Medical Devices-Evidence and Research最新文献

{"title":"A Human Factors Validation of a Smart Autoinjector Accessory Designed to Improve Self-Injection Outcomes and User Confidence.","authors":"Stephan Wegner, Jana Milenkovic, Anthony D Andre, Carson P Whitaker, Tobias Theiler","doi":"10.2147/MDER.S545256","DOIUrl":"https://doi.org/10.2147/MDER.S545256","url":null,"abstract":"<p><strong>Purpose: </strong>Enhancing user guidance via visual and auditory real-time feedback during subcutaneous injections-combined with automated injection-data logging-has the potential to improve self-injection outcomes and increase user confidence. To meet these objectives, a Smart Autoinjector Accessory (SAA) was developed to help patients, caregivers, and healthcare practitioners (HCPs) manage the injection process more effectively. This human factors validation study assessed whether the SAA, together with its Instructions for Use (IFU), could be operated safely and effectively with an autoinjector by the intended user population.</p><p><strong>Methods: </strong>Seventy-five untrained participants (patients, n=45; caregivers, n= 15; HCPs, n=15) were evaluated on completion of SAA use tasks and IFU knowledge tasks in a simulated use environment.</p><p><strong>Results: </strong>All participants (75/75, 100%) successfully delivered the full dose with the associated autoinjector. A total of 1196 out of 1200 use tasks (99.7%) delivering a simulated injection with the SAA and 2772 out of 2775 knowledge tasks (99.9%) concerning content in the IFU were completed successfully. Therefore, the overall results show near perfect success rates. All observed errors were isolated to individual participants, and no patterns of recurring use- or knowledge-task errors were found. Root cause analysis attributed these errors to inattention rather than deficiencies in the IFU clarity or device design.</p><p><strong>Conclusion: </strong>This study shows that the intended users can operate the SAA safely and effectively. Given the strong usability outcomes, the results warrant further investigation into the SAA's potential to improve treatment adherence and persistence in longer-term studies. In post-launch use, the SAA could play a key role in facilitating the onboarding of inexperienced patients or those undergoing more complex treatment regimens. Beyond individual therapy, the SAA also holds promise in digitalizing real-world evidence collection for post-market insights and clinical drug development, supporting decentralized clinical trial designs, where patients administer injections at home rather than in clinical environments.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"477-483"},"PeriodicalIF":1.5,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12499574/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145245478","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":"Modelling and Simulation of the Pediatric Respiratory System with Endotracheal Tube During Pressure-Controlled Ventilation.","authors":"Mohamed Bourti, Said Younous, Abdelaziz Belaguid","doi":"10.2147/MDER.S549778","DOIUrl":"10.2147/MDER.S549778","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the impact of pediatric endotracheal tube (ETT) size on airflow and tidal volume (V_T) waveforms during pressure-controlled ventilation (PCV) by developing and validating linear and nonlinear respiratory system models that incorporate ETT resistance.</p><p><strong>Methods: </strong>Five pediatric ETTs (inner diameters: 3.5-5.5 mm) were analyzed using both linear (Poiseuille's law) and nonlinear (Rohrer's equation) mathematical models implemented in MATLAB Simulink. The models simulated PCV conditions and were validated against clinical data collected from nine pediatric ICU patients undergoing mechanical ventilation with ETTs in the same size range. Simulated signals for flow and tidal volume were compared with measured data using percentage differences and Student's <i>t</i>-test.</p><p><strong>Results: </strong>The nonlinear model closely approximated clinical data, with average percentage differences of 9.85% for tidal volume and 15.68% for peak flow, significantly outperforming the linear model (17.67% and 46.87%, respectively; <i>p</i> < 0.001). Simulation results also demonstrated that smaller-diameter ETTs substantially increased airflow resistance, reducing delivered V_T and requiring longer expiratory times to avoid air trapping.</p><p><strong>Conclusion: </strong>Incorporating nonlinear ETT resistance into respiratory system models improves prediction accuracy under PCV, particularly in pediatric patients with smaller airways. The findings emphasize the importance of ETT size in ventilator parameter adjustment to optimize ventilation efficiency and minimize lung injury. The validated model provides a useful clinical tool for predicting ETT-related effects and guiding safer ventilation strategies in pediatric intensive care.