Medical Devices-Evidence and Research最新文献

{"title":"A Physiology-Based Bridging Framework for Preliminary Cross-Population Evaluation of Plateletpheresis Devices: A Case Study of the NGL XF3000.","authors":"Feng Lin, Huifang Zhang, Xu He, Yi Huang","doi":"10.2147/MDER.S616529","DOIUrl":"10.2147/MDER.S616529","url":null,"abstract":"<p><strong>Background and objective: </strong>Evaluation of new plateletpheresis devices across diverse donor populations traditionally relies on extensive multicenter clinical studies. This study proposes a physiology-based evaluation framework that integrates physiological modeling with external clinical observations to provide preliminary evidence for cross-population applicability.</p><p><strong>Methods: </strong>Physiological operating envelopes were derived from published anthropometric and hematological data together with established transfusion medicine principles. The framework was externally validated using published observations from the mature MCS+ plateletpheresis platform. The preliminary framework was subsequently applied to the NGL XF3000 by comparing its operating specifications and available clinical observations with the validated operating envelopes.</p><p><strong>Results: </strong>The predicted operating envelopes accommodated physiological variation across major ethnic populations and were consistent with the operating characteristics of both the MCS+ platform and the NGL XF3000. Published MCS+ observations supported the physiological assumptions underlying the framework, while the available NGL XF3000 data were comparable with published reference observations regarding blood component changes and remained within the validated performance envelope.</p><p><strong>Conclusion: </strong>The proposed framework provides a physiology-based, resource-efficient approach for the preliminary evaluation of plateletpheresis devices before large-scale clinical validation. By integrating mechanistic modeling with external clinical evidence, it may facilitate the regulatory assessment of new devices intended for use across diverse donor populations.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"616529"},"PeriodicalIF":1.5,"publicationDate":"2026-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13496123/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148799432","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":"Availability and Utilization of Radiological Guidance Tools in Interventional Radiology Units in Kinshasa, Democratic Republic of the Congo.","authors":"Frederick Tshibasu Tshienda, Tasnime Hamdeni, Jean Mukaya Tshibola, Antoine Molua Aundu, Jean-Marie Kayembe Ntumba, Jean Marie Mbuyi Muamba","doi":"10.2147/MDER.S614792","DOIUrl":"https://doi.org/10.2147/MDER.S614792","url":null,"abstract":"<p><strong>Background and rationale: </strong>Various guidance techniques can be performed under ultrasound (US), computed tomography (CT), fluoroscopy, and magnetic resonance imaging (MRI) guidance; They pave the way for simple, intermediate, and complex minimally invasive procedures by improving visualization of the target, the access route, and device progression.</p><p><strong>Objective: </strong>This study aimed to evaluate the availability and utilization of radiological guidance tools in interventional radiology units in Kinshasa, Democratic Republic of the Congo.</p><p><strong>Materials and methods: </strong>This descriptive study was conducted in selected medical facilities in Kinshasa. Data were collected from January 2018 to June 2024 using a structured questionnaire and medical record review. Eligible cases included patients who underwent semi-invasive diagnostic or therapeutic interventional radiology procedures performed under direct imaging guidance, with acceptable hemostatic parameters and documented informed consent. The evaluated outcomes included the type of radiological guidance used, anatomical or disease target, procedure complexity, and procedure-related incidents. Data were analyzed using descriptive statistics. Categorical variables were summarized as frequencies and percentages, and continuous variables were summarized as means and standard deviations when applicable.</p><p><strong>Results: </strong>A total of 471 image-guided interventional radiology procedures were analyzed. The evaluated cases involved a range of anatomical and disease-related targets, including liver, breast, thyroid, prostate, spinal, cervical soft-tissue, splenic, pancreatic, renal, lymph-node, and other abdominal or soft-tissue lesions. Female patients represented 55.3% of the study population. Among the 471 interventional radiology procedures analyzed, age was available for 469 cases. The mean age was 48.2 ± 17.2 years, with a range of 1 to 84 years. Ultrasound was the most frequently used guidance modality, accounting for 384 procedures (81.5%), followed by CT guidance in 63 procedures (13.4%) and fluoroscopic guidance in 24 procedures (5.1%). Cone-beam CT guidance was not used. Simple interventional radiology procedures were the most common, accounting for 327 procedures (69.4%), followed by intermediate procedures in 126 cases (26.8%) and complex procedures in 18 cases (3.8%).