2. Application of the Regulations
The Regulations apply to:
Exposure of patients as part of their own
medical diagnosis and treatment.
This includes most uses of a Mini C Arm
for extremity work
3. Application of the Regulations
Exposure of individuals as part of health
screening programmes. (Not likely for
Mini C Arms)
Exposures of patients voluntarily
participating in research programmes.
(Covers any exposures as part of research
including any that would have been part of
routine care)
4. Application of the Regulations
To Carers and Comforters (see later for
definition etc).
To asymptomatic individuals
To non-medical imaging using medical
radiological equipment. (E.g. assessing
bone age for junior sports persons)
5. Application of the Regulations
The regulations were made under Health
and Safety at Work Regulations
However, the are enforced by the Care
Quality Commission I(RM)ER Inspectorate
A scheme of routine inspection is required
under the Directive!
6. Definitions
These are the most relevant definitions from
the regulations with explantions where
necessary
Accidental exposure: means an exposure of
an individual as a result of an accident.
All accidental exposures leading to patients
receiving doses much greater than intended
are covered by these Regulations.
7. Definitions (Continued)
Adequate training: means training which
satisfies the requirements of Schedule 3 of
the Regulations (training syllabus).
This includes the theoretical training as
covered by this course.
However, it also requires practical
experience in the radiographic techniques to
be used, which cannot be fully covered here.
9. Definitions (Continued)
Carers and comforters: means individuals
knowingly and willingly incurring an
exposure to ionising radiation by helping,
other than as part of their occupation, in the
support and comfort of individuals
undergoing an exposure
10. Definitions (Continued)
Clinical audit: means a systematic examination or
review of medical radiological procedures which
seeks to improve the quality and outcome of
patient care through structured review, whereby
medical radiological practices, procedures and
results are examined against agreed standards for
good medical radiological procedures, with
modification of practices, where indicated, and the
application of new standards if necessary.
11. Definitions (Continued)
There are no detailed requirements for
clinical audit in the regulations.
However, it is recommended that the use of
radiation is included in any clinical audits
you carry out
12. Definitions (Continued)
Diagnostic reference levels: (DRL) means
dose levels in medical radiodiagnostic or
interventional radiology practices, for typical
examinations for groups of standard-sized
individuals or standard phantoms for
broadly defined types of equipment.
13. Definitions (Continued)
There are no dose limits for medical
radiation exposures but DRLs are used as a
benchmark for dose audit locally and
nationally.
14. Dose constraint: means a restriction set on
the prospective doses of individuals which
may result from a given radiation source.
Again, as there are no formal dose limits, we
can set prospective benchmark doses
This can be useful such as for carrying out a
new technique
Definitions (Continued)
15. Definitions (Continued)
Employer: means any person who, in the
course of a trade, business or other
undertaking, carries out (other than as an
employee), or engages others to carry out,
those exposures described in regulation 3
(i.e. exposures covered by IR(ME)R) or
practical aspects, at a given radiological
installation.
17. Equipment: Means equipment that delivers
ionising radiation to a person undergoing
medical examination and equipment which
directly controls the extent of such exposure.
That means any part of the imaging system
that can affect the patient dose.
Definitions (Continued)
18. Definitions (Continued)
Ethics committee: in these Regulations
means an ethics committee established or
recognised in accordance with Part 2 of the
Medicines for Human Use (Clinical Trials)
Regulations 2004(a)
19. Definitions (Continued)
Evaluation: means interpretation of the
outcome and implications of, and of the
information resulting from, an exposure.
This could be a formal report, or an
evaluation of the outcome recorded in the
patient’s notes after a procedure is carried
out
20. Definitions (Continued)
Health screening: means a procedure for
early diagnosis in population groups at risk
Interventional radiology: means the use of
x-ray imaging techniques to facilitate the
introduction and guidance of devices in the
body for diagnostic or treatment purposes
21. Definitions (Continued)
Individual detriment: means clinically
observable deleterious effects in individuals
or their descendants, the appearance of
which is either immediate or delayed and, in
the latter case, implies a probability rather
than a certainty of appearance.
22. Definitions (Continued)
Medical Physics Expert: (MPE) means an
individual or a group of individuals, having
the knowledge, training and experience to
act or give advice on matters relating to
radiation physics applied to exposure, whose
competence in this respect is recognised by
the Secretary of State
The role of the MPE is now much greater
than previously.
23. Definitions (Continued)
Non-medical Imaging Exposure: means any
deliberate exposure of humans for imaging
purposes where the primary intention of the
exposure is not to bring a health benefit to
the individual being exposed.
