Warehousing, Storage, and Transportation of Clean and

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Warehousing, Storage, and Transportation of
Clean and Sterile Medical Devices

• Colleen Landers
• Registered Nurse Consultant

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Warehousing, Storage and Transportation

• How this effects the reprocessing departments.
• Canadian Standards
• How to protect the sterility of supplies during
  storage and transport to the patient.
• Tools on how to make supplies easy to access and
  transport.
• How the standard assists in Event Related
  Sterility

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Canadian Standards Association

• Written in Canada, and designed for use in
  Canadian hospitals, the standards are intended to
  help health care providers identify the critical
  elements of medical device processing and
  infection control, and to make sure these
  elements are part of health care facility
  procedures.

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Canadian Standards

• The standards represent their consensus on best
  practices with respect to policies and
  procedures, personnel, facility management, and
  routine practices.
• The CSA standards for health care facilities
  provide a comprehensive set of requirements aimed
  at protecting the health of patients and staff.
• They should be in all Reprocessing departments,
  and should be used to write facility policies
  and procedures related to medical device
  reprocessing and infection control.

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Standards Warehousing, Storage and
Transportation of Clean and Sterile Medical
Devices

• Standard CSA Z314.15 Search under www.csa.ca 2010
  published
• Brought on by regionalization of health care
  services and the increased use of contract
  services
• On or off-site warehouses
• Reprocessing also provided by some contract
  reprocessing and laundry services.

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What it States in CSA Z314.15-10

• 9 Handling
• 9.1 General
• 9.1.1 Procedures shall be established for the
  safe storage
• and handling of clean and sterile medical
  devices.
• 9.1.2 Clean and sterile medical devices shall be
  maintained
• in clean containers or on shelves until picked.
  Only one box
• of medical devices should be open at any given
  time. The
• remaining medical devices shall be kept in closed
  
• containers. Medical devices shall be protected
  from
• contamination and other damage at all times.
• .

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CSA Z314.15-10

• 9.2 Picking of supplies and medical devices
• 9.2.1 When picking medical devices in preparation
  for transportation or
• distribution, personnel shall inspect the
  packaging of each device for
• damage. Medical devices whose packaging is
  crushed, bent,
• compressed, or punctured are no longer sterile
  and shall be discarded.
• If the packaging is not clearly damaged, but
  there is doubt about its
• condition, the contents shall be either discarded
  or reprocessed in
• accordance with the manufacturers validated
  instructions.
• 9.2.2 Each occurrence of damaged or questionable
  packaging shall be
• documented, along with the action taken.
• Notes (1) Products with questionable packaging
  will in some
• circumstances need to be
  returned to the manufacturer or
• distributor.
• (2) Reprocessed medical devices that
  are damaged should be
• reported to the medical device
  reprocessing departments

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CSA Z314.15-10

• 9.2.3 Items shall be handled with care and shall
  
• not be thrown, tossed, or dropped.
• Note Throwing, tossing, or dropping items can
• compromise their packaging and damage or
• contaminate the items themselves.
• 9.2.4 An item that is wet or damp, or has come
  into
• direct contact with the floor, shall be either
• discarded or reprocessed in accordance with the
• facilitys procedures.

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CSA Z314.15-10

• 9.2.5 Soiled shipping containers shall not be
  used
• Note Medical devices stored unprotected can be
• damaged and will accumulate bio burden.
• 9.2.6 Medical devices shall be handled with clean
  
• hands and shall not touch clothing or any other
• part of the body.
• Note See Annex B for guidance on storage and
  handling.

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CSA Z314.15-10 Annex B

• B.1.1
• Storage and handling procedures are
• intended to
• (a) protect clean and sterile medical devices
• from contamination and damage
• (b) foster good inventory control
• (c) facilitate the identification and proper
  disposal of damaged items.

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CSA Z314.15-10

• B.1.2
• Storage and handling procedures should address
• the following considerations
• (a) stocking date for rotation purposes
• (b) protecting the clean and sterile integrity of
  
• items being removed from soiled shipping
• containers
• (c) picking practices (first-in, first-out)
• (d) adequate spacing of packages
• (e) easy visibility and retrieval of packages
  and
• (f) visual inspection of all packaging before
  use.
• Note The probability of contamination increases
  as
• handling and environmental stresses
  increase.

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CSA Z314.15-10

• B.2 Shelf life
• The shelf life of a sterile package is event
  related rather than time related. Event-related
  shelf life is based on the concept that items
  that have been decontaminated, wrapped,
  sterilized, stored, and handled in accordance
  with the procedures established by the health
  care facility will remain sterile indefinitely
  unless the integrity of their packaging is
  compromised.

