The regulation of medical devices: A comparative study of American and EEC Law

Part I of this thesis will describe the regulation of medical devices in the EEC. Before coming to the actual medical device legislation, a description of the legislative system in Europe will be given, to the extent that it is relevant for the Directives on medical devices. After dealing with the history of Directives and their current contents, the status of the Directives and their future prospects will be discussed. Part II will deal with the regulation of medical devices in the United States under the Food Drug & Cosmetic Act as amended by Medical Device Amendments of 1976. First, the history of the regulation for medical devices will be examined. Next the regulatory system in the United States and the problems that arose with its implementation will be elaborated. The latter section also will touch upon recent developments. Part III will identify the differences between the European and American systems and the problems that these differences might cause manufactures of the medical devices in Europe and the United States. Possible solutions to those problems, particularly with respect to the European system, will be suggestions in the last section of the third part. Finally, a conclusion will summaries the observation of the previous parts

Verslag van de projectendag Kennis voor Klimaat ‘Maak Kennis met Klimaat’

De hotspot-formule biedt een uitstekende kans om wetenschappelijk onderzoek te ontwikkelen dat toegesneden is op praktijksituaties. De hotspots fungeren als real life laboratories waar kennis toegepast kan worden. Een belangrijk aspect van al deze hotspotprojecten is kennisontwikkeling en kennisdoorwerking. Daarover is gesproken op een kennisdag: via discussies, lagerhuisdebat, rollenspel etc. Voornaamste doel van deze dag: elkaar leren kenne

Klimaatkennis in de praktijk, dat werkt

Deze uitgave geeft voorbeelden van wat er gebeurt met kennis die is ontwikkeld binnen Klimaat voor Ruimte. In het eerste deel zetten we in een analyse uiteen hoe Klimaat voor Ruimte kennis in de praktijk laat doorstromen. Vervolgens worden vier projecten voor het voetlicht gebracht: de Klimaateffectatlas, de Natuurkalender, Klimaat in de Stad en de hotspot Zuidplaspolder. In stroomschema’s is inzichtelijk gemaakt hoe de kennis vanuit deze projecten naar hogescholen, provincies en bedrijven is doorgestroom

Beleidsrelevantie van de onderzoeksprogramma's Klimaat voor Ruimte Kennis voor Klimaat

Onderzoekvoorstellen worden getoetst op wetenschappelijke kwaliteit én maatschappelijke kwaliteit door onafhankelijke deskundigen. De onderzoekprogramma’s hebben voor de Deltacommissie informatie aangedragen over de mogelijk te verwachten zeespiegelstijging. Na het verschijnen van het rapport van de commissie Veerman is mede op initiatief van Klimaat voor Ruimte en Kennis voor Klimaat door de kennisinstellingen een kennis-agenda in beeld gebracht, die aansluit op het rapport van de commissie. Met hulp daarvan wordt op dit moment gewerkt aan de kennisagenda van de deel-programma’s van het Deltaprogramma en wordt nagegaan hoe kan worden aangesloten op de programmering van de onderzoekprogramma’s. Nergens in Nederland is tot nu toe het klimaat zo uitdrukkelijk in de planvorming meegenomen als in de Zuidplaspolder. De polder is aangewezen als verstedelijkingslocatie. Vaak is twijfel geuit of deze diepe polder daar wel geschikt voor zou zijn vanwege de diepe ligging en de nabijheid van rivieren en zee, waar klimaatverandering grote invloed op heeft. Modelsimulaties wijzen uit dat een groot overstromingsrisico niet verwacht wordt en met maatregelen nog verkleind kan worden, mits het Rijk de primaire waterkeringen, inclusief de stormkeringen, op orde heeft en de aanbevelingen van de Deltacommissie uitvoert. Naast veiligheid hebben de onderzoekers ook gekeken naar wateroverlast, waterkwaliteit en natuur

Water and spatial development: the implementation of the Water Framework Directive in the Netherlands

This paper discusses how water managers and spatial planners could co-operate on local level in combination with the implementation of the Water Framework Directive and the Birds and Habitats Directives in the Netherlands. Recent evaluations of the European Commission show that implementation of environmental directives prove to be a challenging task for the responsible authorities. Studies show that legal and procedural aspects of planning and decision making gain the most attention at the EU level, the formal side, while environmental goals are fading into the background, especially on the EU level. The difficulties that arise in the implementation process on a local and regional level are discussed combined with the integration of both directives from policy and practice. The local co-operation between water managers and spatial planners depends heavily on its basic element: competing interests. Aspects that shape this cooperation and define its effectiveness are: language (discipline related jargon), contracts, trust, personal competence, policy tuning & policy instruments, institutional innovations, instrumental innovations and mental innovations. These aspects will be discussed based on two case studies with water management and spatial planning aspects. This local co-operation is mainly informal of character.Land Use Planning, Wageningen University, The Netherlands

Control of support limb muscles in recovery after tripping in young and older subjects

Older people fall more often after tripping than young people due to a slower development of mechanical responses. This might be due to age-related changes in muscle properties, but also to changes in motor control. The purpose of the present study was to determine whether (a) timing and sequencing of muscle activation and (b) the magnitude and rate of development of muscle activation in recovery after a trip differs between young and older subjects. We focused on the support limb, as it contributes to recovery after tripping by counteracting the forward angular momentum. Ten young (25 years) and seven older (68 years) men and women walked over a platform and were tripped several times at different points in the gait cycle. Kinematics and EMG of the support limb muscles were measured. After tripping, rapid EMG responses (60-80 ms) were observed in hamstring and triceps surae muscles in both young and older subjects. A slightly increased delay (11 ms) was found only in the soleus muscle of the older subjects. The muscle activity patterns (timing and sequencing) were similar in young and older subjects, but the magnitude and rate of development of muscle activity were significantly lower in older subjects. Especially the lower rate of development of muscle activation in the support limb of older subjects is likely to reduce the rate of force generation, which can contribute to inadequate recovery responses and falls. © Springer-Verlag 2004

DO FUNCTIONAL PERTURBATIONS AFFECT ROTATIONAL KNEE JOINT KINEMATICS?

The purpose of this study was the assessment of rotational knee joint kinematics following a functional perturbation. Perturbations were applied at different phases of the gait cycle with the subjects (n=18) running on a treadmill. During half of the trials a dual task was applied. A statistical comparison took place between strides with and without perturbations applied, showing significant differences. Therefore, the method presented in this study of the application of perturbations to mimic situations in which knee injuries are known to occur, resulted in changed rotational knee joint kinematics

Constitutively active acetylcholine-dependent potassium current increases atrial defibrillation threshold by favoring post-shock re-initiation

Electrical cardioversion (ECV), a mainstay in atrial fibrillation (AF) treatment, is unsuccessful in up to 10-20% of patients. An important aspect of the remodeling process caused by AF is the constitutive activition of the atrium-specific acetylcholine-dependent potassium current (I-K,I-ACh -> I-K,I-ACh-c), which is associated with ECV failure. This study investigated the role of I-K,I-ACh-c in ECV failure and setting the atrial defibrillation threshold (aDFT) in optically mapped neonatal rat cardiomyocyte monolayers. AF was induced by burst pacing followed by application of biphasic shocks of 25-100 V to determine aDFT. Blocking I-K,I-ACh-c by tertiapin significantly decreased DFT, which correlated with a significant increase in wavelength during reentry. Genetic knockdown experiments, using lentiviral vectors encoding a Kcnj5-specific shRNA to modulate I-K,I-ACh-c, yielded similar results. Mechanistically, failed ECV was attributed to incomplete phase singularity (PS) removal or reemergence of PSs (i.e. re-initiation) through unidirectional propagation of shock-induced action potentials. Re-initiation occurred at significantly higher voltages than incomplete PS-removal and was inhibited by I-K,I-ACh-c blockade. Whole-heart mapping confirmed our findings showing a 60% increase in ECV success rate after I-K,I-ACh-c blockade. This study provides new mechanistic insight into failing ECV of AF and identifies I-K,I-ACh-c as possible atrium-specific target to increase ECV effectiveness, while decreasing its harmfulness

Electrophysiological deterioration and resurrection in the scarred heart.

While currently available therapeutic options for the treatment of acute myocardial infarction are sufficient for the treatment of symptoms, the underlying causes usually remain unresolved, being loss of electrically active, contractile, myocardial tissue. Recently, extensive research has been performed in the field of cell and gene therapy. The ultimate aim of these therapies is to __heal__ the infarcted area on a more biological basis, by repopulating the damaged area with __new__ cells that contribute to proper cardiac function, including electrical activation of the myocardium. In order to comprehend the potential therapeutic value and hazard of cell modification and transplantation for ischemic heart diseases, one should consider the heart as a highly integrative, electromechanical organ. Therefore, the aim of this thesis was to explore, from a mechanistic and electrophysiological point of view, the integrative and functional aspects of cell modification and transplantation as therapeutic options to cure the damaged, ischemic heart.UBL - phd migration 201