0% found this document useful (0 votes)
73 views

Guidance For Appointed Doctors On The Ionising Radiations Regulations 2017

ms33
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
73 views

Guidance For Appointed Doctors On The Ionising Radiations Regulations 2017

ms33
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 13

Health and Safety

Executive

Guidance for appointed doctors on the


Ionising Radiations Regulations 2017
Medical surveillance of classified persons

Introduction

1 This document provides guidance for appointed doctors on


conducting medical surveillance of workers exposed to ionising radiation,
for the purposes of the Ionising Radiations Regulations 2017 (IRR).1
It replaces the previous version, which was based on the Ionising
Radiations Regulations 1999 and published in 2011. The 2017 Regulations
implement EU Basic Safety Standards Directive 2013/59/Euratom for
protection against the dangers arising from exposure to ionising
radiation.2 Appointed doctors should also be familiar with the Approved
Code of Practice and guidance: Work with ionising radiation (L121)3 and
the Health and Safety Executive (HSE) appointed doctor website.4

Background

2 Ionising radiation (IR) is carcinogenic and the risk of cancer induction


cannot be excluded even at low doses. There is no ‘safe level’ of
radiation exposure. Practices involving exposure to IR must firstly be
justified – the benefits to society and exposed individuals must outweigh
the health risk. Secondly, the protection provided to control radiation
exposures must be optimised. Thirdly, there must be a system for dose
limitation for workers and the public. The principles and methods for
restricting radiation exposures to as low as reasonably practicable
(ALARP) are well established. For example, in relation to an external
radiation hazard, they may involve:
˜˜ restriction of the length of time of exposure;
˜˜ introduction of distance to separate the individual from the source of
exposure; and
˜˜ use of shielding.

3 Further information on IR and radiation protection is available on


HSE’s IR website5 and from Public Health England.6

General principles underlying medical surveillance

4 Under IRR, classified persons require medical surveillance by an


appointed doctor or employment medical adviser. The purpose of
medical surveillance is to confirm that an individual is fit or continues to
be fit for the intended work with IR. Classified persons are defined as

Guidance for appointed doctors on IRR 2017 Page 1 of 13


Health and Safety
Executive

those exposed workers likely to receive an effective dose of radiation


greater than 6 mSv per year or an equivalent dose greater than 15 mSv
per year to the lens of the eye or greater than 150 mSv per year to the
skin and extremities. Employers must also arrange for adequate medical
surveillance for any employee who has received an overexposure,
whether or not they have been designated as a classified person.
5 The requirements of adequate medical surveillance comprise:
˜˜ a medical assessment before first being designated as a classified
person in a role involving work with IR;
˜˜ periodic reviews of health at least once every year;
˜˜ special medical surveillance of an employee when a relevant dose
limit has been exceeded;
˜˜ determining whether specific conditions for working with IR are
necessary; and
˜˜ a review of health after ending work involving IR where this is
necessary to safeguard a person’s health.
6 The format of medical surveillance for each employee should take
account of the nature of their work with IR and their state of health.

Roles and responsibilities


Employer
7 The responsibilities of the employer, with regard to medical
surveillance, include:
˜˜ designating workers as classified persons;
˜˜ consulting with the radiation protection adviser (RPA) as required;
˜˜ arranging for medical surveillance of classified workers;
˜˜ maintaining a valid health record for each classified worker;
˜˜ ensuring that any conditions specified in the health record by the
appointed doctor (eg no work with unsealed sources) are observed;
˜˜ providing the appointed doctor with relevant information before
periodic reviews of health, the minimum being the health record,
summaries of dose records, sickness absence records, any other
medical concerns brought to their attention by the employee and any
change in the employee’s duties since the last review;
˜˜ permitting the appointed doctor to view the workplace;
˜˜ providing facilities for medical examinations or allowing workers to
attend the appointed doctor’s premises to be examined;
˜˜ notifying the appointed doctor of any suspected overexposure
received by any of their employees arising as a result of their work;
and
˜˜ cooperating with other employers as necessary, to ensure
compliance with IRR.

