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Medical devices

Simran Chahal, Kanchan Vohra, Ashit Syngle
Peripheral artery disease (PAD) is the major risk factor for cardiovascular disease and lower extremity amputation in patients with diabetes. Autonomic neuropathy is a risk factor for cardiovascular-related morbidity and mortality. Sudomotor dysfunction is well established in type 2 diabetes mellitus (T2DM) and reflects small fibre neuropathy, cardiovascular autonomic neuropathy and peripheral sympathetic autonomic neuropathy. However, the relationship between sudomotor dysfunction and PAD remains unexplored...
October 25, 2016: Neurological Sciences
Paige C Woodham, James W Fulcher, Michael E Ward
Ligature strangulation, although typically homicidal in nature, has been reported as accidental in both the pediatric and adult populations. The unique mode of accidental strangulation with a gastric feeding tube in a 23-month-old with Down syndrome is currently unreported in the literature and has prompted us to report this case and look into safety modifications that can be made to these common medical devices. Given the number of children with gastric feeding tubes and concern over this exact scenario brought up by parents, it is unusual that a similar case has not been reported...
October 25, 2016: American Journal of Forensic Medicine and Pathology
Alexander Pfeil, Laura Krojniak, Diane M Renz, Lisa Reinhardt, Marcus Franz, Peter Oelzner, Gunter Wolf, Joachim Böttcher
BACKGROUND: BoneXpert (BX) is a newly developed medical device based on digital X-ray radiogrammetry to measure human cortical bone thickness. The aim of this study was to quantify cortical bone loss of the metacarpals in patients with psoriatic arthritis (PsA) and compare these findings with other radiological scoring methods. METHODS: The study includes 104 patients with verified PsA. The BX method was used to measure the Metacarpal Index (MCI) at the metacarpal bones (II-IV)...
October 25, 2016: Arthritis Research & Therapy
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
Brian D Holt, Zoe M Wright, Anne M Arnold, Stefanie A Sydlik
Graphene oxide (GO), the oxidized form of graphene, holds great potential as a component of biomedical devices, deriving utility from its ability to support a broad range of chemical functionalities and its exceptional mechanical, electronic, and thermal properties. GO composites can be tuned chemically to be biomimetic, and mechanically to be stiff yet strong. These unique properties make GO-based materials promising candidates as a scaffold for bone regeneration. However, questions still exist as to the compatibility and long-term toxicity of nanocarbon materials...
October 26, 2016: Wiley Interdisciplinary Reviews. Nanomedicine and Nanobiotechnology
Debbie C Yen, Mara H Watson, Lindsey D Burgess, Maragatha Kuchibhatla, Chetan B Patel, Kristen B Campbell, Alyssa K Vora
STUDY OBJECTIVE: To evaluate the impact of continuous-flow left ventricular assist device (LVAD) implantation on glycemic control in patients with type 2 diabetes mellitus and advanced chronic systolic heart failure. DESIGN: Retrospective medical record review. SETTING: Large, academic, tertiary and quaternary care hospital. PATIENTS: Eighty-three adults with type 2 diabetes mellitus and advanced chronic systolic heart failure who underwent implantation of a continuous-flow LVAD between July 1, 2008, and June 30, 2013...
October 25, 2016: Pharmacotherapy
P Roldan-Ramos, L A Reyes-Figueroa, J Rumia, E Martinez-Lizana, A Donaire, M Carreno-Martinez
AIM: To describe clinical results and complications derived from vagal nerve stimulation therapy in drug resistant epileptic patients unsuitable for other surgical treatments, since the first implant in an epilepsy national referral centre. PATIENTS AND METHODS: A retrospective analysis of the patients implanted in our centre was held. Data related to baseline characteristics of their epilepsy and therapy complications was collected. RESULTS: 32 new implants in 31 patients are included, mean age of 34 years, 29...
November 1, 2016: Revista de Neurologia
H G Kenngott, M Wagner, A A Preukschas, B P Müller-Stich
Modern operating room (OR) suites are mostly digitally connected but until now the primary focus was on the presentation, transfer and distribution of images. Device information and processes within the operating theaters are barely considered. Cognitive assistance systems have triggered a fundamental rethinking in the automotive industry as well as in logistics. In principle, tasks in the OR, some of which are highly repetitive, also have great potential to be supported by automated cognitive assistance via a self-thinking system...
October 24, 2016: Der Chirurg; Zeitschrift Für Alle Gebiete der Operativen Medizen
Aleksei A Filippov, Pedro J Del Nido, Nikolay V Vasilyev
In recent decades, significant progress has been made in the diagnosis and management of congenitally corrected transposition of the great arteries (ccTGA). Nevertheless, gradual dysfunction and failure of the right ventricle (RV) in the systemic circulation remain the main contributors to mortality and disability for patients with ccTGA, especially after adolescence. Anatomic repair of ccTGA effectively resolves the problem of failure of the systemic RV and has good early and midterm results. However, this strategy is applicable primarily in infants and children up to their teens and has associated risks and limitations, and new challenges can arise in the late postoperative period...
October 25, 2016: Circulation
Elizabeth A Gonzalez, Poulomi Nandy, Anne D Lucas, Victoria M Hitchins
Cleaning reusable medical devices removes organic and inorganic soil, which allows for effective disinfection and sterilization. However, it is not always clear what variables to consider when validating cleaning. This study compared the ability of 3 different cleaning agents (ie, water, alcohol, and bleach) to remove bacteria (ie, vegetative and spores) and artificial blood test soil from 2 common device materials: polypropylene and ultra-high-molecular-weight polyethylene. There was a complex interaction between bacteria, soil, and surface roughness...
October 21, 2016: American Journal of Infection Control
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
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