Using basic ethical principles to evaluate safety efforts in transfusion medicine.

Pursuit of pharmaceutical purity of the blood in the bag has led to a shrinking donor base and a significantly more expensive product. Decisions regarding new infectious marker testing and donor deferrals have typically been made emphasizing decreasing one specific risk without considering the effect the intervention will have on the overall safety and availability of blood transfusion. Regulations have been formulated by governmental agencies with limited input from the medical community. The decision making process has lacked risk benefit analyses and has not had the robustness associated with spirited discussions. Policies made in this manner may result in certain risks being decreased but can also have adverse unintended consequences. Being guided by the ethical principles of nonmaleficence, beneficence, autonomy, and justice, we need to evaluate our actions in the context of overall blood safety rather than narrowly focusing on any one area.