Medical Devices-Evidence and Research最新文献

{"title":"Evaluating the Impact of Smart Infusion Pump Interoperability on Reducing Medication Administration Errors: A Systematic Literature Review.","authors":"Eric P Borrelli, Julia D Lucaci, Nicole S Wilson, Ashley Taneja, Mia Weiss, Idal Beer","doi":"10.2147/MDER.S522534","DOIUrl":"https://doi.org/10.2147/MDER.S522534","url":null,"abstract":"<p><strong>Purpose: </strong>Medication administration errors remain a persistent issue in the US healthcare system, impacting patient safety and leading to worsened outcomes, including increased mortality. Smart infusion pump interoperability with electronic health records (EHRs) has the potential to reduce intravenous (IV) medication administration errors. Smart Infusion pumps safely deliver IV medications using drug libraries that set standard dosing limits. Interoperability is their ability to wirelessly connect to EHRs to receive medications orders directly minimizing error-prone manual programming steps. However, despite being implemented over a decade ago, its real-world impact remains largely underexplored.</p><p><strong>Methods and materials: </strong>A systematic literature review (SLR) of PubMed/Medline and Embase in November 2024 identified peer-reviewed studies assessing medication administration errors pre- and post- interoperability implementation in the inpatient hospital setting. The primary outcome measured error types directly impacted by interoperability. The secondary outcome assessed the cumulative reduction in medication administration errors.</p><p><strong>Results: </strong>Three studies met the inclusion criteria, spanning general community hospitals, pediatric facilities, and intensive care units (ICUs). For the primary outcome of assessing medication administration errors impactable by interoperability, interoperability implementation resulted in a 15.4% to 54.8% reduction in specific medication administration errors. For the secondary outcome of all medication administration errors, the cumulative reductions in medication administration errors post-implementation ranged from 21.2% to 90.5%, with variability influenced by baseline compliance, study setting, and patient populations.</p><p><strong>Conclusion: </strong>Smart infusion pump interoperability demonstrated consistent potential to enhance medication safety by addressing key error types and reducing cumulative errors in real-world settings. However, future research is needed to assess its impact on adverse drug events, clinician workflows, and patient outcomes. These findings underscore the importance of tailored implementation strategies to maximize interoperability's effectiveness in improving patient safety.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"247-260"},"PeriodicalIF":1.3,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12009041/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144034913","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":"Systolic Pressure and Pulse Rate Range Performance Comparison of Seven Non-Invasive Blood Pressure Monitors.","authors":"John Beard, Karim Pichard, Jonah E Attebery, Halit O Yapici, René Coffeng","doi":"10.2147/MDER.S520615","DOIUrl":"https://doi.org/10.2147/MDER.S520615","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate blood pressure (BP) and pulse rate (PR) measurement range and determination time of selected non-invasive blood pressure (NIBP) monitors.</p><p><strong>Patients and methods: </strong>Seven oscillometric NIBP monitors underwent laboratory-based simulations of high and low BP and PR values to determine the outer bounds that each monitor could measure. Reliability was determined by devices' ability to detect simulation signals of chosen BP/PR values. Determination times were analyzed using One-Way ANOVA followed by post-hoc Tukey honestly significant difference.</p><p><strong>Results: </strong>All monitors reliably reported 50-180 mmHg and 80-140 bpm simulations, except Connex which provided the narrowest ranges (only reliable at 140 and 230 bpm; 50-180 mmHg). B125 and Efficia CM120 had the widest ranges for PR (30-240 bpm and 30-220 bpm, respectively) and systolic BP (30-250 mmHg for both). Connex presented the quickest mean determination time (19.23s), followed by B125 (24.14s).</p><p><strong>Conclusion: </strong>NIBP monitor performances varied considerably outside mid-range BP/PR and there were significant differences across determination times. NIBP devices that strike a balance between range and speed may provide the greatest clinical utility.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"241-246"},"PeriodicalIF":1.3,"publicationDate":"2025-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12007952/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144053067","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and Performance of OptiVantage, a CT Contrast Media Injector, in Multi-Patient Mode.","authors":"Angela Tirri, Filippo Nicolò Iannelli, Anthony Sequeira, Frantz Hebert","doi":"10.2147/MDER.S507263","DOIUrl":"https://doi.org/10.2147/MDER.S507263","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the safety, performance and user's satisfaction of OptiVantage^®, a dual head CT Contrast Delivery System, in multi-patient mode for patients requiring a contrast-enhanced CT examination.