Medical Devices-Evidence and Research最新文献

Introduction: Early diagnosis of eye diseases improves outcomes and reduces blindness. However, diagnostic capacity in resource-poor settings is limited by a shortage of trained and equipped healthcare professionals. The Arclight device is a user-friendly, cost-effective diagnostic tool for both anterior and posterior segment eye diseases that requires minimal training. Studies have shown it to be effective for assessing the fundal reflex and performing fundoscopy; however, its accuracy and acceptability for anterior segment eye disease are still unknown.

Methods: This was a cross-sectional study carried out at Mulago National Super Specialised Hospital, where 21 ophthalmic clinical officers (OCOs) were recruited from surrounding districts. Each participant evaluated eleven patients with anterior segment pathologies and one normal case using the Arclight loupe and a handheld Slit Lamp. The diagnosis and the proportion of correctly identified conditions were recorded. Focus group discussions were held to assess the acceptability of using the devices. Discussions were transcribed verbatim and analysed using latent and manifest content analysis.

Results: Of the 21 participants, 13 (61.9%) were female, with a median age of 39 (IQR: 33-49), and had practiced for 6 to 10 years, representing 76.2%. The majority of conditions were correctly identified by both the Arclight (71.2%) and handheld slit lamp (72.3%). Pterygium was the most accurately diagnosed condition (100%) with the Arclight. Based on themes from Sekhon's framework and the Technology Acceptance Model, the Arclight device was found to be highly acceptable and easy for OCOs to use.

Conclusion: The performance of the OCOs in diagnosing anterior segment diseases with the Arclight is comparable to that of a handheld Slit lamp. It was also found to be an acceptable device for diagnostic purposes. In conclusion, the Arclight device is a suitable, low-cost alternative to the handheld Slit Lamp, especially in resource-limited settings.

Background: This study evaluates the association between the type of topical haemostatic agents used during surgery-categorized as active, passive, or a combination of both-and their relationship with intraoperative blood loss and bleeding-related postoperative outcomes.

Methods: A retrospective analysis was conducted at Cooper Health System, Camden, New Jersey, US, using patient records to compare the clinical performance of three haemostatic strategies: active agents, passive agents, and a combined approach.

Results: A total of 149 patients were included in the analysis: 51 treated with passive agents, 51 with active agents, and 47 with both. The mean age at admission was 55.9 years (SD ±16.3). General surgery was the most frequently represented specialty (24.8%), followed by spine (22.1%), neurosurgery (16.8%), and solid organ procedures (16.1%). The combination group showed the highest estimated blood loss (EBL) at 521.3 mL (SD ±1456.83; 95% CI: 93.5-949.0), compared to 390.7 mL (SD ±1004.81; CI: 108.1-673.3) in the active group and 301.5 mL (SD ±295.78; CI: 218.3-384.7) in the passive group. However, ANCOVA results showed no statistically significant difference in adjusted mean EBL between groups (p = 0.309). Notably, patients in the combination group experienced longer operative times, extended ICU stays, and higher mortality.

Conclusion: Numerical trends suggest greater bleeding and more complex postoperative courses in patients treated with the combination of active and passive haemostats. The use of standardized, validated measures of intraoperative bleeding, paired with a strategic approach that anticipates and manages bleeding complications, may support improved clinical outcomes.

Introduction: Pain due to injection and fear of needles is documented barriers to vaccination in children. Needle-Free Injection System ie N-FIS^®, is an innovative delivery solution that addresses these limitations. To demonstrate its performance, study was conducted to compare immunogenicity and safety of the MMR vaccine when administered by N-FIS, to that administered using needle-syringe and needle.

Methodology: This was a prospective, randomized, parallel group study (January-September 2024). Eligible participants 9-12 months of age were administered MMR vaccine 0.5 mL, subcutaneously using either N-FIS^® or syringe. Immunogenicity and safety were assessed before and 28 days post vaccination.

Results: A total of 60 infants with mean age of 10.5 months were enrolled in the study. At 28 day post dose 1 there was a significant and comparable rise in the MMR GMTs between the two groups. Similarly, at 28 day post vaccination, there was a significant rise in the proportions of seropositive subjects and the rates were comparable between the two groups (Measles: 100% vs 83%, p = 0.046; Mumps: 96.1% vs 95.8%, p = 0.999, Rubella: 92.3% vs 100%, p = 0.491). N-FIS was well tolerated and significantly lower number of subjects experienced pain (12% with N-FIS vs 33% with syringe). No serious or severe adverse events were reported.

Conclusion: Administration of MMR vaccine using N-FIS induced robust and comparable immune responses to that observed with use of Needle-syringe and was well tolerated providing an alternative to paediatrician over conventional delivery system.

Introduction: Spinal surgeries often require the manipulation of bone structures while at the same time protecting sensitive tissues. Existing surgical systems involve manual force, which has a high risk of damaging the vertebrae and instruments interfere with the visibility between the vertebrae, which complicates work. The OrtoWell^® Distractor System, an intra-surgical hydraulic tool for vertebrae separation, offers incremental and stable force control and better visibility during distraction procedures in spinal surgeries. This study aims to fill the gap of still pending clinical trials using the device, by evaluating performance and safety of it across lumbar and thoracic surgeries.

Materials and methods: This study is a prospective, single-arm, multi-center observational study and was conducted between April 2018 and April 2023 at 3 German sites in patients undergoing anterior or lateral spinal surgery requiring vertebral separation. The device's safety and usability were assessed through surgeon-completed questionnaires on the device and its subcomponents, clinical outcomes and cardiovascular assessments. Assessments were conducted at four time points, at baseline, time of the index procedure, discharge and at a 30-day follow-up.

Results: 31 patients (13 males, mean age 62.33) were included. Single and multi-level treatments were performed using different accesses. The device facilitated spinal surgeries without any complications or device-related adverse events. Usability, stability and force control were evaluated as uniformly positive and all procedures proceeded as planned. Mean applied pressure was 147.69±29.48 bar. There were no major delays in surgical time and a mean blood loss of 215.17±113.57 cc. Cardiovascular parameters remained stable, with no significant changes between baseline and follow-up. Hospital stays averaged 16.39±10.25 days. Surgeons unanimously reported that the distractor simplified surgery.

Discussion and conclusions: The investigated device demonstrated high safety and performance, enabling precise force control and simplifying spinal surgeries. These findings suggest that hydraulic distractors could enhance surgical outcomes by improving intraoperative control and reducing procedural challenges.

Trial registration: Registered at ClinicalTrials.gov (NCT03501810, 12 Mar 2018).

Background: Micropulse transscleral diode cyclophotocoagulation (MP-TSCPC) has been developed as an alternative and safer approach to cyclodestructive procedures. While MP-TSCPC has an improved safety profile, reported complications of this procedure, though uncommon, include anterior chamber inflammation, mydriasis, hypotony, macular edema, corneal edema, phthisis bulbi, vitreous hemorrhage (VH), and conjunctival hemorrhage.

Case presentation: We report a case of a 76-year-old male who underwent uneventful MP-TSCPC for the left eye due to moderate primary-open angle glaucoma. A few days following the procedure, dense VH developed without hyphema or suprachoroidal hemorrhage. The VH persisted despite observation, and pars plana vitrectomy was performed, the patient recovered quickly, and achieved a visual acuity of 6/12 with an intraocular pressure of 10 mmHg.

Conclusion: MP-TSCPC is considered a safe and effective procedure in glaucoma management. However, the treating ophthalmologist should always be aware of rare but potentially serious complications. In our case report, we report a case of dense VH without hyphema or suprachoroidal hemorrhage following MP-TSCPC.

Introduction: The ScopeControl (Dovideq Medical, Hengelo, The Netherlands) measures the optical quality of rigid endoscopes in the sterilization department's cleanroom. Endoscopes with low quality are rejected for use and must be repaired or replaced.

Methods: An analysis of 500,000 measurements from 95 ScopeControls worldwide was conducted to evaluate hospital strategies, such as endoscope replacement timing, repair versus replace decisions, brand selection, and the impact of operating room to central sterile department processes. For the UMC Utrecht, repair data and usage data from surgery were included in the analysis. Custom software was used to filter out inexplicable, deviating measurements and calculate trend parameters such as initial and average quality, average quality decrease, and time to failure.

Results: The ScopeControl measurements are generally of good quality. Data exploration revealed significant variations between endoscopes. Lifespan ranged from 15 to 400 usages, with endoscopes often failing suddenly due to a broken lens, likely caused by mechanical or thermal shock. For specific endoscope types, comparisons between new and repaired endoscopes showed that repaired endoscopes have a median lifespan of 30% fewer usages and median light transmission that is 11% lower than new endoscopes. Entry measurements are highly recommended due to the large variation in the optical quality of both new and repaired endoscopes. Additionally, users appear to accept lower quality for vulnerable, long, thin pediatric endoscopes, possibly due to the high replacement cost, compared to endoscopes used for adult applications.

Conclusion: ScopeControl enables objective assessment of endoscope quality and supports data-driven decisions on repair and replacement. Our analysis suggests that repaired endoscopes generally do not match the optical quality of new ones, and we provide initial estimates of this difference. These findings highlight the need for further data collection and may encourage improvements in repair processes. Sudden failures underline the importance of regular checks, and linking ScopeControl data with repair and usage information remains essential for optimizing maintenance strategies and improving endoscope longevity.

Objective: Laser therapy is increasingly used in clinical medicine, ranging from high-level laser therapy (HLLT) to low-level laser therapy (LLLT). This study proposes standardized guidelines for reporting parameters and procedures of HLLT and LLLT in medical research articles, aiming to improve clarity, reproducibility, and scientific rigor in clinical reporting.

Methods: The recommendations are based on insights from peer-reviewed studies that consistently identify gaps in the reporting of laser parameters and procedures. The key parameters include wavelength, power density, energy, energy density, and beam characteristics. Common issues noted are missing data, miscalculated doses, and unverified device specifications. To strengthen these recommendations, selected laser-tissue interactions were modeled using COMSOL Multiphysics. This modeling illustrates how power, spot size, and penetration depth affect treatment outcomes.

