Search

Policy Points Current medical device regulatory frameworks date back half a century and are ill suited for the next generation of medical devices that involve a significant software component. Existing Food and Drug Administration efforts are insufficient because of a lack of statutory authority, whereas international examples offer lessons for improving and harmonizing domestic medical device regulatory policy. A voluntary alternative pathway built upon two-stage review with individual component review followed by holistic review for integrated devices would provide regulators with new tools to address a changing medical device marketplace.

Bioelectronic Medicine stands as an emerging field that rapidly evolves and offers distinctive clinical benefits, alongside unique challenges. It consists of the modulation of the nervous system by precise delivery of electrical current for the treatment of clinical conditions, such as post-stroke movement recovery or drug-resistant disorders. The unquestionable clinical impact of Bioelectronic Medicine is underscored by the successful translation to humans in the last decades, and the long list of preclinical studies. Given the emergency of accelerating the progress in new neuromodulation treatments (i.e., drug-resistant hypertension, autoimmune and degenerative diseases), collaboration between multiple fields is imperative. This work intends to foster multidisciplinary work and bring together different fields to provide the fundamental basis underlying Bioelectronic Medicine. In this review we will go from the biophysics of the cell membrane, which we consider the inner core of neuromodulation, to patient care. We will discuss the recently discovered mechanism of neurotransmission switching and how it will impact neuromodulation design, and we will provide an update on neuronal and glial basis in health and disease. The advances in biomedical technology have facilitated the collection of large amounts of data, thereby introducing new challenges in data analysis. We will discuss the current approaches and challenges in high throughput data analysis, encompassing big data, networks, artificial intelligence, and internet of things. Emphasis will be placed on understanding the electrochemical properties of neural interfaces, along with the integration of biocompatible and reliable materials and compliance with biomedical regulations for translational applications. Preclinical validation is foundational to the translational process, and we will discuss the critical aspects of such animal studies. Finally, we will focus on the patient point-of-care and challenges in neuromodulation as the ultimate goal of bioelectronic medicine. This review is a call to scientists from different fields to work together with a common endeavor: accelerate the decoding and modulation of the nervous system in a new era of therapeutic possibilities.

Background: Artificial intelligence (AI) is increasingly used for prevention, diagnosis, monitoring, and treatment of cardiovascular diseases. Despite the potential for AI to improve care, ethical concerns and mistrust in AI-enabled healthcare exist among the public and medical community. Given the rapid and transformative recent growth of AI in cardiovascular care, to inform practice guidelines and regulatory policies that facilitate ethical and trustworthy use of AI in medicine, we conducted a literature review to identify key ethical and trust barriers and facilitators from patients' and healthcare providers' perspectives when using AI in cardiovascular care. Methods: In this rapid literature review, we searched six bibliographic databases to identify publications discussing transparency, trust, or ethical concerns (outcomes of interest) associated with AI-based medical devices (interventions of interest) in the context of cardiovascular care from patients', caregivers', or healthcare providers' perspectives. The search was completed on May 24, 2022 and was not limited by date or study design. Results: After reviewing 7,925 papers from six databases and 3,603 papers identified through citation chasing, 145 articles were included. Key ethical concerns included privacy, security, or confidentiality issues (n = 59, 40.7%); risk of healthcare inequity or disparity (n = 36, 24.8%); risk of patient harm (n = 24, 16.6%); accountability and responsibility concerns (n = 19, 13.1%); problematic informed consent and potential loss of patient autonomy (n = 17, 11.7%); and issues related to data ownership (n = 11, 7.6%). Major trust barriers included data privacy and security concerns, potential risk of patient harm, perceived lack of transparency about AI-enabled medical devices, concerns about AI replacing human aspects of care, concerns about prioritizing profits over patients' interests, and lack of robust evidence related to the accuracy and limitations of AI-based medical devices. Ethical and trust facilitators included ensuring data privacy and data validation, conducting clinical trials in diverse cohorts, providing appropriate training and resources to patients and healthcare providers and improving their engagement in different phases of AI implementation, and establishing further regulatory oversights. Conclusion: This review revealed key ethical concerns and barriers and facilitators of trust in AI-enabled medical devices from patients' and healthcare providers' perspectives. Successful integration of AI into cardiovascular care necessitates implementation of mitigation strategies. These strategies should focus on enhanced regulatory oversight on the use of patient data and promoting transparency around the use of AI in patient care. [ABSTRACT FROM AUTHOR]

Introduction Despite the significant need for mechanical ventilation in- and out-of-hospital, mechanical ventilators remain inaccessible in many instances because of cost or size constraints. Mechanical ventilation is especially critical in trauma scenarios, but the impractical size and weight of standard mechanical ventilators restrict first responders from carrying them in medical aid bags, leading to reliance on imprecise manual bag-mask ventilation. This is particularly important in combat-related injury, where airway compromise and respiratory failure are leading causes of preventable death, but medics are left without necessary mechanical ventilation. To address the serious gaps in mechanical ventilation accessibility, we are developing an Autonomous, Modular, and Portable Ventilation platform (AMP-Vent) suitable for austere environments, prolonged critical care, surgical applications, mass casualty incidents, and stockpiling. The core system is remarkably compact, weighing <2.3 kg, and can fit inside a shoebox (23.4 cm × 17.8 cm × 10.7 cm). Notably, this device is 65% lighter than standard transport ventilators and astoundingly 96% lighter than typical intensive care unit ventilators. Beyond its exceptional portability, AMP-Vent can be manufactured at less than one-tenth the cost of conventional ventilators. Despite its reduced size and cost, the system's functionality is uncompromised. The core system is equipped with closed-loop sensors and advanced modes of ventilation (pressure-control, volume-control, and synchronized intermittent mandatory ventilation), enabling quality care in a portable form factor. The current prototype has undergone preliminary preclinical testing and optimization through trials using a breathing simulator (ASL 5000) and in a large animal model (swine). This report aims to introduce a novel ventilation system and substantiate its promising performance through evidence gathered from preclinical studies. Materials and Methods Lung simulator testing was performed using the ASL 5000, in accordance with table 201.105 "pressure-control inflation-type testing" from ISO 80601-2-12:2020. Following simulations, AMP-Vent was tested in healthy 10-kg female domestic piglets. The Children's Hospital of Philadelphia Institutional Animal Care and Use Committee approved all animal procedures. Swine received 4-min blocks of alternating ventilation, where AMP-Vent and a conventional anesthesia ventilator (GE AISYS CS2) were used to titrate to varied end-tidal carbon dioxide (EtCO2) goals with the initial ventilator switching for each ascending target (35, 40, 45, 50, 55 mmHg). Results During ASL 5000 simulations, AMP-Vent exhibited consistent performance under varied conditions, maintaining a coefficient of variation of 2% or less within each test. In a large animal study, AMP-Vent maintained EtCO2 and SpO2 targets with comparable performance to a conventional anesthesia ventilator (GE AISYS CS2). Furthermore, the comparison of minute ventilation (V e) distributions between the conventional anesthesia ventilator and AMP-Vent at several EtCO2 goals (35, 40, 45, 50, and 55 mmHg) revealed no statistically significant differences (p  = 0.46 using the Kruskal–Wallis rank sum test). Conclusions Preclinical results from this study highlight AMP-Vent's core functionality and consistent performance across varied scenarios. AMP-Vent sets a benchmark for portability with its remarkably compact design, positioning it to revolutionize trauma care in previously inaccessible medical scenarios. [ABSTRACT FROM AUTHOR]

Introduction Musculoskeletal injuries (MSKIs) among active duty soldiers result in more than 10 million limited duty days each year and account for more than 70% of the medically nondeployable population. Overuse injuries in lower limbs from running, foot marching long distances with heavy loads, and lifting heavy objects are the most common types of injuries in the military. Physical training and rehabilitation exercises for greater resiliency through aerobic, muscle strength, endurance, and agility conditioning programs can prevent or reduce the effects of MSKIs if Soldiers adhere to proper biomechanics and training techniques. We are introducing a three-dimensional (3D) camera-based platform for Optical Screening and Conditioning for Injury Resilience (OSCIR) that is designed to identify and correct high-risk movement patterns based on quantifiable biomechanical measurements in clinical or field settings. Our goal is to improve resilience to MSKI by offering greater access to quality of movement skills in warfighters through an autonomous device that can be used in Sports Medicine and Reconditioning Team (SMART) clinics and High-Intensity Tactical Training (HITT) sites. Materials and Methods OSCIR fuses four pairs of Kinect Azure cameras into a concise footprint to achieve suitable sampling rates and an unobstructed field of view for accurate dynamic movement tracking using a custom point cloud solution. We designed a unique multistage 3D joint tracking algorithm architecture to methodically isolate the human body point cloud from the background, identify individual limb segments, and perform iterative joint optimization at the global and local joint levels. We evaluated the feasibility of our prototype system among N  = 12 control participants (6 M/6 F; 21-37 years) in compliance with the Western Institutional Review Board (Tracking #20225920, approved on November 4, 2022). Five task-specific MSKI outcome metrics identified by end-user physical therapists and athletic trainers as indicators for movement quality were assessed across 7 lower-extremity exercises derived from standardized MSK assessment/conditioning batteries used in the military. Data were recorded concurrently by OSCIR and a reference standard Vicon motion capture system for validating system accuracy. Results Task-specific MSKI indicators for knee flexion and hip flexion range of motion achieved an average error of 4.05 ± 2.34°, while 3D position-based postural outcomes of left-right foot distance, left-right hand distance, and step length obtained mean absolute errors of 2.58 ± 2.30 cm. Results support the feasibility of our system in achieving outcomes that are comparable to currently accepted laboratory standards. Conclusions Our study describes the integration process for a 3D camera-based clinical system for MSKI conditioning and rehabilitation. The impact of our system will enable key stakeholders in the military to manage MSKIs in warfighters by automating key assessment and rehabilitation test batteries; making tests more readily accessible, and interpretations more accurate by providing objective biomechanical measures. OSCIR is undergoing turn-key design features to serve as a screening tool for warfighters to readily assess susceptibility to MSKI or as a training platform to help guide exercise techniques to achieve resiliency against future injuries. [ABSTRACT FROM AUTHOR]

