739,170 research outputs found

    REGULATORY APPROVAL OF NEW MEDICAL DEVICES: A CROSS SECTIONAL STUDY

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    Objective To investigate the regulatory approval of new medical devices. Design Cross sectional study of new medical devices reported in the biomedical literature. Data sources PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval. Eligibility criteria for study selection Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.” Main outcome measures Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device. Results 5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be “substantially equivalent” to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published. Conclusions We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study

    CAMMD: Context Aware Mobile Medical Devices

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    Telemedicine applications on a medical practitioners mobile device should be context-aware. This can vastly improve the effectiveness of mobile applications and is a step towards realising the vision of a ubiquitous telemedicine environment. The nomadic nature of a medical practitioner emphasises location, activity and time as key context-aware elements. An intelligent middleware is needed to effectively interpret and exploit these contextual elements. This paper proposes an agent-based architectural solution called Context-Aware Mobile Medical Devices (CAMMD). This framework can proactively communicate patient records to a portable device based upon the active context of its medical practitioner. An expert system is utilised to cross-reference the context-aware data of location and time against a practitioners work schedule. This proactive distribution of medical data enhances the usability and portability of mobile medical devices. The proposed methodology alleviates constraints on memory storage and enhances user interaction with the handheld device. The framework also improves utilisation of network bandwidth resources. An experimental prototype is presented highlighting the potential of this approach

    Rapid fabrication of annuloplasty rings by electron beam melting

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    Electron Beam Melting (EBM) is an Additive Manufacturing (AM) technology capable of producing intricate parts by melting powder metal with the aid of an electron beam gun. EBM has facilitated the production of standard and customisable implants. Customizable implants such as orthopaedic implants, cranial implants and dental implants have already been developed and implanted successfully after being fabricated by AM technology. Other medical devices can also benefit from the possibilities offered by AM. An example of such a medical device would be the annuloplasty ring. Standard annuloplasty rings are implanted whenever a patient is diagnosed with mitral valve regurgitation. This problem arises when the mitral valve does not close properly, causing back leakage through the closed valve resulting in blood flowing to the atrium instead of the aorta during systole. The latest designs of annuloplasty rings allow restoration of the mitral annulus configuration to a saddle-shaped shape.peer-reviewe

    Eliciting usage contexts of safety-critical medical devices

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    This position paper outlines our approach to improve the usage choice of suitable devices in different health care environments (contexts). Safety-critical medical devices are presumed to have undergone a thorough (user-centred) design process to optimize the device for the intended purpose, user group and environment. However, in real-life health care scenarios, actual usage may not reflect the original design parameters. We suggest the identification of further usage contexts for safety-critical medical devices through ethnographic and other studies, to assist better modelling of the challenges of different usage environments. In combination with system and interaction models, these context models can then be used for decision-support in choosing medical devices that are suitable for the intended environment

    Medical Devices Competitiveness and Impact on Public Health Expenditure

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    This study provides an analytical overview of the state of the European Union medical device industry. The medical device industry sector encompasses an extremely large variety of products and technologies. It covers hundreds of thousands of products that range from more traditional products, such as bandages or syringes, to sophisticated devices that incorporate bioinformatics, nanotechnology and engineered cells. These are designed for use by practitioners, patients and healthy individuals in a variety of settings: hospitals, surgeries and private homes. Besides being a vital and innovative industry, medical devices are a key component of healthcare systems and represent, together with pharmaceuticals, the bulk of ‘medical technology’. The analysis of the sector must therefore investigate medical devices as an industry – an innovative contributor to the economy – as well its key input to healthcare systems. The following aspects are taken into account: a) the impact of innovation in medical devices on health costs and expenditure; b) the innovativeness of the European medical device industry; c) the competitiveness of the European medical device industry as compared to that of the United States and Japan.healthcare expenditure; medical devices; competitiveness; innovation
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