Medical Devices-Evidence and Research最新文献

{"title":"Design and Driving Performance Study of Soft Actuators for Hand Rehabilitation Training.","authors":"Zhilin Zhang, Aldrin D Calderon, Xingyu Huang, Guixian Wu, Chuanjian Liang","doi":"10.2147/MDER.S476464","DOIUrl":"10.2147/MDER.S476464","url":null,"abstract":"<p><strong>Purpose: </strong>To address the application requirements of soft actuators in rehabilitation training gloves, and in combination with ergonomic requirements, we designed a segmented soft actuator with bending and elongation modules. This actuator can achieve independent or coupled movements of the finger joints.</p><p><strong>Methods: </strong>A finite element model of the joint actuator was established to compare the driving performance of actuators with different structural forms. Numerical calculations were used to analyze the effects of structural size parameters on the bending characteristics and end output force of the actuator. The design was then refined based on these analyses.</p><p><strong>Results: </strong>The joint actuator designed in this study demonstrated a 71% increase in bending angle compared to the standard fast pneumatic network structure. Key factors affecting the driving performance include the thickness of the constraint layer, the inner wall thickness of the chamber, chamber height, chamber width, chamber spacing, chamber length, and the number of chambers. After improvements, the bending angle of the joint actuator increased by 60.6%, and the output force increased by 145.9%, indicating significant improvement.</p><p><strong>Conclusion: </strong>This study designed and improved a soft actuator for hand rehabilitation training, achieving independent and coupled joint movements. The bending angle, bending shape, and joint driving force of the soft actuator meet the requirements for finger rehabilitation training.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"237-260"},"PeriodicalIF":1.3,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11216218/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141477667","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":"Human Factors Validation of a Wearable, On-Body Infusor for Subcutaneous Administration of Furosemide.","authors":"Anthony D Andre, John F Mohr, Barbara W Cornelius, Matthew M Goodwin, Carson P Whitaker, Bhavini H Patel, Jessica A Huckleberry, Michael D Hassman","doi":"10.2147/MDER.S462573","DOIUrl":"10.2147/MDER.S462573","url":null,"abstract":"<p><strong>Purpose: </strong>Furoscix^® (subcutaneous furosemide) is administered using a wearable On-Body Infusor (OBI) and is approved for the treatment of congestion associated with heart failure (HF). The purpose of this study was to assess the safe and effective use of the OBI and Instructions for Use (IFU) by patients with HF, caregivers, and healthcare practitioners (HCPs).</p><p><strong>Methods: </strong>Sixty participants (patients, n=30; caregivers, n=15; HCPs, n=15) were evaluated on completion of OBI use tasks and IFU knowledge tasks in a simulated use environment. Fifteen of the patients received OBI/IFU training before evaluation.</p><p><strong>Results: </strong>Overall, 893/900 (99.2%) use tasks and 2211/2220 (99.6%) knowledge tasks were completed successfully, without differences due to training. The most common (n=6) use error was failure to wipe skin or cartridge tip with an alcohol wipe. Errors were due to forgetfulness/misinterpretation rather than IFU clarity.</p><p><strong>Conclusion: </strong>The subcutaneous furosemide OBI can be safely and effectively used by patients, caregivers, and HCPs, regardless of training.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"229-235"},"PeriodicalIF":1.3,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11212806/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141471523","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":"Mechanical Improvement of Gas Monitoring System in Monoplace Hyperbaric Chamber to Advance the Safety and Efficacy.","authors":"Hee Young Lee, Yoonsuk Lee, Hyun Kim, Jin Hui Paik","doi":"10.2147/MDER.S465022","DOIUrl":"10.2147/MDER.S465022","url":null,"abstract":"<p><strong>Introduction: </strong>A Monoplace hyperbaric chamber delivers oxygen to the patient's tissues through breathing. Gas monitoring inside the chamber is important because oxygen (O₂) is consumed, and carbon dioxide (CO₂) is increased because treatment is performed in a closed volume. This study aimed to advance the safety and efficacy of the monoplace hyperbaric chamber (MHC) through mechanical improvement in a gas monitoring system (GMS).