Documenting the steam sterilization process

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                                                                         SELF-STUDY SERIES                                      Sponsored by

            October 2007
            The self-study lesson on this central service topic was
                                                                         Documenting the steam
            developed by 3M and AAMI (Association for the Ad-
            vancement of Medical Instrumentation). The lessons
            are administered by KSR.
                                                                         sterilization process
            Earn CEUs                                                    by Susan Flynn, BESc, CSPDT
            The series can assist readers in maintaining their CS
            certification. After careful study of the lesson, complete

            the examination at the end of this section. Mail the                      ocumentation, while not glamor-           values are provided in Table 1. It is the re-
            complete examination and scoring fee to Healthcare                        ous, is an essential element of the       sponsibility of personnel in each work area
            Purchasing News for grading. We will notify you if you                    Sterile Processing department’s           to record the temperature and relative hu-
            have a passing score of 70 percent or higher, and you        Quality Control program. Commonly re-                  midity daily.
                                                                         ferred to as recordkeeping, documentation
            will receive a certificate of completion within 30 days.
                                                                         makes an inventory of the materials that               Mechanical cleaning equipment
            Previous lessons are available on the Internet at
                                                                         have been processed and the results of the             Documenting the monitoring and verifica-
                                                                         sterilization process monitoring. All data is          tion of mechanical cleaning equipment is
                                                                         incorporated into a paper or electronic log            recommended as part of a complete quality
            Certification                                                system or filed as individual documenta-               assurance program because decontamina-
            This in-service has been pre-approved by the CBSPD           tion records. This documentation is essen-             tion is such a critical step in device repro-
            for 1 Contact Hour. Follow the CBSPD CEU Protocols           tial in determining the reasons for                    cessing. If available, the cycle printout
            for pre-approved in-services. The protocols can be found     sterilization process failures which can in-           should be reviewed and initialed. Verifica-
            on CBSPD website or by calling         clude human error, equipment failures,                 tion methods include visual inspection of
            CBSPD office at 908-454-9555.                                and/or poor sterilant quantity and quality.            cleaned instruments, the use of test devices
                                                                         Documentation is also used when products               (e.g. metal coupons with test soil that simu-
            For more information                                         need to be recalled in the healthcare facility.        lates coagulated blood), or the use of artifi-
            Direct any questions to Healthcare Purchasing News           This self-study highlights the information             cial soil on medical devices.1
                                                                         required to document the steam steriliza-
            (941) 927-9345, ext 202.
                                                                         tion process and to facilitate product recall          Sterilizers - Maintenance record and
                                                                         of healthcare manufactured products. The               calibration
            Learning                                                     main references used in the preparation of
                                                                         this self-study were:
                                                                                                                                A major part of recordkeeping is documen-
                                                                                                                                tation of the maintenance of each sterilizer
            Objectives                                                   • Association for the Advancement of
                                                                            Medical Instrumentation’s (AAMI’s) Com-
                                                                                                                                in a healthcare facility. This documentation
                                                                                                                                “should include information to identify the
            1. Develop a policy and procedure for                           prehensive guide to steam sterilization and ste-    equipment and to establish a continuous
            documentation of sterilizer                                     rility assurance in health care facilities (ANSI/   history of all scheduled and unscheduled
            maintenance, product identification                             AAMI ST79:2006).1                                   service.”1 This information is important be-
            and traceability, and the results of                         • Association of periOperative Registered              cause it can be used to verify that the ster-
            routine sterilizer efficacy monitoring,                         Nurses (AORN), Recommended Practices for            ilizers are working, have appropriate
            sterilizer qualification testing and                            Sterilization in Perioperative Practice Settings.   preventive maintenance, were repaired
            product testing.                                                AORN Standards, Recommended Prac-                   when a problem was identified, and assist
                                                                            tices, and Guidelines:2007.2                        in troubleshooting when a sterilizer mal-
            2. Develop a policy and procedure for
                                                                                                                                functions or a sterilization process failure
            documentation of implant loads.                              Work area and equipment                                occurs.
            3. Describe how to use documented                                                                                      According to ANSI/AAMI ST79:2006, a
            results to do a recall and solve                             Work area                                              maintenance record should be kept for
            sterilization process failures.                              Controlling the temperature and relative               each sterilizer. This maintenance record
                                                                         humidity in the work area at recommended               should include:
                                                                         values helps minimize microbial growth,                1. date on which service was requested;
            Sponsored by:                                                improve employee comfort, and prevent                  2. model and serial number of the
                                                                         excessively dry materials from adversely                  sterilizer;
                                                                         affecting sterilization cycles. Recommended            3. location of the equipment (healthcare fa-