</p><p><strong>Conclusion: </strong>This study shows that ultrasound guidance remains the most commonly used radiological guidance method in interventional radiology settings in Kinshasa. However, MRI, fluoroscopy-CT, electromagnetic, and cone-beam CT guidance were not used in this series. These findings provide baseline local evidence on current technical capacity and unmet equipment needs, and may help guide future planning and development of interventional radiology services in the Democratic Republic of the Congo.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"614792"},"PeriodicalIF":1.5,"publicationDate":"2026-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13477163/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148765426","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 versus Electronic Infusion Systems in Subcutaneous Immunoglobulin Therapy: A Structured Literature Review of Infusion-Site Reactions and Device Performance.","authors":"Anna Majapuro-Hirvonen, Brent Rutland, Jasmin Bosshard","doi":"10.2147/MDER.S620773","DOIUrl":"10.2147/MDER.S620773","url":null,"abstract":"<p><strong>Objective: </strong>Objective was to compare spring-driven mechanical and electronic infusion systems used for subcutaneous immunoglobulin (SCIg) therapy in patients with primary or secondary immunodeficiency (PID, SID) and chronic inflammatory demyelinating polyneuropathy (CIDP), with a focus on local infusion-site reactions and reliable dose delivery.</p><p><strong>Methods: </strong>A structured literature review was conducted (PubMed, Cochrane Library, Google Scholar; January 26, 2026). Eligible studies reported safety outcomes. As direct measures of dose delivery were not consistently reported, infusion system performance was evaluated using pharmacodynamic response, with immunoglobulin G (IgG) levels at the end of the study period considered an indicator of successful dose delivery. Data were extracted and descriptively aggregated across studies. Risk of bias was appraised using validated tools appropriate to study design.</p><p><strong>Results: </strong>Fourteen studies met the inclusion criteria (4 mechanical, 10 electronic). Mechanical infusion systems were associated with lower reported proportions of local infusion-site reactions, including swelling (23.1% vs 61.4%), redness (28.6% vs 44.0%), and soreness (22.9% vs 50.0%) compared with electronic infusion systems. Variability across studies was substantial, likely reflecting differences in patient populations, immunoglobulin formulations, infusion protocols, publication era, and outcome reporting methods. Across studies, both mechanical and electronic infusion systems achieved IgG levels consistent with therapeutic targets, supporting effective SCIg delivery.</p><p><strong>Conclusion: </strong>Mechanical infusion systems were associated with consistently lower reported rates of local infusion-site reactions compared with electronic infusion systems in this descriptive synthesis, while both system types effectively achieved IgG levels consistent with adequate dose delivery. Although variability across studies warrants cautious interpretation, the overall pattern suggests a favorable tolerability profile for mechanical systems. Device selection should remain individualized, and further comparative research is warranted.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"620773"},"PeriodicalIF":1.5,"publicationDate":"2026-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13426497/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148654719","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":"Preclinical Performance Evaluation of an Oxidized Regenerated Cellulose Hemostat: Antibacterial Activity and Wound Healing Outcomes.","authors":"Piyush G Patel, Bhavin Trivedi, Shahid N Karatela","doi":"10.2147/MDER.S610024","DOIUrl":"10.2147/MDER.S610024","url":null,"abstract":"<p><strong>Purpose: </strong>Antimicrobial resistance (AMR) complicates surgical site infections (SSI), making it important to address surgical bleeding and bacterial bioburden. Oxidized regenerated cellulose (ORC) is a topical hemostat that generates a localized acidic microenvironment hostile to the survival of microbes. The present study evaluated the intrinsic antibacterial action and wound healing results of a commercial ORC-based hemostat in an infected wound environment.