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The Current Challenges in the North American Reprocessing Field and Proposed Solution!


Medical Device Specific Instructions for Reprocessing What you don t Know? ... rigid containers or pouches) should be included in the validation process. – PowerPoint PPT presentation

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Title: The Current Challenges in the North American Reprocessing Field and Proposed Solution!

The Current Challenges in the North American
Reprocessing Field and Proposed Solution!
  • By Colleen Landers
  • Registered Nurse
  • Consultant

  • Define the major issues facing reprocessing
  • Provide options to solve these issues.
  • Refer to the standards that reprocessing
    departments require to solve these issues.

  • Cleaning and sterilization instructions.
  • Turn around demands.
  • Sterilization extended cycles.
  • Staff orientation, education and competency
  • Weight of Sets.
  • Loaner Sets.
  • Flash Sterilization

Medical Procedures
  • First Do no Harm
  • New Millennium Age of the Internet and
    Litigation!!(The Public are informed and
    demanding more
  • of HealthCare).

Cleaning and Sterilization of Medical Devices
  • Medical Devices have become increasingly complex
    as more sophisticated and less invasive surgical
    procedures are developed.
  • The manufacturers validated reprocessing
    instructions for these devices have not kept pace
    with the requirements listed in the Canadian and
    American standards.

Cleaning and Sterilization of Medical Devices
  • Along with this issue, the increased demand to do
    more surgical procedures, requires faster turn
    around of instruments to meet the surgical
  • Concern regarding the safety of patients
    receiving healthcare in North America has
    required the standards to be reviewed and
    requirements increased.

Cleaning of Medical Devices Who is responsible
for What??
  • Manufacturers validate that instrument can be
    reliably cleaned and sterilized/disinfected and
    is therefore re-usable.
  • Users verify that cleaning sterilization
    equipment is working properly and that
    in-hospital cleaning sterilization methods are
    consistently performed and verified.

Medical Device Specific Instructions for
  • What you dont
  • Know?

Manufacturer recommended cleaning that is not
  • Ivory Snow!
  • No detergent! (only sterile distilled water)
  • Use regular hospital cleaning protocol!

Crud Issue
Patient-used (no side-panel) un cleaned
Patient-used repeatedly side-panel removed
Show Me the MONEY!!
  • STERILE Crud???- Acetabular reamers- Electronic
    drill Hand pieces
  • No infection risk ? ? What is the issue?
  • Cost/Benefit What is realistic???

Sterile Crud ???
  • Foreign organic material- Endotoxin (LPS) from
    dead bacteria- blood and other organic debris
    from previous patient or from cleaning process
    (e.g. enzymatic detergent residuals, water
    organisms etc).
  • Adverse antigenic reaction to foreign organic
    material (e.g. implants LPS).
  • Foreign body Nidus for endogenous infection.

Xing et al. Accumulation of LPS by polyethylene
particles decreases bone attachment to implants.
J Orthopedic Res 200624959-966
Cleaning and Sterilization of Medical Devices
  • Health Care Facilities need to make sound
    decisions when purchasing a reusable medical
  • Documents that guide you are
  • ISO 17664 Information to be provided by the
    manufacturer for reprocessing of a resterilizable
    medical devices. (CSA Z17664)
  • AAMI ST81 Sterilization of medical devices
    Information to be provided by the manufacturer
    for the processing of resterilizable medical

Comply with ISO 17664 AAMI ST81Validated
Cleaning Methods
Coiled reamer
Alternative solid shaft
Crud from between coils
Information provided by manufacturers
  • Adequate and appropriate cleaning and
  • Instruments with cannulation (lumens or holes)
    these instructions need to be device specific
    include ultrasonic. If the device retracts or
    requires disassembly include pictures.
  • Instruments with crevices (i.e. nuts, bolts,
    broaches, cutting blocks) device specific.
  • Instruments that are hinged (i.e. pliers,
    cutters, forceps) instructions to include
  • Cleaning brush size and type
  • Ultrasonic
  • Lubrication if required type of lubricant that
    is recommended.

Information provided by manufacturers
  • Flexible reamers Instructions need to be device
    specific including pictures.
  • Manufacturers to give maximum number of
    reprocessing times for implants (i.e. screws,
    plates) how to identify when replacement is
  • Manufacturers to review design. Cleaning tools
    should be provided by manufacturers.
  • Ensure that when manufacturers update, revise
    and/or change sterilization instructions for
    medical devices the new procedures are
    communicated to the current users in a systematic
    documented fashion.

