News from France: Radiation Incident at CK Center

from the IV MB, by yyy60:

>>News from France: Radiation Incident at CK Center

http://www.asn.fr/index.php/S-informer/Actualites/2010/Centre-de-lutte-contre-le-cancer-Oscar-Lambret-Lille

** translated from French **

ASN (Nuclear Safety Authority)

Incident Radiation at the Center of the fight against cancer Lambret Oscar de Lille (North)

Backgrounder General
Paris, January 18, 2010


On November 9, 2009, ASN was informed by the Center for the fight against cancer Lambret Oscar de Lille, an error has impacted the treatment of 13 patients supported on the CyberKnife ® [1]. Of these 13 patients, this error affected the dose delivered to total 9 patients and for the other 4, the error rate could be compensated during further processing.

This incident report follows an error setting the software calculation of dose on one of the two consoles treatment planning associated with the CyberKnife ®.

This issue is related to human error (incomplete data entry), technical (lack of centralization of data on both consoles) and organizational (not verify the proper data entry on both consoles). Center Oscar Lambret immediately put in place measures to prevent the recurrence of such errors, including checking the operation of two identical consoles treatment planning and systematic double counting of new treatment plans.

The ASN has conducted an inspection December 14, 2009 to examine more precisely the circumstances of the event and the first corrective measures taken by the center. She requested a declaration under materiovigilance be done with the AFSSAPS.

The ASN has ensured that the same error had been committed by the other two centers users CyberKnife ® [2].

She requested a risk analysis is conducted at each change of material, for example when adding a second console.

This incident has resulted, for 9 patients, underdosing or overdosing of the region irradiated by type of treatment carried out, without, however, the dose of critical organ tolerance has been exceeded. Patients have been informed and are under medical supervision especially from the medical team of the Center Oscar Lambret.

Of the 9 cases, 4 are likely to moderate impairment of an organ or function.

Accordingly, the ASN class provisionally incident at Level 2 of the DSC-scale SFRO [3] events in radiation therapy which has 8 (0 to 7).

- Consult the DSC-scale SFRO