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Medical Devices: Evidence and Research

Ross W McQuivey, Jon E Block, Robert A Massaro
As a leading cause of maternal death, postpartum hemorrhage (PPH) remains a worldwide obstetrical problem. However, in most cases, mortality and morbidity can be averted if efforts are immediately undertaken to achieve hemostasis. Uterine balloon tamponade has been shown to provide effective control of PPH and avoid more invasive surgical procedures and even the emergency peripartum hysterectomy. Recent clinical recommendation suggests that balloon tamponade should be considered earlier in the treatment cascade in conjunction with uterotonic agents to ensure hemostasis in the most timely fashion and maximize clinical outcomes...
2018: Medical Devices: Evidence and Research
Utkarsh Ojha, Raihan Mohammed
As diabetes mellitus (DM) has approached pandemic proportions, the pressure for effective glycemic management is mounting. The starting point for managing and living well with DM involves early diagnosis and monitoring blood glucose levels. Therefore, self-monitoring of blood glucose (SMBG) can help patients maintain their blood glucose levels within the appropriate range. The general principle behind the current SMBG method involves a finger prick test to obtain a blood drop, which is applied onto a reagent strip and read by an automated device...
2018: Medical Devices: Evidence and Research
Lawton R Burns, Michael G Housman, Robert E Booth, Aaron M Koenig
Background: The USA devotes roughly $200 billion (6%) of annual national health expenditures to medical devices. A substantial proportion of this spending occurs during orthopedic (eg, hip and knee) arthroplasties - two high-volume hospital procedures. The implants used in these procedures are commonly known as physician preference items (PPIs), reflecting the physician's choice of implant and vendor used. The foundations for this preference are not entirely clear. This study examines what implant and vendor characteristics, as evaluated by orthopedic surgeons, are associated with their preference...
2018: Medical Devices: Evidence and Research
Supreeya Swarup, Amgad N Makaryus
Cardiovascular disease (CVD) is recognized as the leading cause of mortality throughout the world. About one-third of global mortality is attributable to CVD. In addition to clinical presentation, specific clinical exam findings can assist in treating and preventing CVD. CVD may initially manifest as pulmonary pathology, and thus, accurate cardiopulmonary auscultation is paramount to establishing accurate diagnosis. One of the most powerful tools available to physicians is the stethoscope. The stethoscope first emerged in the year 1818, invented by a French physician, René Laennec...
2018: Medical Devices: Evidence and Research
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[This corrects the article on p. 189 in vol. 10, PMID: 28860875.].
2018: Medical Devices: Evidence and Research
Domenico A Restivo, Shaheen Hamdy
Neurogenic dysphagia (ND) can occur in patients with nervous system diseases of varying etiologies. Moreover, recovery from ND is not guaranteed. The therapeutic approaches for oropharyngeal ND have drastically changed over the last decade, mainly due to a better knowledge of the neurophysiology of swallowing along with the progress of neuroimaging and neurophysiological studies. For this reason, it is a priority to develop a treatment that is repeatable, safe, and can be carried out at the bedside as well as for outpatients...
2018: Medical Devices: Evidence and Research
Mirna N Chahine, Jirar Topouchian, Parounak Zelveian, Zoya Hakobyan, Arevik Melkonyan, Alaa Azaki, Reem Diab, Aya Harb, Roland Asmar
Background: Following the European Society of Hypertension International Protocol (ESH-IP) Revision 2010, QardioArm® and Omron M6 Comfort IT® oscillometric devices were evaluated in the general population and in patients with type II diabetes, respectively, for self-blood pressure (BP) measurement. Methods: Both devices, QardioArm® and Omron M6 Comfort®, measure BP at the brachial level. The ESH-IP Revision 2010 includes a total number of 33 subjects. For each measure, the difference between observer and device BP values was calculated...
