Emerging infectious agents and the nation's blood supply: responding to potential threats in the 21st century.

In the early 1990s, the Department of Health and Human Services (DHHS) asked the Institute of Medicine (IOM) to assess how the government, the private sector, and other stakeholders had responded to the human immunodeficiency virus (HIV) epidemic and its impact on blood safety. In its executive summary published in TRANSFUSION,1 the IOM Committee to Study HIV Transmission Through Blood and Blood Products noted that although stakes were high, decisions had to be made under a cloud of uncertainty and that responses were slowed by imprecise and incomplete knowledge, personal and institutional biases, and ultimately by failures in leadership. Emphasizing that blood safety is a shared responsibility, the IOM Committee issued 14 recommendations related to structure and policy including the designation of a Blood Secretary Director by DHHS, the establishment of a Blood Safety Council by the US Public Health Service (PHS), and several recommendations to the Federal agencies involved in the evaluation of an infectious threat, in particular, the Food and Drug Administration (FDA). Since then, these recommendations have been implemented and the blood safety community (blood collectors, blood safety experts, and relevant Federal agencies) has responded to other emerging infectious disease (EID) threats, such as West Nile virus (WNV) and most recently the xenotropic murine leukemia virus–related virus (XMRV). Responding to any new threat entails assessing the risk to the blood supply and recipients’ health; evaluating how best to manage and/or control each potential risk; and communicating this information to blood donors, recipients, physicians, and the general public. Although the FDA has the regulatory authority to develop guidance documents and new regulations in response to EID threats based on available data, the challenge of generating that data and responding to potential risks requires concerted and coordinated actions by the multiple PHS agencies (Centers for Disease Control and Prevention [CDC], FDA, National Institutes of Health [NIH]) and by the broader transfusion medicine community (AABB and blood providers). It is therefore incumbent upon the transfusion medicine professionals to collect and provide robust data in a timely manner to policymakers to inform their decision process, as well as take an active role in risk communication. All stakeholders must recognize what they can do and provide leadership and timely research and risk assessments. In so doing, they must take a hard look at their responses and learn lessons from history. Such a process does not involve a confirmation or criticism of what has been done in previous responses to potential threats to the blood supply, but an assessment of how responses can be improved for future threats. In the aftermath of the recent XMRV investigation and the inevitable occurrence of future infectious threats, the National Heart, Lung, and Blood Institute (NHLBI) convened an expert task force charged with evaluating how lessons from previous EID blood safety threat assessments could be used to optimize future response strategies. The task force was asked to review and discuss responses to past epidemics and recent EIDs and to consider: What worked? What could have worked better? What data are necessary to assess blood safety risk? Who needs to be engaged in the evaluation of risk; that is, who are the stakeholders? What methods and/or processes need to be in place and when? What resources, infrastructure, and capacity are needed? How best to train future experts? And how can a scientific culture be encouraged that encourages cooperation? In a first session, responses to earlier epidemics were examined, followed by a discussion on responses to recent agents of concern, including an in-depth look at the latest potential threat, XMRV. A general overview of other agents of potential concerns (the horizon) ensued followed by a general discussion on lessons learned and consideration of future strategies. This report summarizes the results of these discussions.