24. Operator: means any person who is entitled, in
accordance with the employer’s procedures, to
carry out practical aspects including those to
whom practical aspects have been allocated.
This includes medical physics experts and, except
where they do so under the direct supervision of a
person who is adequately trained, persons
participating in practical aspects as part of
practical training.
Definitions (Continued)
25. Definitions (Continued)
This means an operator is someone who
makes the exposure, sets up the equipment
etc.
After completing this course, you will not be
able to carry out the role of operator
unsupervised until you have completed
sufficient practical training.
26. Practical aspects:
This primarily deals with the carrying out medical
radiation exposures
However, it also includes any supporting actions
that can affect the exposure
It also includes processing, manipulating and
evaluating images, checking and calibrating
equipment etc.
Definitions (Continued)
27. Practitioner: means a registered health care
professional who is entitled in accordance
with the employer’s procedures to take
responsibility for an individual exposure.
Often the term ‘IRMER Practitioner’ is used.
This course will train you to carry out the
role of IRMER Practitioner
Definitions (Continued)
28. Definitions (Continued)
Quality assurance: means all those planned
and systematic actions necessary to provide
adequate assurance that a structure, system,
component or procedure will perform
satisfactorily in compliance with generally
applicable standards and quality control is a
part of quality assurance
Note that QA of procedures and equipment
is now covered by IRMER
29. Definitions (Continued)
Referrer: means a registered health care
professional who is entitled in accordance
with the employer’s procedures to refer
individuals for exposure to a practitioner.
It is most likely that you will also take the
role of referrer for the medical exposures
that you carry out
30. Duties of the Employer
The regulations put a number of duties on
the employer
The employer may be a large NHS Trust,
private company, or could be an individual
in private practice
In most cases, the role of carrying out the
employer duties will be delegated
31. Duties of the Employer (Continued)
IRMER procedures need to be written as
given in Schedule 2 of the Regulations
These are overarching procedures for all
medical exposures
A summary list of the Schedule 2 Procedures
is included at the end of this presentation
32. Duties of the Employer (Continued)
These procedures will already exist where
medical radiation exposures are currently
carried out, but may need modifying.
The employer must takes steps to ensure
referrers, practitioners and operators comply
with written procedures.
33. Duties of the Employer (Continued)
Employers must ensure that Practitioners
and Operators are adequately trained
Larger employers will have guidance on the
minimum requirements for training
You will need to ensure that your employer
recognises the IRMER training you receive
34. Duties of the Employer (Continued)
Employers must ensure that Practitioners and
Operators carry out relevant Continuing
Professional Development (CPD)
It is important that you carry out appropriate CPD
to maintain your competence under these
regulations
There is no formal requirement for refresher
training, but it is one way of achieving suitable
CPD
35. Duties of the Employer (Continued)
There need to be Clinical Protocols in place
that define how each type of examination is
carried out
These will need to be specifically written for
each procedure that you carry out.
These do not need to be over long or
excessively detailed
36. Duties of the Employer (Continued)
The easiest way to write a clinical protocol is
to imagine you are explaining how to do a
procedure to a new colleague.
You then simply write down the necessary
setup and steps of the procedure, plus where
imaging is used etc, such that they could
follow it in practice.
37. Duties of the Employer (Continued)
Referral criteria need to be written stating
the reasons for carrying out a procedure.
These need to be specific for each
procedure you employ.
These are still required even if the referrer,
operator and practitioner is the same
person!
38. Duties of the Employer (Continued)
As for the clinical protocols, if you were to
explain to a colleague what clinical
indications are required for a particular
procedure, and write them down, that will
suffice.
These likewise do not need to contain
excessive detail
39. Duties of the Employer (Continued)
Quality Assurance programmes need to be
established
For these regulations this means keeping
both the procedures etc. up to date and
routine checking of the equipment
40. Duties of the Employer (Continued)
Diagnostic Reference Levels need to be set
for all procedures
This entails recording dose information for
at least ten (preferably 20) typical examples
of each procedure
You would then need to round up the
doses to a sensible value as the DRL
41. Diagnostic Reference Levels
They are not dose limits, but an audit tool to
be used retrospectively
They are not intended to be used to assess
the dose to individual patients
They can be exceeded for specific
techniques on specific equipment where
everything has been done to reduce the dose
42. Duties of the Employer (DRL)
The units used to set your DRL values can
be in Dose Area Product (if this is recorded
on your equipment) or screening time in
seconds.
You will then need to audit typical doses
every three years
Compare these with national DRLS where
they are available.
