Medical Devices-Evidence and Research最新文献

{"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}

{"title":"Novel Measure of Acetabular Cup Inclination and Anteversion During Total Hip Arthroplasty.","authors":"William L Walter, Neri A Baker, Daniel Marsden-Jones, Ameneh Sadeghpour","doi":"10.2147/MDER.S339669","DOIUrl":"10.2147/MDER.S339669","url":null,"abstract":"<p><strong>Purpose: </strong>The purposes of the present research were to assess the accuracy and usability of the inertial navigation system (INS).</p><p><strong>Materials and methods: </strong>The accuracy of the device navigation subsystem was assessed using benchtop testing. The usability was assessed through simulated use with surgeons. These results were compared to recent cadaveric results for the same system.</p><p><strong>Results: </strong>The navigation subsystem had an overall mean absolute error of 1.21° and a maximum absolute error across all devices of 4.79°. The device was found to be usable and to add an estimated 7 minutes to surgery time.</p><p><strong>Conclusion: </strong>The INS uses a novel approach to provide the surgeon with accurate and fast acetabular cup inclination and anteversion angles during THA.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"1-14"},"PeriodicalIF":1.3,"publicationDate":"2022-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f7/4d/mder-15-1.PMC8806051.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39583341","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":"Evaluation of Advanced Bimanual Skills in Novices Using the Wrist-Like FlexDex™ Articulating Laparoscopic Needle Holder in 2D and 3D Vision: A Randomised Trial.","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.S344975","DOIUrl":"https://doi.org/10.2147/MDER.S344975","url":null,"abstract":"<p><strong>Aim: </strong>The aim of this study was to evaluate the novice performance of advanced bimanual laparoscopic skills using the articulating FlexDex^TM laparoscopic needle holder in two-dimensional (2D) and three-dimensional (3D) visual systems.</p><p><strong>Methods: </strong>In this prospective randomised trial, novices (n=40) without laparoscopic experience were recruited from a university cohort and randomised into two groups, which used the FlexDex^TM and 2D or the FlexDex™ and 3D. Both groups performed 10 repetitions of a validated assessment task. Times taken and error rates were measured, and assessments were made based on completion times, error rates and learning curves.</p><p><strong>Results: </strong>The intervention group that used FlexDex^TM and 3D visual output completed 10 attempts of the standardised laparoscopic task quicker than the control group that used FlexDex^TM with standard 2D visual output (268 seconds vs 415 seconds taken for the first three attempts and 176 seconds vs 283 seconds taken for the last three attempts, respectively). Moreover, each attempt was completed faster by the intervention group compared to the control group. The difference in average time for the first three and last three attempts reached statistical significance (P < 0.001).</p><p><strong>Conclusion: </strong>Combination of 3D visual systems and the FlexDex^TM laparoscopic needle holder resulted in superior task performance speed, leading to shorter completion times and quicker learning effect. Although the 3D group demonstrated lower mean error rates, it did not reach statistical significance.</p><p><strong>Key statement: </strong>3D visual systems lead to faster task completion times when combined with an articulating laparoscopic needle holder compared to 2D vision. This effect however is not seen in error rates.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"14 ","pages":"469-480"},"PeriodicalIF":1.3,"publicationDate":"2021-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ca/fc/mder-14-469.PMC8722694.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39800005","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":"The Medical Device Unique Device Identifier as the Single Source of Truth in Healthcare Enterprises - Roadmap for Implementation of the Clinically Integrated Supply Chain.","authors":"James E Tcheng,&nbsp;Miriam V Nguyen,&nbsp;Helen W Brann,&nbsp;Patricia A Clarke,&nbsp;Maureen Pfeiffer,&nbsp;Jane R Pleasants,&nbsp;Gregory W Shelton,&nbsp;Joseph F Kelly","doi":"10.2147/MDER.S344132","DOIUrl":"https://doi.org/10.2147/MDER.S344132","url":null,"abstract":"<p><p>Documentation and tracking of supplies, equipment and medical devices is central to operational, financial, and clinical aspects of safe, efficient, and effective patient care. The labeling of medical devices with a unique device identifier (UDI) creates the opportunity to tightly integrate device information across health information systems by using the UDI as the index \"source of truth\". Across 3 hospitals of the Duke University Health System, we executed a comprehensive implementation of UDI-based device and supply information management in our cardiac catheterization and electrophysiology laboratories. Following are our key insights. Implementing a UDI-centric environment is a complex undertaking requiring integration of information systems, management processes, and clinical workflows involving leadership, inventory management, supply chain, clinical and billing teams. Implementation involves the domains of procedure documentation, electronic health records (EHRs), charge capture and billing, and interface and information technology systems, including information systems vendors. Replacing manual processes with electronic messages is not simply an exercise in programming information systems - successful execution requires orchestrated re-engineering of clinical and operational workflows. Our initiative resulted in a more efficient and effective supply chain, eliminated operational and clinical documentation errors, automated the posting of device implant data to the EHR, reduced clinician burden, improved charge capture, and produced a substantial financial benefit, with return on investment recognized in well under 1 year. We believe our stepwise approach to accomplishing a clinically integrated supply chain can serve as a roadmap for other healthcare enterprises to follow.