keyword
MENU ▼
Read by QxMD icon Read
search

Device AND safety

keyword
https://www.readbyqxmd.com/read/28319551/a-contemporary-medicolegal-analysis-of-implanted-devices-for-chronic-pain-management
#1
Christopher R Abrecht, Penny Greenberg, Ellen Song, Richard D Urman, James P Rathmell
BACKGROUND: Analysis of closed malpractice claims allows the study of rare but serious complications and likely results in improved patient safety by raising awareness of such complications. Clinical studies and closed claims analyses have previously reported on the common complications associated with intrathecal drug delivery systems (IDDS) and spinal cord stimulators (SCS). This study provides a contemporary analysis of claims from within the past 10 years. METHODS: We performed a closed claims analysis for a period January 1, 2009 to December 31, 2013 for cases with pain medicine as the primary service...
April 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28319519/process-improvement-initiative-for-the-perioperative-management-of-patients-with-a-cardiovascular-implantable-electronic-device
#2
Margaret K Menzel Ellis, Miriam M Treggiari, Jamie M Robertson, Marc A Rozner, Peter F Graven, Michael F Aziz, Matthias J Merkel, Edward A Kahl, Norman A Cohen, Eric C Stecker, Peter M Schulman
BACKGROUND: Economic, personnel, and procedural challenges often complicate and interfere with efficient and safe perioperative care of patients with cardiovascular implantable electronic devices (CIEDs). In the context of a process improvement initiative, we created and implemented a comprehensive anesthesiologist-run perioperative CIED service to respond to all routine requests for perioperative CIED consultations at a large academic medical center. This study was designed to determine whether this new care model was associated with improved operating room efficiency, reduced institutional cost, and adequate patient safety...
March 17, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28319472/infective-endocarditis-in-children-an-update
#3
Garth Dixon, Georgi Christov
PURPOSE OF REVIEW: Infective endocarditis in children remains a clinical challenge. Here, we review the impact of the updated 2015 American Heart Association and European Society of Cardiology guidelines on management as well as the significance of the new predisposing factors, diagnostic and treatment options, and the impact of the 2007-2008 change in prophylaxis recommendations. RECENT FINDINGS: The new 2015 infective endocarditis guidelines introduced the endocarditis team, added the new imaging modalities of computer tomography and PET-computer tomography into the diagnostic criteria and endorsed the concept of safety of relatively early surgical treatment...
March 17, 2017: Current Opinion in Infectious Diseases
https://www.readbyqxmd.com/read/28319034/sc-co-sub-2-sub-assisted-process-for-high-energy-density-aerogel-supercapacitor-the-effect-of-go-loading
#4
Maria Sarno, Lucia Baldino, Carmela Scudieri, Stefano Cardea, Paolo Ciambelli, Ernesto Reverchon
Energy density, safety, simple and environmentally friendly preparation methods are very significant aspects in the realization of a compact supercapacitor. Herein we report the use of a supercritical CO2 assisted gel drying process (SC-CO2) for the preparation of porous electrodes containing dispersed graphene in a Poly(vinylidene fluoride-co-hexafluoropropylene) (PVDF-HFP) binder membrane to sandwich in a new portable supercapacitor based on graphene oxide (GO). A GO loading of 60 wt.% has been found to give the better combination of factors (porosity, wettability, mechanical and electrochemical properties,...
March 20, 2017: Nanotechnology
https://www.readbyqxmd.com/read/28318054/efficacy-and-safety-of-targeted-high-intensity-medium-band-304-312-nm-ultraviolet-b-light-in-pediatric-vitiligo
#5
Da-Ke Dong, Zhan-Yan Pan, Juan Zhang, Xue-Fen Lu, Cheng Jin, Shi-Qin Tao, Li-Jia Yang
BACKGROUND/OBJECTIVES: Phototherapy is a commonly used treatment for vitiligo that has demonstrated safety and efficacy. High-intensity targeted ultraviolet B (UVB) light (304-312 nm) delivered using a phototherapy device is a useful therapeutic option because it can induce repigmentation in a short time without global exposure to radiation, but information regarding this device in children is limited. METHODS: We performed a retrospective analysis of 95 patches of vitiligo in 27 children treated using a targeted phototherapy device...