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CSA Z314.15-10

• The integrity of a sterile package depends on,
  but is not limited to, the following factors
• (a) the method and level of care used when
  removing the
• package from shipping containers or
  boxes
• (b) the materials and design of the package
• (c) whether the package is stored on closed
  or open
• shelving
• (d) the method and frequency of handling
• (e) the method, frequency, and conditions of
• transportation
• (f) environmental conditions in the storage
  area
• (e.g., temperature, relative humidity,
  ventilation, and
• cleanliness)
• (g) control and monitoring of access to
  storage areas

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CSA Z314.3

• 7.2 Sterile Storage
• 7.2.1 Storage area
• The sterile storage area shall be located
  adjacent to the sterilization area,
• preferably in a separate, enclosed,
  limited-access area. The dedicated function of
• this area shall be the storage of sterile and
  clean supplies.
• This area shall be
• (a) protected from moisture contamination
• Note Utility pipes can be a source of dripping
  water due to condensation or leaks.
• (b) protected from the entry of dust from
  adjacent areas and ventilation systems
• (c) protected from vermin and
• (d) provided with adequate storage space to
  prevent crushing or damage to packages.
• Notes
• (1) The use of closed shelves may aid in
  complying with the requirements of this Clause.
• (2) If open shelves are used, it is recommended
  that sterilized medical devices be stored at
  least 250 mm (10 in) off the floor, 460 mm (18
  in) from the ceiling, and 50 mm (2 in) from an
  outside wall.

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CSA Z314.3

• Shelving shall be made of materials that are
  non-porous on all
• surfaces, and non-shedding, easily cleanable, and
  free of burrs and
• sharp or rough edges. The top and bottom shelves
  shall be solid. If
• open shelving units are used for storage of
  sterilized medical devices,
• the shelves should be at least 250mm (10) off
  the floor, 460 mm (18)
• from the ceiling and 50 mm (2) from an outside
  wall.
• Note
• Maintenance of the sterility of a device to the
  point of use is essential.
• Most packaging does not provide an absolute
  microbial barrier
• therefore, it is important that environmental
  contamination be minimized
• to avoid compromising the sterility of devices
  during storage.

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CSA Z314.3-09

• 10.3.6 During unloading, packs shall be inspected
  for
• a) package integrity
• b) dryness
• c) intact seal (if used) and
• d) the correct change in an external CI.
• If a package does not meet inspection criteria,
  the contents shall be repackaged and reprocessed.
  
• Note Textile packs should be re-laundered before
  being re sterilized.

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CSA Z314.3-09

• 10.3.7 Items that have been dropped on the floor,
  or that are
• compressed, torn, or wet, are contaminated.
  These items
• shall be repackaged and reprocessed.
• 10.4 Dust Covers
• Plastic dust covers, if used, shall be medical
  grade covers that
• are designated as being for this use clearly
  marked as a dust
• cover applied by personnel with clean hands
  (hands shall be
• washed immediately prior to applying the dust
  cover) or clean
• gloves and sealed with a heat-sealing device,
  tape designed
• to seal plastic, or a self-sealing closure.
• Dust covers shall not obscure package labels.
• Note A clear plastic dust cover may be used if
  the package label is visible through the
  dust cover.

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CSA Z314.3-09

• 11.2 Storage Area
• 11.2.1 Storage areas for sterile supplies shall
  comply with the requirements of Clause 7.2.
• 11.2.2 Sterile processing areas shall not be used
  for the storage of supplies and materials other
  than those used in reprocessing.
• 11.2.3 Shipping containers (i.e. corrugated
  cardboard boxes) shall not be kept in the areas
  where clean or sterile items are stored. Items
  in shipping containers shall be immediately
  unpacked and stored. All stored items shall be
  kept in storage shelving units appropriate to the
  task.

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Storage Area

• 11.2.4 Windows and doors in the clean / sterile
• storage area shall be kept closed. Clean and
• sterile items shall not be stored on the floor,
  on
• window sills, or under sinks. Medical devices
  shall
• not be stored on the floor.
• 11.2.5 Access to the storage area shall be
• restricted to persons whose normal
  responsibilities
• require them to enter this area. Persons in
  street
• attire shall not be allowed into the storage
  area.

