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:
- Initiation: The OR staff contacts the SPD
to request IUSS, initiating the process.
- Specification: The OR specifies whether
individual instruments or an entire tray requires sterilization.
- Alternatives
Assessment: SPD investigates if sterile alternatives are available at the Main
facility or Outpatient Surgery Center (OPSC).
- 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:
- 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).
- Bowie-Dick Test: A blue pack is run on a 4.1.270
cycle. Post-cycle, the test sheet is documented and stored.
- 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.
References
- 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.
- Healthcare
Sterile Processing Association. (2023). Best practices for sterile
processing professionals. HSPA.
- The Joint
Commission. (2022). Infection prevention and control standards for
hospitals. TJC.