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https://www.readbyqxmd.com/read/28087552/screening-for-atrial-fibrillation-using-economical-and-accurate-technology-safety-a-pilot-study
#1
Mark Lown, Arthur Yue, George Lewith, Paul Little, Mike Moore
INTRODUCTION: Atrial fibrillation (AF) is a cause of stroke and a marker of atherosclerosis and of all patients with stroke, around 17% have AF. The screening and treatment of AF could prevent about 12% of all strokes. Several relatively low-cost devices with good accuracy now exist which can detect AF including WatchBP and AliveCor. However, they can only measure the ECG or pulse over short time periods. Inexpensive devices such as heart rate monitors, which are widely available, can measure heart rate for prolonged periods and may have potential in screening for AF...
January 13, 2017: BMJ Open
https://www.readbyqxmd.com/read/28087178/acupuncture-for-serum-uric-acid-in-patients-with-asymptomatic-hyperuricemia-a-randomized-double-blind-placebo-controlled-trial
#2
Yingjuan Huang, Jun Meng, Baoguo Sun, Ting Xiang, Xin Zhou, Biyu Xu, Yingzi Wu, Zexiong Chen, Shijun Zhang
BACKGROUND: Hyperuricemia (HUA) is the most common disease associated with cardiovascular disease, metabolic syndrome, hypertension, and kidney disease. The objective of the current study was to evaluate the preliminary efficacy, mechanism, and safety of acupuncture on serum uric acid in patients with asymptomatic HUA. METHODS: A randomized, placebo-controlled trial among 123 patients with asymptomatic HUA was conducted. The acupoints used in the acupuncture group were bilateral Five Shu in Spleen Meridian...
January 6, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/28086805/the-safety-of-introducing-a-new-generation-tavr-device-one-departments-experience-from-introducing-a-second-generation-repositionable-tavr
#3
Henrik Bjursten, Shahab Nozohoor, Malin Johansson, Igor Zindovic, Carl-Fredrik Appel, Johan Sjögren, Magnus Dencker, Göran Olivecrona, Jan Harnek, Sasha Koul, Ted Feldman, Michael J Reardon, Matthias Götberg
BACKGROUND: In the evolving field of transcatheter aortic valve replacements a new generation of valves have been introduced to clinical practice. With the complexity of the TAVR procedure and the unique aspects of each TAVR device, there is a perceived risk that changing or adding a new valve in a department could lead to a worse outcome for patients, especially during the learning phase. The objective was to study the safety aspect of introducing a second generation repositionable transcatheter valve (Boston Scientific Lotus valve besides Edwards Sapien valve) in a department...
January 13, 2017: BMC Cardiovascular Disorders
https://www.readbyqxmd.com/read/28081433/what-s-the-law-got-to-do-with-it-legislation-regarding-in-vehicle-technology-use-and-its-impact-on-driver-distraction
#4
Katie J Parnell, Neville A Stanton, Katherine L Plant
Legislation in the road transport domain aims to control safety on the roads. Despite this, a critical issue affecting road safety is that of driver distraction. Although poorly defined, distraction is a significant road safety issue which, in part, is caused by the prevalence of technology within vehicles. Legislation surrounding the use of in-vehicle technologies are explored in this paper from a socio-technical system perspective. This reveals the wider context of the road transport system operating under the current laws using an Accimap analysis...
January 9, 2017: Accident; Analysis and Prevention
https://www.readbyqxmd.com/read/28080154/biocompatibility-assessments-for-medical-devices-evolving-regulatory-considerations
#5
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/28078822/development-and-testing-of-a-grasper-for-notes-powered-by-variable-stiffness-pneumatic-actuation
#6
Michele Gabrio Antonelli, Pierluigi Beomonte Zobel, Francesco Durante, Fabio Gaj
BACKGROUND: In natural orifice transluminal endoscopic surgery (NOTES) the peritoneal cavity is reached through natural orifices (mouth, rectus and transvaginal duct), by means of little cuttings in the walls of hollow organs. Due to narrow spaces, NOTES needs robotic systems to assure operation/movement precision and patient safety. Variable stiffness actuation (VSA) assures both requirements. METHODS: The authors developed a grasper for NOTES, provided with VSA, to use as an end-effector for snail robot devices...
