Healthcare technology management professionals play an important role in reporting medical device adverse events to the Food and Drug Administration by helping to identify and report device concerns, providing critical context to medical device reports, and mitigating safety concerns. The expert opinions and insights shared by healthcare technology management professionals are beneficial to the Food and Drug Administration and help the agency mitigate device-related problems and improve patient safety. This article is a case study that discusses how a medical device report involving infusion pump controllers was submitted to the Food and Drug Administration's Medical Product Safety Network reporting program and contributed to a voluntary class I recall affecting more than 800,000 devices nationwide. The details and context provided in the medical device report by the reporting team helped inform the investigation into, and resolution of, a device safety concern.
In the context of gift theory and the range of epistolary and text presentation practice in the period, this article analyses all the extant texts written by John Donne for Lucy, Countess of Bedford, in a male‐to‐female, client‐patron relationship. Using an inclusive policy, eighteen texts are analysed from the most prominent exponent in England of ‘social authorship’ in manuscript form, embracing letters, verse letters, and other occasional presentational texts. The series includes a problematic and generally unpopular set of poems about deaths in the family and household, for all of which Lady Bedford is the prime reader. Particular attention is paid to the material features of the texts, and all are interpreted as transactional in the developing or fluctuating relationship between the two correspondents. Various new readings are suggested, and it is demonstrated how one text may provide the terms of reference for another, and how the appeal to memories of earlier services may dictate the terms of later exchanges. The series is understood as a series, within a code of mutual obligation. It is suggested that many features can be seen in other cases, both within the Donne oeuvre and more widely in early modern society.
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