2018: Medical Devices: Evidence and Research
Nadia Sutton, Melinda H MacDonald, John Lombard, Bodgan Ilie, Piet Hinoul, Douglas A Granger
Aim: To evaluate whether performing ventral hernia repairs using the Ethicon Physiomesh™ Open Flexible Composite Mesh Device in conjunction with the Ethicon Securestrap® Open Absorbable Strap Fixation Device reduces surgical time and surgeon stress levels, compared with traditional surgical repair methods. Methods: To repair a simulated ventral incisional hernia, two surgeries were performed by eight experienced surgeons using a live porcine model. One procedure involved traditional suture methods and a flat mesh, and the other procedure involved a mechanical fixation device and a skirted flexible composite mesh...
2018: Medical Devices: Evidence and Research
Melinda H MacDonald, Allen Y Wang, Jeffrey W Clymer, Richard W Hutchinson, Richard Kocharian
Background: Usage of topical hemostatic agents in surgery is increasing, including use during minimally invasive procedures, and even for surgeries that have a low risk of bleeding complications. A novel product, Surgicel® Powder - Absorbable Hemostatic Powder (SP), made from oxidized regenerated cellulose (ORC) fabric, has been developed for adjunctive use in surgical procedures to assist in control of oozing bleeding over broad areas and where access could be difficult with a fabric ORC product...
2017: Medical Devices: Evidence and Research
Sabine Ettinger, Michal Stanak, Piotr Szymański, Claudia Wild, Romana Tandara Haček, Darija Erčević, Renata Grenković, Mirjana Huić
Aim: To summarize the evidence on clinical effectiveness and safety of wearable cardioverter defibrillator (WCD) therapy for primary and secondary prevention of sudden cardiac arrest in patients at risk. Methods: We performed a systematic literature search in databases including MEDLINE via OVID, Embase, the Cochrane Library, and CRD (DARE, NHS-EED, HTA). The evidence obtained was summarized according to GRADE methodology. A health technology assessment (HTA) was conducted using the HTA Core Model® for rapid relative effectiveness assessment...
2017: Medical Devices: Evidence and Research
Christian Loubert, Mélissa Ouellette, Valérie Zaphiratos, Issam Tanoubi
Purpose: Near-infrared spectroscopy provides a non-invasive continuous real-time monitoring of tissue oxygen saturation. As uterine contractions during labor may be associated with a transient uteroplacental hypoperfusion, this prospective, observational study investigates the ability of near-infrared spectroscopy to detect variation in uteroplacental oximetry during uterine contractions. Patients and methods: Four Invos™ oximetry probes (Medtronic®, Minneapolis, MN, USA) per subjects were applied on the placental surface (PLA), the abdomen (MYO), the forearm (ARM) and the leg (LEG), of twenty healthy laboring parturients with epidural analgesia...
2017: Medical Devices: Evidence and Research
Sonal Batra, Ross A Baker, Tao Wang, Felicia Forma, Faith DiBiasi, Timothy Peters-Strickland
BACKGROUND: As the capabilities and reach of technology have expanded, there is an accompanying proliferation of digital technologies developed for use in the care of patients with mental illness. The objective of this review was to systematically search published literature to identify currently available health technologies and their intended uses for patients with serious mental illness. MATERIALS AND METHODS: The Medline, Embase, and BIOSIS Previews electronic databases were searched to identify peer-reviewed English language articles that reported the use of digital, mobile, and other advanced technology in patients with schizophrenia/schizoaffective disorder, bipolar disorder, and major depressive disorder...
2017: Medical Devices: Evidence and Research
Catherine E Cooke, Jennifer M Stephens
INTRODUCTION: Needlestick injuries (NSIs) from a contaminated needle put healthcare workers (HCWs) at risk of becoming infected with a blood-borne virus and suffering serious short- and long-term medical consequences. Hypodermic injections using disposable syringes and needles are the most frequent cause of NSIs. OBJECTIVE: To perform a systematic literature review on NSI and active safety-engineered devices for hypodermic injection. METHODS: MEDLINE, EMBASE, and COCHRANE databases were searched for studies that evaluated the clinical, economic, or humanistic outcomes of NSI or active safety-engineered devices...