43. Duties of the Employer (DRL)
If DRLs are consistently exceeded for
typical procedures, a review of equipment
and techniques will be required
44. Duties of the Employer (Continued)
Dose constraints must be set for research
giving no direct benefit to the individual
Most research exposures will be of benefit to
the patient
Large employers will have existing suitable
guidance available
45. Carers and Comforters (see
definition above)
For Mini C Arms, this includes someone
who supports the patient (physically,
emotionally, or a chaperone).
Dose constraints need to be set for carers
and comforters based on suitable risk
assessments.
46. Duties of the Employer (cont)
“A dose constraint must be established in
terms of individual patient effective or
equivalent doses over a defined appropriate
time period.”
At this stage, we don’t know how this may
be applied to Mini C Arms!
47. Duties of the Employer (Cont)
The employer must take measures to raise
awareness of the effects of ionising radiation
amongst individuals capable of childbearing
A procedure for dealing with women of
childbearing age is required in Schedule 2 of
the regulations.
48. Duties of the Employer – Clinical
Audit
Procedures must include carrying out
clinical audit
This means taking the use of radiation into
account during any clinical audit
Or a specific audit of using the Mini C
Arm on groups of patients.
49. Duties of the Employer (cont.)
There needs to be a system to investigate
where an overexposure of a patient is
suspected.
This includes a means of informing the
referrer, practitioner and the patient (or their
representative) of any clinically significant
accidental exposure.
50. Overexposure From CQC
Guidance has been issued on exposures
‘much greater than intended’ (MGTI) and
gives a multiplying factor where relevant
The multiplying factors vary according to
the type of exposure and the circumstances
For Mini C Arms, a factor of 20 can be
applied in most cases
51. Table 1 – Examples of unintended medical exposures
that require notification
Example When to notify (what constitutes an
exposure much greater than
intended)
Wrong patient exposed All cases – regardless of dose
Wrong examination including incorrect
body part or modality.
Excluding diagnostic imaging laterality
errors in the anatomy distal to the hip
and shoulder. These incidents do not
require notification but should be
investigated locally.
Apply guideline factors in Table 2
(20 times the intended dose)
Timing errors when an additional
unintended examination is undertaken
e.g. outside clinically acceptable time
frame of the intended date
Apply guideline factors in Table 2
(20 times the intended dose)
52. Where an incident involves exposure of
several people to an extent that is greater
than intended (but less than the guideline
factors) as a result of a systematic process
or clinical failure
All cases – regardless of dose
Failure to follow procedure regarding
pregnancy and breastfeeding enquiries
resulting in an unintended exposure to the
foetus or unintended exposure of a child
through breastfeeding
All cases – regardless of dose
Unintended foetal exposure where there
was no failure to follow procedure
regarding pregnancy enquiries
When the foetal dose is greater than
10 mGy
Any other situation where a patient has
been exposed to ionising radiation, which
in the judgement of the employer, is much
greater than was intended for that patient
All other cases – regardless of dose
at the employer’s discretion
53. Table 2 – Guideline factors for diagnostic procedures
TYPE OF EXAMINATION/TREATMENT MULTIPLYING
FACTOR
Low dose examinations, where the intended dose is
less than 0.5mSv, to include DEXA, skull, dentition,
chest, in-vitro nuclear medicine
20
Note that the CQC is required to disseminate
information learned from reported incidents
54. Duties of Employer (cont)
Note that overexposure excludes ‘technical
repeats’
e.g. anatomy missed off, patient movement.
Where an investigation shows that the
exposure was MGTI, the incident needs to
be notified to CQC
You should consult your Medical Physics
Expert during any investigations.
55. Duties of the Practitioner, Operator
and Referrer
The practitioner and operator must comply
with the procedures and protocols discussed
above.
The practitioner and operator must also co-
operate with other specialist staff involved in
a medical exposure
56. Duties of the Practitioner
The practitioner is responsible for justifying
the exposure as giving a ‘net benefit’
They are individually responsible for the
exposure
The Practitioner also has to authorise the
exposure (but see below), and may allocate
‘practical aspects’ to operators
57. Duties of the Practitioner (continued)
The Practitioner must take any data
supplied by the referrer into account when
deciding if an exposure is justified or not.
This is primarily to avoid unnecessary
exposures.
58. Duties of the Operator
The operator is responsible for any Practical
Aspects that they carry out.
The operator is responsible for ensuring the
exposure has been authorised by the
practitioner after it has been justified.
