FDA targets avoiding device fragments
Accreditation Connection, January 18, 2008
The Food and Drug Administration's (FDA) Center for Devices and Radiology Health each year receives roughly 1,000 reports on adverse events regarding unretrieved fragments unintentionally separated from medical devices during surgery. Now the FDA has provided resources for practitioners to avoid such occurrences in the future.
Among the suggestions provided by the FDA:
- Inspect devices for damage before use and upon removal from the patient
- Retain damaged devices to assist the manufacture's analysis
- Discuss with patients the safety of unretrieved fragments
To view the official statement, click here.
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