By Howard Sklamberg, J.D., Jeffrey Shuren, M.D., J.D., & Melinda K. Plaisier, M.S.W. – Across FDA, we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive–and increase–product and manufacturing quality.
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By Nina L. Hunter PhD & Robert M. Califf MD – We recently announced the first FDA Patient Engagement Advisory Committee (PEAC), supported by the Center of Devices and Radiological Health (CDRH). The Committee will provide advice to the FDA Commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients.
By Nina L. Hunter PhD & Robert M. Califf MD – Although it may seem odd in retrospect, the development of new technologies intended to improve patients’ lives has largely relied upon expert opinions rather than asking patients and families directly what they consider most important.
By Taha Kass-Hout, Roselie A. Bright & Ann Ferriter – OpenFDA is releasing information on medical devices that could spur innovation and advance scientific research. OpenFDA’s Application Programming Interface (API) expands on the previous openFDA resources concerning medical device-related adverse events and recalls by incorporating information from the medical device product life cycle.
By John Halamka MD – Last week the U.S. Food and Drug Administration advised hospitals not to use Hospira’s Symbiq infusion system, concluding that a security vulnerability enables hackers to take remote control of the system. The agency issued the advisory some 10 days after the U.S. Department of Homeland Security warned of the vulnerability in the pump.
By Jonathon Dreyer – I’ll admit it: I’m a James Bond fan. And one of the things I love most is the obligatory scene in every film where Q does a run-down of all the gadgets with which Bond will be outfitted—including the upgrades to his always-impressive car.
By Jonathan Krasner – There are a large number of potential attack vectors on any network. Medical devices on a healthcare network is certainly one of them. While medical devices represent a potential threat, it is important to keep in mind that the threat level posed by any given medical device should be determined by a Security Risk Assessment (SRA) and dealt with appropriately.
By Jeffrey Shuren – We know that patients with life-threatening or irreversibly debilitating conditions lack treatment and diagnostic options. For these patients, earlier access to promising new devices is critically important. At the same time, delayed access may mean the difference between life and death, or may result in irreversible disability.
By Sarianne Gruber – How much impact could medical device interoperability have on improving safety? A West Health IDEA series hosted care experts to address this question in an open forum titled “Missed Connections, Costly Medicine: Frontline Views on Interoperability and Improved Patient Care”.