Legislative requirements under Act 304

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LEGISLATIVE LEGISLATIVE REQUIREMENTS REQUIREMENTS UNDER THE ACT UNDER THE ACT 304 IN MEDICAL 304 IN MEDICAL

PURPOSES PURPOSES

RADIATION HEALTH & SAFETYMINISTRY OF HEALTH

MALAYSIA

CONTENTS• PURPOSES

• INTRODUCTION

• ACT & SUBSIDIARY REGULATIONS

• CONTROL&LICENSING

• RADIOLOGICAL PROTECTION SYSTEM OCCUPATIONAL EXPOSURE & MEDICAL EXPOSURE

• DOSE LIMITS

• DECOMMISSIONING OF IRRADIATING APPARATUS

• QUALITY AUDIT MANAGEMENTS

• CURRENT ISSUES

To informed the several elements of

legislative requirements in radiation

safety under the Atomic Energy

Licensing Act 1984(Act 304) for

medical purposes. This is to assure theradiation safety and protection to

occupational, member of publif as well

as patients.

PURPOSESPURPOSES THE USAGE OF IONIZING RADIATION

IN MEDICINE

• DIAGNOSIS

• THERAPY

• PREVENTION

• FORENSIC

• MEDICAL RESEARCH

Cont.

INTRODUCTIONINTRODUCTION

To ensure protection & safety from

the effecteffect of ionizing radiation :

(1) environmental; properties & member

of public;

(2) Occupational/radiation workers;

(3) Patient : optimize use and quality

OBJECTIVE OF RADIATION OBJECTIVE OF RADIATION SAFETY SAFETY

Good Regulatory Practice Cont.

To ensure that the

images produced

are of diagnostic

quality with the least

possible exposure tothe patient

OBJECTIVE OF RADIATION

IN MEDICAL - DIAGNOSTIC

Cont.

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(1) Lack of consensus regarding risk of

radiation exposure & appropriate

dose;

(2) Lack of access to patient information

(3) Improper devices;

(4) Lack of awareness of legislative

requirements and recommendations.

FACTORS CONTRIBUTING TO FACTORS CONTRIBUTING TO

UNNECESSARY EXPOSUREUNNECESSARY EXPOSURE

Good Regulatory Practice

∗ GAZETTED IN 28 JUN 1984

∗ AIM OF THE ACT 304 :

- TO PROTECT PERSONS AND THE ENVIRONMENT FROM THE HARMFUL EFFECTS OF PARTICULAR SOURCES OF IONIZING RADIATION

ATOMIC ENERGY LICENSING ACT (ACT 304)

ACT 304 & SUBSIDIARY REGULATIONSACT 304 & SUBSIDIARY REGULATIONS

Cont.

CONTINUE

ATOMIC ENERGY LICENSING ACT 1984 (ACT 304)

- repealed Radioactive Substances Act 1968;

- Act 304 was gazetted under the purview of MOSTIMOSTI;

- The Director-General of Health where the activity to be licensed or licensed under this Act is in respect of the usage of ionizing radiation for medical purpose as determined in Section 15 (2)Section 15 (2) Act 304;

- Radiation Safety Section, MOH is entrusted as the working committee for the D-G of Health, in all activities that related to the controlling of the use of ionizing radiation for medical purposes.

Cont.

ACT AND LEGISLATIVE REQUIREMENTS

1. RADIATION PROTECTION (LICENSING) REGULATIONS 1. RADIATION PROTECTION (LICENSING) REGULATIONS 19861986

2. RADIATION PROTECTION(TRANSPORT) 19892. RADIATION PROTECTION(TRANSPORT) 1989

3. ATOMIC ENERGY LICENSING (BASIC SAFETY 3. ATOMIC ENERGY LICENSING (BASIC SAFETY RADIATION PROTECTION) REGULATIONS 2010RADIATION PROTECTION) REGULATIONS 2010

4. RADIATION PROTECTION (RADIOACTIVE WASTE 4. RADIATION PROTECTION (RADIOACTIVE WASTE MANAGEMENT) REGULATIONS 2011MANAGEMENT) REGULATIONS 2011

5. 19 CURRENT KPK’s CIRCULARS, GUIDELINES AND 5. 19 CURRENT KPK’s CIRCULARS, GUIDELINES AND CRITERIACRITERIA

Cont

MALAYSIAN LEGISLATION HIERACHY

ACTACT

SUBSIDIARY REGULATIONSSUBSIDIARY REGULATIONS

CIRCULARS/ STANDARDS*/CIRCULARS/ STANDARDS*/

GUIDELINES*GUIDELINES*

LOCAL RULES/LOCAL RULES/

INSTRUCTION MANUALSINSTRUCTION MANUALS

11

22

33

44

Mandatory/Legally

Bound

Advisory

* Not regulatory by itself but becomes mandatory if linked to Regulations/Acts

SUBSIDIARY REGULATIONS

ii. Radiation Protection (Transport)

