Nuclear Medicine: Analysis of IRR 2018 Regulations and its Impact

This report provides an analysis of the Ionising Radiation Regulations (IRR) 2018 in the UK and their impact on the field of Nuclear Medicine. It examines the changes introduced by the regulations, particularly in relation to the EU Basic Safety Standards Directive 2013/59, and compares them to the previous IRR17 and IRR99. The report highlights the key changes, including new requirements for registration with the Health and Safety Executive (HSE), the introduction of a graded approach for employers, and the obligation to notify patients of accidental radiation exposure. It also discusses the implications of these changes on nuclear medicine practices, such as the need for new training programs, changes in operational cycles, and the requirement for medical physics experts. The report concludes that the new regulations have a significant impact on both personnel and the medicine manufacturing system, necessitating facility renovations and changes in operational procedures. Furthermore, the report underlines the need for clear guidelines regarding radioactive waste management and patient care, while also emphasizing the importance of compliance with the new regulations to ensure the safety of workers and patients. The analysis also reflects on the need for the new regulation to address the issues of compensation for unintended or accidental exposure to radiation.

Running head: NUCLEAR MEDICINE
Impact of Ionising Radiation Regulations 2018 on Nuclear Medicine
Name of the Student
Name of the University
Author note

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Executive Summary
The aim of this discussion is to analyse the changes adopted in new Ionising Radiation
Regulation UK 2018 while examining impact on the Nuclear medicine. Throughout this
discussion, the EU Basic Safety Standards outlines and its adaptation in new regulations have
been explored. The discussion has focused on the impact of these changes in Nuclear
medicine.

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Table of Continent
Introduction................................................................................................................................3
Changes Ionisation Radiation regulations..................................................................................3
EU Basic Safety Standards Directive.........................................................................................4
Reflection of EU Basic Safety Standards Directive on IRR18..................................................5
Impact of these changes on Nuclear Medicine..........................................................................5
Conclusion..................................................................................................................................7
References: Vancouver..............................................................................................................8

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Introduction
Radioactive substances are substances containing one or more radionuclide that
cannot be disregarded from a radiation protection point of view. Due to variations in the way
different radioactive substances are metabolised and concentrated in the body, an absolute
level of radioactivity is not more closely defined. Utilisation of these particles in Nuclear
Medicine industry is very high. In 2013 the EUBSSD or European Union adopted Basic
Safety Standards Directive 2013/59 aiming to implement the standardisation system in
ionisation radian within UK by February, 2018.1 The new changes are directed by the EU
directive where the BREXIT will not make any impact, because UK will remain in European
Union. The purpose of these regulations is ensuring health and safety of workers of Ionising
and Radiation industry concerning the medical exposures. In this report the changes adopted
in Ionising Radiation Regulation will be discussed comparing the Ionising Radiation
Regulation 2017 or IRR17.2 Throughout this discussion, the EU Basic Safety Standards
outlines and its adaptation in new regulations will be explored. The discussion will focus on
the impact of these changes in Nuclear medicine. Therefore, the purpose of this discussion is
to analyse the changes adopted in new Ionising Radiation Regulation UK 2018 while
examining impact on the Nuclear medicine.
Changes Ionisation Radiation regulations
UK already has a regulatory policy named Ionising Radiation Medical Exposure
regulation of IRMER (2000) based on the Ionising Regulation of 1999. In Ionising Radiation
Regulation 2017 or IRR17 no major change can be identified compared to the Ionising
Radiation Regulation 1999 or IRR99.2 The major changes were the alteration of eye dose
limit and a new responsibility to notify the HSE regarding the undertaken Ionising Radiation

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procedures repeatedly. In these changes the major stakeholders who have experienced
significant changes in process are:
 Health and safety officers
 Safety representatives
 Radiation protection advisers and supervisors
The purpose of this new Ionising Radiation Regulation 2018 or IRR18 is to adopt the
changes outlined by the EUBSSD in 2013. In 2013 the EUBSSD or European Union adopted
Basic Safety Standards Directive 2013/59 aiming to implement the standardisation system in
ionisation radian within UK by February, 2018. 3 In this new regulation, the HSE (Health,
Safety and Environment) will introduce a new graded approach for employers to follow
during conducting Ionising Radiation related operation through legitimate workforce
structure. As per standard of 2018, these employers should re-register them to HSE via
notification, registration or consent through an on-line portal where each register-able
practice will require separate application. The new regulation also creates an obligation to
notify the patient and others regarding any accidental or unintended exposure. Besides, the
new regulation also introduced new requirement for each employer to obtain a licence from
Public Health England or equivalent bodies in Scotland and Wales.
EU Basic Safety Standards Directive
First Basic Safety Standard or BSS Directive was adopted in 1959 to ensure the
protective environment of the workers against the potential hazards because of Ionising
Radiation.4 These safety standards were developed aiming to all the nations within European
Union. It includes better radiation protection measures for the employees as well as for the
patients. The directives are also focuses on the preparedness for any emergency situation. The
training and workforce development was included as a major part of this standardisation. It

