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.
Medical devices manufactured today typically require a number of different components and materials. Commonly, mass-produced devices utilize biocompatible polymers for their external surfaces. In this article, we discuss common failure mechanisms of polymers and a number of contributing factors, related to both the use and manufacturing of these devices. Reprocessing and cleaning of reusable medical devices can also contribute to their failures when incompatible substances or techniques are used. Thorough postmarket reporting of any medical device failure can allow enhancements of the device to be made and will ultimately improve patient safety.
OBJECTIVES:The NICE Scientific Advice (SA) programme was established in 2009. It provides written advice to pharmaceutical companies and device manufacturers about development plans for their products to ensure they produce relevant evidence for future submission to NICE. Herein we present a detailed analysis of the NICE SA programme over the past three years. METHODS: The NICE SA process involves assessment of the manufacturer's briefing book with input from external clinical experts, health economists and methodological experts. Following a faceto-face meeting between the manufacturer, the expert panel and the SA technical team, a formal written report summarising the advice is produced. In addition, NICE SA provides advice alongside the European Medicines Agency (EMA) and other Health Technology Assessment (HTA) agencies. Whilst such collaborations do not include a formal written report, advice is given verbally at joint meetings. Following these meetings, NICE SA provides a commentary on the manufacturer's minutes, clarifying the issues identified from the perspective of NICE. RESULTS: To date the programme has successfully completed 52 formal written advice projects. Requests for advice alongside the EMA and other HTA agencies have been steadily increasing with 13 projects completed since 2010. We produced detailed analyses of all requests to the NICE SA programme to date. Specifically, we will report on the types of questions posed in manufacturers' briefing books including questions on health economic evaluation. We will include a breakdown by therapeutic area, frequency of requests by company, type of company, profiles of participants at meetings, and trends over time. CONCLUSIONS: We will reflect on how the various models of advice projects differ, how manufacturers can get the most from the process, and how the NICE SA programme is expected to evolve.
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