Search Results for: icu medical

AAMI Cautions FDA About “Unintended Consequences” of Regulating Medical Device Repair

Asserting its role as “a neutral organization that highly values its…’honest broker reputation,’ ” AAMI has submitted comments to the FDA concerning medical device repair and refurbishment in advance of the agency’s June 3 deadline. The 18-page letter, followed by nearly 40 more pages of attachments, notes the dangers of silo-based thinking and advocates for consensus-based standards over regulation.

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Lucian Leape Institute Releases Patient Safety Compendium

The National Patient Safety Foundation’s Lucian Leape Institute has released a compendium of the executive summaries and recommendations from five other reports published by the Institute between 2010 and 2015. Transforming Health Care, as it’s called, was recently announced at the 18th Annual Patient Safety Congress in Scottsdale, Ariz.

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The Many, Many Causes of Medical Device Failure

The failure of medical devices is a high-stakes issue, but unearthing the root cause when breakdowns occur can be difficult, particularly if multiple factors come into play. A recent list of key reasons for failure point to the need for comprehensive safety checks across the manufacturing, regulatory, and maintenance ecosystems.

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Shriners Hospital Installs Orthopedic Imaging System

French manufacturer EOS imaging has sold its 10th 2D/3D orthopedic imaging system to the Shriners Hospitals for Children Network, which will be installed at the Shriners’ Los Angeles location. The acquisition, which marks the 11th EOS system installed in the Shriners’ network since 2011, comes on the heels of an agreement the philanthropic society forged with EOS last year.

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