Medical Devices-Evidence and Research最新文献

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.

Background: Approximately 2.3 million neonates die annually. UNICEF proposes that the deployment of specialist, quality neonatal care could help reduce neonatal mortality rates by 28% by 2025. Syringe pumps are a key medical device for providing accurate and precise fluid and drug delivery to neonates. However, syringe pumps are expensive, complicated to use and not designed for the additional challenges of providing quality healthcare in low resource healthcare settings. Several open-source designs for low-cost syringe pumps already exist, however, they all have respective limitations.

Objective: To design and test a simple, open-source, screw mechanism, with the potential to be used in a future low-cost syringe pump.

Methods and materials: A low-cost screw mechanism for a syringe pump, using a non-captive stepper motor, was developed. The prototype's accuracy was tested using 5mL, 20mL, 30mL and 60mL syringes at different rates. The rate was measured by recording the changing mass of saline fluid dispensed onto a weighing scale. The mean flow rate error from each run was calculated as the time taken to infuse 75% of the nominal volume, as per the ISO 286020:2020 standard.

Results: The prototype produced a total mean flow rate error of 0.38%±1.62%. All errors were within the 3% limit (Z-score: 0.125) stipulated by the UNICEF and NEST360 target product profile. Compared to the other open-source designs, the prototype has the fewest parts, can accommodate a range of syringe sizes and is more accurate than many of the other open-source designs. Future work should involve testing the device with more viscous fluids, a greater range of rates and microstep settings, and improving the accuracy with further software and hardware development.

Augmented reality head-mounted devices (AR HMDs) are increasingly deployed in healthcare. Given the stringent safety and efficacy requirements of medical settings, proactive quantitative testing of key performance attributes prior to deployment is critical for risk assessment. A systematic performance evaluation framework is essential not only to support clinical adoption but also to secure regulatory approval. This review systematically summarizes hardware, software, and usability assessment methods for AR HMDs in healthcare, analyzes current research and experimental designs, and identifies challenges arising from device heterogeneity, limited coupling with real-world clinical scenarios, and subjective bias. To address these issues, we propose five design principles to guide the development of objective and practical evaluation methods: (1) identify key components based on core functions; (2) prioritize testing by functional contribution; (3) replicate authentic clinical and human-visual conditions; (4) objectify subjective perception; (5) test functionally linked components jointly.

This study focuses on the mid-term management theory of equipment lifecycle and systematically examines the impact of operating room instrument management on operational efficiency optimization. The review mainly covers four key aspects: operator training, information technology application, cost control, and quality assurance. The results indicate that mid-term management plays a crucial role in the full lifecycle management of operating room equipment and plays a key role in improving the quality of operating room operations. This management model is undergoing a profound transformation from experience driven to evidence-based practice, and from single control to system integration. Future research should focus on developing standardized evaluation metrics, scalable digital management platforms, and cross institutional data sharing models for optimizing the lifecycle of medical devices.

[This corrects the article DOI: 10.2147/MDER.S206530.].

Many developers of medical devices face a new reality with the increasing demand for clinical evidence that is generated by clinical investigations. This affects biotechnology companies, start-ups and academic research centres. The participants' informed consent form (ICF), which includes the participant information sheet (PIS), is among the critical documents that are part of the clinical investigation. While many countries around the world follow the principles of good clinical practice (GCP), there are country-specific variations of the ICF requirements. In addition, many of the country guidelines are focused on medicinal products rather than medical devices. Clinical investigations involving medical devices have their unique challenges and need additional guidance to help developers improve the ICF and PIS content. This review provides information on the latest regulatory recommendations from Europe, USA and Asia regarding the content of the ICF and offers practical advice from professionals experienced in preparing ICFs. It also includes some ethical considerations that must be taken into account.