Journal of electrocardiology
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In patients with ST-elevation myocardial infarction, fast initiation of reperfusion therapy is mandatory. It is well established that prehospital diagnosis results in earlier initiation of fibrinolysis, but there is limited evidence concerning the value of prehospital evaluation in patients treated with primary percutaneous coronary intervention (PCI). ⋯ In this setting, continuous real-time 1-lead ECG transmission from ambulance to hospital may allow physicians to support ambulance personnel in the treatment of arrhythmias during transportation; and (4) equipment used for prehospital ECG acquisition and transmission has built-in features for continuous ST-segment monitoring. It is hypothesized that continuous ST-segment monitoring performed in the prehospital phase and during primary PCI may provide important prognostic information, with the potential of triaging future pharmacological and interventional treatment at time of PCI.
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In keeping with its mandate to provide the least burdensome means of product regulation, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health uses many different standards to facilitate the review of premarket submissions of medical devices. The benefits of using standards in this manner include providing a set of common requirements and test protocols to the device manufacturer, thus reducing the manufacturer's need to "reinvent the wheel" for each new bench test to ensure safety and effectiveness of the device. With the current trend toward international harmonization of standards, tests performed in accordance with an international standard may be acceptable to several countries. ⋯ One approach begins with the recognition of only some provisions of a standard, or more commonly, excluding those parts of a standard that are unacceptable to the FDA for regulatory or scientific validity reasons. Other approaches include working with the standards development organizations to revise the standard to include language more agreeable to all parties involved. Specific examples will be presented on medical devices, such as electrocardiogram cables and connectors, and noninvasive blood pressure monitors.