PubMed · 14460267
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H KUENLEN, E SCHACHT. 1961. [Practical experiences with the Kodak developing machine M3].. https://pubmed.ncbi.nlm.nih.gov/14460267/
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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.
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AIM: To solve problems concerning patient equipment with emphasis on patient care, nursing quality and better nursing management. METHODS: A monitoring system, designed to follow the patient around in the hospital was discovered. Based on this concept a special, standardized pool system managed by the Clinical Engineering Department was developed. RESULTS: An all-department standardization of monitors and pumps was tried. With pumps it was a success. With monitors, two of 21 departments preferred non-standardized equipment. The equipment pool has successfully been run for 5 years. CONCLUSIONS: An evaluation showed that nursing care is better and that only 2% of those asked disapproved of the system. The pool eliminated problems like lack of equipment when needed, the wrong type of equipment found, lack of fitting disposables, the items that could be found being out of order or too dirty to be used. Nurses no longer waste time searching for equipment ready for use. Bedside equipment in working order can always be found in one of the storerooms. As a result, patient safety was greatly enhanced. We also show that this is economically a good system.