Validation & Assurance

To make sure items are sterile, the Sterile Services Department (SSD) needs to monitor every step of the process. Validation is crucial for ensuring sterility. It means proving without a doubt that the equipment works and the department can consistently produce sterile products using a reliable system with quality control measures.

LTrace software helps record results and, when possible, ensures adherence to processes. However, it’s important to understand that LTrace alone can’t guarantee sterility; it depends on staff following proper procedures. Visual inspection and common sense are essential, and the system should not distract staff from inspecting items or handling emergencies and exceptions wisely.

Software or Procedures

The LTrace software and procedures should be closely integrated. Although many features in LTrace are optional, neglecting them might create gaps in assurance. For instance, counting items in and out of the usage area is optional, but experience suggests that all theaters should actively ensure that all items are properly accounted for after surgery. LTrace offers flexibility to align with existing procedures or workflow. For instance, when recording items sterilized in a batch, you can choose to record them as labels are printed, before sterilization, after using a scanner, or through a computer. Each option has its own advantages.

LTrace + Procedures = Assurance

When implementing a tracking system, reassess your procedures to optimize outcomes considering your budget, staffing, and equipment. LTrace can be tailored to fit your work environment. However, sticking to the old way just because it’s familiar isn’t always the best choice. Embrace change for better efficiency and effectiveness.