</p><p><strong>Methods: </strong>In vitro and in vivo experimental designs were used to evaluate the antibacterial activity. An in vitro experiment was designed to show inhibition zones against 32 Gram-positive and Gram-negative bacterial strains, including antibiotic-resistant pathogens, compared to the negative control. In vivo efficacy was tested in a Wistar rat excisional wound model (n = 42), in which polymicrobial inoculation was performed with the same bacterial strains, and animals allocated to specific groups were monitored for hemostasis time, wound contraction, clinical observations, and histopathology over 28 days.</p><p><strong>Results: </strong>Using an agar diffusion method, ORC hemostat exhibited in vitro antibacterial activity against all the 32 tested strains. In vivo, hemostasis time was significantly reduced in the test groups compared to that in the disease control group (adjusted p < 0.001), achieving hemostasis within 42.2-54 seconds. Similarly, wound healing was statistically significant for the test specimens, achieving up to 88.5% wound closure by day 28 (adjusted p < 0.001). Histopathological analysis after 28 days revealed complete re-epithelialization of the wound bed and reduced inflammatory infiltration.</p><p><strong>Conclusion: </strong>Within the study limitations, the commercial ORC-based hemostat (Surgi-ORC^®) exhibited inherent antibacterial potential against various pathogens including antimicrobial-resistant organisms and provided rapid hemostatic action. These preclinical findings suggest that ORC may help reduce microbial burden, support wound healing along with tissue regeneration. Further clinical studies are warranted to establish the relevance of these observations in surgical practice.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"610024"},"PeriodicalIF":1.5,"publicationDate":"2026-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13404360/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148608588","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":"Agreement and Accuracy of a Commercial Pulse Oximeter Compared with Arterial Oxygen Saturation During Controlled Hypoxemia in Healthy Volunteers.","authors":"Jinqi Lin, Shiyan Pan, Lan Ma, Jilun Ye, Chunsheng Liu, Fan Wang, Xu Zhang","doi":"10.2147/MDER.S626574","DOIUrl":"10.2147/MDER.S626574","url":null,"abstract":"<p><strong>Purpose: </strong>Pulse oxygen saturation (SpO₂) is widely used for continuous non-invasive oxygenation monitoring, but its accuracy can be affected by sensor design, probe placement, peripheral perfusion, skin pigmentation, motion artifacts, and device algorithms. This study evaluated the accuracy and agreement of a commercial pulse oximetry system (model M201 SpO₂ module, Shenzhen Witleaf Medical Electronics Co. Ltd.) with a matched fingertip sensor during non-motion controlled hypoxemia in healthy volunteers, using arterial oxygen saturation (SaO₂) measured by arterial blood gas/co-oximetry analysis as the reference standard.</p><p><strong>Material and methods: </strong>Eighteen healthy volunteers underwent two phases of controlled hypoxemia. Each phase comprised three target SpO₂ plateau ranges (90-100%, 80-89%, and 70-79%). Phase 1 was the desaturation phase, and Phase 2 was a re-oxygenation and repetition phase. After each target plateau stabilized, SpO₂ values from the investigational system were recorded, and paired arterial blood samples were collected for SaO₂ measurement. Measurement error was defined as SpO₂-SaO₂. Bias, mean absolute error (MAE), accuracy root mean square (ARMS), 95% limits of agreement (LOA), and proportions of absolute errors exceeding predefined thresholds were calculated.</p><p><strong>Results: </strong>A total of 432 paired SpO₂-SaO₂ observations were analyzed. SpO₂ showed strong correlation with SaO₂ (Pearson r = 0.990; Spearman r = 0.986; both p < 0.001). Overall bias was -0.061%, with 95% LOA from -2.65% to 2.53%. MAE and ARMS were 1.05% and 1.32%, respectively. Absolute errors exceeding ±2%, ±3%, and ±4% occurred in 11.57%, 2.55%, and 0% of observations, respectively. ARMS values were 1.03%, 1.19%, and 1.66% across the 90-100%, 80-89%, and 70-79% platform phases, respectively, with increased error dispersion and mild SaO₂ underestimation in the 70-79% phase.</p><p><strong>Conclusion: </strong>The commercial pulse oximetry system showed good overall agreement with reference SaO₂ during controlled hypoxemia, with an ARMS of 1.32% (well below the 4% threshold). Error dispersion increased in the 70-79% saturation range, with mild underestimation of SaO₂ by SpO₂. These findings support the clinical performance of this device within the tested saturation range.