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Legislative requirements under Act 304
This document provides an overview of legislative requirements for the use of ionizing radiation in medical purposes under the Atomic Energy Licensing Act 1984 (Act 304) in Malaysia. It discusses the purposes of the Act, introduction, Act and subsidiary regulations, control and licensing, radiation protection systems, dose limits, decommissioning, quality audit management, current issues, and circulars/guidelines. The key objectives are to ensure protection and safety from ionizing radiation effects for the environment, public, occupational workers, and patients by optimizing use and quality through good regulatory practice.
Legislative requirements under Act 304
- 1. 5/7/2015 1 LEGISLATIVELEGISLATIVE REQUIREMENTSREQUIREMENTS UNDER THE ACTUNDERTHE ACT 304 IN MEDICAL304 IN MEDICAL PURPOSESPURPOSES RADIATION HEALTH & SAFETY MINISTRY 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 the radiation 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 RADIATIONOBJECTIVE OF RADIATION SAFETYSAFETY Good Regulatory Practice Cont. To ensure that the images produced are of diagnostic quality with the least possible exposure to the patient OBJECTIVE OF RADIATION IN MEDICAL - DIAGNOSTIC Cont.
- 2. 5/7/2015 2 (1) Lack ofconsensus 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 TOFACTORS 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) REGULATIONS1. RADIATION PROTECTION (LICENSING) REGULATIONS 19861986 2. RADIATION PROTECTION(TRANSPORT) 19892. RADIATION PROTECTION(TRANSPORT) 1989 3. ATOMIC ENERGY LICENSING (BASIC SAFETY3. ATOMIC ENERGY LICENSING (BASIC SAFETY RADIATION PROTECTION) REGULATIONS 2010RADIATION PROTECTION) REGULATIONS 2010 4. RADIATION PROTECTION (RADIOACTIVE WASTE4. RADIATION PROTECTION (RADIOACTIVE WASTE MANAGEMENT) REGULATIONS 2011MANAGEMENT) REGULATIONS 2011 5. 19 CURRENT KPK’s CIRCULARS, GUIDELINES AND5. 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
- 3. 5/7/2015 3 SUBSIDIARY REGULATIONS iv. RadiationProtection (Radioactive Waste Management) Regulations 2011 - Requirements for all aspects of radioactive wastewaste andand wastewaste managementmanagement arising from the medical, industrial and research applications 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 ContCont ContCont RADIATION PROTECTION AND SAFETY (MEDICAL, DENTAL & VETERINARY USAGE OF RADIATION) REGULATIONS 201x - Meeting for amendment of the regulation in par with currentcurrent requirementrequirement && practicepractice - More specific & comprehensive requirements to control the use of ionizing radiation under the purview of the MOH (medical usage) - Finalized in January 2014 at MOH’s level & submitted to Board for approval by Minister. 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 – Proses semakan semula. 1994 Cont CIRCULAR/GUIDELINE/ CRITERIA/MANUAL YEAR Guidelines For Medical Diagnostic Procedures Using X-ray For Women of Childbearing Potential - 10 Day Rule / 28 Day Rule 1998 Keperluan Tambahan QAP DiBawah Akta Perlesenan Tenaga Atom 1984 Bagi Institusi- Institusi Perubatan Swasta – Pengamal Perubatan Swasta, GP’s 1999 Circulars to TKPK(Medical), TKPK(Public Health) & Pengarah Perancang & Pembangunan 2001 Circulars to Pengarah Perancang & Pembangunan 2001 Cont CIRCULAR/GUIDELINE/ CRITERIA/MANUAL YEAR Guidelines For Medical Diagnostic Procedures Using X-ray For Women of Childbearing Potential - 10 Day Rule / 28 Day Rule 1998 Guidelines On The Use of Mobile X-ray Machines 2005 Keperluan Mendapatkan Khidmat Juru X-Ray Berkelayakan Sebagai Pengendali Radas Penyinaran Bagi Klinik Pengamal Perubatan dan Institusi Perubatan Swasta Di Bawah Akta 304 2010 Pekeliling Keperluan Pakar Perubatan Nuklear Bagi Perkhidmatan Perubatan Nuklear Di Bawah Akta 304 2010 Cont
- 4. 5/7/2015 4 CIRCULAR/GUIDELINE/ CRITERIA/MANUAL YEAR PekelilingKeperluan 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 CIRCULAR/GUIDELINE/ CRITERIA/MANUAL YEAR Garispanduan Malaysia Diagnostic Reference Levels In Medical Imaging(Radiology) 2013 Garispanduan Malaysia Diagnostic Reference Levels In Nuclear Medicine 2013 Deraf Peraturan-Peraturan Perlesenan Tenaga Atom(Penggunaan Sinaran dalam Perubatan, Pergigian dan Veterinar) 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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