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Different introducers are available to assist with tracheal intubation. Subtle differences in the design of introducers can have a marked effect on safety and performance. The Difficult Airway Society's Airway Device Evaluation Project Team proposal states that devices should only be purchased for which there is at least a case-control study on patients assessing airway devices. However, resources are not currently available to carry out a case-control study on all introducers available on the market. This study comprised a laboratory and manikin-based investigation to identify introducers that could be suitable for clinical investigation. We included six different introducers in laboratory-based assessments (design characteristics) and manikin-based assessments involving the participation of 30 anaesthetists. Each anaesthetist attempted placement in the manikin's trachea with each of the six introducers in a random order. Outcomes included first-time insertion success rate; insertion success rate; number of attempts; time to placement; and distance placed. Each anaesthetist also completed a questionnaire. First-time insertion success rate depended significantly on the introducer used (p = 0.0016) and varied from 47% (Armstrong and P3) to 77% (Intersurgical and Frova). Median time to placement (including oesophageal placement) varied from 10 s (Eschmann and Frova) to 20 s (P3) (p = 0.0025). Median time to successful placement in the trachea varied from 9 s (Frova) to 22 s (Armstrong) (p = 0.037). We found that the Armstrong and P3 devices were not as acceptable as other introducers and, without significant improvements to their design and characteristics, the use of these devices in studies on patients is questionable. The study protocol is suitable for differentiating between different introducers and could be used as a basis for assessing other types of devices.

OBJECTIVE: This paper assesses the effect of a passive shoulder exoskeleton prototype, Exo4Work, on muscle activity, muscle fatigue and subjective experience during simulated occupational overhead and non-overhead work. METHODS: Twenty-two healthy males performed six simulated industrial tasks with and without Exo4Work exoskeleton in a randomized counterbalanced cross-over design. During these tasks electromyography, heart rate, metabolic cost, subjective parameters and performance parameters were acquired. The effect of the exoskeleton and the body side on these parameters was investigated. RESULTS: Anterior deltoid activity and fatigue reduced up to 16% and 41%, respectively, during isometric overhead work, and minimized hindrance of the device during non-overhead tasks. Wearing the exoskeleton increased feelings of frustration and increased discomfort in the areas where the exoskeleton and the body interfaced. The assistive effect of the exoskeleton was less prominent during dynamic tasks. CONCLUSION: This exoskeleton may reduce muscle activity and delay development of muscle fatigue in an overhead working scenario. For dynamic applications, the exoskeleton's assistive profile, which mimics the gravitational torque of the arm, is potentially sub-optimal. SIGNIFICANCE: This evaluation paper is the first to report reduced muscle fatigue and activity when working with an occupational shoulder exoskeleton providing one third of the gravitational torque of the arm during overhead work. These results stress the potential of occupational shoulder exoskeletons in overhead working situations and may direct towards longitudinal field experiments. Additionally, this experiment may stimulate future work to further investigate the effect of different assistive profiles. ispartof: IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING vol:69 issue:10 pages:3008-3020 ispartof: location:United States status: published

In this fast-growing technological world biosensors become more substantial in human life and the extensive use of biosensors creates enormous research interest among researchers to define different approaches to detect biomolecules. The FET based biosensors have gained a lot of attention among all because of its high detection ability, low power, low cost, label-free detection of biomolecules, and CMOS compatible on-chip integration. The sensitivity of the biosensor inversely proportional to device size since they detect low concentration yields quick response time. Although FET based biosensor is having a lot of advantages among others but the short channel effects (SCE’s) and the theoretical limitation on the subthreshold swing (SS > 60mv/dec) of the FET leads to restrict device sensitivity and also have higher power dissipation due to the thermionic emission of electrons. To avoid these problems researchers focus shifts to the new technology FET based biosensors i.e. TFET based biosensors which are having low power and superior characteristics due to Band to band tunneling of carrier and steep subthreshold swing. This manuscript describes the full-fledged detail about the TFET based biosensors right from unfolding the device evaluation to biosensor application which includes qualitative and quantitative parameters analysis study like sensitivity parameters and different factors affecting the sensitivity by comparing different structures and the mechanisms involved. The manuscript also describes a brief review of different sensitivity parameters and improvement techniques. This manuscript will give researchers a brief idea for developing for the future generation TFET biosensors with better performance and ease of fabrication.

ObjectivesTo determine the feasibility of using real-world data to assess the safety and effectiveness of two cardiac ablation catheters for the treatment of persistent atrial fibrillation and ischaemic ventricular tachycardia.DesignRetrospective cohort.SettingThree health systems in the USA.ParticipantsPatients receiving ablation with the two ablation catheters of interest at any of the three health systems.Main outcome measuresFeasibility of identifying the medical devices and participant populations of interest as well as the duration of follow-up and positive predictive values (PPVs) for serious safety (ischaemic stroke, acute heart failure and cardiac tamponade) and effectiveness (arrhythmia-related hospitalisation) clinical outcomes of interest compared with manual chart validation by clinicians.ResultsOverall, the catheter of interest for treatment of persistent atrial fibrillation was used for 4280 ablations and the catheter of interest for ischaemic ventricular tachycardia was used 1516 times across the data available within the three health systems. The duration of patient follow-up in the three health systems ranged from 91% to 97% at ≥7 days, 89% to 96% at ≥30 days, 77% to 90% at ≥6 months and 66% to 84% at ≥1 year. PPVs were 63.4% for ischaemic stroke, 96.4% for acute heart failure, 100% at one health system for cardiac tamponade and 55.7% for arrhythmia-related hospitalisation.ConclusionsIt is feasible to use real-world health system data to evaluate the safety and effectiveness of cardiac ablation catheters, though evaluations must consider the implications of variation in follow-up and endpoint ascertainment among health systems.

