Radiation protection and the safe use of X-ray equipment: Laws, regulations and responsibilities

Background. South Africa’s regulatory framework for electromagnetic medical devices has come under considerable criticism. Here it is reviewed in terms of how it has given form to protective measures against ionising radiation. The Hazardous Substances Act provides for effective protection against radiation, but has been undermined by poor administration and uncertainty about regulations and licensing conditions. The legal weight of enforcing licensing conditions through a website without proper consultation with all parties concerned is questionable and ineffective. Effective and legal radiation control is possible by activating the National Advisory Committee on Electronic Products, provided for in Regulation R326 published in 1979, but this has never been implemented. The possible impact of annual quality assurance tests currently enforced through licensing conditions on radiation dosage to the population is not cost-effective, as new training and accreditation structures have to be created. Conclusions. That more than 80% of overexposures are generally caused by human error is a clear indication that training of the regular users of X-ray equipment should be emphasised, and not the training and accreditation of the technicians responsible for a single quality assurance test per year. Constructive engagement with the professional bodies involved in the medical use of X-rays through a National Advisory Committee on Electronic Products may be a cost effective solution for lowering radiation dosage to the population.