January 12, 2017: International Journal of Medical Robotics + Computer Assisted Surgery: MRCAS
https://www.readbyqxmd.com/read/28078110/radioembolization-with-90-y-glass-microspheres-for-the-treatment-of-unresectable-metastatic-liver-disease-from-chemotherapy-refractory-gastrointestinal-cancers-final-report-of-a-prospective-pilot-study
#7
Nicholas Fidelman, Robert K Kerlan, Randall A Hawkins, Miguel Pampaloni, Andrew G Taylor, Maureen P Kohi, K Pallav Kolli, Chloe E Atreya, Emily K Bergsland, R Kate Kelley, Andrew H Ko, W Michael Korn, Katherine Van Loon, Ryan M McWhirter, Jennifer Luan, Curt Johanson, Alan P Venook
BACKGROUND: This prospective pilot single-institution study was undertaken to document the feasibility, safety, and efficacy of radioembolization of liver-dominant metastatic gastrointestinal cancer using (90)Y glass microspheres. METHODS: Between June 2010 and October 2013, 42 adult patients (26 men, 16 women; median age 60 years) with metastatic chemotherapy-refractory unresectable colorectal (n=21), neuroendocrine (n=11), intrahepatic bile duct (n=7), pancreas (n=2), and esophageal (n=1) carcinomas underwent 60 lobar or segmental administrations of (90)Y glass microspheres...
December 2016: Journal of Gastrointestinal Oncology
https://www.readbyqxmd.com/read/28076626/development-of-a-multifunctional-needle-for-percutaneous-heart-biopsy-and-cell-therapy-a-technical-note
#8
Nathan Valle Soubihe, Agnes Afrodite S Albuquerque, Livia Arcêncio, José Antonio Thomazini, Andre Schmidt, Paulo Roberto B Evora
Validation of transendocardial injection as a method for delivering therapeutic agents to the diseased heart is increasing. Puncture heart biopsies should re-emerge as a possible alternative method to allow access to the myocardium and implantable biomaterial for cell therapy. Therefore, this work aims to present a percutaneous puncture device for biopsy and intramyocardial biomaterial injection, standardize the technique and attest to the safety of the method. The adaptation consists of creating myocardial microlesions that allow for better fixation of stem cells...
November 2016: Brazilian Journal of Cardiovascular Surgery
https://www.readbyqxmd.com/read/28076593/brachial-insertion-of-fully-implantable-venous-catheters-for-chemotherapy-complications-and-quality-of-life-assessment-in-35-patients
#9
Igor Yoshio Imagawa Fonseca, Mariana Krutman, Kenji Nishinari, Guilherme Yazbek, Marcelo Passos Teivelis, Guilherme André Zottele Bomfim, Rafael Noronha Cavalcante, Nelson Wolosker
Objective: To prospectively evaluate the perioperative safety, early complications and satisfaction of patients who underwent the implantation of central catheters peripherally inserted via basilic vein. Methods: Thirty-five consecutive patients with active oncologic disease requiring chemotherapy were prospectively followed up after undergoing peripheral implantation of indwelling venous catheters, between November 2013 and June 2014. The procedures were performed in the operating room by the same team of three vascular surgeons...