Introduction Presently, traumatic brain injury (TBI) triage in field settings relies on symptom-based screening tools such as the updated Military Acute Concussion Evaluation. Objective eye-tracking may provide an alternative means of neurotrauma screening due to sensitivity to neurotrauma brain-health changes. Previously, the US Army Medical Research and Development Command Non-Invasive NeuroAssessment Devices (NINAD) Integrated Product Team identified 3 commercially available eye-tracking devices (SyncThink EYE-SYNC, Oculogica EyeBOX, NeuroKinetics IPAS) as meeting criteria toward being operationally effective in the detection of TBI in service members. We compared these devices to assess their relative performance in the classification of mild traumatic brain injury (mTBI) subjects versus normal healthy controls. Materials and Methods Participants 18 to 45 years of age were assigned to Acute mTBI, Chronic mTBI, or Control group per study criteria. Each completed a TBI assessment protocol with all 3 devices counterbalanced across participants. Acute mTBI participants were tested within 72 hours following injury whereas time since last injury for the Chronic mTBI group ranged from months to years. Discriminant analysis was undertaken to determine device classification performance in separating TBI subjects from controls. Area Under the Curves (AUCs) were calculated and used to compare the accuracy of device performance. Device-related factors including data quality, the need to repeat tests, and technical issues experienced were aggregated for reporting. Results A total of 63 participants were recruited as Acute mTBI subjects, 34 as Chronic mTBI subjects, and 119 participants without history of TBI as controls. To maximize outcomes, poorer quality data were excluded from analysis using specific criteria where possible. Final analysis utilized 49 (43 male/6 female, mean [x̅] age = 24.3 years, SD [s] = 5.1) Acute mTBI subjects, and 34 (33 male/1 female, x̅ age = 38.8 years, s = 3.9) Chronic mTBI subjects were age- and gender-matched as closely as possible with Control subjects. AUCs obtained with 80% of total dataset ranged from 0.690 to 0.950 for the Acute Group and from 0.753 to 0.811 for the Chronic mTBI group. Validation with the remaining 20% of dataset produced AUCs ranging from 0.600 to 0.750 for Acute mTBI group and 0.490 to 0.571 for the Chronic mTBI group. Conclusions Potential eye-tracking detection of mTBI, per training model outcomes, ranged from acceptable to excellent for the Acute mTBI group; however, it was less consistent for the Chronic mTBI group. The self-imposed targeted performance (AUC of 0.850) appears achievable, but further device improvements and research are necessary. Discriminant analysis models differed for the Acute versus Chronic mTBI groups, suggesting performance differences in eye-tracking. Although eye-tracking demonstrated sensitivity in the Chronic group, a more rigorous and/or longitudinal study design is required to evaluate this observation. mTBI injuries were not controlled for this study, potentially reducing eye-tracking assessment sensitivity. Overall, these findings indicate that while eye-tracking remains a viable means of mTBI screening, device-specific variability in data quality, length of testing, and ease of use must be addressed to achieve NINAD objectives and DoD implementation. [ABSTRACT FROM AUTHOR]

Introduction Recovering from neuromuscular injuries or conditions can be a challenging journey that involves complex surgeries and extensive physical rehabilitation. During this process, individuals often rely on orthotic devices to support and enable movement of the affected limb. However, users have criticized current commercially available powered orthotic devices for their bulky and heavy design. To address these limitations, we developed a novel powered myoelectric elbow orthosis. Materials and Methods The orthosis incorporates 3 mechanisms: a solenoid brake, a Bowden cable-powered constant torque elbow mechanism, and an extension limiter. The device controller and battery are in a backpack to reduce the weight on the affected arm. We performed extensive calculations and testing to ensure that the orthosis could withstand at least 15 Nm of elbow torque. We developed a custom software effectively control the orthosis, enhancing its usability and functionality. A certified orthotist fitted a subject who had undergone a gracilis free functioning muscle transfer surgery with the device. We studied the subject under Mayo clinic IRB no. 20-006849 and obtained objective measurements to assess the orthosis's impact on upper extremity functionality during daily activities. Results The results are promising since the orthosis significantly improved elbow flexion range of motion by 40° and reduced compensatory movements at the shoulder (humerothoracic joint) by 50°. Additionally, the subject was able to perform tasks which were not possible before, such as carrying a basket with weights, highlighting the enhanced functionality provided by the orthosis. Conclusion In brief, by addressing the limitations of existing devices, this novel powered myoelectric elbow orthosis offers individuals with neuromuscular injuries/conditions improved quality of life. Further research will expand the patient population and control mechanisms. [ABSTRACT FROM AUTHOR]

Introduction Inhaled nitric oxide (INO) is a selective pulmonary vasodilator delivered from compressed gas cylinders filled to 2,200 psig (137.8 bar) with 800 ppm of NO in a balance of nitrogen. NO is currently FDA-approved for use in term or near-term infants with hypoxemia and signs of pulmonary hypertension in the absence of cardiac disease. INO has also been shown to improve oxygenation in adults with refractory hypoxemia. Current doctrine precludes the use of NO during military aeromedical transport owing to the requirement for large compressed gas cylinders. We performed a bench evaluation of 2 delivery systems that create NO from room air without the need for pressurized cylinders, Materials and Methods We evaluated 2 portable nitric oxide INO generation systems (LungFit PH, Beyond Air Inc, Garden City, NJ and a prototype NO generator, Odic Inc, Littleton, MA) at ground level, 8,000, and 14,000 feet (2,437 and 4,267 meter) simulated altitude in an altitude chamber. The output from each device was injected into the inspiratory limb of the ventilator circuit that was attached to a test lung. A 731 ventilator (Zoll Medical, Chelmsford, MA) and T1 (Hamilton Medical, Reno, NV) were used employing 24 combinations of ventilator settings each repeated in duplicate. An INOmax DS IR was used to measure delivered INO and NO2 via a sampling line attached in the ventilator circuit inspiratory limb. A fast response oxygen analyzer (O2CAP, Oxigraf Inc, Sunnyvale, CA) was used to measure inspired FiO2. Target INO concentration was 20 ppm. Results Across all ventilator settings, the LungFit device delivered INO was 19.8 ± 1.6 ppm, 16.1 ± 1.9 ppm, and 11.6 ± 1.7 ppm at ground level, 8,000 ft (2,437 meter), and 14,000 ft (4,267 meter), respectively. The Odic device delivered INO dose was 20.6 ± 1.4 ppm, 21.3 ± 5.5 ppm, and 20.4 ± 9.1 ppm at ground level, 8,000 ft (2,437 meter), and 14,000 ft (4,267 meter), respectively. Conclusions Both devices delivered a reliable INO dose at ground level. Altitude significantly affected INO delivery accuracy at 14,000 ft (4,267 meter) (P  < 0.01) with both devices and at 8,000 ft (2,437 meter) (P  < 0.01) with LungFit. Differences in INO dosage were not statistically significant with the Odic device at 8,000 ft (2,437 meter)(P  > 0.05) although there were large variations with selected ventilator settings. With careful monitoring, devices creating INO from room air without cylinders could be used during aeromedical transport without the need for pressurized cylinders. [ABSTRACT FROM AUTHOR]

Introduction Bloodstream infections are a significant threat to soldiers wounded in combat and contribute to preventable deaths. Novel and combination therapies that can be delivered on the battlefield or in lower roles of care are urgently needed to address the threat of bloodstream infection among military personnel. In this manuscript, we tested the antibacterial capability of silver ions (Ag+), with long-appreciated antibacterial properties, against ESKAPEE (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter species, and Escherichia coli) pathogens. Materials and Methods We used the GENESYS (RAIN LLC) device to deliver Ag+ to Gram-positive and Gram-negative ESKAPEE organisms grown in broth, human blood, and serum. Following the Ag+ treatment, we quantified the antibacterial effects by quantifying colony-forming units. Results We found that Ag+ was bactericidal against 5 Gram-negative organisms, K pneumoniae, A baumannii, P aeruginosa , E cloacae , and E coli , and bacteriostatic against 2 Gram-positive organisms, E faecium and S aureus. The whole blood and serum inhibited the bactericidal activity of Ag+ against a common agent of bloodstream infection, P aeruginosa. Finally, when Ag+ was added in conjunction with antibiotic in the presence of whole blood, there was no significant effect of Ag+ over antibiotic alone. Conclusions Our results confirmed that Ag+ has broad-spectrum antibacterial properties. However, the therapeutic value of Ag+ may not extend to the treatment of bloodstream infections because of the inhibition of Ag+ activity in blood and serum. [ABSTRACT FROM AUTHOR]

