Medical Devices-Evidence and Research最新文献

Purpose: 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.

Patients and methods: 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.

Results: 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.

Conclusion: 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.

Purpose: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Background: 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.

Objective: The first aim of this review is to assess the diagnostic accuracy of lung ultrasound in comparison with chest X-rays and CT scans.

Methods: 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.

Results: 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.

Conclusion: 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.

Purpose: Laser surgery can use photo-chemical, photo-thermal, photo-ablative, and photo-mechanical effects to treat various tissues in the human body, and has unique advantages of extremely high precision, non-invasive penetration, and fast operation speed. However, at present, the effective penetration depth of directly illuminating light in the body is only several millimeters. Therefore, increasing the safe operating depth for non-invasive laser surgery will have important, widespread, and irreplaceable applications in the future.

Methods: The method is based on improving a recently emerged technique. Its principle involves using a negative dispersion device to broaden the width of the short light pulse first. Then, after the pulse enters the body, as its peak intensity is reduced, the skin and healthy tissues in the laser propagation path cannot be injured. Meanwhile, since body tissues have positive dispersion, the broadened width of the laser pulse will be shortened back. When the broadened pulse is completely shortened, a thin inner light layer with high intensity will be formed in the body and used as a scalpel to treat target tissue.

Results: The theoretical calculation results have shown that the designed apparatus has excellent performance. Its safe non-invasive operating depth can be more than 70 millimeters with the possibility of up to 130 millimeters. Surgery precisions are around 1 micron transversely and about 1 millimeter longitudinally in theory.

Conclusion: An improved method of non-invasive laser surgery with deep operation depth has been investigated theoretically. The calculations show that the designed apparatus has excellent performance. The proposed method depends on two well-known physical phenomena: light pulse broadening and shortening caused by optical negative and positive dispersions, and thus has solid basis. The developed method will have important, widespread and irreplaceable applications in the medical surgery field.

Background: The burden of neurological disorders in low- and middle-income countries (LMICs) may be underestimated due to the limited number of diagnostic imaging devices and trained specialists to operate and interpret scans. Recent advancements in low-field (<100 milliteslas) magnetic resonance imaging (LFMRI) hold significant promise for improving access to pediatric neuroimaging due to the technology's lower costs, portability, and reduced infrastructure and training requirements.

Purpose: Explore user needs and experiences on the training and use of a portable LFMRI for pediatric neuroimaging in LMICs.

Methods: We conducted qualitative interviews with end users of the LFMRI systems across 11 sites in Bangladesh, Ethiopia, Ghana, Malawi, Pakistan, South Africa, Uganda, and Zambia. A semi-structured questionnaire with open-ended questions on usability and feasibility was used to encourage participants to share their experiences and opinions on ease of use, user satisfaction, and integration into local health systems.

Results: Among 46 participants, key challenges were reported in infant positioning, power stability, and internet connectivity. Suggestions included developing reference materials with content and format tailored to local needs and contexts, conducting refresher trainings, and providing education that includes technical and maintenance support crucial for appropriate utilization and implementation sustainability.

Conclusion: This study underscores the importance of incorporating human-centered design principles and user feedback into identifying and resolving usability issues, sharing insights for successful integration of LFMRI within existing health care infrastructures in LMICs, and optimizing LFMRI use for pediatric populations.

Introduction: Sedatives and anesthetics can modify airway tone and induce respiratory depression, exacerbating the gas exchange impairments associated with obesity. In obese patients undergoing gastrointestinal endoscopy, upper airway obstruction and hypoventilation are prevalent, leading to frequent occurrences of hypoxemia during the procedure. This study aims to investigate the effects of the nasopharyngeal airway in mitigating hypoxemia via alleviating upper airway obstruction in obese outpatients during painless gastrointestinal endoscopy procedure.

