Governance and innovation: experience with a policy on the introduction of new interventional procedures.

BACKGROUND: Changing consumer expectations, particularly in the area of informed consent, coupled with a history of an unanticipated rise in adverse events following the introduction of some new interventional procedures, have produced a need for the more formal evaluation of such procedures before their introduction into a health-care facility. Moreover, a need exists to ensure that the outcomes of such procedures are monitored. Descriptions of such formal evaluation processes were lacking before 2000. The experience of a large regional health service with the implementation of a brief but comprehensive evaluation process for the introduction of new interventional procedures is described.
METHODS: A policy outlining the approval and monitoring processes, including a simple, 15-point checklist, was developed in consultation with clinicians and managers and was implemented in 2000. The experience with this policy between January 2001 and December 2004 (inclusive) is described.
RESULTS: Twenty-nine applications for the introduction of new procedures, from a range of clinical disciplines, were submitted and approved. Some required significant modification, particularly in the areas of clinical risk description and other data required to facilitate the provision of informed consent.
CONCLUSIONS: Innovation can be protected and encouraged by processes that allow for appropriate scrutiny of the benefits and requirements for the successful introduction of new interventional procedures. The approach described has since been used as the basis for the New South Wales Health Department statewide policy on this matter and as a model policy by the Royal Australasian College of Surgeons.