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Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
In 2010, while the ERHMS framework was still in development, the Deepwater Horizon oil spill took place. NIOSH and the Unified Area Command (UAC), implemented some of the initial ERHMS guidelines, including deployment-phase rostering, injury and illness surveillance, assessment of and protection from chemical and environmental exposures, as well as prompt and accessible communication with ...
In those with contrast allergy, or allergy to food or medications, the procedure can still be carried out with prednisolone coverage. Other relative contraindications include coagulopathy (abnormal coagulation) or platelet count less than 50x10 9 /L. However, if the port is needed urgently, platelet transfusion may be given while the procedure ...
[1] [2] The protocol was created by the WHO Ebola Ethics Working Group in 2014 [3] [4] in the context of the 2014 West Africa Ebola outbreak. The WHO recommends that the term be preferred to the term "compassionate use" or "expanded access" for the controlled use of unregistered treatments in public health emergency measures. [5] [6]
Medical device reporting (MDR), which is the reporting of adverse events with medical devices, is similar to that with medicinal products, although there are differences. In contrast to reporting of medical products reports of side-effects play only a minor role with most medical devices.
Retrograde pyelography is generally done when an intravenous excretory study (intravenous pyelogram or contrast CT scan) cannot be done because of renal disease or allergy to intravenous contrast. Relative contraindications include the presence of infected urine, pregnancy (because of radiation), or allergy to the contrast. [13]
The guidance document "MEDDEV 2.12-1 rev 8" offers a comprehensive guidance on best practice for medical device post-market surveillance (materiovigilance). The concept of post market surveillance is linked to the concepts of vigilance and market surveillance. A manufacturer of medical devices is required to report incidents (serious adverse ...
Anaphylaxis is a medical emergency that may require resuscitation measures such as airway management, supplemental oxygen, large volumes of intravenous fluids, and close monitoring. [9] Passive leg raise may also be helpful in the emergency management. [45]