New surgical procedures should be monitored after their introduction. The
approval process should decide the type of monitoring to be undertaken.
• As a minimum, audits of indications and outcomes should be done.
• Access to reliable surgical data (local and global), organised in such a
way that performance comparisons can be made.
• It is highly desirable to coordinate and standardise any study designs,
e.g. outcomes measured in the same way for case series and audits
across hospital services or as done in previous studies.
If an audit or controlled clinical study is being contemplated, consider
whether this can be done as part of a multi-centre study.
• Develop/amend internal processes for the reporting of any adverse
events from new procedures and consider external processes e.g. as
part of multicentre audits or advising the Therapeutic Goods Authority
or the New Zealand New Technology Committee re problems with
devices.
