European Journal of Radiology 76 (2010) 1519

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European Journal of Radiology

journal homepage: www.elsevier.com/locate/ejrad

Current issues and actions in radiation protection of patients

Ola Holmberg a, , Jim Malone b , Madan Rehani a , Donald McLean c , Renate Czarwinski d
a
Radiation Protection of Patients Unit, Radiation Safety & Monitoring Section, Division of Radiation, Transport and Waste Safety, International Atomic Energy Agency,
Wagramer Strasse 5, P.O. Box 100, 1400 Vienna, Austria
b
Trinity College, St Jamess Hospital, Dublin 8, Ireland
c
Dosimetry and Medical Radiation Physics Section, Division of Human Health, International Atomic Energy Agency, Wagramer Strasse 5, P.O. Box 100, 1400 Vienna, Austria
d
Radiation Safety & Monitoring Section, Division of Radiation, Transport and Waste Safety, International Atomic Energy Agency, Wagramer Strasse 5,
P.O. Box 100, 1400 Vienna, Austria

a r t i c l e i n f o a b s t r a c t

Article history: Medical application of ionizing radiation is a massive and increasing activity globally. While the use of
Received 14 June 2010 ionizing radiation in medicine brings tremendous benets to the global population, the associated risks
Accepted 15 June 2010 due to stochastic and deterministic effects make it necessary to protect patients from potential harm.
Current issues in radiation protection of patients include not only the rapidly increasing collective dose to
Keywords: the global population from medical exposure, but also that a substantial percentage of diagnostic imaging
Radiation protection
examinations are unnecessary, and the cumulative dose to individuals from medical exposure is growing.
Medical exposure
In addition to this, continued reports on deterministic injuries from safety related events in the medical
Justication
Electronic health record
use of ionizing radiation are raising awareness on the necessity for accident prevention measures. The
Quality audit International Atomic Energy Agency is engaged in several activities to reverse the negative trends of
Incident reporting these current issues, including improvement of the justication process, the tracking of radiation history
of individual patients, shared learning of safety signicant events, and the use of comprehensive quality
audits in the clinical environment.
2010 Elsevier Ireland Ltd. All rights reserved.

1. Introduction and background
Every day around the world, ionizing radiation is used for
imaging of patients in more than 10 million diagnostic radiology
procedures, and 100,000 diagnostic nuclear medicine procedures
[1]. Ionizing radiation is also used daily for therapy of patients in
the 20,000 radiotherapy courses started [1] and also in many ther-
apeutic nuclear medicine procedures. The scale of this activity is
massive and increasing. Ionizing radiation has, since its discovery,
proved to be able to bring the human population tremendous ben-
ets when used in medicine, but as ionizing radiation is associated
with risks due to stochastic and deterministic effects, it is necessary
to consider the protection of patients from potential harm.
Unnecessary exposure of patients can arise from medical pro-
cedures that are not justied for a specied objective, application
of procedures to individuals that are not justied on the basis of
their conditions, and medical exposures that are not appropriately
optimized for the situation in which they are used. This can lead to
unnecessary risks due to stochastic effects. Unintended exposure of
Corresponding author. Tel.: +43 1 2600 22718; fax: +43 1 26007.
E-mail addresses: O.Holmberg@iaea.org (O. Holmberg), jfmalone@tcd.ie
(J. Malone), M.M.Rehani@iaea.org (M. Rehani), I.Mclean@iaea.org (D. McLean),
R.Czarwinski@iaea.org (R. Czarwinski).
patients can arise from unsafe design or use of medical technology,
leading to deterministic effects or loss of tumour control. Radiation
protection of patients means to protect from both unnecessary and
unintended exposures.
There are a number of current trends in the medical use of ion-
izing radiation, which are leading to current issues to deal with
in relation to radiation protection of patients. A major trend is
the rapid increase of new technology for medical exposure, and
the corresponding speed of clinical introduction of this technol-
ogy. In particular, the increased use of computed tomography
(CT) scanners for radiological imaging procedures, with relatively
high associated patient doses, is a clear trend. The percentage
contribution from CT to the global collective dose from med-
ical X-ray examinations grew from less than 15% in the time
period 19851990 compared to more than 30% in the time period
19911996 [2].
According to the latest global gures, CT-scanning accounts for
42% of the total collective effective dose arising from medical diag-
nostic radiology [1]. This is happening in an environment where
the total contribution from medical exposure to the overall radi-
ation burden of the global population is increasing rapidly [1,2],
which is seen even more clearly in some national data [3] (Fig. 1).
Other current important trends include the increased attention,
from both health professionals and the public, to the inappropriate-
ness of a substantial percentage of diagnostic imaging procedures

