A Study on Performance and Safety Tests of Defibrillator Equipment

Area of Science:

• Biomedical Engineering
• Medical Device Metrology

Background:

• Hospitals utilize over 10,000 medical device types, necessitating stringent safety and performance standards.
• Defibrillators are critical for Cardiopulmonary Resuscitation (CPR), with reliable devices improving patient outcomes.
• Ensuring the accuracy and reliability of medical electrical equipment is paramount for effective healthcare.

Purpose of the Study:

• To evaluate the metrological reliability of frequently used manual defibrillators in Iranian hospitals.
• To assess compliance with international and national standards for medical device performance.

Main Methods:

• Assessed the metrological reliability of twenty manual defibrillators across ten hospitals in Iran.
• Evaluated device performance against established international and national standards.

Main Results:

• Quantitative analysis revealed critical accuracy issues in many defibrillator units, particularly those with depleted batteries.
• Only twelve of the assessed units met acceptable output values for delivered energy.
• Precision in output energy measurements was notably low, especially under weak battery conditions and after discharge alarm activation.

Conclusions:

• Results underscore the urgent need for stricter regulations on periodic performance verification and quality control for high-risk medical instruments.
• Implementing comprehensive training programs for medical staff on metrology fundamentals and device performance is essential.
• Enhanced focus on metrology in medicine is required to ensure accuracy and reliability of critical medical devices.