Read by QxMD icon Read

Medical device

Righab Hamdan, Pierre Nassar, Ali Zein, Mohamad Issa, Hassan Mansour, Mohamad Saab
Peripartum cardiomyopathy remains a challenging obstetric and cardiologic emergency. We report 5 interesting cases of peripartum cardiomyopathy with different clinical courses, with 3 patients requiring left ventricular assist device implantation. One patient underwent pump explantation and aortic balloon valvuloplasty postsurgery. Two patients improved with the medical treatment alone without the need of assistance. We will review main important related issues.
October 11, 2016: Journal of Critical Care
Lionel Tortolano, Senda Hammami, Katia Manerlax, Bernard Do, Najet Yagoubi
Acrylic copolymers are useful in medical therapeutics. As in dental implants or intraocular lenses, acrylics are present in many medical devices or drug adjuvants. Industrial using of acrylics is still important in painting or textile manufacturing. Scientific research background has proved that acrylic suffer for depolymerized and cross-linking mechanisms under heating and photo-oxidative conditions. Those aging processes could lead to release of unreacted monomers and degradation products. We developed a new RP-HPLC method with good resolution, recovery, linearity, detection and quantification limits that is efficient for acrylic monomers quantification in in vitro and in vivo saline solution matrices...
October 18, 2016: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Hannah Maslen, Thomas Douglas, Roi Cohen Kadosh, Neil Levy, Julian Savulescu
Our (2014) model for the regulation of cognitive enhancement devices (CEDs) received a great deal of interest from those involved in European device regulation and from academic commentators. Further, since the publication of our recommendations, the number of manufacturers of brain stimulation devices for non-medical purposes has increased, underscoring the need for a regulatory response. In this paper, we clarify aspects of our original proposal and address additional regulatory issues beyond our original focus on the sale of devices...
November 2015: Journal of Law and the Biosciences
Anna Wexler
Several recent articles have called for the regulation of consumer transcranial direct current stimulation (tDCS) devices, which provide low levels of electrical current to the brain. However, most of the discussion to-date has focused on ethical or normative considerations; there has been a notable absence of scholarship regarding the actual legal framework in the United States. This article aims to fill that gap by providing a pragmatic analysis of the consumer tDCS market and relevant laws and regulations...
November 2015: Journal of Law and the Biosciences
Gillian Franklin, Homero Harari, Samavi Ahsan, Dhimiter Bello, David A Sterling, Jonathan Nedrelow, Scott Raynaud, Swati Biswas, Youcheng Liu
We conducted a pilot qualitative and quantitative assessment of residual isocyanates and their potential initial exposures in neonates, as little is known about their contact effect. After a neonatal intensive care unit (NICU) stockroom inventory, polyurethane (PU) and PU foam (PUF) devices and products were qualitatively evaluated for residual isocyanates using Surface SWYPE™. Those containing isocyanates were quantitatively tested for methylene diphenyl diisocyanate (MDI) species, using UPLC-UV-MS/MS method...
2016: Environmental Health Insights
A Ohannessian, C Jamin
OBJECTIVE: To establish guidelines of the French National College of Gynecologists and Obstetricians about post-abortion contraception. MATERIALS AND METHODS: A systematic review of the literature about post-abortion contraception was performed on Medline and Cochrane Database between 1978 and March 2016. The guidelines of the French and foreign scientific societies were also consulted. RESULTS AND DISCUSSION: After an abortion, if the woman wishes to use a contraception, it should be started as soon as possible because of the very early ovulation resumption...
October 20, 2016: Journal de Gynécologie, Obstétrique et Biologie de la Reproduction
Nir Uriel, Sirtaz Adatya, Jiří Malý, Eric Kruse, Daniel Rodgers, Gerald Heatley, Aleš Herman, Poornima Sood, Dominik Berliner, Johann Bauersachs, Axel Haverich, Michael Želízko, Jan D Schmitto, Ivan Netuka
BACKGROUND: The HeartMate 3 (HM3) is a Conformiteé Européenne (CE) mark-approved left ventricular assist device (LVAD) with a fully magnetically levitated rotor with features consisting of a wide range of operational speeds, wide flow paths and an artificial pulse. We performed a hemodynamic and echocardiographic evaluation of patients implanted with the HM3 LVAD to assess the speed range for optimal hemodynamic support. METHODS: Sixteen HM3 patients underwent pump speed ramp tests with right heart catheterization (including central venous pressure [CVP], pulmonary artery pressure, pulmonary capillary wedge pressure [PCWP] and blood pressure [BP]) and 3-dimensional echocardiography (3DE)...