  • Health Care facilities require a policy and
    procedure requiring all information on
    reprocessing from the manufacturer of the device
    prior to reprocessing cleaning, decontamination,
    wrapping and sterilization.
  • Required prior to purchase, lease, trial or
    evaluation or purchase.
  • Why?
  • To protect the facility from error and
    protect patients from risk.

  • Requires the following
  • Purchase approved by the Reprocessing Manager and
    Infection Prevention and Control prior to
    evaluation, consignment, loaned/leased or
  • Written manufacturers instructions for cleaning,
    wrapping and sterilization reviewed and
    attainable by Central Processing department
    before purchase.
  • In-service for cleaning and sterilization shall
    be provided to all staff, prior to the medical
    device being placed in circulation for use on a

  • The decisions to make changes to cleaning
    products, purchases of new equipment for surgical
    procedures, etc., shall be performed by a
    Product Evaluation Team endorsed by the OEM.
  • All medical devices that will be loaned/leased,
    used on consignment, evaluated or purchased will
    be reviewed and a decision made by the Product
    Evaluation Team.

  • To determine if the medical device can be cleaned
    and sterilized in the facility before evaluation,
    consignment, loaned/leased or purchased in the
    healthcare facility.
  • To ensure that the reprocessing will meet the
    requirement for organism kill.
  • To prevent risk to patients and staff.

  • If healthcare facilities require staff to
    reprocess medical devices then clearly written
    instructions with pictures are required.
  • In service of all medical devices given to the
    reprocessing staff on the cleaning, wrapping and
    sterilization prior to the implementation of the
    device in the health care facility.
  • Sound decisions, when purchasing the medical
    device, to ensure it can reprocessed in the
    facility to meet the best practices required in
    the standards.

  • If increased numbers of surgical procedures are
    required then increase in instrumentation to meet
    these demands is required.
  • Short cuts in reprocessing are a risk to
    patients! They are are not a means to meet the
  • All patients have the right to the same level of
    care and the same level of reprocessed
  • ST79 covers these requirements as does CSA Z314.3
    and Z314.8.

Sterilization Cycles
  • Typical steam sterilization method used in health
    care are
  • the dynamic air removal cycles.
  • Typical cycles are
  • 3 Minutes at 135 degrees C (275F)
  • 4 Minutes at 132 degrees C (270 F)
  • Cycle is dependent upon specific sterilizer
  • Hospital sterilizers are only validated for these
  • cycles.
  • Gravity cycles rarely used today in healthcare

Extended Cycles
  • Up to 10 different extended cycle times exist and
    the number grow daily!
  • These cycles are greater than the standard
  • hospital cycles.
  • Extended cycles are now being recommended by
  • various device manufacturers.
  • e.g. Range of 5 to 40 minutes

Sterilizer Manufacturer Validated Cycles
This table represents the variation in
sterilizer manufacturers recommendations for
exposure at different temperatures. For a
specific sterilizer, consult only that
manufacturers recommendations. Dry times have
not been indicated as this varies substantially
depending upon the sterilizer manufacturer,
season and/or other site specific issues. Note
Extracted from AAMI DS2/ST79/2005-02-07
  • Large sterilizers are designed to
  • accommodate loads of multiple devices
  • with similar requirements for sterilization.
  • Having only a small number of sets in a large
    sterilizer chamber increases the challenge to
    sterilization and the likelihood that air will
    not be completely removed from the set being
    reprocessed. This may compromise sterilization.
  • It is inefficient to run a load with a single
    device that requires a different sterilization
  • Sterilizing items in multiple loads does not
  • departments to meet the daily
    sterilization demands.

  • Changing the settings on sterilizer
  • equipment, for each load, can lead to
  • human error resulting in the wrong cycle
  • being selected.
  • This can lead to devices being weakened,
    destroyed or incorrectly sterilized in subsequent

  • Packaging for containment of devices or sets
  • has not been validated for use in extended
  • cycles e.g. reusable and single use wraps,
  • pouches, rigid containers and their filters.
  • May not maintain sterility .
  • May not allow sterilization of all device
    surfaces due to tightness of fitting, excessive
    metal mass or layering of devices.

Recommended Solution
  • Standardize to a minimum number of cycles e.g.
  • one extended cycle, the length of time to be
  • determined, in addition to the 3 or 4 minute
  • routinely used.
  • to allow BI and CI manufacturers to develop
    products specific to these cycles.
  • to decrease likelihood of human error.
  • to increase productivity.
  • to decrease likelihood of sterilization failure.

