What are important considerations associated with Immediate-Use Steam Sterilization?
Immediate-Use Steam Sterilization (IUSS), formerly termed “flash” sterilization, is described as “the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field”. IUSS items are not intended to be stored for future use.
Considerations for IUSS:
• Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the
IFUs regarding cycle type, temperature setting, exposure time, and drying times.
• IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
• Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
• IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
• Evidence-based guidelines should be adopted to minimize the use of IUSS. Scenarios when IUSS may be appropriate include:
o When a specific instrument is needed for an emergency procedure.
o When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
o When an item has dropped on the floor and is needed to continue a surgical procedure.
Identifying Gaps and Risk reduction strategies to consider:
• When ‘loaner’ trays or instruments (including those brought in by a provider) are used, establish an agreement with the vendor/provider requiring that delivery
occurs sufficiently in advance of scheduled case(s)
to allow complete reprocessing of trays by the organization. Such a requirement is an example of a performance expectation to include in a contract (see
LD.04.03.09).
• Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
• Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical. Such rounds should include:
o Review of manufacturer’s IFUs for both the device used for IUSS as well as the equipment/instruments being reprocessed to ensure compliance with
their guidelines.
o Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
o Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
• Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
• When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care (see LD.03.03.01).
• Ensure that sterilization practices, in all locations, have been fully incorporated into the organization’s Quality Assessment Performance Improvement (QAPI) activities (see LD.01.03.01 EP 21 and PI.01.01.01 EP 4).
• Evaluate the IUSS process in all locations that it is being performed. Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization (see IC.02.02.01 EP 2).
• Conducting a risk assessment is a helpful way of identifying risks and gaps in compliance with evidence-based guidelines and product manufacturer’s instructions for use. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Resources:
• The Association for Professionals in Infection Control and Epidemiology (APIC)
• The Association of periOperative Registered Nurses (AORN)
• The Association for the Advancement of Medical Instrumentation (AAMI).
• CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.