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Monitoring and Releasing of Sterilization Loads

New sterile processing (SP) technicians begin their careers in the field following new standards and using the latest technology in instrument reprocessing. They study a curriculum that includes sterilization basics; however, once SP techs begin working at the hospital, they must adhere to processes and protocols set by new regulatory guidelines.

Years ago, the sterilization process was simple, and SP techs followed parameters set by the operating room (OR). When a new instrument was purchased, there was no emphasis on reading and following instructions for use (IFUs). Sterile processing techs were required to process (or gas) any instrument that looked like plastic by using the ethylene oxide sterilizer. Instruments were manually recorded and placed into the sterilization process; steam or gas were the only options in most hospitals. After instruments were taken out of the sterilizer (or the oven) and cool to the touch, SP techs sent them the OR.

Sterilization procedures have come a long way since. Today, SP techs are required to follow new guidelines and regulations to determine when instruments are ready for use and potentially free of contaminants. Despite improvements, some questions remain. Can we guarantee sterility? Can we guarantee that items sent to the OR are not compromised? What is the best practice for releasing sterilization loads? How can new SP techs master the process for releasing sterilization loads? The Load Release Four Cs Model breaks down the process into four steps: Control, Check, Classify, and Confirm.

The Load Release Four Cs Model
Control: The first step is to establish the controls of the sterilization process. In a controlled environment, all loads must:

  • Be documented. Every item must appear in the load record alongside its assigned service or unit in the event of a load recall.
  • Have an assigned lot control number.
  • Contain a challenge device with a Class 5 or Class 6 Integrator, and a biological culture. A process control device (PCD) should preferably be used with every load, or at least once per week.
  • Contain external chemical indicators. Wrapped packages should have external tape for the appropriate sterilization process. Rigid containers should have indicator cards and tamper-proof locks.
  • Have adequate space between packages to allow for circulation and avoid overloading the carts.
  • Have proper package location. When mixing loads, hard goods should be on the bottom shelves.
  • Not touch the sterilizer walls.

Additionally:

  • Basins should stand on the edge to allow for drainage.
  • Pouches should stand on the edge or on a peel pouch rack as to not overload the rack.
  • Any liner added to cart shelves should be absorbent.
  • The sterilizer printer should have paper in case you need to reprint the load outcome.

Check: Once the sterilizer cycle is complete, conduct a quality audit of the physical and chemical monitors to ensure the outcome of the load was successful.

  • Review all sterilization printouts to confirm all parameters are met. Verify the results of the load with your signature and properly attach the sterilizer printout to the load record.
  • Remove the PCD and review the outcome of the integrator and the biological culture chemical strip. Ensure they meet the set parameters and incubate the biological test.
  • Evaluate packages to ensure there is no evidence of moisture. If you find evidence of moisture or several wet packs, the load should be reprocessed.
  • Quarantine the load until the results of the biological test is obtained or follow your hospital protocol for devices used to monitor the loads. Some organizations use emulating indicators that allow them to release loads immediately after they obtain an acceptable test outcome. Always follow your hospital protocol and the device manufacturer’s IFU.
  • Record the biological test outcome on relevant documents to release the load.
  • Loads with implants should only be released upon obtaining a negative biological culture unless there is a documented medical emergency.
  • Use an infrared thermometer to measure the temperature of packages before transferring them to transport carts. Packages should achieve ambient temperature before they are touched and transferred from the sterilization cart.
  • Audit packages for tears or signs of compromised sterility as they are transferred to transport carts.
  • Audit packages to confirm the lot number labels are still on the package and chemical indicators have properly changed color.
  • If any of the parameters or quality checks fail, a process for reporting nonconformities should be in place, and the item in question reprocessed.

Classify: It is best practice to group packages by delivery location or service.

  • Group packages by location or service in bins or carts to minimize handling.
  • Use an infrared thermometer to verify that all packages are cooled before moving or handling them.
  • Audit packages for tears or signs of compromised sterility.
  • Use liners or transport trays to prevent tears.

Confirm: It is important to confirm that packages are delivered to the right location, in the right amounts, and at the right time.

  • Keep a record of every package delivery to each location. Track the time, date, and the name of the person making the delivery.
  • Confirm the outcome of the biological culture result before a load is delivered to any location. The biological indicator (BI) results can be included with the delivery manifest to notify the customer that the package or tray has passed all quality assurance tests. Some hospitals adhere a green label to implant trays to indicate “BI passed,” however, each organization should define their own processes around this.
  • Add the quality audit document to the delivery manifest to alert the customer the packages were audited for quality assurance.
  • Confirm the load was delivered.

Whether the organization uses a computerized or manual system, all basic identification and traceability parameters must be followed. Controls must be in place to ensure that every technician performs tasks by following the same steps, and that the steps are effective. It is also critical to ensure that the task of releasing loads is assigned only to experienced and qualified individuals. The safety of our patients and the success of surgical outcomes is greatly impacted by the quality of the products we assemble in the sterile processing department. This, in turn, is determined by the controlled conditions that we implement for the release and delivery of sterile surgical instruments.


Mary Olivera, MHA, CRCST, CHL, FCS has over 30 years of experience in numerous roles in healthcare sterile processing, distribution, and materials management. Ms. Olivera participates in monitoring, surveying, and training interdepartmental staff in the proper cleaning, decontamination, and sterilization practices, and has been highly committed to the standardization of interdepartmental processes. A regular recruit on expert panels regarding sterile processing and a past president of the New York State Central Service organization, she continues to play a major role in promoting higher educational requirements for central service professionals to increase patient safety.

Ms. Olivera brings to the table extensive knowledge of Joint Commission, DNV-GL, AAMI, OSHA, CDC, and DoH regulations. She specializes in budgeting, change management, inventory management, process re-engineering, program and project management, vendor relationships, quality control, Six Sigma, supply chain, and total quality management.

Ms. Olivera is an educator and has published numerous articles related to sterile processing, surgical services, process improvement, and guides to achieve successful accreditation surveys.

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