Recommended Solutions
  • When a device manufacturer develops extended
    cycle recommendations, the type of appropriate
    packaging to be used for the extended cycle
    (reusable or single use wrappers, rigid
    containers or pouches) should be included in the
    validation process.
  • Packaging manufacturers should validate their
    products for extended cycle times.

AAMI TIR 31- Process Challenge Devices/test packs
used for healthcare facilities.
  • The standard extended cycles has been addressed
    in this AAMI TIR.
  • They include
  • Pre Vacuum cycles 270 274 degrees at
  • 10 or 20 minutes.
  • Gravity 250 degrees 40 or 60 minutes.
  • Recommend Solid Load PCD and Hollow
  • Load PCD for each recommended cycle.

Proposed Chart for Extended Cycles

Standard Extended Steam Sterilization Cycle Times and Temperature Standard Extended Steam Sterilization Cycle Times and Temperature Standard Extended Steam Sterilization Cycle Times and Temperature Standard Extended Steam Sterilization Cycle Times and Temperature
Cycle Type Temperature Time (minutes)
Dynamic-air removal 132C - 135C (270F - 275F) 10
Dynamic-air removal 132C - 135C (270F - 275F) 20
Gravity-displacement 121C (250F) 40
Gravity-displacement 121C (250F) 60
Recommended Solution
  • This will allow PCD manufacturers to develop PCDS
    for these cycles.
  • Adopted by the ST 8 - Hospital Steam Sterilizers
    so sterilizers validated for these cycles.
  • Adopted as hospital cycles in ST79 Comprehensive
    Guide to steam sterilization and sterility
    assurance in health care facilities.
  • Wrapping manufacturers can then test their wrap
    at these cycles.
  • CSA in Canada has agreed to also adopt these
    cycles recommended.

Conclusion Extended Cycles
  • Device manufacturers must work together, with
    other manufacturers, to ensure that the
    recommended extended cycle meets capabilities of
    the sterilizer, the packaging, and process
    monitors to be used.
  • Health Canada and the FDA, when reviewing pre
    market applications for devices will require the
    medical device manufacturer to provide
    appropriate Validation
  • Packaging will be validated for these cycles.
  • Process monitoring device will be available for
    these cycles.
  • Healthcare sterilizers will be validated for all
    of the hospital cycles recognized as healthcare
    steam sterilization cycles.

Staff Orientation, Training and Competency
Reprocessing Staff
  • Since the 1990s with the advent of Minimal
    Invasive Surgery, instruments became complex and
    more difficult to clean.
  • Simple instruments like kockers and criles made
    of stainless steel are no longer the norm.
  • These changes brought larger challenges for
    cleaning, requiring knowledgeable staff that are
    current and trained.
  • Staff now require greater education and critical
    thinking abilities in order to do the cleaning
    and reprocessing safely.
  • Reprocessing departments require a Quality System
  • which requires monitoring and documentation.

Quality Control
  • Standards require
  • Continuous supervision of personnel performance.
  • Competency testing.
  • Supervision of work practices.
  • Ongoing verification of adherence to
  • policies and procedures.
  • Verification of reprocessing practices.

Quality Systems
  • Deviations from normal operating procedures are
    identified, investigated and evaluated.
  • Corrective action required.
  • Audits
  • Internal audits by knowledgeable staff to verify
    effectiveness of system. Audit reviews documented
    and corrective action taken.
  • Periodic external reviews to measure progress are
  • Contractors or other organizations that perform
  • functions that could effect quality systems
    then they
  • must demonstrate they will have adequate
    control and
  • supervisions so as not to effect quality

This Requires Educated Staff with Critical
Thinking Skills!
  • Challenge is to find these people and then to
    maintain them in the field.
  • Orientation after they obtain a formal course
    requires months of supervision before they can
    function alone.
  • Due to the complexity of the instruments and vast
    numbers of sets to master, this does not occur
  • Ongoing education, competency testing of staff
    yearly, in service on all new medical devices is
    costly and time consuming.
  • Staffing compliments must address release time
    for this to occur and is rarely considered when
    financial allocations are given to reprocessing

