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https://www.readbyqxmd.com/read/28080154/biocompatibility-assessments-for-medical-devices-evolving-regulatory-considerations
#1
Lesley Reeve, Paul Baldrick
Biocompatibility assessment provides key data supporting medical device development and marketing. Although regional and international guidance is available, differences in proposed biocompatibility assessments or test methods lead to confusion and inefficiencies in generating the package of supporting nonclinical data. Areas covered: Modifications to available guidance for biological safety testing of medical devices, as described by the International Organisation for Standardisation (ISO) and the US Food and Drug Administration (FDA), have, over time, sometimes increased and sometimes decreased the level of harmonisation in testing requirements...
January 12, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28078339/simultaneous-topographical-electrical-and-optical-microscopy-of-optoelectronic-devices-at-the-nanoscale
#2
Naresh Kumar, Alina Zoladek-Lemanczyk, Anne A Y Guilbert, Weitao Su, Sachetan M Tuladhar, Thomas Kirchartz, Bob C Schroeder, Iain McCulloch, Jenny Nelson, Debdulal Roy, Fernando A Castro
Novel optoelectronic devices rely on complex nanomaterial systems where the nanoscale morphology and local chemical composition are critical to performance. However, the lack of analytical techniques that can directly probe these structure-property relationships at the nanoscale presents a major obstacle to device development. In this work, we present a novel method for non-destructive, simultaneous mapping of the morphology, chemical composition and photoelectrical properties with <20 nm spatial resolution by combining plasmonic optical signal enhancement with electrical-mode scanning probe microscopy...
January 12, 2017: Nanoscale
https://www.readbyqxmd.com/read/28025239/off-label-use-of-medical-devices-in-children
#3
(no author information available yet)
Despite widespread therapeutic needs, the majority of medical and surgical devices used in children do not have approval or clearance from the Food and Drug Administration (FDA) for use in pediatric populations. The clinical need for devices to diagnose and treat diseases or conditions occurring in children has led to the widespread and necessary practice in pediatric medicine and surgery of using approved devices for "off-label" or "physician-directed" applications that are not included in FDA-approved labeling...
January 2017: Pediatrics
https://www.readbyqxmd.com/read/28003530/the-stentable-in-vitro-artery-an-instrumented-platform-for-endovascular-device-development-and-optimization
#4
Elizabeth E Antoine, François P Cornat, Abdul I Barakat
Although vascular disease is a leading cause of mortality, in vitro tools for controlled, quantitative studies of vascular biological processes in an environment that reflects physiological complexity remain limited. We developed a novel in vitro artery that exhibits a number of unique features distinguishing it from tissue-engineered or organ-on-a-chip constructs, most notably that it allows deployment of endovascular devices including stents, quantitative real-time tracking of cellular responses and detailed measurement of flow velocity and lumenal shear stress using particle image velocimetry...
December 2016: Journal of the Royal Society, Interface
https://www.readbyqxmd.com/read/27997307/caervest-%C3%A2-a-novel-endothermic-hypothermic-device-for-core-temperature-cooling-safety-and-efficacy-testing
#5
Ashley G B Willmott, Alex Bliss, William H Simpson, Steve M Tocker, Rowland Cottingham, Neil S Maxwell
INTRODUCTION: Cooling of the body is used to treat hyperthermic individuals with heatstroke or to depress core temperature below normal for neuroprotection. A novel chemically activated, unpowered cooling device, CAERvest(®), was investigated for safety and efficacy, with the feedback used to inform device development. METHODS: Eight healthy male participants (body mass 79.9±1.9kg and body fat percentage 16.1±3.8%) visited the laboratory (20°C, 40% RH) on four occasions...
December 20, 2016: International Journal of Occupational Safety and Ergonomics: JOSE
https://www.readbyqxmd.com/read/27987941/investigation-of-bio-polymer-electrolyte-based-on-cellulose-acetate-ammonium-nitrate-for-potential-use-in-electrochemical-devices
#6
S Monisha, T Mathavan, S Selvasekarapandian, A Milton Franklin Benial, G Aristatil, N Mani, M Premalatha, D Vinoth Pandi
Proton conducting materials create prime interest in electro chemical device development. Present work has been carried out to design environment friendly new biopolymer electrolytes (BPEs) using cellulose acetate (CA) complex with different concentrations of ammonium nitrate (NH4NO3), which have been prepared as film and characterized. The 50mol% CA and 50mol% NH4NO3 complex has highest ionic conductivity (1.02×10(-3)Scm(-1)). Differential scanning calorimetry shows the changes in glass transition temperature depends on salt concentration...
