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STERIS System 1 Sterilization, Biological Monitoring and


									                                        POLICY/ PROCEDURE/PROTOCOL
Title:  STERIS System 1 Sterilization, Biological Monitoring                    Policy # SPD.36
         and Diagnostic Testing
Audience: Central Sterile Processing Department & Surgical Services

Key Word:       STERIS, Sterilization, Biological, Diagnostic                   Date             Page:
                                                                                5/2001            1 of 4
Distribution:     All Holders of Kaleida Policy & Procedure Manual

Prepared by: Surgical Services Sterile Processing Department Team               Effective
                                                                                Date: 12/27/10

Approved by:                                                    Date:
Surgical Services Standards of Practice                         10/10
Infection Control                                                10/10
Kaleida Health Policy Council                                   10/19/10
Kaleida Health Nurse Executive Committee                        11/5/10

Regulation/ Standards- N/A
Accreditation Standards:
Review Date         12/04  1/2/07
Revision Date         5/01       2/02      10/10

I.       Introduction
         It is the policy of Kaleida Health to provide equipment and instruments which are safe for use on
         individuals seeking care or treatment. In order to achieve sterilization of reusable instruments
         the item must be thoroughly cleaned. The equipment must be registered with the Environmental
         Protection Agency and must have Food and Drug Administration approval. The equipment must
         be used in accordance with the manufacturer’s recommendations.
         The STERIS System 1 is a process that utilizes Paracetic Acid to achieve sterility of instruments
         and scopes.
         The STERIS System requires daily Diagnostic testing to ensure that all Electro/mechanical
         systems and sterile water filters are functioning correctly.
         The system also requires daily Biological Monitoring.

II.      Communication and Responsibility
         Sterile Processing, Surgery, Emergency Department and Special Procedures, Director of
         Surgical Services, Department Managers, Nurse Managers, Unit Supervisors, and all Charge

III.     Scope of Practice
         Surgical Services Staff

IV.      Policy
         A.       Steris System 1 Sterilization
                  1.     Clean item according to manufacturer instruction utilizing hospital approved
                         cleaning agent.
Title: STERIS System 1 Sterilization, Biological Monitoring        Date          Page        Policy #
       and Diagnostic Testing                                      Issued:       2 of 4      SPD.36

               2.     Prepare and load items. Place one clean scope in proper tray or one or more
                      clean devices in appropriate processing tray.
               3.     Ensure that the correct quick connector is applied to the appropriate scope
                      channel (see manufacturer instructions).
               4.     To add Steris sterilant, lower sterilant into compartment, push spike into steriliant
                      container and be sure lid is flush with the tray.
               5.     Insert aspirator probes, biological monitors and test strip. Line up the tip of the
                      aspirator. Insert probe in a downward motion. The top of aspirator should rest on
                      the lid of the sterilant. The probe and tubing should be in the 5 o’clock position.
               6.     Close lid. If resistance is met, inspect and reposition tray.
               7.     Press “Start”. Light 1 – on, Ready light – off, Printer will begin showing date, load
                      ID, time, etc.
               8.     Sterile Processing Cycle is less than or equal to 30 minutes time depending on
                      temperature and pressure of incoming water and filter cleanliness.
               9.     At completion of Sterile Processing Cycle you will hear an audible tone – five (1)
                      second beeps. Light 1-4 will be off, complete light will be on.
               10.    Press cancel; ready light will come on. Complete light will turn off, inflatable seal
                      will deflate. The Printer will print chamber “OPEN” time, and will show the
                      complete cycle record.
               11.    Open lid once the seal deflates.
               12.    Remove aspirator probe from sterilant and check container. The load cannot be
                      considered sterile if steriliant is present in the container. Visually check chemical
                      indicator to ensure color change and discard. Verify the quick connection. Refer
                      to disposal instructions.
                      **Keypoint: Chemical Indicator starts light purple and will turn white if passes.
               13.    Remove processed items, tray, etc. Follow departmental procedures for
                      transportation to sterile field (Items must be used immediately).

                      **Keypoint: The processor will not reprint a load cycle. (Be sure to check paper
                      chamber at the beginning of the cycle). Operator must verify cycle parameters or
                      the contents cannot be considered “sterile”. Printout must accompany

               14.    Safety Precautions:
                      a.     All employees working with Steris must wear gloves, a gown and goggles
                             or face shield.
                      b.     An eyewash station must be kept in area of Steris.
                      c.     Please contact the site Safety Officer with exposure concerns.