Proposed Solutions
  • Require formal education as hiring practice.
  • Ensure the staff have job satisfaction.
  • Provide ongoing education opportunities for
  • Have internal audits be opportunities for
  • Staff that know why they are required to do
    something do a better job.
  • Ensure you have detailed procedure cards for all
    cleaning and reprocessing practices for all
    medical devices that are current and have
    pictures to facilitate processes.
  • Provide opportunities for open houses in the
    department so users understand the complex tasks
    the reprocessing staff deal with on a daily

Proposed Solutions!
  • Offer opportunities for user staff to spend time
    in reprocessing.
  • Offer opportunities for reprocessing staff to
    view surgical procedures so they understand the
    use of medical devices.
  • Celebrate success!
  • Teach staff to understand that an error is a
    learning opportunity as long as corrective action
  • Do customer service surveys and involve staff in
    the results and solutions.
  • Liaison staff between the operating room and
    reprocessing is a requirement, in order to solve
    issues rather then let them become issues that
    break relationships.

Proposed Solutions!
  • Reprocessing budgets must include release time
    for training and ongoing education.
  • Auditing must be scheduled documented!
  • Recommendations must be documented, and
    addressed to improve process and action taken!

Why knowledge is Important?
Weight of Sets!
Imagine working in a Reprocessing Department or
Operating Room where there is a maximum weight
limit on instrument trays! Imagine that this
maximum weight limit policy is routinely
enforced! Picture your staff no longer
complaining about having to repeatedly lift heavy
trays! Imagine if you did not have to deal with
wet pack problems or other sterilization
concerns due to heavy trays! This vision can
come true by just saying NO to instrument
trays that are too heavy!
Heavy Sets!
  • No matter what the reason for an instrument set
    being on the heavy side, it can be a problem when
    it comes to the sterilization process.
  • Overweight sets and sets that do not have the
    metal mass evenly distributed can create concerns
    with adequate steam contact with all surfaces.
  • In addition, a problem with drying may result in
    the potential for wet packs.
  • The Association of Preoperative Registered Nurses
    (A O R N s) 2006 recommended practice for
    Packaging Systems states rigid container systems
    should be used according to manufacturers
    instructions. The approved sterilization method
    and cycle exposure times for each rigid container
    system should be provided in the manufacturers
    data and instructions.
  • Your sterilization standards state weight of a
    wrapped instruments set should be no more then 16
  • The sterilizers are validated for this weight.

Heavy Sets
  • Why? The more mass metal the more steam forms
    water thus drying issues wet packs.
  • The new CSA Z314.3 states the total weight with
    container cannot be over 10 kg/22 pounds.
  • Sterilization cannot occur unless the steriliant
    can reach all surfaces of the instrument. With
    multi layer sets users must verify that the
    steriliant will sterilize all medical devices in
    all areas.
  • Testing with BIs has been done and failure has
    occurred. (User Alert- Problems with process
    monitors for extended cycles)

Instrument sets excessive weight mass
  • If failure of any BIs report to medical device
  • Break down set to smaller tray sets and re-test

Ergonomic Concerns with Heavy Sets
  • In the hospital setting we see many injuries of
    staff due to repeated lifting of heavy instrument
  • The health and safety of healthcare workers
    should be protected through reasonable weight
    restrictions, especially when these trays must be
    lifted an average of 12 to 15 times each time the
    set is used and reprocessed.
  • Instrument sets used for a surgical procedure are
    lifted on and off case carts, on and off surgical
    areas, in and out of instrument washers, onto and
    off of processing tables, lifted to be wrapped or
    containerized, into and out of the sterilizer, on
    and off storage shelves, etc.
  • This repetitive lifting can be an ergonomic
    nightmare, particularly when the set weight
    exceeds 10kg/22 pounds or if there are several
    heavy sets.
  • Studies have shown that repetitive lifting
    greater then 9kg will cause injury to staff such
    as shoulder, arm, back, neck.
  • The statistics are showing that these heavy sets
    are making patients of our reprocessing and
    operating room staff.

Solution Say No!
  • Write policy statement, no instrument set,
    including its package is to exceed 20 pounds.
    Once we had the policy in place we could enforce
  • SPD purchased a scale for the instrument room,
    and the weighed all of the sets that we owned
    that seemed heavy.
  • We found about 25 sets that exceeded the 20-pound
    weight limit. The majority of hefty sets were
    orthopedic, and we also found some urology,
    neurology, cardiovascular and retractor sets that
    exceeded our weight limit.
  • We put together a list and then asked the OR
    service leader for each area to help us eliminate
    some items in each set or to separate the sets.

