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NANTES DIVISION
1. ASSESSMENT BY DOMAIN
1.1 The nuclear installations
The company Ionisos operates two industrial irradiation
facilities used chiefly for two applications: product
sterilisation (essentially medical equipment, and to a
lesser extent foodstuffs) and the treatment of plastic
materials to improve their mechanical characteristics.
Two inspections conducted in 2015 served to examine
compliance with the baseline safety requirements of the
installations in Pouzauges end Sablé-sur-Sarthe and assess
the progress in implementing the provisions of the Order
of 7th February 2012 setting the general rules for BNIs.
These inspections confirmed that the requestsmade during
the previous inspections concerning the verification of
the lifting devices and satisfactory performance of the
periodic tests for verifying operation of the safety systems
had been taken into account. The requirements of the
Order of 7th February 2012 seem to be well complied
with on the whole, even though improvements in the
monitoring of outside companies are to be planned for.
In June 2015, Ionisos submitted a periodic safety review
summary file for the irradiator in Sablé-sur-Sarthe, as
agreed. ASN requested IRSN’s opinion on this file, asking
it to examine more particularly the relevance of the
licensee’s proposed action plan and the corresponding
implementation schedule. This periodic safety review
will also be used to study the additional measures to
be put in place concerning accesses to the irradiation
cell, further to the incident of June 2009 involving the
untimely opening of the irradiation cell access door on
the Pouzauges site.
Ionisos will carry out the periodic safety review of the
Pouzauges site in 2017, whichmust integrate the lessons
identified by ASN during the examination of this safety
review.
1.2 Radiation protection
in the medical field
Radiotherapy
The technical and organisational changes (relocations,
groupings) undertaken by the radiotherapy centres in
the Bretagne and Pays de la Loire regions over the last few
years continue while preserving the regional meshing of
their locations is preserved. In this context, nine of the
fourteen radiotherapy centres in the Bretagne and Pays
de la Loire regions were inspected in 2015.
All the radiotherapy centres in these two regionsmeet the
criteria relative to the control of treatment planning and
delivery. The radiotherapy centres have also engaged in
a treatment quality and safety management process in a
generally similar and satisfactorymanner. The disparities
observed between the two regions until 2013 thus seem
corrected and today the centres are entering a phase of
consolidation and enrichment of their treatment quality
and safety management system. In this context, several
radiotherapy centres, particularly in Bretagne, have started
a process of inter-centre cross-audits supported by the
AFQSR (French Association for Quality and Safety in
Radiotherapy) created in 2013.
Nevertheless, themobilisation of the centresmust continue
their efforts to ensure that their documentation system,
the study of risks run by patients and the procedures for
stopping or continuing the treatments associated with
these new techniques are kept up to date overtime and
as technical and material development occur.
With regard to the identification and treatment of adverse
events, all the centres have tools for managing internal
reporting of adverse events andhave undertaken to conduct
new awareness-raising campaigns for their personnel on
these subjects. Their systems for managing and analysing
events that could arise during the radiotherapy treatment
process are also operational, but retrospective analyses of
events nevertheless remain brief and must still be taken
further in nearly 40% of the centres.
Finally, the efforts made in the last few years to recruit
medical physicists, dosimetrists andphysicalmeasurement
technicians enable all the centres to ensure the presence
of at least one medical physicist during the treatment
periods each day while freeingmedical radiation physics
time for the deployment of new treatment techniques.
Nonetheless, some centres occasionally had to review
their organisation in 2015 to ensure this presence due to
temporary and unforeseen vacancies inmedical physics
positions.
Interventional practices
A regional investigation carried out in 2013 with the
healthcare centres of the Bretagne and Pays de la Loire
regions providedmore detailedknowledge of interventional
practices (see chapter 9, point 1.1.2). ASNhas stepped up
its oversight actions since then: 21 centres were inspected
in 2015 compared with 16 in 2014 and nine in 2013.
The effort made in terms of inspection volumes and
prioritisation has also enabled the largest centres in the two
regions to be re-inspected and the tracking of identified
areas for progress to be tightened. It has resulted among
other things in significant improvement in the levels of
training in occupational and patient radiation protection.
On the other hand, for the other centres inspected,
the findings remain relatively similar to those of the
previous years, with occupational radiation protection
generally being better catered for than patient radiation
protection. In this latter domain, there is still much
room for improvement, whether in the presence and
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CHAPTER 08 :
REGIONAL OVERVIEW OF NUCLEAR SAFETY AND RADIATION PROTECTION
ASN report on the state of nuclear safety and radiation protection in France in 2015