Kang Hae Sung, Khoraki Jad, Gie Jessie, Duval Dielle, Haynes Susan, Siev Michael, Shah Jay, Kim Fernando, Mangino Martin, Procter Levi, Autorino Riccardo, Weprin Samuel
Department of Surgery, Virginia Commonwealth University Health, Richmond, VA, USA.
Department of Urology, Stanford Health, Palo Alto, CA, USA.
Patient Saf Surg. 2023 Apr 26;17(1):10. doi: 10.1186/s13037-023-00359-8.
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.
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.
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).
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.
手术中遗留锐器（RSS）是一种“绝不应该发生的事件”，虽然可以预防，但即便计数正确且X线检查为阴性仍可能发生。本研究评估一种新型设备（“Melzi锐器探测器®”或MSF）有效检测RSS的可行性。
第一项研究包括在体外模型（腹腔镜训练箱内装有干草的容器）中确定RSS的存在或识别RSS。第二项研究包括在体内模型（成年活体约克夏猪的腹腔镜检查）中确定RSS的存在，分为3组：C形臂组、带MSF的C形臂组和MSF组。第三项研究使用类似设备，但为剖腹手术，包括2组：手动搜索组和MSF组。
在第一项研究中，MSF组识别针的比率更高，与对照组相比，定位针的时间缩短（98.1%对22.0%，p<0.001；1.64分钟±1.12对3.34分钟±1.28，p<0.001）。其确定针存在的准确性也提高，做出该判断的时间缩短（100%对58.8%，p<0.001；1.69分钟±1.43对4.89分钟±0.63，p<0.001）。在第二项研究中，每组确定针存在的准确性及做出该判断的时间相当（88.9%对100%对84.5%，p<0.49；2.2分钟±2.2对2.7分钟±2.1对2.8分钟±1.7，p=0.68）。在第三项研究中，MSF组确定针存在的准确性高于对照组，做出该判断的时间缩短（97.0%对46.7%，p<0.001；2.0分钟±1.5对3.9分钟±1.4；p<0.001）。多变量分析显示，使用MSF与准确确定针的存在独立相关（比值比12.1，p<0.001）。
本研究的RSS模型中使用MSF有助于确定RSS的存在及定位，表现为识别针的比率增加、识别时间缩短以及确定针存在的准确性更高。该设备可与放射成像联合使用，因为在搜索RSS过程中能为使用者提供实时视觉和听觉反馈。