2017: Medical Devices: Evidence and Research
Ana María Gómez, Diana Cristina Henao Carrillo, Oscar Mauricio Muñoz Velandia
Continuous glucose monitoring (CGM) is a tool that allows constant evaluation of glycemic control, providing data such as the trend and fluctuation of interstitial glucose levels over time. In clinical practice, there are two modalities: the professional or retrospective and the personal or real-time CGM (RT-CGM). The latest-generation sensors are more accurate and sensitive for hypoglycemia, improving adherence to self-monitoring, which has allowed optimizing glycemic control. The development of algorithms that allow the suspension of the infusion of insulin during hypoglycemia gave rise to the integrated therapy or sensor-augmented insulin pump therapy with low glucose suspend, which has proven to be an effective and safe alternative in the treatment of diabetic patients with high risk of hypoglycemia...
2017: Medical Devices: Evidence and Research
Kotaro Takeda, Genichi Tanino, Hiroyuki Miyasaka
Neuromuscular electrical stimulation (NMES), specifically functional electrical stimulation (FES) that compensates for voluntary motion, and therapeutic electrical stimulation (TES) aimed at muscle strengthening and recovery from paralysis are widely used in stroke rehabilitation. The electrical stimulation of muscle contraction should be synchronized with intended motion to restore paralysis. Therefore, NMES devices, which monitor electromyogram (EMG) or electroencephalogram (EEG) changes with motor intention and use them as a trigger, have been developed...
2017: Medical Devices: Evidence and Research
Bimla Sharma, Chand Sahai, Jayashree Sood
Extraglottic airway devices (EADs) have revolutionized the field of airway management. The invention of the laryngeal mask airway was a game changer, and since then, there have been several innovations to improve the EADs in design, functionality, safety and construction material. These have ranged from changes in the shape of the mask, number of cuffs and material used, like rubber, polyvinylchloride and latex. Phthalates, which were added to the construction material in order to increase device flexibility, were later omitted when this chemical was found to have serious adverse reproductive outcomes...
2017: Medical Devices: Evidence and Research
Joseph S Ross, Jonathan Bates, Craig S Parzynski, Joseph G Akar, Jeptha P Curtis, Nihar R Desai, James V Freeman, Ginger M Gamble, Richard Kuntz, Shu-Xia Li, Danica Marinac-Dabic, Frederick A Masoudi, Sharon-Lise T Normand, Isuru Ranasinghe, Richard E Shaw, Harlan M Krumholz
BACKGROUND: Machine learning methods may complement traditional analytic methods for medical device surveillance. METHODS AND RESULTS: Using data from the National Cardiovascular Data Registry for implantable cardioverter-defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models: one specified by subject-matter experts (PS-SME), and the other one by machine learning-based selection (PS-ML)...
2017: Medical Devices: Evidence and Research
Meir Nitzan, Itzchak Slotki, Linda Shavit
The commonly used techniques for systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurement are the auscultatory Korotkoff-based sphygmomanometry and oscillometry. The former technique is relatively accurate but is limited to a physician's office because its automatic variant is subject to noise artifacts. Consequently, the Korotkoff-based measurement overestimates the blood pressure in some patients due to white coat effect, and because it is a single measurement, it cannot properly represent the variable blood pressure...
2017: Medical Devices: Evidence and Research
Gauthier Desuter, Benjamin Mertens, Alain Delchambre, Julie van Lith-Bijl, Peter Paul van Benthem, Elisabeth Sjögren
INTRODUCTION: Glottic leakage during phonation is a direct consequence of unilateral vocal fold (VF) paralysis. This air leakage can be in the horizontal plane and in the vertical plane. Presently, there is no easily applicable medical device allowing noninvasive, office-based measurement of the relative vertical position of the VFs. The larynx ruler (LR) is a laser-based measuring device that could meet the previously stated need, using a flexible endoscope. This study represents a proof of concept regarding the use of the LR in assessing VF relative positions in the vertical plane...
2017: Medical Devices: Evidence and Research
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