The governance of surgical innovation in the UK National Health Service

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Dear Editor, Innovation is pivotal to improve healthcare. Although widely endorsed by healthcare providers, it inherently carries risk and patients may be harmed. An independent enquiry highlighted where this can cause patient harm and recommended better governance of innovation, emphasizing the need for systematic outcome monitoring, and transparent informed consent1. How this is achieved in the UK National Health Service (NHS) for surgery is complex. Whereas the introduction of drugs predominantly occurs within a research framework, the governance of surgical innovation is unclear. The National Institute of Health and Care Excellence (NICE) provides governance guidance for about 30 new interventional procedures annually. NICE may recommend delivery within standard practice, with evidence generation (that is outcome data collected and shared), with research oversight, or advise that it should not be used2. Governance guidance is also provided by NHS hospitals. Dedicated committees, known as New Procedures Committees (NPCs), consider applications for new intervention delivery within a single hospital. Committees usually consist of clinicians (for example surgeons, anaesthetists), administrative and clinical governance staff (for example managers with audit expertise). Unlike NICE or Health Research Authority (HRA) committees they do not usually include methodologists or patient members3. NPCs make similar recommendations to those made by NICE with decisions informed by national governance guidance, published evidence, and clinical judgement. When NICE guidance is unavailable NPCs/innovators are advised to notify NICE of the innovation. The HRA also provides governance for studies evaluating innovative procedures within a research framework4. Literature analyses shows that a minority of surgical innovations are introduced within research5–7. Local hospital NPCs are central to the governance of surgical innovation, although little is known about their workload and decision-making. This study explored the volume and type of governance decisions made by NPCs, and adherence to national governance guidance. We report a 12-month service evaluation study (February 2022 to January 2023) that was undertaken in five English NHS hospitals (Supplement Table S1). An NPC was defined as a system appointed by the medical director to oversee the introduction of new procedures, including where this function operated alone or within a wider remit (for example clinical effectiveness group). Medical directors circulated a standardized email describing the study to clinicians before it began. Eligible were innovative invasive interventions defined as those without evidence of safety and/or efficacy and those being used for the first time in the hospital8. Data extraction forms were developed, piloted and managed using REDCap (Research Electronic Data Capture) electronic tools. Numbers of committee meetings and new procedures were recorded. NPC decisions were noted and categorized by whether this followed national governance guidance. Where no guidance existed, it was recorded whether NICE was notified. The central research team independently examined all the guidance available and held meetings with participating hospitals to discuss the findings. A patient and public involvement and engagement group inputted into the study (details in Supplement). In total, 35 procedures were discussed across 30 meetings with three being considered in more than one trust (Supplement Table S1). National guidance existed for 16 and was followed for 10 (Supplement Table S2). For the remaining six, NPCs recommended mostly lighter touch governance than NICE (that is standard rather than evidence generation/research). Of 22 new procedures without national governance guidance, 18 were approved for standard care with audit, three recommended for research, and one declined (Table 1). Two were notified to NICE and NICE recommended delivery within standard care (each considered a modification of an intervention with a known safety profile). Procedures (n = 22) considered in NPCs without available national governance guidance, whether NICE was notified and local governance decision *Device was considered by two hospitals. †NICE HTE21 (2025) approved five robotic technologies for evidence generation (special arrangements until 2024). ‡Academy of Royal Medical Colleges 2024 (AOMRC) recommended standard arrangements, MIB = Medtech Innovation Briefings (no longer produced after April 2023). Hospitals sometimes reported identifying national guidance for these procedures, although when reviewed by the research team this was not always the case. For example, Medtech Innovation Briefings that do not make governance recommendations were cited (n = 3). Three hospitals approved robotic-assisted surgery for use in standard care citing NICE guidance for laparoscopic surgery (Table 1). This study explored the governance of surgical innovation in a sample of five NHS hospitals. Hospitals made governance decisions largely independently, that is without notifying NICE, following national guidance or referring to research. This practice is of concern. It may jeopardize incremental safety assessment of new procedures and informed patient consent. Figure 1 'Algorithm for selecting NHS governance for new interventional procedures' illustrates how governance for innovative procedures could be strengthened in the NHS. It recommends that NPCs follow national guidance when available, and, for procedures without NICE guidance, that NICE be notified. It is recommended that NICE’s governance responses to notifications are shared across the NHS to provide equitable advice to all hospitals and that an open national database of new procedures being undertaken in hospitals is established. Algorithm for selecting NHS governance for new interventional procedures **A procedure is considered innovative if it does not have published safety and efficacy data.8 **In the NHS it the responsibility of the medical director of each hospital to ensure governance of new invasive interventional procedures is appropriate. This is often delegated to committees such as, e.g. ‘New Procedure Committees', ‘Clinical Effectiveness Committees’ etc.2 ***NICE = The National Institute of Health and Care Excellence provide governance guidance for 30 new invasive interventional procedures annually. **** NICE is notified via this link, https://tinyurl.com/y7x79h7r (accessed 4 February 2026). The UK governance of surgical innovation is similar to that of other high-income countries9,10. Hospitals provide independent governance guidance for delivery of new procedures without a nationally agreed approach, and a minority are delivered within research. One study conducted in England and Wales analysed hospital governance policies and found variation in the type of invasive procedures for delivery with local approval, limited research guidance and deficiencies with patient information provision and informed consent3,11,12. Guidance for reporting and monitoring adverse events and when to abandon a procedure was lacking12. Although this study is original and prospective in design, it had limitations. Data about the time NPCs took to make governance decisions were not captured. Obtaining local governance approvals for innovation delivery may be quicker and less onerous than using other mechanisms, although this requires further investigation. Another limitation is that participating hospitals were aware that they were being monitored and that may have influenced decision-making. Despite this, compliance with NICE guidance was very low. Additionally, the sample was small and practices may differ across the UK. This study highlights how existing systems for the oversight of surgical innovation are disconnected. Although NICE provides governance guidance, it is not always followed, and a significant proportion of new procedures are being undertaken without notification t

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