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"461-475"},"PeriodicalIF":1.5,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12495974/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145233783","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":"Design and Development of a Simple Screw Mechanism for a Low-Cost Neonatal Syringe Pump.","authors":"Oliver Norton, Prashant Jha","doi":"10.2147/MDER.S489922","DOIUrl":"10.2147/MDER.S489922","url":null,"abstract":"<p><strong>Background: </strong>Approximately 2.3 million neonates die annually. UNICEF proposes that the deployment of specialist, quality neonatal care could help reduce neonatal mortality rates by 28% by 2025. Syringe pumps are a key medical device for providing accurate and precise fluid and drug delivery to neonates. However, syringe pumps are expensive, complicated to use and not designed for the additional challenges of providing quality healthcare in low resource healthcare settings. Several open-source designs for low-cost syringe pumps already exist, however, they all have respective limitations.</p><p><strong>Objective: </strong>To design and test a simple, open-source, screw mechanism, with the potential to be used in a future low-cost syringe pump.</p><p><strong>Methods and materials: </strong>A low-cost screw mechanism for a syringe pump, using a non-captive stepper motor, was developed. The prototype's accuracy was tested using 5mL, 20mL, 30mL and 60mL syringes at different rates. The rate was measured by recording the changing mass of saline fluid dispensed onto a weighing scale. The mean flow rate error from each run was calculated as the time taken to infuse 75% of the nominal volume, as per the ISO 286020:2020 standard.</p><p><strong>Results: </strong>The prototype produced a total mean flow rate error of 0.38%±1.62%. All errors were within the 3% limit (Z-score: 0.125) stipulated by the UNICEF and NEST360 target product profile. Compared to the other open-source designs, the prototype has the fewest parts, can accommodate a range of syringe sizes and is more accurate than many of the other open-source designs. Future work should involve testing the device with more viscous fluids, a greater range of rates and microstep settings, and improving the accuracy with further software and hardware development.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"447-459"},"PeriodicalIF":1.5,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12449876/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145114483","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":"Evaluating Augmented Reality Head-Mounted Devices in Healthcare: A Review of Hardware, Software, and Usability Approaches.","authors":"Peiming Zhang, Zihe Wang, Tao Wang, Tielong Liu, Jing Wang, Yimeng Gao, Weiqi Li","doi":"10.2147/MDER.S541187","DOIUrl":"10.2147/MDER.S541187","url":null,"abstract":"<p><p>Augmented reality head-mounted devices (AR HMDs) are increasingly deployed in healthcare. Given the stringent safety and efficacy requirements of medical settings, proactive quantitative testing of key performance attributes prior to deployment is critical for risk assessment. A systematic performance evaluation framework is essential not only to support clinical adoption but also to secure regulatory approval. This review systematically summarizes hardware, software, and usability assessment methods for AR HMDs in healthcare, analyzes current research and experimental designs, and identifies challenges arising from device heterogeneity, limited coupling with real-world clinical scenarios, and subjective bias. To address these issues, we propose five design principles to guide the development of objective and practical evaluation methods: (1) identify key components based on core functions; (2) prioritize testing by functional contribution; (3) replicate authentic clinical and human-visual conditions; (4) objectify subjective perception; (5) test functionally linked components jointly.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"427-445"},"PeriodicalIF":1.5,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12380000/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144973763","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":"Mid-Term Management of Operating Room Equipment: Improving Surgical Quality.","authors":"Yanting Dai, Yunfei Xu, You Zhang, Ke Wang","doi":"10.2147/MDER.S550091","DOIUrl":"10.2147/MDER.S550091","url":null,"abstract":"<p><p>This study focuses on the mid-term management theory of equipment lifecycle and systematically examines the impact of operating room instrument management on operational efficiency optimization. The review mainly covers four key aspects: operator training, information technology application, cost control, and quality assurance. The results indicate that mid-term management plays a crucial role in the full lifecycle management of operating room equipment and plays a key role in improving the quality of operating room operations. This management model is undergoing a profound transformation from experience driven to evidence-based practice, and from single control to system integration. Future research should focus on developing standardized evaluation metrics, scalable digital management platforms, and cross institutional data sharing models for optimizing the lifecycle of medical devices.