Devices

AAMI Medical Device Remote Control Guidelines

The Association for the Advancement of Medical Instrumentation (AAMI) has published a consensus report with guidelines for implementing remote control for many critical medical devices during the Covid-19 pandemic. An AAMI announcement (includes a link to the guidelines) says FDA has already issued emergency use authorizations for many remote devices.

CDRH senior electrical/biomedical engineer Sandy Weininger, who co-chairs the AAMI Covid-19 Response Team, says the agency “has paved the way for innovation with very low overhead because the clinical need is recognized. Early in the pandemic, there was uncertainty. You had this perfect storm of scarcity of parts, testers who aren’t in labs, and constructors trying to innovate in spaces they’re not entirely familiar with. So, we’re leveraging existing device standards while narrowing the scope, slicing up the apple, and only taking the immediately useful parts.”

The guidelines document focuses on highlighting common system elements for engineers and outlining safety and risk control measures that both manufacturers and caretakers should consider, AAMI says. It also carefully defines what “remote-control” is when referring to medical devices.

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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