Introduction Decision-making is a complex process that relies on situational awareness and experience to create a potential list of actions while weighing the risks and benefits of each action. There is a paucity of data evaluating decision-making for individual service members (SM) during the performance of team-based military-relevant activities. Understanding individual performance and decision-making within the context of a team-based activity has potential to aid in the detection and management of mild traumatic brain injuries and assist with safe and timely return-to-duty decision making. The aim of this project was to evaluate cognitive and motor performance in healthy SM during an augmented reality military specific, team-based activity. Materials and Methods Data from 110 SMs from Fort Moore Georgia were analyzed for this project. Service members completed 3 augmented reality room breaching and clearing scenarios (Empty Room, Civilian/Combatant, and Incorrect Position of a unit member) with 3 avatar team members. Participants wore a Microsoft HoloLens 2 (HL2) device and used a replica M4 weapon (Haptech Defense Systems) during scenarios. Three-dimensional position data from the HL2 headset was used to compute temporal measures of room breaching and clearing events while the number and timing of weapon discharge was monitored by the M4. Temporal outcomes included time to enter room, time to fire first shot, time in fatal funnel, and total trial time while motor outcomes were distance traveled and average movement velocity. Results Pairwise comparisons between the Incorrect Position scenario and the Civilian/Combatant scenario demonstrated no difference in time to enter the room (2.36 seconds in both scenarios). Time to fire the first shot in the Civilian/Combatant scenario was longer (0.97 seconds to 0.58 seconds) while time in fatal funnel (2.58 seconds to 3.31 seconds) and time to trial completion (7.46 seconds to 8.41 seconds) were significantly longer in the Incorrect Position scenario. Conclusions Reaction time to fire the first shot, time in the fatal funnel, and total trial time reflect a change in information-processing and decision-making capabilities during military specific, ecological, team-based scenarios when altering the environment inside of the room and modifying avatar movements. Future studies are planned to evaluate the effects of mild traumatic brain injury on specific aspects of military team performance. [ABSTRACT FROM AUTHOR]

Introduction Retrograde Endovascular Balloon Occlusion of the Aorta (REBOA) is an effective management for the transient responder, but the ischemic consequences of complete aortic occlusion currently limit its use. Multiple DoD-funded preclinical studies have clearly demonstrated that partial REBOA reduces distal ischemia to potentially extend safe occlusion times, while still providing effective temporization of noncompressible torso hemorrhage. Early versions of REBOA devices were designed to completely occlude the aorta and had little ability to provide partial occlusion. Recently, a new REBOA device (pREBOA-PRO) was designed specifically to allow for partial occlusion, with the hypothesis that this may reduce the complications of aortic occlusion and extend safe occlusion times while maintaining the benefits on cardiac and cerebrovascular circulation as well as reductions in resuscitation requirements. Materials and Methods To ascertain the impact of a new purpose-built partial REBOA device on the extension of safe occlusion time, the Partial REBOA Outcomes Multicenter ProspecTive (PROMPT) trial compared available data from the pREBOA-PRO with existing data from 200 clinical uses of pREBOA-PRO and available data in the AAST AORTA Registry were reviewed to design primary endpoints and clinical evidence for a prospective multi-center trial, the PROMPT Study. Together with the endpoints identified in preclinical studies of partial REBOA, primary endpoints for the PROMPT study were identified and power analyses were conducted to determine the target patient enrollment goals. Results Results from the clinical implementation of partial REBOA at a single trauma center were used to conduct the initial power analysis for the primary endpoint of Acute Kidney Injury (AKI) after prolonged occlusion. The rate of AKI after complete REBOA was 55% (12/20) compared to 33% (4/12) after partial REBOA (Madurska et al. 2021). With an alpha of 0.05 and power (β) of 0.8, the projected sample size for comparison on a dichotomous outcome is 85 patients for the assessment of AKI. Initial power and endpoint analyses have been confirmed and extended with the ongoing analysis of partial and complete REBOA reported in the AORTA database. These analyses confirm preclinical findings which show that compared to complete REBOA, partial REBOA is associated with extended occlusion time in zone 1 (complete: 31 min vs. partial: 45 min, P  = 0.003), lower rates of AKI after zone 1 occlusion (complete: 33% vs. partial: 19%, P  = 0.05) and reduced resuscitation requirements (e.g. 25% reduction in pRBC administration: complete: 18 units vs. partial: 13 units, P  = 0.02). Conclusions The DoD-funded PROMPT study of partial REBOA will provide prospective observational clinical data on patients being treated with pREBOA-PRO. Outcomes will be stratified based on partial or complete occlusion to address whether partial REBOA has additional clinical benefits over complete REBOA, such as decreased distal ischemia, extension of safe occlusion time, improved hemodynamics during transition to and from occlusion, and reduced interoperative bleeding and blood product use. The results from this study are expected to confirm previous data demonstrating reduction of ischemic sequalae, improved transition to reperfusion, and reduced resuscitative requirements compared to complete REBOA. [ABSTRACT FROM AUTHOR]

Introduction The initial management of penetrating ocular injuries is a major sight-threatening problem for both civilian and military medicine. A novel device (Eye-Aid) temporarily tamponades leakage from such injuries while being easy to remove upon arrival to specialized ophthalmologic care. Eye-Aid consists of a protective eye shield with an adhesive backing that connects to a portable canister containing rapidly deployable thermoresponsive foam. The aim of this study was to compare the use of the novel Eye-Aid device to control in a new live swine ocular injury model. Materials and Methods Bilateral penetrating ocular injuries were created on 14 male Yorkshire swine in a standardized manner using a 16-gauge needle device to puncture the central cornea and cause a full-thickness wound. Researchers randomized eye intervention side, with the contralateral eye used as paired control. Two minutes after the injury, the eye shield components of the Eye-Aid system, which has a sticky pad for attachment to the skin and a luer-lock for foam deployment, were placed bilaterally. Eight minutes after the injury, foam was deployed for the intervention eye according to the device instructions for use. For the control eye, no additional procedures were performed. Six hours post-injury, end A-scan and intraocular pressure (IOP) were measured. Primary study outcome was change in axial length of the globe. Secondary outcomes were as follows: (1) Presence of full anterior chamber collapse, defined as a lack of measurable anterior lens capsule-reflex (ALC-reflex) on A-scan and (2) change in IOP. Outcomes were analyzed as paired intra-animal data, with intervention and control data for each animal. A paired t -test was used to analyze the difference in axial length change and IOP change between treatment groups, whereas a conditional logistic regression was used to analyze dichotomous ALC-reflex outcome and estimate the odds ratio associated with the Eye-Aid device. Results A significant difference (P  < .0001) in mean change in axial length between intervention (−210 μm) and control (−1,202 μm) groups was found. There was a significant difference in ALC-reflex presence, with 79% of eyes having an ALC-reflex in the intervention group, compared to 14% in the control (P  = .008). IOP remained higher in the intervention group, with a mean change of −1.5 mmHg for the intervention group compared to −4.0 mmHg in the control (P  = .0001). Conclusions This study describes the first development of an in vivo large animal ocular injury model that realistically approximates the emergent time course and pathophysiology of patients with full-thickness corneal open globe injuries. It also gives the first description of using thermoreversible hydrogel foam for such injuries. Eye-Aid was found to be significantly better than control for treatment of such injuries, based on measurements of both structure and pressure. Assuming that the absence of an ALC-reflex demonstrates complete anterior chamber collapse, the Eye-Aid group demonstrated a 79% eye "save" rate compared to only 14% in the control group, as described earlier. This results in a Number Needed to Treat of 3 for this finding. Eye-Aid additionally demonstrated several characteristics that would be beneficial in a device targeted for emergent deployment by non-ophthalmologists. [ABSTRACT FROM AUTHOR]

Introduction The U.S. Army Telemedicine and Advanced Technology Research Center Advanced Medical Technology Initiative (AMTI) demonstrate key emerging technologies related to military medicine. AMTI invites researchers to submit proposals for short-term funding opportunities that support this goal. AMTI proposal selection is guided by a time-intensive peer review process, where proposals are rated on innovation, military relevance, metrics for success, and return on investment. Utilizing machine learning (ML) could assist in proposal evaluations by learning relationships between proposal performance and proposal features. This research explores the viability of artificial intelligence/ML for predicting proposal ratings given content-based proposal features. Although not meant to replace experts, a model-based approach to evaluating proposal quality could work alongside experts to provide a fast, minimally biased estimate of proposal performance. This article presents initial stages of a project aiming to use ML to prioritize research proposals. Materials and Methods The initial steps included a literature review to identify potential features. Then, these features were extracted from a dataset consisting of past proposals submissions. The dataset includes 824 proposals submitted to the AMTI program from 2010 to 2022. The analysis will inform a discussion of anticipated next steps toward developing a ML model. The following features were created for future modeling: requested funds; word count by section; readability by section; citations and partners identified; and term frequency—inverse document frequency word vectors. Results This initial process identified the top ranked words (data, health, injury, device, treatment, technology, etc.) among the abstract, problem to be solved, military relevance, and metrics/outcomes text proposal fields. The analysis also evaluated the text fields for readability using the Flesch readability scale. Most proposals text fields were categorized as "college graduate," indicating a challenging readability level. Finally, citations and partners were reviewed as an indicator of proposal successfulness. Conclusions This research was the first stage of a larger project to explore the use of ML to predict proposal ratings for the purpose of providing automated support to proposal reviewers and to reveal the preferences and values of AMTI proposal reviewers and other decision-makers. The result of this work will provide practical insights regarding the review process for the AMTI program. This will facilitate reduction in bias for AMTI innovators and a streamlined and subjective process for AMTI administrators, which benefits the military health system overall. [ABSTRACT FROM AUTHOR]

Introduction Clinical investigations have attributed lumbar spine injuries in combat to the vertical vector. Injury prevention strategies include the determination of spine biomechanics under this vector and developing/evaluating physical devices for use in live fire and evaluation-type tests to enhance Warfighter safety. While biological models have replicated theater injuries in the laboratory, matched-pair tests with physical devices are needed for standardized tests. The objective of this investigation is to determine the responses of the widely used Hybrid III lumbar spine under the vertical impact-loading vector. Materials and Methods Our custom vertical accelerator device was used in the study. The manikin spinal column was mounted between the inferior and superior six-axis load cells, and the impact was delivered to the inferior end. The first group of tests consisted of matched-pair repeatability tests, second group consisted of adding matched-pair tests to this first group to determine the response characteristics, and the third group consisted of repeating the earlier two groups by changing the effective torso mass from 12 to 16 kg. Peak axial, shear, and resultant forces at the two ends of the spine were obtained. Results The first group of 12 repeatability tests showed that the mean difference in the axial force between two tests at the same velocity across the entire range of inputs was <3% at both ends. In the second group, at the inferior end, the axial and shear forces ranged from 4.9-25.2 kN to 0.7-3.0 kN. Shear forces accounted for a mean of 11 ± 6% and 12 ± 4% of axial forces at the two ends. In the third group of tests with increased torso mass, repeatability tests showed that the mean difference in the axial force between the two tests at the same velocity across the entire range of inputs was <2% at both ends. At the inferior end, the axial and shear forces ranged from 5.7-28.7 kN to 0.6-3.4 kN. Shear forces accounted for a mean of 11 ± 8% and 9 ± 3% of axial forces across all tests at the inferior and superior ends. Other data including plots of axial and shear forces at the superior and inferior ends across tested velocities of the spine are given in the paper. Conclusions The Hybrid III lumbar spine when subjected to vertical impact simulating underbody blast levels showed that the impact is transmitted via the axial loading mechanism. This finding paralleled the results of axial force predominance over shear forces and axial loading injuries to human spines. Axial forces increased with increasing velocity suggesting the possibility of developing injury assessment risk curves, i.e. the manikin spine does not saturate, and its response is not a step function. It is possible to associate probability values for different force magnitudes. A similar conclusion was found to be true for both magnitudes of added effective torso mass at the superior end of the manikin spinal column. Additional matched-pair tests are needed to develop injury criteria for the Hybrid III male and female lumbar spines. [ABSTRACT FROM AUTHOR]

Continuous monitoring of electrophysiological biosignals such as electrocardiogram (ECG) and bioimpedance (BioZ) rely on gel‐based electrodes and adhesive skin interfaces requiring active patient interaction inherently restricting chronic use. Current solutions aimed at addressing seamless, comfortable, and reliable recordings with dry electrodes use battery power and are limited to days of operation with clinical‐grade fidelity. Here, current limitations are overcome by uniting at‐distance wirelessly powered wearable electronics with carbon‐doped filament deposition modeling (FDM) printed dry electrodes that overcome impedance degradation by seamless integration into textile and biosymbiotic systems, allowing for high‐fidelity operation over indefinite timescales. These capabilities are demonstrated with ECG during work, activity, and sleep and BioZ recordings documenting gains in forearm training over weeks. [ABSTRACT FROM AUTHOR]

Introduction Musculoskeletal (MSK) injury is an inherent risk for military personnel that can potentially impact job performance, productivity, and military readiness. Evidence is needed to show the efficacy of nonpharmacological, self-managed therapies to reduce MSK symptoms at common injury sites that are feasible for use during expeditionary operations and home stations. This systematic review and meta-analysis identified, summarized, and synthesized available evidence from randomized and non‐randomized trials on the effectiveness of self-managed, home-use therapies to improve pain, muscle strength, and physical performance in military personnel with MSK injuries, when compared to controls. Methods The electronic databases of MEDLINE ALL Ovid, Embase.com, Cochrane Library, Scopus, Clinicaltrial.gov, and CINAHL Complete via EBSCO were systematically searched for relevant reports published in English. Utilizing the Covidence platform and consistent with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, multiple reviewers, using pre-determined data fields, screened for eligibility, assessed risk of bias (RoB), and performed data extraction. Evaluation of treatment effectiveness was determined using multilevel mixed-effects meta-analysis. Results The database and register search yielded 1,643 reports that were screened for eligibility. After screening of titles/abstracts and full texts, 21 reports were identified for evidence synthesis. Of these, two reports were excluded and two described the same study, resulting in a final list of 18 studies (19 reports). For quality assessment, the overall RoB for the 18 studies was categorized as 33.3% low risk, 55.6% with some concerns, and 11.1% high risk. Across the five domains of bias, 70% of the reports were classified as low risk. This systematic review found that the differences in interventions, outcome measures, and design between the studies were associated with a substantial degree of heterogeneity (I2 = 60.74%), with a small overall improvement in outcomes of the interventions relative to their specific control (standard mean difference 0.28; 95% CI, 0.12 to 0.45). There were varying degrees of heterogeneity for individual body regions. This was due, in part, to a small number of studies per bodily location and differences in the study designs. For the neck/shoulder, heterogeneity was moderate, with the clearest positive effect being for physical performance outcomes via other medical devices. For the back, there was substantial heterogeneity between studies, with modest evidence that pain was favorably improved by other medical devices and exercise interventions. For the leg, one study showed a clear large effect for other medical devices (shockwave treatment) on pain with substantial heterogeneity. The best evidence for positive effects was for the knee, with mainly negligible heterogeneity and some benefits from bracing, electrotherapy, and exercise. Conclusion Evidence showed small beneficial effects in pain, strength, and physical performance by individual body regions for some interventions, compared to controls. The best evidence for a positive effect was for the knee. The findings suggest that some benefit may be obtained by including several treatments during deployment in austere environments and prolonged casualty care scenarios of military personnel with MSK injuries. Further research is warranted to better assess the potential benefits of using these treatments during deployments in austere environments as part of an individualized, multimodal approach for MSK injuries. [ABSTRACT FROM AUTHOR]

Introduction Point of use (POU) treatment is a critical first step of medical device reprocessing. Reusable instruments and flexible endoscopes require a minimum of terminal sterilization or high-level disinfection, neither of which can be guaranteed if POU is performed incorrectly. Compliance considerations for POU include hospital accreditation readiness, unique austere surgical mission requirements, and the transition of future conflict towards Large Scale Combat Operations. This integrative review aims to describe POU for reusable instruments and endoscopes, and extrapolate implications for Military Health System policies and future considerations. Materials and methods The authors performed an integrative review and comprehensive literature search in PubMed and CINAHL with the keywords "point of use," "point of use cleaning," "POU," "instrument," "high-level disinfection," "endoscope," and "clean." Articles were limited to "English" and "human" from 2017 to 2023. The authors also performed a thorough review of the Defense Health Agency and service-specific doctrine, as well as national guidelines regarding POU adherence. Results The literature review yielded 18 articles that discussed the transport and reprocessing of reusable medical devices. Regulatory standards and national guidelines were used to supplement the literature. Seventeen evidence-based criteria were extrapolated from the literature to generate two step-by-step guides for the POU treatment of endoscopes and reusable instruments (Tables I and II). Despite increased morbidity and mortality rates linked to inadequate device reprocessing, compliance with POU procedures remains low. Barriers to practice included complex POU processes, intricately designed surgical instruments and endoscopes, lack of healthcare worker (HCW) knowledge and competency, and inadequate or ambiguously written policies. Training, competency assessments, and clearly written policies and procedures can be cost-effective, evidence-based, and feasible solutions. Conclusion Completing POU treatment is critical to a successful surgical mission in both the hospital and austere environment. Implications to practice include implementing evidence-based POU programs that improve patient outcomes and readiness while decreasing costs. [ABSTRACT FROM AUTHOR]

Introduction Intraosseous (IO) infusion, the pressurized injection of fluids into bone through a catheter, is a life-preserving resuscitative technique for treating trauma patients with severe hemorrhage. However, little is known regarding the application times, placement accuracy, and end-user ratings of battery-powered and manual IO access devices. This study was specifically designed to fill these knowledge gaps on six FDA-approved IO access devices. Materials and Methods Three experienced U.S. Navy Emergency Medicine residents each placed commercially available 15-gauge IO catheters in cadaveric swine (Sus scrofa) proximal humeri and sternums in a randomized prospective experimental design. Devices included the battery-powered EZ-IO Rapid Infuser and the manual Jamshidi IO, PerSys NIO, SAM Manual IO, Tactical Advanced Lifesaving IO Needle (TALON), and PYNG First Access for Shock and Trauma 1 (30 trials per device, 10 per user, 210 total trials). Application times, placement accuracy in medullary (zone 1) and trabecular (zone 2) bone while avoiding cortical (zone 3) bone, and eight subjective user ratings were analyzed using ANOVA and nonparametric statistics at P  < .05. Results The EZ-IO demonstrated the fastest application times, high rates in avoiding zone 3, and the highest user ratings (P  < .0001). The TALON conferred intermediate placement times, highest rates of avoiding zone 3, and second-highest user ratings. The SAM Manual IO and Jamshidi performed poorly, with mixed results for the PerSys NIO and PYNG First Access for Shock and Trauma 1. Conclusions The battery-powered EZ-IO performed best and remains the IO access device of choice. The present findings suggest that the TALON should be considered as a manual backup to the EZ-IO. [ABSTRACT FROM AUTHOR]

Introduction This study examines limitations of the current regulatory framework for tobacco advertising on Instagram. We first investigate compliance with Food and Drug Administration (FDA) warning label requirements for posts by tobacco-owned accounts. Next, we examine the prevalence of content that has been restricted in broadcast or print for its youth appeal, followed by content meeting more expansive criteria for youth appeal set forth in the FDA's guidance document. Aims and Methods Posts by tobacco-brand-owned accounts between January 1, 2021, and February 14, 2022, were sampled from Mintel's Comperemedia Omni database. Instagram posts from 15 accounts were examined for violations of FDA warning label requirements and content that has been restricted on other mediums, including cartoons, sports branding, unauthorized claims, and young models (N  = 1243). Finally, a subsample of n  = 453 unambiguously branded posts was coded for themes that met the FDA's criteria of resonating with younger audiences, particularly that "adolescents rely on external information as they seek to shape their own identities." Results Only 12.8% of posts had fully compliant warning labels. Content that has been in some way regulated on other mediums, such as cartoons (1.6%), unauthorized health claims (<1%), sports branding (<1%), and young models (4.4%) were infrequent. However, a conservative analysis focusing only on branded posts found that posts frequently highlighted tech elements (45%), device customizability (24.5%), vaper identity (17.7%), stylized product photography (33.6%), social media engagement (32.2%), and memes (5.7%). Conclusions Enforcement of existing regulations on Instagram is minimal. Explicit content restrictions applying evidence-based guidance on youth-appealing advertising are needed. Implications This research has important implications for enforcing and expanding advertising regulations on social media. First, Instagram's self-imposed regulations are ineffective, permitting tobacco companies to post ads from brand-owned accounts despite claiming to restrict tobacco promotion on the platform. Second, policymakers should seek to apply FDA guidance on youth-appealing advertising informed by decades of research to create explicit enforceable content restrictions that extend beyond cartoons, sports figures, and young models to include content likely to situate tobacco use within the developing self-concept of vulnerable youth such as presenting e-cigarettes as hi-tech devices, highlighting vaper identity, or infiltrating online social media culture. Finally, greater resources for enforcement are needed given the only applicable regulation, warning labels, remains largely ignored. [ABSTRACT FROM AUTHOR]

