Expert review of medical devices最新文献

Objectives: A method of pain assessment is the drawing of pain on a specially designed manikin where the patients color the area representing their pain distribution. In recent years, software applications have been developed for the purpose of digital pain drawing data acquisition and processing. Although such specific software applications have already been released, they have been built with obsolete programming tools. The purpose of the study was to investigate the test - retest reliability of a new pain drawing analysis software, in a sample of patients with shoulder pain.

Methods: Data collected from 31 subjects with shoulder pain. Participants were asked twice to color their pain distribution in the painting environment of a tablet software application called 'Pain Distribution.'

Results: The reliability of pain extent was found to be good (ICC = 0.80). The Jaccard index for the reliability of pain location was found to be moderate, equal to 42.02 ± 19.13%.

Conclusion: The results demonstrated good reliability of pain extent and moderate reliability of pain location using the new pain distribution analysis application 'Pain Distribution.' This pain drawing software application could be a reliable, inexpensive, and clinically usable solution for assessing the distribution of pain in patients with shoulder pain.

Background: The aim of this study was to examine the potential associations between orofacial force-related measures and speech rate in matched groups of 23 adults with dysarthria, and 69 healthy adults.

Research design and methods: A novel piezoresistive sensor-based device was utilized to obtain the orofacial maximum forces (OMFs) and rate of force development (RFD) measures. The study computed alternating motion rates (AMRs), sequential motion rates (SMRs), and articulation rate (AR) for all participants. The analysis included between-group comparisons and correlation analyses. The study also examined the reliability of the OMFs and RFD measures.

Results: Individuals with dysarthria exhibited significantly slower speech rates (approximately 41.89% to 56.53% slower) compared to the control group. Except for a few exceptions in the jaw, the dysarthria group demonstrated significantly lower OMFs and RFD measures. The correlation analysis revealed that OMFs were weakly to moderately correlated (r = .488-.674) and RFD measures were very weak to moderately correlated (r = .047-.578) with speech rate measures.

Conclusions: The findings suggest that reduced OMFs and RFD measures may contribute to the slowed speech rate observed in adults with dysarthria. The study also highlights that OMFs are significantly more reliable (day-to-day) than RFD measures.

Introduction: Spinal implants play a vital role in healthcare delivery, and regulations are necessary to ensure their quality, approval, access, and use. In this article, we examine the current state of regulation and approval procedures for medical devices in low- and middle-income countries (LMICs), emphasizing the situation in Tanzania.

Areas covered: We conducted a systematic literature search and interviewed a local spine implant representative to investigate the approval, availability, and access of surgical and spinal implants in LMICs, particularly in Africa. Out of the 18 included articles, six referred to African regulations, with no mention of spinal implants. Our analysis revealed that LMICs face challenges in accessing implants due to affordability, poor supply chain, and lack of expertise for their application. However, surgeons have found alternative solutions, such as using lower-cost implants from Turkish manufacturers. The Tanzania Medical Devices and Drugs Authority oversees the local regulatory and approval process for implants.

Expert opinion: Regulation and accessibility of spinal implants in LMICs, particularly in Africa, are limited and negatively impact patient care and best medical practice. Potential solutions include capacity building within and collaboration among regulatory organizations to improve regulatory processes and allocating financial resources to qualitative and quantitative implant access.

Introduction: Minimally invasive glaucoma surgeries (MIGS) are now a consolidated reality in many surgical units. The Hydrus Microstent is one of several MIGS devices bypassing trabecular outflow and had excellent results over the years. This article aims to review the key features of the Hydrus Microstent in terms of design, efficacy, and safety.

Areas covered: The present review analyses the main characteristics of the device by evaluating the technical and physical details of its functioning. The evidence that supports a clinical decision summarizes the most influential clinical trials and the most accurate systematic reviews.

