Rethinking medical device manuals to save lives and trees

  • Posted on 09.06.2011

Rethinking medical device manuals to save lives and trees


John Brennan

Director Regulations and Industrial Policy


Useful, absent, useless or simply not up to modern communication and information exchange practices, finally I’ve just seen an honest debate on the thorny subject of instructions for use for medical devices. It seems that the seeds are being sown in the garden of England for future change to the benefit of everyone.

On the 25 May I attended yet another excellent Medical Device Technology Forum by the UK Medicines and Healthcare products Regulatory Agency, MHRA.  In what was a healthy dose of fresh air and realism, the MHRA brought together clinicians, regulators and industry to tackle the, less than hardy, perennial subject of ‘instructions for use’. And, more particularly, why, while meeting the regulations, they are too long, too bulky, staid, not electronic, varying in quality and, as admitted by all, not being read by most?
This is my second MHRA Medical Device Technology Forum, and the first not interrupted by a fire alarm. There was no such slash and burn tactics on this occasion. I’m grateful to the MHRA for again extending the invitation to Eucomed for a full and inclusive debate which I trust was based on our constructive and progressive approach.

This was an exploratory session to consider what, if anything, could be done to tackle the issue.  Considered and honest presentations were given by regulators, clinicians, notified bodies and industry, represented by Andrew Radford of Medtronic, who presented on behalf of Eucomed and ABHI, and Mick Borroff of DePuy.  Acknowledging that significant stakeholders were absent (obviously patients and lay users) all were agreed something could be done.

My take-away was that the problem is not so much the legislation – although undoubtedly some tweaking may be needed and all saw e-labelling and modern use of information and communication technology (ICT) as critical – but the problem of better analysis and understanding of what are we trying to communicate, to whom are we trying to communicate and then how best to communicate to that person or persons.

I’m looking forward to the official outcome and next steps. The chair, Professor Peter Gaines who did a splendid job, called for a specific working group to come up with concrete proposals for improvement that could then be taken forward by the MHRA into the recast of the European medical devices Directives and other appropriate initiatives.

Certainly the mood in the room was focussed not on bureaucratic legal approaches but modern communication and information exchange mechanisms and guidance rooted in practical legal requirements. Right information at the right time with proper education, training and support were the words that set all heads nodding in agreement around the room. Not useless reams of paper that nobody is reading.

Little acorns from great oaks grow…

– John Brennan, Director Regulatory and Technical Affairs

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