ASN Report 2015

on-line notification portal shared by

the French Health Products Safety

Agency (ANSM) and ASN. It will be

extended to cover the entiremedical

sector in 2016.

After a gradual rise over the

period 2007 to 2014, the number

of ESR notified to ASN dipped

slightly in 2015, down to 525:

220 concerned radiotherapy (mainly

patient positioning anomalies) or

brachytherapy, 123nuclearmedicine,

100 computed tomography and

22 interventional radiology. 64%of

them concern patients. 6% of the

ESR concern the workers, primarily

in nuclear medicine.

A rise in the number of ESR rated 2

on the ASN-SFRO

scale should be

noted. Nine ESR rated level 2 or

2+ were notified. These concern

errors in the target volume to be

treated, the side to be treated, the

dose fractioning, patient identity or

brachytherapy activity.

The events notified to ASN in 2015

show that the consequences with

the most significance in radiation

protection terms concern:

•

for the workers; nuclear medicine

and interventional radiology;

•

for the patients; interventional

radiology during lengthy, complex

procedures, radiotherapy – in

particular for hypofractionated

treatments – and nuclearmedicine,

with radiopharmaceuticals

administration errors;

•

for the public and the environment;

nuclear medicine, with leaks from

radioactive effluent pipes and

containments.

The lessons learned from the

significant radiationprotection events

notified toASNunderline the need to

increase the involvement of Persons

Competent in Radiation protection

(PCR) and medical physicists

in the management of radiation

1. This scale is designed for communication

with the public in comprehensible,

explicit terms, concerning radiation

protection events leading to unexpected

or unforeseeable effects on patients

undergoing an external radiotherapy

medical procedure.

protection, to develop the training

of the professionals using ionising

radiation, to implement procedures

for quality management and safety

and for the evaluation of professional

practices.

The radiation protection

situation in radiotherapy

The safety of radiotherapy treatments

is a priority area of ASN regulation

and oversight. ASN systematically

inspects radiotherapy centres every

two years. An annual inspection

frequency is applied for the centres

with vulnerabilities in terms of

human resources or organisation

and particular attention is paid to

departments having undergone

major modifications (organisational

ormaterial),andcentresimplementing

new techniques.

ASN published recommendations

on the implementation of new

radiotherapy techniques. In

May 2015, recommendations were

sent to all radiotherapyunits, inorder

to warn them of the occurrence of

radiationprotection events linked to

radiotherapyexternalbeamasymmetry

and to improve its detection.

ASN observes a continuous

improvement in the implementation

of the quality and safetymanagement

requirements in radiotherapy

departments while at the same time

underlining the variability between

centres. Even if quality systems are

improving, they arenot evaluatedand

take insufficient account of actual

practices.

Risk management is now standard

practice in radiotherapydepartments,

with the implementation and analysis

of anomaly logs. However, efforts are

still needed in the monitoring of the

improvements made. ASN issued

recommendations in2015 to improve

the support given to the radiotherapy

units, reduce the complexity of the

riskassessments andmake themmore

operational.

With regard to brachytherapy,

the departments benefit from the

organisation set up for external

radiotherapy, concerning both the

deployment of a qualitymanagement

system and the radiation protection

of workers and patients. Although

PCR resources are generally available

and training is given, progress is still

needed in the technical inspections

and job description assessments.

The radiation protection

situation in nuclear medicine

A positive point is the increasing

importancebeinggiventotheradiation

protection of workers, patients and

the environment. Risk assessments

andpersonnel dosimetrymonitoring

are now carried out satisfactorily.

Medical physicists are now used as a

matter of course andmedical physics

organisation plans have been drawn

up. Waste and effluent management

is based on management plans.

Efforts are required for jobdescription

assessments, training, technical

inspectionandtheanalysisofdosimetry

data for optimisation purposes.

The radiation protection

situation in conventional radiology

and computed tomography

Owing to the significant contribution

to the exposure of the French

populationbythistypeofexamination,

ASN has maintained the oversight

of radiation protection in the

computed tomography field as one

of its priorities. In 2012, computed

tomography procedures accounted

for 71% of the mean effective dose

receivedby the population, although

they only represent 10% of the

volume of procedures. InMay 2015,

ASN painted a mixed picture of the

management of the doses of ionising

radiationdeliveredtothepatients,with

thedevelopment of goodpractices, but

inadequatehuman resources. In2015,

ASNalsopublished recommendations

on diagnostic reference levels for

medical imaging.

Its inspections also show that

improvementsareneeded,inparticular

with greater preliminary analysis of

prescribed examinations, training

in radiation protection of patients,

optimisation of scanner examination

protocols, analysis of dosimetry data

andevaluationofprofessionalpractices.

ASN Report on the state of nuclear safety and radiation protection in France in 2015

SIGNIFICANT EVENTS IN 2015