Results: The analysis revealed substantial inconsistencies in the way laser parameters are reported, often compromising reproducibility and reliability. The proposed framework introduces a structured checklist to support systematic documentation of treatment protocols, covering laser settings, irradiation, and treatment parameters.

Conclusion: Adopting these proposed guidelines can enhance the accuracy, transparency, and comparability of laser-based studies, filling a critical gap in current reporting practices and ultimately improving treatment validation and advancing the evidence base for HLLT and LLLT.

Purpose: To determine if using different phacoemulsification (phaco) tips will impact thermal energy output utilizing calorimetry.

Methods: The Alcon Centurion was used with the Infiniti OZil handpiece and balanced, hybrid, or MST Dewey A1 mini tip. Settings were 100% power, continuous torsional or longitudinal ultrasound, 0mmHg vacuum limit, and flow rate 12mL/min. Outflow tubing was removed from the handpiece and inflow tubing was manually occluded. The handpiece tip was placed into the calorimeter filled with 50mL of degassed deionized water and ultrasound was initiated for 1 minute. Temperature rise and cumulative dissipated energy (CDE) were recorded; ten trials were performed for each group.

Results: Statistically significant differences in energy output, measured in Joules, were found between all three tips in both ultrasound modes. Balanced tips showed the highest output, Dewey tips had the lowest. Hybrid tips had significantly increased output in longitudinal mode, whereas Dewey tips had significantly decreased output in longitudinal mode. No significant differences were seen in CDE between tips in either ultrasound mode, but significant increases were seen in longitudinal mode within each tip.

Conclusion: This study demonstrated differences in thermal energy production of three different phaco handpiece tips. This provides insight into how thermal injuries occur and what might cause these differences. Our methodology provides a novel way for accurate energy measurement at the tip, though it differs when compared to external energy production measurements. Surgeons should take into consideration the significant variability in thermal energy created by handpiece tips.

Purpose: Enhancing user guidance via visual and auditory real-time feedback during subcutaneous injections-combined with automated injection-data logging-has the potential to improve self-injection outcomes and increase user confidence. To meet these objectives, a Smart Autoinjector Accessory (SAA) was developed to help patients, caregivers, and healthcare practitioners (HCPs) manage the injection process more effectively. This human factors validation study assessed whether the SAA, together with its Instructions for Use (IFU), could be operated safely and effectively with an autoinjector by the intended user population.

Methods: Seventy-five untrained participants (patients, n=45; caregivers, n= 15; HCPs, n=15) were evaluated on completion of SAA use tasks and IFU knowledge tasks in a simulated use environment.

Results: All participants (75/75, 100%) successfully delivered the full dose with the associated autoinjector. A total of 1196 out of 1200 use tasks (99.7%) delivering a simulated injection with the SAA and 2772 out of 2775 knowledge tasks (99.9%) concerning content in the IFU were completed successfully. Therefore, the overall results show near perfect success rates. All observed errors were isolated to individual participants, and no patterns of recurring use- or knowledge-task errors were found. Root cause analysis attributed these errors to inattention rather than deficiencies in the IFU clarity or device design.

Conclusion: This study shows that the intended users can operate the SAA safely and effectively. Given the strong usability outcomes, the results warrant further investigation into the SAA's potential to improve treatment adherence and persistence in longer-term studies. In post-launch use, the SAA could play a key role in facilitating the onboarding of inexperienced patients or those undergoing more complex treatment regimens. Beyond individual therapy, the SAA also holds promise in digitalizing real-world evidence collection for post-market insights and clinical drug development, supporting decentralized clinical trial designs, where patients administer injections at home rather than in clinical environments.

Purpose: To evaluate the impact of pediatric endotracheal tube (ETT) size on airflow and tidal volume (V_T) waveforms during pressure-controlled ventilation (PCV) by developing and validating linear and nonlinear respiratory system models that incorporate ETT resistance.

Methods: Five pediatric ETTs (inner diameters: 3.5-5.5 mm) were analyzed using both linear (Poiseuille's law) and nonlinear (Rohrer's equation) mathematical models implemented in MATLAB Simulink. The models simulated PCV conditions and were validated against clinical data collected from nine pediatric ICU patients undergoing mechanical ventilation with ETTs in the same size range. Simulated signals for flow and tidal volume were compared with measured data using percentage differences and Student's t-test.

Results: The nonlinear model closely approximated clinical data, with average percentage differences of 9.85% for tidal volume and 15.68% for peak flow, significantly outperforming the linear model (17.67% and 46.87%, respectively; p < 0.001). Simulation results also demonstrated that smaller-diameter ETTs substantially increased airflow resistance, reducing delivered V_T and requiring longer expiratory times to avoid air trapping.

Conclusion: Incorporating nonlinear ETT resistance into respiratory system models improves prediction accuracy under PCV, particularly in pediatric patients with smaller airways. The findings emphasize the importance of ETT size in ventilator parameter adjustment to optimize ventilation efficiency and minimize lung injury. The validated model provides a useful clinical tool for predicting ETT-related effects and guiding safer ventilation strategies in pediatric intensive care.