</p><p><strong>Methods: </strong>First, as the oxygen supply method was changed to the direction of the patient's face, it was compared the values of O₂, CO₂, humidity, and temperature were measured in the MHC and the GMS when operating at 2.0 atmosphere absolute (ATA) and 3.0 ATA. Second, to evaluate the effects of variables across measuring time, it was analyzed in a 3-way repeated measure ANOVA (10 min.×20 min.×30 min.). Lastly, the values before and after the optimization of the MHC were compared by applying a cooler to prevent temperature rise inside the MHC.</p><p><strong>Results: </strong>In 2.0 ATA, the average humidity was higher in the MHC than in the GMS (p<0.001). Also, the average temperature was lower in the MHC than in the GMS (p<0.001). In 3.0 ATA, the average CO₂ and humidity were higher in the MHC than in the GMS, respectively (p<0.001, p=0.004). The 3-way repeated measures ANOVA revealed a significant difference in most main and interacted factors (p<0.05). O₂ and temperature, comparing before and after MHC optimization, revealed a significant difference (p<0.05).</p><p><strong>Conclusion: </strong>Few studies have verified safety and effectiveness by evaluating the pressure, oxygen concentration, etc. of a monoplace hyperbaric chamber. Further research is expected to verify the effectiveness of providing comfort to patients receiving hyperbaric oxygen treatment and increase the treatment effect.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"217-227"},"PeriodicalIF":1.3,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11195672/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141447311","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 Hearing Test App for Android Devices: Distinctive Features of Pure-Tone Audiometry Performed on Mobile Devices [Response to Letter].","authors":"Marcin Masalski","doi":"10.2147/MDER.S480072","DOIUrl":"10.2147/MDER.S480072","url":null,"abstract":"","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"215-216"},"PeriodicalIF":1.3,"publicationDate":"2024-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11179668/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141332157","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 Hearing Test App for Android Devices: Distinctive Features of Pure-Tone Audiometry Performed on Mobile Devices [Letter].","authors":"T Triwiyanto","doi":"10.2147/MDER.S478423","DOIUrl":"10.2147/MDER.S478423","url":null,"abstract":"","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"213-214"},"PeriodicalIF":1.3,"publicationDate":"2024-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11141733/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141200943","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":"Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014-2022.","authors":"Matthew J Swanson, Colin L Uyeki, Sarah R Yoder, Sanket S Dhruva, Jennifer E Miller, Joseph S Ross","doi":"10.2147/MDER.S457152","DOIUrl":"https://doi.org/10.2147/MDER.S457152","url":null,"abstract":"<p><strong>Background: </strong>Representation of diverse study populations in pivotal clinical trials for medical devices and subgroup analyses for demographic groups to explore differences in safety and effectiveness are essential to understanding the benefits and risks in diverse populations. The US Food and Drug Administration (FDA) has taken many steps to improve transparency and subgroup analyses over the past decade, but there has not been a recent evaluation of demographic reporting and subgroup analyses.</p><p><strong>Methods: </strong>We reviewed all FDA Premarket Approvals for high-risk cardiovascular devices from 2014 to 2022, focusing on pivotal studies supporting device approval. We abstracted detailed demographic data about the age, sex, race, ethnicity, and socioeconomic position of study participants. We also assessed the presence and results of subgroup analyses to understand the safety and effectiveness of devices across trial populations.</p><p><strong>Results: </strong>Analysis of 92 pivotal studies revealed that age and sex were reported in 96.7% of the studies, while race and ethnicity were reported in 71.7% and 58.7%, respectively. However, only 7.9% of studies explicitly detailed the participation of older adults (≥65 years) and no studies reported patients' socioeconomic position. Subgroup analyses by sex were conducted in 70.7% of studies, with 12.3% reporting significant differences. In contrast, analyses by race and ethnicity were performed in only 12.0% of the studies, with 9.1% reporting significant differences.</p><p><strong>Conclusion: </strong>Approximately one-third of pivotal studies for high-risk cardiovascular devices approved by the FDA from 2014 to 2022 did not report the race of study participants, nearly 40% did not report ethnicity, and more than 90% did not report the participation of older adults (≥65 years). Subgroup analyses were infrequently conducted by age or race and ethnicity. There is a need for better trial demographic reporting and conduct of subgroup analyses in premarketing studies to ensure the safety and effectiveness of medical devices for all patients.