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How amendments to the medical device directive affects the development of medical device software
No full textA recent revision to the European Medical Device Directive (MDD 2007/47/EC) made fourteen amendments to the original directive (93/42/EEC). A number of these changes directly affect the de-velopment of software for use in healthcare. The most significant change in relation to medical device software development is that standalone software is now seen as an active medical device. Prior to this amendment medical device software was developed in accordance with the IEC 62304 standard. However, IEC 62304 is not sufficiently comprehensive to provide guidance in the development of standalone software as an active medical device. Medi SPICE is currently being developed to fill the gaps left by IEC 62304 in developing standalone software as an active medical device and to provide medical device software developers a single point of reference for developing software for use in healthcare
Transition metal ion-substituted polyoxometalates entrapped into polypyrrole as electrochemical sensor for hydrogen peroxide
No full textA conducting polymer was used for the immobilization of various transition metal ion-substituted Dawson-type polyoxometalates (POMs) onto glassy carbon electrodes. Voltammetric responses of films of different thicknesses were stable within the pH domain 2-7 and reveal redox processes associated with the conducting polymer, the entrapped POMs and incorporated metal ions. The resulting POM doped 10 polypyrrole films were found to be extremely stable towards redox switching between the various redox states associated with the incorporated POM. An amperometric sensor for hydrogen peroxide detection based upon the POM doped polymer films was investigated. The detection limits were 0.3 and 0.6 uM, for the Cu 2+ - and Fe 3+ -substituted POM-doped polypyrrole films respectively, with a linear region from 0.1 up to 2mM H 2 O 2 . Surface characterization of the polymer films was carried out using atomic force 15 microscopy, x-ray photoelectron spectroscopy and scanning electron microscopy
Biosignal-driven Art: Beyond biofeedback
No full textBiosignal monitoring in interactive arts, although present for over forty years, remains a relatively little known field of research within the artistic community as compared to other sensing technologies. Since the early 1960s, an ever-increasing number of artists have collaborated with neuroscientists, physicians and electrical engineers, in order to devise means that allow for the acquisition of the minuscule electrical potentials generated by the human body. This has enabled direct manifestations of human physiology to be incorporated into interactive artworks. This paper presents an introduction to this field of artistic practice and scientific research that uses human physiology as its main element. A brief introduction to the main concepts and history of biosignal-driven art is followed by a review of various artworks and scientific enquiry
developed by the authors. This aims at giving a complete overview of the various
strategies developed for biosignal-driven interactive art
The Hill of Slane Archaeological Project
Get PDFThis poster is an introduction to the preliminary work carried out on the Hill of Slane Archaeological Project. This represents the first survey of the Hill of Slane in modern times and as well as exploring the historical and mythological background to the monument complex, aims to use a range of new technologies including LiDAR (terrestrial and airborne), Worldview 2 multispectral satellite imagery, aerial photography, and geophysical techniques like magnetometry, earth resistance, ground penetrating radar, electrical resistivity tomography and magnetic susceptibility to explore the extent and nature archaeological resource
Med-Trace: Traceability Assessment Method for Medical Device Software Development
No full textTraceability is central to medical device software development and is an essential requirement for regulatory approval. To achieve compliance an effective traceability process needs to be in place. This process must ensure the need for clear linkages and traceability from software requirements - including risks - through the different stages of the software development and maintenance lifecycles. This is difficult to achieve due to the lack of
specific guidance which the medical device standards and documentation provide. This has resulted in many medical device companies employing inefficient software traceability
processes. In this paper we outline the development and implementation of Med-Trace a lightweight software traceability process assessment and improvement method for the medical device industry. We also present and discuss our findings from two industry based Med-Trace assessments
Visualising and Interacting with a CAVE using Real-World Sensor Data