Guidance for appointed doctors on IRR 2017 Page 2 of 13


Health and Safety
Executive

Appointed doctor
8 To fulfil the requirements for adequate medical surveillance, as the
appointed doctor you should:
˜˜ liaise with the employer to ensure you understand the nature of the
work being done and the hazards/risks associated with exposure to
IR in that work;
˜˜ assess the fitness of individuals to work with IR;
˜˜ inform an HSE medical adviser in the event of any known or
suspected overexposure (see paragraph 42);
˜˜ provide counselling and advice to individuals regarding medical
aspects of their work with IR;
˜˜ maintain adequate clinical records for the medical examinations
completed;
˜˜ submit statistical returns on request; and
˜˜ undertake IR training at least once every five years (see Appendix 1)
and maintain up-to-date knowledge.

Administrative arrangements
Health record
9 Employers may use any format for the health record, providing it
contains the information listed in Schedule 6 of IRR. A suggested form
for this purpose is provided on HSE’s appointed doctor website (form
F2067).7 The health record should not contain confidential clinical
information (see paragraph 11). The record, or a copy of it, must be kept
until the person it relates to has (or would have) reached the age of 75,
but in any event for at least 30 years from the date of the last entry.
10 On completing the medical assessment before classification and after any
periodic health review, you should record whether you consider the person:
˜˜ fit to work with IR;
˜˜ fit subject to conditions; or
˜˜ unfit.

Clinical records
11 You can use any suitable form for this purpose, such as FODMS101,
available on HSE’s appointed doctor website.8

Change of employment
12 When a classified person has changed employment and is to be
classified by the new employer, a further medical examination may not
be necessary. This applies if the individual has been certified as fit for
that type of work with IR within the preceding 12 months and a copy of
that certification is obtained and kept with the health record. Any
conditions already imposed will continue to apply unless removed or
varied at the next periodic health review.

Guidance for appointed doctors on IRR 2017 Page 3 of 13


Health and Safety
Executive

13 If the change in employment entails a significant change of duties or


work environment (eg a move from work involving sealed sources to
work involving unsealed sources), the new employer should consult their
own appointed doctor. If the medical records from previous medical
surveillance are available to the appointed doctor, they should decide
whether a further medical examination is necessary to determine
whether the individual is fit to undertake their new duties. In the absence
of previous medical records, the appointed doctor should review the
worker before they start the new role. This would also apply when a
classified person remains with the same employer but their duties or
work environment change.

Appeals
14 IRR makes provision for a person who is aggrieved by a decision of
an appointed doctor to apply for the decision to be reviewed by HSE.
Such an application should be made in writing to HSE’s Principal
Medical Adviser within 28 days of being informed of the decision. Details
of the appeals procedure are available on HSE’s website.9

Examination before designation as a classified person

15 The main purpose of this examination is to establish the fitness of


the individual to work with IR, including the wearing of respiratory
protective equipment (RPE) or other personal protective equipment
(PPE), if that is required.

Work environment and tasks


16 When conducting the examination, you should be familiar with the
work environment where the classified person is to be employed and the
type of work with IR. You should therefore visit the workplace, where
practicable, so you can see the working conditions and the workers
under medical surveillance.
17 You should enquire about and record the following (it will be necessary
in most instances to obtain the information from the employer or RPA):
˜˜ What is the source of IR?
˜˜ Is the IR electrically generated or from sealed or unsealed radioactive
materials?
˜˜ To what type of radiation could the employee be exposed (alpha/
beta/gamma/neutrons/X-rays)?
˜˜ What are the risks of internal (inhalation, ingestion or through breaks
in the skin) and external exposures, given the type of work being done?
˜˜ What is the likely annual dose that the classified person will receive
and by which route will exposure occur?
˜˜ What methods will be used to assess the dose?
˜˜ What are the tasks involved?
˜˜ Is the work done in a purpose-built facility with appropriate

Guidance for appointed doctors on IRR 2017 Page 4 of 13


Health and Safety
Executive

engineering controls and shielding to restrict exposures such as an


enclosure/room with a maze entrance or interlocked doors?
˜˜ Is the work done on several different sites?
˜˜ Are large quantities of sealed or unsealed radioactive materials used?
˜˜ Is there potential for significant exposure or overexposure of the
extremities, skin or eyes?
˜˜ Is the wearing of RPE or other PPE necessary?

