device advisory
Official communication from device manufacturers to physicians regarding potential safety issues or performance concerns with specific device models.
Full Definition
A formal notification system used by cardiac device manufacturers to inform healthcare providers about identified safety issues, performance problems, or recommended actions regarding specific device models or lots. Device advisories range from routine safety updates to urgent safety communications requiring immediate action such as device replacement. These advisories are typically coordinated with regulatory authorities and may include specific patient management recommendations, monitoring protocols, or device programming changes.
Usage
Usage note: Distinguish from formal recalls, which have specific regulatory implications.
In Context
- "The device advisory recommended increased follow-up frequency for affected models." — Clinical communication
- "All patients with devices covered by the advisory were contacted within 48 hours." — Hospital protocol