternative technologies, or face potential closure. In fact, as of November 2024, the EPA estimated that 63 of 86 commercial sterilizers failed to meet the new requirements (MedTech Dive, 2024). Facilities now have a narrow 2-to-3-year window to comply, which started on April 5th, 2024. Smaller sterilization facilities are at risk of shutting down due to not being able to afford high costs of compliance and the lack of a viable alternative. One example is the closure of Sterilization Services of Tennessee in South Memphis, which stopped operations last May under the pressure from the community and published regulations (Tennessee Lookout, 2024). Larger facilities, such as Becton Dickinson and Company (BD) have spent over $70 million to install dry bed systems to absorb residual ethylene oxide emissions (MedTech Dive, 2023b).
Despite the regulatory challenges faced by the ethylene oxide industry, the need for safe, reliable, and effective sterilization remains high. The EPA and FDA are actively searching for viable, sustainable alternatives as medical devices must continue to be sterilized to ensure patient safety and well-being. The closure of sterilization facilities could lead to bottlenecks in the supply chain, creating an even greater urgency for alternative technologies. NanoGuard’s High Voltage Atmospheric Cold Plasma technology provides a promising solution by enhancing safety, ensuring regulatory compliance, and improving operational efficiency. Our process uses only air and electricity, leaving no harmful residues, as the reactive gas species revert back to air. This not only helps facilities meet emission regulations but also eliminates the cancer-causing risks tied to ethylene oxide.
To learn more, please see the following references:
EPA (2024, March 14). EPA announces final rule to slash toxic emissions of ethylene oxide and reduce cancer risk. United States Environmental Protection Agency. https://www.epa.gov/newsreleases/epa-announces-final-rule-slash-toxic-emissions-ethylene-oxide-and-reduce-cancer-risk
MedTech Dive (2023a, June 9). EPA’s proposed ethylene oxide regulations may cost sterilizers more than estimated: Moody’s. MedTech Dive. https://www.medtechdive.com/news/epa-rule-limits-eto-emissions-medical-sterilizers/710307/#:~:text=Dive%20Brief%3A&text=The%20new%20limits%20are%20expected,sterilizers%20by%20more%20than%2090%25.
MedTech Dive (2023b, November 27). Why medical device companies are worried about the EPA’s planned sterilization regs. MedTech Dive. https://www.medtechdive.com/news/ethylene-oxide-medical-device-regulations-epa-fda/700742/
MedTech Dive (2024, March 14). EPA final rule limits EtO emissions for medical device sterilizers. MedTech Dive.https://www.medtechdive.com/news/epa-rule-limits-eto-emissions-medical-sterilizers/710307/#:~:text=Dive%20Brief%3A&text=The%20new%20limits%20are%20expected,sterilizers%20by%20more%20than%2090%25.
Tennessee Lookout (2024, May 15). South Memphis celebrates its collective power after closure of toxic facility. Tennessee Lookout. https://tennesseelookout.com/2024/05/15/south-memphis-celebrates-its-collective-power-after-closure-of-toxic-facility/