BACKGROUND: Despite the potential of occupational passive shoulder exoskeletons (PSEs) to relieve overhead work, limited insights in overhead work precision performance impedes large-scale adoption in industry. OBJECTIVE: To investigate the effect of PSE support on the reduction in task performance caused by physical fatigue. METHODS: This experiment consisted of a randomized, counterbalanced cross-over design comparing Exo4Work PSE support and no support, in a physically fatigued state and a control condition. Precision performance was determined using execution speed and drilling errors. Muscle activity and shoulder joint kinematics were recorded. RESULTS: Fatigue altered task performance, shoulder joint kinematics, muscle activity and subjective experience during overhead work. The PSE support mitigated the fatigue-induced changes in shoulder kinematics. Additionally, a part of the fatigue-induced co-activation of shoulder stabilizing muscles was avoided when working with the PSE. The PSE support also reduced the activity of the anterior and medial deltoid. CONCLUSION: Physical fatigue provokes compensatory movements and increased co-contraction of muscles when executing overhead work. These fatigue-induced alterations are generally believed to increase the overall musculoskeletal load. The support provided by the PSE reduced muscle activity of muscles working to elevate the arm, but also partially mitigated those fatigue-induced effects. SIGNIFICANCE: This study shows that the effect of PSE support on precision performance is limited, and suggested that, apart from the known effects of PSE support during overhead work, wearing the exoskeleton in a physically fatigued state may provide additional advantages. ispartof: APPLIED ERGONOMICS vol:106 ispartof: location:England status: published

ObjectivesIntraoperative fluorescence imaging is currently used in a variety of surgical fields for four main purposes: assessing tissue perfusion; identifying/localizing cancer; mapping lymphatic systems; and visualizing anatomy. To establish evidence-based guidance for research and practice, understanding the state of research on fluorescence imaging in different surgical fields is needed. We evaluated the evidence on fluorescence imaging for perfusion assessments using the Idea, Development,Exploration, Assessment, Long Term Study (IDEAL) framework, which was designed for describing the stages of innovation in surgery and other interventional procedures.DesignNarrative literature review with analysis of IDEAL stage of each field of study.SettingAll publications on intraoperative fluorescence imaging for perfusion assessments reported in PubMed through 2019 were identified for six surgical procedures: coronary artery bypass grafting (CABG), upper gastrointestinal (GI) surgery, colorectal surgery, solid organ transplantation, reconstructive surgery, and cerebral aneurysm surgery.Main outcome measuresThe IDEAL stage of research evidence was determined for each specialty field using a previously described approach.Results196 articles (15 003 cases) were selected for analysis. Current status of research evidence was determined to be IDEAL Stage 2a for upper GI and transplantation surgery, IDEAL 2b for CABG, colorectal and cerebral aneurysm surgery, and IDEAL Stage 3 for reconstructive surgery. Using the technique resulted in a high (up to 50%) rate of revisions among surgical procedures, but its efficacy improving postoperative outcomes has not yet been demonstrated by randomized controlled trials in any discipline. Only one possible adverse reaction to intravenous indocyanine green was reported.ConclusionsUsing fluorescence imaging intraoperatively to assess perfusion is feasible and appears useful for surgical decision making across a range of disciplines. Identifying the IDEAL stage of current research knowledge aids in planning further studies to establish the potential for patient benefit.

Uveitis is a major cause of ocular morbidity, potentially leading to significant visual impairment. The recent adoption of alternative drug delivery options has led to the development of new sustained-delivery corticosteroid systems, able to manage successfully chronic noninfectious posterior uveitis. The treatment goal is to target the site of inflammation with low dose of corticosteroids, delivered over an extended period of time, to minimize the cumulative damage resulting from repeated recurrences, reducing both injections frequency and ocular side effects. This article will review the pharmacology and preliminary clinical data of the 0.18 mg fluocinolone acetonide intravitreal implant (YUTIQ™), to show its efficacy and safety in the treatment of noninfectious posterior uveitis.

The neuromorphic system is a hardware-level biosimulation system that implements neuron and synaptic elements. It has the same advantages as the human brain, such as low power consumption and small size. We proposed the synapse consisting of a memcapacitor for low power consumption. In this study, we created a capacitor-type synapses with ferroelectric thin films. Electrical characteristics were measured as a device evaluation, and they showed usefulness as a synapse. It is expected that if character correction learning is performed using the capacitor-type synapses, the modified pattern will match the memorized pattern, indicating successful training.