July 17, 2016: Journal of Heart and Lung Transplantation
Debabrata Dash
Despite the continuing developments of improved medical devices and increasing operator expertize, coronary chronic total occlusion (CTO) remains as one of the most challenging lesion subsets in interventional cardiology. Percutaneous coronary intervention (PCI) of CTO is a complex procedure carrying the risk of complications that are responsible for significant morbidity and mortality. The complications can be classified as coronary (such as coronary occlusion, perforation, device embolization, or entrapment); cardiac non-coronary (such as periprocedural myocardial infarction); extra cardiac (such as vascular access complications, systemic embolization, contrast-induced nephropathy, and radiation-induced injury)...
September 2016: Indian Heart Journal
Tony Lu, Shayan Owji, Ponraj Chinnadurai, Thomas M Loh, Adeline Schwein, Alan B Lumsden, Jean Bismuth
A 62-year-old man with coronary artery disease and ischemic cardiomyopathy after coronary artery bypass grafting and insertion of a HeartMate II (Thoratec, Pleasanton, CA) left ventricular assist device (LVAD) presented with spontaneous incisional bleeding and an ascending aortic pseudoaneurysm. Aortic angiography revealed an anomalous connection between the pseudoaneurysm and the LVAD conduit. We were able to partially embolize the tract with standard techniques, but the patient returned with repeated bleeding...
November 2016: Annals of Thoracic Surgery
Ismail Omrani, Niloofar Babanejad, Hasan Kashef Shendi, Mohammad Reza Nabid
Polyurethanes are important class of biomaterials that are extensively used in medical devices. In spite of their easy synthesis, polyurethanes that are fully degradable in response to the intracellular reducing environment are less explored for controlled drug delivery. Herein, a novel glutathione degradable waterborne polyurethane (WPU) nanocarrier for redox triggered intracellular delivery of a model lipophilic anticancer drug, doxorubicin (DOX) is reported. The WPU was prepared from polyaddition reaction of isophorone diisocyanate (IPDI) and a novel linear polyester polyol involving disulfide linkage, disulfide labeled chain extender, dimethylolpropionic acid (DMPA) using dibutyltin dilaurate (DBTDL) as a catalyst...
January 1, 2017: Materials Science & Engineering. C, Materials for Biological Applications
Gaurav Kumar Pal, P V Suresh
Collagen and collagen fibers have been widely documented as a potential and competitive biomaterial for medical applications. However, the searches for safe and realistic new collagen sources are still underway. Currently, fishery by-products (scales), a promising collagen source are usually discarded. In the present study, in vitro fibril-forming ability of the extracted fish scale collagen is reported. The aim of the investigation was to evaluate the concomitant comparison of fibril-forming abilities and characteristics of acid and pepsin soluble collagens from the scales of Indian major carp catla (Catla catla) and rohu (Labeo rohita)...
January 1, 2017: Materials Science & Engineering. C, Materials for Biological Applications
Hongli Li, Victoria M Hitchins, Samanthi Wickramasekara
Bacterial endotoxins are lipopolysaccharides bound to the bacterial cell wall and released when bacteria rupture or disintegrate. Possible contamination of endotoxin in ophthalmic devices can cause a painful eye inflammation or result in toxic anterior segment syndrome after cataract surgery. Measurement of bacterial endotoxin in medical device materials is difficult since endotoxin binds with polymer matrix and some of the materials are very viscous and non-water soluble, where traditional enzyme-based Limulus amebocyte lysate (LAL) assay cannot be applied...
November 2, 2016: Analytica Chimica Acta
Brent Burbridge, Kunal Goyal
INTRODUCTION: Venous access devices are essential for the provision of care for patients requiring chemotherapy. Totally implanted venous access devices (TIVADs), also known as ports, are an option for infusion care. Medical devices have an impact upon patient quality of life. We assessed the impact on quality of life and satisfaction with their venous device, for patients with a chest TIVAD versus an upper arm TIVAD. MATERIALS AND METHODS: Sequential subjects were administered a questionnaire, "Quality of Life Assessment, Venous Device - Port (QLAVD-P)" at the time of their TIVAD removal...
