Expert review of medical devices最新文献

Introduction: Ophthalmic implants including intraocular lenses, glaucoma drainage devices, corneal inlays, and keratoprosthesis are transformative in vision restoration. While randomized controlled trials (RCTs) establish pre-market safety and efficacy, they are limited in scope, duration, and generalizability. Post-market surveillance leveraging real-world evidence (RWE) has become indispensable to detect long-term complications, refine clinical practice, and support regulatory oversight.

Areas covered: This article reviews the evolution of post-market surveillance from spontaneous reporting systems to structured registries, mandated post-approval studies, and digital innovations. It highlights global regulatory frameworks such as FDA, EU MDR, and ISO, alongside international registries like IRIS®, EUREQUO, and MAUDE. The expanding role of artificial intelligence, tele-ophthalmology, and smart sensors in accelerating safety signal detection is emphasized. Ethical, legal, and privacy considerations, including GDPR and HIPAA compliance, are also discussed, with attention to disparities in low-resource settings.

Expert opinion: RWE is reshaping ophthalmic device surveillance by enabling early detection of rare adverse events, supporting value-based procurement, and guiding personalized implant selection. However, challenges remain in harmonizing regulatory pathways, ensuring patient privacy, and expanding infrastructure in resource-limited settings. Future priorities include fostering global data-sharing consortia, validating AI-driven analytics, and embedding continuous quality improvement to translate surveillance into safer, patient-centered care.

Introduction: Noninvasive brain monitoring and stimulation techniques are widely used in research and clinical applications. These techniques allow researchers and clinicians to study and affect brain activity safely, without any risk associated with invasive procedures.

Areas covered: The present review paper is focused on noninvasive brain monitoring and stimulation techniques. First, noninvasive brain monitoring techniques that are beneficial for clinical experts to detect neurological disorders are highlighted. These techniques also help to identify the exact locations where cognitive functions are disturbed. Second, noninvasive brain stimulation (NIBS) techniques that are provided to the patient's specific locations to improve the cognitive function by modulating the neuronal excitability are also discussed in this paper.

Expert opinion: Several clinical studies provide strong evidence related to the improvement of cognitive functions of patients suffering from neurological disorders using NIBS procedures. Various studies are being carried out to upgrade the noninvasive brain monitoring and stimulation techniques combined with artificial intelligence (AI) as transformative tool for advancing personalized portable home-based care, which may be beneficial to improve the lifestyle of patients suffering from the neurological disorders.

Background: Mechanically ventilated patients are at risk of respiratory complications, which may be reduced by proper oral care. The oral cleaning device (Swishkit, Swiftsure, Vancouver, Canada) was developed to facilitate cleansing, moisturization, and debris removal in intubated patients. We aimed to evaluate the feasibility and usability of this device in adult intensive care patients.

Methods: We conducted a prospective, single-center study at the Cleveland Clinic. Adult patients recovering from cardiac surgery and expected to remain intubated ≥2 hours were included. Feasibility was defined as successful completion of the procedure by nursing staff in addition to standard care. Usability was assessed with the Device Use Questionnaire (DUQ), scored on a 5-point scale (1 = easiest, 2.5 = neutral, 5 = difficult).

Results: Twenty-two patients were enrolled. The procedure was completed in 21/22 (95.5%). One attempt failed due to jaw clenching that prevented device placement, but this patient was included in the analysis. DUQ scores ranged from 1.3 to 2.3, reflecting easy to neutral usability. More than 85% of responses to usability questions were positive, and no residual saline was observed in the subglottic region.

Conclusion: Oral cavity cleansing with the oral cleaning device proved feasible and clinically usable in intubated patients recovering from cardiac surgery.

Trial registration: ClinicalTrials.gov Identifier: NCT05578599.

Background: Continuous renal replacement therapy (CRRT) devices are essential for critically ill patients but present significant usability challenges that create use-related risks affecting patient safety. This study applied expert-involved usability engineering to develop a user-centered CRRT device.

Methods: A three-phase study engaged 233 experts: Phase 1 assessed user needs through an online survey (n = 204) identifying use-related risks. Phase 2 developed and iteratively refined a CRRT prototype through expert review (n = 8) and heuristic evaluation (n = 5). Phase 3 validated the final prototype with ICU nurses (n = 16) through task performance in simulated ICU environments. Main outcomes included user satisfaction scores and use error observations.

