Abstract:
Devices of clinical laboratory analyze body fluids for specific substances of interest and to report the results in a form which is of value to clinicians in the diagnosis and treatment of disease, Whilst Histopathology devices used for embalming, cutting tissue and check to see if there is a malignant disease or any type of disease infected tissue so to be treated.
The objective of this proposal is designing SOPs and provide guidance for which laboratories medical device that important for providing basic health service and which not absolutely important, creating technical specification and standards list of histology and clinical chemistry laboratories medical devices to improve the quality of instruments in terms of safety and performance, good riddance of waste which comes from the device to prevent contamination that may occur and to Improve health care system as general.
To apply SOPs for Clinical chemistry and Histopathology laboratory medical devices, this is the steps which has been followed to accomplish this project; device technical specification, device operation instruction, device Environment, the device Safety, Contamination, the Classification of the device and finally the device labeling.
The experimental results were a check for used histopathology and clinical chemistry devices in some hospital and used histopathology and clinical chemistry devices to check its possibility to entering Sudan. The results shows that all used histopathology and clinical chemistry devices in Sudan were not under the Sops. The SOPs for histopathology and clinical chemistry devices are important for safely healthcare and this work is the beginning step to improve the use of the histopathology and clinical chemistry devices to give a better work.
