Significant radiation protection event at the Le Mans Hospital: ASN conducted an inspection

On 8^th March 2018, the Le Mans Hospital notified ASN of a significant radiation protection event concerning a pregnant woman who underwent a computed tomography (CT) scan during the night of 6^th March 2018.

Due to the inappropriate utilisation of a control button, the patient and her child were accidentally exposed to a radiation dose very much higher than that usually delivered in this type of examination.

In the wake of this event, on 23^rd March 2018 the hospital notified the ANSM (French Health Products Safety Agency) of a medical devices vigilance event.

As soon as the event was detected, the hospital contacted the IRSN (French Institute for Radiation Protection and Nuclear Safety) and asked it evaluate the exposure of the patient and her child and the possible consequences of this exposure. The results of the IRSN analysis and expert assessment were communicated to the medical team concerned.

On 27^th March 2018, accompanied by members of the IRSN and the Regional Health Agency (ARS) of the Pays de la Loire, ASN conducted an inspection to analyse the malfunctions associated with this event. The inspection confirmed that inappropriate and repeated use of a one of the CT scanner control buttons during the examination of the patient had generated no alert signal and that the radiographer did not have immediate access to the information concerning the total dose delivered. The inspection also provided information on the first corrective and preventive measures identified by the hospital to prevent the recurrence of such an event, such as:

• the drafting of a procedure concerning the utilisation of this control button;
• the activation of a delivered dose monitoring function;
• training all the radiographers with regard to these changes.

The inspection also highlighted the need to:

• organize, for medical emergencies, the possibility of increased use of examinations by MRI (medical resonance imaging);
• fill the radiographer vacancies;
• improve the structure of the training and define the radiographer authorisation conditions;
• improve the ergonomics of the control button on this type of scanner in order to monitor patient exposure levels and inform the medical staff if the alert thresholds are exceeded.

In view of the large number of scanners of this type in service in France, ASN will - after consulting the medical learned societies - publish technical recommendations based in particular on its recommendations of 13^th June 2016 relative to training in the use of medical devices emitting ionizing radiation.