Volume 19, Issue 6, June 2019, Page 28-29.

Improving surgical interventions is key to improving outcomes. Ensuring the safe and transparent translation of such improvements is essential. Evaluation and governance initiatives, including the IDEAL framework and the Macquarie Surgical Innovation Identification Tool have begun to address this. Yet without a definition of innovation that allows non-surgeons to identify when it is occurring, these initiatives are of limited value. A definition seems elusive, so we undertook a conceptual study of surgical innovation. This indicated common conceptual areas in discussions of (...) innovation, that we categorised alliteratively under the themes of “purpose”, “place”, “process”, “product” and “person”. These conceptual areas are used in varying—sometimes contradictory—ways in different discussions. Highlighting these conceptual areas of surgical innovation may be useful in clarifying what should be reported in registries of innovation. However our wider conclusion was that the term “innovation” carries too much conceptual baggage to inform normative inquiry about surgical practice. Instead, we propose elimination of the term “innovation” from serious discourse aimed at evaluation and regulation of surgery. In our view researchers, philosophers and policy-makers should consider what it is about surgical activity that needs attention and develop robust definitions to identify these areas: for our own focus on transparency and safety, this means finding criteria that can objectively identify certain risk profiles during the development of surgery. (shrink)

Surgical innovation involves practices, such as new devices, technologies, procedures, or applications, which are novel and untested. Although innovative practices are believed to offer an improvement on the standard surgical approach, they may prove to be inefficacious or even dangerous. This article considers how surgeons considering innovation should reason in the conditions of uncertainty that characterize innovative surgery. What attitude to the unknown risks of innovative surgery should they take? The answer to this question involves value judgments about the acceptability (...) of risk taking when satisfactory scientific information is not available. This question has been confronted in legal contexts, where risk aversion in the form of the precautionary principle has become increasingly influential as a regulatory response to innovative technologies that pose uncertain future hazards. This article considers whether it is appropriate to apply a precautionary approach when making decisions about innovative surgery. (shrink)