The application of FMEA method in the risk management of medical device during the lifecycle

2010 2nd International Conference on E-Business and Information System Security, EBISS2010

Volumn , Issue , 2010, Pages 455-458

  Zhao, Xiuxu ^a   Bai, Xiaoli ^a  

^a WUHAN UNIVERSITY OF TECHNOLOGY   (China)

Author keywords

FMEA; Medical device quality control; Risk management; Risk priority number

Indexed keywords

FAILURE MODE AND EFFECT ANALYSIS; FMEA; HUMAN LIVES; KEYPOINTS; MANAGEMENT STRATEGIES; MEDICAL DEVICE QUALITY CONTROL; MEDICAL DEVICES; PATIENT HEALTH; POTENTIAL HAZARDS; QUANTITATIVE LEVEL; RISK MANAGEMENT PROCESS; RISK PRIORITY NUMBER; UNCERTAIN FACTORS;

BIOMEDICAL ENGINEERING; CUSTOMER SATISFACTION; ELECTRONIC COMMERCE; FAILURE ANALYSIS; HEALTH HAZARDS; HEALTH RISKS; INFORMATION SYSTEMS; QUALITY ASSURANCE; RISK MANAGEMENT; SAFETY FACTOR; TOTAL QUALITY MANAGEMENT; UNCERTAINTY ANALYSIS;

QUALITY CONTROL;

EID: 77954359153     PISSN: None     EISSN: None     Source Type: Conference Proceeding    
DOI: 10.1109/EBISS.2010.5473713     Document Type: Conference Paper

References (11)

1. Tidimogo Gaamangwe, Agustina Krivoy, Petr Kresta, "Applying risk Management principles to medical devices performance assurance program-defining the process", Biomedical Instrumentation & Technology 2008; 42:401-406.
2. R.D.Wilkins, L.K.Holley, "Risk Management in Medical Equipment Managment", Proceedings of the 20th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Vol. 20, No 6,1998.
3. R.D.Wilkins, L.K.Holley, "Risk management in medical equipment management", Proceedings of the 20th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Vol. 20, No 6,1998.
4. Fergal McCaffery, John Burton, Ita Richardson, "Improving Software risk management in a medical device company", ICSE'09, May 16-24, 2009.
5. Steven M. Donn, "Medical liability, risk management, and the quality of health care", Seminars in Fetal & Neonatal Medicine (2005) 10, 3-9. (Pubitemid 40138861)
6. R. Masterton et.al, "Hospital infection society/association of medical microbiologists 'Towards a Consensus II' workshop I hospital-acquired infection and risk management", Journal of Hospital Infection (2002) 51: 17-20.
7. Steve McRoberts, CSci CPhys MInstP, "Risk Management of Product Safety", Product Safety Engineering, 2005 IEEE Symposium on 3-4 Oct. 2005 Page(s): 65-71.
8. Grace Bartoo, "risk management", IEEE Engineering in Medicine and Biology magazine, 2003.
9. AAMI/ISO 14971 -RiskManagement - Application of risk management to medical devices.
10. G.Cassanelli et.al, "Failure Analysis-assisted FMEA", Microelectronics Reliability 46(2006) 1795-1799.
11. CEI/IEC 60812-Analysis techniques for system reliability-Procedure for failure mode and effects analysis (FMEA).