Methods: This is a prospective single-center randomized controlled study. After signing the written informed consent, eligible outpatients scheduled for painless gastrointestinal endoscopy will be randomly allocated into the nasopharyngeal airway group (group N) and control group (group C), with 88 patients in each group. Patients in group N will undergo intubation of the nasopharyngeal airway prior to examination, whereas patients in group C will receive oxygen therapy through an endoscopic respiratory mask at a flow rate of 10 L/min during the procedure. All patients in two groups will receive propofol and opioids for procedural sedation. The primary outcome will be the incidence of hypoxemia. The secondary outcomes will be the incidence of epistaxis, suspended examination due to hypoxemia, manual ventilation, the times of attempt to nasopharynx airway insertion, duration of insertion of nasopharyngeal airway, tracheal/laryngeal mask intubation, adverse cardiovascular events, gastrointestinal complications, VAS score of nasopharynx pain after removing the nasopharyngeal airway, satisfaction score of patients, endoscopist and anesthesiologists.

Discussion: This study evaluates the effects of nasopharyngeal airway insertion on hypoxemia caused by procedural sedation in obese patients undergoing gastrointestinal endoscopy. The results of this study are expected to provide evidence for the use of nasopharyngeal airway in obese outpatients.

Trial registration number: ChiCTR2300078892.

Background: Empyema patients with poor physical condition and severe comorbidities face a significant challenge, with difficulties in choosing appropriate treatment methods, limited treatment outcomes, and a high rate of complications and mortality.

Objective: To comment on the indications and to evaluate the treatment outcomes of pleural empyema in patients with poor physical condition and severe comorbidities by thoracoscopic surgery.

Methods: An observational study on 12 patients treated at the Department of Thoracic Surgery - Military Hospital 103, from January 2017 to December 2022.

Results: The mean of age was 63.4 ± 12.4 years old, with a male/female ratio of 5/1. In this study, 83.3% of cases were presented with stage II empyema. The mean Karnofsky score was 50.0 ± 6.1. Some comorbidities contained chronic obstructive pulmonary disease (COPD) (25.0%), spontaneous esophageal perforation (16.7%), liver cancer, cirrhosis, esophageal cancer, end-stage renal failure - chronic dialysis (8.7%). The surgery procedures were efficient with a short duration (65.6 ± 9.4 minutes), low incidence of blood transfusion (8.3%), and lower rate of postoperative complications (surgical wound infection 8.3%). The length of postoperative stay was 16.8 ± 9.9 days. Pleural drainage was removed in 11 out of 12 cases after an average of 60.1 ± 8.5 days, while one patient had their drainage retained due to esophageal cancer. The total recovery rate at the 1-year follow-up was 91.7%.

Conclusion: Video-Assisted Thoracoscopic Surgery (VATS) exhibits positive outcomes in treating stage I and II pleural empyema patients who incurred severe comorbidities.

Purpose: This study compared the performance of the new LigaSure™ XP Maryland Jaw Sealer/Divider (XP Maryland) to that of LigaSure Atlas™ (Atlas) and LigaSure™ Dolphin Tip (Dolphin Tip), two early LigaSure™ (LigaSure) devices characterized by consistent and reliable clinical performance.

Methods: Ex vivo bench testing on porcine renal arteries compared burst pressures, seal times, and rates of sticking, incomplete cuts, and charring between XP Maryland and Atlas and between XP Maryland and Dolphin Tip. In vivo acute testing on a porcine model compared thermal spread, seal times, and rates of hemostasis, sticking, and incomplete cuts between XP Maryland and the two early LigaSure devices.

