The Royal College of Surgeons (RCS) has recently 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.
The RCS has previously called for national guidelines on the introduction of new procedures and technologies and has said that it is ready to work with the Department of Health and Social Care (DHSC) and the General Medical Council (GMC) in developing these guidelines. This followed an inquiry by the Newcastle Coroner, Karen Dilks, into the tragic death of a 69-year-old man, who suffered multiple organ failure after robot-assisted heart valve surgery. The RCS has since written to the Newcastle Coroner to outline the training and consent requirements in relation to the introduction of new surgical techniques.
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.
Mr Peter Lamont, who helped develop the new guidance and is a Royal College of Surgeons Council Member, said: “As our Commission on the Future of Surgery recently found, surgery is set to be transformed for millions of patients by a new wave of technologies. These technologies are expected to affect every type of surgery, including the way it is provided and the way we train surgeons.
“Historically though, the development of new surgical techniques have often taken place in the absence of the rigour associated with the development of new medicines or devices.
“It is absolutely vital that surgical innovation places both patient safety and the best interests of the patients at the core. The introduction of new technologies or techniques in surgery has no place for the maverick surgeon who proceeds without appropriate peer review or training.
“Surgeons by nature are innovators and we hope that these guidelines will help them bring their new ideas forward in a way that most benefits patient care.”
The new RCS 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 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.
It highlights 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 RCS says that once a surgical innovation is introduced into routine practice, there needs to be mechanisms put in place to monitor its long-term impact. This is required to detect adverse events or long-term outcomes that could not be observed directly in the original evaluation, as well as to access whether effects observed in earlier evaluation are replicated in routine practice.
Surgeons are also expected to keep an accurate and accessible record of all their surgical activity and submit activity data to national audits, registries and databases relevant to their practice. The RCS has long called for all new surgical procedures and devices to be registered, with related data collected in appropriate national audits before they are routinely offered to patients. This would cover the use of innovative treatments, such as robot-assisted surgery, in both independent and NHS sector.
The full report of the Commission on the Future of Surgery is available at https://futureofsurgery.rcseng.ac.uk/