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"14 ","pages":"459-467"},"PeriodicalIF":1.3,"publicationDate":"2021-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/35/4e/mder-14-459.PMC8714004.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39668381","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":"Mobile Cardiac Outpatient Telemetry Patch vs Implantable Loop Recorder in Cryptogenic Stroke Patients in the US - Cost-Minimization Model.","authors":"Goran Medic,&nbsp;Nikos Kotsopoulos,&nbsp;Mark P Connolly,&nbsp;Jennifer Lavelle,&nbsp;Vincent Norlock,&nbsp;Manish Wadhwa,&nbsp;Belinda A Mohr,&nbsp;Wayne M Derkac","doi":"10.2147/MDER.S337142","DOIUrl":"https://doi.org/10.2147/MDER.S337142","url":null,"abstract":"<p><strong>Purpose: </strong>The aim of this study was to compare costs and outcomes of mobile cardiac outpatient telemetry (MCOT) patch followed by implantable loop recorder (ILR) compared to ILR alone in cryptogenic stroke patients from the US health-care payors' perspective.</p><p><strong>Patients and methods: </strong>A quantitative decision tree cost-minimization simulation model was developed. Eligible patients were 18 years of age or older and were diagnosed with having a cryptogenic stroke, without previously documented atrial fibrillation (AF). All patients were assigned first to one then to the alternative monitoring strategies. Following AF detection, patients were initiated on oral anticoagulants (OAC). The model assessed direct costs for one year attributed to MCOT patch followed by ILR or ILR alone using a monitoring duration of 30 days post-cryptogenic stroke.</p><p><strong>Results: </strong>In the base case modeling, the MCOT patch arm detected 4.6 more patients with AFs compared to the ILR alone arm in a cohort of 1000 patients (209 vs 45 patients with detected AFs, respectively). Using MCOT patch followed by ILR in half of the patients initially undiagnosed with AF leads to significant cost savings of US$4,083,214 compared to ILR alone in a cohort of 1000 patients. Cost per patient with detected AF was significantly lower in the MCOT patch arm $29,598 vs $228,507 in the ILR only arm.</p><p><strong>Conclusion: </strong>An initial strategy of 30-day electrocardiogram (ECG) monitoring with MCOT patch in diagnosis of AF in cryptogenic stroke patients realizes significant cost-savings compared to proceeding directly to ILR only. Almost 8 times lower costs were achieved with improved detection rates and reduction of secondary stroke risk due to new anticoagulant use in subjects with MCOT patch detected AF. These results strengthen emerging recommendations for prolonged ECG monitoring in secondary stroke prevention.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"14 ","pages":"445-458"},"PeriodicalIF":1.3,"publicationDate":"2021-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/69/94/mder-14-445.PMC8694406.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39763758","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":"A Cadaver-Based Biomechanical Evaluation of a Novel Posterior Approach to Sacroiliac Joint Fusion: Analysis of the Fixation and Center of the Instantaneous Axis of Rotation.","authors":"Dawood Sayed,&nbsp;Kasra Amirdelfan,&nbsp;Ramana K Naidu,&nbsp;Oluwatodimu R Raji,&nbsp;Steven Falowski","doi":"10.2147/MDER.S347763","DOIUrl":"https://doi.org/10.2147/MDER.S347763","url":null,"abstract":"<p><strong>Purpose: </strong>The purpose of this study was to assess the stabilizing effect of a posterior joint fixation technique using a novel cortical allograft implant in unilateral and bilateral fixation constructs. We hypothesize that fixation would reduce the joint's range of motion during flexion-extension, axial rotation, and lateral bending loads. We also hypothesize that fixation would shift the center of the instantaneous axis of rotation during the predominant flexion-extension motions towards the implant's location, and that this shift would be correlated with the reduction in flexion-extension range of motion.</p><p><strong>Materials and methods: </strong>Six cadaveric sacroiliac joint specimens were tested under intact, unilateral fixation, and bilateral fixation conditions. The total range of motion (ROM) of the sacroiliac joint in flexion-extension, lateral bending, and axial rotation were evaluated by an optical tracking system, in a multidirectional flexibility pure moment model, between ± 7.5 Nm applied moment loads. The centers of the instantaneous axis of rotation (cIAR) of the sacroiliac joint were evaluated during flexion-extension loading. A correlation analysis was performed between the ROM reduction in flexion-extension upon implantation and shift of the cIAR to the graft implantation site.