October 15, 2016: Journal of Vascular Access
David Feifel, Katherine Pappas
Repetitive transcranial magnetic stimulation (rTMS) is an emerging non-pharmacological approach to treating many brain-based disorders. rTMS uses electromagnetic coils to stimulate areas of the brain non-invasively. Deep transcranial magnetic stimulation (dTMS) with the Brainsway H1-coil system specifically is a type of rTMS indicated for treating patients with major depressive disorder (MDD) who are resistant to medication. The unique H1-coil design of this device is able to stimulate neuronal pathways that lie deeper in the targeted brain areas than those reached by conventional rTMS coils...
October 4, 2016: Journal of Visualized Experiments: JoVE
Jong Chul Han, Young Hoon Hwang, Byung Heon Ahn
PURPOSE: To evaluate the safety and efficacy of a novel membrane-tube (MT)-type glaucoma shunt device for refractory glaucoma surgery. The device consists of an expanded polytetrafluoroethylene membranous reservoir, as well as a silicone tube (300-μm external and 200-μm internal diameter) with an intraluminal stent. We named the device "Finetube MT". METHODS: The Finetube MT was implanted into 44 glaucomatous eyes that had insufficient intraocular pressure (IOP) control despite medical treatment or previous trabeculectomy...
October 20, 2016: Graefe's Archive for Clinical and Experimental Ophthalmology
Hassan Taghipour, Mina Alizadeh, Reza Dehghanzadeh, Mohammad Reza Farshchian, Mohammad Ganbari, Mohammad Shakerkhatibi
Background: The number of studies available on the performance of on-site medical waste treatment facilities is rare, to date. The aim of this study was to evaluate the performance of onsite medical waste treatment equipment in hospitals of Tabriz, Iran. Methods: A various range of the on-site medical waste disinfection equipment (autoclave, chemical disinfection, hydroclave, and dry thermal treatment) was considered to select 10 out of 22 hospitals in Tabriz to be included in the survey. The apparatus were monitored mechanically, chemically, and biologically for a six months period in all of the selected hospitals...
2016: Health Promotion Perspectives
Luca Ivan Ardolino, Marisa Meloni, Giuseppe Brugali, Emanuela Corsini, Corrado Lodovico Galli
BACKGROUND: Polybactum (Effik International, Brussels, Belgium) is a vaginal mucoadhesive product (medical device) designed to form a film that acts as a mechanical barrier with the aim of inhibiting colonization by specific pathogens. It contains polycarbophil, a bioadhesive agent, and lauryl glucoside (LG), a nonionic surfactant that reinforces the barrier effect through its tensioactive properties. OBJECTIVE: To assess the local safety profile, tolerability, and efficacy of Polybactum formulations...
2016: Current Therapeutic Research, Clinical and Experimental
Jessica Rimsans, Katelyn W Sylvester, Jean M Connors
Available options for the treatment of advanced heart failure have expanded to include the use of mechanical circulatory assist devices to improve quality of life in those both eligible and ineligible for heart transplant. Although there have been significant advancements in device technologies, anticoagulation protocols, and multidisciplinary team management, bleeding and thrombosis are the most common adverse effects. Management strategies for pump thrombosis and their outcomes vary considerably among mechanical circulatory support centers and include intensification of antithrombotic therapy (medical) and device exchange (surgical)...
October 7, 2016: Clinical and Applied Thrombosis/hemostasis
Raffick A R Bowen, Dorothy Adcock
Blood collection tubes (BCTs) are an often under-recognized variable in the preanalytical phase of clinical laboratory testing. Unfortunately, even the best-designed and manufactured BCTs may not work well in all clinical settings. Clinical laboratories, in collaboration with healthcare providers, should carefully evaluate BCTs prior to putting them into clinical use to determine their limitations and ensure that patients are not placed at risk because of inaccuracies due to poor tube performance. Selection of the best BCTs can be achieved through comparing advertising materials, reviewing the literature, observing the device at a scientific meeting, receiving a demonstration, evaluating the device under simulated conditions, or testing the device with patient samples...
October 17, 2016: Clinical Biochemistry
David R Holmes, Robert Califf, Andrew Farb, Dorothy Abel, Michael Mack, Tamara Syrek Jensen, Bram Zuckerman, Martin Leon, Jeff Shuren
Initial clinical studies of new medical technologies involve a complex balance of research participant benefits versus risks and costs of uncertainty when novel concepts are tested. The Food and Drug Administration Center for Devices and Radiological Health has recently introduced the Early Feasibility Study (EFS) Program for facilitating the conduct of these studies under the Investigational Device Exemption regulations. However, a systematic approach is needed to successfully implement this program while affording appropriate preservation of the rights and interests of patients...
October 25, 2016: Journal of the American College of Cardiology
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"