Administrative Protocol Page 1 of 5 FSC & JDH OR / CSSIR / Sterile Processing Unit Practice Manuals John Dempsey Hospital

Dept. of Nursing

PROCEDURE FOR:

Sterilization

POLICY: 1. Items to be sterilized should be cleaned, decontaminated, sterilized, and stored in a controlled environment, per the Procedure for: Care of Surgical Instruments and Powered Equipment in the Perioperative Setting, this policy, and with the device manufacturer's written instructions. More detailed reference may also be made to the AORN Recommended Practices for Sterilization and the Association for the Advancement of Medical Instrumentation (AAMI) Standards and Recommendations for Sterilization in Health Care Facilities. 2. Items to be sterilized will be packaged in systems (indicators, containers, etc.) that are approved for the specific type of sterilization used. Medical-grade, allpaper pouches will be used for organization of items within sets; combination paper/plastic peel pouches will not be used for this purpose. 3. The sterilizer manufacturer's written instructions for use, monitoring, and maintenance of each specific sterilizer will be followed during use. 4. Load configuration and placement of items inside the sterilizers will comply with the sterilizer manufacturer's recommendations and/or accepted guidelines from AAMI and AORN. 5. Saturated steam under pressure should be used to sterilize heat- and moisture-stable items unless otherwise indicated by the device manufacturer: a. manufacturers' written instructions for operating steam sterilizers and for items sterilized should be followed; certain types of equipment and implants (eg, some pneumatically powered instruments; specialty orthopedic, neurosurgery, trauma instruments) may require prolonged exposure times or drying times; b. following steam sterilization, the contents of the sterilizer should be removed from the chamber and left untouched for a period of at least 30 minutes; c. warm or hot items should not be placed on cool or cold surfaces;

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Administrative Protocol Page 2 of 5 FSC & JDH OR / CSSIR / Sterile Processing Unit Practice Manuals John Dempsey Hospital Dept. of Nursing

PROCEDURE FOR:

Sterilization d. sterilized packages or containers that have formed condensate should be considered unsterile and none of the contents used; e. steam sterilization integrators will be used internally and indicators used externally for all sterilized items. Rapid-action biological spore-test indicators will be used in all loads processed in CSS/IR and for all loads containing implants when processed in steam autoclaves in the surgical suites. 6. Use of flash sterilization should be kept to a minimum: a. flash sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method. b. items that are flash sterilized should be noted on the Flash Sterilization Log to guide purchase of additional inventory; c. packaging and wrapping (eg, textiles, paper/plastic pouches, nonwoven wrappers) should not be used in flash sterilization cycles d. a rapid-action biological spore-test indicator must be run for a minimum of 10 minutes with any implant that is flash sterilized; each flash sterilization cycle should be monitored to verify that parameters required for sterilization have been met and the results are acceptable. Label indicator with last name of patient for whom the implant has been flash sterilized for traceability. e. users should adhere to aseptic technique for flashsterilized items during transport to the point of use; f. it is strongly preferred that a rigid sterilization containers designed and intended for flash-sterilization cycles be used; CSS/IR / Sterile Processing is responsible for routine cleaning of rigid sterilization containers and nursing is responsible for inspecting containers prior to use; g. nursing is responsible for documenting patient and device information on the Flash Log; CSS/IR / Sterile Processing is

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Administrative Protocol Page 3 of 5 FSC & JDH OR / CSSIR / Sterile Processing Unit Practice Manuals John Dempsey Hospital Dept. of Nursing

PROCEDURE FOR:

Sterilization responsible for maintaining documentation of sterilizer cycle information. 7. Ethylene oxide (EO) sterilization that is appropriate for heat- and moisture-sensitive surgical items when indicated by the device manufacturer will be performed only at the JDH CSS/IR site. a. Research Safety is responsible for monitoring air in the enclosed sterilizer location and maintaining records of same; b. manufacturers recommendations will be followed for preparation, exposure, and aeration of items sterilized. 8. Low-temperature hydrogen peroxide gas plasma sterilization methods (Sterrad) will be used for moisture-sensitive and heat-sensitive items and when indicated by the device manufacturer: a. Items to be gas-plasma sterilized should clean and dry and packaged in pouches designed for this sterilization method; b. only trays designed and validated for use with lowtemperature hydrogen peroxide gas plasma sterilization should be used. 9. All loaned instrumentation and equipment that must be sterilized will be handled according to the procedure for: Loaned Instrumentation and Equipment: Inventory and Processing. 10. Sterilized materials should be packaged, labeled, and stored in a manner to ensure sterility, and each item should be marked with the sterilization date. Shelf life is to be considered event-related unless the manufacturer requires / recommends use of an expiration date. 11. Transportation of sterile items should be controlled:

a. sterile items should be transported in covered or enclosed carts; items transported outside the perioperative are should be transported in carts with closed bottoms;

