Medical Devices-Evidence and Research最新文献

{"title":"Use of a Portable Electronic Interface Improves Clinical Handoffs and Adherence to Lung Protective Ventilation.","authors":"Neil R Euliano, Paul Stephan, Konstantinos Michalopoulos, Michael A Gentile, A Joseph Layon, Andrea Gabrielli","doi":"10.2147/MDER.S372333","DOIUrl":"10.2147/MDER.S372333","url":null,"abstract":"<p><strong>Background: </strong>Mechanical ventilation (MV) is used to support patients with respiratory impairment. Evidence supports the use of lung-protective ventilation (LPV) during MV to improve outcomes. However, studies have demonstrated poor adherence to LPV guidelines. We hypothesized that an electronic platform adapted to a hand-held tablet receiving real-time ventilatory parameters could increase clinician awareness of key LPV parameters. Furthermore, we speculated that an electronic shift-change tool could improve the quality of clinician handoffs.</p><p><strong>Methods: </strong>Using a specially designed Wi-Fi dongle to transmit data from three ventilators and a respiratory monitor, we implemented a system that displays data from all ventilators under the care of a Respiratory Care Practitioner (RCP) on an electronic tablet. In addition, the tablet created a handoff checklist to improve shift-change communication. In a simulated ICU environment, we monitored the performance of eight RCPs at baseline and while using the system.</p><p><strong>Results: </strong>Using the system, the time above guideline Pplat decreased by 74% from control, and the time outside the VT range decreased by 60% from control, p = 0.007 and 0.015, respectively. The handoff scores improved quality significantly from 2.8 to 1.6 on a scale of 1 to 5 (1 being best), p = 0.03.</p><p><strong>Conclusion: </strong>In a simulated environment, an electronic RT tool can significantly improve shift-change communication and increase the RCP's level of LPV adherence.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"263-275"},"PeriodicalIF":1.3,"publicationDate":"2022-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/33/48/mder-15-263.PMC9362905.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40690125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biomechanical and Physiological Evaluation of Respiratory Protective Equipment Application.","authors":"Silvia Caggiari,&nbsp;Dan L Bader,&nbsp;Finn Foxell,&nbsp;Nicholas Pipe,&nbsp;Seana Couch,&nbsp;Abbie Turner,&nbsp;Peter R Worsley","doi":"10.2147/MDER.S370142","DOIUrl":"https://doi.org/10.2147/MDER.S370142","url":null,"abstract":"<p><strong>Purpose: </strong>Respiratory protective equipment is widely used in healthcare settings to protect clinicians whilst treating patients with COVID-19. However, their generic designs do not accommodate the variability in face shape across genders and ethnicities. Accordingly, they are regularly overtightened to compensate for a poor fit. The present study aims at investigating the biomechanical and thermal loads during respirator application and the associated changes in local skin physiology at the skin-device interface.</p><p><strong>Materials and methods: </strong>Sixteen healthy volunteers were recruited and reflected a range of gender, ethnicities and facial anthropometrics. Four single-use respirators were evaluated representing different geometries, size and material interfaces. Participants were asked to wear each respirator in a random order while a series of measurements were recorded, including interface pressure, temperature and relative humidity. Measures of transepidermal water loss and skin hydration were assessed pre- and post-respirator application, and after 20 minutes of recovery. Statistical analysis assessed differences between respirator designs and associations between demographics, interface conditions and parameters of skin health.</p><p><strong>Results: </strong>Results showed a statistically significant negative correlation (p < 0.05) between the alar width and interface pressures at the nasal bridge, for three of the respirator designs. The nasal bridge site also corresponded to the highest pressures for all respirator designs. Temperature and humidity significantly increased (p < 0.05) during each respirator application. Significant increases in transepidermal water loss values (p < 0.05) were observed after the application of the respirators in females, which were most apparent at the nasal bridge.</p><p><strong>Conclusion: </strong>The results revealed that specific facial features affected the distribution of interface pressures and depending on the respirator design and material, changes in skin barrier function were evident. The development of respirator designs that accommodate a diverse range of face shapes and protect the end users from skin damage are required to support the long-term use of these devices.