FDA Safety Communication for Frameless Stereotaxic Navigation Systems

PUBLISHED: Jun 15, 2017
Relevant to: Hospitals

The US Food and Drug Administration (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.

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.

The FDA believes that there are many factors that contribute to these errors, and no particular system carries greater risk than others. The FDA analyzed data from multiple sources and determined that navigational accuracy errors may occur due to problems associated with one or more of the following:

  • Navigation Software and Hardware, including software anomalies and hardware damage or defects;
  • System Complexity (Human Factors), including use errors in inputs, system setup and execution of system and surgical techniques;
  • Compatibility, including the use of incompatible accessory instruments with the stereotaxic navigation system;
  • Anatomical Complexity, including surgical requirements and intraoperative shift (e.g., brain shift, local tissue deformation from tissue resection, spinal movement);
  • Registration & Tracking, including poor registration and movement of the registration fiducials or reference array; and
  • Medical Image Quality, including insufficient image resolution and incomplete images.

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.

Recommendations for Health Care Providers:

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.

The safety communication presents specific recommendations for each possible source of error. Please see the safety communication for additional recommendations on

  • Navigation Software and Hardware
  • System Complexity
  • Compatibility
  • Anatomical Complexity
  • Registration & Tracking
  • Medical Image Quality

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