February 10, 2017: Carbohydrate Polymers
https://www.readbyqxmd.com/read/27986513/fixed-flexion-knee-radiography-using-a-new-positioning-device-produced-highly-repeatable-measurements-of-joint-space-width-elsa-brasil-musculoskeletal-study-elsa-brasil-msk
#7
Rosa Weiss Telles, Luciana Costa-Silva, Luciana A C Machado, Rodrigo Citton Padilha Dos Reis, Sandhi Maria Barreto
OBJECTIVE: To describe the performance of a non-fluoroscopic fixed-flexion PA radiographic protocol with a new positioning device, developed for the assessment of knee osteoarthritis (OA) in ELSA-Brasil MSK. MATERIAL AND METHODS: A test-retest design including 19 adults (38 knee images) was conducted. Feasibility of the radiographic protocol was assessed by image quality parameters and presence of radioanatomic alignment according to intermargin distance (IMD) values...
November 26, 2016: Revista Brasileira de Reumatologia
https://www.readbyqxmd.com/read/27971602/assessment-of-adhesion-response-to-3d-printed-materials-for-ophthalmic-device-development
#8
M Alband, R M Lee, M Penny, S Brocchini, S T Hilton
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27898390/novel-concentrated-insulin-delivery-devices-developments-for-safe-and-simple-dose-conversions
#9
REVIEW
Jeremy L Johnson, Jessica M Downes, Cassandra K Obi, Nana B Asante
To aid the burden of large dosing volumes, concentrated insulin products have been available in some form since the 1950s, albeit requiring significant and cumbersome detail in prescribing, converting doses from other products, and educating patients on how to administer. In 2015 and 2016, new concentrated products have been introduced that are available exclusively in pen devices that perform the conversion automatically, and thus, help to bypass the necessity for confusing calculations or administration. Providers and patients accustomed to traditional methods must recognize the differences and utility of these products to avoid dosing errors, as there are major differences in dosing procedures as well as their role in clinical practice...
November 27, 2016: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/27890135/human-factors-in-the-design-of-medical-devices-approaches-to-meeting-international-standards-in-the-european-union-and-usa
#10
Mary Beth Privitera, Mark Evans, Darren Southee
This paper focuses on the challenges of meeting agency requirements as it pertains to the application of human factors in the medical device development (MDD) process. Individual case studies of the design and development process for 18 medical device manufacturers located in the US and EU were analyzed and compared using a multiple case study design. The results indicate that there are four main challenges in implementing international standards. These include a lack of direct access to users for the purposes of device development; a lack of understanding by users with regards to the impact of their feedback on the development process; contract formalities limiting user exchanges; and the attitude of clinical users directly impacting on the device developer's invitation to participate in the development processes...
March 2017: Applied Ergonomics
https://www.readbyqxmd.com/read/27871889/spontaneous-prosocial-choice-by-captive-bottlenose-dolphins-tursiops-truncatus
#11
Fumio Nakahara, Masayuki Komaba, Ryoichi Sato, Hisako Ikeda, Kumiko Komaba, Akihiro Kawakubo
Dolphins exhibit prosocial behavior across several different contexts. However, only a few experimental studies have investigated the psychological mechanisms underlying this behavior. In this study, we investigated the mechanisms underlying prosociality in bottlenose dolphins (Tursiops truncatus). In the experiments, water shower devices, developed as environmental enrichment items, were used. Two paradigms were used to measure prosociality. The first was the prosocial choice task, involving the subject typically being offered one choice between two options...
November 18, 2016: Behavioural Processes
https://www.readbyqxmd.com/read/27867466/a-training-paradigm-to-enhance-performance-and-safe-use-of-an-innovative-neuroendovascular-device
#12
Donald R Ricci, Thomas R Marotta, Howard A Riina, Martina Wan, Joost De Vries
Training has been important to facilitate the safe use of new devices designed to repair vascular structures. This paper outlines the generic elements of a training program for vascular devices and uses as an example the actual training requirements for a novel device developed for the treatment of bifurcation intracranial aneurysms. Critical elements of the program include awareness of the clinical problem, technical features of device, case selection, and use of a simulator. Formal proctoring, evaluation of the training, and recording the clinical outcomes complement these elements...
2016: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/27855988/development-of-a-platelet-adhesion-transport-equation-for-a-computational-thrombosis-model
#13
Joshua O Taylor, Ling Yang, Steven Deutsch, Keefe B Manning
Thrombosis is a significant issue for cardiovascular device development and use. While thrombosis models are available, very few are device-related and none have been thoroughly validated experimentally. Here, we introduce a surface adherent platelet transport equation into a continuum model to account for the biomaterial interface/blood interaction. Using a rotating disc system and polyurethane-urea material, we characterize steady and pulsatile flow fields using laser Doppler velocimetry. In vitro measurements of platelet adhesion are used in combination with the LDV data to provide further experimental validation...
January 4, 2017: Journal of Biomechanics
https://www.readbyqxmd.com/read/27818053/biosensors-for-plant-pathogen-detection
#14
Mohga Khater, Alfredo de la Escosura-Muñiz, Arben Merkoçi
Infectious plant diseases are caused by pathogenic microorganisms such as fungi, bacteria, viruses, viroids, phytoplasma and nematodes. Worldwide, plant pathogen infections are among main factors limiting crop productivity and increasing economic losses. Plant pathogen detection is important as first step to manage a plant disease in greenhouses, field conditions and at the country boarders. Current immunological techniques used to detect pathogens in plant include enzyme-linked immunosorbent assays (ELISA) and direct tissue blot immunoassays (DTBIA)...