               15.    Storage
                      Storage steriliant is a dry and cool environment.

               16.    Disposal of excess steriliant:
                      a.    Dispose of in septic system
                      b.    Dispose of any unused steriliant by submersing under water.
                      c.    Call Manufacturer’s Customer Service as necessary.

       B.      Performing Diagnostic Cycle
               1.    Diagnostic Cycle is performed daily.
               2.    Place tray in processor.
                     **Keypoint: Never use sterilant for diagnostic cycle
Title: STERIS System 1 Sterilization, Biological Monitoring          Date         Page         Policy #
       and Diagnostic Testing                                        Issued:      3 of 4       SPD.36

               3.       Close the lid and press “Diagnostic” button. Diagnostic light will turn on;
                        “Ready” light will turn off. The printer will start.
               4.       A series of tests will be performed during the diagnostic cycle.
               5.       When the cycle is complete the “Diagnostic” light will go out and the “Ready” light
                        will turn on. The inflatable seal automatically deflates. Printout will advance to
                        show cycle message: Operator ID, processor serial number and current cycle
                        count (“system diagnostic test passed”).
               6.       Lift the handle, open lid. System 1 Processor is now ready to process devices.
               7.       If print out reads “system diagnostic test failed”, perform another diagnostic test.
                        If system fails a second time, remove the processor from service and notify the
                        Clinical Engineering Department.
                        **Keypoint: Refer to the STERIS System 1 manual to troubleshoot diagnostic
                        cycle; Problem sections 6-17 through 6-36. The manufacturer may also be
                        contacted if unable to resolve the error.

       C.      Biological Monitoring
               1.     The biological monitoring process is performed daily after the diagnostic test.
               2.     Grasp spore strip and envelope with one hand. Tear the envelope crosswise to
                      expose strip
               3.     Grasp strip with orange vascu-stat clip. USE OF HEMOSTATS OR CLAMPS IS
                      NOT RECOMMENDED.
                      **Keypoint: Failure to use the clip may result in a positive growth.
               4.     Place orange vascu-stat clip and spore strip in accessory rack. Testing may be
                      done with or without devices in tray.
               5.     Add steriliant and chemical indicator
               6.     Complete sterilization cycle, open lid.
               7.     Put on sterile gloves. To reduce risk of contamination, DO NOT remove strip yet.
               8.     Hold vial in one hand. Grasp vial cap with little finger of outer hand. Remove lid
                      from vial. Open vial, then angle until spore has been inserted.
               9.     Remove the orange clip (with spore strip) from processor, AVOID contact with
                      non-sterile surfaces.
               10.    Insert spore into vial and close cap. Be sure spore strip is FULLY immersed.
               11.    Prepare label for vial. Mark load # and date on vial before incubation.
               12.    Place vial in incubator. Incubator temperature must be 56C.
                      Check vial daily for growth. A color change from orange to yellow is a positive.
                      A control test is performed weekly for visual comparison
               13.    The incubation period is 48 hours. Record results at the end of the 48 hours.
               14.    Dispose of all Biological Vials in hazardous waste containers.

V.     Procedure – N/A

VI.    Protocol – N/A

VII.   Documentation
       A log (site specific) will be maintained in each area of use to include:
       Name of Item
       Operators’ initials
       Patient and physician name
       Attach printout to log.
Title: STERIS System 1 Sterilization, Biological Monitoring                              Date              Page            Policy #
       and Diagnostic Testing                                                            Issued:           4 of 4          SPD.36

VIII.     References
          AAMI (Association of the Advancement for Medical Instrumentation)

          AORN Standards, Recommended Practice, and Guidelines 2010

          STERIS System 1 Operator Manual

Kaleida Health developed these policies and procedures in conjunction with administrative and clinical departments. These documents were
designed to aid the qualified health care team in making clinical decisions about patient care. These policies and procedures should not be
construed as dictating exclusive courses of treatment and/or procedures. No health care team member should view these documents and their
bibliographic references as a final authority on patient care. Variations of these policies and procedures in practice may be warranted based
on individual patient characteristics and unique clinical circumstances. Please contact the print shop regarding any associated forms.

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