Medical Devices-Evidence and Research最新文献

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.

The popularity of mobile devices, combined with advances in electronic design and internet technology, has enabled home-based hearing tests in recent years. The purpose of this article is to highlight the distinctive aspects of pure-tone audiometry performed on a mobile device by means of the Hearing Test app for Android devices. The first version of this app was released a decade ago, and since then the app has been systematically improved, which required addressing many issues common to the majority of mobile apps for hearing testing. The article discusses techniques for mobile device calibration, outlines the testing procedure and how it differs from traditional pure-tone audiometry, explores the potential for bone conduction testing, and provides considerations for interpreting mobile audiometry including test duration and background noise. The article concludes by detailing clinically relevant aspects requiring special attention during testing and interpretation of results which are of substantial value to the hundreds of thousands of active users of the Hearing Test app worldwide, as well as to users of other hearing test apps.

Methods: We used a Urethrotech catheterisation device in 57 male patients with spinal cord injury, in whom urethral catheterisation was unsuccessful or previous catheterisation was difficult.

Results: Urethrotech catheter could be inserted in 51 patients. No patient developed urinary tract infection. In one patient, the guidewire could not be introduced into the bladder, and a coude Foley catheter was inserted. In two patients, the guidewire was inserted into the bladder, but a 16 CH catheter could not be advanced over the guidewire. Emergency suprapubic cystostomy was performed in one case; in the other, urethral stricture was dilated; a size 12 CH catheter was inserted. In three patients, the guidewire curled back into the urethra because of severe spasm of the urethral sphincter. Catheterisation with a Tiemann catheter was successful after administration of diazepam and/or stretching of the anal sphincter by another health professional, which caused reflex relaxation of the urethral sphincter. Complications of Urethrotech catheterisation included urethral bleeding, haematuria, pain, doubling back of the guidewire due to spasm of the urethral sphincter or from an empty bladder. We adopted variations in technique, eg filling the bladder with saline prior to catheterisation when feasible, insertion of the guidewire by the side of the old catheter, use of Tiemann tip catheters, administration of antibiotics, diazepam to control spasms, nifedipine to control autonomic dysreflexia, analgesics, stretching of the anal sphincter to induce reflex relaxation of the urethral sphincter, urgent imaging studies to confirm correct positioning of the catheter, omitting anticoagulants and monitoring patients, who developed bleeding.

Conclusion: Use of Urethrotech in spinal injury patients warranted adaptations to the technique, which required expertise, experience, and backup facilities. To ensure patient safety, Urethrotech catheter should be used in a hospital setting, and by medical personnel with experience in the management of spinal cord injury patients.

Purpose: Volume measurement in critically ill children can be conducted using invasive procedure such as Central Venous Pressure (CVP), or non-invasive procedure such as measurement of Inferior Vena Cava (IVC) indices using ultrasonography. However, their accuracy and efficacy are still under scrutiny. We aim to compare CVP and IVC indices as non-invasive parameters in assessing volume status in critically ill children.

Methods: We conducted a systematic review based on literature searching from four electronic databases which were PubMed, Cochrane, ScienceDirect, SpringerLink with keywords: "CENTRAL VENOUS PRESSURE", "INFERIOR VENA CAVA DIAMETER", "INFERIOR VENA CAVA COLLAPSIBILITY", "INFERIOR VENA CAVA AORTIC-RATIO", "VOLUME STATUS", "FLUID STATUS", "CRITICAL ILL", "CHILDREN", and "PEDIATRICS". We included relevant studies in English published from 2000 to 2023 on critically ill children aged 0-18 years. Comparison between CVP and IVC indices was resumed.

Results: Eight articles were included in this study. Majority of the studies showed a consistent correlation between CVP and IVC indices. IVC-CI was the most common parameter evaluated in the included studies. There was moderate to strong correlations using IVC-CI and IVC-DI, and moderate correlation using IVC-Ao ratio.

Conclusion: We found that non-invasive tools might have a potential role to measure volume in critically ill children equals to CVP. Further high-quality and longitudinal studies are needed to validate these findings and to establish a clear guideline for the non-invasive tool to be used in daily clinical practice.

Purpose: To evaluate if the Strokefinder MD 100 by Medfield Diagnostics AB can be used as a point of care device in overcrowded Emergency Departments (ED).

