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https://www.readbyqxmd.com/read/28500861/overview-of-high-risk-medical-device-recalls-in%C3%A2-obstetrics%C3%A2-and-gynecology-from-2002-through-2016-%C3%A2-implications-for-device-safety
#1
Timothy M Janetos, Comeron W Ghobadi, Shuai Xu, Jessica R Walter
The field of women's health has endured numerous recent controversies involving medical devices such as pelvic meshes, laparoscopic morcellators, and a hysteroscopic sterilization device. With the recent passage of the 21st Century Cures Act, new legislation will change how the Food and Drug Administration regulates medical devices. Given these controversies and new changes, we investigated high-risk, class I recalls in women's health from 2002 through 2016. Class I recalls for medical devices are defined by the Food and Drug Administration as the most serious recall events and are designated for situations when there is a reasonable probability of serious adverse health consequences or death...
April 29, 2017: American Journal of Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28470445/ftir-microscopy-contribution-for-comprehension-of-degradation-mechanisms-in-pla-based-implantable-medical-devices
#2
Adrien Leroy, Sofia Ribeiro, Carole Grossiord, Antoine Alves, Robert H Vestberg, Vincent Salles, Céline Brunon, Kerstin Gritsch, Brigitte Grosgogeat, Yves Bayon
The integration and evolution of implantable medical devices made of bioresorbable polymers and used for temporary biomedical applications are crucial criteria in the success of a therapy and means of follow-up after implantation are needed. The objective of this work is to develop and evaluate a method based on microscopic Fourier Transform InfraRed spectroscopy (FTIR) mappings to monitor the degradation of such polymers on tissue explant sections, after implantation. This technique provided information on their location and on both their composition and crystallinity, which is directly linked to their state of degradation induced predominantly by chain scissions...
June 2017: Journal of Materials Science. Materials in Medicine
https://www.readbyqxmd.com/read/28463314/surface-structural-damage-study-in-cortical-bone-due-to-medical-drilling
#3
Cesar G Tavera R, Manuel H De la Torre-I, Jorge M Flores-M, Ma Del Socorro Hernandez M, Fernando Mendoza-Santoyo, Manuel de J Briones-R, Jorge Sanchez-P
A bone's fracture could be produced by an excessive, repetitive, or sudden load. A regular medical practice to heal it is to fix it in two possible ways: external immobilization, using a ferule, or an internal fixation, using a prosthetic device commonly attached to the bone by means of surgical screws. The bone's volume loss due to this drilling modifies its structure either in the presence or absence of a fracture. To observe the bone's surface behavior caused by the drilling effects, a digital holographic interferometer is used to analyze the displacement surface's variations in nonfractured post-mortem porcine femoral bones...
May 1, 2017: Applied Optics
https://www.readbyqxmd.com/read/28441181/inhaled-treprostinil-drug-delivery-during-mechanical-ventilation-and-spontaneous-breathing-using-two-different-nebulizers
#4
Donna K Parker, Shuijie Shen, Jiang Zheng, D Dunbar Ivy, Dave N Crotwell, Justin C Hotz, Robert M DiBlasi
OBJECTIVES: To determine the feasibility of delivering inhaled treprostinil during mechanical ventilation and spontaneous unassisted ventilation using the Tyvaso Inhalation System and the vibrating mesh nebulizer. We sought to compare differences in fine particle fraction, and absolute inhaled treprostinil mass delivered to neonatal, pediatric, and adult models affixed with a face mask, conventional, and high-frequency ventilation between Tyvaso Inhalation System and with different nebulizer locations between Tyvaso Inhalation System and vibrating mesh nebulizer...
April 22, 2017: Pediatric Critical Care Medicine
https://www.readbyqxmd.com/read/28398930/management-of-mesh-and-graft-complications-in-gynecologic-surgery
#5
(no author information available yet)
This document focuses on the management of complications related to mesh used to correct stress urinary incontinence or pelvic organ prolapse. Persistent vaginal bleeding, vaginal discharge, or recurrent urinary tract infections after mesh placement should prompt an examination and possible further evaluation for exposure or erosion. A careful history and physical examination is essential in the diagnosis of mesh and graft complications. A clear understanding of the location and extent of mesh placement, as well as the patient's symptoms and therapy goals, are necessary to plan treatment approaches...
