Devices

CDRH Pushing Device Interoperability

CDRH associate director for digital health Bakul Patel says the Center has taken steps to encourage interoperability of medical devices as a way to improve patient care and reduce errors. Writing in an FDA Voice blog post, Patel defines interoperability as the “rapid transfer and use of information between and among different medical devices.” It is less about basic communication, he says, and more about the smart and safe interaction among medical devices and information systems.

“Seamless interoperability among medical devices can improve patient care, reduce errors and adverse events, and lower costs,” Patel writes. “In fact, interoperability is one of the key factors that can drive innovation in care delivery.”

He notes that FDA has been collaborating with hospitals, healthcare providers, manufacturers, standards-development organizations, and other interested parties to promote medical device interoperability because it helps patients.

Patel lists steps the agency has taken as (1) a 2012 Summit on Medical Device Interoperability that identified the challenges; (2) the 2013 recognition of a set of standards manufacturers could use to improve patient care by making sure devices work well together; and (3) the 2015 finalization of a guidance on medical device data systems that encouraged the development of devices that can openly transfer, store, display, or convert data.

According to Patel, a recent draft guidance on design considerations and pre-market submission recommendations for interoperable medical devices is intended to promote and facilitate development of safe and effective interoperable devices, thus strengthening the case for such devices. “We intend to work with stakeholders toward a future where interoperable devices increase care efficiency and reduce healthcare costs, while keeping patient safety in the forefront,” he concludes. “We believe now is the time for all stakeholders, including medical device manufacturers, healthcare organizations, researchers, and information systems firms, to come together and continue to build this case to accelerate the development and availability of safe interoperable medical devices.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

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FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome