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

1. 1 Warehousing, Storage, and Transportation of Clean and Sterile Medical Devices Colleen Landers Registered Nurse Consultant

2. 2 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�

3. 3 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.

4. 4 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.

5. 5 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.

6. 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. .

7. 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 manufacturer�s 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 - Picking supplies you must inspect package of every device for damage. , If package is crushed bent, punctured it is no longer sterile and must be reprocessed or discarded. Think of packages of single use medical devices in the same aspect. If single use they are returned to manufacturer and if reusable returned to the reprocessing department to be reprocessed. Remember this means decontaminated, new wrapper and chemical indicators and sterilized - Picking supplies you must inspect package of every device for damage. , If package is crushed bent, punctured it is no longer sterile and must be reprocessed or discarded. Think of packages of single use medical devices in the same aspect. If single use they are returned to manufacturer and if reusable returned to the reprocessing department to be reprocessed. Remember this means decontaminated, new wrapper and chemical indicators and sterilized

8. 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 facility�s procedures. We need to handle sterile medical devices with care Any item that has been exposed to moisture is no longer sterile. Floor fddirties area so if they hit the floor minutes after sterilization they are no longer sterile No 5 second rule. We need to handle sterile medical devices with care Any item that has been exposed to moisture is no longer sterile. Floor fddirties area so if they hit the floor minutes after sterilization they are no longer sterile No 5 second rule.

9. 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. Cardboard boxes cannot be used to store sterile supplies give example Soiled shipping cartons can mean the packaging inside is compromised so return to manufacturer. Han washing is required before handling sterile packages. Cardboard boxes cannot be used to store sterile supplies give example Soiled shipping cartons can mean the packaging inside is compromised so return to manufacturer. Han washing is required before handling sterile packages.

10. 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. - Inventory control is facilitate by using the oldest date first and rotating stock. - Inventory control is facilitate by using the oldest date first and rotating stock.

11. 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.

12. 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.

13. 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

14. 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.

15. 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. Wood cannot be used and if laminate then it has to be chemically treated so it can be disinfected. Stainless steel best shelving for reprocessing and sterile storage areas Wood cannot be used and if laminate then it has to be chemically treated so it can be disinfected. Stainless steel best shelving for reprocessing and sterile storage areas

16. 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. A cloth wrapper has to be landered as the sterilization closes the pores of the linen and if not laundered the sterilant cannot get in A cloth wrapper has to be landered as the sterilization closes the pores of the linen and if not laundered the sterilant cannot get in

17. 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. Baggies or other plastic bags cannot be used as dust covers as not a medical product and has not been validated to maintain sterility.Baggies or other plastic bags cannot be used as dust covers as not a medical product and has not been validated to maintain sterility.

18. 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. Sterile processing has become a place to store many items that do not belong there. We are not a stores department and should only store items required for cleaning and disinfection, packaging, monitoring and sterilization. Single use sterile medical devices should not be in reprocessing. Card board boxes cannot be brought into reprocessing as a source of infection and cardboard cannot be disinfected. Sterile processing has become a place to store many items that do not belong there. We are not a stores department and should only store items required for cleaning and disinfection, packaging, monitoring and sterilization. Single use sterile medical devices should not be in reprocessing. Card board boxes cannot be brought into reprocessing as a source of infection and cardboard cannot be disinfected.

19. 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. Closed doors locked with buzzers. Everyone should not be admitted and if someone has to come in then a procedure for then to dress appropriately.Closed doors locked with buzzers. Everyone should not be admitted and if someone has to come in then a procedure for then to dress appropriately.

20. 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. Talk abut time related and how we checked shelves weekly no we think items are sterile forever but proper storage an cleaning effects sterility and is part of event related sterility. Environmental 60-80% humidity Temperature These must be monitored and recorded daily in sterile storage areas. Give example Talk abut time related and how we checked shelves weekly no we think items are sterile forever but proper storage an cleaning effects sterility and is part of event related sterility. Environmental 60-80% humidity Temperature These must be monitored and recorded daily in sterile storage areas. Give example

21. 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 facility�s 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.

22. 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. Inventory assessment so reduce stock not used and increase items that are turning over quickly and calls are required by clients to have stock to serve patients Inventory assessment so reduce stock not used and increase items that are turning over quickly and calls are required by clients to have stock to serve patients

23. 23 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

24. 24 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

25. 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.

26. 26 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?

27. 27 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

28. 28 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

29. 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

30. 30 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

31. 31 Environmental Controls:Event-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 it�s single use or reprocessed.

32. 32 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.

33. 33 Environmental Controls Placement of Shelving Two to three inches away from walls. Ten inches above the floor Eighteen inches from the ceiling/sprinkler heads.

34. 34 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

35. 35 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.

36. 36 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

37. 37 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)

38. 38 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

39. 39 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.

40. 40 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

41. 41 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

42. 42 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.�

43. Storage and Sterility Time related sterility -staff checked weekly for dates and conditions. Event related -checking of stock stopped and it shouldn�t 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.

44. 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.

45. 45 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!

46. 46 Let�s all provide every patient with the care that we all would like to receive! 

47. 47 THANK YOU!