Is a safety inspection mandatory for all defibrillator operators?

Section 12 paragraph 2 removes the previously required obligation to carry out safety checks for automatic external defibrillators (AEDs) installed in non-public spaces, provided that the AED is self-testing and the operator carries out regular visual inspections. This obligation has long since ceased to exist for AEDs accessible in public spaces. This also responds to the uncertainty that exists in practice when it comes to distinguishing between non-public and public spaces.

The "STK-exempt" AEDs can only be those that independently carry out daily, weekly and monthly internal functional analyses at regular intervals and display possible faults on the display of the defibrillator. The proposed exemption can only be justified in cases where the manufacturer can simultaneously ensure and prove, on the basis of risk management in accordance with ISO 14971, that the device is designed and manufactured in such a way that no additional hazard can arise if the STK is completely omitted.

Source: 23.05.2024 Ordinance of the Federal Ministry of Health

How often does a STK have to be carried out?

Safety checks may need to be carried out every two years.

What needs to be checked during a STK?

The operator must carry out the safety checks (STK) or have them carried out in accordance with the manufacturer's specifications and the generally applicable rules of technology. The STK carried out must be recorded and the test certificate given to the operator. The operator and the person carrying out the check must keep this until the next check.

What is checked during a safety check of a lay defibrillator?

The actual shock energy delivered is measured and documented using a calibrated defibrillator test device for three electric shocks (based on VF1, VF2, VF3)! The device memory is checked, the software version is updated if necessary and the application data (if available) is saved. Other settings such as alarm messages, LED displays, voice announcements and additional functions are checked and documented. Defibrillators that are equipped with WLAN/WiFi functions receive new batteries (if necessary).