In Product-specific information and advice

Cardiac pacemakers and defibrillators (implantable)

There are now over 240,000 UK citizens benefiting from an implantable pacemaker or implantable cardioverter defibrillator (ICD). Many of these may need some form of general surgery during their lifetime, for example – surgery following an accident or hip replacement etc. Pacemakers and defibrillators sense very small electrical signals from within the heart and deliver therapy according to need. Although these implants are designed to be very robust as far as electrical interference is concerned, it is important that care is exercised when surgical equipment – such as diathermy/electrocautery is used close to where the device is implanted. MHRA’s Committee on Safety of Devices (CSD) identified a need for general guidelines to be developed which outline issues that should be considered when patients with pacemakers and ICDs undergo surgical procedures.

Implantable pacemakers and implantable cardioverter defibrillators (ICDs) and their lead systems etc, are regulated as Active Implantable Medical Devices. The MHRA is responsible for ensuring that implantable pacemakers and defibrillators placed on the UK market meet appropriate standards of safety, quality and performance, and that they comply with the requirements of the Active Implantable Medical Devices Directive.


Page last modified: 04 April 2006