No full textA CAVE (Cave Automatic Virtual Environment) is a 3D interactive environment that enables a user to be fully immersed in a virtual world and o ers a unique way to visualise and interact with digital information. In this paper we build a foundation of CAVE interaction design by characterising generic a ordances of such an environment and enumerating currently conceivable/implementable interaction mechanisms. In particular, we focus on how different aspects of the CAVE a ordances relate to virtual worlds that are generated for the purpose of visualising and interacting with real-world
sensor data. In support of this we present a case study which explores how the CAVE can be used to visualise and better understand data from 16 residential apartments where
we have been collecting daily home usage information for
the past year. We summarise our on-going work by demonstrating how the unique characteristics of the CAVE can be used to visualise this large quantity of heterogeneous data, which provides more novel possibilities than traditional data visualisation and interaction methods
Surface Immobilisation of Transition Metal Substituted Krebs Type Polyoxometalates, [X 2 W 20 M 2 O 70 (H 2 O) 6 ] n-(X = Bi or Sb, M = Co 2+ or Cu 2+ ), by the Layer by Layer Technique
No full textA series of transition metal (i.e. Cu 2+ and Co 2+ ) substituted Krebs type Polyoxometalates (POMs), of the general formula [X 2 W 20 M 2 O 70 (H 2 O) 6 ] n- , X = Sb or Bi, M = Co(II) or Cu(II), have been successfully immobilised onto carbon electrode surfaces through the employment of the layer-by-layer (LBL) technique. This involved the construction of alternating anionic POM, [X 2 W 20 M 2 O 70 (H 2 O) 6 ] n- , layers and the cationic metallodendrimer, Ru(II)-metallodendrimer as the cationic layers, in addition to a [poly(diallyldimethylammonium chloride)] PDDA base layer. Stable multielectron redox couples associated with the W-O framework, for the Krebs type POMs, and the Ru(III/II) for the metallodendrimer, were clearly observed upon layer construction and redox switching within the pH domain of 2 to 6.5. The constructed multilayer assemblies exhibited pH dependent redox activity and thin layer behaviour up to 100 mV s -1 . The
porosity and permeability of the individual multilayer assemblies towards an anionic probe was determined by AC impedance and cyclic voltammetry. The surface morphology of each multilayer was also determined by Atomic Force Microscopy (AFM).
Keywords
Cajal beyond the gut : interstitial cells in the urinary system – towards general regulatory mechanisms of smooth muscle contractility ?
No full textInterstitial cells of Cajal (ICC), similar to GI pacemakers have
been identified throughout the urinary system. Although each part
of the system serves a different function, ranging from peristalsis
of the ureters, storage of urine by the bladder, and a sphincteric
action by the urethra, they share a common mechanism in being
able to generate phasic myogenic contractions. Even the urethra,
often considered to be a ‘tonic’ smooth muscle, achieves an apparently
sustained contraction by averaging numerous small asynchronous
‘phasic’ contractions. This activity can occur in the
absence of any neural input, implying the presence of an intrinsic
pacemaker. Intracellular microelectrode recordings from urethral
muscle strips reveal electrical slow waves similar to those of the GI
tract. To study this further, we isolated single cells from rabbit urethra
and found not only smooth muscle cells (SMC), but a second
cell type comprising ~10% of the total. The latter cells were
branched and non-contractile and closely resembled intestinal
ICC. Electrophyiological studies revealed that, while the isolated
smooth muscle cells were electrically quiescent, the ‘ICC’ fired
electrical slow waves similar to those observed in the whole tissue.
The basis of this difference was the presence of a large pacemaker
current involving the activation of calcium-activated Cl - channels
by spontaneous intracellular Ca 2+ waves. These, in turn, have been
shown to be modulated by neurotransmitters such as nitric oxide,
noradrenaline and ATP, thus providing a possible mechanism
whereby neural regulation of the urethra, as well as spontaneous
tone, may be mediated via ICC
US FDA releases final rule on Medical Device Data Systems - what does this mean for device manufacturers?
Get PDFOn 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data systems (MDDSs) came into force. This rule attempts to remove the uncertainty surrounding the safety classification of certain information technology systems used in healthcare. Devices that now meet the criteria of being an MDDS are classified as Class I (general controls). However, this final ruling explicitly precludes specific software applications that meet the definition of an MDDS, such as electronic health record applications and computerised physician order entry applications, as being beyond the scope of an MDDS. Similarly, ambiguity still remains surrounding mobile device applications. The purpose of this article by Martin McHugh, Fergal McCaffery and Valentine Casey is to provide an overview of the FDA’s final rule on the safety classification of an MDDS, how this rule has been amended in comparison to the proposed rule and what this rule means for MDDS manufacturers. In addition, the authors will be discussing the challenges medical device manufacturers face in the changing regulatory environment