REGULATION OF IONIZING RADIATION IN MEDICAL...

REGULATION

OF IONIZING RADIATION

IN MEDICAL FACILITIES

Asep Saefulloh Hermawan

Deputy Director for Licensing of Medical Facilities

Nuclear Energy Regulatory Agency of Indonesia

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IONIZING RADIATION

Types of ionizing Rad:

• Alpha Particles travel short distance, have large

mass and cannot even penetrate a paper, only

become a hazard when inside the human body

because they will disrupting living cells.

• Beta Particles electrons or positrons travelling at

very high energies, travel further than alpha particles.

In fallout can cause severe burns to the skin, known

as beta burn.

• Gamma Rays and X-Rays (photons) radiation

consist of packets of energy known as photons.

Photons have no mass and travel in straight lines.

Photons can penetrate deeply into human body. 3

IONIZING RADIATION

Sources

• Radioactive Material (Co-60, Cs-137, Ir-192,

Ra-226, Kr-85, I-131, etc)

• Ionizing Radiation Generator (X Ray Machine,

Linear Accelerator, etc)

Biological Effect

• Stochastic Effect (Leukemia, Cancer, Genetic

Effect, etc)

• Deterministic Effect (Catharacs, Sterility, etc)

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Ionizing Radiation Practices

• RADIOTHERAPY

• NUCLEAR MEDICINE

• DIAGNOSTIC RADIOLOGY

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• Medical speciality

involving the

application of

ionizing radiation for

treatment of disease

• In this treatment

ionizing radiation used

to kill cancer cell.

target Patient

Critical organ

Beam direction

RADIOTHERAPY

RADIOTHERAPY EQUIPMENT

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Medical speciality involving the

application of radioactive material

(radioisotope) for diagnosis and

treatment of disease.

NUCLEAR MEDICINE

NUCLEAR MEDICINE EQUIPMENT

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RADIOISOTOPE

GAMMA CAMERA

Field of medicine that uses imaging

exams and procedures to diagnose

patients using ionizing radiation (X-ray).

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Diagnostic Radiology

DIAGNOSTIC RADIOLOGY

EQUIPMENT

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UU No. 10 Th. 1997

Ketenaganukliran

Executing Body (Art. 3)

To execute the use of Nuclear Energy

BAPETEN

Regulatory Body

Act No. 10, 1997 On Nuclear Energy

BATAN

Executing Body (R&D, promotion, application)

Established based on President Decree No 76 Th. 1998

NUCLEAR ENERGY REGULATORY

AGENCY

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BAPETEN

The control for the use of ionizing radiation

carried out by Badan Pengawas Tenaga

Nuklir (BAPETEN) as the regulatory body

The control implemented through:

Establishing Regulation

Licensing service

Performing Inspection

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Pedoman/Juklak

CONSTITUTION

ACTS

GOVERNMENT REGULATIONS

BAPETEN CHAIRMAN DECREE

GUIDANCES

HIERARCHY OF NUCLEAR ENERGY REGULATIONS

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Regulations of ionizing

radiation in medical

1 Act Act No. 10 /1997 on Nuclear Energy

2 Government

Regulation (GR)

• GR No. 33/2007 on Safety of Ionizing Radiation and

Security of Radioactive Sources

• GR No. 29/2008 on licensIng of Ionizing Radiation

Sources and Nuclear Material

• GR No. 56/2014 on License Fee

3 BAPETEN

Chairman Decree

(BCR)

• BCR No. 8/2011 on Radiation Safety in Diagnostic

Radiology

• BCR No. 17/2012 on Radiation Safety in Nuclear

Medicine

• BCR No. 3/2013 on Radiation Safety in Radiotherapy

• BCR No. 9/2011 on Compliance Testing of X-Ray unit

• BCR No. 16/2014 on Working License for Radiation

Protection Officer

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Article 17

Any use of nuclear energy shall be subjected for licensing, except in certain cases that will be further stipulated by Government Regulation

Article 43

Any person who acts contraverse to the provision pursuant to article 17 shall be punished by fine not more than Rp. 100.000.000 or imprisonment for not more than 1 year.

Act No 10 year 1997

On Nuclear Energy

LICENSING

Flow Chart of Licensing Process

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INSPECTION

• Performed by Inspector to ensure the

compliance of regulation.

• Conducted periodically or at any time, with

or without notofication

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Period of Inspection

No Risk Practices Period

1 High • Radiotherapy

• Nuclear Medicine

Every year

2 Midle Interventional Radiology Once every 2 year

3 Low Diagnostic Radiology Once every 3-4 year

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CHALLENGES

• Number of user increase every year

• Technology Development (Tomotherapy,

Boron Neutron Capture Therapy,

Mammography NM, etc)

• Public demand regarding transparancy and

accountability of public service

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STRATEGIES

• Using online system for licensing

http://balis.bapeten.go.id

• Transfer knowledge with expert, vendor

• Intensive coordination with stakeholders

(ministry of health, customs, etc)

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Thank You

Contact us

Facebook: Subdit Perizinan Fasilitas Kesehatan BAPETEN

Twitter: @SDPFK_BAPETEN

Phone & Whatsapp: 087808780322

Helpdesk : (+62-21) 63854883, 63854879

a.hermawan@bapeten.go.id

+62815 1111 0163