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"415-425"},"PeriodicalIF":1.5,"publicationDate":"2025-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12360330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144884080","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":"Erratum: Normative Data for the Balance Tracking System Modified Clinical Test of Sensory Integration and Balance Protocol [Corrigendum].","authors":"","doi":"10.2147/MDER.S558478","DOIUrl":"https://doi.org/10.2147/MDER.S558478","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.2147/MDER.S206530.].</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"413-414"},"PeriodicalIF":1.5,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339242/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144838187","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":"Enhancing Informed Consent Forms for Medical Devices: International Regulatory Guidance and Ethical Recommendations.","authors":"Olga Marius Peycheva, Lydia R Ainsworth, Galina Fujimori-Petrikova, Wai Theng Lee","doi":"10.2147/MDER.S522922","DOIUrl":"10.2147/MDER.S522922","url":null,"abstract":"<p><p>Many developers of medical devices face a new reality with the increasing demand for clinical evidence that is generated by clinical investigations. This affects biotechnology companies, start-ups and academic research centres. The participants' informed consent form (ICF), which includes the participant information sheet (PIS), is among the critical documents that are part of the clinical investigation. While many countries around the world follow the principles of good clinical practice (GCP), there are country-specific variations of the ICF requirements. In addition, many of the country guidelines are focused on medicinal products rather than medical devices. Clinical investigations involving medical devices have their unique challenges and need additional guidance to help developers improve the ICF and PIS content. This review provides information on the latest regulatory recommendations from Europe, USA and Asia regarding the content of the ICF and offers practical advice from professionals experienced in preparing ICFs. It also includes some ethical considerations that must be taken into account.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"397-411"},"PeriodicalIF":1.5,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12311233/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144761725","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 Buccal Mucosal Oximeter Accurately Measures Arterial Oxyhemoglobin Saturation.","authors":"Connor Snow, Shane Magnison-Benoit, Matiram Pun, Thomas R Tripp, Aimee Clarke, Sophie Berghmans, Bradley Hansen, Leo Transfiguracion, Saleema Adatia, Jean M Rawling, Steven Roy, Giovanni Di Simone, Ming-Lai Lai, Erin V Mosca, John E Remmers, Marc J Poulin","doi":"10.2147/MDER.S527510","DOIUrl":"10.2147/MDER.S527510","url":null,"abstract":"<p><strong>Purpose: </strong>While arterial oxyhemoglobin saturation (SaO₂) decreases during sleep in many patients with sleep apnea and pulmonary diseases, personalized oximeters suitable for multi-night monitoring of SpO₂ are not readily available. The present report describes a custom buccal mucosal intraoral oximeter that might provide the opportunity for such long-term monitoring given its strong accuracy in measuring SpO₂ over a range of clinically relevant hypoxemia.</p><p><strong>Patients and methods: </strong>The intraoral buccal mucosal oximeter was constructed by encapsulating a reflectance pulse oximeter in an overlay of the maxillary dentition. Accuracy was assessed during non-motion conditions in normal participants (n = 12) made progressively hypoxic by decreasing the partial pressure of end-tidal oxygen (PETO₂). CO-oximeter values of SaO₂ from arterial blood constituted the \"gold standard\" for comparison with the buccal mucosal oximeter's values. The oximeter's pulse rate and an electrocardiogram (ECG) determined heart rate were also compared.</p><p><strong>Results: </strong>Analysis of 325 paired SaO₂ values from the CO-oximeter and buccal mucosal oximeter yielded the following: r = 0.95; bias = 0.72; and accuracy root-mean-square (A_RMS) = 2.94%. Results from the pulse rate/ECG analysis were: r = 0.99; bias = 0.30; and A_RMS = 2.08 bpm.</p><p><strong>Conclusion: </strong>These results reveal robust accuracy of the buccal mucosal oximeter measurement of SaO₂ and pulse rate, as shown by good agreement with a \"gold standard\" over a wide range of arterial hypoxemia. Such clinically acceptable accuracy indicates that this novel reflectance oximeter may prove useful in management of patients with sleep-induced hypoxemia by allowing for long-term monitoring of SaO₂.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"387-395"},"PeriodicalIF":1.3,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12266342/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144650877","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":"Hemostatic Benefits of an Absorbable Polysaccharide Powder in Redo Cardiac Surgery: A Comparative Study.","authors":"Sarah E Schroeder, Robert Oakes, Ryan Shelstad, Richard Thompson","doi":"10.2147/MDER.S509115","DOIUrl":"10.2147/MDER.S509115","url":null,"abstract":"<p><strong>Background: </strong>Redo cardiac surgery outcomes, including increased transfusions and risk of reoperation, worsen with post-operative bleeding. This study aimed to directly compare the use of an absorbable polysaccharide powder to no hemostatic agent use during planned non-emergent redo cardiac surgery.