BACKGROUND Cardiac implantable electronic devices (CIEDs) are widely used according to consensus guidelines in various patient categories. The longevity of CIED is a major determinant of the frequency with which patients require device replacement. Given the mismatch between the useful life of the devices and patient survival, device replacement is often needed. There is a great variability in the criteria used by manufacturers to determine the longevity of pacemakers (PM), implantable defibrillators (ICDs) and devices for cardiac resynchronization therapy (CRT). Thus a fair comparison and an effective device evaluation is often difficult. METHODS The objective of this paper is to provide standardized criteria based on typical clinical settings for estimating the longevity of single and dual chamber ICDs, cardiac resynchronization defibrillators (CRT-D), single and dual chamber PMs and cardiac resynchronization PMs (CRT- P) to be used in heath technology assessment for an appropriate comparison among different devices. RESULTS The proposed parameters, if applied to the current marketed devices, provide longevity values in the range 5-17.2 years. CONCLUSION The values of longevity with the non-standardized criteria used by the manufacturers result in higher maximum values respect to the proposed standardized criteria for CRT-D, CRTD-MPP, CRT-P and Dual-chamber PM.

Numerical simulation is growing in its importance toward the design, testing and evaluation of medical devices. Computational fluid dynamics and finite element analysis allow improved calculation of stress, heat transfer, and flow to better understand the medical device environment. Current research focuses not only on improving medical devices, but also on improving the computational tools themselves. As methods and computer technology allow for faster simulation times, iterations and trials can be performed faster to collect more data. Given the adverse events associated with long-term inferior vena cava (IVC) filter placement, IVC filter design and device evaluation are of paramount importance. This work reviews computational methods used to develop, test, and improve IVC filters to ultimately serve the needs of the patient.

Type 1 diabetes (T1D) is a medical condition that requires constant management, including monitoring of blood glucose levels and administration of insulin. Advancements in diabetes technology have offered methods to reduce the burden on people with T1D. Several hybrid closed-loop systems are commercially available or in clinical trials, each with unique features to improve care for patients with T1D. This article reviews the Omnipod® 5 Automated Glucose Control System Powered by Horizon™ and the safety and efficacy data to support its use in the management of T1D.

Background The penumbra occlusion device (POD) is a recently developed metallic coil with a unique anchor segment. The purpose of this study was to investigate the anchoring function of the POD for embolization of medium-sized vessels in detail. Materials and methods We reviewed a series of cases of proximal embolization of medium-sized vessels in which the POD was used. Endovascular outcomes and complications were assessed. The distance between the distal end of the first-indwelled POD and the microcatheter tip was defined as the “landing distance,” and this was also evaluated via fluoroscopic analysis. Results POD deployment was successful in 17 of 18 patients. The median landing distance was 9.6 mm, and no distal POD migration was observed after the formation of anchor loops. Conclusions The specific anchoring function of the POD enables effective proximal occlusion of medium-sized vessels.

BackgroundReal-world data (RWD) from the Society for Vascular Surgery Vascular Quality Initiative (VQI) registry has been used to support US Food and Drug Administration (FDA) regulatory decisions regarding vascular devices. The variables of cost and time needed for these registry-based studies have not been previously compared to traditional, independent, industry studies that would otherwise have been conducted to support regulatory decisions.ObjectivesTo determine the potential value (cost and time saving and return on investment) created by device evaluation studies using the VQI registry infrastructure.MethodsWe compared studies that used data from the VQI registry with estimated costs of independent industry studies (counterfactual studies) using an established model using design specifications determined by FDA reviewers.ResultsWe analyzed the initial six studies evaluating vascular devices for regulatory decisions using data from the VQI registry that generated evidence for four device manufacturers. Return on investment for these studies was estimated to be 143% and cost saving as 59% based on an actual per patient (with 5-year follow-up) cost of US$11K using VQI data versus US$26K from the counterfactual when averaged across all studies. Significant enrollment time savings (45%–71%) were also realized compared with industry-based estimates.ConclusionsThe use of RWD from the VQI registry in this study and the transcatheter valve treatment coordinated registry network in a prior study indicates that substantial value was added to device evaluation projects by the reuse of registry data, with additional potential savings if linked claims data can be used instead of costly long-term in-person follow-up.

Extraglottic airway devices (EADs) have revolutionized the field of airway management. The invention of the laryngeal mask airway was a game changer, and since then, there have been several innovations to improve the EADs in design, functionality, safety and construction material. These have ranged from changes in the shape of the mask, number of cuffs and material used, like rubber, polyvinylchloride and latex. Phthalates, which were added to the construction material in order to increase device flexibility, were later omitted when this chemical was found to have serious adverse reproductive outcomes. The various designs brought out by numerous companies manufacturing EADs resulted in the addition of several devices to the airway market. These airway devices were put to use, many of them with inadequate or no evidence base regarding their efficacy and safety. To reduce the possibility of compromising the safety of the patient, the Difficult Airway Society (DAS) formed the Airway Device Evaluation Project Team (ADEPT) to strengthen the evidence base for airway equipment and vet the new extraglottic devices. A preuse careful analysis of the design and structure may help in better understanding of the functionality of a particular device. In the meantime, the search for the ideal EAD continues.

