Management of intracardiac device recalls: A consensus conference

PACE - Pacing and Clinical Electrophysiology

Volumn 19, Issue 1, 1996, Pages 7-17

  Goldman, Bernard S ^a,e,f   Newman, David ^b   Fraser, Jennifer ^c   Irwin, Marleen ^d  

^a UNIVERSITY OF TORONTO   (Canada)

^b ST MICHAEL'S HOSPITAL   (Canada)

^c Peterborough Clinic   (Canada)

^d GREY NUNS COMMUNITY HOSPITAL   (Canada)

^e SUNNYBROOK RESEARCH INSTITUTE   (Canada)

^f NASPE   (United States)

Author keywords

device recalls; safety alert

Indexed keywords

ARTICLE; ARTIFICIAL HEART PACEMAKER; COST EFFECTIVENESS ANALYSIS; DEFIBRILLATOR; DEVICE; FOOD AND DRUG ADMINISTRATION; HEART PACING; HEART PERFORMANCE; HUMAN; PACEMAKER ELECTRODE; PULSE GENERATOR; SAFETY;

DEFIBRILLATORS, IMPLANTABLE; ELECTRODES, IMPLANTED; HEART VALVE PROSTHESIS; HUMANS; PACEMAKER, ARTIFICIAL; PRODUCT SURVEILLANCE, POSTMARKETING; REGISTRIES;

EID: 0030040927     PISSN: 01478389     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1540-8159.1996.tb04785.x     Document Type: Article

References (14)

1. General Accounting Office, Report to the Chairman, Subcommittee on Health and the Environment, Committee on Energy and Commerce, US House of Representatives. "Medical Device Recalls," August, 1989.
2. Tyers GFO. FDA Recall: How do manufacturers compare? Ann Thorac Surg 1989; 48: 390-396.
3. Crosby P. Consensus Conference, March 6, 1995. Personal Communication.
4. Furman S. The Bilitch report. PACE 1994; 17: 690-696.
5. Schoenfeld MH. Recommendations for implementation of a North American multicenter arrhythmia device/lead database. PACE 1992; 15: 1633-1635.
6. Maloney JD, Hayes DL, Timmis GC. Report of the policy conference of NASPE on device/lead performance and the development of a post market surveillance database. PACE 1993; 16: 1945-1952.
7. MacCregor DC, Noble EJ, Morrow JD, et al. Management of a pacemaker recall, J Thorac Cardiovasc Surg 1977; 74:657-667.
8. Schoenfeld MH. Quality assurance in cardiac electrophysiology and pacing: A brief synopsis. PACE 1994; 17:267-269.
9. Pittman Estate vs Bain et al. (1994) 19 Canadian Cases Law of Tort (C.C.L.T.) (2d) 1.
10. World Health Organization, Division of Mental Health. Communicating Bad News. Geneva, Switzerland, 1993.
11. Bernstein AD, Irwin ME, Parsonnet V, et al. Report of the NASPE Policy Conference on antibradycardia pacemaker follow-up: Effectiveness, needs and resources. PACE 1994; 17:1714-1729.
12. Parsonnet V. June 20, 1995. Personal communication.
13. Parsonnet V. The retention wire fix. PACE 1995; 18:955-957.
14. Scully H, Goldman B, Fulop J, et al. Five year follow up of Hancock pericardial valves: Management of premature failure. J Cardiac Surg 1988; 3: 397-403.