The EPA’s new ethylene oxide (EtO) regulations are poised to transform healthcare sterilization. EtO sterilizes nearly half of U.S. medical devices, so these changes could trigger supply chain disruptions, workflow shifts, and added pressure on sterile processing departments (SPD).
OR Today Magazine (March 2025) warns that hospitals and ASCs may need to adapt as alternative methods gain traction. This puts SPD teams at the forefront of ensuring patient safety and regulatory compliance amid evolving standards.
At PKT, we see a growing need to keep SPD equipment in top shape. As facilities lean on in-house sterilization to offset delays, deep cleaning and maintenance are critical to prevent biofilm, contamination, and inefficiencies.
Key Impacts of the New EtO Regulations:
✔️Device Shortages: Supply chain hiccups may delay sterilized instruments.
✔️SPD Workload Surge: More in-house sterilization means higher demand for reliable, clean equipment.
✔️Compliance Upgrades: New rules could mandate better ventilation and emission controls.
✔️Method Shifts: Transitions to vaporized hydrogen peroxide or gamma radiation require pristine processing environments.
With PKT’s expert SPD cleaning services, hospitals can maintain compliant, efficient, and safe sterilization processes during this shift.
Source: OR Today, March 2025 – [“How Might New EtO Regulations Affect the Perioperative Environment?”] https://ortoday.com/how-
Let’s talk! How is your facility preparing for these changes? Drop your thoughts in the comments or reach out to discuss how PKT can support your SPD team.
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