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"165-172"},"PeriodicalIF":1.3,"publicationDate":"2024-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11067925/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140866889","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 Hearing Test App for Android Devices: Distinctive Features of Pure-Tone Audiometry Performed on Mobile Devices.","authors":"Marcin Masalski","doi":"10.2147/MDER.S454359","DOIUrl":"10.2147/MDER.S454359","url":null,"abstract":"<p><p>The popularity of mobile devices, combined with advances in electronic design and internet technology, has enabled home-based hearing tests in recent years. The purpose of this article is to highlight the distinctive aspects of pure-tone audiometry performed on a mobile device by means of the Hearing Test app for Android devices. The first version of this app was released a decade ago, and since then the app has been systematically improved, which required addressing many issues common to the majority of mobile apps for hearing testing. The article discusses techniques for mobile device calibration, outlines the testing procedure and how it differs from traditional pure-tone audiometry, explores the potential for bone conduction testing, and provides considerations for interpreting mobile audiometry including test duration and background noise. The article concludes by detailing clinically relevant aspects requiring special attention during testing and interpretation of results which are of substantial value to the hundreds of thousands of active users of the Hearing Test app worldwide, as well as to users of other hearing test apps.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"151-163"},"PeriodicalIF":1.3,"publicationDate":"2024-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11041974/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140870138","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":"Value and Limitations of Urethrotech Catheterisation Device to Manage Difficult Urethral Catheterisation in Male Spinal Cord Injury Patients.","authors":"Vaidyanathan Subramanian, Bakulesh Madhusudan Soni","doi":"10.2147/MDER.S457784","DOIUrl":"https://doi.org/10.2147/MDER.S457784","url":null,"abstract":"<p><strong>Methods: </strong>We used a Urethrotech catheterisation device in 57 male patients with spinal cord injury, in whom urethral catheterisation was unsuccessful or previous catheterisation was difficult.</p><p><strong>Results: </strong>Urethrotech catheter could be inserted in 51 patients. No patient developed urinary tract infection. In one patient, the guidewire could not be introduced into the bladder, and a coude Foley catheter was inserted. In two patients, the guidewire was inserted into the bladder, but a 16 CH catheter could not be advanced over the guidewire. Emergency suprapubic cystostomy was performed in one case; in the other, urethral stricture was dilated; a size 12 CH catheter was inserted. In three patients, the guidewire curled back into the urethra because of severe spasm of the urethral sphincter. Catheterisation with a Tiemann catheter was successful after administration of diazepam and/or stretching of the anal sphincter by another health professional, which caused reflex relaxation of the urethral sphincter. Complications of Urethrotech catheterisation included urethral bleeding, haematuria, pain, doubling back of the guidewire due to spasm of the urethral sphincter or from an empty bladder. We adopted variations in technique, eg filling the bladder with saline prior to catheterisation when feasible, insertion of the guidewire by the side of the old catheter, use of Tiemann tip catheters, administration of antibiotics, diazepam to control spasms, nifedipine to control autonomic dysreflexia, analgesics, stretching of the anal sphincter to induce reflex relaxation of the urethral sphincter, urgent imaging studies to confirm correct positioning of the catheter, omitting anticoagulants and monitoring patients, who developed bleeding.</p><p><strong>Conclusion: </strong>Use of Urethrotech in spinal injury patients warranted adaptations to the technique, which required expertise, experience, and backup facilities. To ensure patient safety, Urethrotech catheter should be used in a hospital setting, and by medical personnel with experience in the management of spinal cord injury patients.