Immediate-Use Steam Sterilization: Practices, Protocols, and Considerations

 

By Martin Li, MA, CRCST, CER, CIS, CHL

Introduction

Immediate-Use Steam Sterilization (IUSS), often referred to as "flash sterilization," is a critical process in healthcare settings, particularly within operating rooms (ORs), to rapidly sterilize instruments when no pre-sterilized alternatives are available. Managed by the Sterile Processing Department (SPD), IUSS adheres to best practices outlined by the Healthcare Sterile Processing Association (HSPA), the Association for the Advancement of Medical Instrumentation (AAMI), and The Joint Commission (TJC). This article explores the IUSS process, its current and future states, vendor-specific guidelines, and daily qualification testing protocols.

The IUSS Process

When an OR room requires IUSS, a structured workflow ensures compliance and safety:

1. Initiation: The OR staff contacts the SPD to request IUSS, initiating the process.
2. Specification: The OR specifies whether individual instruments or an entire tray requires sterilization.
3. Alternatives Assessment: SPD investigates if sterile alternatives are available at the Main facility or Outpatient Surgery Center (OPSC).
4. Sterilization Execution: If no alternatives exist, SPD assists in operating the core sterilizer, documenting the load and biological indicators using Sterile Processing Management (SPM) software.

This process ensures IUSS is used only when necessary, aligning with industry standards to minimize risks associated with rapid sterilization.

Current vs. Future State

Currently, IUSS is employed as an emergency measure when immediate instrument availability is critical. However, its use is discouraged for complex instruments or trays due to potential sterilization inadequacies. The future state envisions reduced reliance on IUSS through improved inventory management and pre-sterilization practices, reserving IUSS for rare, unavoidable emergencies. Transitioning to this state requires enhanced collaboration between OR and SPD teams, alongside investments in sterile instrument stockpiles.

Instruments and Vendor Guidelines

Certain instruments cannot undergo IUSS due to manufacturer Instructions for Use (IFU) or cycle parameter restrictions. Examples include:

• ENT/Shonka Spandex Cheek Retractor: Prohibited due to cycle parameters (GR.30.10.250).
• EYE/MST Instruments: Flash sterilization incompatible (PV 10.20.270).
• NSG/Budde Halo Neuro Retractor: Cannot be flashed per IFU (PV 8.30.270).
• EYE/Resight Tray : Flash sterilization explicitly not permitted (PV 4.30.270).

Vendor IFUs further clarify IUSS limitations:

• Stryker Mako: Does not recommend IUSS for reusable instruments.
• Depuy Synthes: Supports IUSS only for individual instruments in emergencies, not sets or implants.
• Zimmer: Permits IUSS as an emergency procedure without dry time, per specified conditions.
• Acumed and Shukla Medical: Explicitly advise against IUSS.

These restrictions highlight the need for adherence to IFUs and local policies to ensure patient safety and equipment integrity.

Daily Qualification Testing

To maintain IUSS reliability, daily tests are conducted:

1. Control Biological Test: A non-sterilized biological indicator is crushed and incubated in well #1 (marked "C"). After 24 minutes, a positive (+) reading confirms incubator functionality; a negative result prompts contacting Clinical Engineering (CE).
2. Bowie-Dick Test: A blue pack is run on a 4.1.270 cycle. Post-cycle, the test sheet is documented and stored.
3. Attest Pack Test: A white pack with a biological indicator and strip is run on a 4.1.270 cycle. The ampule is crushed post-cycle, incubated in a 490H reader, and documented, with the strip retained for morning review.

These tests ensure sterilizer efficacy and compliance with regulatory standards.

Conclusion

IUSS remains a vital yet cautiously applied tool in healthcare settings. SPD teams can balance urgency with safety by adhering to HSPA, AAMI, and TJC guidelines. As the industry evolves, minimizing IUSS through proactive planning will enhance sterilization practices, ensuring optimal patient outcomes.

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References

1. Association for the Advancement of Medical Instrumentation. (2020). Comprehensive guide to steam sterilization and sterility assurance in health care facilities (ANSI/AAMI ST79:2017). AAMI.
2. Healthcare Sterile Processing Association. (2023). Best practices for sterile processing professionals. HSPA.
3. The Joint Commission. (2022). Infection prevention and control standards for hospitals. TJC.