Proposal of Standard Operation Procedure and Policies (SOPs) for Medical Imaging Instruments in Sudan

Abstract

Imaging devices are playing a big and important role in the diagnosis of the diseases. Unfortunately there are conflicting in the rules and regulations which were made by different organizations such as [national medicines and poisons board(NMPB), Sudanese standards and metrology organization(SSMO), Sudan Atomic Energy commission(SAEC) and medical supplies(MS)] to control the import and operation of these devices. The multiplicity of organizations in this matter are Causing many problems that's make the standardized procedures lack in Sudan. The aim of this work is to make an attempt unification of technical and operational measures for medical imaging devices in the Department of Radiology, improve the quality of service diagnostic of the disease and make written procedures followed by the staff to perform the job properly, ensure quality, prevent risks and mistakes, improve errors and reduce the costs. In The first step in this work to reach that aims we followed operating procedures as it described in the operating manual of the devices. Secondly we determined the technical specifications of the device corresponding on the international specification such as The Food and Drug Administration FDA, Common Era CE, and International Organization for Standardization ISO. In the Third step we wrote the procedures of the Safety (Electrical and radiation). Fourthly we determined the environmental conditions of the devices which were required. at the last step we tagged that there were a simple contamination (bacterial) in these devices and we provided how to avoid it. After these steps we have been making a format to verify the experimental results which were obtained to know if the international standards are applying in the hospitals of Sudan. The results showed that recently began attention occurring for the Imaging devices after returning to the manufacturer to make sure that they get on the after-sales service, spare parts and basic safeguards, in accordance with the principles and controls which were put by the different organizations in Sudan including making an impact on the provision of service desired. It also found that the safety measures (electric and radiation) for these devices are followed accurately and knowledge of how to make safety tests which are not available to the staff.