Critical assessment of new devices

Perfusion

Volumn 22, Issue 3, 2007, Pages 167-171

  Hamilton, Carole ^a  

^a UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL RESEARCH; GOVERNMENT REGULATION; INFORMATION DISSEMINATION; MEDICAL APPARATUS, EQUIPMENT AND SUPPLIES; MEDICAL ERROR; PATIENT SAFETY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; QUALITY CONTROL; RESEARCH ETHICS; RISK ASSESSMENT; STANDARDIZATION;

EQUIPMENT AND SUPPLIES; EQUIPMENT DESIGN; EQUIPMENT FAILURE; EQUIPMENT SAFETY; ETHICS, RESEARCH; EUROPEAN UNION; EVALUATION STUDIES AS TOPIC; HUMANS; INFORMATION SERVICES; MEDICAL ERRORS; PRODUCT SURVEILLANCE, POSTMARKETING; QUALITY CONTROL; SAFETY MANAGEMENT; TECHNOLOGY ASSESSMENT, BIOMEDICAL;

EID: 35549001773     PISSN: 02676591     EISSN: None     Source Type: Journal    
DOI: 10.1177/0267659107076877     Document Type: Article

References (9)

1. Medical Device Directives (93/42/EEC).
2. Competent Authorities charged with safeguarding public health. European Commission Designation and Monitoring of Notified Bodies within the Framework of EC Directives on Medical Devices: April 2001.
3. Kurusz M. Standards update on perfusion equipment and practice. Perfusion 2005; 20: 205-208.
4. Le Cocq A. Application of human factors engineering to cardioplegia delivery system design. Canadian Perfusion Canadienne 1996; 8, (3).
5. Kurusz M, Conti VR, Arents JF et al, Perfusion accident survey, Proceedings of the AACP, 1986; 7:57-65.
6. Bridgland I.A, Menon D.K. Monitoring medical devices: the need for new evaluation methodology. Br J Anaesth 2001; 87: 678-81.
7. Medical Device Problem Reporting Guidance Health Devices Aug 1998; 28(8):277-92.
8. Keller H.P. Demonstrating the safety of medical devices-seeking common ground for the use of humans in clinical investigations. Secretary ISO/ TC 194/WG 4.
9. Kohn L, Corrigan J, Donaldson M, eds., To Err Is Human: Building a Safer Health System Washington, DC: Institute of Medicine National Academy Press, 2000.