Optimization of a Sterile Processing Department Using Lean Six Sigma Methodology, Staffing Enhancement, and Capital Investment

Background: Many hospitals and surgery centers have focused improvement efforts on operating room inefficiencies. A common inefficiency is missing and unusable surgical instrumentation, which can result in case delays and decreased effectiveness. Lean Six Sigma methodology, a set of process improvement tools focused on the reduction of waste and variation, has been used to identify and correct root causes of missing and unusable instrumentation.

Methods: An analysis of current operations was performed within the Sterile Processing Department (SPD). The team assessed physical workflows, including decontamination, assembly, sterilization, and sterile storage, as well as digital processes. The team identified five drivers of defects: (1) staffing and training, (2) inventory management, (3) equipment and SPD physical environment, (4) standard workflows and communication, and (5) governance structure. A root cause was established for each driver, and Lean Six Sigma principles were applied. Two metrics were established to assess accuracy and efficiency in the SPD. First pass yield was defined as the proportion of trays processed that were usable after the first cycle. Tray defect rate was defined as the proportion of requested instruments that were missing or unusable.

Results: After implementation, the SPD increased first pass yield from 81.0% to 97.4% (p < 0.001) and reduced the defect rate from 2.2% to < 0.10% (p < 0.001) with sustainment for more than a year.

Conclusion: Application of Lean Six Sigma methodology improved tray accuracy in a hospital's SPD. It is feasible and beneficial to apply improvement methodology developed for manufacturing in the hospital setting to reduce missing and unusable instrumentation.