PubMed · 10307355
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S R Shemitz. 1978. Ambient/task lighting.. https://pubmed.ncbi.nlm.nih.gov/10307355/
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BACKGROUND: This research aims to assess the current impact of the medical and in-vitro diagnostic devices regulations (MDR/IVDR) on the device industry in the EU, under the lens of postimplementation and the amending regulation, and in advance of the final transition to the IVDR/MDR in the future. RESEARCH DESIGN AND METHODS: A quantitative survey was administered to a diverse cohort of medical device enterprises, ranging from micro to large organizations. RESULTS: The survey indicates that the MDR/IVDR has harmed innovation, leading many manufacturers to seek initial device approval and launch elsewhere before in Europe. There is evidence that some manufacturers have rationalized their existing product portfolios and removed devices from the market as they stated they would in previous industry surveys. The MDR/IVDR has been shown to negatively impact manufacturers, with increased costs related to notified body (NB) fees, maintaining and updating documentation, recertification fees, and hiring additional staff. CONCLUSION: This study provides a current status of the effects of MDR/IVDR on manufacturers and finds that despite amending regulations and other interventions taken by the EU to mitigate regulatory burden, ensure product availability, and address stakeholder concerns, the EU is no longer the market of choice for new products.
The guideline on pressure ulcers by the Dutch College of General Practitioners is good in the aspects of simplicity and giving very practical advice. It can be used as a guideline for prevention as well as treatment of pressure ulcers. Some aspects, however, are insufficiently dealt with. There is no summing up of the differences in anti-pressure ulcer devices such as mattresses and cushions. Use is made of the international classification of pressure ulcers in 4 stages, but also of a kind of rating in three colours (red-yellow-black), of which it is known that it underestimates the severity of pressure ulcers. There is an advice to use the knowledge of surgeons, dermatologists and nursing home doctors in difficult cases in the home care, where training and deployment of nurses specialised in this specific field might be preferable. Nevertheless, the guideline is well documented and useful in general practice.
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