March 20, 2017: Pediatric Dermatology
https://www.readbyqxmd.com/read/28317684/comparison-of-the-performance-and-safety-of-2-ophthalmic-viscosurgical-devices-in-cataract-surgery
#6
Gerd U Auffarth, Florian N Auerbach, Tanja Rabsilber, José A Gegúndez, Ricardo Cuiña, Yves Renard, Paolo Vinciguerra, Fabrizio Camesasca, Francoise Van Cauwenberge, Thierry Amzallag, Gysbert Van Setten, Mike P Holzer
PURPOSE: To compare the clinical performance and safety of 2 ophthalmic viscosurgical devices (OVDs)-Twinvisc (OVD 1) and Duovisc (OVD 2)-in cataract surgery. SETTING: European multicenter study. DESIGN: Prospective randomized controlled study. METHODS: Patients with cataract had phacoemulsification and intraocular lens implantation in 1 eye. They were randomly assigned to receive OVD 1 or OVD 2. Preoperative and postoperative examinations over 3 months included mean intraocular pressure (IOP), incidence of IOP peaks (≥30 mm Hg and ≥24 mm Hg), endothelial cell count (ECC), corneal thickness, and intraocular inflammation...
January 2017: Journal of Cataract and Refractive Surgery
https://www.readbyqxmd.com/read/28317660/safety-tolerability-and-efficacy-of-intradermal-rabies-immunization-with-debioject%C3%A2
#7
Paul Vescovo, Nils Rettby, Nirinarilala Ramaniraka, Julie Liberman, Karen Hart, Astrid Cachemaille, Laurent-Dominique Piveteau, Reto Zanoni, Pierre-Alexandre Bart, Giuseppe Pantaleo
In a single-center study, 66 healthy volunteers aged between 18 and 50years were randomized to be immunized against rabies with three different injection routes: intradermal with DebioJect™ (IDJ), standard intradermal with classical needle (IDS), also called Mantoux method, and intramuscular with classical needle (IM). "Vaccin rabique Pasteur®" and saline solution (NaCl 0.9%) were administered at D0, D7 and D28. Antigen doses for both intradermal routes were 1/5 of the dose for IM. Tolerability, safety and induced immunogenicity of IDJ were compared to IDS and IM routes...
March 27, 2017: Vaccine
https://www.readbyqxmd.com/read/28316276/levosimendan-in-patients-with-left-ventricular-dysfunction-undergoing-cardiac-surgery
#8
Rajendra H Mehta, Jeffrey D Leimberger, Sean van Diepen, James Meza, Alice Wang, Rachael Jankowich, Robert W Harrison, Douglas Hay, Stephen Fremes, Andra Duncan, Edward G Soltesz, John Luber, Soon Park, Michael Argenziano, Edward Murphy, Randy Marcel, Dimitri Kalavrouziotis, Dave Nagpal, John Bozinovski, Wolfgang Toller, Matthias Heringlake, Shaun G Goodman, Jerrold H Levy, Robert A Harrington, Kevin J Anstrom, John H Alexander
Background Levosimendan is an inotropic agent that has been shown in small studies to prevent or treat the low cardiac output syndrome after cardiac surgery. Methods In a multicenter, randomized, placebo-controlled, phase 3 trial, we evaluated the efficacy and safety of levosimendan in patients with a left ventricular ejection fraction of 35% or less who were undergoing cardiac surgery with the use of cardiopulmonary bypass. Patients were randomly assigned to receive either intravenous levosimendan (at a dose of 0...
March 19, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28315824/near-field-investigation-of-the-explosive-dispersal-of-radioactive-material-based-on-a-reconstructed-spherical-blast-wave-flow
#9
David Hummel, Lucian Ivan
A "dirty bomb" is a type of radiological dispersal device (RDD) that has been the subject of significant safety and security concerns given the disruption that would result from a postulated terrorist attack. Assessing the risks of radioactive dose in a hypothetical scenario requires models that can accurately predict dispersion in a realistic environment. Modelling a RDD is complicated by the fact that the most important phenomena occur over vastly disparate spatial and temporal length scales. Particulate dispersion in the air is generally considered on scales of hundreds to thousands of meters, and over periods of minutes and hours...
March 15, 2017: Journal of Environmental Radioactivity
https://www.readbyqxmd.com/read/28315666/feasibility-and-safety-of-a-powered-exoskeleton-for-assisted-walking-for-persons-with-multiple-sclerosis-a-single-group-preliminary-study
#10
Allan J Kozlowski, Michelle Fabian, Dipan Lad, Andrew Delgado
OBJECTIVE: To examine the feasibility, safety, and secondary benefit potential of exoskeleton-assisted walking with one device for persons with multiple sclerosis (MS) DESIGN: Single-group longitudinal preliminary study with 8-week baseline, 8-week intervention, and 4-week follow-up. SETTING: Outpatient MS clinic at tertiary care hospital. PARTICIPANTS: The 13 participants were mostly female who ranged in age from 38-62 years and on Expanded Disability Status Scale scores from 5...
