Applying Lean Methods to Improve Quality and Safety in Surgical Sterile Instrument Processing

Background: Surgical instrument processing is critical to safe, high-quality surgical care but has received little attention in the medical literature. Typical hospitals have inventories in the tens of thousands of surgical instruments organized into thousands of instrument sets. The use of these instruments for multiple procedures per day leads to millions of instrument sets being reprocessed yearly in a single hospital. Errors in the processing of sterile instruments may lead to increased operative times and costs, as well as potentially contributing to surgical infections and perioperative morbidity. Methods: At Virginia Mason Medical Center (Seattle), a quality monitoring approach was developed to identify and categorize errors in sterile instrument processing, through use of a Daily Defect Sheet. Lean methods were used to improve the quality of surgical instrument processing through redefining operator roles, alteration of the workspace, mistake-proofing, quality monitoring, staff training, and continuous feedback. To study the effectiveness of the quality improvement project, a before/after comparison of prospectively collected sterile processing error rates during a 37-month time frame was performed. Results: Before the intervention, instrument processing errors occurred in 3.0% of surgical cases, decreasing to 1.5% at the final follow-up (p < .001). Improvements were observed in multiple categories of error types, particularly the assembly errors of packaging (from 0.66 to 0.24 errors per hundred cases, p = .004), and foreign objects (0.17 to 0.02 errors per hundred cases, p = .025). Conclusion: Surgical instrument processing errors are a barrier to the highest quality and safety in surgical care but are amenable to substantial improvement using Lean techniques.