Hiding behind ‘innovation’: the case for regulated risk assessment in surgery

Abstract

There have been numerous recent high-profile cases of 'surgical innovation' gone wrong, including vaginal mesh 1 , the da Vinci Robot 2 , and synthetic tracheas 3 . All were new developments in surgery that failed to reach their potential to benefit patients and surgeons, and instead caused harm. There is now urgent interest in how surgical innovation should be regulated.Surgical innovation has the potential to bring significant benefit to patients, and innovator surgeons are historically heralded as inspirational leaders, and courageous risk-takers 4 , who develop more efficient and more effective procedures and devices that improve patient outcomes.Currently, in the UK, surgeons are able to modify procedures, introduce procedures and devices, or use existing devices for new purposes with very little, if any, oversight. Guidance from the National Institute for Health and Care Excellence (NICE) is not followed 5 . Research itself is heavily regulated, and many UK hospitals have New Procedure Committees or Clinical Effectiveness Committees (or such like), providing an alternative 'research approval' process. They, in theory, monitor and authorize new procedures and new uses of devices 6,7 . Yet, if surgeons do not identify their practice as 'research', or do not self-identify as doing something 'new', these mechanisms fail, and practice goes unregulated and unmonitored.Compounding this, there are limited reporting mechanisms for failed innovations, and existing ones are underused [5][6][7] . Consequently, innovations associated with harms/risks go unreported (unless picked up by regulators, the coroner, and/or the media) and future innovators cannot learn from them, meaning mistakes may be repeated. Mandated (cardiac surgery) 8 and optional (e.g. arthroplasty) registries are designed to monitor standard (not innovative) procedures, and data capture is not routine. Although changes are occurring for the introduction of new devices, these are yet to be implemented. One challenge is defining what constitutes a new procedure, the associated risk, and what magnitude of modification/risk requires registration and/or regulation.There is currently much focus on regulating surgical innovation 9,10 to improve patient safety. We agree but, perhaps controversially, contend that the term 'innovation' should be eliminated.

Maintaining Standards in Colorectal Cancer Surgery During the Global Pandemic: A Cohort Study

“…Lastly, without robust evidence‐based guidance, clinicians and managers had to consider the potential for litigation, if decisions were considered ill‐advised in retrospect [11].…”

Examining the application of the IDEAL framework in the reporting and evaluation of innovative invasive procedures: secondary qualitative analysis of a systematic review

“…Others have noted this problem with existing definitions of ‘innovation’ being described as overly broad 82 and lacking in practical utility because they do not distinguish between expected variation in standard clinical practice and changes made to procedures that are evaluated within research. 24 Ives et al 16 recommend a change in terminology is needed around the term innovation. Rather than using words such as ‘new, innovative or modified’, Ives et al recommended that invasive procedures are classified by the level of known risk associated with them based on objective assessments of existing evidence.…”

“…The terminology of such a system needs to avoid words that are loaded with inherent bias. The term ‘innovation’ is synonymous with positive progress and benefit, 16 19 and this may be a factor in influencing research. Positive outcome bias is a recognised limitation in biomedical research.…”

“…86 87 When introducing or evaluating innovations, instead of a focus on ‘how new is this procedure?’, a more appropriate question may be ‘how does this change affect the procedure in terms of risks and benefits, and subsequent impact on outcomes?’. 16 19 Defining and categorising new and modified interventions in terms of degree of risk and evidence of safety and effectiveness, rather than undefined vague language 16 19 would promote safe and transparent innovation by facilitating the appropriate choice of study design and governance.…”

“… 11–15 It can also be defined as something with uncertain levels of risk. 16 Requirements for additional training 13 15 and the degree of evidence of safety and efficacy 17 18 have been used to determine how innovative an intervention is. However, some of these definitions are difficult to apply in practice.…”