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"626574"},"PeriodicalIF":1.5,"publicationDate":"2026-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13381327/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148608573","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":"Tensile and Tear Strength Evaluation of Clean-Grade Silicone with Cellulose Nanocrystals Reinforcement as an Alternative Material for Maxillofacial Prostheses: An Experimental Study.","authors":"Sara Stefany, An-Nissa Kusumadewi, Lisda Damayanti, Veni Takarini","doi":"10.2147/MDER.S621954","DOIUrl":"10.2147/MDER.S621954","url":null,"abstract":"<p><strong>Introduction: </strong>Silicone elastomers are widely used in maxillofacial prostheses owing to their elasticity, esthetic properties, and biocompatibility. Clean-grade silicone serves as an affordable alternative to medical-grade silicone. The addition of Cellulose Nanocrystals (CNC) and intrinsic pigments is expected to enhance the performance of clean-grade silicone.</p><p><strong>Purpose: </strong>This study aims to evaluate the effects of CNC and intrinsic pigments on the tensile strength, elongation percentage, and tear strength of clean-grade silicone as an alternative material for maxillofacial prostheses.</p><p><strong>Materials and methods: </strong>Six groups of clean-grade silicone were evaluated: control, A (with pigment), B (with 0.5% CNC), C (with 0.5% CNC and pigment), D (with 1% CNC), and E (with 1% CNC and pigment). Scanning Electron Microscopy (SEM) and Fourier Transform Infrared Spectroscopy (FTIR) were conducted to evaluate the morphological and functional group characteristics; tensile strength, elongation percentage, and tear strength were measured to assess changes in mechanical properties and were analyzed statistically.</p><p><strong>Results: </strong>SEM analysis showed microstructure formation characterized by dispersed particles with the addition of 1% CNC and intrinsic pigments. As the filler and pigment were added, the FTIR revealed increased absorption intensities of Si-O-Si functional groups, detected at 1022-1026 cm^-1. The tensile trength (3.87-4.84 MPa) was successfully increased compared to the control group (3.63 MPa), a statistically significant difference (p<0.05). Group D had the highest tensile strength, aligning closely with medical-grade silicone (approximately 2.53-8.36 MPa). Meanwhile, the lowest elongation percentage and the highest tear strength (3.84 kN/m) resulted in Group E, both of which are close to the range of maxillofacial prosthesis requirements.</p><p><strong>Conclusion: </strong>The addition of 1% CNC and intrinsic pigments successfully increased tensile and tear strength while reducing the elongation percentage of clean-grade silicone that potential as an alternative material; however, future optimization on the tear strength still required before maxillofacial prosthesis application.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"621954"},"PeriodicalIF":1.5,"publicationDate":"2026-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13361784/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148438232","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 Technical Validation of a Novel O2 Mixed Fitting for Dual Connection in Medical Oxygen Delivery Systems.","authors":"Oscar Ivan Quintero Osorio, Berkan Basançelebi, Elinaldo da Conceição Dos Santos, Sergio I Prada, David Alexander Lemos, Andrés Felipe Domínguez, Antonio M Esquinas","doi":"10.2147/MDER.S612748","DOIUrl":"10.2147/MDER.S612748","url":null,"abstract":"<p><strong>Background: </strong>Medical oxygen delivery systems require adaptable connection interfaces capable of supporting different clinical configurations during oxygen therapy. Integrating multifunctional connection mechanisms within a single component offers an opportunity to improve system versatility and connection management in respiratory care settings.</p><p><strong>Objective: </strong>To design and experimentally validate a novel dual-connection fitting for medical oxygen delivery, designated as the O2 Mixed Fitting, that enables simultaneous attachment of both a bubble humidifier and conventional oxygen tubing while remaining installed on the flowmeter.</p><p><strong>Methods: </strong>A comprehensive state-of-the-art review informed the conceptual development of the device. Iterative design refinement was performed using computer-aided design. The final device was manufactured by injection molding using medical-grade Acrylonitrile Butadiene Styrene. Validation included gas flow analysis, leak and pressure-holding tests, microbiological and physical stability evaluation under controlled climatic conditions, and sustainability assessment using a structured eco-design framework.