BACKGROUND AND PURPOSE: Tandem aneurysms are defined as multiple aneurysms located in close proximity on the same parent vessel. Endovascular treatment of these aneurysms has rarely been reported. Our aim was to evaluate the safety and efficacy of a single Pipeline Embolization Device for the treatment of tandem aneurysms of the internal carotid artery. MATERIALS AND METHODS: A retrospective analysis of consecutive aneurysms treated with the Pipeline Embolization Device between 2009 and 2016 at 3 institutions in the United States was performed. Cases included aneurysms of the ICA treated with a single Pipeline Embolization Device, and they were divided into tandem versus solitary. Angiographic and clinical outcomes were compared. RESULTS: The solitary group (median age, 58 years) underwent 184 Pipeline Embolization Device procedures for 184 aneurysms. The tandem group (median age, 50.5 years) underwent 34 procedures for 78 aneurysms. Aneurysms were primarily located along the paraophthalmic segment of the ICA in both the single and tandem groups (72.3% versus 78.2%, respectively, P = .53). The median maximal diameters in the solitary and tandem groups were 6.2 and 6.7 mm, respectively. Complete occlusion on the last angiographic follow-up was achieved in 75.1% of aneurysms in the single compared with 88.6%% in the tandem group (P = .06). Symptomatic thromboembolic complications were encountered in 2.7% and 8.8% of procedures in the single and tandem groups, respectively (P = .08). CONCLUSIONS: Tandem aneurysms of the ICA can be treated with a single Pipeline Embolization Device with high rates of complete occlusion. While there appeared to be a trend toward higher thromboembolic complication rates, this did not reach statistical significance.

The elastic analysis of a dynamic compression plate (DCP) used for the forearm bone fracture reduction is presented. For this propose is employed a tool based on the Boundary Element Method (BEM) and an iterative domain decomposition technique with which is possible to develop 3D models and non-homogeneous materials. The numerical results obtained for the analysis has been validated establishing a comparison with an experimental test employing a DCP made of steel 316L with real dimensions. The results demonstrate that it is possible to use the BEM for the osteosynthesis devices design.

To compare diabetic retinopathy (DR) identification and ungradable image rates between nonmydriatic ultrawide field (UWF) imaging and nonmydriatic multifield fundus photography (NMFP) in a large multistate population-based DR teleophthalmology program.Multiple-site, nonrandomized, consecutive, cross-sectional, retrospective, uncontrolled imaging device evaluation.Thirty-five thousand fifty-two eyes (17 526 patients) imaged using NMFP and 16 218 eyes (8109 patients) imaged using UWF imaging.All patients undergoing Joslin Vision Network (JVN) imaging with either NMFP or UWF imaging from May 1, 2014, through August 30, 2015, within the Indian Health Service-JVN program, which serves American Indian and Alaska Native communities at 97 sites across 25 states, were evaluated. All retinal images were graded using a standardized validated protocol in a centralized reading center.Ungradable rate for DR and diabetic macular edema (DME).The ungradable rate per patient for DR and DME was significantly lower with UWF imaging compared with NMFP (DR, 2.8% vs. 26.9% [P0.0001]; DME, 3.8% vs. 26.2% [P0.0001]). Identification of eyes with either DR or referable DR (moderate nonproliferative DR or DME or worse) was increased using UWF imaging from 11.7% to 24.2% (P0.0001) and from 6.2% to 13.6% (P0.0001), respectively. In eyes with DR imaged with UWF imaging (n = 3926 eyes of 2402 patients), the presence of predominantly peripheral lesions suggested a more severe level of DR in 7.2% of eyes (9.6% of patients).In a large, widely distributed DR ocular telehealth program, as compared with NMFP, nonmydriatic UWF imaging reduced the number of ungradable eyes by 81%, increased the identification of DR nearly 2-fold, and identified peripheral lesions suggesting more severe DR in almost 10% of patients, thus demonstrating significant benefits of this imaging method for large DR teleophthalmology programs.

Objectives Neonates in the neonatal intensive care unit often require considerable support with endotracheal tubes, umbilical arterial and venous catheters, and peripherally inserted central venous catheters. Support device evaluation with radiography exposes neonates to ionizing radiation. This study evaluated the effectiveness of sonographic localization for endotracheal tubes, umbilical arterial and venous catheters, and peripherally inserted central venous catheters. Methods This blinded prospective Institutional Review Board-approved, Health Insurance Portability and Accountability Act-compliant study with informed consent compared sonography to radiography for endotracheal tube, umbilical arterial and venous catheter, and peripherally inserted central venous catheter localization. Participants were consecutively recruited NICU patients of any weight, gestation, and chronologic age who had an endotracheal tube, umbilical arterial catheter, umbilical venous catheter, or peripherally inserted central venous catheter placed or adjusted and had subsequent radiographic confirmation within 24 hours. Sonographic evaluation was obtained as soon as possible, without prior review of the radiograph, and results were compared. Results Thirty sonographic studies were performed in 25 patients (14 male and 11 female), for a total of 50 lines and tubes: 18 umbilical venous catheters, 12 umbilical arterial catheters, 11 peripherally inserted central venous catheters, and 9 endotracheal tubes. Forty-nine support devices (98%) were visualized with sonography, all concordant with radiography. Forty-four were correctly positioned, and 6 were malpositioned. Sonography identified the location of umbilical venous catheters in all 18 cases (100%), umbilical arterial catheters in all 12 (100%), peripherally inserted central venous catheters in 10 (91%), and endotracheal tubes in 9 (100%). Conclusions The effectiveness of sonography was excellent for evaluation of umbilical arterial and venous catheters, endotracheal tubes, and peripherally inserted central venous catheters. These results support the goal of further point-of-care training and accreditation to use sonography as a primary modality for complete evaluation of NICU support devices.