0720-048X/$ see front matter 2010 Elsevier Ireland Ltd. All rights reserved.
doi:10.1016/j.ejrad.2010.06.033
16 O. Holmberg et al. / European Journal of Radiology 76 (2010) 1519
Fig. 1. Increasing annual per caput effective dose to the worlds population from
medical exposure, compared with natural background and other exposure [1,2], and
the annual per caput effective dose from medical exposure to the U.S. population
[3].
performed, and also to recurring safety issues in interventional
and therapeutic applications. All these issues are explored more in
depth in the following sections, including descriptions of some of
the activities performed by the International Atomic Energy Agency
(IAEA) in response to the issues.
2. First issue: justication of medical exposures
The International Commission on Radiological Protection (ICRP)
states that Any decision that alters the radiation exposure situa-
tion should do more good than harm [46]. A stronger position
on justication of medical exposures is often taken to the effect
that the good (i.e. the benets) should substantially outweigh any
risks that may be incurred, in part because of the uncertainty of the
risks [7].
ICRP has also recommended a multi-level approach to justica-
tion of the medical exposures [57] (Fig. 2). Level 1 deals with the
use of radiation in medicine in general. In practice, it is taken for
granted that this is justied. Level 2 deals with specied procedures
with a specied objective (e.g. chest radiographs for patients show-
ing relevant symptoms). The aim at this level is to judge whether
the procedure will improve diagnosis or provide necessary infor-
mation about those exposed. Level 3 deals with the application of
the procedure to an individual. In practice, all individual medical
exposures should be justied in advance, taking into account the
specic objectives of the exposure and the characteristics of the
individual. At this level, justication normally involves both a refer-
ring medical practitioner (e.g. the patients physician or surgeon)
and a radiological medical practitioner (under whose responsibility
Fig. 2. Justication of medical exposures operates at three levels, as identied by the International Commission on Radiological Protection (ICRP) [5,6].
the examination is conducted). It is important also that alternative
techniques, which do not use ionizing radiation (e.g. ultrasound
and magnetic resonance imaging) be considered.
This multi-level approach provides an excellent intellectual
framework for justication. However, there are signicant and
well-founded concerns that the method has not been as well
implemented in practice as it might be. Indeed, there may be sig-
nicant overutilization of radiology [711]. Recently, the IAEA and
the European Commission (EC) organized a joint Workshop enti-
tled Justication of Medical Exposure in Diagnostic Imaging, and
endorsed these views [12]. In addition, to ensure that justication
works well in practice, education and training of both referring
physicians and radiologists play a crucial role, but the published
literature suggests that in many clinical settings, training in this
area is inadequate [713]. It is also important that more attention
be given to consent, particularly to the information provided to
patients, and that more consideration is given to their dignity as
individuals [7,911].
Tools are available to facilitate identication of the correct
radiological examination for a particular patient and presenta-
tion. The most widely known involve appropriateness or referral
criteria/guidelines and provide advice on the common imaging
techniques used for common clinical presentations. In addition, the
radiation dose and the strength of the evidence base for the advice
offered are indicated. These guidelines should be available to all
clinicians who request imaging studies [7,9,12,14,15]. When well
integrated into a service, they can provide an effective technology
that has recently been reviewed [9].
There is widespread pressure to use radiological imaging tech-
niques to screen for many diseases. However, the forms of screening
involved frequently cannot be justied for unselected populations.
Well justied programmes are likely to be based on the advice
of professional bodies and/or be in accordance with national or
regional policies, such as those established for selected groups (e.g.
mammography for women in certain age groups).
A seriously neglected aspect of justication of medical expo-
sures has been audit of its effectiveness. Recent developments in
clinical audit of radiology have included approaches to audit of
justication [9,16]. Some studies have demonstrated potential for
signicant sustainable dose savings in the range of 2075% [9].
3. Second issue: tracking radiation exposure of patients
Just a decade ago, it was unusual to nd a patient who would
have undergone scores of CT examinations within a few years. More
recently, reports of patients undergoing a number of CT scans in a
few years or even in a single year have started to appear [17]. The
 O. Holmberg et al. / European Journal of Radiology 76 (2010) 1519
cumulative effective dose exceeding 100 mSv, and in some cases
1 Sv, are now being reported [17]. Radiation-induced skin injury
(erythema or hair loss) resulting from a clinical CT protocol or acci-
dental excess exposure is a very recent phenomena that started to
appear in 2005, and most recently in over 200 patients undergo-
ing perfusion CT protocols, which prompted intervention by the
U.S. Food and Drug Administration (FDA) [18,19]. Patients are also
undergoing repeated interventional procedures within a few years,
and a patient with radiation-induced injury to the skin from inter-
ventional procedures is occurring every month or two in the USA
[20].
One compelling response to this problem would be to focus on