General medical history


18 You should obtain a full medical history before the individual is
designated as a classified person. Most of the information will be
relevant to the general duties of the post but of particular importance to
those aspects of work involving IR will be a history of:
˜˜ chronic skin disease;
˜˜ chronic pulmonary disease;
˜˜ psychiatric illness or personality disorder;
˜˜ blood disorder;
˜˜ inherited predisposition to malignancy;
˜˜ medical exposure to IR; and
˜˜ treatment with cytotoxic drugs.
19 However, they should not be regarded as reasons for automatically
excluding an individual from work with IR. In deciding on fitness, you
should adopt a risk-based approach in each case.

Previous occupational history


20 In addition to obtaining general information about previous
employment, you should record any previous occupational exposures to
IR or other known carcinogenic agents (eg asbestos).
21 For individuals who were classified by their previous employer, details
of previous exposure to IR should be set out in the dosimetry termination
record. The worker should receive a copy of this record from their
previous employer. When such an individual is to be classified by a new
employer, the prospective employer should ensure a copy of this record
is made available to the appointed doctor. For individuals who have not
previously been classified, but have worked in controlled areas and/or
been subject to personal dose monitoring, the previous employer should
be able to provide the individual with monitoring results or assessments
for at least the past two years.

Previous medical exposure to ionising radiation


22 It is important to establish and document previous diagnostic and
therapeutic exposures to IR. However, even though a significant previous
occupational or other exposure to IR has occurred, this may not be of
paramount importance in deciding on fitness of an applicant for
employment as a classified person. To put the issue into perspective, a
course of radiotherapy for carcinoma of the prostate commonly requires

Guidance for appointed doctors on IRR 2017 Page 5 of 13


Health and Safety
Executive

a total dose of around 60 Gy to be delivered to the bladder over a


6-week period. In contrast, the lifetime occupational effective dose that a
classified worker receives may be no more than several mSv.

Female workers
23 The employer must inform female employees engaged in work with IR
of the possible risks to the foetus and nursing infant arising from
exposure to IR and the importance of informing the employer in writing
as soon as possible if they become pregnant or start breastfeeding.
24 When an employee has notified her employer in writing that she is
pregnant or breastfeeding, the employer must ensure that:
˜˜ the equivalent dose to the foetus is not likely to exceed 1 mSv during
the remainder of the pregnancy (ie a dose limit similar to that applying
to members of the public); and
˜˜ in the case of an employee who is breastfeeding, the conditions of
exposure are restricted to prevent significant bodily contamination of
that employee.
25 More information is given in the HSE leaflet: Working safely with
ionising radiation: Guidelines for expectant or breastfeeding mothers.10

Mental health
26 The way in which classified persons carry out their duties is often
critical to their own safety and that of their colleagues. Therefore, you
should be alert to the presence of any psychiatric illness or personality
disorder inconsistent with the need for psychological stability and self-
discipline in such workers.

Clinical examination
27 The precise format of the clinical examination will depend on the
information obtained from the medical and occupational history.
Skin
28 Where work will be done using unsealed sources, you should
examine exposed areas of the skin to identify lesions which could allow
entry of radioactive materials into the body and be difficult to
decontaminate. You should find out which protective measures may be
implemented, for example appropriate use of PPE, and monitoring of
PPE, clothing and skin for contamination.
29 Some people who suffer from a chronic skin condition (eg eczema or
psoriasis) may be deemed unfit for work with unsealed sources. Others
with less severe diseases may be found fit to work with unsealed
sources subject to specific conditions such as more frequent clinical
assessment. These specific conditions for working with IR should be
entered in the health record.

Guidance for appointed doctors on IRR 2017 Page 6 of 13


Health and Safety
Executive

Respiratory system
30 If there is a need to use breathing apparatus or impervious protective
clothing, whether routinely or in an emergency, you should carefully
assess the respiratory system. It might be inappropriate to deploy an
individual with chronic respiratory disease (eg asthma) in such a workplace
as the increased respiratory effort involved in using this apparatus may
result in respiratory distress. If an episode occurs in a contaminated
area, removal of the apparatus in an effort to gain relief or to administer
first aid would inevitably result in internal contamination of the worker.
Blood test
31 There is no requirement for a full blood count either as part of the
initial examination or at periodic review, unless clinically indicated.

