French hospital and its staff are charged over radiotherapy errorsBMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e6802 (Published 12 October 2012) Cite this as: BMJ 2012;345:e6802
The trial of the hospital and staff members at the centre of France’s most serious incident involving radiotherapy error opened on 24 September and is likely to run till the end of October.
Two radiotherapists, a radiophysicist, the Jean Monnet Hospital in Épinal (in the Vosges), and four health officials are facing charges in a criminal court in Paris of unintentional homicide and injuries and failure to assist people in danger.
The judges will try to establish responsibility for two separate incidents at the hospital that have led to at least seven deaths and affected 448 patients between 2001 and 2006.
Investigations have unearthed at least two errors: mistakes in settings on radiotherapy equipment and incorrect calculations of how much cumulated radiation patients had received.
Incorrect equipment settings were uncovered in 2004. They occurred in a software program when the hospital was introducing a new generation of radiotherapy equipment. As a result 24 patients undergoing radiotherapy for cancer between May 2004 and August 2005 received an estimated 20% excess dose.
Overexposure from incorrect calculations of cumulative radiation affected 424 patients treated over six years from 2001 to 2006. In these cases excess doses varied between 8% and 10%.
On 26 September the court heard from Patrick Gourmelon, an expert and former member of the French Radioprotection and Nuclear Safety Institute, who said that “in radiotherapy the maximum dosing error acceptable is 5%. Beyond that the probability of complications rises very quickly.”
In October 2006 the Ministry of Health announced details of the first incident, which had affected men undergoing radiotherapy for prostate cancer, after an administrative investigation it had requested. It also commissioned a new investigation that it conducted together with the Nuclear Safety Authority. The second report, published in March 2007, blamed the mistakes on organisational problems in the radiotherapy department, poor communication among staff, lack of training for radiology technicians who had to use software in English, and faults in the way the crisis was managed.
Alain Noël, a radiophysicist who was sent to work in Jean Monnet Hospital after the three staff members were suspended, told the Paris Criminal Court on 2 October that he was struck by the “somewhat unusual atmosphere” in the department. When he asked about treatment protocols, some staff members told him about the second series of errors: that staff did not take into account the amount of radiation patients had already received. Noël believed that one of the suspended radiophysicists had tried to cover his tracks, because documents stating how much radiation patients had received were missing from patients’ records.
Over 200 patients are plaintiffs in the case. When the trial opened half of them came to Paris from northeast France to attend the hearings. Many who were unable to travel were able to watch the proceedings in Épinal thanks to a broadcast allowed by the court.
Plaintiffs, who had already received compensation from the national medical accidents indemnity fund, began testifying on 1 October and described the effects on them of the excess radiation. They hoped that the trial would help people to “understand the tragedy and see the culprits punished,” said a spokeperson for the Association des Victimes de Surirradiations à l’Hôpital d’Épinal, which was set up to defend the affected patients.
Cite this as: BMJ 2012;345:e6802