the cumulative radiation exposure of an individual patient [21].
What is required is the attention to track the radiation exposure
(radiation history), whether it is the number of examinations or
radiation dose estimations, to the individual patient. The driving
force for radiation protection of patients in the past has been the
increasing collective dose to the population from medical exposure.
However, the cumulative dose (exposure history) to individual
patients is an increasingly mandated focus and requires additional
consideration.
In 2006, as part of its programme and budget, the IAEA initiated
a smart card project for individual medical exposure tracking by
enabling project funding starting in 2008. This project is currently
named SmartRadTrack [22], and the IAEA is involving a number of
stakeholders in this initiative.
Integrated Health Enterprises (IHE) connects healthcare pro-
fessionals and industry to improve the way computer systems
in healthcare share information. IHE promotes the coordinated
use of established information standards such as DICOM and HL7
to address specic clinical needs in support of optimal patient
care. The systems developed in accordance with IHE provide more
effective communication with one another, thereby facilitating
the tracking of individual patients. Medical imaging vendors are
increasingly complying with IHE protocols.
Another stakeholder group involved deals with Electronic
Health Records (EHR). EHR is developing quickly in many countries,
particularly in Europe. The IAEA is working to include the tracking
of radiological procedures and dose information in the functional
criteria of EHR. EHR groups are currently developing trans-border
data communication, which should be achieved in participating
countries of Europe (seventeen plus ve new) by 2012. There are
projects that are working to achieve inter-operability among coun-
tries in Europe by 2015, but there are some actions that rst must
be taken before tracking of procedures and dose can be included in
the EHR functional criteria.
In addition, the IAEA has involved professional societies such
as the International Society of Radiology (ISR), the American
College of Radiology (ACR), the International Radiology Quality
Network (IRQN), the International Commission on Radiological
Protection (ICRP) and the International Organization of Medi-
cal Physics (IOMP). The group has achieved consensus on what
parameters to be tracked in which cases, including radiation dose
indices applicable in different imaging modalities and in interven-
tional procedures. Recommendations have been developed for each
stakeholder.
4. Third issue: staying ahead of the technology train with
comprehensive quality audits
To affect change in the collective dose to the population from
diagnostic radiology, it is important to increase communication
between clinicians in radiological practice and health professionals
who are knowledgeable in effective dose reduction strategies. It is
clear that the development of regulatory structures external to the
17
clinical environment has a positive effect on instituting standards
for the protection of patients. However, a purposeful clinical struc-
ture is required, which incorporates good radiation protection to
create sustainable and appropriate patient dose control. Perhaps
the best example of this is that described above with the devel-
opment of a systematic approach to the justication of medical
radiological examinations. The use of new methods to track patient
exposure is another attempt to systematically raise awareness of
patient dose, and to incorporate the inclusion of this data into
the considerations for patient management. Both these examples
involve complex integration before they can become meaningful
parts of an active clinical department. It is here that the process
of clinical audit can assist using non-threatening and educative
methods of peer review.
Clinical audits are required by the European directive
97/43/Euratom [23], which has dened such audits as a systematic
examination or review of medical radiological procedures which
seeks to improve the quality and outcome of patient care through
structural review whereby radiological practices, procedures and
results are examined against agreed standards for good medical
radiological procedures, with modication of practices where indi-
cated and the application of new standards if necessary. Clinical
audits have been further claried in the literature [24], including a
recent EC publication [16] that looks at the purpose and practice of
clinical audit in a European context. Further, a practical document
for implementation of clinical audit for diagnostic radiological prac-
tices has recently been published by the IAEA [25]. The key features
of clinical audit, particularly as described in the IAEA document, are
its condentiality, its objective of improvement and learning rather
than regulation, and the structured comparison of clinical practice
with accepted standards, often through an external process that
assures independence.
A typical audit following the process described in this IAEA doc-
ument would involve an on-site visit from a team comprised of
a radiologist, a medical physicist and a radiographer or clinical
administrator. The guideline provides sets of standards for quality
management and infrastructure, patient and technical procedures,
and for education, training and research programmes. One example
amongst many of the stated principles and criteria of good practice
for patient-related procedures is in the important area of patient
referral practice, and the appropriateness or justication of the
selected examination. An audit team would seek evidence of doc-
umented referral guidelines and their distribution to both external