Solution Say No!
  • We then added a deadline of three weeks to
    complete this project, knowing that if we set a
    deadline it was more likely to be completed in a
    timely manner.
  • In some instances we were able to remove
    infrequently or unused instruments that were
    added to the set in case they were needed. We put
    these additional items in peel packs or small
  • In other cases, such as cardiovascular (CV) sets,
    we separated the string instruments and the
    retractor and put them in separate smaller pans.

  • The number of pans is irrelevant to the outcome
    of the procedure, as long as the correct items
    are readily available. Moreover, in addition to
    being readily available, the sterility assurance
    of each device had been verified, which is
    essential for safe patient care.
  • SPD gets asked to add an instrument to a set, we
    ask if we can remove anything first.
  • Once the changes had been made, and the
    sterilization process was verified, the surgeons
    preference lists were updated to reflect the
    changes and the need to pick both parts of a set,
    since some were now in more than one package
    (i.e., trays are labeled A and B). In addition,
    we made sure the pick list made note of just
    in case items to be picked that were taken out
    of sets and wrapped or peel packed separately.
  • We realize that even though surgeons may say they
    want everything in one pan, all they really want
    is to make sure they have what they need, when
    they need it. It doesnt matter if it is in one
    or more pans.

Weighing Sets and Limiting Weight

Instrument set being weighed
Fukushima Day Retractor set with one level
wrapped separately
  • Work with the manufacturers as users to educate
    them that the weight is important and to aim for
    10kg/22 pound weight.
  • Users when making purchases start standing up for
    the weight requirement to achieve sterility,
    protect workers as our sterilizers are validated
    with 16 pounds of mass metal.
  • Health care committees when making purchasing
    decisions this must be taken into account.
  • If we dont say NO to overweight sets, you will
    all be an occupational injury before you reach
    retirement age.
  • Remember we are humans not robots!
  • Our body will react to abuse by breaking down!
  • Why should we make reprocessing and operating
    staff suffer injury when we can divide sets into
    reasonable weights?

Loaner Specialty Equipment Sets
Loaner Specialty Equipment Sets
  • Inventory issues!
  • Receipt on site 48 hours prior to scheduled
    surgical procedure.
  • - Cleaning- Sterilization
  • Quality Control for sets!

Loaner Sets
  • Healthcare facilities use loaned and shared
    medical devices for a number of procedures for
    potential cost savings from not purchasing
    expensive devices in their inventory.
  • Loaned and shared devices allow facilities to
    save on maintenance costs and keep up with
    changing technology.
  • The biggest concern comes from those instrument
    sets that we do not own.
  • Loaner sets come and go without written
    instructions, pictures, in service, etc. all not
    meeting ISO 17664, AAMI ST81, and CSA Z314.22
    Management of Loaned, Shared, Leased Medical
  • If you write your policy for your facility
    meeting these standards you will eliminate the

  • Sets coming with no list of items.
  • No pictures.
  • No cleaning or sterilization instructions.
  • No in service.
  • Heavy sets.
  • Sets received in complete or soiled from previous
  • Come with no time to check and reprocess the sets
  • Sets received and not sure what is supposed to be
    in the set.
  • All of these issues place the patient at risk of
    injury and infection!
  • If manufacturers want your business then they
    will follow your policy.
  • When doing the evaluation of which vendor you
    will deal with use the standards to set policy to
    get all your concerns addressed.

Write Policy as a Solution!
  • Policy must address
  • Identify responsibilities as sender, receiver,
    qualifications and training of personnel, risk
    management, quality management and insurance.
  • Have a policy to cover emergencies related to
    loaned and shared devices including the necessary
    signatures to designate that situation as an
  • Not accept Medical Devices unless they are
    licensed by Health Canada and FDA, and conform to
    codes and standards.
  • Have procedures in place for sending,
    transporting and receiving of loaned and shared
  • Have in place mutually accepted written
    documentation, outlining the responsibilities of
    individuals during the transactions between
    senders and receivers.

Write Policy as a Solution!
  • In written form (e.g. in binders, manuals or
    monographs) and/or electronic format.
  • In a central location so they are readily
    accessible and shall be updated as required.
  • Documented and reviewed on a regular basis by the
    facilitys Infection Prevention and Control or
    Risk Management personnel, or their designates.
  • Policies required for
  • Quality system!
  • Documentation!

  • Check environmental and handling conditions

  • required and transport accordingly.
  • Routinely clean and maintain the trucks.
  • Prevent physical damage, tampering and loss.
  • Maintain records of devices transported.
  • Deliver the device to the next organization or
  • facility at the contractually agreed time.