The electrocardiogram (ECG) interpretation in patients with implantable pacemaker is often a perplexing problem. The difficulty in the device evaluation increases in the presence of novel timing cycles and additional functions. Authors describe a special function frequently encountered in Medtronic dual-chamber pacemakers and implantable cardioverter-defibrillator devices called managed ventricular pacing (MVP) and demonstrate its performance in the patient with undersensing episodes in ventricular channel. Intermittent ventricular undersensing in the device with MVP feature turned on caused repetitive mode switches between AAI and DDD mode. This report shows unexceptional occurrence of tricky ECG findings in patient with Medtronic dual-chamber device.

Onychomycosis is a difficult to treat fungal infection of the nails. The chronic nature of onychomycosis contributes to high recurrence rates and the difficulty in treating both dermatophyte and non-dermatophyte infections. It has been hypothesized that the formation of biofilms, sessile, multicellular communities of fungi surrounded by a protective extracellular matrix, allow for fungi to evade current antifungal therapies and contribute to observed antifungal resistance. This review presents the experimental evidence that has accumulated in recent years implicating biofilms in the pathogenesis of onychomycosis. Dermatophytes, non-dermatophyte molds, and yeasts form biofilms in vitro and a model using ex vivo healthy nail fragments has demonstrated biofilm formation on nails for dermatophyte, Candida, and Fusarium species. Implications for disease management are discussed with further research required to incorporate biofilm formation into future drug/device evaluation and treatment protocols.

The objective of this study was to determine the accuracy of the Hingmed WBP-02A device for ambulatory blood pressure (BP) monitoring according to the International Protocol of the European Society of Hypertension (ESH-IP). Device evaluation was carried out in 33 patients. The mean age was 69.8±13.8 years, the mean systolic BP was 137.6±27.0 mmHg (range: 96-172), the mean diastolic BP was 86.7±20.1 mmHg (range: 48-124) and the mean arm circumference was 30.1±6.2 cm (range: 20-43). The protocol requirements were followed precisely. Four different cuffs, small, standard, large, and extra-large were used. The device comfortably passed all ESH-IP requirements, as 84 out of 99 device-observer systolic BP differences and 97 of 99 diastolic BP differences were within ±5 mmHg thereby fulfilling the standards of the protocol. Device-observer BP differences were unrelated to arm circumference. These data show that the Hingmed WBP-02A device for ambulatory BP monitoring met the requirements for validation by the ESH-IP and can be recommended for clinical use in the adult population.

This article provides a brief overview of the technology of humanoid robots. First, historical development and hardware progress are presented mainly on human-size full-body biped humanoid robots, together with progress in pattern generation of biped locomotion. Then, «whole-body motion» – coordinating leg and arm movements to fully leverage humanoids’ high degrees of freedom – is presented, followed by its applications in fields such as device evaluation and large-scale assembly. Upper-body humanoids with a mobile base, which are mainly utilized for research on human-robot interaction and cognitive robotics, are also introduced before addressing current issues and perspectives.

In this paper, we propose a novel method for retargeting human movements including the steps taken by a humanoid robot. For applications, such as wearable device evaluation by a humanoid, it is necessary to reproduce the original human motions as closely as possible and to generate motions that can be realized on a real robot without the robot losing its balance. The proposed method features the optimization framework that integrates the walking pattern generation based on the linear inverted pendulum model whose parameters are optimized to ensure both human likeness and feasibility of the generated motions. The effectiveness of the retargeting method is validated by experiments that reproducing the measured human working motion on the humanoid HRP-4.

This paper presents recent heavy ion single-event effects test results for commercial off the shelf devices. Data was taken in CY17 for device evaluation for use in a Class D NASA interplanetary mission payload.

Protein inhalation is a delivery route which offers high potential for direct local lung application of proteins. Liquid formulations are usually available in early stages of biopharmaceutical development and nebulizers are the device of choice for atomization avoiding additional process steps like drying and enabling fast progression to clinical trials. While some proteins were proven to remain stable throughout aerosolization e.g. DNase, many biopharmaceuticals are more susceptible towards the stresses encountered during nebulization. The main reason for protein instability is unfolding and aggregation at the air-liquid interface, a problem which is of particular challenge in the case of ultrasound and jet nebulizers due to recirculation of much of the generated droplets. Surfactants are an important formulation component to protect the sensitive biomolecules. A second important challenge is warming of ultrasound and vibrating mesh devices, which can be overcome by overfilling, precooled solutions or cooling of the reservoir. Ultimately, formulation development has to go hand in hand with device evaluation.