</p><p><strong>Results: </strong>The integrated dual-connection mechanism enabled transition between humidified and non-humidified oxygen delivery without detachment from the flowmeter. Gas flow measurements remained within predefined accuracy tolerances, including ±0.5 L/min at low flows and ±10% at higher flows. No leakage was detected during pressure testing up to 10 psi. During the 12-month natural stability study, physical and microbiological parameters remained within predefined acceptance criteria under climatic zone IVb conditions. The eco-design assessment demonstrated favorable environmental performance.</p><p><strong>Conclusion: </strong>The O2 Mixed Fitting represents an innovative dual-connection solution for medical oxygen delivery applications. Laboratory validation confirmed structural integrity, flow stability, pressure resistance, and physical and microbiological stability under the evaluated conditions. The integrated design enhances functional versatility while maintaining full compatibility with existing clinical infrastructure. Further clinical and operational studies are warranted to evaluate its potential impact on patient care and clinical workflow.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"612748"},"PeriodicalIF":1.5,"publicationDate":"2026-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13361348/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148437991","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 a Portable Ultrasound System for Peripheral Intravenous Access: Performance and Safety in a Clinical Setting.","authors":"Matthew Kessel, Victor Ryan Bernal, Rebecca Galer-Siegfried, Trevor J Steele","doi":"10.2147/MDER.S631735","DOIUrl":"10.2147/MDER.S631735","url":null,"abstract":"<p><strong>Background: </strong>Ultrasound-guided vascular access has been increasingly used in clinical practice with studies supporting improved insertion success and reduced complications. To meet the needs of various vascular access applications, ultrasound systems have been evolving with specific features. This study evaluated the safety and performance of a recently developed portable ultrasound system with needle tracking technology for peripheral intravenous catheterization.</p><p><strong>Methods: </strong>The prospective observational clinical study was conducted at one US medical center between November 2025 and January 2026. Eligible participants requiring peripheral intravenous access underwent ultrasound-guided insertion for peripheral intravenous catheterization. Primary endpoints included successful visualization of target vasculature and successful intravenous access. Safety was assessed by the incidence of device-related adverse events. Descriptive statistics and exact binomial confidence intervals were calculated.</p><p><strong>Results: </strong>A total of 149 subjects were enrolled, including 17 pediatric (1-17 years) and 132 adult (≥18 years) patients. Ninety-six of these patients presented with at least one DIVA risk factor, including no visible veins, no palpable veins, a history of difficult IV access, IV drug use, or a BMI ≥ 30 kg/m². With ultrasound guidance, visualization of vasculature was achieved in all participants (100%; 95% CI: 97.6%, 100.0%), and the overall catheter insertion success rate was 100% (95% CI: 97.6%, 100.0%). The mean number of attempts to achieve successful vascular access was 1.05±0.25. While the overall first-attempt success rate was 95.3%, a rate of 100% was observed in pediatric patients and 94.7% in adult patients. For the adults with any DIVA risk factor, the first-attempt success rate was 92.0%. There were no device-related adverse events observed in the study.</p><p><strong>Conclusion: </strong>The portable ultrasound system was associated with high first-attempt insertion success and high vascular visualization for peripheral intravenous access with no adverse events. The portable ultrasound system can be successfully used for bedside vascular access in a real-world environment.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"631735"},"PeriodicalIF":1.5,"publicationDate":"2026-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13356862/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148431295","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":"Comparing Post-Occlusion Surge at Decreasing Intraocular Pressures with Pressure Sensing Handpiece.","authors":"Jessie A Montgomery, Coby Soule, Nathan Sherbotie, Ivan A Cardenas, Jenna L Jensen, Jacob A Bell, William R Barlow Jnr, Kolja Klug, Lincoln Wagner, Jeff H Pettey","doi":"10.2147/MDER.S592098","DOIUrl":"10.2147/MDER.S592098","url":null,"abstract":"<p><strong>Purpose: </strong>To compare post-occlusion surge pressure at various intraocular pressures using the Active Sentry handpiece.