An accident happened in a hospital in Germany that involved a remote controlled X-ray system which was also covered by the media. During a routine examination the column with the X-ray tube had started moving downward unintentionally and descended within the time window at maximum speed of approx. 4 sec.. The clinical staff present could not engage the emergency stop button on the proximity console or the remote console in time and the patient who was lying in the bed was crushed.

The following investigations and the risk assessment by the BfArM led to the result that many remote controlled X-ray systems are designed comparable with regard to the protection systems against the risk of collision between moving parts and patients or users. Whereas these systems based on the current state of knowledge provide adequate protection in the case of horizontal radiography methods, the BfArM identified missing protective precautions for vertical diagnostic procedures, e. g. in bed exposures, for which the table top is tilted up and the X-ray tube is turned 90 degrees. From BfArM’s view the available safety measures only consisting of emergency stop buttons and warnings in the operating instructions are not effectual based on the remaining reaction time in the event of an unintentional movement.

Therefore, the BfArM recommends that the manufacturers modify the affected systems by corrective measures according to the principle of the inherent safe design and construction. Meanwhile different solutions for these problems have been developed by the manufacturers and appropriate retrofit kits are already available partially.

The BfArM points out that it considers the implementation of these corrective measures mandatory in oder to exclude comparable servere incidents in the future.

In case of questions please contact:

Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Telephone: +49 (0)228 99 307-5306 (active medical devices and in vitro diagnostics)
Facsimile: +49 (0)228 99 307-5300
E-Mail: md-vigilance@bfarm.de