Medical device manufacturer, Brainlab AG, has issued a medical device safety alert concerning its ExacTrac Patient Positioning System: Additional instructions and warnings for beam authorization by ExacTrac via Auxiliary Device Interface (ADI) [Product Reference: ExacTrac version 6.0 - 6.5].
The manufacturer has become aware that the usage of workflows would deviate from the recommended specifications in the User manual for ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with ADI and Varian Clinac or Varian TrueBeam, which may result in misinterpretation of beam authorization via ADI.
When using ExacTrac (version 6.0 - 6.5) on a Varian Clinac or Varian TrueBeam system equipped with the ADI, beam requests of the treatment application have to be authorized by ExacTrac to enable treatment. As is described in the corresponding User Guides if no patient data is loaded in ExacTrac, ExacTrac always authorizes every beam request from the Varian side. This authorization is required and intended for clinical treatments for which ExacTrac is not used for patient positioning (e.g. Cone beam-based). When a patient has been loaded in ExacTrac, ExacTrac verifies the position of the patient and authorizes beam requests if the patient is correctly positioned (i.e. OK icon visible on ExacTrac screen).
According to the manufacturer, if a deviation of the patient position from the planned treatment position remains undetected by the user and the actual treatment beam that has been previously authorized by ExacTrac via ADI is initialized by the user, underdose of the planned target volume and/or overdose of healthy tissue could occur if the deviation exceeds clinically acceptable tolerances for the indication being treated.
The manufacturer intends to clarify that the beam authorization by ExacTrac via ADI is not a safety feature to ensure correct patient positioning before treatment. For any treatments performed with ExacTrac always verify that ExacTrac confirms the target position by displaying the OK icon. Do not treat the patient if the OK icon is not displayed.
An update to the Instructions for Use (IFU) BL-IL-60960- 84_Rev1.0 regarding Beam Authorization by ExacTrac via ADI will be sent to the affected customers.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 09 February 2018