Cromheecke M, de Mol B; International Society of Technology Assessment in Health Care. Meeting.
Annu Meet Int Soc Technol Assess Health Care Int Soc Technol Assess Health Care Meet. 1998; 14: 51.
Academic Medical Center of the Unversity of Amsterdam, The Netherlands.
OBJECTIVE: Evaluation of the potential value of a risk communication model based on the product's lifecycle to reduce the risk of mortality due to heart valve fracture. METHOD: We conducted an accident analysis focused on risk communication and the use of guidelines on prevention, involving all 7 cases of fracture of the Bork-Shiley convexoconcave heart valve in The Netherlands between 1995 and 1997 which all led to death. RESULTS: 1) In 3 patients, prophylactic valve replacement should have been performed. 2) In 6 patients, immediate referral to a cardiac-surgical center and the diagnosis of fracture had been delayed considerably, even though all patients or their relatives had stressed the possibility of valve fracture. 3) Patients nor cardiologists had been prepared sufficiently for emergencies. 4) Patients nor cardiologists had perceived the risk of death due to valve fracture as a potential reality, even though this risk had been known for 15 years. 5) More than 15 disciplines had been involved in generating, collecting, and distributing risk information: (inter)national health authorities, manufacturer, distributors, hospitals, doctors, consumer organizations, etc., but they had failed to reach a consensus on who should take responsibility for updating the patients on new scientific findings. CONCLUSIONS: The guidelines for risk reduction and risk communication appeared ineffective. Ownership of risks and duties to communicate should be allocated on the basis of the product's life cycle. For implantees, the implanting doctor should be the central figure.
Publication Types:
Keywords:
- Aortic Valve
- Heart Valves
- Humans
- Mitral Valve
- Models, Biological
- Netherlands
- hsrmtgs
Other ID:
UI: 102234635
From Meeting Abstracts