Aims: Continuous glucose monitors (CGMs) have expanded their scope beyond indicated uses for diabetes management and are gaining traction among people not living with diabetes (PNLD). CGMs track in time glucose levels and are proposed as tools for the early detection of abnormal glucose and a potential solution for its normalisation through behavioural change, particularly, diet personalisation and motivation of physical activity. This becomes relevance given the growing incidence of metabolic conditions, such as type 2 diabetes mellitus (T2DM). Clinical guidelines, however, do not recommend CGMs in contexts outside type 1 diabetes (T1DM) or insulin‐treated T2DM. Therefore, there is a visible disconnect between the indicated and real‐world usage of these medical devices. While the commercial market for CGMs in PNLD is expanding rapidly, a comprehensive and evidence‐based evaluation of the devices' utility in this population has not been done. Therefore, this review aims to formulate a working model for CGM utility in PNLD as proposed by the 'health and wellness' market that advertises and distributes it to these individuals. Methods: We aim to critically analyse the available research addressing components of the working model, that is (1) detection of abnormal glucose; (2) behavioural change, and (3) metabolic health improvement. Results: We find a lack of consistent and high‐quality evidence to support the utility of CGMs for these purposes. We identify significantly under‐reserved areas including clinical benchmarks and scoring procedures for CGM measures, device acceptability, and potential adverse effects of CGMs on eating habits in PNLD. We also raise concerns about the robustness of available CGM research. Conclusion: In the face of these research gaps, we urge for the commercial claims suggesting the utility of the device in PNLD to be labelled as misleading. We argue that there is a regulatory inadequacy that fuels 'off‐label' CGM distribution and calls for the strengthening of post‐market clinical follow‐up oversight for CGMs. We hope this will help to avert the continued misinformation risk to PNLD and 'off‐label' exacerbation of health disparities. [ABSTRACT FROM AUTHOR]

Background: Although a variety of drug delivery devices have been launched in recent years, few studies have comprehensively investigated the market trends of combination drugs and medical devices approved or certified in Japan and the regulatory challenges related to their approval. Among the drug delivery devices, autoinjectors are more convenient than traditional prefilled syringes and are designed with safety features to prevent needlestick accidents, allowing self-injection by patients. Therefore, autoinjectors have been incorporated into the treatment of various diseases and have shown significant growth among drug delivery devices. Aim: This study aimed to investigate the market trends of combination drugs approved in Japan, especially those with autoinjector formulations, and to explore the challenges in the regulatory aspects of combination drugs. Methods: Information on the number of marketed drugs and medical devices was obtained from the Pharmaceuticals and Medical Devices Agency (PMDA) database using specific definitions. We looked at the annual changes in the number of drug delivery devices approved and certified as combination drugs or medical devices and the number of canceled certifications. We also examined the classification and main certification criteria for Japanese medical device nomenclature. Results: The study suggested that the number of combination drugs with autoinjector formulations is increasing, replacing previously approved or certified pen-type medication injectors. Moreover, 53% of all drug products were approved for autoinjector formulations after the initial authorization approval in Japan, and more than half of them obtained approval for additional formulations for autoinjectors within five years of the initial authorization approval, with the largest number of cases obtaining approval for additional formulations two years later. Conclusion: The lack of clear regulatory requirements for autoinjectors may lead to confusion among applicants. Furthermore, there are challenges in filing regulatory applications, thus hindering the rapid launch of combination drugutilizing devices with superior usability. [ABSTRACT FROM AUTHOR]

Bioelectronic Medicine (BEM), which uses implantable electronic medical devices to interface with electrically active tissues, aspires to revolutionize the way we understand and fight disease. By leveraging knowledge from microelectronics, materials science, information technology, neuroscience and medicine, BEM promises to offer novel solutions that address unmet clinical needs and change the concept of therapeutics. This perspective communicates our vision for the future of BEM and presents the necessary steps that need to be taken and the challenges that need to be faced before this new technology can flourish. [ABSTRACT FROM AUTHOR]

Decades of research have shown that magnetocardiography (MCG) has the potential to improve cardiac care decisions. However, sensor and system limitations have prevented its widespread adoption in clinical practice. We report an MCG system built around an array of scalar, optically pumped magnetometers (OPMs) that effectively rejects ambient magnetic interference without magnetic shielding. We successfully used this system, in conjunction with custom hardware and noise rejection algorithms, to record magneto-cardiograms and functional magnetic field maps from 30 volunteers in a regular downtown office environment. This demonstrates the technical feasibility of deploying our device architecture at the point-of-care, a key step in making MCG usable in real-world settings. [ABSTRACT FROM AUTHOR]

Objectives: Identify, through a systematic review, the main domains and methods to support health technology assessment of Medical Devices (MD) from the perspective of technological incorporation into healthcare systems. Methods: Performed structured searches in MEDLINE, Embase, BVS, Cochrane Library, and Web of Science for full studies published between 2017 and May 2023. Selection, extraction, and quality assessment were performed by two blinded reviewers, and discrepancies were resolved by a third reviewer. Results: A total of 5,790 studies were retrieved, of which 41 were included. We grouped the identified criteria into eight domains for the evaluations. Conclusion: Overall, studies discuss the need to establish specific methods for conducting HTA in MD. Due to the wide diversity of MD types, a single methodological guideline may not encompass all the specificities and intrinsic characteristics of the plurality of MD. Studies suggest using clustering criteria through technological characterization as a strategy to make the process as standardized as possible. [ABSTRACT FROM AUTHOR]

Background: 3D printers have gained prominence in rapid prototyping and viable in creating dimensionally accurate objects that are both safe within a Magnetic Resonance Imaging (MRI) environment and visible in MRI scans. A challenge when making MRI-visible objects using 3D printing is that hard plastics are invisible in standard MRI scans, while fluids are not. So typically, a hollow object will be printed and filled with a liquid that will be visible in MRI scans. This poses an engineering challenge however since objects created using traditional Fused Deposition Modeling (FDM) 3D-printing techniques are prone to leakage. Digital Light Processing (DLP) is a relatively modern and affordable 3D-printing technique using UV-hardened resin, capable of creating objects that are inherently liquid-tight. When printing hollow parts using DLP printers, one typically requires adding drainage holes for uncured liquid resin to escape during the printing process. If this is not done liquid resin will remain inside the object, which in our application is the desired outcome. Purpose: We devised a method to produce an inherently MRI-visible accessory using DLP technology with low dimensional tolerance to facilitate MRI-guided breast biopsies. Methods: By hollowing out the object without adding drainage holes and tuning printing parameters such as z-lift distance to retain as much uncured liquid resin inside as possible through surface tension, objects that are inherently visible in MRI scans can be created without further post-processing treatment. Results: Objects created through our method are simple and inexpensive to recreate, have minimal manufacturing steps, and are shown to be dimensionally exact and inherently MRI visible to be directly used in various applications without further treatment. Conclusion: Our proposed method of manufacturing objects that are inherently both MRI safe, and MRI visible. The proposed process is simple and does not require additional materials and tools beyond a DLP 3D-printer. With only an inexpensive DLP 3D-printer kit and basic cleaning and sanitation materials found in the hospital, we have demonstrated the viability of our process by successfully creating an object containing fine structures with low spatial tolerances used for MRI-guided breast biopsies. [ABSTRACT FROM AUTHOR]

OBJECTIVES The aim of this study is to demonstrate the ability of the Versius surgical system to successfully and safely complete a range of thoracic procedures aligned with Stage 2a (Development) of the Idea, Development, Exploration, Assessment and Long-term follow-up framework for surgical innovation. METHODS This prospective study included the first 30 consecutive patients who underwent robotic surgery with Versius by 2 surgeons without prior robotic experience between 1 April 2023 and 30 December 2023 [25 lung resections (wedge, segmentectomy and lobectomy) and 5 thymectomies]. There were no specific predetermined selection criteria for each case. The primary outcome was safe completion of the procedure without unplanned conversion. Secondary outcomes included intraoperative and postoperative complications, intraoperative device-related outcomes and pathology results. RESULTS Twenty-eight (93.3%) cases were completed without conversion. Both conversions were to thoracoscopy, one due to a 'console alarm' and the other due to pulmonary artery bleeding. In lung resections, median console time was 103 (90–129) min. Five (20%) patients experienced postoperative complications, most frequent was persistent air leak (16%). Median length-of-stay was 3 (2–4) days. Neither readmissions nor mortality was observed. In thymectomies, no intraoperative or postoperative complications, readmissions, reinterventions or mortality were observed. Median console time was 77 (75–89) min and median length of stay was 1 (1–1) day. CONCLUSIONS This phase 2a IDEAL-D study confirms lung resections and thymectomies are feasible with the use of Versius system, laying the foundation for larger phase 2b and 3 clinical studies within the IDEAL-D framework. [ABSTRACT FROM AUTHOR]