                                                                               Table 1: Recommended Temperature and Relative Humidity Values1
                                                                          Work Area                    Recommended Temperature1         Recommended Relative Humidity1
                                                                          Decontamination              16°C to 18°C (60°F to 65°F)      30% to 60%
                                                                          Prep and Pack                20°C to 23°C (68°F to 73°F)      30% to 60%
                                                                                                                                        (ideally 50%, and not less than 35%
                                                                                                                                        for best results)

                                                                          Sterile Storage              20°C to 24°C (68°F to 75°F)      <70%

            50 October 2007 • HEALTHCARE PURCHASING NEWS •
                                                  Sponsored by                                        SELF-STUDY SERIES
   cility identification, if applicable);                                                             and the optional use of a Process Challenge
4. name of individual from                                                                            Device (PCD or test pack) containing one
   healthcare facility who                                                                            of the following: a biological indicator (BI),
   requested and authorized                                                                           a BI and a Class 5 integrating indicator, a BI
    service;                                                                Figure 1:                 and an enzyme-only indicator, a Class 5 in-
5. reason for service request;                                        Options for lot control         tegrating indicator, or an enzyme-only in-
6. description of service per-                                           identifier labels            dicator.
   formed (e.g., calibration,                                                                            Sterilization records for each cycle must
   repair);                                                                                           be maintained either in a paper or electronic
7. types and quantities of parts                                                                      system, with electronic records recom-
   replaced;                                                              Lot control numbers         mended because they facilitate access to in-
8. name of the person who per-                                            Each item or pack           formation for a quicker response when ster-
   formed the service;                                               should be labeled with a         ilization process failures occur. The
9. date the work was completed;                   lot control identifier (sterilizer identification   information for each sterilization cycle in-
10. handwritten or electronic signature and       number or code, date of sterilization and           cludes:
   title of person who acknowledged               cycle number). These lot control labels are         • lot number;
   completion of the work; and                    typically bar-code labels printed as the ster-      • contents of load;
11. results of any post-maintenance testing       ilizer cart is being loaded or sterilization la-    • exposure time and temperature if not on
   performed, if needed, before the steril-       bels applied using a label applicator (see             a recording chart;
   izer was returned to service.1                 Figure 1).                                          • operator identification;
   “These records must be maintained by                                                               • results of BI testing, if applicable;
the healthcare facility” for the time deter-      Expiration dating                                   • results of the Bowie-Dick testing, if
mined by state and local regulations, legal       For proper stock rotation, each item should            applicable;
considerations, individual situation, and         also be labeled with an expiration date or          • results of chemical indicator (CI) in
according to the facility’s policies and pro-     statement such as: “Contents sterile unless            the PCD (BI challenge test pack, BI chal-
cedures.1 These records should be kept by         package is open or damaged. Please check               lenge test tray, CI challenge test pack), if
all of the following:                             before using.”1                                        applicable;
• supervisor responsible for the equipment          For flash sterilization, labels are not used,     • any reports of inconclusive or nonrespon-
   (e.g. sterile processing, OR, etc.);           but the following information should be                sive CIs in the load.1
• hospital engineering staff;                     generated for each sterilization cycle using           For flash sterilization, AORN recommen-
• service person;                                 a load record:                                      dations state:
• whomever deemed appropriate by the              • sterilizer identification and cycle               • Record the physical parameters for each
   healthcare facility.1                            number;                                              cycle, and verify the results before the item
   In addition to keeping a maintenance           • contents of load;                                    is transferred to the point of use;
record for each sterilizer, periodic              • time and temperature of exposure phase            • Use a sterilization process monitoring de-
calibration, as specified in the manu-              of cycle;                                            vice with each load to be flash sterilized;
facturer’s operating manual, should be per-       • signature or identification of operator;          • Documentation should be traceable to
formed and documented. Recalibration              • date and time of cycle.                              each patient;
should also be done after repair or replace-                                                          • Document information on each load:
ment of any component that may affect             Sterilization process outcomes                         1. Device(s) processed;
sterilizer performance.1                          Chapter 10 of ANSI/AAMI ST79:2006                      2. Patient receiving item(s);
                                                  discusses the four essential elements of an            3. Reason for flash sterilization.
Product identification and                        effective sterility assurance program:
traceability                                      • Routine load release for both implant and         Routine load release for implant loads
This part of recordkeeping documents each           nonimplant loads;                                 Monitoring tools recommended to release
item or product processed, assists in proper      • Routine sterilizer efficacy monitoring;           implant loads are the sterilizer’s physical
stock rotation, establishes accountability        • Sterilizer qualification testing;                 monitors, external and internal chemical
and assists with recalls. Both AAMI and           • Periodic product quality assurance                monitoring of packages, and a PCD con-
AORN stress the goal of traceability. AAMI          testing.                                          taining either a BI and a Class 5 integrat-
ST79:2006 states: “Ideally, every repro-            Details about performing each of these            ing indicator or a BI and an enzyme-only
cessed medical device, especially an im-          elements were provided in previous self-            indicator. Except in defined emergency
plant, should be fully traceable to the           study articles.3, 4, 5, 6 This article focuses on   situations, the implant should not be re-
patient on whom it is used or in whom it is       the documentation requirements associated           leased until the results of the BI are avail-
implanted; such traceability can be accom-        with each element.                                  able. AAMI ST79:2006 references the CDC
plished by recording the sterilizer load                                                              to stress this point: “The load should be
identifier on the patient chart or the patient    Routine load release                                quarantined until the results of the BI test-
name on the load record.”1 While AORN’s           for nonimplant loads                                ing are available (CDC, 2003a).”1 If an im-
practice guidelines reads: “Documentation         The sterilization monitoring tools used to          plant is prematurely released before the BI
should be maintained to allow for trace-          release a nonimplant load include the               result is available, the event should be
ability of every load to the patient for who      sterilizer’s physical monitors, external and        documented using an implant exception
the instruments are used.”2                       internal chemical monitoring of packages,                         See SELF-STUDY on page 52
                                  Self-Test Answers: 1. A, 2. A, 3. A, 4. B, 5. A, 6. A, 7. A, 8. A, 9. A, 10. A

