Harmonising telemetric reading and programming devices for defibrillators and pacemakers
27.2.2013
Question for written answer E-002227-13
to the Commission
Rule 117
Thomas Ulmer (PPE)
In Germany around 500 000 people have pacemakers, with around 60 000 being added a year. For many people, these devices make it possible for them to lead a normal life.
However, particularly in emergencies, there are still serious problems. With so many manufacturers, it has not yet been possible to develop hardware and software in these devices enabling reading and programming using a uniform interface on standardised equipment.
This causes serious problems for both hospitals and patients:
- — Hospitals have to purchase a separate computer for reading and programming devices from each manufacturer
- — Costly training courses have to be provided for several devices
- — In emergencies patients are at the mercy of chance as to whether emergency doctors can read their devices
- — Patients are ‘tied’ to the location where their devices can be read (holidays become very difficult)
To what extent can improvements or harmonisation be achieved in this area? How does the Commission intend to ensure that patients are better protected and are not restricted in their movements? What kind of legislative proposal could be made to this effect?
OJ C 372 E, 19/12/2013