</p><p><strong>Patients and methods: </strong>A total of 100 subjects were included in this multicentre observational clinical investigation, conducted between April 20, 2023, and October 6, 2023. The primary endpoint for safety was the rate of extravasation, and the primary endpoint for performance was the success of injection assessed by the investigator. Secondary endpoints for safety were the rates of air embolism and sepsis as well as adverse events (AE) related to the injection. Other data collected included indication, set-up time, injection parameters and user's satisfaction.</p><p><strong>Results: </strong>The study population included 59% of women. The mean age was 63.6 ± 12.7 years (range: 18 to 83 years), with the majority of patients (55%) older than 65 years. The main indications for undergoing contrast-enhanced CT were breast cancer, colon cancer and lung cancer or nodules. The mean volume injected was 119.5 ± 14.4 mL and the injection rate ranged from 2.8 to 4.5 mL/s (mean; 3.6 ± 0.3 mL/s). No extravasation or other adverse event, including air embolism and sepsis, was reported in any of the subjects (95% CI: [0.00%, 3.62%]). All the injections (100%; 95% CI: 95.39%, 100.00%) were considered as successful for the obtention of diagnostic images. The preparation of the subject, including the setting of the patient line, took between 6 and 10 seconds in most cases (68%) and 16 to 20 seconds for 30 patients (30%). The dayset was changed for 15 subjects and in all cases, it took no more than one minute.</p><p><strong>Conclusion: </strong>In conclusion, this study confirms the safety and performance of the OptiVantage^® Dual head in multi-use mode for contrast injection in adult patients, particularly elderly, undergoing contrast-enhanced CT.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"233-240"},"PeriodicalIF":1.3,"publicationDate":"2025-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12002069/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144044793","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":"Pain Relief and Protection of Corns, Calluses and Bunions Using COMPEED^® Foot Care Hydrocolloid Plasters: A Prospective Non-Interventional Study in Primary Care/Community Pharmacies.","authors":"Jérôme Zakka Bajjani, Pascale Auzou, Hubert Paniez, Maria Katsogiannou, Véronique Chapalain, Carole Pierre, Sandra Wiederkehr, Rémi Gauchoux, Matthieu Gauthier, Cécile Artus-Arduise","doi":"10.2147/MDER.S501122","DOIUrl":"10.2147/MDER.S501122","url":null,"abstract":"<p><strong>Purpose: </strong>Pathologic hyperkeratosis due to skin thickness increase includes corn, callous, and bunion. These conditions can cause important pain and discomfort. Treatment relies on eliminating the cause of friction and/or rubbing. Moreover, hydrocolloid occlusive dressings rehydrate hard skin, leading to maceration, facilitating removal of dead skin. Our goal was to further confirm real-life clinical performance and benefits of COMPEED^® Foot Care plasters in providing pain/discomfort relief, protection and cushioning of corns, calluses and bunions.</p><p><strong>Patients and methods: </strong>This was a non-interventional, longitudinal, multi-center investigation, conducted from July 2021 until February 2022, during which participants were enrolled in 36 community pharmacies in France. Eligible participants were ≥18 years old at enrolment, presented painful corn, callous and/or bunion on at least one foot, accepted to buy from the participating pharmacist at least one box of targeted COMPEED^® Foot Care plasters, to be used according to their instructions for use.</p><p><strong>Results: </strong>Overall, 417 participants gave their consent to participate in the study, and analysis was performed on 391 participants: 199 with corn, 106 with callous, 87 with bunion, whose median age was, respectively, 55.0, 59.0 and 55.0 years old (overall ranging 20.0 to 94.0 years old). Among participants with either of the 3 conditions, 21.7-37.9% reported instant pain/discomfort relief upon plaster application and an increasing number of participants with corns, calluses or bunions reported pain/discomfort elimination over the 21-days follow-up period. Significant increases in pressure relief and cushioning were also observed during follow-up in all 3 conditions. Median duration of plasters was 3 days. At study end, 66.0% of participants with calluses and up to 73.0% with corns reported their condition was removed.</p><p><strong>Conclusion: </strong>This investigation demonstrated and confirmed COMPEED^® Foot Care plasters clinical benefits in pain/discomfort and pressure relief, cushioning against rubbing/friction of corns, calluses and bunions, and adhesion to skin, in the general population.