March 15, 2017: Archives of Physical Medicine and Rehabilitation
https://www.readbyqxmd.com/read/28315503/does-the-roller-pump-adjustment-in-cardiopulmonary-bypass-settings-influence-hemolysis
#11
Francisco U Vieira Junior, Nilson Antunes, Pedro P de Oliveira, Lindemberg M Silveira Filho, Karlos A S Vilarinho, Eduardo T Costa
INTRODUCTION: Roller pumps are widely used in procedures involving cardiopulmonary bypass (CPB) due to their ease of operation and maintenance, safety, and cost. Several studies in the literature have compared the use of roller pumps with centrifugal pumps, but the influence of the roller pump adjustment on hemolysis has been poorly explored. METHODS: Measurements of hemolysis rates were carried out in 86 patients. The pump was adjusted by the dynamic calibration method, which was performed by an auxiliary device, and the patients were grouped according to the pump calibration: Group 1 (n = 20) 75 mmHg; Group 2 (n = 24) 150 mmHg; Group 3 (n = 22) 300 mmHg and Group 4 (n = 21) 450 mmHg...
March 3, 2017: International Journal of Artificial Organs
https://www.readbyqxmd.com/read/28314673/can-we-perform-rotational-atherectomy-in-patients-with-severe-aortic-stenosis-substudy-from-the-ocean-tavi-registry
#12
Toru Naganuma, Hiroyoshi Kawamoto, Kensuke Takagi, Hiroto Yabushita, Satoru Mitomo, Yusuke Watanabe, Shinichi Shirai, Motoharu Araki, Norio Tada, Futoshi Yamanaka, Masanori Yamamoto, Hirokazu Onishi, Sunao Nakamura, Akihiro Higashimori, Minoru Tabata, Kazuki Mizutani, Hiroshi Ueno, Kentaro Hayashida
PURPOSE: The aim of this study was to report the safety of coronary rotational atherectomy (RA) in patients with severe aortic stenosis (AS). RA in the clinical setting seems challenging because coronary slow flow leads to hemodynamic instability. METHODS: Between October 2013 and May 2016, 1401 patients in the Optimized transCathEter vAlvular iNtervention (OCEAN) registry in Japan underwent transcatheter aortic valve implantation (TAVI). The primary study endpoint was procedural success, defined as residual stenosis <20% with final Thrombolysis in Myocardial Infarction flow 3...
February 28, 2017: Cardiovascular Revascularization Medicine: Including Molecular Interventions
https://www.readbyqxmd.com/read/28314636/comparing-non-safety-with-safety-device-sharps-injury-incidence-data-from-two-different-occupational-surveillance-systems
#13
A H Mitchell, G B Parker, H Kanamori, W A Rutala, D J Weber
The United States Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard as amended by the Needlestick Safety and Prevention Act requiring the use of safety-engineered medical devices to prevent needlesticks and sharps injuries has been in place since 2001. Injury changes over time include differences between those from non-safety compared with safety-engineered medical devices. This research compares two US occupational incident surveillance systems to determine whether these data can be generalized to other facilities and other countries either with legislation in place or considering developing national policies for the prevention of sharps injuries among healthcare personnel...
February 27, 2017: Journal of Hospital Infection
https://www.readbyqxmd.com/read/28314534/total-cavopulmonary-connection-with-a-new-bioabsorbable-vascular-graft-first-clinical-experience
#14
Leo A Bockeria, Oleg Svanidze, Alex Kim, Konstantin Shatalov, Vladimir Makarenko, Martijn Cox, Thierry Carrel
OBJECTIVES: To assess safety and clinical performance of a novel bioabsorbable vascular graft in pediatric patients with univentricular cardiac malformation who received surgical correction via an extracardiac cavopulmonary conduit. METHODS: The implanted graft material is designed to attract patient's own cells and proteins, which trigger a cascade of physiological events leading to endogenous tissue restoration. As the graft resorbs progressively after implantation, components of native tissue including collagen, endothelial lining, and capillary blood vessels develop and organize into a natural tissue...
February 7, 2017: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/28314163/radon-measurements-and-dose-estimate-of-workers-in-a-manganese-ore-mine
#15
Amin Shahrokhi, Tamás Vigh, Csaba Németh, Anita Csordás, Tibor Kovács
In the new European Basic Safety Standard (EU-BSS), a new reference level for indoor radon concentration in workplaces has recommended that the annual average activity concentration of indoor radon shall not be higher than 300Bqm(-3). This paper describes the radon concentration level in an underground workplace (manganese ore mine) over long time intervals (4 years). Several common radon monitors devices - including NRPB and Raduet (as a passive method based on CR-39), AlphaGUARD PQ 2000Pro, SARAD EQF3220, TESLA and Pylon WLX (as active methods) - were used for continuous radon measurements...
