Medical Devices-Evidence and Research最新文献

Background:  To evaluate the radiant power of the light cure units (LCUs) in relation to their type, radiant exitance, number of years in clinical use, and condition of LCUs tips in governmental and public clinics in Dental Faculties in Sana'a City.

Materials and methods: LCUs were collected from different colleges at Sanaa City, Yemen, then LCU data as type, clinical age (<1 year, between 1-5 and ˃ 5-years), tip condition was visually inspected for damage and adhering debris, and the radiant exitance values of the tested LCUs. Radiant exitance values were subcategorized into three groups: <400, 400-850, and >850 mW/cm², labeled as inadequate, marginal, and adequate radiant exitances, respectively. A Woodpecker radiometer was used with a mode lasting of 20 seconds was used with each LCU. Descriptive statistics of the different parameters were evaluated with SPSS version 25. One-way ANOVA and Mann-Whitney tests were performed to determine the mean difference between the groups with a significance value of ˂ 0.05 was considered.

Results: Two hundred twenty-three LCUs were surveyed, and the majority were Light-emitting diode (LED). Forty-nine (21.9%), 117 (52.4%), 57 (25.6%) recorded lesser than, 400-850, and more than 850 mW/cm², respectively. Radiant exitances of < year-old units were found to be higher than those of units used for ˃ 5 years with significant differences (p=0.001). The ANOVA test showed significant differences between the radiant exitance with clinical age and LCU tip conditions and a strong correlation p ˃ 0.050.

Conclusion: LED curing lights were the most used in the tested Dental Faculties. More than half of the used LCU offered sufficient radiant exitance. Clinical age, the presence or absence of composite buildups, and damage to curing tips showed significantly affect radiant exitance values.

Navigational bronchoscopy is increasingly used to target peripheral pulmonary nodules using electromagnetic navigational platforms (ENB), fluoroscopic navigation, or robotic-assisted bronchoscopy. The selection of equipment largely depends on the availability of technology, expertise, and the characteristics of the nodule and patient. Radial EBUS (r-EBUS) is often combined with these techniques for real-time confirmation of the nodule location. A bronchus sign is considered to have a higher diagnostic yield when biopsy tools can directly reach the nodule. We describe a case series of creating a false airway into the nodule when an eccentric r-EBUS signal is seen to subsequently obtain a concentric signal.

Purpose: The main aim of this study was to compare and analyze hematological profiles using menstrual blood, as an alternative to peripheral blood.

Patients and methods: This study used menstrual and peripheral blood samples from women who were menstruating. The design of this research is analytical observational.

Results: Menstrual blood can show an overall hematological profile similar to peripheral blood. Data shows the detection of blood component parameters, white blood cells and reticulocytes in MB with a range within and outside normal blood. Data on MB that show higher values (WBC, MCH, MCHC, PLT, RDW-CV, PDW, MPV, P-LCR, PCT, neutrophils, lymphocytes, monocytes, basophils, reticulocytes, LFR, Ret-He) and lower values lower (RBC, HGB, HCT, MVC, RDW-SD, Eosinophils, IRF, MFR, HFR) when compared with peripheral blood controls. The hematological profiles of Menstrual and peripheral blood showed significant differences (p < 0.01) for several parameters, while several other parameters did not show significant differences (p > 0.05) according to the Wilcoxon test.

Conclusion: All hematological profile parameters were detected in menstrual blood. The new concept that menstrual blood can be used as a supporting medium for hematological examinations opens up opportunities for developing independent hematological detection tools in productive women.

Background: While formative and summative usability testing is essential to confirm safe and effective product use, it may not be sufficient to comprehensively understand user capabilities and limitations in device interactions. Therefore, this research aims to quantify user handling forces for different device handling steps of pen injectors through sensor-augmented simulated use studies.

Research design and methods: The study involved 46 participants who were divided into two groups: a healthy control group and a group of users with dexterity impairments. All participants were instructed to perform simulated handling steps using non-functional dummy devices equipped with force and torque sensors. Each handling step was performed twice: first at what participants considered a comfortable force level and then at their maximum force. The study then analyzed force data to investigate the impact of user characteristics and device geometry on force exertion during the different handling steps.

Results: The study demonstrates differences in the perceived comfortable and maximum force levels between the control and patient groups. These force levels decrease slightly with the user's age and level of dexterity impairment. Furthermore, the forces applied by the users are dependent on the geometry of the device and the holding pattern.

Conclusion: The results highlight the significance of sensor-augmented simulated use studies as a tool for providing quantitative insights into users' ability to exert force while handling self-injection devices. These data offer comprehensive insights that inform the definition of performance requirements and specifications for injection device design, thereby supporting the advancement of future self-injection devices.

Purpose: To address the application requirements of soft actuators in rehabilitation training gloves, and in combination with ergonomic requirements, we designed a segmented soft actuator with bending and elongation modules. This actuator can achieve independent or coupled movements of the finger joints.

Methods: A finite element model of the joint actuator was established to compare the driving performance of actuators with different structural forms. Numerical calculations were used to analyze the effects of structural size parameters on the bending characteristics and end output force of the actuator. The design was then refined based on these analyses.