referring doctors and radiological practitioners.
In the area of technical procedures, the audit team might look
into the area of dosimetry and particularly the areas of CT and
mammographic dose estimation. Evidence of the use of accepted
dosimetric practice [26] would be sought and the auditors could
discuss best practice methods with the physicist responsible. Other
areas where clinical facilities have requested assistance in the past
include long-term planning for an X-ray facility and other areas of
organization and infrastructure. At the conclusion of the audit visit,
the ndings are shared with the staff and a report is drafted iden-
tifying strengths and weaknesses. In some cases, the solution to a
particular weakness may lay outside the resources of the facility.
The audit results will, however, provide a basis for future planning
for quality improvement. Such peer review situations promote the
exchange of information on emerging technologies, particularly in
the area of information management, and build an environment
generally conducive to dose reduction strategies and patient safety.
5. Fourth issue: shared learning of safety signicant events
Fluoroscopically guided diagnostic and interventional proce-
dures are being performed with increasing frequency in large parts
18 O. Holmberg et al. / European Journal of Radiology 76 (2010) 1519
of the world, including developing countries [27]. In some situ-
ations, these procedures may be the mainstream procedure, or
the procedure of choice, to address serious and life-threatening
conditions. High radiation doses occur in some interventional
procedures and case reports describing deterministic effects
(radiation-induced skin injury) have been reported in the litera-
ture, and there is also concern for long-term stochastic effects in
children [20,28,29]. There is an absence of any international and
regional reporting systems for radiation injuries arising from these
procedures, and a gross lack of national systems in most countries.
The IAEA has recently launched a voluntary reporting sys-
tem called Safety in Radiological Procedures (SAFRAD), in which
patients who are submitted to dened trigger levels or events in u-
oroscopically guided diagnostic and interventional procedures are
included in an international database [30]. The primary objective
of the system is educational. It is believed that the process of enter-
ing information into SAFRAD might itself lead to increased focus on
safety and quality of service. The data furnished will remain acces-
sible to the participant, who also will have access periodically to
analysed results. The IAEA will publish overall summary reports of
SAFRAD data from time to time. The Agency will not supply iden-
tiable SAFRAD data to any governmental authority or other third
party.
Enhancing safety in radiotherapy is also of key concern cur-
rently. This complex treatment modality has a low associated risk of
injury or death from adverse events reported [31] but has recently
received wide attention on safety related issues in the public
press [32]. Accidents and incidents that are repetitions of previous
occurrences are sometimes seen in radiotherapy, and it is gener-
ally accepted that one aspect of achieving safety improvement in
radiotherapy is by the establishment of a comprehensive global
safety reporting and learning system. Some countries currently
have national and mandatory incident reporting mechanisms for
radiotherapy. The focus of these is the reporting of major incidents
involving large dose errors or affecting a series of patients, and the
output of investigations into these major incidents often remains
condential. Open and voluntary reporting systems can comple-
ment these national and mandatory reporting systems, and enable
learning on a wider scale, with the ability to capture near-incidents
and other safety related events.
The IAEA is in the process of developing an educational report-
ing system for voluntary reporting of safety signicant events in
radiotherapy called Safety in Radiation Oncology (SAFRON). The
objectives of the SAFRON project are to develop and implement a
global safety reporting and learning system that encompasses ret-
rospective reporting and prospective risk analysis within a learning
environment that will improve the safe planning and delivery of
radiotherapy. The integration of prospective risk analysis together
with retrospective reporting enables the system to be proactive,
which is of value when considering the rapid development of new
medical technology.
6. Conclusions
Current trends in the medical use of ionizing radiation have led
to current issues in relation to radiation protection of patients. The
continued rapid growth of CT-scanning is a major factor in the
increasing collective dose to the global population from medical
exposure. Considering current reports that a substantial percent-
age of diagnostic imaging examinations are unjustied, this is an
area where an unnecessary radiation burden is placed on the pop-
ulation and where radiation protection of patients can be more
efcient. In addition to an increasing collective dose, the cumu-
lative dose to individuals from medical exposure is becoming more
of an issue, making the tracking of individual radiation history
a valuable tool for radiation protection of patients. As aware-
ness of deterministic injuries from the use of ionizing radiation
in medicine is currently increasing, this presents an opportunity
to introduce voluntary systems for shared learning of safety sig-
nicant events. Finally, clinical audit is a tool that can foster more
long-term efforts to protect patients in the clinical environment.
The IAEA is taking action in all these areas for the benet of patients
globally.
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