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"241-252"},"PeriodicalIF":1.3,"publicationDate":"2022-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9343257/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40682770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Revision of Failed Sacroiliac Joint Posterior Interpositional Structural Allograft Stabilization with Lateral Porous Titanium Implants: A Multicenter Case Series.","authors":"Andy Kranenburg,&nbsp;Gabriel Garcia-Diaz,&nbsp;Judson H Cook,&nbsp;Michael Thambuswamy,&nbsp;Whitney James,&nbsp;David Stevens,&nbsp;Adam Bruggeman,&nbsp;Ying Chen,&nbsp;Robyn Capobianco,&nbsp;W Carlton Reckling,&nbsp;Joel D Siegal","doi":"10.2147/MDER.S369808","DOIUrl":"https://doi.org/10.2147/MDER.S369808","url":null,"abstract":"<p><strong>Background: </strong>Distraction arthrodesis (DA) and stabilization of the sacroiliac (SI) joint by placing standalone structural allograft (SA) into the joint from a posterior trajectory has recently been introduced as a surgical procedure for chronic SI joint pain refractory to non-operative care.</p><p><strong>Methods: </strong>Retrospective case series of patients with recurrent and/or persistent pain after placement of one or more interpositional/intraarticular standalone SAs between the ilium and sacrum using a posterior procedure to treat SI joint pain/dysfunction. Patients subsequently underwent surgical revision with porous titanium fusion implants using a lateral transfixing procedure. The demographic, clinical, and radiographic features of these cases are described.</p><p><strong>Results: </strong>Data were available for 37 patients. The average (SD) age was 57 (13) years, 62% were female, and the average BMI was 31 (5.4). On average, two SA implants were placed per joint; 46% of cases were bilateral. At follow-up, two common themes were identified: lucencies around the implants and suboptimal implant position. None of the cases showed radiographic fusion of the SI joint prior to revision. One patient had an inflammatory reaction to the SA. All patients presented for revision due to either continued (49%) or recurrence (51%) of pain. In one revision case, the SA was forced ventrally, resulting in a sacral fracture, which was treated conservatively without sequelae.</p><p><strong>Conclusions: </strong>The popularity of standalone SA for SI joint stabilization/fusion with a posterior procedure is increasing. This case series demonstrates that clinical failures from this procedure may require surgical revision. The proposed fusion strategy (DA) for these products is unproven in the SI joint, and, therefore, properly conducted prospective randomized clinical trials with long-term clinical and radiographic follow-up are important to establish the safety and efficacy of this approach. In the meantime, the placement of lateral titanium implants appears to be an effective revision strategy.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"229-239"},"PeriodicalIF":1.3,"publicationDate":"2022-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/51/f6/mder-15-229.PMC9309279.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40639949","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Proof of Concept for Stabilization of Tracheostomy Tubes Using Novel DYNAtraq Device.","authors":"Mauricio Orozco-Levi,&nbsp;Carlos Reyes,&nbsp;Neikel Quintero,&nbsp;Diana Tiga-Loza,&nbsp;Mabel Reyes,&nbsp;Sandra Sanabria,&nbsp;Camilo Pizarro,&nbsp;Juan De Hoyos,&nbsp;Norma Serrano,&nbsp;Victor Castillo,&nbsp;Alba Ramírez-Sarmiento","doi":"10.2147/MDER.S366829","DOIUrl":"https://doi.org/10.2147/MDER.S366829","url":null,"abstract":"<p><strong>Introduction: </strong>Tracheostomy is one of the most common surgical strategies in intensive care units (ICU) and provides relevant clinical benefit for multiple indications. However, the complications associated with its use range from 5 to 40% according to different series. The risk of these complications could be reduced if fixation strategies and alignment of the tracheostomy tube with respect to the tracheal axis are improved.</p><p><strong>Aim: </strong>To build a functional device of technological innovation in respiratory medicine for the fixation and alignment of tracheostomy cannula (acronym DYNAtraq) and to evaluate its feasibility and safety in a pilot study in mechanically ventilated patients.</p><p><strong>Methods: </strong>Study carried out in four phases: (1) design engineering and functional prototyping of the device; (2) study of cytotoxicity and tolerance to the force of traction and push; (3) pilot study of feasibility and safety of its use in tracheostomized and mechanically ventilated patients; and (4) health workers satisfaction study.