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Flash Sterilization

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Title: Flash Sterilization


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Flash Sterilization By Colleen
Landers Registered Nurse Consultant
Surgical Suites Sterile
Processing Department
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What is flash sterilization?
Z314.13-01(CSA) Emergency Sterilization
Which now will be replaced by CSA Z314.3
Why? Flash sterilization - a special steam
sterilization process designed and used for the
emergency sterilization of surgical goods when
proper sterilization cannot be done.
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Flash Sterilization
Flash sterilization, if used by facility policy,
shall be used only for emergency sterilization
(for example when a dropped instrument requires
immediate sterilization). Flash sterilization
shall not be used to compensate for inventory
shortages or scheduling problems. Flash
sterilizers will be biologically monitored
minimally daily and all items traceable to the
patient.
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Current practice!
Flashing total sets and implants is
routine. Quick rinse in a sub-sterile room or
scrub-sink area -Uniform or scrub suit sink is
now contaminated Excess flashing due to lack of
inventory and scheduling practices. Flash
Sterilizers with no preventative maintenance No
verification of sterility of items being
sterilized.
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Where do we need to be?
  • Instrument sets should not be flash sterilized.
    Flash sterilizers are only validated for 1-2
    instruments.
  • The following conditions shall be met if you are
    flashing
  • a) there is an urgent unplanned need
  • b) there are documented procedures for this
    practice
  • the physical layout and documented procedures
    assure direct delivery of the sterilized item to
    the point of immediate use.
  • d) The flash sterilizers has routine preventative
    maintenance that is documented.
  • e) Staff trained in reprocessing practices and
    yearly competency testing.

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Where we need to be contd
d. Proper decontamination of instruments
Performed in a separate room/environment
by people who are properly attired with PPE
(personal protective equipment). CSA Z314.8
e. Load documentation monitoring system is
in place. f. All flashed items tracked to
the patient .
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Measures to Avoid Flash Sterilization
  • Measure to avoid flash sterilization
  • maintenance of adequate inventories of medical
    devices
  • coordinating device reprocessing with surgical
    schedules so that properly processed devices are
    available when needed
  • adherence to policies and procedures for loaned
    and shared instrumentation (see Z314.22) so that
    devices arrive in time for proper reprocessing
    and
  • education of medical staff and materials managers
    in the risks associated with flash sterilization
  • Computerized booking systems that cannot be
    converted to override inventory.

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Why not Flash Sterilize?
  • Sterilization process itself can be similar to
    sterilization process performed in reprocessing
    department but the lack of pre- and post-
    sterilization precautions introduces additional
    risks to the use of flashed devices.
  • The facility has a responsibility to ensure that
    every patient receives the same level of care
    therefore should endeavour to avoid the
    additional risks to patient safety associated
    with flash sterilization.
  • Remember that flash sterilizers are only
    validated for 1-2 instruments, and should only be
    used for life and death situations or loss of
    limb not routine for scheduling and lack of
    instrumentation.
  • CSA Standard Z314.3 Flash sterilization shall
    not be used on
  • complete sets or trays of instruments.

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What can be done to change?
  • Develop policies based on CSA standards that both
    SPD and OR staff could follow and live with!
  • How do we do that?
  • Research the CSA documents which are best
    practices in reprocessing
  • Invite an expert to speak to the Peri operative
    Policy and Procedure Committee about the CSA
    Standards.
  • ORNAC Standards are based on CSA.

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CSA Standards and ORNAC
  • Are they mandatory?
  • Why are they written if hospitals cant follow?
    Why write a policy based on CSA Standard that
    cant be upheld due to resources available?
  • Do we bend the Standard to fit resources of the
    hospital?
  • Lots of great questions!

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What can be done to change practices?
  • Develop policies AND..
  • Standardize practices throughout Canada for OR
    SPD
  • Identify staff competencies
  • Develop an education plan
  • Decrease flash sterilization
  • Share our resources 
  • Be a leader!
  • Provide every patient with the same level of
    care

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Policies and Procedures
  • The requirements for policies, procedures,
    documentation and quality
  • system are required.
  • If a flash sterilized medical device is used in a
    procedure, an incident
  • report shall be created that includes the
    following information
  • patients name
  • physicians name
  • date and time the of procedure using the flash
    sterilized device
  • procedure it was used for
  • reason that flash sterilization was needed
  • results of physical monitoring and biological /
    chemical indicator monitoring of the sterilizer
    and load.
  • Periodic review incident reports to help identify
    ways to reduce the need for flash sterilization.

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Policies
  • Flash sterilization process is composed of
    several phases that are critical to achieving and
    maintaining sterility.
  • These phases include
  • transport of contaminated devices to
    decontamination area
  • disassembly and decontamination
  • c) preparation
  • d) loading the sterilizer
  • e) sterilization procedures
  • f) monitoring and recording of cycle parameters
  • f) unloading and aseptic transfer of items to the
    sterile field.