OBJECTIVES The use of ventricular assist devices (VADs) in children is increasing. However, absolute numbers in individual centres and countries remain small. Collaborative efforts such as the Paedi-European Registry for Patients with Mechanical Circulatory Support (EUROMACS) are therefore essential for combining international experience with paediatric VADs. Our goal was to present the results from the fourth Paedi-EUROMACS report. METHODS All paediatric (<19 years) patients from the EUROMACS database supported by a VAD were included. Patients were stratified into a congenital heart disease (CHD) group and a group with a non-congenital aetiology. End points included mortality, a transplant and recovery. Cox proportional hazard models were used to explore associated factors for mortality, cerebrovascular accident and pump thrombosis. RESULTS A total of 590 primary implants were included. The congenital group was significantly younger (2.5 vs 8.0 years, respectively, P  < 0.001) and was more commonly supported by a pulsatile flow device (73.5% vs 59.9%, P  < 0.001). Mortality was significantly higher in the congenital group (30.8% vs 20.4%, P  = 0.009) than in the non-congenital group. However, in multivariable analyses, CHD was not significantly associated with mortality [hazard ratio (HR) 1.285; confidence interval (CI) 0.8111–2.036, P  = 0.740]. Pump thrombosis was the most frequently reported adverse event (377 events in 132 patients; 0.925 events per patient-year) and was significantly associated with body surface area (HR 0.524, CI 0.333–0.823, P  = 0.005), CHD (HR 1.641, CI 1.054–2.555, P  = 0.028) and pulsatile flow support (HR 2.345, CI 1.406–3.910, P  = 0.001) in multivariable analyses. CONCLUSIONS This fourth Paedi-EUROMACS report highlights the increasing use of paediatric VADs. The patient populations with congenital and non-congenital aetiologies exhibit distinct characteristics and clinical outcomes. [ABSTRACT FROM AUTHOR]

Devices for the gastrointestinal tract are widely available and constantly advancing with less invasive techniques. They play a crucial role in diagnostic and therapeutic interventions and are commonly placed by interventional radiologists, gastroenterologists, and surgeons. These devices frequently appear in imaging studies, which verify their proper placement, identify any complications, or may be incidentally detected. Radiologists must be able to identify these devices at imaging and understand their intended purpose to assess their efficacy, detect complications such as incorrect positioning, and avoid misinterpreting them as abnormalities. Furthermore, many patients with these devices may require MRI, making assessing compatibility essential for safe patient care. This review seeks to provide a succinct and practical handbook for radiologists regarding both common and uncommon gastrointestinal devices. In addition to textual descriptions of clinical indications, imaging findings, complications, and MRI compatibility, the review incorporates a summary table as a quick reference point for key information and illustrative images for each device. [ABSTRACT FROM AUTHOR]

Background: Dry powder inhalers (DPIs) rely on both internal resistance and patients' inspiratory capacity for effective operation. Optimal inspiratory technique is crucial for DPI users. This study assessed the accuracy and repeatability of two available devices, PF810® and In-Check DIAL®, and analyzed their measurement errors and consistency in detecting inspiratory capacity. Methods: The accuracy and repeatability of peak inspiratory flow (PIF) and forced inspiratory vital capacity (FIVC) against various internal resistances of the two devices were assessed using standard waveforms generated by a breathing simulator. The agreement of PIF measurements between the two devices in healthy volunteers and chronic obstructive pulmonary disease (COPD) patients was analyzed with the intraclass correlation coefficient and Bland–Altman graphical analysis. Results: PF810® showed great accuracy and repeatability in measuring PIF, except for square waveforms at the lowest flow rate (20 L/min). In-Check DIAL® exhibited poor accuracy against high resistance levels. In scenarios with no resistance, In-Check DIAL® had significantly smaller measurement errors than PF810®, but larger errors against high resistance levels. The two devices showed excellent agreement (ICC > 0.80, P < 0.05), except for healthy volunteers against medium to high resistance (R3-R5) where the ICC was insignificant. Bland–Altman plots indicated small disagreements between the two devices for both healthy volunteers and COPD patients. Conclusions: In-Check DIAL® exhibited poor accuracy and larger measurement errors than PF810® when detecting PIFs against higher internal resistances. However, its good performance against lower internal resistances, along with its cost-effectiveness and convenience made it appropriate for primary care. PF810® showed good accuracy and repeatability and could detect additional parameters of inspiratory capacity beyond PIF, though required further studies to confirm its clinical benefits. [ABSTRACT FROM AUTHOR]

Background: Medical devices are now an essential component of modern healthcare, providing better illness screening, diagnosis, and treatment. Every medical equipment has some level of health risk. Health-care professionals such as resident doctors, intern doctors, and nursing staff play an important role in identifying and reporting adverse events caused by medical devices. Aim and Objective: The study aimed to evaluate Healthcare professionals' awareness, attitudes and practices concerning Materiovigilance within a tertiary care hospital setting. Materials and Methods: This was a cross-sectional questionnaire-based study done among resident doctors, intern doctors, and nursing staff of a Tertiary Care Teaching Hospital. To collect the relevant data of the study variable, a self-administered Google Form-based questionnaire was created. It consists of a total of 18 questions related to KAP aspects of the Materiovigilance. The study participants were given access to the questionnaire via a digital web link using several social media platforms, and their responses were collected. Results: A total of 147 participants responded, of which 40.1% were resident doctors, 29.9% were intern doctors, and 29.9% were nursing staff. After analysis of responded data, 50% had proper Knowledge, 77.5% had proper Attitude, and 37.4% had a proper practice of materiovigilance. Conclusion: It was discovered that the participants in our study lacked adequate Materiovigilance knowledge and practice, but had better attitudes toward Materiovigilance. For the purpose of raising awareness and encouraging the reporting of adverse events caused by medical devices, more workshops and training programs must be held. [ABSTRACT FROM AUTHOR]

AbstractInnovation in menstrual cups and panties addresses “period poverty” and ecological sustainability. However, menstrual cups and panties are not currently subject to Food and Drug Administration (FDA) review. We used data from three U.S. FDA databases and found an increase in adverse event reports associated with menstrual cups and that one-quarter of registered establishments have generic menstrual cups without brand names. Menstrual cups may be beneficial ecologically and economically because they replace single-use devices. However, there are health issues associated with cups, which may increase in incidence as their usage increases during a time when the FDA has reduced safeguards. [ABSTRACT FROM AUTHOR]

This paper examines the Saudi Food and Drug Authority's (SFDA) Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices (the MDS-G010). The SFDA has pioneered binding requirements designed for manufacturers to obtain Medical Device Marketing Authorization. The regulation of AI in health is at an early stage worldwide. Therefore, it is critical to examine the scope and nature of the MDS-G010, its influences, and its future directions. It is argued that the guidance is a patchwork of existing international best practices concerning AI regulation, incorporates adapted forms of non-AI-based guidelines, and builds on existing legal requirements in the SFDA's existing regulatory architecture. There is particular congruence with the approaches of the US Food and Drug Administration (FDA) and the International Medical Device Regulators Forum (IMDRF), but the SFDA goes beyond those approaches to incorporate other best practices into its guidance. Additionally, the binding nature of the MDS-G010 is complex. There are binding 'components' within the guidance, but the incorporation of non-binding international best practices which are subordinate to national law results in a lack of clarity about how penalties for non-compliance will operate. [ABSTRACT FROM AUTHOR]

Tissue regeneration and remodeling involve many complex stages. Macrophages are critical in maintaining micro-environmental homeostasis by regulating inflammation and orchestrating wound healing. They display high plasticity in response to various stimuli, showing a spectrum of functional phenotypes that vary from M1 (pro-inflammatory) to M2 (anti-inflammatory) macrophages. While transient inflammation is an essential trigger for tissue healing following an injury, sustained inflammation (e.g., in foreign body response to implants, diabetes or inflammatory diseases) can hinder tissue healing and cause tissue damage. Modulating macrophage polarization has emerged as an effective strategy for enhancing immune-mediated tissue regeneration and promoting better integration of implantable materials in the host. This article provides an overview of macrophages' functional properties followed by discussing different strategies for modulating macrophage polarization. Advances in the use of synthetic and natural biomaterials to fabricate immune-modulatory materials are highlighted. This reveals that the development and clinical application of more effective immunomodulatory systems targeting macrophage polarization under pathological conditions will be driven by a detailed understanding of the factors that regulate macrophage polarization and biological function in order to optimize existing methods and generate novel strategies to control cell phenotype. [ABSTRACT FROM AUTHOR]

Aim: To determine the incidence of pressure injuries from medical devices in children. Background: Medical devices can cause pressure injuries on skin and soft tissues. Design: A prospective, descriptive study adhering to STROBE guidelines. Methods: This study was conducted in the third‐level Paediatric Intensive Care Unit of Ege University Hospital in İzmir, Türkiye between April 2019 and October 2019 in Türkiye. Patients aged between 1 month and 18 years with medical devices were observed for pressure injuries using Braden scales and a specific monitoring form. Results: In this study, we followed 522 medical devices applied to 96 patients. The three most commonly used medical devices were the ECG probe (21%), the blood pressure cuff (16%) and the saturation probe. Out of the 522 medical devices followed, 36 caused pressure injuries (6.8%). Conclusion: The incidence of medical device‐related pressure injuries was found to be high. Effective training and implementation strategies need to be devised for paediatric nurses to prevent pressure injuries associated with medical devices. Relevance to Clinical Practice: The results of this study reveal that pressure injuries related to medical devices are an important health problem in paediatric hospitals. Therefore, awareness‐raising and educational activities among health professionals and nurses should be accelerated. Patient or Public Contribution: No patient or public contribution in the study. [ABSTRACT FROM AUTHOR]

