Chairman Interventional Procedures and Medical Technologies Advisory Committees, National Institute for Health and Care Excellence, 10 Spring Gardens, London SW1A 2BU, UK.
Br Med Bull. 2013;107:5-18. doi: 10.1093/bmb/ldt022. Epub 2013 Jul 29.
Recent problems with medical devices have highlighted the need for improved surveillance. New procedures are largely unregulated.
Information from regulators. Guidance produced by the National Institute for Health and Care Excellence Interventional Procedures and Medical Technologies Advisory Committees and the evidence used in their evaluations.
More and better evidence is required for new medical devices and procedures when they are introduced into practice. Routine collection of observational data on outcomes should be improved.
How best to protect patients from harm while allowing rapid access to potentially beneficial interventions.
Establishing systems for good data collection on the use of devices and procedures.
How to accrue more and better evidence about devices and procedures through clinical trials and various avenues of observational data collection.
医疗器械近期出现的问题突显了加强监测的必要性。新程序在很大程度上不受监管。
监管机构的信息。国家卫生与保健卓越研究所介入程序和医疗技术咨询委员会发布的指南以及他们评估中使用的证据。
新的医疗器械和程序在引入实践时需要更多和更好的证据。应改进对结果的观察性数据的常规收集。
如何在允许快速获得潜在有益干预措施的同时，最好地保护患者免受伤害。
建立设备和程序使用的良好数据收集系统。
如何通过临床试验和各种观察性数据收集途径获得更多关于设备和程序的更好证据。
