Using Lean methodology to improve sterilization of surgical instruments

Proper sterilization of instruments used in surgical procedures is a crucial step toward reducing surgical infections, perioperative morbidity, and operative time and cost. Although health care providers are well aware of how important it is to clean, disinfect, and sterilize medical equipment, devices, and supplies, The Joint Commission has observed several significant missteps in these processes in recent years. More specifically, issues related to the proper use of steam sterilization as well as the unprecedented pace at which new devices and resistant pathogens have emerged and generated concern. In response, The Joint Commission has revised a standard and two elements of performance related to reducing these risks in ambulatory care facilities, critical access hospitals, hospitals, long-term care facilities, and office-based surgery centers.

Surgeons and health care providers seeking to address these issues and improve surgical outcomes use accreditation requirements and guidelines from the Centers for Disease Control and Prevention (CDC) and other professional agencies and organizations to standardize sterilization practices. One health care provider recently reported that use of Lean quality improvement techniques produced significantly better results in sterile surgical instrument processing. Lean is a set of production improvement tools that companies such as Toyota have used to increase customer value by eliminating waste and creating flow throughout the value stream. Details of the project were reported in the March issue of The Joint Commission Journal on Quality and Patient Safety.*

In a study undertaken at The Joint Commission-accredited Virginia Mason Medical Center in Seattle, WA, quality improvement interventions in the surgical instrument sterilization process were based on adoption of a specific set of Lean production improvement methods called the Virginia Mason Production System (VMPS). The article describes how the center used VMPS to improve surgical sterile instrument processing in its 24 operating rooms (ORs) where approximately 18,000 operative procedures are performed annually.

The daily defect sheet

The 37-month project at Virginia Mason relied on a quality monitoring approach that was developed to identify and categorize errors in sterile instrument processing through use of a daily defect sheet.

The organization used Lean methods to reduce risks in sterile processing of surgical instruments by creating separate steps of defined work related to assembling and packaging the instruments and by rearranging the physically confined sterile processing workspace to accommodate the new work processes. The center also developed a brief checklist and other processes to mistake-proof sterilization, created an instrument sterilization certification training program for staff, and sought continuous feedback on the sterilization processes.

The daily defect sheet was used to track errors, discover the causes of mistakes, foster accountability, and communicate across departments and disciplines. For example, OR staff’s discovery of multiple errors in functionality of the same instrument type led sterile processing staff to initiate a discussion, which revealed that the OR team was using laparoscopic tissue forceps to pull on a drain in a manner beyond its load tolerance, leading to frequent failures.

With the implementation of the Lean-based strategies, health care professionals at Virginia Mason reported that the instrument sterilization error rate decreased 50 percent, from 3.0 per 100 surgical procedures at baseline to 1.5 in the final sustainability period. Improvements were observed in multiple categories of error types, particularly assembly errors in packaging (from 0.66 to 0.24 errors per hundred cases, p = .004) and foreign objects such as pens and paper clips (0.17 to 0.02 errors per hundred cases, p = .025). Although process reviewers at Virginia Mason were unable to directly measure and attribute specific clinical outcomes to the surgical instrument processing interventions, reviewers anticipate the improved processes will contribute to lower infection rates, fewer surgical errors, and reduced costs.

In addition, the Center’s team expects to uncover direct linkages between OR delays and surgery times with sterile processing errors. The authors of the study concluded that surgical sterile instrument errors may be markedly reduced through the rigorous application of the VMPS Lean quality improvement methodology, with potential improvement in surgical quality and efficiency.

The Joint Commission Journal on Quality and Patient Safety, published monthly by Joint Commission Resources, features peer-reviewed research and case studies on improving quality and safety in health care organizations. For more information about the Journal, visit

For more information regarding the Virginia Mason study, Applying Lean Methods to Improve Quality and Safety in Surgical Sterile Instrument Processing, contact C. Craig Blackmore, MD, MPH, director of the Center for Health Services Research, Virginia Mason Medical Center, Seattle, WA, at

*Blackmore CC, Bishop R, Luker S, Williams BL. Applying Lean Methods to improve quality and safety in surgical sterile instrument processing. Jt Comm J Qual Patient Saf. 2013;39(3):99.

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