Multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps: a proof-of-concept study. Patient safety in surgery Kang, H. S., Khoraki, J., Gie, J., Duval, D., Haynes, S., Siev, M., Shah, J., Kim, F., Mangino, M., Procter, L., Autorino, R., Weprin, S. 2023; 17 (1): 10

Abstract

BACKGROUND: Retained surgical sharps (RSS) is a "never event" that is preventable but may still occur despite of correct count and negative X-ray. This study assesses the feasibility of a novel device ("Melzi Sharps Finder" or MSF) in effective detection of RSS.METHODS: The first study consisted of determination of the presence of RSS or identification of RSS in an ex-vivo model (a container with hay in a laparoscopic trainer box). The second study consisted of determining presence of RSS in an in-vivo model (laparoscopy in live adult Yorkshire pigs) with 3 groups: C-arm, C-arm with MSF and MSF. The third study used similar apparatus though with laparotomy and included 2 groups: manual search and MSF.RESULTS: In the first study, the MSF group had a higher rate of identification of a needle and decreased time to locate a needle versus control (98.1% vs. 22.0%, p<0.001; 1.64min±1.12vs. 3.34min±1.28, p<0.001). It also had increased accuracy of determining the presence of a needle and decreased time to reach this decision (100% vs. 58.8%, p<0.001; 1.69min±1.43 vs. 4.89min±0.63, p<0.001). In-the second study, the accuracy of determining the presence of a needle and time to reach this decision were comparable in each group (88.9% vs. 100% vs. 84.5%, p<0.49; 2.2min±2.2 vs. 2.7min±2.1vs. 2.8min±1.7, p=0.68). In the third study, MSF group had higher accuracy in determining the presence of a needle and decreased time to reach this decision than the control (97.0% vs. 46.7%, p<0.001; 2.0min±1.5 vs. 3.9min±1.4; p<0.001). Multivariable analysis showed that MSF use was independently associated with an accurate determination of the presence of a needle (OR 12.1, p<0.001).CONCLUSIONS: The use of MSF in this study's RSS models facilitated the determination of presence and localization of RSS as shown by the increased rate of identification of a needle, decreased time to identification and higher accuracy in determining the presence of a needle. This device may be used in conjunction with radiography as it gives live visual and auditory feedback for users during the search for RSS.

View details for DOI 10.1186/s13037-023-00359-8

View details for PubMedID 37101230