                                                             • HEALTHCARE PURCHASING NEWS • October 2007 51
SELF-STUDY SERIES                                Sponsored by

form. This form requires providing the fol-        test, test and control BIs) using either a        Recall of products processed
lowing information each time an implant            paper or electronic record keeping system.        within a healthcare facility
is prematurely released:                                                                             The objective of a recall is to “expedite the
• Name of implant prematurely released,            Sterilizer qualification testing                  retrieval of processed items that are sus-
  patient and surgeon;                             Sterilizer qualification testing should be        pected to be nonsterile and to ensure ad-
• Reason for premature release;                    conducted in cooperation with the steril-         equate follow-up actions such as quarantine
• What could have prevented premature              izer manufacturer. Sterilizer qualification       of the sterilizer, notification of physicians
  release of the implant?                          testing using a biological indicator process      and affected clinical departments, and sur-
  Documentation described in ST79 related          challenge device (BI PCD) is performed            veillance of patients.”1
to processing implants that may be new to          after sterilizer installation; sterilizer relo-      Each healthcare facility should have writ-
your facility includes:                            cation; sterilizer malfunctions; sterilizer       ten policies and procedures for the recall of
• Recording the results for the Class 5 in-        major repairs; and sterilization process fail-    items from issued or stored sterilization pro-
  tegrating indicator or enzyme-only indi-         ures. 1 Qualification testing is also per-        cess loads. These policies and procedures
  cator now included in the BI PCD for             formed when major repairs or changes are          should be developed for compliance with the
  implant loads;                                   made to the utilities connected to the ster-      Safe Medical Devices Act of 1990 as it per-
• Implant Devices Load Record (sam-                ilizer that may affect its performance. These     tains to failures of reusable medical devices.1
  ple provided in Annex L of AAMI                  include: changes necessitated by water-           Documentation, from the lot control num-
  ST79:2006);                                      main breaks, annual boiler maintenance,           bers and sterilization records to the recall re-
• Written guidance defining emergency              additional equipment loads that place a           port, is the major ingredient for an effective
  situations developed in consultation             strain on the utilities, and installation of      and timely recall. A computerized or elec-
  with infection control, surgeons, and risk       new boilers.1                                     tronic recordkeeping system can simplify the
  management;                                         Three consecutive empty cycles (except         recall and the investigation of a sterilization
• Exception Form for Premature Release of          in tabletop sterilizers where this testing is     process failure. With such a system, it is easier
  Implantable Device/Tray (sample pro-             done in a full load) should be run with a BI      to review the various types of monitoring
  vided in Annex L of AAMI ST79:2006).             PCD. In dynamic-air-removal sterilizers,          data and to identify items in the failure load,
                                                   this testing is followed by Bowie-Dick test       other loads from the specific sterilizer, and
Implants and flash sterilization                   packs (BD PCDs) run in three consecutive          all loads recently processed by a particular
Neither AAMI nor AORN recommend                    empty cycles.                                     operator. An electronic system may also per-
flash sterilization of implantable devices.           Documentation of this verification that        mit access to sterilizer maintenance records,
If flash sterilization of an implant is done,      the sterilizer is functioning properly would      which may provide links to previous steril-
