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National Radiation Protection Authority

protecting people and the environment against the harmful effects of radiation

Overview of Medical Exposure


in Namibia

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Scope of presentation
Legislative Instruments
Medical exposure control regulations
Current activities in Medical exposure
optimisation
Way forward

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

REGULATORY TOOLS

Institution Responsible for Administration of Legal Instruments

Atomic Energy Board National Radiation Protection


Authority

Advisory Body on all matter Regulatory Body -


relating to nuclear energy and controlling and monitoring
radiation sources activities associated with
radiation

Recommend Regulations and Ensure compliance with


Standards for Protection Against regulatory requirements
Radiation
National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Purpose of Atomic Energy & Radiation Protection Act

to minimize the exposure of persons and the environment


in Namibia to the effects of harmful radiation

to ensure that adequate control is exercised over the


possession, production, processing, sale, export and
import of radiation sources and nuclear material;

to create the necessary mechanisms to facilitate the


compliance with the obligations of Namibia under
international agreements relating to nuclear energy,
nuclear weapons and protection against the harmful
effects of radiation.
National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

REGULATORY TOOLS

Institution Responsible for Administration of Legal Instruments

Atomic Energy Board National Radiation Protection


Authority

Advisory Body on all matter Regulatory Body -


relating to nuclear energy and controlling and monitoring
radiation sources activities associated with
radiation

Recommend Regulations and Ensure compliance with


Standards for Protection Against regulatory requirements
Radiation
National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Medical Exposure control

Chapter 7

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

TOPICS
Definition
Medical Exposure Responsibilities
Radiation Protection
Requirements - Justification
Optimization of Protection for
Medical Exposure
Dose Constraint
Guidance Levels
Investigation of Accidental
Medical Exposures

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Overview/Objective
To become familiar with the Regulation
requirement for medical exposure and
investigation modalities associated to
unwanted exposure.

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Definition
Medical Exposure means:
Exposure incurred by human patients as part of
their own medical diagnosis or treatment
By person (other than those occupationally
exposed) while voluntarily helping in support and
comfort of patients
By volunteers in a programme of biomedical
research involving their exposure

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Medical exposure responsibilities (Reg 33)


LICENSEES SHALL ENSURE THAT:
No patient be administrated a diagnostic or therapeutic medical
exposure unless the exposure is prescribed by a medical
practitioner

Medical practitioners be assigned the primary task and obligation


of ensuring overall patient protection and safety in the prescription
of, and during the delivery of, medical exposure
Medical and paramedical personnel be available as needed, and
either be health professionals and have appropriate training
adequately to discharge assigned tasks

For therapeutic uses of radiation, the calibration, dosimetry and quality


assurance requirements of the Standards be conducted by or under
the supervision of a qualified expert in radiotherapy physics

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Medical exposure responsibilities (Reg 33)


LICENSEES SHALL ENSURE THAT:
The exposure of individuals incurred knowingly
while voluntarily helping in the care, visit, support
or comfort of patients undergoing medical
diagnosis or treatment be constrained so that it is
unlikely that her or his dose will exceed 5 mSv
during the period of a patients diagnostic
examination or treatment.

Training of personnel is carried out appropriately

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

JUSTIFICATION (Reg 34)


GENERIC MATTER
No practice or source within a practice should be authorized
unless the practice produces sufficient benefit to the exposed
individuals or to society to offset the radiation harm that it might
cause i.e.: unless the practice is justified, taking into account
social, economic and other relevant factors

MEDICAL EXPOSURE
Medical exposure should be justified by weighing the diagnostic
or therapeutic benefits they produce against the radiation
detriment they might cause, taking into account the benefits and
risk of available alternative techniques that not involve medical
exposure

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

JUSTIFICATION (Reg 34)


MEDICAL EXPOSURE
In justifying each type of diagnostic examination by radiography,
fluoroscopy or nuclear medicine, relevant guidelines will be taken
into account, such as those established by the WHO
Any radiological examination for occupational, legal, or health
insurance purposes undertaken without reference to clinical
indications is deemed to be not justified unless it is expected to
provide useful information on the health of the individual examined
or unless the specific type of examination is justified by those
requesting it in consultation with relevant professional bodies
Mass screening of population groups involving medical exposure is
deemed to be not justified unless the expected advantages for the
individual examined or for the population as a whole are sufficient to
compensate for the economic and social costs, including radiation
detriment
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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

