Regulatory Aspects and
Radiation Protection in
Medicine
Outline
• Introduction
• Applications of radiation sources in Medicine
• Radiation protection
• Regulatory framework
• Conclusions
Application of Radiation in Medicine
Radiation in Medicine
Diagnostic Therapy
Diagnostic Nuclear Medicine Radiotherapy Nuclear Medicine
Radiology
Teletherapy Brachytherapy
51 centers
>50, 000 143facilities (includes
equipment 836 equipment in 352 facilities diagnostics)
Radiotherapy
An estimated 5.1 million courses of radiotherapy treatment were
administered annually between 1997 and 2007.
UNSCEAR 2008 Report
Every year, 1 million new cancer cases are detected in India of which
40,000 cancer cases occur in children.
TMH,Mumbai Report
Over the last three decades, at least 3000 patients have been
affected by radiotherapy incidents and accidents.
These accidents do not affect patients directly (e.g. harm and
death), but might also undermine the public’s confidence in the
treatment.
Preventable medical errors overall also cost countries billions of
dollars each year.
IAEA
Diagnostic Radiology
An estimated 3.6 billion (3.1 medical and 0.5 dental) x-ray examinations
were undertaken annually in the world between 1997 and 2007.
Total annual collective effective dose to the global population (6,446
millions) from diagnostic medical exposures was estimated to be 4000
x103 manSv .
Annual per caput effective dose is 0.62 mSv.
CT scanning accounts 43% of the total collective effective dose due to
diagnostic medical radiology.
UNSCEAR 2008 Report
Nuclear Medicine
• Nuclear medicine includes all uses of unsealed radioactive sources
for diagnostic and therapeutic purposes.
• An estimated 33 million diagnostic nuclear medicine examinations
performed annually worldwide.
• Annual collective effective dose to the world population due to
diagnostic nuclear medicine examinations is estimated to be 202
x103 manSv.
• For diagnostic nuclear medicine, the main contribution to the
collective effective dose arise from Tc-99m bone scans, Tl-201
cardiovascular studies and iodine thyroid scans.
UNSCEAR 2008 Report
Global Increase in Diagnostic X-ray
Examinations
(Ref.UNSCEAR 2008 Report : Diagnostic X-ray examinations )
Year Annual Number of Annual Frequency Annual per capita
Exams (MM) per 1,000 Dose (mSv)
population
1998 1,380 280 0.35
1993 1,600 300 0.3
2000 1,960 330 0.4
2008 3,143 488 0.62
Increasing dose ..because of..few reasons !
1. Shorter scanning times and thinner slices requires higher tube current
to maintain good image quality
2. For cardiac CT, excessive tissue overlap (low pitch) is aften required to
reduce motion artifacts-translates to higher patient dose
3. Image quality higher than necessary
4. Unjustified examinations ( reported cases > 30%)
5. Not using the features for dose reduction that the machine provides
Global Annual Collective Effective Dose
• World Population 6,446 million
• Annual collective effective dose (manSv)
Medical- 4000 x103 manSv
Dental- 11 x103 manSv
Nuclear Medicine- 202 x103 manSv
Total- 4200 x103 manSv
Annual per caput effective dose to the global population due to all
sources of ionization is 3.1 mSv.
Natural background radiation represents 2.4 mSv (79%) and diagnostic
x-ray examinations represents 0.66 mSv (20%) of the average annual
per caput dose to the global population.
UNSCEAR 2008 Report
Principles of Radiation Protection
• Justification- whether benefit of
use of radiation outweighs the
risk
• Optimisation- If exposure
justified, then keep it as low as
reasonably achievable (ALARA)
• Dose Limits- exposures should
be within the prescribed dose
limits
Adult Occupational Dose Limits
Lens
Whole Body (everything except extremities) 150 mSv
30 mSv maximum per year (New limit
20 mSv/y
20 mSv averaged over 5 years
to be
adopted)
Skin of the Whole Body
500 mSv per year
Extremities
500 mSv per year
• In case of a WOMAN worker of Reproductive age
, once PREGNANCY has been established, the
Conceptus shall be protected by applying
Supplementary Equivalent Dose Limit to the Surface
of the Women’s Abdomen (Lower Trunk) of 1 mSv
for the remainder of the pregnancy.
