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

• Published in: Patient safety in surgery 2023-04, Vol.17 (1), p.10-10, Article 10
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: Abdomen; Accuracy; Auditory stimuli; Care and treatment; Diagnosis; Feasibility studies; Feedback; Foreign bodies (Medical care); Health care policy; Laparoscopy; Localization; Magnetic fields; Melzi Sharps Finder; Never event; Patient safety; Prevention; Radiography; Retained surgical sharps; Sensory integration; Surgery; Surgical equipment and supplies; Surgical errors; Testing; Urology
• ISSN: 1754-9493; 1754-9493
• 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