</p><p><strong>Results: </strong>The design of the innovative DYNAtraq device included, on the one hand, a connector with very little additional dead space to be inserted between the cannula and the ventilation tubes, and, on the other hand, a shaft with two supports for adhesion to the skin of the thorax with very high tolerance (several kilograms) to pull and push. In patients, the device corrected the malpositioned tracheostomy tubes for the latero-lateral (p < 0.001) and cephalo-caudal angles (p < 0.001). Its effect was maintained throughout the follow-up time (p < 0.001). The use of DYNAtraq did not induce serious adverse events and showed a 70% protective effect for complications (RR = 0.3, p < 0.001) in patients.</p><p><strong>Conclusion: </strong>DYNAtraq is a new device for respiratory medicine that allows the stabilization, alignment and fixation of tracheostomy tubes in mechanically ventilated patients. Its use provides additional benefits to traditional forms of support as it corrects misalignment and increases tolerance to habitual or forced movements. DYNAtraq is a safe element and can reduce the complications of tracheostomy tubes.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"215-227"},"PeriodicalIF":1.3,"publicationDate":"2022-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/bf/46/mder-15-215.PMC9289456.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40540086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preference Testing in Medical Devices: Current Framework and Regulatory Gaps.","authors":"Amy Lewis,&nbsp;Despoina Douka,&nbsp;Angeliki Koukoura,&nbsp;Vasiliki Valla,&nbsp;Amie Smirthwaite,&nbsp;Susanne Holm Faarbaek,&nbsp;Efstathios Vassiliadis","doi":"10.2147/MDER.S368420","DOIUrl":"https://doi.org/10.2147/MDER.S368420","url":null,"abstract":"<p><p>Preference testing is a valuable source of information that can be provided by both healthcare professionals (HCPs) and patients (users). It can be used to improve the design and development of medical devices by feeding into device usability and, ultimately, risk management. Furthermore, it can aid with selecting the most appropriate clinical endpoints to be used in the clinical evaluation of a device and increase patient engagement by incorporating patient-relevant outcomes. Preference testing is widely conducted in the food industry but is not widespread in the medical field due to limited guidelines and a lack of regulatory framework. As such, manufacturers may be unaware of the benefits of preference testing and fail to take full advantage of it, or conversely, may use inappropriate methodology and/or analyses and consequently fail to collect meaningful data. In this position paper, we aim to highlight the benefits and uses of preference testing, along with potential methods that could be used for preference testing of medical devices. A key step towards the wider implementation of preference testing in medical devices is for the publication of international standards and guidelines for the collection, assessment, and implementation of preference data into the life cycle of a medical device.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"199-213"},"PeriodicalIF":1.3,"publicationDate":"2022-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5b/d7/mder-15-199.PMC9271283.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40584895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Nonclinical Bench Performance Testing of a Very Low-Cost Nonelectric Bubble Continuous Positive Airway Pressure (bCPAP) and Blenders Device Designed for Newborn Respiratory Support.","authors":"Patricia S Coffey, Alec Wollen","doi":"10.2147/MDER.S318218","DOIUrl":"10.2147/MDER.S318218","url":null,"abstract":"<p><strong>Purpose: </strong>Bubble continuous positive airway pressure (bCPAP) is often used to treat respiratory distress experienced by some 15 million preterm infants born globally every year. In low- and middle-income countries, improvised bCPAP devices are used, often without a blender that protects the infant from the sequelae of excessive oxygen exposure.</p><p><strong>Materials and methods: </strong>The aim of this bench testing was to assess the mechanical safety and performance of the PATH bCPAP and blenders device, which provides a stable and reliable source of pressurized blended gas without the requirement for a source of compressed medical air or electricity. The device includes two fixed ratio blenders: a \"low\" blend that provides 37% oxygen and a \"high\" blend that provides 60% oxygen. We performed bench testing to characterize the performance of the bCPAP and blenders, including respiratory circuit verification, blender verification, conditioned humidity testing, and sound measurement.</p><p><strong>Results: </strong>Test results for all performance variables met the acceptance criteria of our product requirement specification. The device provides a fixed ratio of air and oxygen that is consistent over the entire range of clinically relevant pressures (4 to 8 cmH₂O) and remains consistent despite changes in flow (2 to 7 liters per minute). The blend is stable within ± 5% of the blenders' nominal blend ratio when used with a 100% oxygen source, irrespective of the flow and pressure from the oxygen source or the flow and pressure of the blended gas delivered to the neonate. Sound and humidity test results were within specifications.