Automated external defibrillators (AEDs) are portable, life-saving devices designed to treat people experiencing sudden cardiac arrest, a medical condition in which the heart stops beating suddenly and unexpectedly. The AED system includes accessories, such as a battery and pad electrodes that are necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock [1].

Types of Defibrillators

      There are several different types of defibrillators, and they work in different ways.

Automated external defibrillators (AEDs): These are found in public places and can be used by layperson in an emergency. They guide you through each step of the process. They will not give an electric shock unless it is necessary, so you can’t harm people by using an AED. some of defibrillator models guide you how to deliver the shock, and other models deliver the shock automatically.

Manual defibrillators: health professionals use these — for example, in an ambulance or emergency department.

Implantable cardioverter defibrillators (ICDs): These are defibrillators that are surgically placed inside the body. They are designed for people who are at high risk of a life-threatening heart rhythm problem (such as those who may have had a recent heart attack or who have certain medical conditions).

Wearable cardioverter defibrillators (WCDs): These defibrillators are placed on the body. Patients who are recovering from a heart attack or who are waiting for a heart transplant usually use them. [2]

In this study, we evaluate the safety of the AED system, and collect information regarding the potential incidents that may require further actions from the manufacturer side. The scope of this evaluation report is Saudi healthcare facilities who used Automated external defibrillators, to assure the readiness of the medical professionals in hospitals and to make sure their remedy action is ready.

Part I: Methodology

   This is a survey-based study, which is designed to collect and analyze feedbacks from the users of the AED who have dealt with these devices, such as medical professionals, nurses, and engineers. The survey was distributed over 40 healthcare facilities and it covered different sites in the Kingdom. The survey consists of 14 questions about the safety of the AED devices.

Part II: Results

The below table shows the result of the survey based on the responses received. The results indicate a satisfactory level of compliance for most of the requirements of the AED devices.

However, there are some participants affirmed that there is no a back-up system in place, which affects badly the safe use of the device. One participant, said that the Processor board damaged during daily checkup, besides the capacitors was damaged, and this was discovered during the daily checkup. While another participant confirmed that Therapy Knob issues considered a negative part for the device. Regarding to device malfunction, some of participants encountered this problem. Moreover, only one participant encountered a pads/paddles failure.

Table.1: The distribution of the research sample according to the answers to the questions

Part III: Conclusion

   The study results show that 27% of the study participants do not have a backup defibrillator, which is a factor of not readiness and noncompliance with the requirements of safe use of the device at health care facilities. Maintaining periodically, checking devices daily, and providing spare parts have significantly contributed to solving the defects of malfunctions of the devices. Some healthcare practitioners may find it challenging to deal with the device's technical errors; therefore, enhancing awareness of the use and troubleshooting AEDs is crucial.

This study is authored by Rashed Abuhaimed, who designed the survey, collected and analyzed data, and wrote up the content of the study.  With the appreciation to Post-market Clinical Evaluation Section head for monitoring the study progress and  Sara Alharthi for drafting this summary and the post-market clinical evaluation team for their efforts in conducting this work.

          For further information or inquiries related to this study, you may contact us at: cia.md@sfda.gov.sa

[1]  US.FDA, "Automated External Defibrillators (AEDs)," [Online]. Available: https://www.fda.gov/medical-devices/cardiovascular-devices/automated-external-defibrillators-aeds#what.

[2]  healthdirect, "defibrillators," [Online]. Available: https://www.healthdirect.gov.au/defibrillators.

[3]  p. i. lawer، "Reasons for AED Failures،" [متصل]. Available: https://pricebenowitz.com/heart-attack-injuries/reasons-for-aed-failures/.

[4]  ASHI and MEDIC First Aid Blog، "TROUBLESHOOTING YOUR AED،" 22 January 2016. [متصل]. Available: https://emergencycare.hsi.com/blog/troubleshooting-your-aed.

[5]  ASHI and MEDIC First Aid Blog, "TROUBLESHOOTING AN AED," 18 February 2020. [Online]. Available: https://emergencycare.hsi.com/blog/troubleshooting-an-aed.

[6]  SFDA, "Medical device market authorization," [Online]. Available: https://mdma.sfda.gov.sa/.

[7]  Master Medical Equipment ، "Philips HeartStart XL Defibrillator Monitor،" [متصل]. Available: https://www.mmemed.com/philips-defibrillators-pro/philips-heartstart-xl-defibrillator-monitor-model-m4735a/.