Counselling
32 The stochastic effects (eg malignancy) which may result from exposure
to IR can result in anxiety, particularly when any positive findings from
new research are reported in the media. You should be prepared to
address any such concerns which become apparent during medical
surveillance, whether or not these arise directly from a clinical finding.
33 You should be familiar with basic information about radiation and its
biological effects. You should also understand the comparative risks
arising from other work activities and from activities in daily life, and be
able to present and interpret these risks in the context of an individual
worker’s employment.
34 You should be familiar with the magnitude of the reproductive risks
from exposure to IR and be able to put them into context alongside other
risks associated with reproduction.

Periodic reviews of health

35 IRR requires the state of health of all classified persons to be


reviewed by an appointed doctor every 12 months, or after a shorter
period as may have been specified at the time of the last review. In
practice, the review may be carried out from one month before to one
month after the expiry date of the last entry on the health record. It will
be treated as if carried out on that expiry date. The next periodic review
would normally be due 12 months after that date. Where a period of
more than 13 months has passed since the start of the current period of
validity, the appointed doctor should carry out a medical examination.
36 The purpose of the periodic review is to reassess the general state of
health of the classified person and confirm their continued medical
fitness for the work in which they are employed. When conducting the
review, you should take account of:
˜˜ recorded doses of radiation exposure;

Guidance for appointed doctors on IRR 2017 Page 7 of 13


Health and Safety
Executive

˜˜ the sickness absence record and any medical concerns brought to


your attention;
˜˜ matters requiring follow-up from an earlier review; and
˜˜ any change in duties since the last review.

37 Whether periodic review should include a face-to-face assessment


with the worker is usually a matter of clinical judgement based on the
issues referred to in paragraph 36 and an assessment of risk. Where
there is a high risk of exposure (eg site radiography or people working in
areas of significant surface or airborne contamination), the review will
often include a face-to-face assessment. Even where the work
environment is well controlled and low-risk, a face-to-face assessment at
least once every five years should be considered. This would provide an
opportunity for the classified worker to raise any concerns they may have
about their health, work or work environment, with you.
38 It is recognised that in some cases, the radiation dose received by
the extremities of workers may not be accurately reflected by whole-
body dosimetry. Examples of such work include industrial radiography
and interventional radiology. Where such a risk is identified, the employer
should make arrangements with the Approved Dosimetry Service for
routine monitoring of extremity doses.
39 Periodic review of classified persons at risk of high radiation doses to
the extremities, for example site industrial radiographers, should include
a clinical examination.
40 You should enter the fitness to work decision in the health record.

Counselling
41 At periodic review, counselling may be indicated where a significant
cumulative dose of radiation has accrued or where an episode of ill
health that could be caused by radiation has occurred.

Overexposure – special medical surveillance

42 When it is suspected that a classified person, or any other person,


has been subjected to an overexposure, the employer must notify HSE
as soon as practicable. Where the person in question is their employee,
they must also notify the appointed doctor. Special medical surveillance
may be necessary for any employee who has received an overexposure
(and is subject to an investigation under regulation 26 of IRR). In these
circumstances, the appointed doctor should contact an HSE medical
adviser to discuss the case.4 They will work in consultation with the
appointed doctor and others, as appropriate, to determine the content of
special medical surveillance. It should include a medical assessment,
counselling and detailing of possible restrictions on further exposure.
Specific tests, such as chromosome aberration dosimetry, may be
warranted to help establish the degree of any overexposure.

Guidance for appointed doctors on IRR 2017 Page 8 of 13


Health and Safety
Executive

43 An essential first step is for the appointed doctor to establish, usually


through discussions with the employer, employee and RPA, full details of
the circumstances of the suspected overexposure. The form that any
subsequent clinical examination takes will be dependent on this
information. It may include looking for clinical evidence of radiation
exposure and then taking appropriate action.

Whole-body overexposures exceeding 1 Sv


44 Where the overexposure is known or believed to have exceeded 1 Sv
and to have been received over a brief period, the individual should be
kept under careful observation in an appropriate hospital for signs of
acute radiation syndrome.