There needs to be a record of authorisation
59. Duties of the Operator (continued)
The operator may not carry out a medical
exposure unless:
It has been authorised by the practitioner
or fits the authorisation guidelines (see
below)
Research exposures must have been
approved by an ethics committee.
60. Duties of the Operator (continued)
However:
“Where it is not practicable for the
practitioner to authorise an exposure,
the operator shall do so in accordance
with guidelines issued by the
practitioner.”
61. Duties of the Referrer
The referrer shall supply the practitioner
with sufficient medical information relevant
to the requested examination.
This should allow the practitioner to decide
on whether the exposure is justified.
In most cases where the same person is
practitioner and operator, the referral
information still needs to be recorded
62. Justification of individual exposures
must take account of:
The examination’s objectives and the
individual’s characteristics
The benefits of the exposure to the
individual and society as a whole and the
individual potential detriment
The risk, benefit and efficacy of alternative
techniques with less or no radiation dose.
63. Justification of individual
exposures must take account of:
Research exposures have been approved by
an ethics committee
Non-medical exposures must comply with
the procedures previously written for them
Consideration must be given to women of
childbearing age
64. Justification of individual
exposures must take account of:
Asymptomatic individuals for the early
detection of disease, health screening etc.
The specific requirements for individual
patients outside of normal guidance.
Guidance issued by scientific societies,
relevant bodies of the Secretary of State
65. Women of Childbearing Age
The exposure to expectant mothers and the
unborn child has to be considered.
The foetus is treated as an individual
For extremity work, the risk to the foetus is
negligible: this needs to be reflected in your
local procedures
66. Women of Childbearing Age
Justification and authorisation needs to take
the urgency of the exposure into account
Where examinations take place on pregnant
patients, optimisation is important
In some cases (severe trauma) it will not be
possible to establish pregnancy first
67. Exposures of Carers and Comforters
must take into account:
The direct benefit to the patient (e.g. better
able to achieve the desired outcome)
Any benefits to the Carer/Comforter (as a
result of the outcome to the patient
themselves).
Any detriments to either patient or carer.
68. Optimisation
Optimisation means that doses to patients
are kept as low as reasonably practicable
(ALARP) consistent with the intended
diagnostic purpose.
The practitioner and operator can have a
role in optimisation
You also need to adhere to DRLs
69. Optimisation (Cont)
The operator has to select equipment and
techniques to minimise the radiation dose to
the patient.
For example using a Mini C Arm!
Also, clinical protocols are written in terms
of what exposures are normally required and
general ‘good radiography practice’.
70. Optimisation for Research
For research, the practitioner shall ensure:
that the individuals participate voluntarily
(including mental capacity issues).
that they are informed in advance of the risk
of the exposure
Exposures of any Carers and Comforters
must be included in the employer’s
procedures
71. Optimisation for Research (continued)
Dose constraints are adhered to where there
is no net benefit to the individual – these
should be set by the employer and be found
in local policies.
Where the research will have net benefit to
the patient an individual ‘target dose’ must
be planned.
72. Optimisation for Research (continued)
All of the above need to be dealt with in
consultation with the lead Medical Physics
Expert and Clinical Radiation Expert for the
trial.
Details of how you will comply need to be
included in the ethics application.
73. Typical flow from referral to x-ray
A referrer makes a request according to the
referral criteria
The Practitioner will justify the exposure
and may directly authorise it (e.g. CT scan)
In many cases the operator will authorise
exposures according to guidelines
The operator will carry out the exposure on
the patient
74. Operator
May Authorise X-ray the Patient
Practitioner
Justify May Authorise
Referrer
Referral Clinical Information
75. How does this differ for Mini C Arms?
Often the surgeon will act as referrer
practitioner and operator
In individual private practice you may also
be the employer!
The regulations still require that written
systems are in place and adhered to.
76. Clinical Evaluation
A clinical evaluation of the outcome of
each medical exposure must be
carried out (except for
carers/comforters)
This may be a ‘report’ or other record
in the patient notes
Reporting is an operator role
77. For fluoroscopy:
Turning off automatic exposure
controls must be justified
As part of practical training, you will
need to be familiar with any
circumstances requiring manual
setting of exposure factors
78. Medical Physics Expert
The employer is required to have the services
of ‘Medical Physics Experts’ for consultation
on:
Optimisation of dose/image quality
Patient dose measurements and DRLs
Quality assurance of equipment
Acceptance testing of equipment
Specifications for equipment/installations
79. Medical Physics Expert
Surveillance of installations
Analysis of accidental exposures
Equipment to measure patient doses
Training of Practitioners and others
Advising the employer on complying with
the IR(ME) Regulations.
