Spigelman Allan D
Clinical Governance Unit, Hunter Area Health Service, and Surgical Science, Faculty of Health, The University of Newcastle, New Lambton, Newcastle, NSW 2305, Australia.
ANZ J Surg. 2006 Jan-Feb;76(1-2):9-13. doi: 10.1111/j.1445-2197.2006.03648.x.
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.
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.
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.
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.
消费者期望的不断变化，尤其是在知情同意领域，再加上一些新的介入性程序引入后不良事件意外增加的历史，使得在将此类程序引入医疗保健机构之前需要进行更正式的评估。此外，还需要确保对这些程序的结果进行监测。2000年之前缺乏对此类正式评估过程的描述。本文描述了一个大型区域卫生服务机构在实施新介入性程序简短但全面的评估过程中的经验。
与临床医生和管理人员协商制定了一项概述批准和监测过程的政策，包括一个简单的15点清单，并于2000年实施。描述了2001年1月至2004年12月（含）期间该政策的实施经验。
提交并批准了来自一系列临床学科的29项新程序引入申请。有些申请需要进行重大修改，特别是在临床风险描述和为提供知情同意所需的其他数据方面。
通过对新介入性程序成功引入的益处和要求进行适当审查的流程，可以保护和鼓励创新。所描述的方法此后被用作新南威尔士州卫生部关于此事的全州政策的基础，并被澳大利亚皇家外科医师学院用作示范政策。
