Inspection of an Ultrasonography Device by Using Ultrasound Phantom : An Example of Operator Proficiency Test

Our country is largely dependent on the outside in terms of both the device and the service in the medical device sector. For example, according to a nationwide survey conducted by Science, Industry and Technology Ministry, General Directorate of Metrology and Standardizing, calibration of the phantoms that are used both in operator training and quality control of the ultrasound devices can not be done in Turkey. However, TUBITAK UME Medical Metrology Laboratory can now perform Ultrasound Phantom Proficiency Tests in the UME. Ultrasound phantoms have a critical condition for both quality control of ultrasound devices and user training, and there are thousands of ultrasonic devices in our country. The fact that Ultrason Phantom Qualification Tests are performed in our country is a significant performance indicator in the system inspections of calibration laboratories (ISO 9001, ISO 17025). In this study, the proficiency test of ultrasonic imaging device in our laboratory was tested with seven different operators using CIRS brand ultrasonic imaging phantom. Based on the tolerances given in the standards according to the Z number (score) test, all operators have passed the test successfully.