May 2017: Female Pelvic Medicine & Reconstructive Surgery
https://www.readbyqxmd.com/read/28394653/in-vitro-in-vivo-comparison-of-inhaled-salbutamol-dose-delivered-by-jet-nebulizer-vibrating-mesh-nebulizer-and-metered-dose-inhaler-with-spacer-during-non-invasive-ventilation
#6
Ahmed Hassan, Randa Salah Eldin, Maha M Abdelrahman, Mohamed E Abdelrahim
BACKGROUND: Patients receiving noninvasive ventilation (NIV) may benefit from medical aerosol, but most guidance on dosing with different aerosol devices is limited to in-vitro studies. The study was designed to in-vitro, ex-vivo, and in-vivo compare aerosol delivery during bilevel NIV with three types of aerosol generators: metered dose inhaler with AeroChamber-MV spacer (AC), Aerogen Pro vibrating mesh nebulizer (PRO), and Sidestream jet nebulizer (SIDE). MATERIALS AND METHOD: A bilevel ventilator with dry single limb circuit and fixed expiratory port was set in spontaneous mode with initial inspiratory and expiratory pressures of 20 and 5 cmH20, 1:3 inspiratory-expiratory ratio, and 15 breaths...
February 2017: Experimental Lung Research
https://www.readbyqxmd.com/read/28333822/committee-opinion-no-694-management-of-mesh-and-graft-complications-in-gynecologic-surgery
#7
(no author information available yet)
This document focuses on the management of complications related to mesh used to correct stress urinary incontinence or pelvic organ prolapse. Persistent vaginal bleeding, vaginal discharge, or recurrent urinary tract infections after mesh placement should prompt an examination and possible further evaluation for exposure or erosion. A careful history and physical examination is essential in the diagnosis of mesh and graft complications. A clear understanding of the location and extent of mesh placement, as well as the patient's symptoms and therapy goals, are necessary to plan treatment approaches...
April 2017: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28333814/committee-opinion-no-694-summary-management-of-mesh-and-graft-complications-in-gynecologic-surgery
#8
(no author information available yet)
This document focuses on the management of complications related to mesh used to correct stress urinary incontinence or pelvic organ prolapse. Persistent vaginal bleeding, vaginal discharge, or recurrent urinary tract infections after mesh placement should prompt an examination and possible further evaluation for exposure or erosion. A careful history and physical examination is essential in the diagnosis of mesh and graft complications. A clear understanding of the location and extent of mesh placement, as well as the patient's symptoms and therapy goals, are necessary to plan treatment approaches...
April 2017: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28318504/-economic-evaluation-of-medical-devices-not-included-in-the-french-list-of-products-and-services-qualifying-for-reimbursement-example-of-biologic-meshes
#9
A Sainfort, I Denis-Hallouard, G Aulagner, O Nuiry, X Armoiry
OBJECTIVES: To present a method aimed to evaluate the economic impact associated with the use of medical devices (DM) not reimbursed in addition to diagnosis related groups (DRGs) tariffs using the example of biological meshes for parietal reinforcement. METHODS: In this multicenter retrospective cohort study, we included all patients who received a biological mesh between January 2010-April 2014 (University hospitals of Saint-Étienne, France) or between January 2010-March 2015 (Lyon University hospitals, France)...
March 16, 2017: Annales Pharmaceutiques Françaises
https://www.readbyqxmd.com/read/28288349/perivascular-medical-devices-and-drug-delivery-systems-making-the-right-choices
#10
REVIEW
Ioanna Mylonaki, Éric Allémann, François Saucy, Jacques-Antoine Haefliger, Florence Delie, Olivier Jordan
Perivascular medical devices and perivascular drug delivery systems are conceived for local application around a blood vessel during open vascular surgery. These systems provide mechanical support and/or pharmacological activity for the prevention of intimal hyperplasia following vessel injury. Despite abundant reports in the literature and numerous clinical trials, no efficient perivascular treatment is available. In this review, the existing perivascular medical devices and perivascular drug delivery systems, such as polymeric gels, meshes, sheaths, wraps, matrices, and metal meshes, are jointly evaluated...