Blood test
45 A full blood count and film should only be regarded as mandatory
where it is believed the individual has received a radiation dose from
X-rays, gamma rays or neutrons exceeding 250 mSv. However, apart
from an early fall in the number of circulating lymphocytes, it is likely that
several days will elapse before obvious abnormalities appear in the
peripheral blood.

Chromosome aberration dosimetry


46 The presence of chromosome aberrations in peripheral blood
lymphocytes may be used as a biological dosimeter following radiation
overexposure. On a routine basis, the lower limit of detection is
equivalent to a whole-body dose of about 100 mSv for gamma rays.
Before requesting this test, you should discuss it with an HSE medical
adviser (see paragraph 42).
47 This technique is relatively expensive and only available at a few
specialist facilities. Structural aberrations arise as the result of
discontinuities or breaks in the DNA and typically take the form of
dicentric, ring and fragmented chromosomes. Dicentric aberration is
almost unique to radiation, with a low frequency (about 1 per 100 000) in
people exposed solely to background radiation.
48 It is advisable, particularly in the case of partial-body or non-uniform
exposure, to wait 24 hours after radiation exposure before taking the
blood sample. This will allow circulating and pooled lymphocytes to mix
and equilibrate, ensuring the sample contains a representative proportion
of irradiated cells.
49 If IR exposure has been less than 20% of total body area,
chromosome aberration testing is unlikely to be helpful, even if there has
been sufficient local irradiation to cause injury. When counselling the
individual before the test, you should consider the psychological effect of
a positive result.

Guidance for appointed doctors on IRR 2017 Page 9 of 13


Health and Safety
Executive

Fluorescence in-situ hybridisation


50 Fluorescence in-situ hybridisation (FISH) is a test looking at
chromosomal translocations that do not decline with time. It is
appropriate for people who want to know their exposure to ionising
radiation over preceding decades (eg when working abroad). It is rarely
performed and expensive.

Decontamination
51 Decontamination is not a specific part of appointed doctor work.
However, many appointed doctors have additional training in
decontamination due to the nature of their roles within the nuclear
industry. They should be familiar with the decontamination arrangements
in the organisations where they provide appointed doctor services.

Counselling
52 Receiving an overexposure, or the suspicion of one, is inevitably a
stressful experience. A face-to-face medical assessment of the worker is
indicated, to address any anxieties resulting from the experience.
53 Once the immediate effects of overexposure have been managed, it
will be possible to consider any longer-term consequences for the individual.

Dose limitation for overexposed employees


54 Under IRR, the employer must ensure they limit further exposure of an
overexposed employee during the remainder of the dose limitation period.
The employee must not receive a dose of IR greater than that proportion of
any dose limit calculated by relating the remaining part of the dose limitation
period to the whole of that period, as shown in the following example:
˜˜ A classified worker receives an effective dose of 32 mSv in the first
3 months of their dose limitation period (12 months in total). The
annual dose limit is 20 mSv. For the rest of that dose limitation
period, ie for the next 9 months, the worker must not receive a dose
of IR greater than 20 x (9/12) = 15 mSv.

Working with ionising radiation following an overexposure


55 A classified worker who receives a significant overexposure should
be kept under appropriate surveillance by the appointed doctor to
identify early deterministic effects (eg skin erythema). You should
consider the nature and extent of any such effects when deciding on
return to work with IR. In general, it is not justifiable to restrict
subsequent employment solely on the possibility of late stochastic
effects. The additional doses of IR, which the individual will receive
during the remainder of their working life, are likely to be comparatively
small (see paragraphs 22 and 56). The only situation where it may not be
appropriate for the individual to continue work with IR is if they remain
distressed by the experience.

Guidance for appointed doctors on IRR 2017 Page 10 of 13


Health and Safety
Executive

Risk estimates

56 Where the issue in question is accumulated dose, then an estimate of


the lifetime risk of cancer can be made using risk factors which are
widely published. For example, a worker who has a total occupational
dose of radiation of 100 mSv has a lifetime risk of cancer (in addition to
their background risk) of 0.4%, based on the current estimate of risk to
an adult of 4% per Sv.11 This information is not of great value until put
into context. For example, approximately 1 in 2 people born after 1960 in
the UK will develop some form of cancer during their lifetime.12

Cancer in a classified person

57 Where a case of cancer occurs in a classified person, there are two


key issues – firstly, whether the cancer may have been caused by IR and,
secondly, whether the individual can continue as a classified person. A
formal calculation of the probability of causation can be made which
forms the basis of the compensation scheme agreed between some
nuclear employers and trade unions.
58 The decision about continuing employment as a classified person
can only be taken in the light of full information about the disease and its
treatment. Of equal importance to medical details will be the individual’s
psychological response to the illness.