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Personnel Requirements
  • 1. All aspects of emergency steam sterilization
    require
  • supervised staff that are knowledgeable,
    trained
  • personnel wearing appropriate attire,
    including personal
  • protective equipment.
  • 2. Personnel must have demonstrated expertise in
    medical
  • device reprocessing and in the use and
    application of the
  • steam sterilization process.
  • 3. Control of bio burden and containment of
    contaminants are essential to the sterilization
    process.

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Personnel Requirements
  • 4. The health care facility administration to
    ensure that operators of all steam sterilizers
    used for flash sterilization in the facility are
    trained.
  • 5. Education documented with ongoing competency
    in the operation of steam sterilizers.
  • 6. Staff are aware of the hazards associated with
    steam sterilizers.
  • 7. Monitoring and maintenance of sterilizers
    required.

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Flash Sterilization Personnel
  • Flash sterilization personnel must be responsible
    for verifying exposure time and temperature, and
    for aseptically transferring the sterilized items
    to the point of use.
  • Personnel engaged in the processing of items for
    flash sterilization require an initial
    orientation and on-the-job training, including
    instruction in the following
  • a) sterilizer operation and monitoring
    (sterility assurance)
  • b) the parameters of steam sterilization
  • c) basic microbiological principles
  • d) the health care facility's infection
    control and prevention
  • policies and procedures
  • e) decontamination of medical devices

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Flash Sterilization Personnel
  • f) monitoring of sterilization
  • g) preparation of the incident report
  • h) action to be taken if there is a failure
    during reprocessing
  • i) unloading and transfer to the sterile
    field.
  • The facility shall assign specific responsibility
    to a staff
  • member or position for the maintenance of quality
    system
  • documentation relating to flash sterilization,
    including
  • documentation of staff training, and the
    collection, review
  • and retention of flash sterilization incident
    reports.

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Work Area for Flash Sterilization
  • The steam sterilizer used for flash sterilization
    shall be
  • located in a restricted-access area
    immediately adjacent to the area where the
    sterilized items will be used in patient care.
  • The sterilizer shall not be located in the
    operating room theatre, and shall not be near any
    potential source of contamination, such as sinks,
    hoppers, linen, or trash disposal areas.
  • Sterile storage shall not be located immediately
    adjacent to
  • the sterilizer used for flash sterilization.
  • Flash sterilization must be carried out in a
    clean environment.
  • Devices processed by this method must be
    transferred and handled as little as possible as
    may not be protected by packaging before or
    immediately after the sterilization process.

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Work Area
  • At least one flash sterilizer in the OR suite
    shall be on the emergency power system.
  • The facility shall have written validation from
    the sterilizer manufacturer that it is suitable
    for flash sterilization and specifying the size
    of loads for which it has been validated.
  • All instruments shall be cleaned and
    decontaminated prior to sterilization by trained
    staff wearing appropriate PPE. Refer to Z314.8.
    Saline shall not be used. Before they are
    cleaned, general operating instruments shall be
    separated from delicate instruments or devices
    requiring special handling.

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Work Area Decontame
  • Soiled items shall be contained during the
    transport from the point of use to the
    decontamination area.
  • They shall be cleaned immediately.
  • Gloves and appropriate PPE shall be worn when
    handling soiled items.
  • Containment may be accomplished by any means that
    adequately prevents inadvertent personnel contact
    with or exposure to the soiled items during the
    transfer.
  • Reusable transportation containers shall be
    cleaned and decontaminated after each use.

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Sterilization
  • High-temperature saturated steam must come into
    direct contact with all surfaces of all items.
  • Air removal, steam contact, and drainage of
    condensate are enhanced by proper positioning and
    by the use of perforated or mesh bottom trays.
    Items to be sterilized may be placed in
  • (a) protective organizing cases
  • (b) open trays
  • (c) rigid sterilization container systems
  • (d) single wrapped trays
  • Closed container system is preferred, to minimize
    the chance
  • of contamination occurring between sterilizer and
    patient.

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STERILIZATION
  • The health care facility shall follow the
    device manufacturers instructions, including
    those for
  • time and temperature
  • load size (including any necessary adjustments to
    time or temperature with relation to load size)
  • maximum loads (by weight or by number of
    instruments)
  • load configuration
  • Each flash sterilization cycle shall be verified
    by the health care facility through actual
    testing of loads configured as specified in the
    manufacturers instructions.

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Sterilization
  • If flashing will occur for life, limb or organ
    emergency disaster then after
  • cleaning, items shall be placed in a perforated
    or mesh bottom
  • instrument tray and arranged in the following
    manner
  • (a) instruments and devices with concave surfaces
    shall be positioned with the open side down
  • (b) all hinged instruments shall be opened,
    without engaging the ratchet, and shall be
    placed on racks or stringers as needed
  • (c) items with easily removable parts shall be
    disassembled
  • (e) for complex instruments (eg, air-powered
    instruments), the instructions of the device
    manufacturer shall be followed
  • (f) lumens of tubing, suction devices, and
    needles shall be moistened with pyrogen-free
    water immediately prior to steam sterilization.