February 28, 2017: Biomaterials
https://www.readbyqxmd.com/read/28169513/multilayer-nanoscale-encapsulation-of-biofunctional-peptides-to-enhance-bone-tissue-regeneration-in-vivo
#11
Piergiorgio Gentile, Ana Marina Ferreira, Jill T Callaghan, Cheryl A Miller, Joss Atkinson, Christine Freeman, Paul V Hatton
Bone tissue healing is a dynamic process that is initiated by the recruitment of osteoprogenitor cells followed by their migration, proliferation, differentiation, and development of a mineralizing extracellular matrix. The work aims to manufacture a functionalized porous membrane that stimulates early events in bone healing for initiating a regenerative cascade. Layer-by-layer (LbL) assembly is proposed to modify the surface of osteoconductive electrospun meshes, based on poly(lactic-co-glycolic acid) and nanohydroxyapatite, by using poly(allylamine hydrochloride) and poly(sodium 4-styrenesulfonate) as polyelectrolytes...
April 2017: Advanced Healthcare Materials
https://www.readbyqxmd.com/read/28073994/vibrating-mesh-nebulizer-compared-with-metered-dose-inhaler-in-mechanically-ventilated-subjects
#12
Meagan N Dubosky, Yi-Fan Chen, Mary E Henriksen, David L Vines
BACKGROUND: The impact of various aerosol delivery devices on patient outcomes during mechanical ventilation is unknown. If one method of delivery results in a higher ventilator-associated pneumonia (VAP) rate than another, multiple patient outcomes may be affected. This study aimed to determine whether there was a difference in VAP occurrence and patient outcomes (days receiving ventilation and in-hospital mortality) between the vibrating mesh nebulizer (AeroNeb Solo) and the metered-dose inhaler (MDI)...
January 10, 2017: Respiratory Care
https://www.readbyqxmd.com/read/28044355/a-cellular-model-of-shear-induced-hemolysis
#13
Salman Sohrabi, Yaling Liu
A novel model is presented to study red blood cell (RBC) hemolysis at cellular level. Under high shear rates, pores form on RBC membranes through which hemoglobin (Hb) leaks out and increases free Hb content of plasma leading to hemolysis. By coupling lattice Boltzmann and spring connected network models through immersed boundary method, we estimate hemolysis of a single RBC under various shear rates. First, we use adaptive meshing to find local strain distribution and critical sites on RBC membranes, and then we apply underlying molecular dynamics simulations to evaluate damage...
January 3, 2017: Artificial Organs
https://www.readbyqxmd.com/read/28007752/assessment-of-the-uterus-with-three-dimensional-ultrasound-in-women-undergoing-art
#14
Sotirios H Saravelos, Kannamannadiar Jayaprakasan, Kamal Ojha, Tin-Chiu Li
BACKGROUND: A detailed assessment of the uterus forms a pivotal part of the ART treatment process. The emergence of three-dimensional ultrasound (3D US) has provided clinicians with a highly powerful tool in this respect. Assessments with 3D US range from the reconstruction of anatomical planes elusive to conventional US, to the objective measurement of anatomical volumes and vascularization parameters. However, despite the ever increasing number of publications emerging in the literature, the question of which aspects of 3D US are of most clinical value remains a topic of debate...
March 1, 2017: Human Reproduction Update
https://www.readbyqxmd.com/read/27796291/graphene-coated-meshes-for-electroactive-flow-control-devices-utilizing-two-antagonistic-functions-of-repellency-and-permeability
#15
Rassoul Tabassian, Jung-Hwan Oh, Sooyeun Kim, Donggyu Kim, Seunghwa Ryu, Seung-Min Cho, Nikhil Koratkar, Il-Kwon Oh
The wettability of graphene on various substrates has been intensively investigated for practical applications including surgical and medical tools, textiles, water harvesting, self-cleaning, oil spill removal and microfluidic devices. However, most previous studies have been limited to investigating the intrinsic and passive wettability of graphene and graphene hybrid composites. Here, we report the electrowetting of graphene-coated metal meshes for use as electroactive flow control devices, utilizing two antagonistic functions, hydrophobic repellency versus liquid permeability...
