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Work systems analysis of sterile processing: assembly
  1. Myrtede Alfred1,
  2. Ken Catchpole1,
  3. Emily Huffer2,
  4. Larry Fredendall3,
  5. Kevin M Taaffe2
  1. 1Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina, Charleston, South Carolina, USA
  2. 2Department of Industrial Engineering, Clemson University, Clemson, South Carolina, USA
  3. 3Department of Management, Clemson University, Clemson, South Carolina, USA
  1. Correspondence to Dr Myrtede Alfred, Anesthesia and Perioperative Medicine, Medical University of South Carolina, Charleston, SC 29425, USA; alfredm{at}


Background Sterile processing departments (SPDs) play a crucial role in surgical safety and efficiency. SPDs clean instruments to remove contaminants (decontamination), inspect and reorganise instruments into their correct trays (assembly), then sterilise and store instruments for future use (sterilisation and storage). However, broken, missing or inappropriately cleaned instruments are a frequent problem for surgical teams. These issues should be identified and corrected during the assembly phase.

Objective A work systems analysis, framed within the Systems Engineering Initiative for Patient Safety (SEIPS) model, was used to develop a comprehensive understanding of the assembly stage of reprocessing, identify the range of work challenges and uncover the inter-relationship among system components influencing reliable instrument reprocessing.

Methods The study was conducted at a 700-bed academic hospital in the Southeastern United States with two reprocessing facilities from October 2017 to October 2018. Fifty-six hours of direct observations, 36 interviews were used to iteratively develop the work systems analysis. This included the process map and task analysis developed to describe the assembly system, the abstraction hierarchy developed to identify the possible performance shaping factors (based on SEIPS) and a variance matrix developed to illustrate the relationship among the tasks, performance shaping factors, failures and outcomes. Operating room (OR) reported tray defect data from July 2016 to December 2017 were analysed to identify the percentage and types of defects across reprocessing phases the most common assembly defects.

Results The majority of the 3900 tray defects occurred during the assembly phase; impacting 5% of surgical cases (n=41 799). Missing instruments, which could result in OR delays and increased surgical duration, were the most commonly reported assembly defect (17.6%, n=700). High variability was observed in the reassembling of trays with failures including adding incorrect instruments, omitting instruments and failing to remove damaged instrument. These failures were precipitated by technological shortcomings, production pressures, tray composition, unstandardised instrument nomenclature and inadequate SPD staff training.

Conclusions Supporting patient safety, minimising tray defects and OR delays and improving overall reliability of instrument reprocessing require a well-designed instrument tracking system, standardised nomenclature, effective coordination of reprocessing tasks between SPD and the OR and well-trained sterile processing technicians.

  • human factors
  • patient safety
  • health services research
  • qualitative research

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  • Twitter @KenCatchpole

  • Contributors KC, KMT and LF conceived the presented idea and secured the funding for study. MA and EH collected the data and developed the preliminary models under the supervision of KC. All of the authors assisted with the data analysis, synthesis of the results and development of the manuscript.

  • Funding This study was funded by the Agency for Healthcare Research and Quality (grant number: 1R03-HS025538-01).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request.

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