Multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps: a proof-of-concept study
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 cons...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-04-01
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| Series: | Patient Safety in Surgery |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13037-023-00359-8 |
| _version_ | 1797836303935471616 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Hae Sung Kang |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T15:07:45Z |
| format | Article |
| id | doaj.art-b4596e864d0c45c5be8e63d8e2243867 |
| institution | Directory Open Access Journal |
| issn | 1754-9493 |
| language | English |
| last_indexed | 2024-04-09T15:07:45Z |
| publishDate | 2023-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Patient Safety in Surgery |
| spelling | doaj.art-b4596e864d0c45c5be8e63d8e22438672023-04-30T11:24:13ZengBMCPatient Safety in Surgery1754-94932023-04-011711810.1186/s13037-023-00359-8Multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps: a proof-of-concept studyHae Sung Kang0Jad Khoraki1Jessie Gie2Dielle Duval3Susan Haynes4Michael Siev5Jay Shah6Fernando Kim7Martin Mangino8Levi Procter9Riccardo Autorino10Samuel Weprin11Department of Surgery, Virginia Commonwealth University HealthDepartment of Surgery, Virginia Commonwealth University HealthDepartment of Urology, Stanford HealthDepartment of Urology, Graves Gilbert ClinicDepartment of Surgery, Virginia Commonwealth University HealthDepartment of Urology, Yale School of MedicineDepartment of Urology, Stanford HealthDepartment of Urology, University of ColoradoDepartment of Surgery, Virginia Commonwealth University HealthDepartment of Surgery, Virginia Commonwealth University HealthDepartment of Surgery, Virginia Commonwealth University HealthNew Jersey Urology, Summit HealthAbstract 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.https://doi.org/10.1186/s13037-023-00359-8Patient safetyRetained surgical sharpsMelzi Sharps FinderNever event |
| spellingShingle | 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 Multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps: a proof-of-concept study Patient Safety in Surgery Patient safety Retained surgical sharps Melzi Sharps Finder Never event |
| title | Multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps: a proof-of-concept study |
| title_full | Multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps: a proof-of-concept study |
| title_fullStr | Multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps: a proof-of-concept study |
| title_full_unstemmed | Multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps: a proof-of-concept study |
| title_short | Multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps: a proof-of-concept study |
| title_sort | multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps a proof of concept study |
| topic | Patient safety Retained surgical sharps Melzi Sharps Finder Never event |
| url | https://doi.org/10.1186/s13037-023-00359-8 |
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