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At least 487 records · Page 27Linked to original sources
PubMed2001

The regulation of medical devices and the role of the Medical Devices Agency.

This article reviews the regulation of medical devices in the UK and Europe and compares the regulatory regime with that for pharmaceuticals. The regulation of devices follows the 'New Approach' policy of the EC Commission and involves more self-regulation and conformity assessment. The controls are relatively recent beginning in 1993 for Active Implantable Devices and concluding with the In Vitro Diagnostic Directive implemented in June 2000. The article describes how the directives have been implemented in the UK, the role of the Notified Bodies and the role of the Medical Device Agency (MDA) as the competent authority. In particular the Agency's compliance and standards work is described along with the strategy and post marketing surveillance and adverse incident scheme. The MDA is a key international device regulatory agency and its international role is discussed. So too is its device evaluation programme for the NHS and how this complements the work of NICE. The article also considers the future direction of the MDA and changes in the device sector.

Device Approval↗
PubMedDate not supplied

Implications of the appraisal function of the National Institute for Clinical Excellence (NICE).

The National Institute of Clinical Excellence (NICE) has three main roles. It provides guidance to the National Health Service (NHS) on the use of selected new and existing technologies (the appraisal process), provides clinical guidelines for clinicians and physicians in important treatment areas, and develops audit methodologies. This paper discusses the NICE appraisal process. The specific steps of the appraisal process are described, including the basis for topic selection. An overview of NICE guidelines for manufacturers and sponsors is reported. First-year experience is assessed, reflecting on the quality of submitted evidence, and the content of the forthcoming program is presented. Finally, the impact of NICE appraisals is explored in terms of potential benefits and risks.

Academies and Institutes↗
PubMedDate not supplied

Modeling for health care and other policy decisions: uses, roles, and validity.

The role of models to support recommendations on the cost-effective use of medical technologies and pharmaceuticals is controversial. At the heart of the controversy is the degree to which experimental or other empirical evidence should be required prior to model use. The controversy stems in part from a misconception that the role of models is to establish truth rather than to guide clinical and policy decisions. In other domains of public policy that involve human life and health, such as environmental protection and defense strategy, models are generally accepted as decision aids, and many models have been formally incorporated into regulatory processes and governmental decision making. We formulate an analytical framework for evaluating the role of models as aids to decision making. Implications for the implementation of Section 114 of the Food and Drug Administration Modernization Act (FDAMA) are derived from this framework.

Chlorofluorocarbons↗
PubMed2003

Fresenius AS.TEC204 blood cell separator.

Fresenius AS.TEC204 is a third-generation blood cell separator that incorporates the continuous centrifugal separation method and automatic control of the cell separation process. Continuous centrifugation separates cell components according to their specific gravity, and different cell components are either harvested or eliminated as needed. The interface between the red blood cell and plasma is optically detected, and the Interface Control (IFC) cooperates with different pumps, monitors and detectors to harvest required components automatically. The system is composed of three major sections; the Front Panel Unit; the Pump Unit, and the Centrifuge Unit. This unit can be used for a wide variety of clinical applications including collection of platelets, peripheral blood stem cells, bone marrow stem cells, granulocytes, mononuclear cells, and exchange of plasma or red cells, and for plasma treatment.

Automation↗
PubMed2006

Inventing our future: training the next generation of surgeon innovators.

Current surgical care and technology has evolved over the centuries from the interplay between creative surgeons and new technologies. As both fields become more specialized, that interplay is threatened. A 2-year educational fellowship is described which teaches both the process and the discipline of medical/surgical device innovation. Multi-disciplinary teams (surgeons, engineers, business grads) are assembled to educate a generation of translators, who can bridge the gap between scientific and technologic advances and the needs of the physician and the patient.

Child↗
PubMed2004

Endovascular graft limb occlusion.

Endovascular aneurysm repair (EVAR) has undergone a tremendous evolution in the nearly 15 years since it was first described. Continual refinement of the technology and techniques associated with EVAR and the respectable short-term results of this procedure led the United States Food and Drug Administration to approve several devices for the endovascular treatment of abdominal aortic aneurysm (AAA). There has been a corresponding rapid dissemination of this technology throughout the vascular surgery community in the United States. Availability and critical analysis of mid- and long-term follow-up data on the increasing number of patients who have undergone EVAR has begun to raise questions about the long-term durability and effectiveness of EVAR. Numerous complications of EVAR are now recognized and well described in the literature. One of these is graft limb dysfunction. Graft limb occlusion occurs in a significant number of patients and it is imperative that physicians who perform EVAR have a thorough understanding of this condition. There are a variety of factors that predispose patients to development of graft limb occlusion. These factors can be classified as either anatomic or graft-related. When patients present with graft limb occlusion, endovascular treatment is usually possible and it is highly effective. Some cases require traditional surgical treatment. Prevention of graft limb occlusion is of paramount importance. It can only be achieved with an aggressive search for graft limb compromise and liberal use of angioplasty and/or stenting at the time of graft implantation.

Aortic Aneurysm, Abdominal↗
PubMed2004

Overview of success of EVAR: progress to date.

Endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms has been challenged by a number of groups, and the shortcomings of this procedure have been documented in the scientific literature. However, patients and physicians continue to pursue this procedure as a viable means of treating abdominal aortic aneurysms. Both device evolution and advancement of technical skills have led to dramatic improvements in the outcomes of EVAR within the last decade. These improvements and accomplishments have also been chronicled in the literature. This review looks at the successes of EVAR, based on both US Food and Drug Administration trials and independent studies comparing conventional open repair and endovascular repair.

Aortic Aneurysm, Abdominal↗
PubMed2003

[Endovascular brachytherapy to prevent restenosis after angioplasty].

Endovascular radiotherapy is the first effective prophylaxis of restenosis after percutaneous transluminal angioplasty (PTA) and stenting. The FDA recently approved two devices for the delivery of intracoronary radiation following coronary artery stenting. Published multicenter, double-blind, randomized trials of intracoronary radiation therapy report good results for preventing in-stent restenosis, while the data for the peripheral circulation are still inconclusive. Beta-emitters are easier applicable and probably also safer, whereas gamma-emitters have been more extensively evaluated clinically so far. Primary indication for endovascular brachytherapy are patients at high risk for restenosis, such as previous restenoses, in-stent hyperplasia, long stented segment, long PTA lesion, narrow residual vascular lumen and diabetes. Data from coronary circulation suggest a safety margin of at least 4 to 10 mm at both ends of the angioplastic segment to avoid edge restenosis. To prevent late thrombosis of the treated coronary segment, antiplatelet therapy with clopidogrel and aspirin are recommended for at least 6 months after PTA and for 12 months after a newly implanted stent. An established medication regimen after radiotherapy of peripheral arteries is still lacking.

Angioplasty, Balloon↗