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Ethics and the FDA.

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Biomedical Engineering↗
PubMed2004

New endoluminal technology: efficacy and safety--whose responsibility?

New endoluminal technology is being increasingly used in the management of arterial disease. With this increased usage of often experimental devices there is a growing responsibility for clinicians to collect data and report adverse events particularly in the longer term, when initial feasibility studies have been concluded. Many of these devices will have a perceived advantage so great that randomized controlled trials are not feasible. It is important that these perceptions are based on robust data not clinical impressions. The following article discusses methods of device assessment and looks at who is responsible for ongoing device evaluation.

Angioplasty↗
PubMed1994

The effect of product safety regulation on safety precautions.

This paper explores the means by which lighter safety regulations alter the precautionary behavior of 200 subjects in a field test of cigarette lighters with a child-resistant feature. The new lighter design leads respondents to believe the lighters are safer, but there is no clear-cut evidence that the effect on perceived risk levels is excessive. Using the estimated relationship between cigarette lighter risk perceptions and a variety of measures of precautions, this paper provides explicit estimates of the effect of regulations on precautionary behavior and on lighter safety. On balance, the child-resistant feature will reduce fire-related injuries by much more than any diminished precaution taking.

Accident Prevention↗