Korean Defibrillators

1. Overview of Defibrillators

A defibrillator is a specialized medical device designed to restore a normal heart rhythm in patients suffering from sudden cardiac arrest or dangerous arrhythmias such as ventricular fibrillation. The device works by delivering a short, powerful electric shock to the heart, helping to "restart" electrical activity and re-establish a regular heartbeat.

Defibrillators are currently categorized into three main types:

• Automated External Defibrillator (AED): Designed simply for use by laypeople; the device automatically analyzes the heart rhythm and delivers a shock only when necessary.

• Semi-automated Defibrillator: Requires the user to press a shock button after the machine analyzes the rhythm and recommends a shock.

• Manual Defibrillator: Intended for trained doctors and medical personnel, allowing manual adjustment of energy levels and shock timing.

In the Cardiopulmonary Resuscitation (CPR) process, the defibrillator plays an essential role alongside chest compressions and rescue breathing. Using it at the right time—within the first 3–5 minutes after the heart stops—can increase survival rates by up to 70%, clearly demonstrating the irreplaceable role of this device in emergency rescue.

2. Defibrillator Manufacturers in South Korea

South Korea is one of the countries with a highly developed medical device industry, notably featuring defibrillator manufacturers with modern technology that meets the needs of both hospitals and the community.

• Mediana: One of the leading brands in Korea in the defibrillator sector. Their representative product is the D500 model, known for its multi-functional design integrating a monitor to track heart rate, blood pressure, and SpO2, allowing for simultaneous defibrillation and real-time patient monitoring. Mediana targets the hospital, ambulance, and professional medical organization segments.

• CU Medical Systems: A famous brand known for the CU-SP1 automated defibrillator line, designed to be compact, easy to use, and suitable for non-professionals. This device is popular in public areas such as airports, shopping malls, and schools.

Additionally, the Korean market includes other medical device manufacturers such as BioSignal, Cardia, and DefiTech. However, Mediana and CU Medical still hold the largest market share due to their stability in quality and extensive domestic and international distribution networks.

3. Korean Standards and Regulations for Defibrillators

In South Korea, defibrillators are strictly regulated by the Ministry of Food and Drug Safety (MFDS). These devices belong to the high-risk medical device group and must adhere to stringent standards before being circulated in the market.

The MFDS classifies medical devices into four risk levels (Class I to Class IV). Defibrillators fall under Class III or IV due to their direct impact on patient survival. For this group, the registration and approval process is more demanding, involving detailed evaluations of the device's design, performance, and safety.

The approval process includes: product registration, technical dossier review, sample testing, and if necessary, clinical trials. Manufacturers are mandatory required to provide full documentation proving safety, efficacy, and compliance with international technical standards.

Furthermore, the MFDS requires periodic Post-Market Surveillance reports, recording any incidents or feedback related to the device to facilitate timely adjustments, recalls, or technical improvements. This helps protect end-users and ensures the equipment is always in optimal operating condition, especially for life-saving devices like defibrillators.

4. Defibrillator Usage Guidelines (2020 Recommendations)

According to the latest 2020 recommendations, the correct use of a defibrillator is a vital factor in cardiac arrest rescue. For children, the recommended initial shock energy level is 2 J/kg, ensuring safety and effectiveness without causing damage to the heart muscle.

A notable point is the preference for biphasic waveform defibrillators over monophasic ones. Biphasic devices are capable of transmitting current more effectively, helping to restore heart rhythm quickly with lower energy levels, thereby reducing the risk of myocardial injury after the shock.

The "golden time" to perform defibrillation is within the first 3 to 5 minutes after detecting cardiac arrest. Every second of delay significantly reduces the patient's chance of survival. Caption: Biphasic defibrillation and pacing devices reduce the risk of myocardial injury.

Early recognition and rapid, precise manipulation of the defibrillator are extremely important. Therefore, equipping oneself with knowledge and practicing the use of defibrillators according to recommendations helps increase survival rates and limit long-term sequelae for patients.

Reference:
Republic of Korea Medical Device Regulatory Updates – AHWP