Quality Assurance and Documentation for Using IUSS - Immediate Use Steam Sterilization

 

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

Sharing my personal notes

As an SPD educator, it's crucial to emphasize the importance of strict adherence to protocols when performing Immediate Use Steam Sterilization (IUSS). This ensures patient safety and maintains compliance with regulatory standards. Below are my notes in searching guidelines for providing quality assurance and thorough documentation during the IUSS process.

Pre-Sterilization Process

1. Cleaning/Decontamination:
• Instruments must be cleaned and decontaminated in the Sterile Processing Services (SPS) or an appropriate negative pressure-soiled utility room equipped with a sink in the OR.
• Transport the instrument to the OR in a contained system to maintain cleanliness.
2. Preparation for IUSS:
• Place the instrument in an appropriate rigid container designed for IUSS, using a Class V or VI chemical indicator.
• Seal the rigid container and apply the necessary filters. Ensure the container is not locked to prevent potential shelf placement if the item is not used.
• Do not use wrappers for the IUSS process.
• Select the appropriate IUSS cycle based on the manufacturer's Instructions for Use (IFU). If processing multiple items, use the most rigorous cycle values.

Post-Sterilization Process

1. Verification and Documentation:
• Verify sterilization parameters using the mechanical printout. If any parameters are not met, the item must not be used.
• Promptly remove the sterile item from the autoclave using heat mittens or gloves and transport it to the OR.
• Place the rigid container on a clean surface, and remove the lid aseptically using heat mittens or gloves.
• The scrub person should verify the color change of the internal chemical indicator and remove the item aseptically. The item must not be used if the indicator shows an inappropriate or no color change.
• Complete the documentation of the IUSS cycle.

Quality Assurance Cycles

1. Daily Biological Indicator (BI) Testing:
• Run a BI test daily for each cycle type and temperature, as pre-vacuum and gravity processes require different indicators. Use Geobacillus stearothermophilus spores to challenge the sterilization process.
• Document the results of BI testing, including incubation time based on the cycle type.
2. Record Keeping:
• Save all items related to the sterilizer load, including the mechanical printout and internal chemical indicator.
• Document patient information, case details, surgeon, date/time of IUSS, and load number per facility policy.
3. Documentation Log:
• Ensure access to complete sterilization records, including:
• Items processed.
• Load number and mechanical printout.
• Chemical indicator results.
• Cycle parameters, date, and time.
• Operator information (who initiated and removed the items).
• Reason for IUSS.
• Results of the DART/Bowie-Dick test if using a pre-vacuum cycle.
• Results of the most recent BI testing.

Documentation for OR Nurse Manager Records

1. Traceability and Compliance:
• Record the medical record number and patient name for traceability, along with the staff member's name performing the IUSS process.
• Document the date, time, load number, OR number, autoclave ID, cycle duration, temperature, items sterilized, and reason for IUSS.
• Verify and document that sterilization parameters were met.
• Include names of staff operating the sterilizer and removing the processed items.
• Report any potential sterilizer failures to SPD/Nursing/Surgery leadership.
2. Monitoring and Reporting:
• Use Class 5 or 6 chemical integrating indicators within each sterilizer container or tray.
• Monthly, report the total number of IUSS cycles, types of instruments processed, and reasons for cycles to the Infection Control office or IUSS Usage Review committee. The committee reviews these reports to determine necessary actions to prevent recurrence.

By following these guidelines, OR and SPD staff can ensure the efficacy of the IUSS process, maintain exacting standards of patient safety, and comply with documentation requirements.

Sources used:

1.         Joint Commission - Instrument Reprocessing - Immediate Use Steam https://www.jointcommission.org/standards/standard-faqs/ambulatory/infection-prevention-and-control-ic/000002122/

2.         AJIC - Immediate use steam sterilization: Moving beyond current https://www.ajicjournal.org/article/S0196-6553(13)00006-0/fulltext

3.         ASC Quality - Immediate-Use Steam Sterilization Policy https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fascquality.org%2Fwp-content%2Fuploads%2F2024%2F02%2FImmediate-Use_Steam_Sterilization_P_P_Template-3.doc100.docx&wdOrigin=BROWSELINK

4.         Quizlet - Chapter 13 Point-of-Use Processing Flashcards

5.         ANSI/AAMI ST79:2017/(R)2022