National Department of Health Presentation to the Portfolio

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National Department of Health Presentation to the Portfolio Committee on Health Radiation Control 10

National Department of Health Presentation to the Portfolio Committee on Health Radiation Control 10 November 2010 1

DIR: RADIATION CONTROL MAIN FUNCTIONS • THE REGULATORY CONTROL OF: • IONISING RADIATION EQUIPMENT

DIR: RADIATION CONTROL MAIN FUNCTIONS • THE REGULATORY CONTROL OF: • IONISING RADIATION EQUIPMENT • NON-IONISING RADIATION EQUIPMENT – FROM POWER LINES TO MICROWAVES • MEDIUM & HIGH RISK MEDICAL DEVICES • RADIOACTIVE MATERIALS THAT ARE OUTSIDE OF A NUCLEAR FACILITY AND USED FOR MEDICAL, SCIENTIFIC, AGRICULTURAL, INDUSTRIAL AND COMMERCIAL PURPOSES 2

DIR: RADIATION CONTROL LEGAL FRAMEWORK • HAZARDOUS SUBSTANCES ACT, 1973 (ACT 15 OF 1973)

DIR: RADIATION CONTROL LEGAL FRAMEWORK • HAZARDOUS SUBSTANCES ACT, 1973 (ACT 15 OF 1973) • REGULATIONS RELATING TO GROUP III HAZARDOUS SUBSTANCES • REGULATIONS RELATING TO GROUP IV HAZARDOUS SUBSTANCES • REGULATIONS “GOVERNING THE PROVISION OF MEDICAL DEVICES” • VARIOUS CODES OF PRACTICE, REQUIREMENT DOCUMENTS, ETC. (ON DOH WEBSITE) 3

DIR: RADIATION CONTROL CURRENT ACTIVITIES • EXECUTE A LARGE NUMBER OF LINE FUNCTION ACTIVITIES

DIR: RADIATION CONTROL CURRENT ACTIVITIES • EXECUTE A LARGE NUMBER OF LINE FUNCTION ACTIVITIES • MANAGED SYSTEMS APPROACH TO INSPECTIONS, ETC. – BASED ON ISO 9001 • REVISED LEGAL (REGULATORY) FRAMEWORK INCLUDING THE REGULATION OF RF DEVICES (CELL PHONES) • SELF-ASSESSMENT OF REGULATORY INFRASTRUCTURE- WITH OTHER AFRICAN REGULATORS AND NNR • 2010 – HTTT AND CBRN COMMITTEE – SECURITY OF RADIOLOGICAL SOURCES 4

DIR: RADIATION CONTROL EXTEND OF WORKLOAD • X-Ray License holders = 6 581 –

DIR: RADIATION CONTROL EXTEND OF WORKLOAD • X-Ray License holders = 6 581 – Licensed units = 16 041 • Authority Holders = 2 259 – Sources = 16 671 • Licensed MRI units = 130 • Licensed Lasers = 1000+ • Distributors of Medical devices = 240 – Licensed models = 2519 5

DIR: RADIATION CONTROL OBSTACLES • SEVERE LACK CAPASITY WHICH CURTAILS OUR LOCAL EFFECTIVENESS AND

DIR: RADIATION CONTROL OBSTACLES • SEVERE LACK CAPASITY WHICH CURTAILS OUR LOCAL EFFECTIVENESS AND ALL BUT PREVENT OUR ROLE IN REGIONAL AND INTERNATIONAL RADIATION CONTROL MATTERS. • WORSE OFF IN TERMS OF STAFF THAN MANY OF OUR FELLOW REGULATORS IN AFRICA – BOTSWANA, TANZANIA, KENIA, NAMIBIA • CONSEQUENTLY NOT ABLE TO FULLFIL OUR LEGAL OBLIGATIONS. • A NUMBER OF MORATORIUMS ON FILLING OF POSTS HAVE MADE MATTERS PROGRESIVELY WORSE. 6

DIR: RADIATION CONTROL CURRENT STAFF SITUATION • • ADMIN SECTION – 12 officials +

DIR: RADIATION CONTROL CURRENT STAFF SITUATION • • ADMIN SECTION – 12 officials + 5 vacancies IONISING RAD. – 2 officials + 1 vacancy NIRMED – 3 officials + 1 vacancy RADIO-NUCLIDES – I official + 4 vacancies – (4 posts were advertised –busy with short-listing) • INSPECTORATE – Bellville - 3 officials + 1 vacancy – Pretoria - 4 officials + 2 vacancies – Durban - 2 vacancies – (5 posts were advertised – short-listing) 7

DIR: RADIATION CONTROL “LOST SOURCES” • Database Information not accurate, needed to be tidied

DIR: RADIATION CONTROL “LOST SOURCES” • Database Information not accurate, needed to be tidied up • Printout of expired Authorities as starting point • Process: – Check information on files against database and correct. – Contact Authority Holder, if required. – Arrange on-site inspection. 8

DIR: RADIATION CONTROL “LOST SOURCES” – Hand over cases to SAPS Priority Crimes Unit

DIR: RADIATION CONTROL “LOST SOURCES” – Hand over cases to SAPS Priority Crimes Unit for tracing and possible prosecution. • Errors Found – Files not closed when sources were sold or disposed. – Documentation filed, but DB not updated – Sources were confiscated. – Sources previously lost – Holders disappeared 9

DIR: RADIATION CONTROL ACTUAL LOST SOURCES (Last 5 Years) • • • Soil /

DIR: RADIATION CONTROL ACTUAL LOST SOURCES (Last 5 Years) • • • Soil / Density gauges = 25 Level / Density gauges (Mines) = 7 Reference/ Educational =7 XRF /ECD =5 Beta Light =1 Lost at Sea =1 Lost in Transit =1 Lost in Zambia =1 Lost containers =2 Damaged =4 10

DIR: RADIATION CONTROL FUTURE • Initial results of the SAT indicate a wide range

DIR: RADIATION CONTROL FUTURE • Initial results of the SAT indicate a wide range of regulatory deficiencies. – Severe HR constrains – No Financial (and other) Independence • Essential that the Directorate move towards a semi-autonomous situation • The Green-Thompson report recommended that we move to SAHPRA. • However with the exception of Medical Devices no provision has been made for such move 11