Beyond Immediate-Use Steam Sterilization: Ensuring Safe and Efficient Sterilization in the Operating Room

Sterile Processing Perspectives with Marjorie Wall, EDBA, MLOS, CRCST, CIS, CHL, CSSBB

Sterile processing is critical in ensuring patient safety by preventing surgical site infections (SSIs). While traditional sterilization cycles in sterile processing departments (SPD) provide robust reprocessing, the demand for rapid instrument turnover in operating rooms (OR) necessitates alternative methods.

Immediate-use steam sterilization (IUSS) has been widely discouraged due to its risks and regulatory concerns, but short-cycle sterilization has emerged as an alternative. Unlike IUSS, short-cycle sterilization meets manufacturer-recommended minimum drying times, allowing instruments to be properly packaged and stored until use. However, several factors—including compliance with manufacturer instructions for use (IFU), validation of cycle parameters, and protocols for safe hot transport—must be carefully managed to ensure this process remains safe and effective.^1,2

Understanding Short-Cycle Sterilization

Short-cycle sterilization is distinct from IUSS in that it allows for the packaging of instruments, meeting sterilization and drying parameters that enable safe storage until needed. This method is beneficial in high-turnover surgical environments, such as ophthalmology, orthopedics, and cardiovascular surgery, where instrument demand is high and conventional sterilization turnaround times may be too slow to support surgical schedules.

The Centers for Medicare & Medicaid Services² has clarified that short-cycle sterilization is not equivalent to IUSS, provided it adheres to validated sterilization parameters, packaging requirements, and storage protocols.² Facilities that utilize short-cycle sterilization must validate their process to ensure that shortened dry times do not compromise sterility and packaging integrity. This differentiation is essential for compliance with regulatory standards and infection control best practices.²

Regulatory and Manufacturer IFU Compliance

For a short-cycle sterilization process to be considered safe, it must comply with the manufacturer’s IFU for both the sterilizer and the instruments being reprocessed. Some sterilizers offer validated short cycles with adjusted parameters that meet sterilization requirements while reducing processing time. However, it is the responsibility of the health care facility to ensure that the instruments themselves can tolerate these modified conditions.¹ The Association for the Advancement of Medical Instrumentation (AAMI) provides guidelines that require facilities to verify and document that shortened drying times still yield dry, sterile, and properly packaged instruments. According to the American National Standards Institute (ANSI)/AAMI ST8:2013/(R)2018, hospital steam sterilizers must demonstrate that reduced drying times do not result in residual moisture, which could compromise sterility.¹

Regulatory agencies like CMS and The Joint Commission expect health care facilities to perform sterility assurance testing when implementing short-cycle sterilization protocols. This may include biological indicator testing, residual moisture checks, and validation studies to confirm that sterility and dryness are reliably achieved in every cycle.²

Comparing Short-Cycle Sterilization and IUSS

Despite their similarities in expedited sterilization, short-cycle sterilization differs from IUSS, which is designed only for immediate-use cases and does not allow for storage of sterilized instruments. One key difference is packaging and storage—short-cycle sterilization ensures instruments are properly packaged and can be stored until needed, whereas IUSS typically involves specialty packaging not validated for storage and mandates immediate use, increasing contamination risk. Another difference is drying time validation—short-cycle sterilization follows minimum drying times as per instrument manufacturers, while IUSS typically lacks a drying phase, leaving instruments moist and vulnerable to microbial contamination.

Additionally, short-cycle compliance and tracking requirements include proper documentation and adherence to sterilizer and instrument IFUs, whereas IUSS is strictly regulated and allowed only for unplanned emergencies.¹ Given these differences, short-cycle sterilization offers a robust and compliant alternative for surgical teams that need fast but safe instrument turnover.

Hot Transport: Managing Instrument Cooling and Safety

One challenge associated with short-cycle sterilization is ensuring that instruments are safely transported to the OR before fully cooling. This process, often called “hot transport,” raises concerns about staff safety and sterility maintenance. Regarding staff safety, handling hot trays can lead to thermal burns, particularly if OR staff are not trained in proper handling techniques. Strategies to minimize risk include using insulated gloves or tools for handling heated trays, implementing designated transport protocols to prevent direct contact with hot metal surfaces, and ensuring that OR teams are trained to safely manage warm instruments upon arrival.

Maintaining sterility during transport is equally critical. Sterile instruments must be handled to preserve their integrity during transport. Facilities should ensure that trays remain within their sterile packaging throughout transport, use validated transport containers that allow heat dissipation without compromising sterility, and maintain proper air circulation in transport carts to prevent condensation buildup. These measures help mitigate risks associated with hot transport, ensuring that short-cycle sterilized instruments arrive sterile, intact, and safe for use.

Best Practices for Implementing Short-Cycle Sterilization

To successfully incorporate short-cycle sterilization, health care facilities should follow best practices prioritizing safety, efficiency, and compliance. First, validating the process is essential—this includes conducting sterility assurance testing and residual moisture checks to confirm that cycles achieve consistent, dry, and sterile results. Second, training staff on proper use is critical. Both SPD and OR teams should be educated on instrument IFUs, sterilizer parameters, and transport safety protocols. Facilities should also establish monitoring and auditing practices to track moisture levels, packaging integrity, and sterility assurance data while ensuring that staff adhere to best practices. Finally, proper storage and handling procedures should be in place.

Establishing a designated area for trays that have not yet been cooled and training OR staff to handle sterilized trays correctly can prevent contamination. By implementing these evidence-based best practices, hospitals can integrate short-cycle sterilization safely and effectively, improving surgical efficiency while maintaining strict infection control standards.

Conclusion

Short-cycle sterilization presents a safe, efficient, and regulatory-compliant alternative to IUSS, allowing facilities to achieve faster instrument turnover without compromising sterility. Hospitals can successfully integrate short-cycle sterilization by following manufacturer IFUs, validating cycle parameters, and implementing rigorous handling protocols while ensuring compliance with infection prevention standards.^1,2

Furthermore, addressing hot transport concerns and providing staff training on safe handling practices can further enhance patient safety and operational efficiency. As health care facilities seek innovative solutions to optimize surgical workflows, short-cycle sterilization stands out as a proven strategy for meeting modern perioperative demands.

References

1. Association of periOperative Registered Nurses (AORN). AORN updating guideline for sterilization. OR Today. 2024. Accessed February 23, 2025. https://ortoday.com/aorn-updating-guideline-for-sterilization/
2. Centers for Medicare & Medicaid Services (CMS). Clarification of short-cycle sterilization. American Society of Cataract and Refractive Surgery (ASCRS). 2015. Accessed February 23, 2025. https://ascrs.org/-/media/files/advocacy/cms-clarification-of-short-cycle-sterilization-2515.pdf