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Maintenance and quality control of medical devices
Maintenance and quality control, both internal and
external, of medical devices using ionising radiation
(Articles R. 5211-5 to R. 5211-35 of the Public Health
Code) have been mandatory since publication of the
Order of 3rd March 2003. External quality control is
entrusted to organisations approved by the Director
General of the ANSM (French National Agency for
the Safety of Medication and Health Products) who
is responsible for issuing a decision defining the
acceptability criteria, the monitoring parameters and
the frequency of the inspections on the medical devices
concerned. The published decisions are posted on the
ANSM website.
Training and information
Additional major factors in the optimisation approach are
the training of health professionals and the information
of patients.
Thus the objectives and content of training programmes for
personnel conducting procedures using ionising radiation,
or who take part in these procedures, were defined in the
Order of 18thMay 2004. To ensure the traceability of the
data on application of the justification and optimisation
principles, the report on the procedure, written by the
medical practitioner carrying out the examination, must
provide information justifying the procedures and the
operations carried out as well as the data used to estimate
the dose received by the patient (Order of 22nd September
2006). These training courses were evaluated by ASN in
2012, and work is in progress to improve this training
system, withupdating of theOrder bymeans of a resolution
being planned for 2016.
Finally, before carrying out a diagnostic or therapeutic
procedure using radionuclides (nuclear medicine),
the physician must give the patient oral and written
guidelines on radiation protection that are of use
to him/herself, his/her relations, the public and the
environment. In the case of a therapeutic nuclear
medicine procedure, this information - which is
contained in a written document – gives advice on
day to day living such as to minimise external exposure
of the patient’s friends and family and the risk of any
contamination, for example by specifying the number
of days during which contact with the spouse and
children must be limited. Recommendations (French
High Public Health Council, learned societies) were
distributed by ASN (January 2007) to enable the content
of the information already sent out to be harmonised.
2.2.3 Forensic applications of ionising radiation
In the forensic field, ionising radiation is used in a wide
variety of sectors such as occupational medicine, sports
medicine or for investigative procedures required by
the courts or insurance companies. The principles of
justification and optimisation apply to both the person
requesting the examinations and the person performing
them.
In occupational medicine, ionising radiation is used
for medical monitoring of workers (whether or not
professionally exposed to ionising radiation, for example
workers exposed to asbestos).
The new Euratom Directive and the Public Health
Code (radiation protection of patients)
The new Euratom Directive 2013/59 introduces the
obligation to define a
“system for recognition of experts
in medical physics”.
This requirement should lead to
a forthcoming publication defining a status for medical
physicists and dosimetrists (currently under preparation
under the responsibility of the General Directorate for Health
Care – DGOS). For radiotherapy, the Directive makes risk
assessment, recording and analysis of undesirable events
mandatory, along with their notification to the authorities,
a system which is already in force in France.
For forensic applications of ionising radiation,
the new Euratom Directive introduces a new terminology
(“deliverable exposure of individuals for non-medical imaging
purposes”)
and should lead to a review of the existing
arrangements, with more operational application of the
justification principles.
UNDERSTAND
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CHAPTER 03:
REGULATIONS
ASN report on the state of nuclear safety and radiation protection in France in 2015