March 10, 2017: Applied Radiation and Isotopes
https://www.readbyqxmd.com/read/28306515/decentralized-safety-concept-for-closed-loop-controlled-intensive-care
#16
Jan Kühn, Christian Brendle, André Stollenwerk, Martin Schweigler, Stefan Kowalewski, Thorsten Janisch, Rolf Rossaint, Steffen Leonhardt, Marian Walter, Rüdger Kopp
This paper presents a decentralized safety concept for networked intensive care setups, for which a decentralized network of sensors and actuators is realized by embedded microcontroller nodes. It is evaluated for up to eleven medical devices in a setup for automated acute respiratory distress syndrome (ARDS) therapy. In this contribution we highlight a blood pump supervision as exemplary safety measure, which allows a reliable bubble detection in an extracorporeal blood circulation. The approach is validated with data of animal experiments including 35 bubbles with a size between 0...
March 17, 2017: Biomedizinische Technik. Biomedical Engineering
https://www.readbyqxmd.com/read/28306175/a-stable-and-convenient-protein-electrophoresis-titration-device-with-bubble-removing-system
#17
Qiang Zhang, Liu-Yin Fan, Wen-Lin Li, Feng-Song Cong, Ran Zhong, Jing-Jing Chen, Yu-Chen He, Hua 'Xiao, Cheng-Xi Cao
Moving reaction boundary titration (MRBT) could be a potential alternative of versatile method viz. enzymatic immunoassay and protein content analysis without disturbance of non-protein nitrogen (NPN) reagent adulteration. However, air bubbles often impair the accuracy of MRBT, and cause leakage of electrolyte that greatly decreases the safety and convenience of electrophoretic titration. Addressing these two issues a reliable MRBT device with modified electrolyte chamber of protein titration was designed. Multiphysics computer simulation was conducted for optimization according to two phase flow...
March 17, 2017: Electrophoresis
https://www.readbyqxmd.com/read/28303634/novel-integrated-3d-multidetector-computed-tomography-and-fluoroscopy-fusion-for-left-atrial-appendage-occlusion-procedures
#18
A K Roy, J Horvilleur, B Cormier, M Cazalas, L Fernandez, M Patane, A Neylon, M Spaziano, F J Sawaya, T Arai, E Bouvier, T Hovasse, T Lefèvre, B Chevalier, P Garot
OBJECTIVES: This report demonstrates the application and feasibility of novel 3D-MDCT real-time fusion technology with fluoroscopy, for left atrial appendage (LAA) occlusion procedures. BACKGROUND: A successful LAA occlusion procedure relies on multiple imaging modalities, including TEE or 3D-MDCT, and fluoroscopy. Effectively integrating these imaging modalities may improve implantation safety and success. To our knowledge this technique has not been previously described for LAA occlusions...
March 17, 2017: Catheterization and Cardiovascular Interventions
https://www.readbyqxmd.com/read/28302594/a-human-centered-design-methodology-to-enhance-the-usability-human-factors-and-user-experience-of-connected-health-systems-a-three-phase-methodology
#19
Richard Harte, Liam Glynn, Alejandro Rodríguez-Molinero, Paul Ma Baker, Thomas Scharf, Leo R Quinlan, Gearóid ÓLaighin
BACKGROUND: Design processes such as human-centered design, which involve the end user throughout the product development and testing process, can be crucial in ensuring that the product meets the needs and capabilities of the user, particularly in terms of safety and user experience. The structured and iterative nature of human-centered design can often present a challenge when design teams are faced with the necessary, rapid, product development life cycles associated with the competitive connected health industry...
March 16, 2017: JMIR Human Factors
https://www.readbyqxmd.com/read/28301947/multicenter-study-on-the-safety-of-bariatric-endoscopy
#20
Eduardo Espinet Coll, Javier Nebreda Durán, Gontrand López-Nava Breviere, Julio Ducóns García, Manuel Rodríguez-Téllez, Javier Crespo García, Carlos Marra-López Valenciano
INTRODUCTION: Bariatric endoscopy includes a series of specific techniques focused on the management of obese patients. As a quality criterion, safety as expressed by a minimal incidence of serious complications is required in addition to efficacy. METHODS: A descriptive, retrospective, multicenter review of the experience recorded at seven hospitals included in the Grupo Español de Endoscopia Bariátrica (GETTEMO) in order to document the incidence, cause, and resolution (including legal consequences) of serious complications reported for each bariatric technique, and according to endoscopist expertise...
March 17, 2017: Revista Española de Enfermedades Digestivas
keyword
keyword
62593
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"