Solution to Loaner Set Weights
  • How can you enforce the weight limit on those
    sets that we
  • borrowed or that the company brought in for us to
    use as
  • long as we purchased their implants?
  • The answer is in policy. The weight limit
    statement into your loaner policy then shared
    with the MDM representatives that had surgical
    instrument sets in our facility.
  • Ask the MDMs to work with you to get their set
    weights down to 20 pounds. Some were very helpful
    and made suggestions on how we could divide the
    sets, while others took a little convincing and
    negotiating to get them to see that if they
    wanted us to sterilize their sets, they had to
    follow our policy.
  • Purchase additional instrument container or two
    to house the items removed from the
    vendor-owned sets.
  • (MDM medical device manufacturer)

Solution to Loaner Set Weights
  • Validated for sterilization by the MDM, and even
    lighter by placing them in two containers, we
    could use its sterilization process
  • Follow manufacturers instructions and conduct
    your own sterilization verification testing per
    AAMIs recommendation on product testing.
  • When it comes to MDMs sterilization validation
    testing, never take the representatives verbal
    word for it. Always ask for that information in
    writing directly from the MDM.

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.
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
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
Where do we need to be?
  • Instrument sets should not be flash sterilized.
    Flash sterilizers are only validated for 1-2
  • The following conditions shall be met if you are
  • a) there is an urgent unplanned need
  • b) there are documented procedures for this
  • 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.

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 .
Measures to Avoid Flash Sterilization
  • Measure to avoid flash sterilization
  • maintenance of adequate inventories of medical
  • 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
  • education of medical staff and materials managers
    in the risks associated with flash sterilization
  • Computerized booking systems that cannot be
    converted to override inventory.

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
  • CSA Standard Z314.3 Flash sterilization shall
    not be used on
  • complete sets or trays of instruments.

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
  • ORNAC Standards are based on CSA.

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
  • Lots of great questions!

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

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.

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

Personnel Requirements
  • 1. All aspects of emergency steam sterilization
  • supervised staff that are knowledgeable,
  • personnel wearing appropriate attire,
    including personal
  • protective equipment.
  • 2. Personnel must have demonstrated expertise in
  • 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

Personnel Requirements
  • 4. The health care facility administration to
    ensure that operators of all steam sterilizers
    used for flash sterilization in the facility are
  • 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

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

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
  • The facility shall assign specific responsibility
    to a staff
  • member or position for the maintenance of quality
  • documentation relating to flash sterilization,
  • documentation of staff training, and the
    collection, review
  • and retention of flash sterilization incident

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.

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.

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
  • Reusable transportation containers shall be
    cleaned and decontaminated after each use.

  • 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

  • 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
  • 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.

  • 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
  • (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
  • (e) for complex instruments (e.g., 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.

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
  • 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

Notice from Ministry Ontario of Health re Flash
Do you meet all these requirements?

Implement to improve patient care!
Set up a Quality Improvement Project
  • Joint Quality Assurance/Accreditation Project
  • Sterile Processing Department and Surgical
  • 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.

Reprocessing Challenges!
  • I have touched on a few challenges but there are
    many more.
  • Reprocessing is complex, always changing, and a
    very demanding profession!
  • It requires ongoing education, and knowledge that
    is current.
  • Staff with critical thinking skills,
    knowledgeable is required.
  • Reprocessing staff must be the patient advocates!

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!

never know when we will require treatment in the
facility we work at! Always advocate for all
patients!When any reprocessing staff or their
family require care, we want to know that the
instruments are the best quality and meet
What Can We do?
  • Raise the bar in reprocessing!
  • Ensure all patients are not put at risk during
    their hospital stay!

  • AAMI ST 79 Comprehensive guide to steam
    sterilization and sterility assurance in a health
    care facilities
  • AAMI TIR 31 Process Challenge devices/test packs
    for use in health care facilities
  • CSA Z314.3 Effective Sterilization in Health Care
    Facilities by the Steam Process
  • CSA Z314.8 Decontamination of Reusable Medical
  • CSA Z314.22 Management of Loaned, Shared and
    Leased Medical Devices
  • Just Say No by Rose Seavey RN, MBA, CNOR, ACSP
  • Best Practices for Cleaning, Disinfection and
    Sterilization in Health Care Facilities

Lets all provide every patient with the care
that we all would like to receive!
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