the sterilization process monitoring results       include recording appropriate CI results          ization process failures, reasons for the fail-
should be documented and fully traceable           (including the Bowie-Dick test result sheets      ure, the resolution required, and the results
to the patient on whom it is used or in            for dynamic-air-removal sterilizers), physi-      of qualification testing of the sterilizer.
whom it is implanted.1,2 AORN’s recom-             cal monitor results (e.g. cycle printouts),
mended practice states: “If an emergency           and all biological indicator results (nega-       When to recall
situation makes flash sterilization unavoid-       tive test BIs and positive control BIs).          In a healthcare facility, when a load of pro-
able, a rapid-action biological monitoring                                                           cessed medical devices is released prior to
device should be used along with a class V         Periodic product quality assurance                obtaining the results of a BI and the BI subse-
chemical integrator. The implant should            testing of routinely processed items              quently indicates a sterilization process fail-
not be released until the rapid-action indi-       Product testing is recommended because the        ure (i.e., is positive), a recall must be initiated.
cator provides a negative result. After the        BI PCDs used for routine and qualification        At that time, all medical devices processed
rapid-action negative result is obtained, the      testing present a known challenge to the          since the last load showing a negative BI
implant can be released for use in the im-         sterilization process but do not necessarily      should be considered nonsterile, retrieved
mediate situation.”2                               reflect the same challenge as items routinely     and reprocessed.1 The only exception would
                                                   processed. Routinely sterilized products          be if it was determined that the sterilization
Routine sterilizer efficacy monitoring             should be tested periodically, and testing        process failure was a result of operator error
Routine sterilizer efficacy monitoring of all      should also occur when “major changes are         such as running the incorrect cycle for the
steam sterilizers should be conducted              made in packaging, wraps, or load configu-        load.
weekly, preferably daily, using appropri-          ration, such as dimensional changes, weight         A recall can also occur if, after the medical
ate BI PCDs, to ensure their effectiveness         changes, or changes in the type or material       devices are released, a review of the moni-
in sterilizing medical devices. Remember           of packaging or wrapper.”1 The testing is         toring data shows that the physical param-
that if a sterilizer is designed to run mul-       conducted both to verify the effectiveness        eters were not met or internal chemical
tiple types of cycles, each sterilization mode     of the sterilization process and to avoid wet     indicators from several packages from a load
should be tested. In addition to the test          packs. Obtaining current recommended re-          did not reach the desired endpoint.
BIs, incubate a nonprocessed BI from the           processing instructions from the medical
same lot as a positive control each day a          device manufacturer is a critical first step in   How to do a recall
test BI is incubated.                              conducting product testing.                       The key to an effective recall is immediate
  Additionally, for dynamic-air-removal              As with any sterilization monitoring,           communication to appropriate personnel
sterilizers, Bowie-Dick tests are conducted        documentation is important. In the case of        and departments responsible for retrieving
daily to evaluate the efficacy of the air re-      product testing, document the test proto-         the medical devices before they reach the
moval and steam penetration. Document              col, the test results (physical monitors, BI      patient. As soon as the BI is positive, recall
the results of all routine efficacy monitor-       and CI results, and evidence of moisture)         all loads processed since the last negative BI.1
ing (CIs, physical monitors, Bowie-Dick            and any corrective action taken.                  Monitoring more frequently with a BI and