</p><p><strong>Conclusion: </strong>This very low-cost nonelectric bCPAP and blenders device is optimally designed to deliver a stable and reliable source of pressurized blended gas.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"187-197"},"PeriodicalIF":1.3,"publicationDate":"2022-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/76/f2/mder-15-187.PMC9249094.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40468820","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers.","authors":"Natalia A Wilson,&nbsp;James E Tcheng,&nbsp;Jove Graham,&nbsp;Joseph P Drozda","doi":"10.2147/MDER.S364539","DOIUrl":"https://doi.org/10.2147/MDER.S364539","url":null,"abstract":"<p><strong>Background: </strong>The requirement for medical device manufacturers to label their devices with a unique device identifier (UDI) was formalized by the 2013 US Food and Drug Administration Unique Device Identification System Rule. However, parallel regulatory requirement for US health systems to use UDIs, particularly the electronic documentation of UDIs during patient care is lacking. Despite the lack of regulation, some health systems have implemented and are using UDIs. To assess the current state, we studied representative health system UDI implementation experiences, including barriers and the strategies to overcome them, and identified next steps to advance UDI adoption.</p><p><strong>Methods: </strong>Semi-structured interviews were performed with health system personnel involved in UDI implementation in their cardiac catheterization labs or operating rooms. Interviews were transcribed and analyzed using the framework methodology of Ritchie and Spencer. An expert panel evaluated findings and informed barriers, strategies, and next steps.</p><p><strong>Results: </strong>Twenty-four interviews at ten health systems were performed. Identified barriers were internal (lack of organizational support, information technology gaps, clinical resistance) and external (information technology vendor resistance, limitations in manufacturer support, gaps in reference data, lack of an overall UDI system). Identified strategies included relationship building, education, engagement, and communication. Next steps to advance UDI adoption focus on education, research, support, and policy.</p><p><strong>Conclusions and implications: </strong>Delineation of UDI implementation barriers and strategies provides guidance and support for health systems to adopt the UDI standard and electronically document UDIs during clinical care. Next steps illuminate critical areas for attention to advance UDI adoption and achieve a comprehensive UDI system in health care to strengthen patient care and safety.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"177-186"},"PeriodicalIF":1.3,"publicationDate":"2022-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f8/14/mder-15-177.PMC9233486.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40406674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cervix Type and Cervical Cancer Classification System Using Deep Learning Techniques.","authors":"Lidiya Wubshet Habtemariam,&nbsp;Elbetel Taye Zewde,&nbsp;Gizeaddis Lamesgin Simegn","doi":"10.2147/MDER.S366303","DOIUrl":"https://doi.org/10.2147/MDER.S366303","url":null,"abstract":"<p><strong>Purpose: </strong>Cervical cancer is the 4th most common cancer among women, worldwide. Incidence and mortality rates are consistently increasing, especially in developing countries, due to the shortage of screening facilities, limited skilled professionals, and lack of awareness. Cervical cancer is screened using visual inspection after application of acetic acid (VIA), papanicolaou (Pap) test, human papillomavirus (HPV) test and histopathology test. Inter- and intra-observer variability may occur during the manual diagnosis procedure, resulting in misdiagnosis. The purpose of this study was to develop an integrated and robust system for automatic cervix type and cervical cancer classification using deep learning techniques.</p><p><strong>Methods: </strong>4005 colposcopy images and 915 histopathology images were collected from different local health facilities and online public datasets. Different pre-trained models were trained and compared for cervix type classification. Prior to classification, the region of interest (ROI) was extracted from cervix images by training and validating a lightweight MobileNetv2-YOLOv3 model to detect the transformation region. The extracted cervix images were then fed to the EffecientNetb0 model for cervix type classification. For cervical cancer classification, an EffecientNetB0 pre-trained model was trained and validated using histogram matched histopathological images.