JUSTIFICATION (Reg 34)


MEDICAL EXPOSURE
The exposure of humans for medical research is
deemed to be not justified unless it is:
If Justified Approval must be granted by the Regulatory
Authority

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

OPTIMIZATION FOR PROTECTION (Reg 35)


Equipment used in medical exposure should be so
designed that:
failure of a single component of the system be promptly
detectable so that any unplanned medical exposure of patients
is minimized
the incidence of human error in the delivery of unplanned
medical exposure be minimized

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

OPTIMIZATION FOR PROTECTION (Reg 35)


Licensees must ensure that x-ray equipment

Whether imported into or manufactured in the country where it is


used, the equipment conform to applicable standards (IEC, ISO)
Performance specifications and operating and maintenance
instructions be provided in a major word language understandable to
the users and in compliance with the relevant IEC and ISO
standards
Radiation beam control mechanisms be provided (devices indicating
clearly and in a fail-safe manner whether the beam is on or off)
As nearly as practicable, the exposure be limited to the area being
examined by using collimating devices aligned with the radiation
beam
The radiation field within the examination area without any radiation
beam modifiers (wedges) be as uniform as practicable and the non
uniformity be stated by the supplier
Exposure rate outside the examination area due to radiation leakage
or scattering be kept as low as reasonably achievable
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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

OPTIMIZATION FOR PROTECTION (Reg 35)


Licensees must ensure that x-ray equipment
Radiation generators and their accessories be designed and
manufactured so as to facilitate the keeping of medical
exposures to the minimum necessary to obtain adequate
diagnostic information
Operational parameters (kVp, filtration, focal spot position,
source-image receptor distance, field size, either tube current
and time or their product) be clearly indicated
Radiographic equipment be provided with devices that
automatically terminate the irradiation after a preset time,
current-time product or dose
Fluoroscopic equipment be provided with a device that
energizes the X Ray tube only when continuously depressed
(such as a dead-mans switch and equipped with indicators of
the elapsed time and/or entrance dose monitors

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

OPTIMIZATION - OPERATIONAL
CONSIDERATIONS (Reg 35)
licensees should ensure for diagnostic radiology that:
The medical practitioners who prescribe or conduct
radiological examinations:
ensure that the appropriate equipment be used
ensure that the exposure of patients be the minimum
necessary to achieve the required diagnostic objective,
taking into account norms of acceptable image quality
take into account relevant information from previous
examinations in order to avoid unnecessary additional
examinations

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

OPTIMIZATION - OPERATIONAL
CONSIDERATIONS (Reg 35)
licensees shall ensure ... that:
The medical practitioner (radiologist), the radiographer or other
imaging staff select the following parameters such that their
combination produce the minimum patient exposure consistent
with acceptable image quality and the clinical purpose of the
examination
the area to be examined, the number and size of views
per examination and the fluoroscopy time
the type of image receptor (e.g. high v.s. low speed
screens)
the use of anti-scatter grids

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

OPTIMIZATION - OPERATIONAL
CONSIDERATIONS (Reg 35)
proper collimation of the primary X Ray beam to minimize the
volume of patient tissue being irradiated and to improve image
quality
appropriate values of operational parameters (kVp, mA)
appropriate image storage techniques in dynamic imaging
(number of images per second)
adequate image processing factors (chemicals, developer
temperature, )

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

OPTIMIZATION - OPERATIONAL
CONSIDERATIONS (Reg 35)
licensees should ensure . that:
Portable and mobile radiological equipment be used
only for examinations where it is impractical or not
medically acceptable to transfer patients to a stationary
radiological installation
Radiological examinations causing exposure of the
abdomen or pelvis of women who are pregnant or likely
to be pregnant be avoided unless there are strong
clinical reasons for such examination
Whenever feasible, shielding of radiosensitive organs
such as gonads, lens of the eye and thyroid be
provided as appropriate

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

OPTIMIZATION -QUALITY ASSURANCE (I)


Licensees should establish a comprehensive QA
program which should include:
measurements of the physical parameters of the
radiation generators, imaging devices at the time of
commissioning and periodically thereafter
verification of the appropriate physical and clinical
factors used in patient diagnosis or treatment
written records of relevant procedures and results
verification of the appropriate calibration and
conditions of operation of dosimetry and monitoring
equipment

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Dose constraints (Regulation 37)


