FDA issues Safety Alert for frameless stereotaxic navigation systems

Editor's Note

The Food and Drug Administration (FDA) on June 15 issued a Safety Alert for frameless stereotaxic navigation systems because of navigational accuracy errors during surgical procedures.

Some of these errors have led to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged surgical procedures.

The FDA believes there are many factors contributing to these errors, and that no particular system has greater risks than others.

The FDA is working with manufacturers to ensure accurate labeling that includes clear user instructions on how to minimize the occurrence of these errors.

Posted 06/15/2017] AUDIENCE: Otolaryngology, Orthopedics, Surgery ISSUE: The FDA is aware that some health care providers have experienced navigational accuracy errors during surgical procedures when using frameless stereotaxic navigation systems. Some of these errors have led to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged medical procedures.