</p><p><strong>Results: </strong>Unilateral and bilateral fixations generated sacroiliac joint ROM reductions in flexion-extension, lateral bending, and axial rotation motions. Fixation shifted the cIAR to the graft implantation site. Reduction in the total range of motion had a moderate correlation with the shift of the cIAR.</p><p><strong>Conclusion: </strong>Our novel posterior approach presents a multifaceted mechanism for stabilizing the joint: first, by the reduction of the total range of motion in all planes of motion; second, by shifting the centers of the instantaneous axis of rotation towards the implant's location in the predominant plane of motion, ensuring little to no motion at the implantation site, thus promoting fusion in this region.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"14 ","pages":"435-444"},"PeriodicalIF":1.3,"publicationDate":"2021-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/20/af/mder-14-435.PMC8691588.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39760165","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":"A New Prototype of Smart Wearable Monitoring System Solution for Alzheimer's Patients.","authors":"Bassam Al-Naami,&nbsp;Hamza Abu Owida,&nbsp;Mohammed Abu Mallouh,&nbsp;Feras Al-Naimat,&nbsp;Moh'd Agha,&nbsp;Abdel-Razzak Al-Hinnawi","doi":"10.2147/MDER.S339855","DOIUrl":"https://doi.org/10.2147/MDER.S339855","url":null,"abstract":"<p><strong>Purpose: </strong>The daily life management of patients with Alzheimer's disease (AD) constitutes a significant and rapidly expanding health-care responsibility. In this study, an innovative prototype of a wireless-sensing smart wearable medical device (SWMD) is proposed as a multi-functions solution for Alzheimer patients. The SWMD is aimed to assemble three main biomedical engineering advances: 1) use of a Wi-Fi microcontroller, 2) simultaneous monitoring of a set of vital biomarkers, and 3) cautions of fall down conditions, in addition to GPS location indicator.</p><p><strong>Methods: </strong>The SWMD employs a Wi-Fi controller that is incorporated with electronic circuits to monitor three vital signals (temperature, heart rate, and oxygen saturation), fall down conditions in three directions (X, Y, and Z axis), and GPS location. The SWMD was connected to the Firebase Service (database hosted on the Internet Cloud). The proposed device was tested on 13 normal volunteers. The left side, right side, forward, and backward fall down conditions were assessed. The prototype's functions during daily activity such as rising hand, sitting down or standing up, and walking conditions were also assessed.</p><p><strong>Results: </strong>The three assembled functions were all successfully incorporated to build the SWDM device as a suggested solution offering real-time alerts during daily activity to AD patients. The Bland-Altman statistical test showed no significant difference (p-value >0.05) between the SWMD biomarkers' acquisition and the reference methods. The gyro/accelerator sensor yielded 93% sensitivity in fall down detection and 95% specificity during daily activities. The GPS yielded correct positioning of the SWDM holder, while the internet cloud allowed saving and managing all vital biomarkers daily.</p><p><strong>Conclusion: </strong>The SWMD is a possible solution for daily life support for AD patients. It incorporates three functions in one single device, GPS location indicator, monitoring set of biomarkers, and fall down alert, which are all controlled via a Wi-Fi micro controller on-line connected to Internet Cloud. It successfully would allow the management of the daily records as well as the real-time alerts to remote persons.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"14 ","pages":"423-433"},"PeriodicalIF":1.3,"publicationDate":"2021-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/7d/a3/mder-14-423.PMC8648277.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39704281","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: A Health System Roadmap to Implement Unique Device Identification at the Point of Care.","authors":"Natalia A Wilson,&nbsp;James E Tcheng,&nbsp;Jove Graham,&nbsp;Joseph P Drozda","doi":"10.2147/MDER.S339232","DOIUrl":"https://doi.org/10.2147/MDER.S339232","url":null,"abstract":"<p><strong>Background: </strong>The US Food and Drug Administration's Unique Device Identification System Rule of 2013 mandated manufacturers to assign unique device identifiers (UDIs) to their medical devices. Most high-risk (Class III), moderate-risk (Class II) and implantable devices now have UDIs. To achieve the necessary next step for a comprehensive UDI-enabled system for patient safety, UDIs must be electronically documented during patient care, a process not routinely done. The purpose of this research was to study the implementation experiences of diverse health systems in order to develop a roadmap for UDI implementation at the point of care.</p><p><strong>Methods: </strong>Semi-structured interviews were conducted with personnel at health systems that had implemented UDI for implantable devices in their cardiac catheterization labs or operating rooms. Interviews were audio-recorded, transcribed, and analyzed using the framework methodology of Ritchie and Spencer. Data interpretation involved development of a conceptual model and detailed recommendations for UDI implementation. An expert panel evaluated and provided input on the roadmap.