Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom issued a medical device alert concerning all defibrillators/monitors used for external pacing with non-invasive transcutaneous pacemaker modules.

Transcutaneous pacing delivered by a defibrillator is also known as"external pacing". It is the delivery of current via the external defibrillation pads. Successful delivery of this technique is reliant on sufficient current to stimulate the myocardium to contract (known as "capture").

Transcutaneous pacing is sometimes used in the emergency setting to treat asystole or bradycardia. This is usually a temporary bridging measure prior to further treatment, such as temporary or permanent pacemaker implantation.

The MHRA reminds the healthcare staff that:

• there is a risk of inadequate external pacing, leading to potential periods of asystole, syncope and possible death;
• factory default start-up pacing current and rate settings on transcutaneous pacemaker modules vary and may be too low to ensure pacing capture. Users should review and evaluate appropriateness of the factory defaults for pacing mode and ensure settings are configured to meet their local protocols;
• further guidance on transcutaneous pacing is being considered by Heart Rhythm UK.

For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON272241

Posted on 13 May 2013