</p><p><strong>Methods: </strong>This experimental (in vitro chamber) study used the Alcon Centurion platform and Active Sentry handpiece with balanced tips. Quad preset was used with settings: vacuum 500 mmHg, aspiration flow 50 mmHg, and IOPs of 30, 50, and 70 mmHg. A rubber disk was fixed within a sealed chamber fitted with an electric pressure sensor to monitor pressure changes. The phacoemulsification tip was inserted into the water-tight port of the pressure chamber, and the foot pedal was set to position two. The tip was put in contact with the disk to replicate tip occlusion and pulled from the disk to simulate occlusion break. Ten trials were performed at each IOP; pressure changes were recorded continuously.</p><p><strong>Results: </strong>At 70 mmHg IOP, average post-occlusion surge magnitude was 5.76 mmHg ± 0.54; average surge duration was 0.45 s ± 0.10. At 50 mmHg IOP, surge magnitude was 5.76 mmHg ± 1.15; surge duration surge was 0.52 s ± 0.23. At 30 mmHg IOP, surge magnitude was 10.46 mmHg ± 2.86; surge duration was 1.27 s ± 0.51. There was a statistically significant difference between surge magnitude and duration at 30 vs. 50 mmHg IOP (P < 0.05) and at 30 vs. 70 mmHg IOP (P < 0.05).</p><p><strong>Conclusion: </strong>When utilizing the Active Sentry handpiece, an increased surge risk was not observed when operative IOP was decreased from 70 mmHg to 50 mmHg. However, our data suggest that surge risk increases when operative IOP is decreased to 30 mmHg. The Active Sentry handpiece at 50 mmHg IOP would not introduce greater surge risk than at 70 mmHg IOP.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"592098"},"PeriodicalIF":1.5,"publicationDate":"2026-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13317769/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148362952","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":"Patient-Reported Outcomes and Wound-Related Quality of Life in Adults with Diabetic Foot Ulcers Treated with Silicone Superabsorbent Polymer Dressings: Exploratory Results from a Prospective Multicenter Nonrandomized Cohort Study.","authors":"David G Armstrong, Jacek Mikosinski, Konrad Panczak, Adam Wegrzynowski, Dorota Piechota, Marek Kotala, Przemyslaw Lipinski, Katarzyna Rybolowicz, Agnieszka Lipinska, Vladica Velickovic, Jacek Bil, Teresa Szenk, Patrycja Buczak, Anitha Pitchika, Sebastian Probst","doi":"10.2147/MDER.S619815","DOIUrl":"10.2147/MDER.S619815","url":null,"abstract":"<p><strong>Background: </strong>Diabetic foot ulcers (DFUs) are associated with substantial clinical and economic burden and impaired health-related quality of life (HRQoL). Although wound healing remains a core endpoint, recent consensus work identifies HRQoL as an essential outcome in DFU studies. This study describes wound healing, patient-reported outcomes, function, and safety in adults with DFU treated with silicone superabsorbent polymer (SAP) dressings.</p><p><strong>Methods: </strong>This exploratory prospective, multicenter, nonrandomized cohort study reports the DFU subgroup from a broader single-arm investigation conducted at eight specialist centers in Poland. Adults with superficial, noninfected DFUs received silicone SAP dressings for up to 6 weeks with standard offloading. Prespecified patient-reported outcome measures were the Patient Benefit Index for wounds (PBI-W) and the Wound Quality of Life questionnaire (Wound-QoL-17). Additional endpoints included wound area reduction (centralized digital planimetry), complete epithelialization, accelerometry-based activity, offloading adherence, and safety.</p><p><strong>Results: </strong>Twenty-eight participants were included (75.0% male; mean age, 63.4 years), with a median wound duration of 166 days. By the final visit, 21 (77.8%) achieved at least 20% wound area reduction before cleansing/debridement and 24 (85.7%) after cleansing/debridement; 6 (22.2%) achieved complete epithelialization. Mean global Wound-QoL improved from 2.4 ± 0.6 to 1.5 ± 1.0 (mean change, -1.0 ± 0.8; P < 0.001), with greatest improvements in psyche and everyday-life domains. Mean PBI-W increased from 2.44 ± 0.94 to 2.94 ± 0.87 (mean change, 0.45 ± 1.10; P = 0.043). Activity intensity remained stable, offloading adherence exceeded 95%, and no device-related adverse events were reported.</p><p><strong>Conclusion: </strong>In this prospective DFU cohort, use of silicone SAP dressings within a structured care setting was associated with improvements in wound area reduction and wound-related quality of life over 6 weeks. These results highlight the feasibility of integrating patient-reported outcomes in DFU studies and provide a clinically relevant platform for future comparative and health-economic evaluations.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"19 ","pages":"619815"},"PeriodicalIF":1.5,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13281877/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148296913","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}