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"213-231"},"PeriodicalIF":1.3,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11956707/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143755012","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 Novel Supraglottic Suction Device in Mechanically Ventilated Patients: A Randomized Controlled Trial.","authors":"Mauricio Orozco-Levi, Diana Carolina Tiga-Loza, Orlando Aya, Carlos Fernando Reyes, Diana Cáceres-Rivera, Angela Espitia, Diana Rey, Karen Patricia Pedrozo Arias, Camilo Pizarro, Sandra M Sanabria-Barrera, Norma Serrano-Díaz, Victor R Castillo, Alba Ramírez-Sarmiento","doi":"10.2147/MDER.S499924","DOIUrl":"10.2147/MDER.S499924","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the efficacy and safety of the SUPRAtube innovation device in preventing ventilator associated events and fluid accumulation in the supraglottic region in patients receiving mechanical ventilation (MV) through orotracheal tubes.</p><p><strong>Methods: </strong>Multicenter, controlled, randomized, parallel, open-label clinical trial with a 1:1 allocation ratio of MV patients compared the use of the SUPRAtube elastomeric device with standard care and aspiration techniques. A series of computer-random numbers and centralized allocation with sealed envelopes were used.</p><p><strong>Setting: </strong>Adult patients (n=108; mean age: 63 yrs, range: 19-85) hospitalized in intensive care units of two centers, the Cardiovascular Foundation of Colombia and the International Hospital of Colombia (Santander, Colombia), were included. All patients received MV through orotracheal tubes, were hemodynamically stable, had upper airway integrity according to fiberoptic bronchoscope findings, and had basic coagulation tests within acceptable risk criteria.</p><p><strong>Interventions: </strong>Comprehensive standard of care, including preventive strategies, medical therapy, positive pressure MV, and routine procedures for management of oropharyngeal and pulmonary secretions (humidification, patient mobilization, and airway suctioning), was compared with the standard of care plus continuous supraglottic suction with the new SUPRAtube device.</p><p><strong>Results: </strong>The study period reached five days before extubation (media 85±7 hours). The weight of the aspirated content was 415 g (P25;P75: 396;536) in the control group and 624 g (P25;P75: 469;824) in the SUPRAtube group (p<0.001), equivalent to a mean difference of 213 g (P₂₅;P₇₅: 55;569; +50%). The device did not induce adverse events.</p><p><strong>Conclusion: </strong>Continuous supraglottic aspiration using SUPRAtube is complementary, effective, safe, simple, and inexpensive and reduces the accumulation of oropharyngeal secretions in mechanically ventilated patients. The relevant clinical benefit in terms of preventing and improving tracheobronchitis earlier on was demonstrated by sequential fiberoptic bronchoscopy.</p><p><strong>Registration in clinical trials: </strong>The present study is registered at clinicaltrials.gov NCT03573609.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"201-212"},"PeriodicalIF":1.3,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11952068/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143755030","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 PEEK Rod-Based Dynamic Instrumentation Construct for the Degenerative Lumbar Spine Disease, First Appraisal Based on Five-year Clinical and Radiological Findings.","authors":"Andrei Anghel, Jonas Garthmann, Baraa Alkahwagi","doi":"10.2147/MDER.S509958","DOIUrl":"10.2147/MDER.S509958","url":null,"abstract":"<p><strong>Purpose: </strong>The present retrospective study delivers first results after the use of a pedicle based, screw and peek rod system. Emphasis was placed on the ability of the construct to prevent adjacent segment disease at an average of 5 years follow-up by maintaining a certain degree of movement in the index segment. This was evaluated via functional X Rays before and after surgery.</p><p><strong>Patients and methods: </strong>The cohort comprised 100 patients which received decompressive surgery in one or more segments with dynamic instrumentation for stenosis of the lumbar spinal canal and degenerative spondylolisthesis. We analyzed diagnostic imagery including functional X Rays prior and after surgery as well as cohort demographics such as reoperation rate, complications and overall patient satisfaction.</p><p><strong>Results: </strong>The average age was 68 years, at 58 months follow-up there were 43 cases of radiological adjacent segment disease. We defined a radiological ASD as an increase of the osteoarthritis on the Wiener scale and stenosis of the spinal canal on the MRI scans. In our cohort 80 patients benefited from the surgery, either being pain free or having improved symptoms at the mean follow-up with the others either requiring renewed surgery or having developed clinically significant ASD. There was no significant statistical correlation between area of spinal canal, gender and outcome.</p><p><strong>Conclusion: </strong>In one segment constructs the system being evaluated showed no major disadvantage when compared to similar non-fusion pedicle-based techniques nor was it able to consequently prevent ASD. Under the clinical point of view there was in our opinion no marked benefit when compared against decompressive surgery and fusion as the accepted standard. Regarding the multi segment instrumentation further larger number studies are needed to reach a conclusion.