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Question for Department of Health

UIN 221843, tabled on 23 January 2015

To ask the Secretary of State for Health, what assessment his Department has made of the adequacy of the instructions provided with automated external defibrillators; and what assessment he has made of the ability of an untrained individual to use such defibrillators effectively on the basis of those instructions alone.

Answered on

2 February 2015

The Medical Devices Directive states that where a device bears instructions required for its operation such information must be understandable and appropriate for the intended user. As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging.

Furthermore, regarding post market surveillance the manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices once in use. This includes an obligation for the manufacturer to notify the competent authorities (the Medicines and Healthcare products Regulatory Agency (MHRA) for the UK) immediately of any adverse incidents or problems with the device which have led or might have led to serious health issues or the death of a patient or user. This would include issues with labelling or the Instructions for Use.

A search of the MHRA Adverse Incident database found 534 entries related to defibrillators since 1 January 2012 to the present. Of those, six concern issues related to the Instructions for Use. All of those six concern defibrillators intended for use by professional users and not automatic external defibrillators for use by the public.

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