</p><p><strong>Results: </strong>Twenty-four interviews at ten health systems were conducted by phone. Participants described implementation steps, factors and barriers impacting implementation. Findings populated a UDI implementation roadmap, that includes Foundational Themes, Key Components, Key Steps, UDI Use, and Outcomes.</p><p><strong>Conclusions and implications: </strong>The UDI implementation roadmap provides a framework for health systems to address the necessary steps and multilevel factors that underpin UDI implementation at the point of care. It is intended to guide and advance routine electronic documentation of UDIs for devices used during clinical care, the critical next step for a comprehensive UDI-enabled system to enhance medical device safety and effectiveness for patients.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"14 ","pages":"411-421"},"PeriodicalIF":1.3,"publicationDate":"2021-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/fe/91/mder-14-411.PMC8645947.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39703839","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":"Less Complexity in Hemodialysis Machines Reduces Time and Physical Load for Operator Actions.","authors":"Uwe Gründler,&nbsp;Eva Ekesbo,&nbsp;Martin Löwe,&nbsp;Adelheid Gauly","doi":"10.2147/MDER.S316610","DOIUrl":"https://doi.org/10.2147/MDER.S316610","url":null,"abstract":"<p><strong>Purpose: </strong>Innovative hemodialysis systems are designed to ensure user safety and reduce operational time to allow health-care personnel to focus on patient care. The 6008 CareSystem has been developed to simplify the extracorporeal circuit of the system through a disposable cassette, automate operation steps, and facilitate handling in comparison to its predecessor - the 5008 CorDiax. The present investigations were performed with the aim of evaluating usability, safety, and ergonomic aspects of the new therapy system.</p><p><strong>Methods: </strong>A time-motion study compared these two hemodialysis systems with video and time recording of handling steps required to prepare, operate, and dismantle a dialysis machine. The ergonomic burden on hands and finger joints was evaluated in a second study, again by video-recording the simulated operation of both dialysis systems.</p><p><strong>Results: </strong>The number of handling steps required for the 6008 CareSystem and critical contact points were reduced by 26% in comparison to the 5008 CorDiax for patients with arteriovenous fistula used for vascular access and by 22% for those with a catheter used for vascular access. Total process time was reduced by 2.83 and 2.57 minutes using fistulae and catheters for vascular access, respectively. The number of hand grips and finger and thumb presses was reduced by approximately 50% and required less strength to execute.</p><p><strong>Conclusion: </strong>The most recent hemodialysis system confirmed its ease of use and user safety through fewer handling steps and less physical burden on the user. Shorter operational time should enable more patient-focused care.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"14 ","pages":"379-387"},"PeriodicalIF":1.3,"publicationDate":"2021-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/03/1f/mder-14-379.PMC8607128.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39655858","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":"Formative Study on the Wearability and Usability of a Large-Volume Patch Injector.","authors":"Jakob Lange,&nbsp;Andreas Schneider,&nbsp;Christoph Jordi,&nbsp;Michael Lau,&nbsp;Timothy Disher","doi":"10.2147/MDER.S337670","DOIUrl":"https://doi.org/10.2147/MDER.S337670","url":null,"abstract":"<p><strong>Background: </strong>The subcutaneous self-administration of biologics using a single large-volume bolus dose requires novel large-volume patch injectors. However, the usability and wearability of such on-body devices has rarely been investigated thus far. Therefore, this formative simulated use experiment studies the overall handling and acceptability in terms of the size and weight of a novel 10 mL large-volume patch injector device platform.</p><p><strong>Methods: </strong>Twenty-three participants, including patients and healthcare professionals, simulated two injections with the large-volume patch injector, each lasting 17 min. During the injections, the patient participants performed predefined movements and activities with the on-body devices. Perceived usability and wearability were assessed through observation by the moderator and participant-reported feedback using five-point Likert scales and open-ended interviews.</p><p><strong>Results: </strong>All participants successfully completed the simulated injections. Only non-serious usability issues were identified. Users rated the device acceptability in terms of wearability and usability with high ratings.</p><p><strong>Conclusion: </strong>The results suggest the safe and effective usage of a novel prefilled large-volume patch injector that enables the subcutaneous delivery of a single bolus dose of up to 10 mL with an injection duration of 15 min. The participants of the simulated use study successfully used the device regardless of the disease state, age, or body size and habitus.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"14 ","pages":"363-377"},"PeriodicalIF":1.3,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/59/16/mder-14-363.PMC8605886.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39652750","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}