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!