Purpose To evaluate the patency and the freedom of target lesion revascularization of the 4-French Pulsar-18 self-expandable (SE) nitinol stent for the treatment of long femoropopliteal occlusive disease in a two-center, prospective, all-comers registry with a follow-up period of 12 months. Methods This registry enrolled 36 patients with symptomatic femoropopliteal long lesions for recanalization and implantation of the 4-French Pulsar-18 SE nitinol stent. Routine follow-up examination including duplex ultrasound was performed after 6 and 12 months. Primary patency was defined as no binary restenosis on duplex ultrasound (Peak systolic velocitiy ration (PSVR) Results Average lesion length of the femoropopliteal segment was 182.3 ± 51.8 mm. Mean stent implantation length was 181.5 ± 35.4 mm. Total occlusion was present in 46 of the 48 (95.8%) treated lesions. Involvement of popliteal segment I–III was present in 3 (6.3%) lesions. The primary patency after 6 and 12 months was 87.5% and 85.4%, respectively. The clinically driven overall freedom from target lesion revascularization (fTLR) was 89.6% after 6 months and 87.5% after 12 months. ABI, pain-free walking distance and Rutherford category, all improved significantly ( P < 0.001) after 6 and 12 months. The primary patency rate in patients with diabetes ( P = 0.18) and renal insufficiency ( P = 0.3) was not significantly lower as compared to the overall primary patency. Conclusions In this two-center, all-comers registry, the use of the Pulsar-18 SE nitinol stent for endovascular intervention of femoropopliteal disease with a mean lesion length of 182.3 ± 51.8 mm showed promising primary patency and fTLR rates after 6 and 12 months. Diabetes and renal insufficiency had no negative impact on the patency rate.

Mechanical circulatory and respiratory support systems are classified as high-risk devices that support or sustain human life by regulatory authorities worldwide and as such are required to undergo rigorous preclinical evaluation prior to adaption as treatment methods. This chapter discusses preclinical evaluation methods used to guide cardiac and respiratory assist device development, with different evaluation strategies (i.e., in silico, in vitro, and in vivo) described in depth. During in silico device evaluation, utilizing numerical simulations, potential devices and their interaction with a simulated cardiovascular system can be tested without having to build actual device prototypes or test set-ups. Actual device prototypes are then evaluated in vitro (e.g., in mock circulation loops, blood loops, or particle image velocimetry systems), which is necessary to comply with FDA regulations prior to in vivo trials. Following in silico and in vitro testing, devices are assessed in vivo utilizing large animal models, which are a critical component in the effort to translate device development into beneficial clinical practice. Only after successful preclinical evaluation can new devices undergo clinical trials and commercial distribution.

Recent technological advances in the management of patients with cardiovascular implantable electronic devices (CIEDs) have expanded clinicians' ability to remotely monitor patients with CIEDs. Remote monitoring, in addition to periodic in-person device evaluation, provides many advantages to patients and clinicians. Aside from the therapeutic and diagnostic benefits of pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization therapy devices, and implantable loop recorders, improvement in clinical outcomes, clinical efficiencies, and patient experience can be realized with the adoption of remote CIED monitoring. These advantages create significant value to both patients and CIED follow-up centers.

During routine endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) procedures, especially with biopsy of lymph nodes in or around the left upper lobe, frequent reports have noted the loss of ultrasound image and needle angulation leading to an inability to biopsy nodes visualised by EBUS. The aim of this research was to investigate and compare this loss of angulation with commercially available scopes. Bench-top experiments and a clinical case study demonstrated the varying loss of scope angulation, flexibility and manoeuvrability with different scopes and biopsy instruments leading to procedural implications. Improvements in both the EBUS scope and needle characteristics are required to overcome this limitation which has implications in bronchoscope navigation and the diagnostic yield of EBUS-TBNA.

The objective of this study was to determine the accuracy of the Thermor BIOS BD215 device for home blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension (ESH). Device evaluation was carried out in 33 patients. The mean age of the patients was 57.0 ± 15.0 years, the mean systolic BP was 142.0 ± 20.3 mmHg (range 100-177 mmHg), the mean diastolic BP was 88.0 ± 14.6 mmHg (range 48-123 mmHg), and the mean arm circumference was 28.0 ± 3.0 cm (range 24-33 cm). The protocol requirements were followed precisely. The device passed all requirements, fulfilling the standards of the protocol. On average, the device overestimated the systolic BP by 0.6 ± 4.2 mmHg and underestimated diastolic BP by -0.5 ± 3.2 mmHg. The device-observer discrepancies were unrelated to patients' clinical characteristics. These data show that the Thermor BIOS BD215 device fulfilled the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

To the Editor: According to the Society for Simulation in Healthcare, “Simulation is the imitation or representation of one act or system by another. Healthcare simulations can be said to have 4 main purposes – education, assessment, research, and health system integration in facilitating

Background: Postpartum intrauterine contraceptive device is inserted within 10 minutes to 48 hours of expulsion of placenta. The objective of the study was to determine acceptability, safety and complications of PPIUCD in tertiary care center.Methods: This is a retrospective study conducted at Zenana Hospital, SMS Medical College, Jaipur over a period of 1 year from April 2018 to March 2019. Women were followed after 6 weeks and their complaints and various parameters were analyzed.Results: 5653 women were inserted PPIUCD during 1 year period. Acceptance rate was 29.26% and higher in multipara (54.30%) and between 18 to 25 years of age (50.29%). The main complaints at follow-up were pain and bleeding which were dealt mainly by reassurance. Main cause of removal was bleeding, pain and family pressure.Conclusions: The acceptance was high in this study group. PPIUCD is safe, effective and acceptable with negligible side effects. PPIUCD has abundant scope in India where accessibility for contraception is lower during interval period and women do not come for follow-up after delivery.

