Long-term medical device accountability: An information technology solution

International Journal of Risk and Safety in Medicine

Volumn 8, Issue 1, 1996, Pages 85-91

  Knapp, T R ^a  

^a LipoMatrix Inc   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ACCOUNTING; CONFERENCE PAPER; DEVICE; HUMAN; IMPLANT; INFORMATION SYSTEM; POSTMARKETING SURVEILLANCE;

EID: 0029893627     PISSN: 09246479     EISSN: None     Source Type: Journal    
DOI: 10.3233/jrs-1996-8115     Document Type: Conference Paper

References (7)

1. Safe Medical Device Act of 1990 (USA), Public Law 101-629 [HR3095], 28 November 1990, Section 519 (21 U.S.C. 3601 (e) 1).
2. J.J. Nobel, D. Woods, M. Argentieri et al., eds, The medical device tracking requirement, in: Medical Device Tracking, Pennsylvania, ECRI, 1992, pp. 1-10.
3. C.F. Hughes, Lessons from failures: The Bjork-Shiley experience, Asia Pacific J. Thorac. Cardiovasc. Surg., 1994, 38-39.
4. C.F. Hughes, The Australia and New Zealand Heart Valve Registry, Asia Pacific J. Thorac. Cardiovasc. Surg., 1994, 40-41.
5. T.R. Knapp, T.L. Monsees and W.A. Andrews, Implant with electrical transponder marker. United States Patent No. 5,300,120, 5 April 1994.
6. J. Fielder and J. Black, But Doctor, It's my hip!: The fate of failed medical devices, Kennedy Inst. Ethics J. (in press).
7. Medtronic's medical device tracking system: Meeting the challenges of a new mandate, Medtronic News 22, 66-70.