</p><p><strong>Results: </strong>Mean average precision (mAP) of 99.88% for the region of interest (ROI) extraction, and test accuracies of 96.84% and 94.5% were achieved for the cervix type and cervical cancer classification, respectively.</p><p><strong>Conclusion: </strong>The experimental results demonstrate that the proposed system can be used as a decision support tool in the diagnosis of cervical cancer, especially in low resources settings, where the expertise and the means are limited.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"163-176"},"PeriodicalIF":1.3,"publicationDate":"2022-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e3/52/mder-15-163.PMC9208738.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40224766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and Efficacy of Inflatable Penile Prostheses for the Treatment of Erectile Dysfunction: Evidence to Date.","authors":"Vinson M Wang,&nbsp;Laurence A Levine","doi":"10.2147/MDER.S251364","DOIUrl":"https://doi.org/10.2147/MDER.S251364","url":null,"abstract":"<p><p>Erectile dysfunction (ED) is a common problem, and prevalence rates are expected to rise as life expectancy increases worldwide. In more severe cases of ED, penile prosthesis implantation has been an excellent option for patients. Over the past few decades, significant design improvements have been made to the penile prosthesis and modifications to surgical technique to improve clinical outcomes. The purpose of this review is to summarize the safety and efficacy of FDA-approved penile implants in the US market. Design modifications have greatly improved the safety and reliability of the implant. Development of improved surgical techniques has decreased intraoperative injuries and reservoir-related complications. With its high overall satisfaction rates and low risk of complications, the inflatable penile prosthesis remains an excellent option for patients with erectile dysfunction.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"27-36"},"PeriodicalIF":1.3,"publicationDate":"2022-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5f/12/mder-15-27.PMC8844936.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39933188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of an Articulating Laparoscopic Needle Holder (FlexDex™) Compared to a Conventional Rigid Needle Holder in 2-Dimension Vision Amongst Novices: A Randomised Controlled Study.","authors":"Nima Motahariasl,&nbsp;Sayed Borna Farzaneh,&nbsp;Sina Motahariasl,&nbsp;Ilya Kokotkin,&nbsp;Sara Sousi,&nbsp;Alexander Zargaran,&nbsp;David Zargaran,&nbsp;Bijendra Patel","doi":"10.2147/MDER.S345140","DOIUrl":"https://doi.org/10.2147/MDER.S345140","url":null,"abstract":"<p><strong>Aim: </strong>This study aims to compare novice performance of advanced bimanual laparoscopic skills using an articulating laparoscopic device (FlexDex™) compared to a standard rigid needle holder amongst surgical novices in 2-dimension (2D) visualisation.</p><p><strong>Methods: </strong>In this prospective randomised trial, novices (n = 40) without laparoscopic experience were recruited and randomised into two groups, which used either traditional rigid needle holders or the FlexDex™. Both groups performed 10 repetitions of a validated assessment task. Times taken and error rates were recorded, and results were evaluated based on completion times, error rates, and learning curves.</p><p><strong>Results: </strong>The intervention group that used the FlexDex™ completed 10 attempts of the standardised laparoscopic task slower than the control group that used traditional rigid needle holder (415 s versus 267 s taken for the first three attempts and 283 s versus 187 s taken for the last three attempts, respectively). The difference in average time for the first three and last three attempts reached statistical significance (P < 0.001). Furthermore, the intervention group demonstrated a higher error rate when compared to the control group (9.3 versus 6.2 errors per individual).</p><p><strong>Conclusion: </strong>When compared to the FlexDex™, the traditional rigid needle holder was observed to be superior in task performance speed, leading to shorter completion times and quicker learning effect, as well as fewer errors.</p><p><strong>Key statement: </strong>Traditional rigid needle holder leads to faster task completion times and lower error rates when compared with an articulating laparoscopic needle holder in 2D vision.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"15-25"},"PeriodicalIF":1.3,"publicationDate":"2022-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/57/bc/mder-15-15.PMC8824294.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39620375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}