Results: The joint actuator designed in this study demonstrated a 71% increase in bending angle compared to the standard fast pneumatic network structure. Key factors affecting the driving performance include the thickness of the constraint layer, the inner wall thickness of the chamber, chamber height, chamber width, chamber spacing, chamber length, and the number of chambers. After improvements, the bending angle of the joint actuator increased by 60.6%, and the output force increased by 145.9%, indicating significant improvement.

Conclusion: This study designed and improved a soft actuator for hand rehabilitation training, achieving independent and coupled joint movements. The bending angle, bending shape, and joint driving force of the soft actuator meet the requirements for finger rehabilitation training.

Purpose: Furoscix^® (subcutaneous furosemide) is administered using a wearable On-Body Infusor (OBI) and is approved for the treatment of congestion associated with heart failure (HF). The purpose of this study was to assess the safe and effective use of the OBI and Instructions for Use (IFU) by patients with HF, caregivers, and healthcare practitioners (HCPs).

Methods: Sixty participants (patients, n=30; caregivers, n=15; HCPs, n=15) were evaluated on completion of OBI use tasks and IFU knowledge tasks in a simulated use environment. Fifteen of the patients received OBI/IFU training before evaluation.

Results: Overall, 893/900 (99.2%) use tasks and 2211/2220 (99.6%) knowledge tasks were completed successfully, without differences due to training. The most common (n=6) use error was failure to wipe skin or cartridge tip with an alcohol wipe. Errors were due to forgetfulness/misinterpretation rather than IFU clarity.

Conclusion: The subcutaneous furosemide OBI can be safely and effectively used by patients, caregivers, and HCPs, regardless of training.

Introduction: A Monoplace hyperbaric chamber delivers oxygen to the patient's tissues through breathing. Gas monitoring inside the chamber is important because oxygen (O₂) is consumed, and carbon dioxide (CO₂) is increased because treatment is performed in a closed volume. This study aimed to advance the safety and efficacy of the monoplace hyperbaric chamber (MHC) through mechanical improvement in a gas monitoring system (GMS).

Methods: First, as the oxygen supply method was changed to the direction of the patient's face, it was compared the values of O₂, CO₂, humidity, and temperature were measured in the MHC and the GMS when operating at 2.0 atmosphere absolute (ATA) and 3.0 ATA. Second, to evaluate the effects of variables across measuring time, it was analyzed in a 3-way repeated measure ANOVA (10 min.×20 min.×30 min.). Lastly, the values before and after the optimization of the MHC were compared by applying a cooler to prevent temperature rise inside the MHC.

Results: In 2.0 ATA, the average humidity was higher in the MHC than in the GMS (p<0.001). Also, the average temperature was lower in the MHC than in the GMS (p<0.001). In 3.0 ATA, the average CO₂ and humidity were higher in the MHC than in the GMS, respectively (p<0.001, p=0.004). The 3-way repeated measures ANOVA revealed a significant difference in most main and interacted factors (p<0.05). O₂ and temperature, comparing before and after MHC optimization, revealed a significant difference (p<0.05).

Conclusion: Few studies have verified safety and effectiveness by evaluating the pressure, oxygen concentration, etc. of a monoplace hyperbaric chamber. Further research is expected to verify the effectiveness of providing comfort to patients receiving hyperbaric oxygen treatment and increase the treatment effect.

Background: Representation of diverse study populations in pivotal clinical trials for medical devices and subgroup analyses for demographic groups to explore differences in safety and effectiveness are essential to understanding the benefits and risks in diverse populations. The US Food and Drug Administration (FDA) has taken many steps to improve transparency and subgroup analyses over the past decade, but there has not been a recent evaluation of demographic reporting and subgroup analyses.

Methods: We reviewed all FDA Premarket Approvals for high-risk cardiovascular devices from 2014 to 2022, focusing on pivotal studies supporting device approval. We abstracted detailed demographic data about the age, sex, race, ethnicity, and socioeconomic position of study participants. We also assessed the presence and results of subgroup analyses to understand the safety and effectiveness of devices across trial populations.

Results: Analysis of 92 pivotal studies revealed that age and sex were reported in 96.7% of the studies, while race and ethnicity were reported in 71.7% and 58.7%, respectively. However, only 7.9% of studies explicitly detailed the participation of older adults (≥65 years) and no studies reported patients' socioeconomic position. Subgroup analyses by sex were conducted in 70.7% of studies, with 12.3% reporting significant differences. In contrast, analyses by race and ethnicity were performed in only 12.0% of the studies, with 9.1% reporting significant differences.

Conclusion: Approximately one-third of pivotal studies for high-risk cardiovascular devices approved by the FDA from 2014 to 2022 did not report the race of study participants, nearly 40% did not report ethnicity, and more than 90% did not report the participation of older adults (≥65 years). Subgroup analyses were infrequently conducted by age or race and ethnicity. There is a need for better trial demographic reporting and conduct of subgroup analyses in premarketing studies to ensure the safety and effectiveness of medical devices for all patients.