Regulations 1989

- Requirements for the transport of radioactive

material.

i. Radiation Protection (Licensing)

Regulations 1986 - Requirements for the application to the licence in

the use of ionizing radiation - classification of

licence, licence fees & forms

ContCont

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SUBSIDIARY REGULATIONS

iv. Radiation Protection (Radioactive Waste Management) Regulations 2011

- Requirements for all aspects of radioactive

wastewaste andand wastewaste managementmanagement arising fromthe medical, industrial and researchapplications and any other application

which may be specified by the Board.

iii. Atomic Energy Licensing (Basic Safety

Radiation Protection) Regulations 2010- Basic requirements for protection against the

risks associated with exposure to ionizing radiation

ContContContCont

RADIATION PROTECTION AND SAFETY (MEDICAL, DENTAL & VETERINARY

USAGE OF RADIATION) REGULATIONS 201x

- Meeting for amendment of the regulationin par with currentcurrent requirementrequirement && practicepractice

- More specific & comprehensiverequirements to control the use of ionizingradiation under the purview of the MOH(medical usage)

- Finalized in January 2014 at MOH’s level& submitted to Board for approval byMinister.

REQUIREMENTS FOR NOTIFICATION

AND AUTHORIZATION IN RADIATION

SAFETY IN MEDICAL

∗ PREMISES – LOCATION OF IR SOURCES & SHIELDING;

∗ IR SOURCES/EQUIPMENTS – SPECIFICATION & RADIATION SAFETY PERFORMANCE;

∗ PERSONNEL & RADIATION WORKERS ;

∗ PROGRAMME & PROCEDURES – RADIATION SAFETY PROGRAM/SOP/LOCAL RULES

ContCont

CIRCULAR/GUIDELINE/ CRITERIA/MANUAL YEAR

Minimum Power Requirements For Diagnostic

X-ray Machine

1985

Acceptable Method Of Decommissioning Of

X-ray Machine

1993

Circular on Employment of Trained X-Ray

Operators By Private General Practitioners

1993

Guidelines To Obtain Class C License Under

the Atomic Energy Licensing Act 1984 – Prosessemakan semula.

1994

Cont


Guidelines For Medical Diagnostic ProceduresUsing X-ray For Women of ChildbearingPotential - 10 Day Rule / 28 Day Rule

1998

Keperluan Tambahan QAP DiBawah Akta

Perlesenan Tenaga Atom 1984 Bagi Institusi-Institusi Perubatan Swasta – PengamalPerubatan Swasta, GP’s

1999

Circulars to TKPK(Medical), TKPK(Public Health)

& Pengarah Perancang & Pembangunan

2001

Circulars to Pengarah Perancang &

Pembangunan

2001

Cont


Guidelines For Medical Diagnostic ProceduresUsing X-ray For Women of ChildbearingPotential - 10 Day Rule / 28 Day Rule

1998

Guidelines On The Use of Mobile X-rayMachines

2005

Keperluan Mendapatkan Khidmat Juru X-RayBerkelayakan Sebagai Pengendali RadasPenyinaran Bagi Klinik Pengamal Perubatandan Institusi Perubatan Swasta Di Bawah Akta304

2010

Pekeliling Keperluan Pakar Perubatan Nuklear

Bagi Perkhidmatan Perubatan Nuklear Di Bawah

Akta 304

2010

Cont

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Pekeliling Keperluan Mendapatkan Khidmat

Personel Berkelayakan Sebagai Pengendali Radas

Penyinaran Bagi Perkhidmatan Pergigian Di

Bawah Akta 304

2010

Guidelines for Management of Brachytherapy for

Prostate Cancer Using Permanently Implanted

Radioactive Sources.

2011

Manual Pelaksanaan Program Penjaminan Mutu

Perkhidmatan Radioterapi di Bawah Akta 304

Bagi Maksud Perubatan

2013

Manual Pelaksanaan Program Penjaminan Mutu

Perkhidmatan Perubatan Nuklear di Bawah Akta

304 Bagi Maksud Perubatan

2013

ContCont


Garispanduan Malaysia Diagnostic

Reference Levels In MedicalImaging(Radiology)

2013

Garispanduan Malaysia Diagnostic

Reference Levels In Nuclear Medicine

2013

Deraf Peraturan-Peraturan Perlesenan

Tenaga Atom(Penggunaan Sinarandalam Perubatan, Pergigian danVeterinar) 201__

-Proses pewartaan.

2013

APPROPRIATE AUTHORITYAPPROPRIATE AUTHORITY

a) The Director-General of Health where the activity to be licensed or licensed under this Act is in respect of a medical purpose

b) The BoardBoard where the activity to be licensed or licensed under this Act is in respect of a purpose other than a medical purpose

SECTION 2 OF ACT 304

ContCont

CONTROL & LICENSINGCONTROL & LICENSING

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Legislative requirements under Act 304

Healthcare

Transcript of Legislative requirements under Act 304