FDA MedWatch - Frameless Stereotaxic Navigation Systems: FDA Safety Communication - Navigational Accuracy Errors

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - Frameless Stereotaxic Navigation Systems: FDA Safety Communication - Navigational Accuracy Errors

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Frameless Stereotaxic Navigation Systems: FDA Safety Communication - Navigational Accuracy Errors

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.

Based on our analysis, the FDA believes that there are many factors that contribute to these errors, and no particular system carries greater risk than others.  See the FDA Safety Communication for more detailed information on the scope of the problems.

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. The FDA will keep the public informed as significant new information becomes available.

BACKGROUND: Stereotaxic navigation systems include a computer system that utilizes patient imaging (e.g., CT, MRI) to guide surgeons with the placement of specialized surgical instruments and implants before and during the procedure. Stereotaxic systems are generally considered framed or frameless.

While this communication is focused on frameless stereotaxic navigation systems since these systems are more commonly used, many of the recommendations provided are applicable to framed and frameless stereotaxic navigation systems.

RECOMMENDATION: See the FDA Safety Communication for complete information on recommendations. 

The FDA recommends that health care providers consider 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Review the MedWatch safety alert, including links to the FDA Safety Communication, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm563337.htm

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