An essential ‘health check’ for all medical devices
S Andrew Spencer, Sarah E Nicklin, Yapa A Wickramasinghe, Andy Nevill and Simon J Ellis
DOI: https://doi.org/10.7861/clinmedicine.3-6-543
Clin Med November 2003 S Andrew Spencer
Keele University, Stoke on Trent
DM FRCPCHSarah E Nicklin
∗University Hospital of North Staffordshire, Stoke on Trent
MBShB MRCPCHYapa A Wickramasinghe
∗University Hospital of North Staffordshire, Stoke on Trent
DPhil(Oxon) CEngAndy Nevill
∗University Hospital of North Staffordshire, Stoke on Trent
PhD CEngSimon J Ellis
∗University Hospital of North Staffordshire, Stoke on Trent
FRCP MDAbstract
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.
- © 2003 Royal College of Physicians
Article Tools
An essential ‘health check’ for all medical devices
S Andrew Spencer, Sarah E Nicklin, Yapa A Wickramasinghe, Andy Nevill, Simon J Ellis
Clinical Medicine Nov 2003, 3 (6) 543-545; DOI: 10.7861/clinmedicine.3-6-543
Citation Manager Formats
Jump to section
Related Articles
- No related articles found.
Cited By...
- No citing articles found.