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"191-199"},"PeriodicalIF":1.3,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11929408/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143693942","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":"Dedicated Ultrasonography Versus Magnetic Resonance Imaging for Breast Implant Evaluation, Initial Study.","authors":"Eduardo De Faria Castro Fleury, Michele Rodrigues da Silva Junqueira, Tiago Sarmet Esteves Teixeira, Pryscilla Alves Ferreira, Giulia Matheus E Castro, Bruna Aguiar Portugal Viotti","doi":"10.2147/MDER.S503466","DOIUrl":"10.2147/MDER.S503466","url":null,"abstract":"<p><strong>Aim: </strong>Describe the role of dedicated ultrasound in evaluating breast implants compared to breast magnetic resonance.</p><p><strong>Materials and methods: </strong>A prospective observational study was conducted in a single center to evaluate breast implant complications in patients referred to breast magnetic resonance (MRI) scan. All patients who had breast implants submitted to MRI scan were invited to a complementary dedicated ultrasound (US) evaluation of the breast implants. The implant changes were classified following a dedicated protocol. The classifiers used to evaluate the implant include evaluation of implant surface (shell), implant internal content homogeneity, fibrous capsule, intracapsular space, pericapsular space, and axillary extension.</p><p><strong>Results: </strong>Preliminary results included evaluating 29 consecutive patients who underwent MRI. Twenty-nine patients with 49 implants were included in the study. The US showed a superior ability to assess the internal contents of the implants, the implant surface, and the intracapsular contents. There were no significant statistical differences in evaluating macro changes such as implant location, intracapsular collection, and radio-frequency identification (RFID) presence. MRI was superior to the US in classifying the fibrous capsule type.</p><p><strong>Conclusion: </strong>US of silicone implants can be used as an alternative to MRI to evaluate implant complications.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"177-189"},"PeriodicalIF":1.3,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11920629/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143665076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Outcomes Among Patients Undergoing Open Abdominal or Orthopedic Surgery with Wound Closure Incorporating Triclosan-Coated Barbed Sutures: A Multi-Institutional, Retrospective Database Study.","authors":"Stephen P Fortin, Kerstin Spychaj, Jörg Tomaszewski, Holly Grebeck, Rithwik Yalla, Paul M Coplan, Shumin Zhang","doi":"10.2147/MDER.S508169","DOIUrl":"10.2147/MDER.S508169","url":null,"abstract":"<p><strong>Purpose: </strong>Determining the best suture for wound closure in high-tension areas by anatomical site and procedure type remains a challenge. This study assessed the cumulative incidence of clinical outcomes among patients undergoing procedures incorporating the STRATAFIX Symmetric PDS™ Plus Knotless Tissue Control Device (STRATAFIX Symmetric) for closure of high-tension areas, such as the abdominal fascia and hip and knee joint capsule, in the course of routine clinical practice.</p><p><strong>Patients and methods: </strong>Patients undergoing open abdominal or orthopedic surgery between October 1, 2016, and October 31, 2023, using size 0 or 1 STRATAFIX Symmetric were identified from the Premier Healthcare Database. The cumulative incidences of 30-day internal wound dehiscence and 30-day surgical site infection (SSI) were measured. To contextualize the results, a targeted literature search of articles published between October 2016 and April 2024 describing the use of STRATAFIX Symmetric for wound closure in the abdominal fascia or joint capsule was performed.</p><p><strong>Results: </strong>A total of 8156 patients undergoing open abdominal surgery and 25,807 patients undergoing open orthopedic surgery met the study criteria. In the abdominal surgery cohort, the cumulative incidences of 30-day internal wound dehiscence and SSI were 0.65% (95% CI: 0.49%, 0.85%) and 3.54% (95% CI: 3.15%, 3.97%), respectively. The overall cumulative incidences of 30-day internal wound dehiscence and SSI in the orthopedic surgery cohort were 0.07% (95% CI: 0.04%, 0.11%) and 0.58% (95% CI: 0.49%, 0.68%), respectively. These findings were within the range of clinical outcomes reported in 12 articles identified during the targeted literature search.</p><p><strong>Conclusion: </strong>The cumulative incidence of 30-day internal wound dehiscence and SSI among patients undergoing abdominal and orthopedic procedures incorporating STRATAFIX Symmetric for wound closure of high-tension areas was low and comparable to prior literature.