65 research outputs found
The need for transparency of clinical evidence for medical devices in Europe
No full textTo use medical devices rationally, health-care professionals must base their choices of which devices to recommend for individual patients on an objective appraisal of their safety and clinical efficacy. The evidence submitted by manufacturers when seeking approval of their high-risk devices must be publicly available, including technical performance and premarket clinical studies. Giving physicians access to this information supplements the peer-reviewed scientific literature and might be essential for comparing alternative devices within any class. Interested patients should be encouraged to review the evidence for any device that has been recommended for them. The new EU law on medical devices states that the manufacturer is to prepare a summary of the evidence for any implantable or high-risk device. Defining its content, however, has been delegated to implementing legislation, which is now being considered. From a clinical perspective, it is imperative that all evidence reviewed by notified bodies and regulatory authorities is disclosed—with the exception, if justified, only of technical specifications that are considered confidential or manufacturing details that are protected as intellectual property—and public access to this evidence must be guaranteed by EU law. From ethical and other perspectives, there are no grounds for less clinical evidence being available to health-care professionals about the medical devices that they use than is already available for new pharmaceutical products. Full transparency is needed; without it, informed decisions relating to the use of new medical devices will remain impossible
The Forum, Volume 2, Issue 4 (November 2002)
No full textEric G. Zaiser: Capitol Critter *Or* How I learned to Stop Worrying and Love Politics by Eric Zaiser
Exams, by Miles Solomon
APPELLATE ADVOCACY, OLYMPIC ICE SKATING, AND THE NATIONAL MOOT COURT COMPETITION--A REFLECTION, by Will Edwards, Editor
Detroit Rock City, by Brian Butchart
The Forum Editorial Board
To Hell in a Hand Basket?, by Arie D. Bax
The Forum Interview with Rebecca Maxwell, by Benje Selan and Scott Mitchell
Letters to the Editor notice
Submissions notice
Count-Pointer Count, Special Edition: An Intimate Portrait, with Frick, by John Frick and Chris Koon
Free T-shirt notice
A Word From Our President, by David Hartman
Barbecue, Flip-Flops and the Wonders of South Carolina, by Oren Goldberg
News Nugs for November, by Jason Scott Luc
Hemocompatibility of materials for use in prosthetic heart valves
No full textThromboembolism (valve thrombosis and systemic embolism) is the main drawback of mechanical heart valve prostheses. The patients carrying these valves have to be subjected to life-long anticoagulant therapy to reduce thromboembolism. This therapy does not completely prevent these complications and may, if not properly controlled, even lead to life-threatening bleeding problems. Hemocompatibility of a mechanical heart valve is related to its engineering design and the construction material. To improve hemocompatibility of a mechanical heart valve, not only design but also valve material must be improved. Therefore the search for new materials or surface coatings that are more hemocompatible than those currently used must continue. The purpose of the present investigation was to develop an in vivo method, and to evaluate and compare hemocompatibility of some materials currently used, and for potential use, in ·prosthetic heart valves. Pyrolytic carbon (PyC), titanium (Ti), cobalt-chromium (CC), glutaraldehyde-treated bovine pericardium (Pe) and some new materials such as titanium nitride (TiN) and diamond-like carbon (DLC) were evaluated in three series of sheep experiments. The test materials were implanted in the central veins in the first and second series, and in the descending aorta in the third series. Up to four different materials could be tested simultaneously in each animal. No anticoagulant was given. After two hours of exposure to flowing blood, the test surfaces were explanted and prepared for photography and scanning electron microscopy (SEM). Thrombus area (the area covered by thrombus) was measured on close-up photographs of each surface using planimetry. Blood cell adhesion and blood-surface interaction were observed with SEM. The results showed more thrombi on PyC and Pe than on Ti and TiN. Leukocytes were the main type of blood cells adhering to PyC and DLC, and erythrocytes to Ti and TiN. Different materials exhibited different patterns of blood-surface interaction. Thrombus composition was largely related to the pattern of cell adhesion, indicating that the mechanism of early thrombus formation might be different on different surfaces. The results suggested that the method is practical and reliable. Under the present conditions PyC was not as hemocompatible as the metals currently used. TiN was more hemocompatible than PyC. Due to its combination of excellent hemocompatibility and wear resistance, TiN may be a promising new surface coating material for metallic components of mechanical heart valves, blood pumps and other devices in contact with blood.</p
Delayed presentation of diaphragmatic injury secondary to rib fracture
No full textSummaryWe present a case of delayed presentation of significant diaphragmatic injury following blunt trauma. The potential fatal risk is discussed and management principles reviewed
The Vegetation That Was Not a Vegetation: Excusable Misinterpretation of Transesophageal Echocardiography Findings in Late Infective Endocarditis of a Prosthetic Mitral Valve
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