October 2016: Einstein
https://www.readbyqxmd.com/read/28076449/long-term-follow-up-of-patients-after-percutaneous-coronary-intervention-with-everolimus-eluting-bioresorbable-vascular-scaffold
#10
Rafael Alexandre Meneguz-Moreno, José de Ribamar Costa, Freddy Antônio Britto Moscoso, Rodolfo Staico, Luiz Fernando Leite Tanajura, Marinella Patrizia Centemero, Auréa Jacob Chaves, Andrea Claudia Leão de Sousa Abizaid, Amanda Guerra de Moraes Rego E Sousa, Alexandre Antonio Cunha Abizaid
Background: Bioresorbable vascular scaffolds (BVS) were developed to improve the long-term results of percutaneous coronary intervention, restoring vasomotion. Objectives: To report very late follow-up of everolimus-eluting Absorb BVS (Abbott Vascular, Santa Clara, USA) in our center. Methods: Observational retrospective study, in a single Brazilian center, from August 2011 to October 2013, including 49 patients submitted to Absorb BVS implantation...
January 9, 2017: Arquivos Brasileiros de Cardiologia
https://www.readbyqxmd.com/read/28075157/visual-occlusion-during-minimally-invasive-surgery-a-contemporary-review-of-methods-to-reduce-laparoscopic-and-robotic-lens-fogging-and-other-sources-of-optical-loss
#11
Todd Galvin Manning, Marlon Perera, Daniel Christidis, Ned Kinnear, Shannon McGrath, Richard O'Beirne, Paul Zotov, Damien M Bolton, Nathan Lawrentschuk
Background Maintenance of optimal vision during minimally invasive surgery is crucial to maintaining operative awareness, efficiency and safety. Hampered vision is commonly caused by laparoscopic lens fogging (LLF) which has prompted the development of various anti-fogging fluids and warming devices. However, limited comparative evidence exists in contemporary literature. Despite technological advancements there remains no consensus as to superior methods to prevent LLF or restore visual acuity once LLF has occurred...
January 11, 2017: Journal of Endourology
https://www.readbyqxmd.com/read/28071876/obstetrical-and-gynecological-devices-reclassification-of-surgical-instrumentation-for-use-with-urogynecologic-surgical-mesh-final-order
#12
(no author information available yet)
The Food and Drug Administration (FDA or the Agency) is reclassifying surgical instrumentation for use with urogynecologic surgical mesh from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and identifying them as "specialized surgical instrumentation for use with urogynecologic surgical mesh." FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information...
6, 2017: Federal Register
https://www.readbyqxmd.com/read/28070456/a-simple-rat-model-of-mild-traumatic-brain-injury-a-device-to-reproduce-anatomical-and-neurological-changes-of-mild-traumatic-brain-injury
#13
Ho Jeong Kim, Soo Jeong Han
Mild traumatic brain injury typically involves temporary impairment of neurological function. Previous studies used water pressure or rotational injury for designing the device to make a rat a mild traumatic brain injury model. The objective of this study was to make a simple model of causing mild traumatic brain injury in rats. The device consisted of a free-fall impactor that was targeted onto the rat skull. The weight (175 g) was freely dropped 30 cm to rat's skull bregma. We installed a safety device made of acrylic panel...
2017: PeerJ
https://www.readbyqxmd.com/read/28070229/novel-device-for-removal-of-blot-clot-obstructions-in-drainage-tubes
#14
Scott M Thompson, Cornelius A Thiels, Johnathon M Aho
Medical drains frequently become obstructed requiring removal or re-intervention. Currently, there is no widely accepted practice for maintaining drain patency. A simple device to remove obstructions from medical drains may have significant benefit. We manufactured a prototype drain clot extractor (DCE) for extracting obstructions. Fresh nonanticoagulated swine blood was instilled within drainage tubes of 16, 20, and 32 French (n = 2 for each size) to generate a 4 cm blood clot. The operator was then equipped with a 0...
March 2017: Journal of Medical Devices
https://www.readbyqxmd.com/read/28069260/drugs-and-medical-devices-adverse-events-and-the-impact-on-women-s-health
#15
REVIEW
Jennifer L Carey, Nathalie Nader, Peter R Chai, Stephanie Carreiro, Matthew K Griswold, Katherine L Boyle
A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed...
