PVC plastics have been widely used in medical practice for more than thirty years. Medical-use PVC is softened with a phthalate plasticizer, diethylhexylphthalate, known to leach from bags and tubing causing direct patient exposures. Periodically concerns about the safety of DEHP use in medical applications arise, in the past because of potential cancer risks. But now DEHP is recognized as a reproductive toxicant, causing damage to the developing male reproductive system in test animals at exposure levels close to or actually experienced by some patients. The precautionary principle forces us to acknowledge scientific uncertainty. It asks us to consider what we know and how we know it, while we consider what to do. More than that, the precautionary principle serves as a guide to help us select among tools for use in decision making. Risk assessment serves as the entrenched tool of regulators even though risk assessment quickly loses any predictive value in circumstances of uncertainty. The precautionary principle invites consideration of other tools more appropriate to the circumstances. It asks us to consider alternatives, reverse the burden of proof, and commit to participatory decision making. PVC medical products will serve as a case study in applying the precautionary principle and enable a distinction between applying the principle to existing and contemplated activities. The ethical implications of choices will be discussed.
Learning Objectives: At the conclusion of this session, the participant will be able to: Identify the relationship between risk assessment and the precautionary principle; and, Describe how the precautionary principle encourages better science and more health-protective practices than risk assessment
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.