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also implies the nuclear industry and other industrial application of radioactive materials and
waves. Besides, the updated standardisation of EUBSSD 2013 took latest scientific findings
and recommendations into account through altering the training and development as well as
emergency handling process. It adopted a standardisation for the workers exposed to ionising
radiation in the working place with indoor radon or Naturally Occurring Radioactive Material
(NORM).5 It also emphasise the radiation waste management control system and related
operational protocols.
Reflection of EU Basic Safety Standards Directive on IRR18
According to the Ionising Radiation Regulation rationale 2018, the purpose of this
new Ionising Radiation Regulation 2018 or IRR18 is to adopt the changes outlined by the
EUBSSD in 2013. There are many aspects that are directly adopted from the EUBSSD 2013,
where some of the aspects are still unaddressed and needs further amendments. The
standardisations for workers of Radiation and Nuclear industry have been adopted by
confirming repeated registration and verification procedures. The west management aspects
however not identified in IRR18 clearly.3 The IRR18 does not clearly present the measuring
process of radioactive waste management. Another major adaptation can be found in patient
care field, where the employers have been considered as most responsible to notify the
patients about the unintended or any accidental exposure to radiation. However, in spite of
having regulated frameworks the process of compensate or providing support to the exposed
person were still inadequate. Most of the changes only made on that particular sections which
has been faced some major force to change as per the audit report.
Impact of these changes on Nuclear Medicine
As a result of new regulatory auditing system imposed by this new regulation both
employers and employees of target industry now are responsible to re-register their

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radioactive operational license.5 There are now also bound to submit their auditing report
regularly to ensure their authenticity and imposition. Similarly, new training and
development program will be required for all the employees and their supervisors to mitigate
the possible risk of violating these regulations.
Due to minor changes in yearly doses permitted for the workforce, changes in
operational cycle will be also required. In other words, now the nuclear medicinal companies
need to change their product development life cycle. Besides, this changes can also involve
the changes in the instrumental operation and even changes in equipment installation. At the
same time, medical physics experts will now require for every nuclear medicinal plan.6 The
functions of the MPE or Medical Physics Experts are different to that radiation protection
advisor or radioactive waste advisor. As defined in the new Ionising Radiation Regulation,
MPE now has the responsibility to inspect and even audit all aspects of industrial operation
aiming to reduce the potentiality of violation of the regulations and safety measures.
In practical aspect the changes will have significant impact on both personnel and
medicine manufacturing system. The operational bandwidth of operational equipments has
been also changed along with the basic guidelines.7 Hence, now the nuclear medicine
companies will need renovation of their facilities. The new inspection and auditing system
should also have its place on the facilitation. Schedule 2(1)(b) requires entitlement and the
scope of practice of practitioners to be clearly defined within the employer’s written
procedures.
According to new regulation the employer should ensure the referral guidelines for
medical exposures required under this regulation are available to all entitled referrers to that
department. Besides, there is an obligation to have these guidelines in place regardless of the
size or type of the department or types of examinations performed. In establishing the referral

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guidelines, it is recommended to consult and agree these with professionals involved in
medical exposures.8 Many departments may already have guidelines in place and information
supplied by professional medical bodies may be useful, for example the Royal College of
Radiologists has produced recommendations for diagnostic practice which include dose
information.
Conclusion
From the above discussion it has been found that Utilisation of these particles in
Nuclear Medicine industry is very high. It can be also clearly leasable that the new changes
are directed by the EU directive where the BREXIT will not make any impact, because UK
will remain in European Union. Moreover, the purpose of this new Ionising Radiation
Regulation 2018 or IRR18 is to adopt the changes outlined by the EUBSSD in 2013. It can
be concluded that the new regulation introduced new requirement for each employer to obtain
a licence from Public Health England or equivalent bodies in Scotland and Wales. It has been
also find the IRR18 does not clearly present the measuring process of radioactive waste
management. The major changes that can be found, is because of this new regulatory auditing
system imposed by this new regulation both employers and employees of target industry now
are responsible to re-register their radioactive operational license. Moreover it can be
conclude that there are many aspects that are directly adopted from the EUBSSD 2013, where
some of the aspects are still unaddressed and needs further amendments.

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References:
[1] Morgan WF, Bair WJ. Issues in low dose radiation biology: the controversy continues. A
perspective. Radiation research. 2013 Apr 24;179(5):501-10.
[2] Kamiya K, Ozasa K, Akiba S, Niwa O, Kodama K, Takamura N, Zaharieva EK, Kimura
Y, Wakeford R. Long-term effects of radiation exposure on health. The lancet. 2015 Aug
1;386(9992):469-78.
[3] Desouky O, Ding N, Zhou G. Targeted and non-targeted effects of ionizing radiation.
Journal of Radiation Research and Applied Sciences. 2015 Apr 1;8(2):247-54.
[4] Glines WM, Markham A. Joint American Nuclear Society and Health Physics Society
Conference: Applicability of Radiation Response Models to Low Dose Protection Standards.
Health physics. 2018 May 1;114(5):527-31.
[5] Horner K. New regulations on X-ray use: likely implications for dental practices. BDJ
Team. 2017 Oct 1;4(9):17148.
[6] Haemmerli V, Bryant PA, Cole P. NUCLEAR NEW BUILD—INTEGRATING
CULTURAL DIFFERENCES IN RADIATION PROTECTION. Radiation protection
dosimetry. 2017 Apr 1;173(1-3):93-9.
[7] McLean AR, Adlen EK, Cardis E, Elliott A, Goodhead DT, Harms-Ringdahl M, Hendry
JH, Hoskin P, Jeggo PA, Mackay DJ, Muirhead CR. A restatement of the natural science
evidence base concerning the health effects of low-level ionizing radiation. Proceedings of
the Royal Society B: Biological Sciences. 2017 Sep 13;284(1862):20171070.

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[8] International Commission on Non-Ionizing Radiation Protection. ICNIRP statement on
diagnostic devices using non-ionizing radiation: existing regulations and potential health
risks. Health physics. 2017 Mar 1;112(3):305-21.