Patterns in staff reported surgical instrument errors point to failures in visualization as a critically weak point in sterile processing of surgical instruments

Background

Surgical Instrument Errors (missing, broken, bioburden/contamination etc.) account for significant delays in the operating room. During sterile processing, instruments must be inspected for correctness, functionality, and cleanliness (bioburden) prior to packaging for sterilization. The environment where these tasks are performed is typically high stress and high throughput. There is a growing body of research in human performance that indicates that under stress, the skill of human visualization (inspection and identification) deteriorates. Furthermore, error modeling of sterile processing of surgical instruments suggests that the tasks at highest risk for errors involve human visualization. Reporting of Surgical Instrument Errors at our institution falls to OR staff and, during the period of this study, was done through a mechanism termed the Patient safety notice or PSN. PSNs are filed via computer through the healthcare system website. There is no integration or linkage of the PSN to the electronic medical record and information in all fields must be typed in as it does not automatically populate. We hypothesized that the most common PSNs reporting Surgical Instrument Errors would involve tasks of visualization (inspection, identification). Accordingly, the most common reported Surgical Instrument Errors would be missing instruments, bioburden/contamination, and broken instruments. We also hypothesized that due to the complexity and lack of both data automation and integration with the electronic medical record in filing PSNs, the majority of PSNs reporting Surgical Instrument Errors would be incomplete. To test these two hypotheses, we analyzed one year's worth staff reported Surgical Instrument Error rates at two hospitals with the operating rooms at both locations serviced by a single sterile processing facility.

Methods

This study was conducted at a major healthcare center that houses 38 ORs located at 3 sites (Children's (8), Adult inpatient (24) and Adult outpatient (6)) all of which share a sterile processing facility. Staff reported Patient Safety Notices (PSNs), a reporting mechanism for safety events, were collected from July 2019 through June of 2020. PSNs reporting the following Surgical Instrument Errors: missing instrument (listed on the count sheet but absent from the tray), broken instrument, assembly or packaging error, wrong instrument, failed sterilization/bioburden/contamination, fleet management (trays missing), extra instrument and transport errors were identified. Raw annual rates of reported Surgical Instrument Errors were determined for each hospital. Rates per surgical service line (percent affected cases) per hospital were then determined by dividing the annual number of reported errors per service by the annual number of cases per service line. Whether the instrument error affected the sterile field was determined as well. An analysis of bioburden/contamination error rates and Surgical Instrument Error types by hospital was also determined.

Results

368 PSNs reporting 419 Surgical Instrument Errors were identified over a 12-month period (0.0432 errors/OR/elective OR day). The majority of reported errors (83 %) had to do with failures in inspection (bioburden/contamination) or in tracking and identification (missing). At both hospitals, cardiovascular surgery had the highest reported error rates per case (4.47 % of cases affected at the Adult hospital and 3.68 % of cases affected at the Children's hospital). In only 64 instances was the sterile field reported to be affected by the error. Bioburden/contamination was the most commonly reported instrument error (68.97 %) with the most common types of bioburden/contamination being debris, blood and tissue, failed instrument cleaning due to incomplete disassembly and the presence of hair. Overall, only 20.4 % of PSN had all fields filled to completion and 15 % were submitted days after the event (average of 12.70 ± 27.97 days, median of 2 days).

Conclusions

the data from this study indicates that failure in human visualization vis-à-vis inspection and identification are the root cause of the majority (83 %) of staff reported Surgical Instrument Errors. This manifests primarily through problems with bioburden/contamination and missing instruments. Implementation of technologies to improve inspection and identification and ultimately tracking of surgical instruments should substantially reduce Surgical Instrument Error rates. Furthermore, staff dependent reporting of these errors is rarely done to completion and a significant portion of events are reported days after an event. These latter findings suggest that the process is cumbersome and likely impedes accurate and timely reporting and may results in underreporting of Surgical Instrument Errors.