Patients and methods: We used the strokefinder MD 100 by Medfield Diagnostics AB in two Greek National Health System (NHS) Hospitals Emergency Departments. Our research protocol was approved by local scientific and ethics committees. We prospectively enrolled 71 adult patients from two NHS emergency departments in whom stroke was included as a differential diagnosis after triage. The feasibility of using the Strokefinder MD 100 by Medfield Diagnostics AB in various emergency department settings was evaluated through a structured questionnaire.

Results: The strokefinder MD 100 was used on 71 patients in various settings in the Emergency Department. In every case, the test was completed at the patient bedside without interfering with other ongoing and diagnostic and resuscitation procedures. There was no additional delay to patient care caused by performing the test when compared with current local Emergency Department practice and protocol. In almost 90% of the cases, a clear result was produced by the device.

Conclusion: The Strokefinder MD 100 can be safely used as a point of care device by all trained healthcare professionals, in the most overcrowded emergency department, in various ED locations.

Mesh terms: Point of Care Systems, Cerebrovascular Stroke, Proof of Concept Study.

Introduction: Laboratory examination is extremely important in handling the COVID-19 pandemic. In the first era of the pandemic, the molecular and antigen tests were limited. Hence, at that time, it was necessary to carry out antibody Rapid Diagnostic Tests (RDT). However, many antibody RDTs were yet to obtain Food and Drug Authorization (FDA)'s approval.

Purpose: Therefore, The Indonesian Association of Clinical Pathology and Medical Laboratory (PDS PatKLIn) decided to conduct a validity test of RDT antibodies to find out the quality of SARS-CoV-2 diagnosis performance based on these RDTs used.

Patient and methods: This is a descriptive observational design with diagnostic analysis. The retrospective secondary data were collected from 34 provinces in Indonesia from May to June 2020. Data analysis was carried out on the sensitivity and specificity values of each antibody RDT brand to the RT-PCR result and analyzed descriptive data.

Results: The amount of secondary data of antibody RDT and RT-PCR results collected was 139,908, consisting of 59 RDT brands of which 44% were authorized by The Indonesian COVID-19 Response Acceleration Task Force (Gugus Tugas Percepatan Penanganan COVID-19 Indonesia). There were huge variations of SARS-CoV-2 antibody RDT performance between total antibody types (sensitivity 59.18%, specificity 62%), IgM RDT (sensitivity 16-100%, specificity 7-97%), and RDT IgG (sensitivity 33-96%, specificity 19-100%).

Conclusion: The variations in the RDT antibodies'performance can cause errors in diagnosis leading to significant material and immaterial losses. Therefore, cooperation from various parties is needed for the pre- and post-marketing surveillance process to assess the performance and the characteristics of each RDT kit and other diagnostic methods to assist the rapid pandemic response process.

Objective: To demonstrate the use of the Data Extraction and Longitudinal Trend Analysis (DELTA) system in the National Evaluation System for health Technology's (NEST) medical device surveillance cloud environment by analyzing coronary stent safety using real world clinical data and comparing results to clinical trial findings.

Design and setting: Electronic health record (EHR) data from two health systems, the Social Security Death Master File, and device databases were ingested into the NEST cloud, and safety analyses of two stents were performed using DELTA.

Participants and interventions: This is an observational study of patients receiving zotarolimus drug-eluting coronary stents (ZES) or everolimus eluting coronary stents (EES) between July 1, 2015 and December 31, 2017.

Results: After exclusions, 3334 patients receiving EES and 1002 receiving ZES were available for study. Analysis using inverse probability weighting showed no significant difference in one-year mortality or major adverse cardiac events (MACE) for EES compared to ZES [Mortality Odds Ratio 0.94 (95% CI 0.81-1.175); p = 0.780] [MACE Odds Ratio 1.04 (95% CI 0.92-1.16; p = 0.551]). Analysis using propensity matching showed no significant difference in EES one-year mortality (547 of 992 alive and available after censoring) compared to ZES (546 of 992) [Log-Rank statistic 0.3348 (p = 0.563)].

Conclusion: Automated cloud-based medical device safety surveillance using EHR data is feasible and was efficiently performed using DELTA. No statistically significant differences in 1-year safety outcomes between ZES and EES were identified using two statistical approaches, consistent with randomized trial findings.