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"161-176"},"PeriodicalIF":1.3,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11894428/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143606628","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":"Engineering a Quality Management System for Academic Research: Navigating Challenges to Comply with the New Medical Device Regulations in Europe.","authors":"Mirka Buist, Max Ortiz-Catalan","doi":"10.2147/MDER.S448049","DOIUrl":"10.2147/MDER.S448049","url":null,"abstract":"<p><strong>Purpose: </strong>The new Medical Device Regulations (MDR) in Europe represent unprecedented challenges for researchers in academic environments. Adherence to regulatory frameworks, like the Medical Device Directive (MDD), was mostly relevant for projects nearing commercialization. However, the MDR now extends its reach into the preliminary phases of pre-clinical research, imposing new challenges and necessitating compliance for any clinical investigation involving medical device safety or performance.</p><p><strong>Methods: </strong>We have systematically engineered and implemented a Quality Management System (QMS) tailored to meet the distinct needs of academic institutions. Our objective was to establish a comprehensive framework that enable our research group to comply with MDR without hindering innovation and discovery. Specifically, we engineered a traditional commercial QMS aligned with ISO13485 to fulfill academic needs. We ensured the QMS focused on requirements relevant to pre-market clinical investigations and considered appropriate roles for an academic setting.</p><p><strong>Results: </strong>We present an optimized QMS implementation to satisfy the urgent need for research institutions to align with the MDR. Notably, our efforts yielded demonstrable results, culminating in the successful approval of research projects by the Swedish Medical Product Agency (MPA). This achievement stands as a testament to the impact of our work within the regulatory landscape.</p><p><strong>Conclusion: </strong>Here, we share the insights and challenges we encountered during the implementation of an appropriate and efficient QMS for academic research, which we believe can serve as a guiding example for other academic research groups. By presenting our QMS implementation validated by an MPA clinical investigation approval, we aim to raise awareness about the pivotal importance of MDR compliance among researchers in Europe. Our contribution seeks to provide a roadmap for fellow research groups in navigating the evolving regulatory landscape while sustaining their focus on groundbreaking research and innovation in the field of biomedical engineering.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"137-147"},"PeriodicalIF":1.3,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11890009/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143587857","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 Ultrasound, Chest X-Ray, and CT Scan for Pneumonia Detection.","authors":"Ziyad F Al Nufaiei, Khalid M Alshamrani","doi":"10.2147/MDER.S501714","DOIUrl":"10.2147/MDER.S501714","url":null,"abstract":"<p><strong>Background: </strong>The clinical methods of diagnosing pneumonia have been for many years chest X-rays (CXR) and computed tomography (CT) scans. However, a relatively new modality that is promising, efficient, and cheap is the lung ultrasound (LUS). The scope of this systematic review focuses on evaluating the diagnostic performance of LUS, CXR, and CT for diagnosing pneumonia.</p><p><strong>Objective: </strong>The first aim of this review is to assess the diagnostic accuracy of lung ultrasound in comparison with chest X-rays and CT scans.</p><p><strong>Methods: </strong>PubMed, Cochrane, Embase, and Scopus were electronically searched without date and language limitations were set. Inclusion criteria covered only those diagnostic studies that involved comparing lung ultrasound, chest X-ray, and CT scans in human beings with suspected pneumonia. Both abstraction and quality of studies were assessed by two researchers and the quality was assessed using PRISMA and QUADAS-2 checklists.</p><p><strong>Results: </strong>There were 13 empirical studies included in the review which referred to different patients and contexts. Although none of the imaging techniques could achieve both high sensitivity and high specificity, CT scans produced the highest sensitivity, with values higher than 95% on all occasions, and specificities ranging between 80% and 90%. Lung US was most helpful in pediatric and acute care populations, whereas CT was preferred when there was uncertainty regarding the presentation.</p><p><strong>Conclusion: </strong>Lung ultrasound is a very sensitive, specific, practical method of subsequent lung examination; it is useful in environments that need fast bedside assessment and for patients particularly vulnerable to radiation exposure, such as children. Even though chest X-ray remains valuable in excluding pneumonia in outpatient practices, it lacks sensitivity and is therefore less useful in diagnosing early disease. Computed tomography scans are the most accurate type of scans but should only be used in the more severe interventions due to cost and radiation exposure.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"18 ","pages":"149-159"},"PeriodicalIF":1.3,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11889995/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143587855","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}