• Dose constraints for comforters and visitors of patients:
5 mSv for adults and 1 mSv for children.
• Diagnostic Reference levels / Guidance Levels
(Radiography, Fluoroscopy, CT & Cardiology
procedures, Nuclear Medicine)
Public Dose Limits
Lens
Whole Body (everything except extremities) 15 mSv
1 mSv per year
Skin of the Whole Body
50 mSv per year
Extremities
50 mSv per year
Average annual occupational exposures in various
practices using radiation sources (2012)
Radiation No. of persons Annual average
practice monitored dose (mSv)
Industrial radiography 7253 0.58
Radiation therapy 9270 0.29
Nuclear Medicine 1989 0.49
Diagnostic Radiology 50868 0.38
Research 4139 0.10
Why regulatory control over radiation
facilities is necessary?
• To ensure that radiological risk from radiation facilities
(e.g. radiotherapy, nuclear medicine, medical x-ray
room, industrial radiography, radiation processing
plants, nucleonic control systems etc.) is prevented
and/or minimized .
• To ensure that radiation sources/equipment are safely
handled, stored, transported and disposed off.
• To ensure that the prescribed dose limits are not
exceeded to occupational workers and the public.
• To ensure that radiation sources do not become
orphan /vulnerable.
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Structure of Legal Framework
Principal requirements Legislation
Atomic Energy Act 1962
Detailed requirements Regulations
AE(RP)R, 2004
Practice specific
requirements Codes of practice
or guidance Practice Specific
(Safety Code on IR)
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Atomic Energy (Radiation Protection) Rules, 2004
(AE(RP)R, 2004)
• Published in August 25, 2004 as GSR 303
• Main basis of Regulatory Framework for Radiation Protection
in India
• Issued under following Sections of Atomic Energy Act, 1962
-- Section 30
-- Section 14
-- Section 16
-- Section 17
Objective
• Establishment of statutory requirements for the
control of practices adopted and interventions
applied with respect to radiation sources and extend
to whole of India.
• Issuance of licence from the Competent Authority.
• The terms and conditions of licence ensure the
compliance with requirements laid down in the
safety standards and safety codes issued under
AE(RP)R, 2004.
Atomic Energy Regulatory Board
(AERB) – the National Regulatory Authority
• AERB constituted in 1983.
• Chairman, AERB is the
Competent Authority for radiation
protection in India to enforce
AE(RP)R-2004.
• The mission of the Board is to
ensure that the use of ionizing
radiation and nuclear energy in
India does not cause undue risk to
health and the environment.
Regulatory Control
Consenting /Licensing Regulatory
process Inspections
Replacement of
Authorizat decayed Decommissioning
Layout ion for Commissio of Unit/
Operation source and
Approval Source/ ning disposal of Installation
Unit disused source
Licence in accordance with AE(RP)R, 2004 from AERB is
mandatory requirement for the procurement and use of
radiation sources in India.
21
Emergency Response Plans and
Preparedness
• Rule – 33 of Atomic Energy (Radiation
Protection) Rules, 2004
• Objective :
“To mitigate radiological consequences of
accidents and prevent / minimise the normal
& potential exposures to workers, members of
the public & the environment”
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Security of radiation sources
… International concern !!!!
Why??
• Its hazardous material
• It can be used for anti-social activities by
adversaries
• May be used with explosives for making RDDs
• Its explosion may lead to severe social, economical,
political Impact
• Waste disposal issues after explosions
• Radiation fear in society
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e-Governance of AERB (e-LORA)
[e-Licensing Of Radiation Applications]
– Online registration of Institutions and radiation
professionals
– Electronic submission of applications for regulatory
clearances
– Online tracking of submitted applications
– e-Approvals
Conclusions
• The applications of ionising radiation for human welfare are well
established and are indispensable.
• It must be realized that radiation can be hazardous if not handled
judiciously.
• The effective regulatory framework for governing control over
radiation sources has been well established in the country.
• The high standard of safety in multifarious applications of
radiation can be achieved through the inherent built-in safety
features incorporated in the design and operational and
administrative controls.
• The prime responsibility for ensuring safety and security of
radiation sources rests with the operating organisation.
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• For more information , you may visit
AERB website at,
“www.aerb.gov.in”
Thank You!!
