Metrological Reliability and Electrical Safety: A Case Study on Defibrillator Equipment

Nowadays more than 10,000 different types of medical devices can be found in hospitals. In this way, medical Electrical equipment are being employed in a wide variety of fields in medical sciences with different physiological effects and measurements. Hospitals and medical centers must ensure that their critical medical devices are safe, accurate, reliable and operating at the required level of performance. Defibrillators are critical resuscitation devices. The use of reliable defibrillators has led to more effective treatments and improved patient safety through better control and management of complications during Cardiopulmonary resuscitation (CPR).In this paper, the metrological reliability of twenty frequent use, manual defibrillators in use ten hospitals (4 privates and 6 publics) in one of the province of Iran according to international and national standards was evaluated. Quantitative analysis of controls and instruments accuracy, showed the amount of the obtained results in many units are critical and have less value over the standard limitations especially in devices with poor battery. For the accuracy of delivered energy analysis, only twelve units delivered acceptable output values and the precision in the output energy measurements especially in weak battery condition, after activation of discharge alarm, were low. Acquiring results indicate a need for new and severe regulations on periodic performance verifications and medical equipment quality control program especially in high risk instruments. It is also necessary to provide training courses on the fundamental of operation and performance parameters for medical staff in the field of metrology in medicine and how can get good accuracy results especially in high risk medical devices.

Keywords:

Metrology , Reliability , Defibrillator , Patient Safety , Medical Electrical Equipment