Healthcare organization policy recommendations for the governance of surgical innovation: review of NHS policies

Background
The governance for introducing innovative surgical procedures/devices differs from the research requirements needed for new drugs. New invasive procedures/devices may be offered to patients outside of research protocols with local organisation oversight alone. Such institutional arrangements exist in many countries and written policies provide guidance for their use, but little is known about their scope or standards.

Methods
We systematically approached acute NHS trusts in England (n=150) and health boards in Wales (n=7) for their policies. A modified framework approach analysed when policies considered new procedures/devices, i) within local organisation remit, and/or ii) requiring research ethics committee (REC) approval.

Results
Of 113 policies obtained, 109 and 34 described when local organisation and REC approval was required, respectively. Procedures/devices being used for the first time in the organisation (n=69) or by a clinician (n=67) were commonly within local remit; only 36 stated these required evidence. Others stated limited evidence as a rationale for needing REC approval (n=13). External guidance categorising procedures as ‘research only’ was the commonest reason to gain REC approval (n=12). Procedures/devices with uncertain outcomes, requiring additional training, and never previously used before were within the remit of n=28, 26 and 6 policies, respectively; others recommended REC application in these situations (n=5, 2 and 7).

Conclusion
This is the first study examining NHS policies for surgical innovation. Procedures/devices appropriate for local oversight or requiring REC application varied. Current NHS standards allow untested innovations to occur without the safety of research oversight. A standard approach is urgently needed.