Background Closed system transfer device (CSTD) mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapour concentrations outside the system. However, various CSTDs are not equally effective. Purpose We evaluated the impact of current and new CSTD systems on exposure of healthcare personnel to chemotherapy agents and how the new CSTD would fit into our workflow. Material and methods To ensure safety and compliance of a new CSTD system, our first step was a hands-on product demonstration to evaluate the new technology. The review included ease of use of the system and review of all system components. The second step was to take surface wipe samples. We used CytoWipe kits from Exposure Control. We carried out two compounding trials (existing CSTD and new CSTD), each lasting 3 weeks. Sampling locations in pharmacy included: Scale in the laminar flow cabinet (LAF) LAF surface. Counter with prepared chemotherapy. Floor in front of the LAF. Pass through surface. Vials. Baseline contamination was determined with initial cleaning with NaOH and HCl. During the trials, cleaning was performed per facility protocol (detergent, IPA and biocid B or C (KlerWipe) daily and 0.05 M NaOH weekly). Monitored drugs were cyclophosphamide and 5-fluorouracil. Exposure Control analysed cyclophosphamide using a GC-MSMS method and 5-fluorouracil using a HPLC system with UV detection. Results We found that while both systems were easy to use, the new CSTD system provided enhanced safety by ensuring compliance without an option to bypass the system. The limited surface wipe sample analysis showed that cleaning and workflow were important factors in minimising exposure of healthcare personnel to chemotherapy agents. With the current CSTD system, cyclophosphamide contamination was found on surfaces 1, 2 and 4, and barely detectable on 5 and 6. No contamination with 5-fluorouracil was found. With the new CSTD, cyclophosphamide contamination was found only on surfaces 4 and 6 that had little or no correlation with compounding. No contamination with 5-fluorouracil was found. Conclusion The study showed that the new CSTD system ensures compliance, fits into our workflow and can help minimise exposure of healthcare personnel to chemotherapy agents. No conflict of interest

Background The present study evaluates the feasibility of a shape memory polymer (SMP) device for fallopian tube occlusion in rabbits. Study design The SMP contraceptive device is made of poly( dl -lactic acid)-based poly(urethane urea) SMP in the shape of a spiral cylinder that was 10 mm long and had a diameter of 2.6 mm. Using this device, bilateral transuterine fallopian tube occlusions were performed in 78 New Zealand white female rabbits. Forty-eight female rabbits (Group 1) were chosen as the experimental group and were implanted with the SMP devices. The remaining 30 female rabbits (Group 2) served as the control group, which only received an incision in the abdomen but no SMP device. Follow-up consisted of hysterosalpingography, histologic evaluation and contraceptive effect. In addition, the shape memory behavior and in vivo degradation characterization of the SMP device were observed in this study. Results Under heat (37°C) stimulation, the temporary shape SMP device returned to its permanent shape within 60 s. The average weight loss percentage of SMP devices was 7.0% at 2 weeks and 72.5% at 12 weeks. The inflammatory reactions caused by SMP devices were aseptic and nonspecific at 2 and 12 weeks, respectively. The SMP device boundaries and the surrounding tissues were obscured by fiber hyperplasia in 11/12 tubes at 24 weeks. Hysterosalpingography showed an occluded fallopian tube of Group 1 in 6/6 rabbits at 12 weeks and 6/6 rabbits at 24 weeks. No pregnancy was found in all 18 rabbits of Group 1 (contraceptive rate of 100%); all 20 rabbits in the control group were pregnant. Conclusion Biodegradable and biocompatible SMP devices could provide reliable, instant and permanent tubal occlusion.

Due to rapid technological development, innovations in diagnostic devices are proceeding at an extremely fast pace. Accordingly, the needs for adopting innovative statistical methods have emerged in the evaluation of diagnostic devices. Statisticians in the Center for Devices and Radiological Health at the Food and Drug Administration have provided leadership in implementing statistical innovations. The innovations discussed in this article include: the adoption of bootstrap and Jackknife methods, the implementation of appropriate multiple reader multiple case study design, the application of robustness analyses for missing data, and the development of study designs and data analyses for companion diagnostics.

This paper presents an overview of the latest Gallium Nitride High Electron Mobility Transistor (GaN HEMT) technology. The latest development and challenges of 30 V to 650 V GaN HEMTs are summarized. The evaluation methodology of the GaN HEMT is presented, including static characterization and dynamic characterization. The paper also demonstrates the application of GaN HEMTs developed by Center for High Performance Power Electronics (CHPPE). Various high efficiency high power density circuit prototypes based on GaN HEMTs are presented.