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Inventory Management CSA Z314.3 Clause 11

• Shelf Life
• 11.32.1.1 The shelf life of a sterilized package
  is event-related. Event-related
• shelf life is based on the concept that if items
  have been properly decontaminated,
• wrapped, sterilized, stored, and handled,
  sterility can be maintained indefinitely,
• unless the integrity of the package is
  compromised. If the integrity of the package
• has been compromised or is questionable, the
  package shall be reprocessed.
• 11.3.1.2 Sterility maintenance is dependent on,
  but not limited to, the
• type of wrapper used
• method of sealing the package
• type of shelving used - whether closed or open
• method and frequency of handling
• method, frequency, and conditions of
  transportation
• environmental conditions of the storage area
  temperature, humidity, ventilation, and
  cleanliness and
• control and monitoring of access to storage areas.

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11.3.2 Inventory Control

• 11.3.2.1 Each facility shall establish policies
  and procedures for inventory
• control and shelf life based on evaluation of the
  factors outlined in Clause
• 11.3.1.2.
• 11.3.2.2 The health care facilitys policies and
  procedures shall address the
• following issues
• sterilization load indicators for tracking
  purposes
• sterilization date for stock rotation purposes
  (i.e. first in / first out)
• adequate spacing of packages
• easy visibility and retrieval of packages and
• visual inspection of all packaging prior to use.
• Note The probability of contamination increases
  with handling and
• environmental stresses.
• 11.3.2.3 Infrequently used sterile packages
  should be stored in closed or
• covered cabinets.

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CSA Z314.3

• 11.3.2.4 The facility should periodically assess
  its infrequently used
• Sterile packages to determine whether they are
  still needed
• see if they could consolidated to reduce their
  numbers (ie by keeping them in a central
  location) and
• confirm that storage conditions are adequate to
  maintain product integrity and sterility.
• 11.4 Distribution
• 11.4.1 Procedures shall be established for the
  handling of sterile
• supplies. Routine distribution of sterilized
  medical devices to different
• areas in a health care facility shall be
  performed using clean enclosed\
• or covered transportation carts, bins, and boxes,
  or plastic bags.
• 11.4.2
• Carts, bins, and boxes that are used for
  transportation of sterile goods
• shall be cleaned regularly.

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Shelf Life/Event-Related Sterility

• Shelf Life The length of time undamaged sterile
  packages are thought to keep contents sterile
• Event-Related over Time-Related Sterility
• Event-Related When something happens to the item
  (torn, dropped, etc.).
• Time-Related Item has an expiration date.
• Even with dust covers, containers, etc. items can
  accumulate microbes over time

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Event Related Sterility

• What effects event related sterility
• Storage location
• Shelving
• Traffic
• Any event that will compromise the
• sterility
• Cleaning practices
• Quality Assurance program for checking sterile
  supplies
• Environmental conditions

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What does this mean to you?

• Storage of sterile supplies effects length of
  sterility.
• It effects the sterile product if not handled and
  stored properly after sterilization causing risk
  to patients.
• Does this apply to all storage areas for sterile
  product? Yes
• This is why you must ensure storage on
  departments and everywhere meet standards.

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Questions to Ask re Storage?

• Traffic (closed to traffic or high volume)?
• How often the area is cleaned?
• How many times will the sterile package be
  handled?
• How often is the storage area checked by MDRD
  staff?
• Does the shelving material meet requirements of
  CSA Standards?
• Is shelving closed or open in high traffic areas?
• Does it meet environmental controls?

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Objectives for STORAGE

• Characteristics of a good sterile storage area,
• in terms of
• Location
• Environmental Conditions
• Types of Storage Equipment
• Organization/Supply rotation
• Cleaning/Housekeeping

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Shelf Life Policy

• Hospital should establish and follow shelf-life
  policy using these methods
• Inventory evaluation and review to reduce
  oversupply and undersupply
• Proper stock rotation methods
• First in, first out
• Storage area design, traffic and
• cleaning practices
• Handling of sterile goods practices

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Location

• Low traffic or if high traffic in enclosed
  containers or closed cupboards
• Not on open shelves in patient treatment areas
• Away from sinks or water.
• Storage meets requirements of CSA Z314.3 and
  Z314.15

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Environmental ControlsTemperature/Humidity

• Temperature in the area maintained in the range
  of 15-30 degrees
• Humidity of 30-60 percent
• Bright lighting
• Adequate air circulation is necessary. No fans or
  heaters

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Environmental ControlsEvent-Related Sterility

• A package is considered unsterile when
• It is unsealed/seal is broken.
• Has been torn or punctured.
• Is or has been wet.
• Has no external indicator of sterility such as
  autoclave tape that has changed color.
• Has been dropped on the floor or thrown.
• If any of these occur the package is tossed if
  its single use or reprocessed.

