BSIR discuss off-label device use

Published date : 15 November 2010
Article date : 12 November 2010

This years BSIR (Liverpool UK) featured an interesting plenary session on ‘off label use of devices-is it legal?’

The speakers included:

Dr Susanne Ludgate giving the MHRA perspective
Mr Peter Merchant giving the legal perspective
Professor Duncan Ettles giving the radiologists perspective

Innovation often comes from the use of a device in an unusual scenario, perhaps a use for which the device was never intended. We’ve probably all done this at times, eg use of a Foley bladder catheter for a replacement gastrostomy tube, thrombin injection for pseudoaneurysms. The session heavily revolved around where we stand legally in using devices ‘off label’.

My understanding is that if a device is used ‘off-label’ and the patient comes to harm then the practitioner may not be prosecuted provided that it is accepted practice to use the device in that way by other clinicians. If it is deemed necessary to use a device ‘off label’ then it is advised that the following are undertaken:

1. A documented risk assessment is carried out.
2. Consider the ethical and legal implications
3. implement suitable precautions to minimise risk
4. Review the risk assessment at suitable periods
5. Inform the patient and gain their consent
6. Record the same in the patients notes
7. Ensure the patient is made aware of the risks
8. Any problems with the device/IFU should be reported to the MHRA (in UK)
9. Discuss the proposed use with colleagues to seek advice and inform the risk management team in the trust.
10. Record the use in the patients notes and the reasons for use.

Clearly all these actions cannot be undertaken in an emergency situation and that could pose problems. How many of use have taken these actions prior to the use of thrombin for treating pseudoaneurysms ? This technique was first published in 1986 and then was revived in the late 90s for femoral pseudoaneurysms. The alternatives to its use are surgery (potential risk) or compression, which is both time consuming and painful. The interesting thing here is that thrombin is not only unlicensed for this use, but its intravascular use is specifically contraindicated in the IFU. You could argue that a pseudoaneurysm is not truly intravascular. I and my colleagues were among the first to undertake this treatment and clearly at this stage in its evolution it was not established practice and if we had a complication we could well have been liable. However we would now have more colleagues to support us.

I am keen to get some discussion going on ‘off-label’ device use and have opened a topic in the forum. Please contribute your opinions.

Further information on this topic can be found at:

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