Author: Michele DeMeo
Contributors: Stephen Kovach, Sue Klacik, Jane Severin, Jon Wilder
Three critical practices to ensure sterile goods are delivered to the point-of-use undamaged, sterile, and safe for patient use it is the purpose of this document. These practices are not exhaustive but provide a guideline in these changing times with rapidly emerging new viruses and other pathogens. While they may seem to be common sense, we have found that the best way to ensure something is understood is by repeating it. Why? New people come into the perioperative, material management, and sterile processing professions who need to learn. Sometimes "we've always done it this way" may not be the best way.
Note: Always follow the CDC's guidelines for handwashing.
Step (1) Using Proper Hand Hygiene
Properly perform hand hygiene after BREAKING DOWN any external cardboard shipping boxes or other external shipping containment devices.
At the start and close of each shift, at a bare minimum, disinfect the assembly workstation or worktable with an EPA-registered surface disinfectant adhering to the procedure in its Instructions for Use (IFU).
Properly perform hand hygiene BEFORE preparing or handling items in sterile packaging.
Always make sure your hands are completely dry before handling items in sterile packaging.
Do not eat or drink after washing your hands or handling (or packaging) items in sterile packaging.
Step (2) Storing and Transferring Sterile Goods Properly
Check and ensure that any storage area for sterile goods has been properly cleaned according to each State's infection control regulations as provided by their Health and Human Services Department and meets the recommendations of AAMI ST79:2017 Section 11.1: Sterile Storage.
Rotate sterile items from "first-in" to "first-out" by placing the newest items towards the storage bin area's back. Reducing the risk of contamination is achieved through minimal handling.
Do not transport sterile items on a dirty cart or store them with used or contaminated items.
Do not store items in sterile packaging under sinks.
Transport sterile items in a manner that will prevent the package from puncture or contamination from moisture, excessive humidity, condensation, insects, vermin, dust and dirt, and excessive pressure. Included in this list are:
not overcrowding bins or cabinets,
not using rubber bands or clips to bind items together or hang them to "fit them all in."
These practices may damage or destroy the sterile barrier.
Refer to the product's IFU for storage conditions. Exposing some items to light or UV sources should not be allowed. Also, wiping packages with disinfectants should not be permitted. Otherwise, contaminants may get into the sterile container and render the item non-sterile or create toxic residues.
Just before storing items, take an additional look and inspect the item and packaging for any signs of compromise such as, but not limited to:
staining on the packaging,
proof of sterility,
tears - regardless of size,
improper packaging (wrong type, wrong method of wrapping or containment, the wrong type of packaging or containment device for sterilization modality and kind).
Note: Performing these sterile inspection criteria should occur before items are issued from the last release point; Sterile Processing (SPD) for in-house processing, or Materials Management (MM), Shipping and Receiving, etc.
Return transfer cart, bin, or other devices to SPD, MM, or other designated department origin or area for subsequent cleaning and disinfection after items are issued.
Return any compromised sterile goods for processing and return to the vendor or other response prescribed by facility policy.
Properly perform hand hygiene at the end of this final task and before entry into your next assignment area.
Do not put sterile packages in pockets, hold them with your mouth, or carry them outside the facility or staff break areas.
Assume an item is contaminated if it is dropped on the floor or an unclean surface. Do NOT use it.
Step (3) Handling and Opening Sterile Goods Properly at Point-of-Use
Ensure your transfer cart, bin, or other device has been properly disinfected before placing items ready to be transferred.
If there is any question about disinfecting your transfer cart, refer to the disinfectant's IFU before disinfecting.
Properly perform hand hygiene BEFORE you touch the package and transfer sterile goods to their secondary and/or final storage staging area and before the point of use.
Re-perform hand hygiene should you inadvertently contaminate your hands, including touching your face or potentially soiled surface in the process of moving and transferring sterile goods.
Thoroughly inspect the package. Take one last look and inspect the item and packaging for any signs of compromise such as but not limited to the following: staining or watermarks on the packaging, proof of sterility, worn areas, tears-regardless of size, improper packaging (wrong type, wrong method of wrapping or containment), expiration date.
Re-perform hand hygiene properly.
The above three steps will help maintain the integrity of the sterile barrier of products within your facility to ensure safe use better. Failure in any of the above steps and tips present risks that may create a host of scenarios, but by far, the most important is the potential spread and transfer of pathogenic organisms. These simple reminders serve to highlight how relatively simple it can be to keep sterile goods sterile and safe for all when these principles are consistently applied.