safety legislation Flashcards
why do we need radiation safety legislation
Risks associated with exposure to X-rays
Regulations are designed to safeguard the health of patients, staff and members of the public
Typical dental X-ray exposure equivalent to 1.5 days or less of natural background radiation exposure
- Higher exposure levels in the past
starting point of radiation safety legislation
work of the International Commission for Radiological Protection, most recently published in ICRP103
- independent, international, non-governmental organization, with the mission to provide recommendations and guidance on radiation protection.
- comprised of over 200 volunteer members.
recommends a legal framework for Radiation Safety.
- ICRP refer to this as the “System of Radiological Protection”
basic principles of ICRP system of radiation exposures
Justified:
- They must do more good than harm
- There must be sufficient benefit to individuals or to society to offset any detriment
Optimised:
- The magnitude of radiation exposures, and the number of persons exposed, must be As Low As Reasonably Practicable, taking into account social and economic factors
Limited:
- A system of individual radiation dose limits is used to ensure no person
receives an unacceptable level of exposure
IAEA
International Atomic Energy Authority
“Model Regulations for the Use of Radiation Sources and for the Management of the Associated Radioactive Waste”
document is based on the ICRP recommendations. It is designed to be used as a template for radiation safety legislation around the world
UK legislation in diagnostic radiology
Ionising Radiations Regulations 2017 (IRR17)
Ionising Radiation (Medical Exposure) Regulations 2017 (IRMER17)
These are enacted under the Health and Safety at Work Act
IRR17
deals with occupational exposure and exposure of the general public
IRMER17
deals with medical exposures of patients
enforcement of IRR17
Health and Safety Executive
The employer is responsible for putting in place arrangements for compliance
Employees are responsible for following the safety arrangements
impact on dentists of IRR17
NHS is responsible for compliance as the employer
Private practice: Owner(s) responsible as the employer
Licensing (Regulation 6):
Employer must obtain Registration from HSE for the use of X-rays
- Obtained through HSE website by answering questions on compliance arrangements and paying £25
Note that for dentists, HSE Registration is required under IRR17 for the ‘use of a radiation generator’ – the X-ray unit
Radiation protection Advisor
RPA
should be consulted by a employer on certain matters
a certificate issued by ‘RPA2000’ based on portfolio of evidence, renewed every 5 years
- Designation of Areas
- Prior examination of plans for installations & acceptance into service of safety features & warning devices
- Regular equipment checks
- Periodic testing of safety features and warning devices
- Radiation risk assessment & dose assessment
- Investigations
- Contingency plans
radiation risk assessment
regulation 8
consider issues
- What safety features are required?
- What level of radiation exposure could staff receive?
Regulation 9 requires exposures to be restricted ALARP, and the risk assessment must consider how.
Adjacent areas must be protected, particularly when Cone-beam CT or OPT units are in use. An RPA will advise if additional plasterboard or lead is required in the walls.
controlled area
defined around the equipment, depending on the risk assessment & workload levels.
For intra-oral X-ray units this is often at 1.5m from the X-ray tube and within the primary beam.
For Cone-beam CT the entire room is normally a controlled area.
No-one should enter this area during exposure, unless special procedures are in place.
local rules
required for controlled area
key working instructions for safe work with the X-ray unit.
document
A Radiation Protection Supervisor must be appointed to oversee the arrangements.
training staff
IRR17
include basic radiation safety measures, any specific requirements for that workplace, basic understanding of risks and awareness of the regulations
dose limits
IRR17
Radiation workers: whole body limit of 6mSv/yr (unclassified staff)
Members of the public: whole body limit of 1mSv/yr
Dental staff dose levels should be far below the dose limits
who enforces IRMER17
Healthcare Improvement Scotland
- took over this role in December 2018 and have a team of 4 inspectors
Previously a single inspector carried out periodic inspections in Scotland, including dental practices.
CQC are the enforcement agency in England
who does IRMER17 apply to
various medically-related types of exposure
- Patients as part of diagnosis or treatment
- Health screening
- Research e.g. CT scans for pharmaceutical effect assessment
- Asymptomatic individuals
- Carers and comforters
- Individuals undergoing non-medical imaging using medical equipment
carers and comforters under IRMER17
individuals who are ‘knowingly and willingly’ exposed to ionising radiation through support and comfort of those undergoing exposure
Individuals acting as
Comforters or Carers are not those doing so as part of their employment
- relatives or friends of those undergoing exposure e.g. parent of child pt
non-medical imaging using medical radiological equipment e.g.
which do not confer a health benefit to the individual exposed
- health assessment for employment purposes
- health assessment for immigration purposes
- health assessment for insurance purposes
- radiological age assessment
- identification of concealed objects within the body.
employer role in IRMER17
putting in place arrangement for compliance
employee role in IRMER17
responsible for following arrangements made by employer
employer’s procedure
made by employer
how the regulations are complied with
regulations specify 14 particular procedures that must be in place e.g.