Additive manufacturing is swiftly transitioning from a prototyping tool to a useful technology for industrial-scale manufacturing. As global industries seek to harness its potential, several 3D printing technologies have been successfully integrated into mainstream manufacturing workflows, based on the range of processable materials, fabrication mechanisms and integration into regulated environments. While metal 3D printing has established a significant niche in the context of aerospace and automotive manufacturing, the upscaled translation of polymer 3D printing lags, limited by several critical challenges, both in the materials domain, as well as the technical fabrication mechanisms. This article seeks to juxtapose the growth, challenges and opportunities of metal and polymer additive manufacturing, emphasizing the latter's potential for future growth in sectors such as polymer waste recycling and point-of-care medical device manufacturing. By dissecting the complexities surrounding feedstocks, manufacturing and post-processing workflows and the advances in simulations and quality control, this review provides comprehensive insights into the progression of 3D printed technologies for industrial-scale additive manufacturing into the future. [ABSTRACT FROM AUTHOR]

Gene delivery has revolutionized conventional medical approaches to vaccination, cancer, and autoimmune diseases. However, current gene delivery methods are limited to either intravenous administration or direct local injections, failing to achieve well biosafety, tissue targeting, drug retention, and transfection efficiency for desired therapeutic outcomes. Transdermal drug delivery based on various delivery strategies can offer improved therapeutic potential and superior patient experiences. Recently, there has been increased foundational and clinical research focusing on the role of the transdermal route in gene delivery and exploring its impact on the efficiency of gene delivery. This review introduces the recent advances in transdermal gene delivery approaches facilitated by drug formulations and medical devices, as well as discusses their prospects. [Display omitted] [ABSTRACT FROM AUTHOR]

BACKGROUND: Adequate equipment maintenance is necessary to ensure efficient dental care facilities and satisfactory medical equipment performance. OBJECTIVE: This study aimed to assess maintenance practices and manpower adequacy in private dental centres (DCs) across Riyadh, Saudi Arabia. METHODS: A questionnaire was designed to evaluate equipment maintenance and manpower strength based on international and national standards. Thirty-three private DCs were visited in-person with the designed questionnaire to conduct the study. The Chi-square test and t -test were performed. RESULTS: Only 21 dental centres had a scheduled maintenance plan for medical equipment, whereas the rest had no plan. Furthermore, only 22 DCs maintained equipment maintenance records, while 11 DCs did not have any records. Additionally, the study found a lack of trained personnel to handle medical equipment and overall inadequate maintenance practices. Significant differences were observed between the responses for many questions (p < 0.05). CONCLUSION: These findings increase health risks to both the patient and the user. To address these issues, DC administrators should implement stricter measures to adhere to local DCs standards and hire qualified personnel who can periodically maintain and repair medical equipment. [ABSTRACT FROM AUTHOR]

The fragmented nature of the medical device market limits our understanding of how particular sub-markets navigate the device development process. Despite the widespread use of transcutaneous neuromuscular electrical stimulation (NMES), its use for acquired dysarthria treatment has not been sufficiently explored. This study aims to provide a preliminary understanding of the stages involved in the development of NMES devices designed for neurorehabilitation. It also aims to investigate manufacturers' perceptions concerning factors that facilitate or impede its development and determine its applicability for acquired dysarthria. In-depth semi-structured online interviews were conducted with eight NMES device manufacturers located across Europe, North America and Oceania. The interviews were video-recorded, automatically transcribed, manually reviewed, and analysed using a qualitative content analysis. NMES device development for neurorehabilitation involves six complex phases with sequential and overlapping activities. Some emerging concepts were comparable to established medical device models, while others were specific to NMES. Its adaptability to different neurological disorders, the positive academia-industry collaborations, the industry's growth prospects and the promising global efforts for standardised regulations are all key facilitators for its development. However, financial, political, regulatory, and natural constraints emerged as barriers. Indications and challenges for the applicability of NMES for acquired dysarthria treatment were also discussed. The findings provide a foundation for further investigations on the NMES market sub-sector, particularly in the context of neurorehabilitation. The study also provides insights into the potential adoption of NMES for acquired dysarthria, which can serve as a reference for future research. The mapped neuromuscular electrical stimulation (NMES) development phases and processes can serve as a framework for new device development initiatives Opportunities for NMES development included its adaptability to neurological disorders, its growth prospects, academia-industry relationships and regulatory standardisation initiatives Financial, political, regulatory, and natural barriers were barriers for concern. From an anatomical and practical standpoint, it seems feasible to use NMES to treat several features of acquired dysarthria, however, clinicians' limited education on the use of electrical stimulation for neurorehabilitation may pose several constraints. [ABSTRACT FROM AUTHOR]

Digital health technology (DHT) is increasingly used to facilitate the conduct of clinical drug trials. The European regulatory environment would benefit from some adjustments to realize the full potential of DHTs. Considering current discussions such as the European Accelerating Clinical Trial Initiative (ACT EU), we propose four concrete adjustments to this regulatory landscape to introduce risk-based qualification approaches for DHTs. In our view, these changes would have the potential to facilitate the use of DHT in clinical research and thus provide access to innovative therapies in Europe. [ABSTRACT FROM AUTHOR]

Purpose: Ineffective management inventory of medical products such as blood and vaccines can create severe repercussions for hospitals, clinics or medical enterprises, such as surgery delays and postponements. Inventory sharing is a form of horizontal collaboration that can provide solutions to key actors of the healthcare supply chain (HSC), yet no prior study reviewed this topic. Design/methodology/approach: This study conducts a systematic literature review of thirty-nine inventory-sharing studies in the context of HSCs published from 2012 until early 2022. The descriptive and thematic analyses include chronological distribution, geographical location, comparison between developed/developing regions, stakeholder and incident analysis. Findings: Thematic analysis classified inventory sharing among five product supply chains (blood, medical supplies, medicines, vaccines and generic medical products). Benefits include shortage reduction, cost minimisation, and wastage mitigation. Barriers include (1) IT infrastructure, (2) social systems, (3) cost and (4) supply chain operations. Perishable inventory policies include Fresher-First (FF), Last-Expire-First-Out (LEFO), First-In-First-Out (FIFO) and First-Expire-First-Out (FEFO). The analysis also showed differences between developed and developing countries. The study identifies several future research opportunities that include (1) product utilisation rate, (2) cost reductions, (3) shortage mitigation and (4) waste reduction. Originality/value: No prior study has systematically reviewed inventory sharing in HSCs to reveal benefits, barriers, patterns and gaps in the current literature. It makes five propositions and develops a research model to guide future research. The study concludes with theoretical and managerial implications. [ABSTRACT FROM AUTHOR]

Purpose: From previous studies, we had observed that the number of biomedical engineers and technicians (BMETs) skilled in the maintenance of medical devices (MDs) were limited in sub-Saharan Africa (SSA) and that a likely parallelism existed between BME maintenance-related tasks and house chores mainly carried out by women in daily life. Our objective in carrying out this study was to understand underlying local cultural and social factors and domestic traditions interfering with the inclusion of women in the field of clinical and biomedical engineering (BME), and to identify existing gaps in opportunities for women in Engineering, Science and Technology (EST) in this region. Methods: We carried out an online survey involving 51 respondents (70.6% women, 29.4% men), to investigate gender-biased and cultural perceptions of maintenance-related tasks among engineers/technologists/technicians in BME and other allied professions in SSA​. The survey was refined through focus groups and pilot tests to assess its validity, and then shared among specific associations of women in engineering and other bodies in EST, as well as some hospital communities and institutions. Results: The survey brought to light evidence of prejudices against women in the society and workplace and showed that the adoption of our parallelism hypothesis has potential for increasing medical device maintenance practices in SSA hospitals. Conclusions: There is an apparent need to further study the possible effects of this sociological model through leveraging local culture and domestic traditions in ways that could ultimately increase the leadership and numbers of women BMETs in SSA. [ABSTRACT FROM AUTHOR]

Purpose: A literature review reveals that, at the moment, all usability tests for Software as a Medical Device (SaMD) are designed in compliance with international standards but it also reveals a lack of formalization in the implementation and administration of such usability tests, which prevents the comparison of results from different tests for the same class of SaMD. This study aims to provide a reproducible usability testing framework for SaMD to establish a standardized protocol which can ensure repeatability and comparisons of similar SaMD for the visualization of medical images and data. Methods: The devised protocol aligns with international standards and literature recommendations for usability and human factors engineering. It encompasses participant selection, testing environments, equipment setup for various testing methods (HDMI vs. wireless), and hardware interfaces (keyboard/mouse vs. touchscreen), as well as the roles of the required testers. The protocol consists of two distinct sections: exploratory tasks and specific scenarios, to assess software functions and real-life tasks, respectively. Effectiveness and efficiency are evaluated using video analysis and a custom Stopwatch software, while user satisfaction is measured through post-test questionnaires. Results: The usability testing protocol was applied to a Multimodal Biomedical Imaging Platform All-in-One software developed by Imaginalis S.r.l. (Sesto Fiorentino, Italy) for validation. The results of the usability testing protocol applied to the case-study software demonstrate good values of software's effectiveness and efficiency, along with user satisfaction supporting the prior heuristic evaluation. The outcomes confirm the robustness, applicability, and reproducibility of the usability testing protocol, aligning with best practices. Conclusions: The proposed usability testing framework enables reliable usability assessment and comparative analysis of medical software. Furthermore, the obtained results can serve as a reference for assessing other biomedical imaging platforms under development or ready for release. [ABSTRACT FROM AUTHOR]