Expert opinion: The Hydrus device has been extensively studied regarding biocompatibility and outflow potential. The subsequent clinical studies have been well-built and proved that the device effectively reduces intraocular pressure (IOP) and the eyedrop load. The device covers almost a quarter of Schlemm's canal circumference, offering at least two advantages: cannulating the Schlemm's canal provides evidence that the device has been implanted correctly; covering a larger area potentially allows to target multiple collector channels or at least areas of active outflow. This scaffold may prove more effective in naïve patients or subjects who used antiglaucoma eyedrops for a limited period, as the prolonged use of hypotonic medications has been associated with the surgical failure of ab interno microhook trabeculotomy.

Introduction: Cochlear implants (CIs) provide access to sound for children and adults who do not receive adequate benefit from hearing aids. Age at implantation is known to affect outcomes across the lifespan.

Areas covered: The effects of age on CI outcomes are examined for infants, children, adolescents, and older adults. A variety of outcome measures are considered, including speech perception, language, cognition, and quality of life measures.

Expert opinion/commentary: For those meeting candidacy criteria, CIs are beneficial at any age. In general, younger age is related to greater benefit when considering pre-lingual deafness. Other factors such as additional disabilities, may mitigate this effect. Post-lingually deafened adults demonstrate similar benefit regardless of age, though the oldest individuals (80+) may see smaller degrees of improvement from preoperative scores. Benefit can be measured in many ways, and the areas of greatest benefit may vary based on age: young children appear to see the greatest effects of age at implantation on language measures, whereas scores on cognitive measures appear to be most impacted for the oldest population. Future research should consider implantation at extreme ages (5-9 months or > 90 years), unconventional measures of CI benefit including qualitative assessments, and longitudinal designs.

Background: Persistent dyspnea is frequent in post-COVID patients, even in the absence of pulmonary embolism (PE). In this scenario, the role of lung perfusion scintigraphy is unclear. The present study correlated scintigraphy-based semiquantitative perfusion parameters with chest high-resolution computed tomography (hrCT) volumetric indexes and clinical data in post-COVID patients with persistent dyspnea.

Research design and methods: Sixty patients (30 post-COVID and 30 not previously affected by COVID-19) with persistent dyspnea submitted to lung perfusion scintigraphy and hrCT were retrospectively recruited. Perfusion rates of the pulmonary fields and hrCT-based normalized inflated, emphysematous, infiltrated, collapsed, and vascular lung volumes were calculated. Inflammatory and coagulation biomarkers were collected. PE at imaging was an exclusion criterion.

Results: Compared to controls, reduced perfusion rates of the lower pulmonary fields and higher perfusion rates of the middle ones were observed in post-COVID patients, while hrCT findings were superimposable between the two groups. Perfusion rates of lower pulmonary fields were significantly associated only with abnormal lung volumes at hrCT.

Conclusions: In post-COVID dyspnea without PE, lung perfusion scintigraphy may reveal a pulmonary involvement not detectable by hrCT. Post-COVID patients may show decreased perfusion rates of lower pulmonary fields in the presence of normal vascular density and markers of inflammation/coagulation.

Introduction: Actuated lower limb prostheses, including powered (active) and semi-active (quasi-passive) joints, are endowed with controllable power and/or impedance, which can be advantageous to limb impairment individuals by improving locomotion mechanics and reducing the overall metabolic cost of ambulation. However, an increasing number of commercial and research-focused options have made navigating this field a daunting task for users, researchers, clinicians, and professionals.

Areas covered: The present paper provides an overview of the latest trends and developments in the field of actuated lower-limb prostheses and corresponding technologies. Following a gentle summary of essential gait features, we introduce and compare various actuated prosthetic solutions in academia and the market designed to provide assistance at different levels of impairments. Correspondingly, we offer insights into the latest developments of sockets and suspension systems, before finally discussing the established and emerging trends in surgical approaches aimed at improving prosthetic experience through enhanced physical and neural interfaces.

Expert opinion: The ongoing challenges and future research opportunities in the field are summarized for exploring potential avenues for development of next generation of actuated lower limb prostheses. In our opinions, a closer multidisciplinary integration can be found in the field of actuated lower-limb prostheses in the future.