Cooperate with the Radiation Protection
Adviser
80. Equipment
The employer needs a programme of quality
assurance for equipment.
The QA needs to include measuring doses
to patients from that equipment.
Testing equipment before use.
81. Equipment (Continued)
An up to date inventory of radiological
equipment must be kept, and made
available to the relevant authority, including
Name of manufacturer
Model number
Serial number or other unique identifier
Year of manufacture
Year of installation
82. New Equipment
Equipment used for interventional radiology
must have a device or other feature capable
of informing any person involved in the
conduct of an exposure of the amount of
radiation produced by the equipment during
such an exposure.
New mini C Arms have a means of
indicating patient dose for the procedure
83. New Equipment (continued)
Where appropriate, have the capacity to
transfer this information to the record of a
person’s exposure.
It is not yet clear how this will be applied to
Mini C Arms, but new equipment will be
able to do this.
84. Training
Practitioners and operators must have been
adequately trained.
There is no fixed requirement in the
Regulations
A suitable certificate from a competent body
will be evidence of adequate training
85. Training (continued)
This course covers only the theoretical
aspects of using the equipment
The employer must keep training a record
for all practitioners and operators
It must show the dates on which training
was completed and the nature of the
training.
86. Training (continued)
In order for your employer to comply with
the regulations, you will need to provide
evidence of training
In addition to this course, you will need to
make a log of practical training locally
This will need to be endorsed by someone
approved by your employer
87. Training (continued)
Trainees can carry out exposures under
supervision as part of their training
Schedule 3 of the Regulations gives details
of the necessary subjects for training
Practitioners and Operators.
88. Training Records
The employer must keep up to date training
records for Practitioners and Operators
These must be available for inspections!
Where people work for more than one
employer, the primary employer is required
to keep the records.
89. Employer’s Procedures (Schedule 2)
The written procedures for medical exposures
shall include (brief summary) -
Identify the patient
identify individuals entitled to act as referrer
or practitioner or operator
Females of childbearing age
Ensure QA Procedures are followed
Assessment of Patient Dose
90. Employer’s Procedures (Schedule 2)
Use and setting of DRLs
Dose constraints for research giving no net
benefit.
(Information to patients receiving
radioactive materials)
Information to patients/representative on
risks/benefits prior to exposures where
practicable.
91. Employer’s Procedures (Schedule 2)
Clinical evaluation of images including,
where appropriate, factors relating to patient
dose
Minimising incidents, so far as practicable.
92. Employer’s Procedures (Schedule 2)
Ensure referrer, practitioner and patient (or
their representative) are informed of
clinically significant untoward incidents
Procedures to be observed for non-medical
imaging
To establish dose constraints and guidance
for carers and comforters.
93. Measuring patient doses
The employer has the responsibility for dose
monitoring
Mini C Arms often have an audit mode that
allows doses to be reviewed later, otherwise
records need to be kept for each patient.
A system of local collation and review
should therefore be established.
94. Measuring Patient Dose
There are two official methods of
measuring patient dose
These is defined in the ‘National
protocol for patient dose measurements
in diagnostic radiology’.
95. National Protocol for Dose
Measurement
Sets out clear and unambiguous quantities
Must be easy to measure
Can then collate figures Nationally
Use data to set National Diagnostic
Reference Levels where possible
96. Measuring patient doses
The Ionising Radiation (Medical Exposures)
Regulations call for:
Diagnostic Reference levels to be set for
typical examinations locally
Doses to be monitored, reviewed & collated.
Persistently exceeding reference levels to be
investigated.
97. ENTRANCE SURFACE DOSE:
It is defined as the absorbed dose to air
at the point of intersection of the X-ray
beam axis with the entrance surface of
the patient, including backscattered
radiation.
It is measured in mGy or µµµµGy
98. DOSE-AREA PRODUCT:
It is defined as the absorbed dose to air
averaged over the area of the X-ray beam in
a plane perpendicular to the beam axis,
multiplied by the area of the beam in the
same plane.
It may be expressed in Gy cm2, cGy cm2
mGy cm2 or µµµµGy m2
99. Dose Area Product Meter
cGy cm2
X-RAYTUBE
ION CHAMBER
PATIENT
ELECTRONICS/
READOUT
100. Dose Area Product
DAP relies in the
inverse square law
As the dose decreases,
the area increases
Multiplying them
together gives a
constant value
101. Dose Area Product
It is recommended that Dose Area Product
is used to record patient dose.
It is available on most existing equipment.
It gives the most convenient overall
indication of the dose to the patient from a
procedure.