Results: Ex vivo, XP Maryland showed a significantly faster mean seal time compared to Dolphin Tip (P < 0.0001) and Atlas (P < 0.0001). XP Maryland had fewer incomplete cuts than Dolphin Tip (P < 0.0001) and fewer sticking incidents than Atlas (P = 0.0019). Atlas had a statistically higher average burst pressure compared to XP Maryland (P < 0.0001). As with ex vivo results, XP Maryland had a significantly faster mean seal time in vivo compared to Dolphin Tip (P = 0.0168) and Atlas (P < 0.0001). Other in vivo results showed XP Maryland had fewer incomplete cuts compared to Dolphin Tip (P < 0.0001) and statistically less lateral thermal spread than Atlas (P = 0.0010). For all other ex vivo and in vivo performance characteristics, no statistically significant differences were found between XP Maryland and the other devices.

Conclusion: The study demonstrated the consistent and reliable performance of XP Maryland and the two early LigaSure devices. In addition, the studies showed XP Maryland has some improved performance characteristics when compared to Atlas and Dolphin Tip that may result in improved procedural efficiency and may reduce potential surgical risks.

Goal: Cost-saving initiatives targeting surgical supplies management have become increasingly common to address rising healthcare costs. However, few studies provide details on hospital stakeholder experiences or learnings from implementing such initiatives. Thus, we sought to evaluate hospital stakeholder satisfaction with conversion to a sole supplier for hemostasis products, in addition to economic and clinical impacts, to help develop best practices for implementation.

Methods: This cross-sectional study assessed satisfaction with converting to a sole supplier for hemostasis products at a large US academic medical center using qualitative interviews and quantitative surveys with clinical and non-clinical stakeholders, on the decision-making process, conversion, and vendor-supported hemostasis optimization program (HOP) post-implementation (February 2022-May 2022). Perioperative hemorrhage events, adjunctive hemostat utilization, and total annual hospital expenditure on hemostatic products were also evaluated pre- and post-conversion (2020-2022) to identify impacts on clinical and economic outcomes.

Findings: Ten hospital stakeholders completed qualitative interviews (n = 7 surgeons, n = 2 surgical technicians, n = 1 administrator) and 22 completed quantitative surveys (n = 6 surgeons, n = 5 surgical technicians, n = 11 nurses). Survey respondents noted overall satisfaction with conversion, including the level of input they provided in the decision-making process (75% were somewhat to extremely satisfied), availability of hemostatic agents during the conversion process (87%), and the vendor-supported HOP (100%). The outcomes analyses revealed a nearly 25% decrease in supply expenditure without changes to the number of postoperative hemorrhage events following implementation.

Practical applications: Converting to a sole vendor for hemostasis products was achieved with high satisfaction among hospital stakeholders and cost savings to the institution without impacting the quality of patient care. This study provides a roadmap of best practices for other institutions interested in implementing similar initiatives and presents an example of a successful transition to a sole vendor for hemostasis products driven by effective supplier, institution, and hospital stakeholder coordination.

Purpose: Lung ultrasound (LUS) is increasingly utilized in the field of anesthesiology due to its focused, quick application and the advantage of not exposing patients to ionizing radiation. This study aims to analyze the status and trends in this area from a macroscopic perspective.

Methods: A bibliometric analysis was conducted using the Web of Science (WoS) Core Collection. The analysis and visualization were performed using WoS, Excel, VOSviewer, and CiteSpace. Parameters such as publications, countries, institutions, journals, and keywords were analyzed.

Results: A total of 133 articles published over the last 10 years were analyzed to clarify the current status and future trends on the use of LUS in anesthesiology. The number of publications increased markedly from May 1, 2014, to April 30, 2024. China is the highest productive country, while the USA had the highest number of citations. In the institution, Seoul National University in South Korea published the most articles and had the highest number of citations. Kim Jin-Tae emerged as the most prolific and influential author. BMC Anesthesiology and the Journal of Cardiothoracic and Vascular Anesthesia were identified as the most popular journals in the field. Keywords such as "atelectasis", "mechanical ventilation", and "pulmonary complications" were closely related to the use of LUS in anesthesiology.

Conclusion: This study provides a comprehensive analysis of research on the use of LUS in anesthesiology, highlighting the growing interest in LUS and its relevance to pulmonary complications.