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Do Health Care facilities meet these requirements?
  • Auditing of healthcare facilities across the
    nation will show that most
  • do not meet these requirements.
  • Most
  • Wash instruments in scrub sinks or small sink in
    between OR theatres.
  • Decontame areas not under negative pressure
    Z314.8
  • Maintenance on these sterilizers not done,
    sterilizers not cleaned, records not kept. Some
    so old should be replaced.
  • Staff not trained to reprocess and do not have
    competency testing or required education.
  • It goes on and
    on!

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Do you meet all these requirements?
  • IF NOT YOUR FACILITY NEEDS
  • TO TAKE ON A PROJECT TO
  • IMPROVE PROCESS!

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Implement to improve patient care!
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Set up a Quality Improvement Project
  • Joint Quality Assurance/Accreditation Project
  • Sterile Processing Department and Surgical
    Suites
  • Called The Flash Project
  • Must have buy in from all parties!
  • Why do it? Best Practices are provided in the CSA
    standards and every facility should be aiming
    for these practices.
  • Accreditation will now be examining flashing
    practices as a part of their review.

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Perioperative Portfolio Meeting
  • Great idea / support evident
  • Invite Quality Decision Support
  • Clerical support required.
  • Infection prevention and control and risk
    management involved.

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The Project
Project Sponsor/Client Director of Perioperative Nursing/ Manager of SPD
Project Stakeholders Director of Perioperative Nursing Manager of SPD/OR Manager OR Staff/SPD Staff Clinical Nurse Educators Physicians/Patients of Capital Health
Corporate Purpose To support the development of district wide Standards and competency based practices
The Team Co-Chairs, Educators, Quality Decision Support, SPD Manager, SPD Supervisors, OR Manager, OR Coordinator, Secretary, Nurse Liaisons, CSA Rep, ORNAC Rep and Infection Control Rep
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Project Objectives
  • To determine frequency/reason for Flash
    sterilization
  • To determine staff competency with Flash
    sterilization.
  • To determine education required.
  • To incorporate Canadian Standards for Flash
    Sterilization
  • To develop a quality monitoring process
  • To improve the standard of patient care and
    improve patient outcomes
  • To share our resources and show you are a leader!

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Goal
  • ALL STAFF PRACTICING FLASH STERILIZATION TO THE
    CANADIAN STANDARDS

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What can be done?
  • Project Map developed with Team in conjunction
    with Management Engineering.
  • Survey/OR Flash Record, developed with Quality
    Decision Support, to obtain full understanding of
    current situation.

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Survey Results
  • Ensure surveys were returned response rate
    then reviewed and results documented.
  • These can be your support to proceed.
  • Staff identified competency re flash sterilizing
    as an issue 79 of the staff felt somewhat or
    not at all confident in their knowledge re flash
    sterilizing.
  • Documentation was also an issue 72 of the staff
    felt somewhat or not at all aware of the
    documentation required for flash sterilization.

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Highlights - Survey Results
  • Only in preparing instruments or equipment for
    flash sterilization, do a slim majority of staff
    (56) feel very competent and comfortable
  • Knowledge about Standards is not an issue
  • 65 of the staff indicated they felt their
    knowledge about Standards for flash sterilization
    is good or very good

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Highlights - Survey Results
  • Staff identified two main reasons for flash
    sterilizing items
  • Items dropped or contaminated during the case
    (10)
  • Scheduling practices (56 )
  • Lack of inventory (34)
  • Was this really the reason data required!

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Flash Sterilization Record
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Purpose of the Flash record
  • Documents
  • Why we are flashing?
  • Traceability to the patient!
  • Frequency of flashing!

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Reasons for Flashing
Booking Contaminated Damage Lack of inventory Other
VG 277 26 5 439 27
HI 156 201 44 309 15
DGH 108 19 30 202 19
HCH 33 3 38 3
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Challenges to Documentation
  • Education to everyone in a timely manner
  • Completion of the form (Accuracy and
    completeness)
  • Timely follow up for omissions
  • Change from current practice
  • Working together so all items can be terminally
    sterilized in the reprocessing department.

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  • Next StepsFinalize policies and education
    modules! Implement policies and provide
    education to all!Evaluate education!Competency
    testing yearly! Document all flash sterilized
    items and meet to solve the issues that required
    this practice!Working together!Re-survey
    staffRe-audit documentation toolReport Data
    results to Leadership

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Change can be accomplished!
  • Working together for the betterment of the
    patient we can all meet best practices in
    reprocessing as
  • Remember!
  • You could be that patient having a surgical
    procedure and
  • would you want a totally processed instrument or
    a flashed
  • one?
  • I know what I would want and so do you!

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REMEMBER, THIS PATIENT COULD BE YOU!! WOULD YOU
WANT THE INSTRUMENTS IN GOOD WORKING ORDER,
CLEAN AND STERILE?
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References
  • CSA Z314.3 Effective Sterilization in Health Care
    Facilities using the Steam Process
  • CSA Z314.8 Decontamination of reusable medical
    devices
  • CSA Z314.22 Management of Loaned, Shared, and
    Leased Medical Devices
  • Linda Jakemans presentation to Health Canada
    Scientif Advisory Panel on Flash Sterilization

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Questions
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Thank-you!
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