Surface microstructures formed by jet electrolytic processing are widely used in aerospace and biomedical applications, and their unique process has an important role in medical devices. To improve the precision and usability of medical devices processed using this process, electrolytic characterization and micropit morphology experiments under different processing parameters were carried out to study the effect of EJM processing on processing efficiency and processing quality. The influencing factors of electrolytic machining rate were deduced by electrochemical theory, the electric field simulation was carried out using Comsol to analyze the electric field distribution and current density profile in the micropit, and the actual machining micropit was measured using a scanning microscope. The experiments show that increasing the peak voltage, reducing the machining gap, and extending the machining time can increase the depth of the micropit by 20%–40% and reduce the height of the silo by 45%–65%, which can effectively improve the surface structure of the medical device. [ABSTRACT FROM AUTHOR]

Swine are increasingly studied as animal models of human disease. The anatomy, size, longevity, physiology, immune system, and metabolism of swine are more like humans than traditional rodent models. In addition, the size of swine is preferred for surgical placement and testing of medical devices destined for humans. These features make swine useful for biomedical, pharmacological, and toxicological research. With recent advances in gene-editing technologies, genetic modifications can readily and efficiently be made in swine to study genetic disorders. In addition, gene-edited swine tissues are necessary for studies testing and validating xenotransplantation into humans to meet the critical shortfall of viable organs versus need. Underlying all of these biomedical applications, the knowledge of husbandry, background diseases and lesions, and biosecurity needs are important for productive, efficient, and reproducible research when using swine as a human disease model for basic research, preclinical testing, and translational studies. [ABSTRACT FROM AUTHOR]

BackgroundMedical devices are critical to providing high-quality, hospital-based newborn care, yet many of these devices are unavailable in low- and middle-income countries (LMIC) and are not designed to be suitable for these settings. Target Product Profiles (TPPs) are often utilised at an early stage in the medical device development process to enable user-defined performance characteristics for a given setting. TPPs can also be applied to assess the profile and match of existing devices for a given context.MethodsWe developed initial TPPs for 15 newborn product categories for LMIC settings. A Delphi-like process was used to develop the TPPs. Respondents completed an online survey where they scored their level of agreement with each of the proposed performance characteristics for each of the 15 devices. Characteristics with  75% agreement. Areas of disagreement were voted on by 69 participants at an in-person consensus meeting, with consensus achieved for 648 (97%) performance characteristics. Only 20 (3%) performance characteristics did not achieve consensus, most (15/20) relating to quality management systems. UNICEF published the 15 TPPs in April 2020, accompanied by a report detailing the online survey results and consensus meeting discussion, which has been viewed 7,039 times (as of January 2023).ConclusionsThese 15 TPPs can inform developers and enable implementers to select neonatal care products for LMIC. Over 2,400 medical devices and diagnostics meeting these TPPs have been installed in 65 hospitals in Nigeria, Tanzania, Kenya, and Malawi through the NEST360 Alliance. Twenty-three medical devices identified and qualified by NEST360 meet nearly all performance characteristics across 11 of the 15 TPPs. Eight of the 23 qualified medical devices are available in the UNICEF Supply Catalogue. Some developers have adjusted their technologies to meet these TPPs. There is potential to adapt the TPP process beyond newborn care.

Sustained release of vaccine components is a potential method to boost efficacy compared with traditional bolus injection. Here, we show that a biodegradable hyaluronic acid (HA)-scaffold, termed HA cryogel, mediates sustained antigen and adjuvant release in vivo leading to a durable immune response. Delivery from subcutaneously injected HA cryogels was assessed and a formulation which enhanced the immune response while minimizing the inflammation associated with the foreign body response was identified, termed CpG-OVA-HAC2. Dose escalation studies with CpG-OVA-HAC2 demonstrated that both the antibody and T cell responses were dose-dependent and influenced by the competency of neutrophils to perform oxidative burst. In immunodeficient post-hematopoietic stem cell transplanted mice, immunization with CpG-OVA-HAC2 elicited a strong antibody response, three orders of magnitude higher than dose-matched bolus injection. In a melanoma model, CpG-OVA-HAC2 induced dose-responsive prophylactic protection, slowing the tumor growth rate and enhancing overall survival. Upon rechallenge, none of the mice developed new tumors suggesting the development of robust immunological memory and long-lasting protection against repeat infections. CpG-OVA-HAC2 also enhanced survival in mice with established tumors. The results from this work support the potential for CpG-OVA-HAC2 to enhance vaccine delivery.

Abstract Background Artificial intelligence (AI) is increasingly used for prevention, diagnosis, monitoring, and treatment of cardiovascular diseases. Despite the potential for AI to improve care, ethical concerns and mistrust in AI-enabled healthcare exist among the public and medical community. Given the rapid and transformative recent growth of AI in cardiovascular care, to inform practice guidelines and regulatory policies that facilitate ethical and trustworthy use of AI in medicine, we conducted a literature review to identify key ethical and trust barriers and facilitators from patients’ and healthcare providers’ perspectives when using AI in cardiovascular care. Methods In this rapid literature review, we searched six bibliographic databases to identify publications discussing transparency, trust, or ethical concerns (outcomes of interest) associated with AI-based medical devices (interventions of interest) in the context of cardiovascular care from patients’, caregivers’, or healthcare providers’ perspectives. The search was completed on May 24, 2022 and was not limited by date or study design. Results After reviewing 7,925 papers from six databases and 3,603 papers identified through citation chasing, 145 articles were included. Key ethical concerns included privacy, security, or confidentiality issues (n = 59, 40.7%); risk of healthcare inequity or disparity (n = 36, 24.8%); risk of patient harm (n = 24, 16.6%); accountability and responsibility concerns (n = 19, 13.1%); problematic informed consent and potential loss of patient autonomy (n = 17, 11.7%); and issues related to data ownership (n = 11, 7.6%). Major trust barriers included data privacy and security concerns, potential risk of patient harm, perceived lack of transparency about AI-enabled medical devices, concerns about AI replacing human aspects of care, concerns about prioritizing profits over patients’ interests, and lack of robust evidence related to the accuracy and limitations of AI-based medical devices. Ethical and trust facilitators included ensuring data privacy and data validation, conducting clinical trials in diverse cohorts, providing appropriate training and resources to patients and healthcare providers and improving their engagement in different phases of AI implementation, and establishing further regulatory oversights. Conclusion This review revealed key ethical concerns and barriers and facilitators of trust in AI-enabled medical devices from patients’ and healthcare providers’ perspectives. Successful integration of AI into cardiovascular care necessitates implementation of mitigation strategies. These strategies should focus on enhanced regulatory oversight on the use of patient data and promoting transparency around the use of AI in patient care.

Abstract Bioelectronic Medicine (BEM), which uses implantable electronic medical devices to interface with electrically active tissues, aspires to revolutionize the way we understand and fight disease. By leveraging knowledge from microelectronics, materials science, information technology, neuroscience and medicine, BEM promises to offer novel solutions that address unmet clinical needs and change the concept of therapeutics. This perspective communicates our vision for the future of BEM and presents the necessary steps that need to be taken and the challenges that need to be faced before this new technology can flourish.

Abstract Background 3D printers have gained prominence in rapid prototyping and viable in creating dimensionally accurate objects that are both safe within a Magnetic Resonance Imaging (MRI) environment and visible in MRI scans. A challenge when making MRI-visible objects using 3D printing is that hard plastics are invisible in standard MRI scans, while fluids are not. So typically, a hollow object will be printed and filled with a liquid that will be visible in MRI scans. This poses an engineering challenge however since objects created using traditional Fused Deposition Modeling (FDM) 3D-printing techniques are prone to leakage. Digital Light Processing (DLP) is a relatively modern and affordable 3D-printing technique using UV-hardened resin, capable of creating objects that are inherently liquid-tight. When printing hollow parts using DLP printers, one typically requires adding drainage holes for uncured liquid resin to escape during the printing process. If this is not done liquid resin will remain inside the object, which in our application is the desired outcome. Purpose We devised a method to produce an inherently MRI-visible accessory using DLP technology with low dimensional tolerance to facilitate MRI-guided breast biopsies. Methods By hollowing out the object without adding drainage holes and tuning printing parameters such as z-lift distance to retain as much uncured liquid resin inside as possible through surface tension, objects that are inherently visible in MRI scans can be created without further post-processing treatment. Results Objects created through our method are simple and inexpensive to recreate, have minimal manufacturing steps, and are shown to be dimensionally exact and inherently MRI visible to be directly used in various applications without further treatment. Conclusion Our proposed method of manufacturing objects that are inherently both MRI safe, and MRI visible. The proposed process is simple and does not require additional materials and tools beyond a DLP 3D-printer. With only an inexpensive DLP 3D-printer kit and basic cleaning and sanitation materials found in the hospital, we have demonstrated the viability of our process by successfully creating an object containing fine structures with low spatial tolerances used for MRI-guided breast biopsies.

Abstract Background Dry powder inhalers (DPIs) rely on both internal resistance and patients’ inspiratory capacity for effective operation. Optimal inspiratory technique is crucial for DPI users. This study assessed the accuracy and repeatability of two available devices, PF810® and In-Check DIAL®, and analyzed their measurement errors and consistency in detecting inspiratory capacity. Methods The accuracy and repeatability of peak inspiratory flow (PIF) and forced inspiratory vital capacity (FIVC) against various internal resistances of the two devices were assessed using standard waveforms generated by a breathing simulator. The agreement of PIF measurements between the two devices in healthy volunteers and chronic obstructive pulmonary disease (COPD) patients was analyzed with the intraclass correlation coefficient and Bland–Altman graphical analysis. Results PF810® showed great accuracy and repeatability in measuring PIF, except for square waveforms at the lowest flow rate (20 L/min). In-Check DIAL® exhibited poor accuracy against high resistance levels. In scenarios with no resistance, In-Check DIAL® had significantly smaller measurement errors than PF810®, but larger errors against high resistance levels. The two devices showed excellent agreement (ICC > 0.80, P