- patient identification
- entitlement of staff
- information provided to patients e.g. poster
4 duty holders defined in IRMER17
referrer
practitioner
operator
employer
dentist may perform all of them
basic framework for carrying out medical exposures
Referral for imaging, requested by a referrer
the examination must be justified by a practitioner who may also authorise it
the examination may be authorised and will be carried out by an operator
the image is assessed and reported by an Operator
the image and report are provided to the referrer
who is the referrer
Registered health care professional
Decide locally which groups can refer
responsibility of referrer
Responsible for providing ‘sufficient medical data’ to the Practitioner to enable justification
- Patient identification
- Clinical details
Employer must provide referral criteria
who is practitioner
Registered health care professional
Decide locally who performs this role
Must have ‘adequate training’
responsibilities of practitioner
Justification (and authorisation) of each exam
Ensure ALARP
Comply with Employer’s procedures
justification
Practitioner must take into account the information supplied by the Referrer and consider:
- The objectives of the exposure and the efficacy, benefits and risks of available alternative techniques
- All the potential benefits of carrying out the exposure, including the direct health benefits to the individual and the benefits to society
- The detriment to the individual
A Justified exposure must then be Authorised: it must be recorded that the exposure is justified and may proceed
who can carry out justification and authorisation
may be a 2-step process where it is not practicable for the Practitioner to carry out authorisation:
- Written Justification guidelines prepared by a Practitioner
- Authorisation as justified by an ‘Operator’ at the time of exposure
- Provided the referral meets the criteria in the written guidelines
what does a radiological exam need to be complete before it can happen
justification
steps for justification before exam
any requests with insufficient information must be referred back to the Referrer
any exams that the practitioner feels are not justified must be referred back to the Referrer
Exams must be authorised as justified before the exposure
who is the operator
anyone who carries out practical aspects that can affect patient dose is an Operator. They must be suitably trained e.g.
- person taking X-ray
- person performing QC on X-ray set
- person cleaning film processor
- person performing clinical evaluation
responsibilities of operator
to select equipment and methods to limit dose to patient consistent with the purpose
follow the Employer’s Procedures
must not perform exam unless authorised as justified
clinical evaluation
procedures by employer to ensure recorded both
- in department
- images sent externally
exposure cannot be justified if it is known clinical evaluation will not happen
how are roles undertaken in IRMER17
clearly entitled by employer with defined scope of practice
need training records
optimisation
required by IRMER17
exposures are as low as reasonably practicable, consistent with the intended purpose
This is a responsibility of both the Practitioner and the Operator
Consider
- Selecting appropriate investigations
- Selecting appropriate equipment
- Using appropriate exposure factors
- Ensuring QA is carried out
- Assessing patient dose
- Adherence to diagnostic reference levels
medical physics expert MPE
additional role specified in regulations
“an individual… having the knowledge, training and experience to act or give advice on matters relating to radiation physics applied to exposure, whose competence… is recognised by the Secretary of State”
Various roles described in the regulations, most notably
“involved as appropriate for consultation on optimisation
NHS GG&C, Health Physics MPEs provide advice on exposure factors and equipment-related matters
quality assurance of radiation equipment
The regulations specify that radiation equipment should be regularly tested to ensure it is working correctly and delivering the expected dose level.
Tests are normally split into:
- Routine local tests, carried out by local staff who normally operate the equipment,
- Physics tests, carried out every 1 to 3 years by specialist staff
diagnostic reference levels
DRLs guideline dose levels for “standard sized” patients undergoing typical examinations.
They can be used as a benchmark against national and local practice.
Some equipment displays a ‘dose indicator’ following an exposure which can be compared against a DRL
For other equipment, dose levels using typical settings are checked during annual or 3-yearly physics QA tests
UK values online
what regulation outlines tests required and recommended for radiation equipment
IPEM91
IR17 summary
Regulates radiation safety of staff and members of the public
Controlled areas with local rules are defined around the equipment
Risk assessments are used to evaluate control measures
IRMER17 summary
Governs medical exposures of patients and others
Exposures must be justified and optimised
Staff must be trained and entitled