Contingency planning and emergency preparedness

59 Under IRR, where the risk assessment shows a radiation accident


is reasonably foreseeable, the employer must prepare a contingency
plan to restrict exposure to IR of employees or others should such an
event occur.
60 Radiation emergency preparedness and public information legislation
provides a framework for protection of the public through emergency
preparedness for radiation accidents. It requires employers to make
arrangements for medical surveillance of employees who have been
subject to emergency exposures. Further information is available on
HSE’s IR website.5
61 National arrangements for incidents involving radioactivity are the
responsibility of Public Health England.6

Guidance for appointed doctors on IRR 2017 Page 11 of 13


Health and Safety
Executive

Appendix 1 Ionising radiation training for appointed doctors

Doctors appointed under IRR are required to undertake specific training


in IR and to refresh that training at least once every five years.4 The
training should cover the following main topics:
˜˜ Introduction, legislation and the role and duties of the appointed doctor
˜˜ Radiation – its nature, biological effects and measurement
˜˜ Epidemiology of carcinogenesis and risk estimates
˜˜ Deterministic and other effects of radiation and radiation protection
˜˜ Assessment of fitness for work with IR
˜˜ Measuring personal exposure – personal dosimetry methods and techniques
˜˜ Medical methods for assessing exposures and their threshold of detection
˜˜ Response to overexposures, real or suspected, and emergencies
˜˜ Counselling of workers and maintenance of knowledge

References

1 The Ionising Radiations Regulations 2017 SI 2017/1075 The Stationery


Office www.legislation.gov.uk/uksi/2017/1075/contents/made
2 Council Directive 2013/59/Euratom of 5 December 2013 laying down
basic safety standards for protection against the dangers arising from
exposure to ionising radiation Official Journal of the European Union
L13 17/1/2014 1-73 ec.europa.eu/energy/sites/ener/files/documents/
CELEX-32013L0059-EN-TXT.pdf
3 Work with ionising radiation. Ionising Radiations Regulations 2017.
Approved Code of Practice and guidance L121 (Second edition)
HSE Books 2018 www.hse.gov.uk/pubns/books/l121.htm
4 HSE’s appointed doctor website: www.hse.gov.uk/doctors
5 HSE’s ionising radiation website: www.hse.gov.uk/radiation/ionising
6 Health Protection: Radiation. Public Health England
www.gov.uk/topic/health-protection/radiation
7 Health record F2067 HSE 2018 www.hse.gov.uk/doctors/forms.htm
8 Clinical record FODMS101 HSE 2018 www.hse.gov.uk/doctors/forms.htm
9 Medical appeal: Ionising Radiations Regulations 2017
www.hse.gov.uk/radiation/ionising/appeals.htm
10 Working safely with ionising radiation: Guidelines for expectant
or breastfeeding mothers INDG334(rev1) HSE 2015
www.hse.gov.uk/pubns/indg334.htm
11 Wrixon AD New ICRP recommendations Journal of Radiological
Protection 2008 28 161-168 iopscience.iop.org
12 Cancer Research UK website: www.cancerresearchuk.org/health-
professional/cancer-statistics/risk/lifetime-risk

Guidance for appointed doctors on IRR 2017 Page 12 of 13


Health and Safety
Executive

Further information

For information about health and safety, or to report inconsistencies or


inaccuracies in this guidance, visit www.hse.gov.uk/.
You can order HSE priced publications at https://books.hse.gov.uk.
HSE priced publications are also available from bookshops.
This publication is available at: www.hse.gov.uk/pubns/ms33.htm.
© Crown copyright If you wish to reuse this information visit
www.hse.gov.uk/copyright.htm for details. First published 05/18.

Published by the Health and Safety Executive 05/18 MS33(rev1) Page 13 of 13

You might also like