The MHRA issues safety information relating to implantable pacemakers and implantable cardioverter defibrillators (ICDs) via Medical Device Alerts.
Medical Device Alerts provide safety and technical information about implantable pacemakers and defibrillators. They also include associated accessories and leads used to deliver therapy to the heart. They are issued in situations where a potential may exist for serious injury, death, or a deterioration in a patient's state of health due to device malfunction or degradation. They are issued by the MHRA’s Biosciences and Implants Unit which is part of the MHRA’s Devices Division. Prior to June 2002, information was distributed via Pacemaker/ICD Technical Notes (PTNs).
Manufacturer Field Safety Notices
Medical Device Alerts (MDAs) relating to pacemakers/ICDs – June 2002 onwards
Guidant Medical Device Alerts (MDAs)
Interference between headphones and implantable pacemakers and defibrillators
12 Nov 2008
The MHRA is aware of a small study in the USA which indicated that headphones used with devices such MP3 players can have a temporary effect on the operation of implantable pacemakers and defibrillators when they are in close proximity. The headphones tested were in-ear and clip-on headphones, many of which contain powerful neodymium magnets.
Details of the study were first made public at the American Heart Association meeting in New Orleans in November 2008. The researchers assessed the function of the pacemaker or ICD in 60 patients during exposure to various headphones. Interference with pacemaker or ICD function was observed in 14 patients (23%). Headphones with a measured magnetic field strength of 10 gauss or higher were more likely to cause interference than those with lower magnetic strength. No interference was noted when the headphones were more than 3 cm from the skin surface.
The MHRA advises that patients with pacemakers or defibrillators can use headphones with devices such as MP3 players with negligible risk, provided they are not placed in close proximity (i.e. less than 3 cm) to the implant. Headphones should not be placed in the breast pocket of a shirt or jacket, or draped around the neck, even when not in use.
You may also be interested in the advice we previously issued about the potential for interference between MP3 players and implantable pacemakers and defibrillators.