Persons exposed to medical research
purposes not producing direct benefit to
exposed individual
Voluntary help in care, support and comfort
of patients undergoing medical exposure
Visitors to patients who have received
therapeutic amounts of radionuclides

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

GUIDANCE LEVELS (Reg 38)


The Regulatory Authority may determine guidance
levels.
Guidance levels to be used by all diagnostic
departments
corrective action be taken as necessary if doses fall
substantially below the guidance levels and the exposures do
not provide useful diagnostic information and do not yield the
expected medical benefit to patient
reviews be considered if doses exceed the guidance levels as
an input to ensuring optimized protection of patients and
maintaining appropriate levels of good practices
for diagnostic radiology, including CT and paediatric
examinations, the guidance levels be derived from the data
from wide scale quality surveys for the most frequent
examinations
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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Investigation of accidental medical


exposure (Reg 40)
licensees shall promptly investigate:
any diagnostic exposure substantially greater than
intended or resulting in doses repeatedly and
substantially exceeding the established guidance
levels
any equipment failure, accident error, mishap or
other unusual occurrence with the potential for
causing a patient exposure significantly different
from that intended.
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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Investigation of accidental medical


exposure (Reg 40)
licensees shall:
submit to the Regulatory Authority, as soon as
possible after the investigation or as otherwise
specified by the Regulatory Authority, a written report
which states the cause of the incident and includes
the information specified in (a) to (c), as relevant, and
any other information required by the Regulatory
Authority
inform the patient and his or her doctor about the
incident.

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Records (Regulation 41)


Licensee shall keep and make available records
of:
- Equipment calibration, clinical dosimetry,
quality assurance (etc.)
- and any necessary information to allow
retrospective assessments of doses
National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

RASIM
IAEA Tool
Evaluation of status of adequacy of radiation protection of
patients determined by 12 performance indicators

1.Regulations
2.Diagnostic Radiology - Qualified Staff
3.Diagnostic Radiology - Optimization
4.Optimization in Fluoroscopy
5.Optimization in Mammography
6.Optimization in Computed Tomography
7.Interventional Procedures Using X-ray Qualified Staff
8.Interventional Procedures Using X-rays-Optimization
9.Nuclear Medicine-Qualified Staff
10.Nuclear Medicine - Optimization
11.Radiotherapy - Qualified staff
12.Radiotherapy - Optimization
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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Way forward 2017-18


Optimisation in Radiology
Optimisation in Computed Tomography
Optimisation in Mammography

Developing DRLs

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Way Forward 2017-18


Phase 1
Frequency of examinations
Paediatric examinations frequency-
commence July 2017

Phase 2
DRLs CT Data collection and document
Document DRLs Diagnostic in progress
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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Phase 1 results
Frequency of X-ray 2010-2015
Number of facilities
80 % of diagnostic facilities

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Phase 1 results cont.

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Phase 1 results cont.

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Phase 1 results cont.

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Top 10 CT procedures 2016


Private top 10 Top 10 CT 2016
State top 10
Examinations Totals EXAMINATIONS S &P total
Examinations Totals
Admonen and 2068 Head/Brain 8423
Head/Brain 6659
Pelvis
Abdomen and 3518
Head/Brain 1764 Abdomen and 1450
Pelvis
Pelvis
Lumbar Spine 1540 Chest 1966
Sinus 618
(Abdomen)
Lumbar spine 1583
CT angiography 1276 CT Myelogram 353 (Abdomen)
( Abdomen,
Kidney, legs) CT angiography ( 1562
Lumbar Spine 1209 Mandible/xaxilla 329 Abdomen, Kidney,
(Spine) legs)
Facial bones 327 Sinus 1529
Chest 1171
Lumbar Spine 1522
CT angiography 1042 Lumbar Spine 313
(Spine)
(Pulmonary) (Spine)
CT angiography 1183
Sinus 911 CT angiography ( 286 (Pulmonary)
Abdomen, Kidney,
legs) High resolution 1000
High resolution 891
Cervical Spine 268 chest
chest
(Neck) Cervical Spine 739
Cervical spine 471
CT angiography 239 (Neck)
neck
(brain/neck)
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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

CT procedures 2016
Private State Total
16 637 13477 30 114

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

Summary
Discussed the legislative tools
Discussed the Regulations pertaining
to Medical Exposure
Current Status with regard to IAEA
Result of frequency of exams
Way forward with regard to DRLs

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National Radiation Protection Authority
protecting people and the environment against the harmful effects of radiation

QUESTIONS ?

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