September 28, 2016: Biosensors & Bioelectronics
https://www.readbyqxmd.com/read/27803736/the-location-of-obstruction-predicts-stent-occlusion-in-malignant-gastric-outlet-obstruction
#15
Douglas Grunwald, Jonah Cohen, Anthony Bartley, Jennifer Sheridan, Ram Chuttani, Mandeep S Sawhney, Douglas K Pleskow, Tyler M Berzin, Meir Mizrahi
BACKGROUND: Gastric outlet obstruction (GOO) can occur with locally invasive or metastatic cancer involving the upper gastrointestinal tract at the pylorus or the duodenum. Endoscopic management with self-expanding metal stents (SEMSs) is often the preferred palliative approach. Stent occlusion is a common reason for failure and reintervention. We set out to determine whether the location of the malignant obstruction is associated with the angulation of the stent and can predict stent occlusion...
November 2016: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/27782610/development-and-characterization-of-a-high-yield-transportable-pulsed-neutron-source-with-efficient-and-compact-pulsed-power-system
#16
Rishi Verma, Ekansh Mishra, Prosenjit Dhang, Karuna Sagar, Manraj Meena, Anurag Shyam
The results of characterization experiments carried out on a newly developed dense plasma focus device based intense pulsed neutron source with efficient and compact pulsed power system are reported. Its high current sealed pseudospark switch based low inductance capacitor bank with maximum stored energy of ∼10 kJ is segregated into four modules of ∼2.5 kJ each and it cumulatively delivers peak current in the range of 400 kA-600 kA (corresponding to charging voltage range of 14 kV-18 kV) in a quarter time period of ∼2 μs...
September 2016: Review of Scientific Instruments
https://www.readbyqxmd.com/read/27771811/constitutive-description-of-human-femoropopliteal-artery-aging
#17
Alexey Kamenskiy, Andreas Seas, Paul Deegan, William Poulson, Eric Anttila, Sylvie Sim, Anastasia Desyatova, Jason MacTaggart
Femoropopliteal artery (FPA) mechanics play a paramount role in pathophysiology and the artery's response to therapeutic interventions, but data on FPA mechanical properties are scarce. Our goal was to characterize human FPAs over a wide population to derive a constitutive description of FPA aging to be used for computational modeling. Fresh human FPA specimens ([Formula: see text]) were obtained from [Formula: see text] predominantly male (80 %) donors 54±15 years old (range 13-82 years). Morphometric characteristics including radius, wall thickness, opening angle, and longitudinal pre-stretch were recorded...
October 22, 2016: Biomechanics and Modeling in Mechanobiology
https://www.readbyqxmd.com/read/27769741/three-dimensional-printing-with-polylactic-acid-pla-thermoplastic-offers-new-opportunities-for-cryobiology
#18
Terrence R Tiersch, William T Monroe
Development of devices through design, prototyping, testing, and fabrication is especially necessary for enhancement of research and eventual application in cryobiology. The advent of 3-dimensional printing offers unique opportunities for this process, given that the materials involved are suitable for use in cryogenic temperatures. We report herein that 3-D printing with polylactic acid (PLA) thermoplastic is ideally suited for cryobiology device development. Devices that are designed and standardized in open-source fashion can be electronically distributed and created locally on increasingly affordable 3-D printers, and can accelerate cryobiology findings and improve reproducibility of results...
December 2016: Cryobiology
https://www.readbyqxmd.com/read/27718757/growth-hormone-delivery-devices-current-features-and-potential-for-enhanced-treatment-adherence
#19
Tilman R Rohrer, Reiko Horikawa, Anne-Marie Kappelgaard
Adherence to daily growth hormone (GH) injections optimizes treatment benefit; however, adherence rates are sometimes poor. Reasons for poor adherence and persistence are multifaceted. GH injection devices are undergoing continual improvement to enhance adherence. Areas covered: This review evaluates published data on the evolution of GH injection devices to meet patients' needs and preferences, patients' perception of new devices and the projected impact of device developments on adherence. Published studies were identified through literature database searches including EMBASE and PubMed (January 1985-November 2015)...
November 4, 2016: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/27711488/observation-of-nanotwinning-and-room-temperature-ferromagnetism-in-sub-5-nm-bifeo3-nanoparticles-a-combined-experimental-and-theoretical-study
#20
Mandar M Shirolkar, Xiaolei Dong, Jieni Li, Shiliu Yin, Ming Li, Haiqian Wang
Particle size significantly affects the properties and therefore the potential applications of multiferroics. However, is there special particle size effect in BiFeO3, which has a spiral modulated spin structure? This is still under investigation for sub-5 nm BiFeO3. In this report, the structural, electronic and magnetic properties are investigated for chemically synthesized BiFeO3 nanoparticles with an average size of 3 nm. We observed nanotwinning features in the specific size regime of the nanoparticles (2-4 nm)...
September 14, 2016: Physical Chemistry Chemical Physics: PCCP
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