Implantable cardiac devices have become the mainstay of the treatment of patients with heart disease. However, data regarding their reliability and, inferentially, safety have been called into question. We reviewed annual reports submitted to the Food and Drug Administration Office of Device Evaluation by device manufacturers from 2003 to 2007. The annual number of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillator (CRT-D) implants, explants, and returned devices were tabulated along with the cumulative (Cum) number of implants for each device. We derived an annual explantation rate (AER) defined as the ratio of the annual number of explants less the number of normal battery depletions/Cum (×1000). From 2003 to 2007, 256,392 CRT-D and 459,300 ICD devices were implanted in the United States. The overall mean (±SD) AERs for ICD and CRT-D devices were, respectively, 49.5 (15.6) per 1000 ICD devices and 82.6 (35.5) per 1000 CRT-D devices. The AER for each device type significantly decreased over the study period (P for trend

The superior sensitivity and specificity associated with the use of molecular assays has greatly improved the field of infectious disease diagnostics by providing clinicians with results that are both accurate and rapidly obtained. Herein, we review molecularly based infectious disease diagnostic tests that are Food and Drug Administration approved or cleared and commercially available in the United States as of December 31, 2010. We describe specific assays and their performance, as stated in the Food and Drug Administration's Summary of Safety and Effectiveness Data or the Office of In Vitro Diagnostic Device Evaluation and Safety's decision summaries, product inserts, or peer-reviewed literature. We summarize indications for testing, limitations, and challenges related to implementation in a clinical laboratory setting for a wide variety of common pathogens. The information presented in this review will be particularly useful for laboratories that plan to implement or expand their molecular offerings in the near term.

Introduction: Patients in underdeveloped nations have limited access to life-saving medical technology including cardiac rhythm management (CRM) devices. We evaluated alternative means to provide such technology to this patient population while assessing the safety and efficacy of such a practice. Methods: Patients in the United States with clinical indications for extraction of CRM devices were consented. Antemortem CRM devices were cleaned and sterilized following a protocol established at our institution. Surveillance in vitro cultures were performed for quality assurance. The functional status of pulse generators was tested with a pacing system analyzer to confirm at least 70% battery life. Most generators were transported, in person, to an implanting institution in Nicaragua. Recipients with a Class I indication for CRM implantation, and meeting economical criteria set forth, were consented for implantation of a recycled device. Results: Between 2003 and 2009, implantation was performed in 17 patients with an average age of 42.1 ± 20.3 years. Of the 17 patients, nine were male and eight were female. Mean follow-up was 68 ± 38 months. Device evaluation occurred prior to discharge, 4 weeks post implantation, and every 6 months thereafter. There were three deaths during the follow-up period secondary to myocardial infarction, stroke, and heart failure. Hematoma formation occurred in one patient. No infections, early battery depletion, or device malfunction were identified during follow-up. Conclusions: Our case series is the longest follow-up of recipients of recycled antemortem CRM devices. Our findings support the feasibility and safety of this alternative acquisition of life-saving technology. (PACE 2011; 653–658)

In Reply: Mr Chatburn begins his letter explaining what should be simulation in medicine. Many of the ventilator bench studies published before are only bench tests, as our study, and not a simulation of a more complex reality. The goal of this study was to test transport ventilators under

Progress in integrated-circuit technology in recent years has led to a significant increase in the performance of system large-scale integrated circuits (LSI). However, since a long time is required in order to learn the aspects of system LSI, such as design, trial fabrication, and device evaluation, it is difficult for company employees and students to learn system LSI technology. Basic research on a consecutive educational system consisting of the design, trial fabrication, and evaluation of an integrated circuits (IC) system is described. © 2010 Wiley Periodicals, Inc. Electron Comm Jpn, 93(10): 12–18, 2010; Published online in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/ecj.10290 5

This review explores recent trends in the development and evaluation of assistive robotic arms, both prosthetic and externally mounted. Evaluations have been organized according to the CATOR taxonomy of assistive device outcomes, which takes into consideration device effectiveness, social significance, and impact on subjective well-being. Questions that have informed the review include: (1) Are robotic arms being comprehensively evaluated along axes of the CATOR taxonomy? (2) Are definitions of effectiveness in accordance with the priorities of users? (3) What gaps in robotic arm evaluation exist, and how might these best be addressed? (4) What further advances can be expected in the next 15 years? Results highlight the need for increased standardization of evaluation methods, increased emphasis on the social significance (i.e., social cost) of devices, and increased emphasis on device impact on quality of life. Several open areas for future research, in terms of both device evaluation and device development, are also discussed.

A test battery was developed for cursor control device evaluation. Four tasks were taken from ISO 9241–9, and three from previous studies conducted at NASA. The tasks focused on basic movements such as pointing, clicking, and dragging. Four cursor control devices were evaluated with and without Extravehicular Activity (EVA) gloves to identify desirable cursor control device characteristics for NASA missions: a large trackball, a Hulapoint mouse, a small trackball, and an aircraft trackball. Conclusions include: 1) the test battery is an efficient tool for differentiating among input devices; 2) devices used with gloves have to be larger, and should allow good hand positioning to counteract the lack of tactile feedback; 3) none of the devices, as designed, were ideal for operation with EVA gloves.