Multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps: a proof-of-concept study

Hae Sung Kang; Jad Khoraki; Jessie Gie; Dielle Duval; Susan Haynes; Michael Siev; Jay Shah; Fernando Kim; Martin Mangino; Levi Procter; Riccardo Autorino; Samuel Weprin

doi:10.1186/s13037-023-00359-8

Multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps: a proof-of-concept study

Patient Saf Surg. 2023 Apr 26;17(1):10. doi: 10.1186/s13037-023-00359-8.

Authors

Affiliations

¹ Department of Surgery, Virginia Commonwealth University Health, Richmond, VA, USA.
² Department of Urology, Stanford Health, Palo Alto, CA, USA.
³ Department of Urology, Graves Gilbert Clinic, Bowling Green, KY, USA.
⁴ Department of Urology, Yale School of Medicine, New Haven, CT, USA.
⁵ Department of Urology, University of Colorado, Denver, CO, USA.
⁶ New Jersey Urology, Summit Health, Cherry Hill, NJ, USA. Weprin.sam@gmail.com.

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; 1.64 min ± 1.12vs. 3.34 min ± 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; 1.69 min ± 1.43 vs. 4.89 min ± 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; 2.2 min ± 2.2 vs. 2.7 min ± 2.1vs. 2.8 min ± 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; 2.0 min ± 1.5 vs. 3.9 min ± 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.

Keywords: Melzi Sharps Finder; Never event; Patient safety; Retained surgical sharps.