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Administrative Protocol Page 4 of 5 FSC & JDH OR / CSSIR / Sterile Processing Unit Practice Manuals John Dempsey Hospital Dept. of Nursing

PROCEDURE FOR:

Sterilization b. items that are processed in either the JDH or FSC sterile processing areas may be used in either locations operating rooms (ORs) without resterilization at the alternate site as long as transportation between sites maintains sterility, preferably by use of the transport bins maintained for this purpose. 12. As part of overall quality monitoring, all OR gravity displacement autoclaves will undergo daily biological monitoring prior to patient care use and per manufacturer recommendations. CSS/IR staff will perform testing of all autoclaves during normal weekday mornings; OR staff will perform testing on weekends and holidays for any autoclave that will be used. 13. All sterilizer failures and corrective actions will be documented and reported to Infection Control and the Director of Perioperative Services or his/her designee. Load inventory records / flash sterilization log of the affected autoclave will be reviewed and the attending surgeon(s) will be notified if patient exposure occurred. 14. Sterilization records and logs shall be maintained by CSS/IR / Sterile Processing for 5 years.

PROCEDURE FOR: EQUIPMENT

Use of Biological Indicator in Gravity Steam Sterilization 3M Attest 1291 Rapid Readout Biological Indicator (BI) for 270F/132C gravity steam cycles:
Rapid readout BI system monitors the effectiveness of the gravity steam sterilization process with results in one hour. System consists of: a. biological indicators, consisting of a Geobacillus

stearothermophilus spore strip, sealed glass ampule with growth medium and dual indicator system, blue color-coded cap with holes for sterilant penetration, hydrophobic filter as a bacterial barrier, and chemical indicator on the label that changes from rose to brown when processed; b. dual function fluorescent auto-reader/incubator, which runs at 140F/60C.; and
c. log book

Action 1. Label control start of day BI with C and place in incubator, crush

Points of Emphasis 1. A positive control / unprocessed BI and a test BI from the same lot and

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Administrative Protocol Page 5 of 5 FSC & JDH OR / CSSIR / Sterile Processing Unit Practice Manuals John Dempsey Hospital Dept. of Nursing

PROCEDURE FOR:

Sterilization manufacturing date must be incubated daily. Incubation of the positive control gives the benefit of a visual color change by providing a positive fluorescent result (red light +).

vial in crusher well, and place in incubator.

2. Place test pack in the center of the chamber and run for a 10-minute exposure cycle. 2. Retrieve test pack, remove BI vial, crush vial in crusher well to join the growth media with the processed spore strip, and place in auto-reader for 1 hour. 2. Automatic readings are taken until a red or green light goes on. (Incubation of the positive control gives the benefit of a visual color change). Processed indicator results are not valid until the positive control reads fluorescent positive (red light +), which indicates a positive result or sterilization failure. 3. At the end of the incubation time, if a negative indicator result is detected, the rapid read instruments green light (-) will illuminate indicating an acceptable sterilization process. A red light (+) will illuminate and an alarm will sound (if the sound feature is turned on), as soon as a positive indicator result is detected. 4. Record testing results information in log book and discard BIs in biohazardous waste or sharps receptacle. 6. Follow instructions above and label with patient information any BI included in a flash-cycle load that contains implants. 7. Report immediately all positive test results (red) for further investigation and/or action, per 5. Negative results (green): indicates an acceptable sterilization process

6. Complete Flash Sterilization Log entry and check auto-reader for results of rapid read out to confirm negative results.

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Administrative Protocol Page 6 of 5 FSC & JDH OR / CSSIR / Sterile Processing Unit Practice Manuals John Dempsey Hospital Dept. of Nursing

PROCEDURE FOR: policy.

Sterilization

APPROVAL: EFFECTIVE DATE: REVISION DATE:

Nursing Standards Committee 10/03 11/11

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