The Food and Drug Administration (FDA) is alerting health care professionals who use frameless stereotaxic navigation systems to place surgical instruments and implants before and during procedures that there is the possibility of navigational accuracy errors, some of which have led to patient deaths, serious or life-threatening injuries, and inaccurate, aborted or prolonged medical procedures.
Sterotaxic navigation systems are generally considered framed or frameless. Frame-based stereotaxic navigation systems require the attachment of a frame to the patient’s head using screws or pins. These systems rely on the fixed location of the frame to calculate a trajectory and distance to a point of interest identified on the patient’s image. Frameless versions of the device generally do not require the placement of a frame on the patient and tend to be more commonly used. These systems rely on various technologies to track the location of the patient and navigated instruments in 3D space relative to registered patient imagery.
The issue is specific to the frameless sterotaxic navigation systems.
The stereotaxic navigation system identifies and registers certain anatomical landmarks between the patient and his radiographic images. These images provide continuous, real-time visualization of surgical instruments such as drivers, cut guides and needles overlaid on the patient’s images. The system creates 2D and 3D images, which guide and assist the surgeon before and during the procedure.
The system is used for surgical procedures such as diagnostic biopsies, tumor resections, bone preparation and implant placement, placement of electroids, otolaryngologic, or neurosurgical procedures.
The FDA Safety Communication regarding frameless steroitaxic navigation systems is designed alert health care providers of the possibility of accuracy errors. Based on current information, the FDA believes the overall benefits of the devices outweigh the risks. However, the FDA recommend health care professionals take measures to identify accuracy errors and reduce patient risk such as assessing navigational accuracy repeatedly throughout a procedure when using a surgical navigation system. If the system does not appear to be accurate despite troubleshooting, do not rely on the navigation system.
Any adverse events related to this Safety Communication should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Safety Communication