Devices

Possible Frameless Stereotaxic System Errors

FDA has issued a safety communication to make healthcare providers aware of possible navigational accuracy errors that may occur when using frameless stereotaxic navigation systems. The communication says that based on current information, the agency “believes the overall benefits of using frameless stereotaxic navigation systems continue to outweigh the risks and the agency has not determined that any particular system carries greater risk than others.” Included in the communication are recommendations for surgeons to consider to help mitigate associated risks to patients, including repeatedly assessing the navigational accuracy throughout a procedure when using a frameless surgical navigation system.

The agency says it is aware that some healthcare providers have experienced navigational accuracy errors during surgical procedures that have led to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged medical procedures. Its analysis indicates that there are many factors that contribute to the errors, FDA says, and no particular system is riskier.

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

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Gupta Raises Concerns About Overton’s Independence, Ideology

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