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.
The collaboration of hospitals, medical device manufacturers, and the US Food and Drug Administration serves to promote patient safety and device performance in the clinical setting. Each entity brings its own set of expertise, perspective, and resources that can be used to perform in-depth investigations into medical device–related safety concerns with the common goal of patient safety and device performance. This article describes the ways in which healthcare technology management professionals, medical device manufacturers, and Food and Drug Administration’s MedSun program work together to resolve medical device–related safety concerns, with a focus on case reports of exemplary communication and resolution of such concerns.
Health technology managers (HTMs) play a pivotal role in ensuring that the devices involved in protecting vulnerable patients from suffering falls are functional and safe for use. Patient falls are common events in healthcare settings, with between 700,000 and 1,000,000 patients suffering falls annually in the United States (Agency for Healthcare Research and Quality. Preventing falls in hospitals. Updated July 2018. https://www.ahrq.gov/patient-safety/settings/hospital/fall-prevention/toolkit/index.html). The experience and expertise of HTMs in handling devices throughout their entire lifecycle provide unique perspective and can help to establish proactive measures to ensure the risks of patient falls are mitigated as much as possible. This article will explore, using several real case examples submitted to Food and Drug Administration's MedSun, the many ways that hospitals can best use their HTMs in enhancing their fall prevention teams and overall patient fall mitigation strategies. Among these effective strategies are preadmission risk assessments and education, fostering a no-blame culture of reporting adverse events and device malfunctions, and regular interdisciplinary fall prevention team meetings where best practices can be discussed and implemented.
Healthcare technology management (HTM) professionals are critical stakeholders in promoting patient safety, regularly troubleshooting medical devices that are unsafe or unable to be used by clinical staff. Healthcare technology management professionals determine, investigate, and often address the root cause (or causes) of medical device concern(s), so that the devices can be used safely and effectively throughout the facility. The HTM professional's investigation, when accompanied by medical device reports, often leads to manufacturer actions, including recalls and corrections, which contribute to continuous improvement of device safety and performance. As highlighted in this case report, healthcare facility reporting teams, which include HTM professionals, provide value to the healthcare community as a whole, affecting real-world outcomes and patient safety.
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