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Significant events concerning patients
(64% of notified ESRs)
In radiotherapy
The majority of events concerning patients notified in
2015 occurred in radiotherapy departments (60%).
Most of them resulted from a patient positioning error.
The large majority of ESRs concerning patients (95%)
had no clinical consequences. 65%of these events were
rated level 1 on the ASN-SFRO scale, which comprises
8 levels from 0 to 7, and were included in the quarterly
appraisals published on
www.asn.fr;
2015 saw an increase in the number of ESRs rated level 2
on the ASN-SFRO scale. Eight ESRs of level 2 were
notified (3 in 2014) and 1 ESR of level 2+ (2 patients
concerned). They concerned errors in the target volume
to treat (4 ESRs), the side to treat, dose fractionation,
patient identity and lastly an error in activity level in
a prostate brachytherapy treatment with permanent
implants of iodine-131 seeds. In this latter event, the error
was facilitated by the use of several units of measure of
which one was not the international unit. The errors are
all themore serious in that they concern hypofractionated
treatments (3 ESRs).
These events highlight the organisational weaknesses in
managing the movements of patients’ files, in validation
steps that are not sufficiently explicit - particularly that
concerning the prescription - and in the upkeep of
patients’ files to ensure an overall view and access to the
necessary information at the right time. Identified risk
situations include the treatment of multiple locations such
as cerebral metastases, the succession of radiotherapy
treatments for a given patient, the absence of a tumoral
syndrome on the image (after surgery, for example),
non-routine treatments, non-harmonisation of practices
within a same given centre, frequent interruptions in
tasks, and lastly a heavy work load with, in particular,
an impact on treatment amplitudes, if the work load
is not properly managed.
In nuclear medicine
The number of ESRs notified in nuclear medicine in
2015 is lower than in the preceding years. About 70 ESRs
were notified in 2015 whereas between 2011 and 2014
the number exceeded one hundred per year. As in the
preceding years, the errors concern the administration
of inappropriate pharmaceuticals, patient identity and
the activity administered.
Eight ESRs concern cohorts of patients (2 to 11 patients).
In one of these cases, incorrect use of the activity meter
was identified. The effective doses received by error,
when they were estimated, range from 2 to 9 mSv for
diagnostic treatments.
Five ESRs were related to extravasations and led to
radiodetermatitis.
With the exception of a few failures (cooling system,
peristaltic pump), the majority of the errors result from
organisational and human causes. Among the causes we
can note problems with personnel training (newcomers,
resident doctors, trainees), insufficient preparation for
technical or organisational changes, and the absence of
medical validation. ASN observed on several occasions
that the departments do not wait for the quality control
results before starting the examinations.
The analysis of these events reveals shortcomings in the
qualitymanagement and riskmanagement culture in the
nuclear medicine departments concerned.
In radiology
The number of ESRs notified remains lowcomparedwith
other fields, with 3%, 8% and 3.5% of the notified ESRs
concerningpatients incomputed tomography, conventional
radiology and interventional radiology respectively.
Although they are few in number, the ESRs notified in the
area of interventional radiology display themost serious
consequences with the appearance of deterministic effects
for the patient. In 3 cases of events notified in 2015, the
occurrence of tissular effects in patients was observed.
NOTIFICATION CRITERIA FOR ESRS
in the medical field
notified to ASN in 2015 (%)
Patient
Others
Worker
Environmental
waste sources
Public
6
20
6
4
64
ESR IN THE MEDICAL FIELD
notified to ASN in 2015 (%)
Interventional
radiology
External-beam
radiotherapy
Conventional
and dental
radiology
Computed
Tomography
Nuclear
medicine
Other activities
or co-activities
Brachytherapy
23
2
10
19
4
41
1
310
CHAPTER 09:
MEDICAL USES OF IONISING RADIATION
ASN report on the state of nuclear safety and radiation protection in France in 2015