January 6, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28068961/contradictory-individualized-self-blaming-a-cross-sectional-study-of-associations-between-expectations-to-managers-coworkers-one-self-and-risk-factors-for-musculoskeletal-disorders-among-construction-workers
#16
Jeppe Zielinski Nguyen Ajslev, Roger Persson, Lars Louis Andersen
BACKGROUND: Within work sociology, several studies have addressed construction workers' practices of masculinity, class, economy, safety risks and production. However, few studies have investigated room for agency in relation to bodily pain or musculoskeletal disorders and even fewer have made a quantitative approach. Accordingly, by means of a questionnaire, we examined the association between construction workers' room for agency and physical exertion, bodily and mental fatigue, and lower back pain...
January 10, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/28068732/-concept-for-a-national-implant-registry-to-improve-patient-safety
#17
L Prantl, U von Fritschen, J Liebau, J von Hassel, E M Baur, P M Vogt, R E Giunta, R E Horch
Since the introduction of silicone implants, several events have led to considerable uncertainty among the patients, public, and users. So far, however, the necessary steps to significantly improving patient safety have not been taken in any of these cases. Requiring stricter approvals for medical devices, improving monitoring by the regulatory authorities and the revision of the Medical Devices Directive are all initial steps in the right direction towards a change in policy, but are insufficient as an early warning system...
December 2016: Handchirurgie, Mikrochirurgie, Plastische Chirurgie
https://www.readbyqxmd.com/read/28068049/medical-devices-neurological-devices-classification-of-the-neurovascular-mechanical-thrombectomy-device-for-acute-ischemic-stroke-treatment-final-order
#18
(no author information available yet)
The Food and Drug Administration (FDA) is classifying the neurovascular mechanical thrombectomy device for acute ischemic stroke treatment into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the neurovascular mechanical thrombectomy device for acute ischemic stroke treatment's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device...
23, 2016: Federal Register
https://www.readbyqxmd.com/read/28067196/management-of-st-elevation-myocardial-infarction-in-young-patients-by-limiting-implantation-of-durable-intracoronary-devices-and-guided-by-optical-frequency-domain-imaging-proof-of-concept-study
#19
Nicolas Combaret, Géraud Souteyrand, Nicolas Barber-Chamoux, Guilhem Malcles, Aimé Amonchot, Bruno Pereira, Louis Le Bivic, Romain Eschalier, Romain Trésorier, Pascal Motreff
AIMS: To demonstrate the feasibility and safety of ST-elevation myocardial infarction (STEMI) management in young patients by limiting implantation of durable intracoronary devices (using bioresorbable stent or medical treatment alone). METHODS AND RESULTS: Patients <50 years admitted for STEMI with single vessel disease received a two-stage management strategy. During a second coronary angiography performed between day 2 and day 7, optical frequency domain imaging (OFDI) enabled to guide therapeutic management: i) in the case of a stenosis greater that 70% or plaque prolapse, implantation of a BVS; ii) in the other cases, continuation of medical management alone without stenting...
January 10, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28066983/endoscopic-ultrasound-guided-antegrade-biliary-stenting-for-unresectable-malignant-biliary-obstruction-in-patients-with-surgically-altered-anatomy-a-single-center-prospective-pilot-study
#20
Takuji Iwashita, Ichiro Yasuda, Tsuyoshi Mukai, Keisuke Iwata, Shinpei Doi, Shinya Uemura, Masatoshi Mabuchi, Mitsuru Okuno, Masahito Shimizu
BACKGROUND AND AIMS: Endoscopic retrograde cholangiography (ERCP) with biliary stenting for the treatment of unresectable malignant biliary obstruction (MBO) is challenging among patients with surgically altered anatomy. Endoscopic ultrasound-guided antegrade biliary stenting (EUS-ABS) was introduced as an alternative biliary drainage method, although it has not been well studied yet. In this single-center prospective pilot study, we aimed to evaluate the feasibility and safety of EUS-ABS for MBO in patients with surgically altered anatomy...
January 9, 2017: Digestive Endoscopy: Official Journal of the Japan Gastroenterological Endoscopy Society
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