                                                                                CONTINUING EDUCATION TEST • OCTOBER 2007
Sponsored by                                                             Documenting the steam sterilization process
obtaining results within a minimal incuba-                              Circle the one correct answer:
tion time (e.g., one or three hours) allows ster-
ilization process failures to be identified                             1. Daily recording of temperature and relative        7. The sterilization process monitoring results of
much sooner, instruments to be turned                                       humidity in each work area is recommended.            an implant should be documented and fully
around faster, costs associated with inven-                                 A. True                                               traceable to the patient on whom it is used or
tory and recall to be reduced, and patient out-                             B. False                                              in whom it is implanted.
comes to be improved.7                                                  2. It is recommended that both a maintenance              A. True
                                                                             record and calibration record be maintained          B. False
Recall report                                                                for each sterilizer.                             8. Written documentation defining emergency
A written report should be prepared follow-                                  A. True                                              situations in which an implant may be
ing the recall. The report serves to document                                B. False                                             released before the BI is available should be
the recall and should include the following:                                                                                      developed in consultation with infection
                                                                        3. Product identification and traceability is
a) The circumstances that prompted the re-                                                                                        prevention and control, the surgeon and risk
                                                                            needed for stock rotation, establishing
  call order;                                                                                                                     management.
                                                                            accountability and assisting with recalls.
b) The total number of products intended to                                 A. True                                               A. True
  be recalled and the percentage actually re-                               B. False                                              B. False
  called;                                                                                                                     9. Documentation is the major ingredient for an
c) Surveillance measures taken if affected                              4. The sterilization record for each cycle does not
                                                                            need to include the contents of the load.             effective and timely recall, beginning with lot
  devices could not be retrieved and have                                                                                         control numbers and sterilization records to
                                                                            A. True
  been in contact with patients;                                                                                                  the recall report.
                                                                            B. False
d) Verification that recalled items were re-                                                                                      A. True
  processed;                                                            5. Perform product quality assurance testing to           B. False
e) Corrective action taken to prevent this situ-                            verify that medical devices are being
                                                                            properly sterilized and that packs/trays are      10. A computerized or electronic record keeping
  ation from occurring again.                                                                                                     system can facilitate a recall and the
                                                                            dry when the medical device manufacturers’
                                                                            instructions for use are followed.                    investigation of a sterilization process failure.
Summary                                                                                                                           A. True
Documentation provides supporting histori-                                  A. True
                                                                            B. False                                              B. False
cal records of the items processed and the
outcome of the steam sterilization process,                             6. A load containing implants should be
both of which are important parts of a Qual-                                quarantined until the results of the BI testing
ity Control program. A healthcare facility                                  are negative.
needs clear policies and procedures in place                                A. True
that describe the documentation required for                                B. False
the sterilizers, sterilization processes, and re-
calls of processed medical devices. It is the                                   CONTINUING EDUCATION TEST • OCTOBER 2007
responsibility of the leadership of the
healthcare facility to ensure that these poli-                                    Presented by            Sponsored by
cies and procedures are in place and followed
so that patient safety is maintained. Review
your department’s record keeping policies
                                                                                                                                         Health Care
and procedures, especially those applicable
to the sterilization of implants, to be sure they                                                                             Detach exam, fold and return to:
reflect current recommended practices. HPN
                                                                          Request for Scoring                                 Continuing Education Division
                                                                          • I have enclosed the scoring fee                   KSR Publishing, Inc.
Susan Flynn, BESc. CSPDT is a Technical Ser-                               of $10. (Please make checks payable                2477 Stickney Point Road, Ste. 315B
vice Specialist with 3M Health Care’s Steriliza-                           to KSR Publishing, Inc. We regret                  Sarasota, FL 34231
tion Assurance group in St. Paul, MN.                                      that no refunds can be given.)                     PH: 941-927-9345 Fax: 941-927-9588
                                                                         Please print or type. Return this page only.
1. Association for the Advancement of Medical Instrumentation.
Comprehensive guide to steam sterilization and sterility assurance
in health care facilities. ANSI/AAMI ST79: 2006.                                   Name
2. Recommended Practices for Sterilization in Perioperative Practice
Settings. Association of periOperative Registered Nurses. AORN                       Title
Standards, Recommended Practices, and Guidelines. 2007.
3. Young, Martha. Condensation of the AAMI Steam Sterilization
Recommended Practices-Quality Control-Section 10 Part 1. Manag-
                                                                          Hospital Name
ing Infection Control. Sept:2006.
4. Young, Martha. Condensation of the AAMI Steam Sterilization
                                                                         Mailing Address
Recommended Practices-Quality Control-Section 10 Part 2. Manag-
ing Infection Control. Oct:2006.                                                Apt/Suite
5. Young, Martha. Routine Steam Sterilizer Efficacy Monitoring and
Steam Sterilizer Qualification Testing - Why and How! Healthcare
Purchasing News. February, 2006.                                          City, State, Zip
6. Flynn, Susan. Why Do We Need To Conduct Product Testing?
Healthcare Purchasing News. April, 2006.                                  Daytime Phone
7. Ross, Edwin. Using Biological Monitoring to Reduce Infection, Risk
and Costs, Surgical Services Management. Vol. 4, No. 7, July 1998.
                                                                                 • HEALTHCARE PURCHASING NEWS • October 53
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                                                                               • HEALTHCARE PURCHASING NEWS • October 2007