PT  - JOURNAL ARTICLE
AU  - S Andrew Spencer
AU  - Sarah E Nicklin
AU  - Yapa A Wickramasinghe
AU  - Andy Nevill
AU  - Simon J Ellis
TI  - An essential ‘health check’ for all medical devices
AID  - 10.7861/clinmedicine.3-6-543
DP  - 2003 Nov 01
TA  - Clinical Medicine
PG  - 543--545
VI  - 3
IP  - 6
4099  - http://www.rcpjournals.org/content/3/6/543.short
4100  - http://www.rcpjournals.org/content/3/6/543.full
SO  - Clin Med2003 Nov 01; 3
AB  - In order to safeguard patient safety, all new or modified medical devices must be assessed for their safety and performance before they are used routinely in clinical practice. Most devices will carry a CE (Confirmity European) mark to demonstrate their safety, but many devices will require an alternative method of assessment. In this article, we discuss the procedures already in place, the significant gaps that exist in the system and the risk management issues. We consider the impact on research and clinical practice, and describe our comprehensive risk management system for objectively assessing the safety of any medical device.