Abstract
Healthcare Technology Management (HTM) professionals are key stakeholders in the medical device ecosystem. When HTMs report medical device concerns to Food and Drug Administration (FDA), they contribute to patient safety, as FDA ensures that medical devices remain safe and effective throughout their use across the continuum of patient care. The HTM's perspective provides valuable context and insights to medical device problems and can lead to device improvements. We present a device concern reported to FDA by HTMs and analyze the strengths of each report. The HTM's perspective, shared clearly and thoroughly, resulted in improvement to the device design to mitigate a recurrent malfunction.
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