October 31, 2016: Nature Communications
https://www.readbyqxmd.com/read/27782014/current-trends-in-electronic-medication-reminders-for-self-care
#16
Kerry Y Fang, Anthony J Maeder, Heidi Bjering
Poor adherence to medication can lead to negative health outcomes and increased financial burdens. We present a literature review on electronic medication reminders used for medication adherence in self care settings, to identify current and possible future trends. A structured PubMed search based on extracted MeSH terms provided a total of 45 publications which were identified as most relevant. Three main categories of electronic solutions were identified: mobile phone reminders, in-home electronic reminder devices, and portable reminder devices...
2016: Studies in Health Technology and Informatics
https://www.readbyqxmd.com/read/27742747/coiling-of-wide-necked-carotid-artery-aneurysms-assisted-by-a-temporary-bridging-device-comaneci-preliminary-experience
#17
S Fischer, A Weber, A Carolus, F Drescher, F Götz, W Weber
BACKGROUND: Endovascular treatment of wide-necked aneurysms remains challenging without the use of adjunctive devices to preserve the parent artery. OBJECTIVE: To present our initial experience with a temporary bridging device, the Comaneci (Rapid Medical, Israel). The compliant remodeling mesh protects the parent artery during coil occlusion without flow arrest in the distal vasculature. Permanent dual antiplatelet therapy is not required since the device is fully removed at the end of the procedure...
October 14, 2016: Journal of Neurointerventional Surgery
https://www.readbyqxmd.com/read/27736195/comparison-of-the-nanopulse-lithotripter-to-the-holmium-laser-stone-fragmentation-efficiency-and-impact-on-flexible-ureteroscope-deflection-and-flow
#18
Adam G Kaplan, Tony T Chen, Georgy Sankin, Chen Yang, Joanne A Dale, W Neal Simmons, Pei Zhong, Glenn M Preminger, Michael Eric Lipkin
INTRODUCTION: The Nanopulse Lithotripter (NPL; Lithotech Medical, Israel) is a novel intracorporeal device that uses a nanosecond duration electrical discharge through a reusable flexible coaxial probe to endoscopically fragment urinary stones. This device was compared with a holmium laser lithotripsy (HoL) with regard to stone fragmentation efficiency (SFE) and its impact on flexible ureteroscope (URS) deflection and flow of irrigation. METHODS: Using a custom bench model, a 6 mm BegoStone cylindrical phantom (mixture 5:2) was confined under 0...
November 2016: Journal of Endourology
https://www.readbyqxmd.com/read/27683978/potentiodynamic-corrosion-testing
#19
Selin Munir, Matthew H Pelletier, William R Walsh
Different metallic materials have different polarization characteristics as dictated by the open circuit potential, breakdown potential, and passivation potential of the material. The detection of these electrochemical parameters identifies the corrosion factors of a material. A reliable and well-functioning corrosion system is required to achieve this. Corrosion of the samples was achieved via a potentiodynamic polarization technique employing a three-electrode configuration, consisting of reference, counter, and working electrodes...
2016: Journal of Visualized Experiments: JoVE
https://www.readbyqxmd.com/read/27649902/educational-strategies-for-teaching-evidence-based-practice-to-undergraduate-health-students-systematic-review
#20
REVIEW
Konstantinos Kyriakoulis, Athina Patelarou, Aggelos Laliotis, Andrew C Wan, Michail Matalliotakis, Chrysoula Tsiou, Evridiki Patelarou
PURPOSE: The aim of this systematic review was to find best teaching strategies for teaching evidence-based practice (EBP) to undergraduate health students that have been adopted over the last years in healthcare institutions worldwide. METHODS: The authors carried out a systematic, comprehensive bibliographic search using Medline database for the years 2005 to March 2015 (updated in March 2016). Search terms used were chosen from the USNLM Institutes of Health list of MeSH (Medical Subject Headings) and free text key terms were used as well...
2016: Journal of Educational Evaluation for Health Professions
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