Training course: Quality Control of Medical Devices. III course. 2022
Authors
Giorgi Chilingarashvili, Giorgi Mazanashvili, Arslan Annayev, Yazan Hassan
The Principal:
Zviad Ghurtskaia
Summary
The purpose of medical device inspection is to ensure that the device is safe, functioning properly, and ready for use with a patient. External control of medical equipment in Georgia is currently not mandatory. This issue is provided for in the Deep and Comprehensive Free Trade Area Agreement (DCFTA) signed between Georgia and the European Union.
The purpose of the inspection is to ensure that the medical device is safe, functioning properly, and ready for patient use. In the best clinics of our country, there are engineering services that work on this issue, but the experience of the world's leading countries shows that the mentioned problem is not solved in this way, and it is necessary to have external control of medical equipment.
In 2013, a medical equipment inspection body was established at the Georgian Technical University, which is equipped with the latest equipment of the world's leading American company Fluke and is staffed by highly qualified engineers. In 2018, the inspection body was accredited according to the ISO 17020 standard, and today it is the only medical equipment inspection service accredited according to this standard.
The purpose of our research was to Checking the safety and functional efficiency of medical equipment in Tbilisi medical institutions. The study was conducted in medical institutions that were randomly selected. A database of clinics and a random number generator created in the Matlab environment were used. Quality control of defibrillators was carried out in randomly selected clinics. Electrical safety and functional indicators of the mentioned tools were checked. Tools used: electrical safety analyzer: Fluke Ase 620, defibrillator analyzer DP7000 The obtained results were processed statistically. The study revealed that all parameters of defibrillators were within normal limits. The tools were safe, correct and ready for use with the patient.