</p><p><strong>Methods: </strong>Fifty-one participants in two cohorts underwent planned non-emergent redo cardiac surgery. The retrospective cohort (n = 26) was chosen from redo cardiac surgeries completed between 2019 and 2020, while the prospective cohort (n = 25) included sequential redo cardiac surgeries with the use of an absorbable polysaccharide powder. Patient operative characteristics, along with first 24-hour transfusion use (packed red blood cells (pRBC), fresh frozen plasma (FFP) and platelets (Plts), chest tube outputs (CTO) at 12, 24 and 48 hours, and reoperation rates were compared.</p><p><strong>Results: </strong>There was a higher non-statistical average of intraoperative pRBC and FFP rates in the retrospective cohort, compared to cases where absorbable polysaccharide powder was used (2 ± 2.9 vs 1.1 ± 1.4 units pRBC, p = 0.414; and 1.4 ± 1.8 vs 0.6 ± 1 units FFP, p = 0.070) while there were statistical differences in Plts use in the retrospective cohort compared to when absorbable polysaccharide powder was used (1 ± 1.3 vs 0.4 ± 0.7 units plts, p = 0.028). Statistically significant lower amounts of CTO in the first 12 hours and the 12-24-hour intervals were found when absorbable polysaccharide powder was used (817 ± 520 vs 558 ± 352 milliliters, p = 0.028; and 1144 ± 704 vs 830 ± 474 milliliters, p = 0.044, respectively). There were three reoperations in the retrospective cohort due to suspected bleeding, compared to no reoperations in the absorbable polysaccharide powder cohort.</p><p><strong>Conclusion: </strong>This study highlights fewer transfusions, lower CTO, and decreased need for reoperation when using absorbable polysaccharide powder in redo cardiac surgeries. Further randomized trials are needed to more accurately define benefits of absorbable polysaccharide powder in redo cardiac surgeries. Word count: 302.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"377-386"},"PeriodicalIF":1.3,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12235016/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144592642","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 Statistical Framework to Detect and Quantify Operator-Learning Curves in Medical Device Safety Evaluation.","authors":"Henry C Ssemaganda, Sharon E Davis, Usha S Govindarajulu, Jejo D Koola, Jialin Mao, Dax Marek Westerman, Amy M Perkins, Theodore Speroff, Craig R Ramsay, Art Sedrakyan, Lucila Ohno-Machado, Michael E Matheny, Frederic S Resnic","doi":"10.2147/MDER.S520191","DOIUrl":"10.2147/MDER.S520191","url":null,"abstract":"<p><strong>Importance: </strong>Safety issues leading to patient harm and significant costs have been identified in several post-market medical devices. Recently, powerful learning effects (LE) have been documented in numerous medical devices. Correctly attributing safety signals to learning or device effects allows for appropriate corrective actions and recommendations to improve patient safety.</p><p><strong>Objective: </strong>To develop and assess the statistical performance of an analytic framework to detect the presence of LE and quantify the learning curve (LC).</p><p><strong>Design and setting: </strong>We generated synthetic datasets based on observed clinical distributions and complex feature correlations among patients hospitalized at US Department of Veterans Affairs facilities. Each dataset represents a hypothetical early experience in the use of high-risk medical devices, with a device of interest and a reference device. The study blinded the analysis team to the data-generation process.</p><p><strong>Methods: </strong>We developed predictive models using generalized additive models and estimated LC parameters using the Levenberg-Marqualdt algorithm. We evaluated the performance using sensitivity, specificity, and likelihood ratio (LR) in detecting the presence of LE and, if present, the goodness-of-fit of the estimated LC based on the root-mean squared error.</p><p><strong>Results: </strong>Among the 2483 simulated datasets, the median (IQR) number of cases was 218,000 (116,000-353,000). LE were detected in 2065 of the 2291 datasets for which learning was specified (sensitivity: 90%; specificity: 88%; LR: 7). We adequately estimated the LC in 1632 (81%) of the 2013 datasets in which LE was detected and estimated LC.</p><p><strong>Discussion: </strong>This study demonstrated the framework to be robust in disentangling LE from device safety signals and in estimating LC.</p><p><strong>Conclusion: </strong>In medical device safety evaluation, the operator-learning effects associated with the safety of medical devices can be effectively modeled and characterized. This study warrants subsequent framework validation by using real-world clinical datasets.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"361-375"},"PeriodicalIF":1.3,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12230321/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585262","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}