ASN publishes report on operating experience feedback from an interventional neuroradiology event at Strasbourg University Hospital with recommendations for improving radiation protection for patients
On 20 March 2009, Strasbourg University Hospital reported a greater than normal number of side effects in patients being treated in a radiology department for arteriovenous malformations in the brain. To gain further information, ASN performed investigations and assessments from which it derives conclusions in a report now available at its website, www.asn.fr.
ASN and the Directorate General for Health jointly requested the French Institute for Radiological Protection and Nuclear Safety (IRSN) to recreate patient doses and analyse possible complications for patients subject to exposure. To date, the hospital’s monitoring of patients has shown no evidence of neurological, meningeal or subcutaneous anomaly and total observed instances of alopecia (hair loss) have decreased significantly.
ASN’s report shows that the device in question had no technical fault but that inadequate attention was given to optimising and monitoring doses received by patients. Observed side effects resulted from use of a new device and conditions for use and adjustment were not optimised due to inadequate training and organisational failures.
Lessons learned from analysis of the event led the hospital to prepare and implement a significant and innovative action plan with the goal of knowing and reducing dose levels for all interventions.
Based on an exemplary approach, the results have led to a considerable reduction of some 40% in doses delivered to patients by making adjustments to the devices and of 30 to 50% by changing how the devices are used. Current dose levels make the occurrence of undesirable side effects exceptional. Efforts to monitor dosimetric data and use of live dosimetry will help improve the accuracy of knowledge about doses patients receive.
As part of the action plan, the hospital will implement radiation protection practices for patients that are among the most advanced in the area of interventional radiology.
With the lessons learned from analysing the event, ASN has prepared an initial report and issued recommendations for improving treatment practices in France.
As a result, on 17 December 2009, ASN sent a circular letter to heads of interventional vascular neuroradiology departments and general directors of regional and university hospitals restating regulatory obligations for
- application of the optimisation principle,
- staff training,
- preparation of radiological protocols,
- involvement of a medical physics specialist to optimise radiological procedures.
Recommendations to facilitate application of the optimisation principle, prepared together with the French Radiology Society (SFR) and the French Medical Physics Society (SFPM), were also distributed.
ASN has provided the French Agency for the Safety of Health Products (AFSSAPS) with this operating experience feedback along with proposals for improving the relationship between device suppliers and users during installation, maintenance and training as well as for ergonomics and optimisation of interventional radiology devices.
ASN's report as well as the actions taken by Strasbourg University Hospital have been brought to the attention of the Permanent Group of Experts on Radiation Protection for Medical and Medical-legal uses of ionizing radiation, created by ASN in January 2009, in order to prepare recommendations for improving protection of patients and workers from radiation arising from interventional radiology. The conclusions of this group of experts, which are expected in 2010, will lead to the preparation of a national action plan.