Authors' objectives:

To provide general guidance to hospitals and health services about the assessment of new surgical procedures and the factors that should be considered prior to their introduction. A new surgical procedure is defined as one that has not previously been used in that hospital or health service, and that represents a significant departure from previous practice.

Authors' results and conclusions: Assessment of new surgical procedures: Prior evaluation of the technique should be considered, bearing in mind the reliability of the evidence and the need for more intensive evaluation for procedures that are highly complex or wide-ranging. The training and experience staff members may have gained from other institutions, and the experience of the hospital or health service concerned in similar procedures, should also be determined. For a new evaluation, clinical governance must be established, and any conflicts of interest of individuals involved are to be declared. An example of an application form for a new procedure is provided, covering topics such as the costs of the procedure, predicted throughput, informed consent and patient information. Conditional approval may be given for a new procedure to be carried out under certain circumstances. Introduction and monitorin: New techniques should only be undertaken by more experienced practitioners. Informed consent is to be obtained from patients. New procedures must be monitored after their introduction, with an audit of indications and outcomes as a minimum requirement. Access to reliable surgical data is important; coordination of any study designs, preferably as part of a multi-centre study, is therefore highly desirable. Processes for reporting of any adverse events need to be developed.

Authors' recommendations: The present and future role of ASERNIP-S in the evaluation and registry of new procedures and the identification of newly emerging and evolving techniques is discussed. A list of other relevant organisations and their web-sites is provided.

Project Status: Completed

URL for project: http://www.surgeons.org/asernip-s/

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Australian Safety and Efficacy Register of New Interventional Procedures-Surgical

Contact Address: ASERNIP-S 24 King William Street, Kent Town SA 5067 Australia Tel: +61 8 8219 0900

Contact Name: racs.asernip@surgeons.org

Contact Email: racs.asernip@surgeons.org

Copyright: Australian Safety and Efficacy Register of New Interventional Procedures - Surgical