Results: Phase 1 identified user needs and use-related risks, which were translated into user interface requirements. The initial prototype was developed and refined after iterative usability tests. The final prototype demonstrated high satisfaction scores: Overall User Experience 4.29 ± 0.53, Ease of Use 4.23 ± 0.50, and Comparative Assessment 3.56 ± 0.72. The validation test confirmed effective mitigation of use-related risks. Eight use errors and 48 use difficulties were identified for further refinement.

Conclusions: Systematic expert involvement in usability engineering successfully developed a CRRT device that effectively mitigated use-related risks while achieving high user satisfaction, demonstrating the value of expert integration in medical device development.

Background: The goal of this study is to perform a propensity score matched analysis of sutureless AVR and TAVR to compare patient characteristics and postoperative outcomes including hemodynamic performance.

Methods: Patients treated with either sutureless aortic valve replacement (SU-AVR) using Perceval^TM or transcatheter aortic valve replacement between October 2017 and June 2022 were included. Propensity score matching (PSM) was used to limit the bias in a non-randomized study.

Results: After PSM, 118 pairs of patients were obtained. The in-hospital mortality rate was 0% in SU-AVR and 4.2% in TAVR (p = 0.063). Postoperative complication rates including disabling stroke (0% vs 2.5%, p = 0.250), new need for dialysis (1.7% vs 0%, p = 0.500), and permanent pacemaker implantation at 30 days (5.9% vs 10.2%, p = 0.332) showed no statistical difference. At discharge, TAVR showed significantly lower peak and mean gradients, while paravalvular leakage higher than 1/4 was significantly higher in TAVR (11% vs 0%, p < 0.001).

Conclusions: TAVR offers significantly better transprosthetic gradients, shorter ICU and hospital stays, and less need for postoperative dialysis. Surgery using a sutureless valve showed less paravalvular leakage.

Introduction: Rural populations bear a disproportionate burden of preventable vision loss due to scant ophthalmic resources, long travel distances, and delayed diagnoses of vision-threatening conditions such as diabetic retinopathy, glaucoma, and age-related macular degeneration. Teleophthalmology, leveraging portable imaging devices, data connectivity, and remote interpretation, offers a critical solution by bringing diagnostic capabilities to underserved communities and enabling earlier intervention before irreversible vision loss occurs.

Areas covered: This report reviews the evolution and performance of handheld fundus cameras and smartphone-based adapters for ophthalmic imaging, as well as portable and home-based OCT systems for high-resolution structural assessment. We summarize key studies that validate device accuracy and examine artificial intelligence algorithms that autonomously grade retinal images with regulatory clearance. We also discuss implementation challenges, including infrastructure gaps, image-quality limitations, cost-utility data, and outline strategies such as hybrid AI-expert workflows, federated learning, and integration of tele-eye care into existing public health programs.

Expert opinion: Teleophthalmology devices have matured into reliable tools that can democratize eye care. Their success depends on robust digital infrastructure, rigorous device and algorithm validation, and sustainable financing models. Investment in local training, community engagement, and interoperable referral networks is crucial for translating technological advances into meaningful reductions in rural vision impairment.

Background: The remote electrical neuromodulation (REN) wearable device offers a noninvasive, non-pharmacological option for migraine management, but its role in Indian healthcare remains unexplored.

Research design and methods: This retrospective, observational, real-world analysis included patients prescribed REN (Nerivio®) by neurologists across India. Deidentified data were collected via the Portea Medical patient support program, with a three-month follow-up. The primary outcome assessed the effectiveness and safety of the device. Secondary outcomes included changes in headache frequency and medication regimes.

Results: The study population included 1033 patients (mean [SD] age: 38.8 [13] years; 74.8% female; 84.6% with chronic migraine). At two hours post-treatment with REN, 57.3% reported pain relief, 29.4% achieved pain freedom, 47.1% experienced relief from functional disability, and 26.1% reported complete freedom from functional disability. At three months, 70.3% found REN effective. The mean visual analog scale score for pain severity decreased by 2.3 units (p < 0.001). No adverse events occurred in 38.7% of patients. REN usage significantly reduced monthly headache days, frequency of oral medication use, and medicine dosage.

Conclusion: REN is an effective, safe, and well-tolerated non-pharmacological option for migraine management in India. However, long-term studies are necessary to extend these findings across diverse populations.

Trial registration: ClinicalTrials.gov (CTRI/2024/11/076750).