Beyond the difficulties at the Jean Monnet d’Epinal clinic, the recently reported radiation therapy incidents in France concern technical issues, although staffing and training are questioned in all incidents.

In April, a radiotherapist in Toulouse reported that the calibration file for a Novalis accelerator from BrainLab (Munich, Germany) did not correspond with the manufacturer’s file, according to l’Autorit S ret Nucl aire (ASN).

BrainLab compared the file with other European hospitals and detected an anomaly in the Toulouse unit that affected the calculation of the radiation beam’s monitoring units. The flaw had been present since the initial calibration one year earlier when the Novalis unit was installed.

Some 145 patients treated were affected, although only in six cases was exposure considered beyond accepted standards.

ASN reported that an English-language instruction manual from BrainLab gives only general advice on calibrating the beams and leaves the configuration to the hospital physicist. “Under no circumstances does the manufacturer carry out a validation of the tests,” said ASN in the report.

The underlying causes remain to be determined, says ASN, including a need for the hospital to “analyze the organizational and human factors, especially human resources, work load, skills and training.”

ASN subsequently alerted beam therapy departments in France to the importance of “the role of people and of organizations” in making treatment safer.

In the midst of the Epinal revelations and following the Toulouse report, BrainLab found itself again in the headlines following a warning issued in June of a target area misalignment for four Novalis machines used at university hospitals in France.

BrainLab said that during the installation of a sterotactic unit for radiation treatments for brain cancer patients in Spain, it discovered a variation of 1.5 mm in radiation targeting when the Novalis unit’s software was used in a specific configuration with the Leksell head ring manufactured by Elekta (Stockholm, Sweden).

BrainLab reported that seven hospitals had purchased this configuration worldwide, including two clinics in the U.S. — the Valley Medical Center (Renton, Washington) and the Cleveland Clinic.

The French government ordered a shutdown of the equipment following the BrainLab warning.

BrainLab downplayed the risks. Stefan Vilsmeier, its founder and CEO, told the Associated Press that the action involved a “small targeting error” that was unlikely to cause problems for patients. But a company notification sent to a U.S. provider warned that injury or death could be caused by the malfunction (Medical Device Daily; June 20, 2007). BrainLab said it replaced the affected configuration at each customer site and is working with clinicians and local authorities to provide information about any incidents.

— John Brosky, European Editor