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Environmental Controls Minimizing airborne
contamination condensation

• Overheads pipes, wiring and ducts enclosed to
  prevent dust accumulation
• No street clothes permitted
• Hair covering must be worn
• Hands must be clean
• Area must be cleaned regularly
• Closed to traffic.

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Environmental Controls Placement of Shelving

• Two to three inches away from walls.
• Ten inches above the floor
• Eighteen inches from the ceiling/sprinkler heads.
  

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Shelf Life Policy

• First in, first out
• Rotate stock with set methods
• Store items on left, take from right or the other
  way around. Just keep the same method!
• Store at rear ,take from front
• Store from bottom, take from top

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Shelving

• Best Mobile and modular open shelving that can
  be disinfected (no wood). Non-porous,
  non-shedding
• Closed storage protects goods but is not good for
  high volume. Needed when area is open to traffic
• No outside cardboard
• Enclosed boxes/containers that can be cleaned
  according to designated maintenance schedule.

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Shelving

• Free of burrs and sharp or rough edges (if
  packages tear they need to be re-sterilized)
• Solid bottom shelf
• Can be cleaned and disinfected minimum monthly
• Top shelf
• If using containers or heavy trays may need
  protective trays or covering so wrappers do not
  ripe
• If using pouches or small items need containers
  or shelving racks that allow small items to be
  stored safely

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Cleaning

• Schedule for Cleaning Frequencies from CSA
  Standard Z314.8 Decontamination of Reusable
  Medical Devices
• Damp mopping/mechanized cleaning daily MDRD and
  OR Sterile Core. No dry mopping. Change mop heads
  after use.
• Cleaning process must minimize air turbulence
  excess moisture
• Clean shelves once every three months at least
• (documented)

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Cleaning

• Case Cart Assembly Areas must comply with
  CAN/CSA-Z314.2 Effective Sterilization in Health
  Care Facilities by the Ethylene Oxide Process or
  CAN/CSA-Z314.3 Effective Sterilization in Health
  Care Facilities by the Steam Process
• Store cleaning products in enclosed area away
  from storage/work areas.
• Wet-scrubber cleaners only
• Refer to Health Canada Infection Control
  Guidelines Hand washing, Cleaning, Disinfection
  and Sterilization in Healthcare

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DISTRIBUTION

• Proper sterile distribution of reprocessed items
  to all areas of the hospital
• Discuss characteristics of case carts,
  centralized dispatch, exchange and top-up
  methods.
• Case carts are most important as they deal with
  the OR. Other methods are used as well so should
  be reviewed.

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Transportation

• Wash Hands before handling Sterile Supplies.
• Transport Carts must be covered or closed when
  out of the department. Can also use closed
  containers, totes or plastic bags on open carts.
  Covers must be tossed or washed.
• Clean and Soiled supplies must never be on the
  same cart or handled by the same person.
• Carts must have a solid base to prevent dust
  from the wheels.
• Remove visible soil from equipment before
  transport through hospital corridors.
• Carts must be cleaned and disinfected between use

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TransportationOn-Site and Off-Site

• If facility has dedicated system for delivery and
  return of items, the carts can be open.
• Containers must be covered during transport
• Maintain same controls for temp and humidity as
  for storage
• For offsite transport, truck compartments must be
  cleaned and disinfected prior to use and also
  have a maintenance schedule.
• Refer to the CSA standards

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CSA Standards re Distribution

• Transportation carts, bins, boxes, and plastic
  bags used for routine distribution of sterilized
  medical devices within a health care facility
  shall be clean and shall also be enclosed or
  covered during distribution unless such
  distribution is entirely within a clean,
  dedicated system.

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Storage and Sterility

• Time related sterility -staff checked weekly for
  dates and conditions.
• Event related -checking of stock stopped and it
  shouldnt have.
• We forget that a product that is sterile will not
  maintain sterility no matter what type of wrapper
  we use, if it is stored or transported
• In high traffic areas
• Open shelving made of wood
• Never cleaned
• Transportation to patient care areas on open
  carts through patient and visitor areas
• Handled multiple times before use as too much
  stock
• Not checked for holes, wetness, sterilization
  tickets removed, or opened and closed.

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Results

• Medical Device that is not sterile and used on a
  patient so a high risk issue.
• Would we want this used on us or our family?
• No! So why are we not following best practices
  standards and meeting storage and transportation
  requirements.

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Communication

• All parts of the system must cooperate
• Develop positive relationships with customers
• MDRD supports Patient Care
• Be Courteous Pleasant.
• You are the Heart of the Hospital!

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