1.2.4 Introduction of new techniques
Introduction of new clinical interventions and surgical techniques (including equipment) that deviate significantly from established practice and are not part of an NHS local ethics committee research programme must be underpinned by rigorous clinical governance processes, having the patient’s interests as the paramount consideration. If you are introducing new surgical techniques and technologies you should:
- Discuss the technique with colleagues who have relevant specialist experience and seek formal approval from your medical director.
- Follow local protocols with regard to obtaining approval by the local ethics committee or the local clinical governance committee. These should include the provision of evidence that the new technique is safe and that all clinical staff who plan to use the new technique will undertake relevant training, mentorship and assessment.
- Contact the Interventional Procedures Programme at the National Institute for Health and Care Excellence (NICE) to learn the status of the procedure and/or register it, and liaise with the relevant surgical specialty association.
- Obtain appropriate training in the new technique, take part in regular educational activities that maintain and develop competence and performance, and enable the training of other surgeons.
- Ensure that any new device complies with European standards and is certified by the competent body.
- Ensure that patients and their supporters know that a technique is new before seeking consent and that all the established alternatives are fully explained prior to recording their agreement to proceed.
- Be open and transparent about the sources of funding for the development of any new technique.
- Contribute to the evaluation of the new procedure by auditing outcomes and reviewing progress with a peer group, and by complying with guidelines by the National Institute of Health and Care Excellence (NICE) or by the Scottish Intercollegiate Guidelines Network (SIGN).
|From Innovation to Adoption||RCS||2014|
|From Theory to Theatre: Overcoming barriers to innovation in surgery||RCS||2011|