FDA Issues Safety Alert on Frameless Stereotaxic Navigation Systems

January 20, 2017

On June 15, the U.S. Food & Drug Administration (FDA) issued a safety alert after some health care providers experienced navigational accuracy errors during surgeries while using frameless stereotaxic navigation systems. Some errors have led to patient deaths, serious or life-threatening injuries, and inaccurate procedures with extensive complications.

Stereotaxic navigation systems include a computer system that utilizes patient imaging to guide surgeons with the placement of specialized surgical instruments and implants before and during the procedure.

The FDA recommends the following information and actions to reduce the potential of serious adverse events:

  • “Be aware that based on current information, the FDA believes the overall benefits of these devices continue to outweigh the risks in appropriately selected patients when used by properly trained surgeons, and we have not determined that any particular system carries greater risk than others.
  • Assess navigational accuracy repeatedly throughout a procedure when using a surgical navigation system.
    • Reconfirm accuracy by positioning the navigated instrument tip on an identifiable anatomical landmark and comparing the actual tip location to that displayed by the system.
    • If the stereotaxic navigation system does not appear to be accurate despite troubleshooting (e.g., resetting the system), do not rely on the navigation system.”

The FDA encourages health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA. Information on how to submit reports is found on the FDA website.

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

See the FDA Safety Communication for more information and recommendations.

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