National Department of Health Presentation to the Portfolio Committee on Health

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

2. DIR: RADIATION CONTROLMAIN 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

3. DIR: RADIATION CONTROLLEGAL 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)

4. DIR: RADIATION CONTROLCURRENT ACTIVITIES • EXECUTE A LARGE NUMBER OF LINE FUNCTION ACTIVITIES • MANAGED SYSTEMS APPROACH TO INSPECTIONS, ETC. – BASED ON ISO9001 • 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

5. DIR: RADIATION CONTROLEXTEND 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

6. DIR: RADIATION CONTROLOBSTACLES • 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.

7. DIR: RADIATION CONTROLCURRENT 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)

8. 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.

9. 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

10. DIR: RADIATION CONTROLACTUAL 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

11. DIR: RADIATION CONTROLFUTURE • 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