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"143-150"},"PeriodicalIF":1.3,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11032119/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140866912","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":"Usefulness of Non-Invasive Parameters (Inferior Vena Cava Diameter, Inferior Vena Cava Collapsibility, Inferior Vena Cava-Aortic Ratio) for Hemodynamic Monitoring in Critically Ill Children: A Systematic Review.","authors":"Dzulfikar Djalil Lukman Hakim, Fina Meilyana, Stanza Uga Peryoga, Irma Arniawati, Elrika Anastasia Wijaya, Muhamad Rinaldhi Martiano","doi":"10.2147/MDER.S454849","DOIUrl":"10.2147/MDER.S454849","url":null,"abstract":"<p><strong>Purpose: </strong>Volume measurement in critically ill children can be conducted using invasive procedure such as Central Venous Pressure (CVP), or non-invasive procedure such as measurement of Inferior Vena Cava (IVC) indices using ultrasonography. However, their accuracy and efficacy are still under scrutiny. We aim to compare CVP and IVC indices as non-invasive parameters in assessing volume status in critically ill children.</p><p><strong>Methods: </strong>We conducted a systematic review based on literature searching from four electronic databases which were PubMed, Cochrane, ScienceDirect, SpringerLink with keywords: \"CENTRAL VENOUS PRESSURE\", \"INFERIOR VENA CAVA DIAMETER\", \"INFERIOR VENA CAVA COLLAPSIBILITY\", \"INFERIOR VENA CAVA AORTIC-RATIO\", \"VOLUME STATUS\", \"FLUID STATUS\", \"CRITICAL ILL\", \"CHILDREN\", and \"PEDIATRICS\". We included relevant studies in English published from 2000 to 2023 on critically ill children aged 0-18 years. Comparison between CVP and IVC indices was resumed.</p><p><strong>Results: </strong>Eight articles were included in this study. Majority of the studies showed a consistent correlation between CVP and IVC indices. IVC-CI was the most common parameter evaluated in the included studies. There was moderate to strong correlations using IVC-CI and IVC-DI, and moderate correlation using IVC-Ao ratio.</p><p><strong>Conclusion: </strong>We found that non-invasive tools might have a potential role to measure volume in critically ill children equals to CVP. Further high-quality and longitudinal studies are needed to validate these findings and to establish a clear guideline for the non-invasive tool to be used in daily clinical practice.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"123-133"},"PeriodicalIF":1.3,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10959115/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140207912","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":"Detecting Stroke at the Emergency Department by a Point of Care Device: A Multicenter Feasibility Study.","authors":"Dimitrios Tsiftsis, Eleni Alexandra Manioti, Georgios Touris, Eleftherios Kyriakakis, Nikolaos Tsamopoulos, Maria Gamvroudi","doi":"10.2147/MDER.S445075","DOIUrl":"10.2147/MDER.S445075","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate if the Strokefinder MD 100 by Medfield Diagnostics AB can be used as a point of care device in overcrowded Emergency Departments (ED).</p><p><strong>Patients and methods: </strong>We used the strokefinder MD 100 by Medfield Diagnostics AB in two Greek National Health System (NHS) Hospitals Emergency Departments. Our research protocol was approved by local scientific and ethics committees. We prospectively enrolled 71 adult patients from two NHS emergency departments in whom stroke was included as a differential diagnosis after triage. The feasibility of using the Strokefinder MD 100 by Medfield Diagnostics AB in various emergency department settings was evaluated through a structured questionnaire.</p><p><strong>Results: </strong>The strokefinder MD 100 was used on 71 patients in various settings in the Emergency Department. In every case, the test was completed at the patient bedside without interfering with other ongoing and diagnostic and resuscitation procedures. There was no additional delay to patient care caused by performing the test when compared with current local Emergency Department practice and protocol. In almost 90% of the cases, a clear result was produced by the device.</p><p><strong>Conclusion: </strong>The Strokefinder MD 100 can be safely used as a point of care device by all trained healthcare professionals, in the most overcrowded emergency department, in various ED locations.</p><p><strong>Mesh terms: </strong>Point of Care Systems, Cerebrovascular Stroke, Proof of Concept Study.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"107-112"},"PeriodicalIF":1.3,"publicationDate":"2024-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928921/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140111759","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}