The Royal College of Surgeons (RCS) has published new guidance to provide surgeons with up-to-date thinking on the development and implementation of surgical innovations, such as robot-assisted surgery and new operating techniques.

Download the guidance here.

The College says a strong framework is needed for developing surgical innovations to ensure that patient safety, as well as the patients’ best interests, always come first.

From developments in three-dimensional printing, artificial intelligence, robotics and nanotechnology to advances in regenerative medicine and the ability to grow organs and tissues in the laboratory, new technologies and techniques have huge potential to improve patient care. The RCS says that as exciting as this is, there are significant risks in allowing innovation to occur in the absence of a clear guiding principle.

Previous calls for national guidelines on the introduction of new procedures and technologies followed an inquiry by the Newcastle Coroner, Karen Dilks, into the tragic death of a 69-year-old man, Stephen Pettitt, who suffered multiple organ failure after robot-assisted heart valve surgery. The College has said it is ‘ready to work with the Department of Health and Social Care (DHSC) and the General Medical Council’ to develop them further.

When new devices are introduced, there must be processes put in place to manage risk and monitor their impact on procedures and the health outcomes of patients. The RCS warns that these may not be apparent immediately, so long-term mechanisms need to be put in place.

What does the guidance include?

Primarily, the guidance highlights the challenges commonly faced by surgeon innovators and signposts sources of assistance. It is also directed at medical and clinical directors charged with providing oversight of surgical activity within their organisations. It also describes the guiding principles all surgeons should consider when developing new techniques, instruments or devices, as well as how surgeons can demonstrate the safety and effectiveness of those innovations.

The guidance sets out:

  • The clinical governance and oversight that is needed to introduce innovations;
  • principles for how training should be undertaken;
  • what the patient consent requirements are;
  • how conflicts of interest should be managed;
  • how new techniques should be translated into wider practice;
  • and the need for measuring long-term outcomes.

The guidelines go further to outline the important role of mentors when introducing innovations. New techniques often require the development of new skills for which training is necessary. Where a technique is being undertaken for the first time, training may involve practising the technique on a cadaver or in a simulation lab.

When the technique has been performed previously by others, training might comprise: hands-on experience of the procedure under supervision; scrubbing in to observe another surgeon operate; undertaking a fellowship; participating in a formal training programme; and performing the procedure under mentorship from a trained surgeon.

The full guide can be read here.