Updated process to oversee the safe introduction of new surgical procedures

The National Institute for Health and Care Excellence (NICE) has worked with researchers from the surgical and orthopaedic innovation theme at the Bristol Biomedical Research Centre (Bristol BRC) to create a flow diagram outlining an updated process for overseeing the safe introduction of new surgical procedures. The diagram, hosted by the Bristol Centre for Surgical Research, is now also available via NICE’s website.

Researchers from the Bristol BRC worked with NICE, members of the Health Research Authority (HRA) and public contributors to develop updated guidance for clinicians to follow when considering the introduction of new or changed procedures. The diagram they created sets out steps a clinician, hospital local committees and NICE should take to ensure patient safety.

Amongst others, these steps involve:

• Following NICE guidance if it exists or notifying NICE if it doesn’t (clinicians)
• Gathering information, developing guidance and deciding whether a procedure could be considered established (NICE)
• Ensuring compliance with guidelines, providing adequate training and resources (hospital local committee)

NICE develops and provides guidance on new surgical procedures that may not yet be considered standard within the NHS. It also provides recommendations about the safe use of new devices as well as publishing versions of guidance for the benefit of patients and other members of the public.

The type of guidance provided by NICE is important in the oversight of surgical innovation because different levels are needed for procedures with different risks. When full research oversight is recommended it means that information for patients about how innovative their procedure is, is peer reviewed and checked before use.

More transparent information is expected to influence patient choice and autonomy. It also means that safety data is collected and shared, which will influence whether the procedure is delivered to larger groups of patients. Innovation requires oversight and management to ensure safety and transparency.

Work on the diagram formed part of the INTRODUCE study, funded by the Bristol BRC and carried out at the Bristol Centre for Surgical Research. The study examined NHS hospital policies for the introduction of new surgical and other invasive procedures and devices in England and Wales. The research team behind the study wanted to find out how hospitals approached surgical innovation because of the different ways in which this was being dealt with across the NHS.

Researchers studied hospital policies about what level of oversight was recommended to deliver new surgeries and invasive procedures. They investigated these policies to explore when new procedures could be delivered with only standard or special arrangements, when they needed to be overseen by local hospital committees, and when they needed research ethics approval.

Professor Jane Blazeby, Bristol Medical School, said:

“This work is throwing light on how surgical innovation takes place in the NHS. It underscores areas for improvement. We are continuing to work with key stakeholders to make surgical innovation safe and widely available.”