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 by a on responses to recent of including an look at the potential threat, general of other of potential by a general on lessons and of future strategies. the of these Blood of The that could be blood and blood was first in in and the first of in with and the first of in In the convened a to review information on and and to to in blood and with that with for of with as transfusion had that of in blood previous In a issued in the noted that of blood has been the of was in but data that the of and for such as the virus the that of was under for of Although the several to risk from were a potential the noted that or were the blood in a process could by or to a of risk blood in at had a process as by were with information risk and with such risk were asked not to was to community to from In and the were that to blood but inform the blood of their risk so the blood be or used for Blood in the to such as Blood or of blood Blood for was not available of research and and were were that be to donors, that blood to the and that of the blood the community of the potential in the community had in the and was a general of blood from the of the of of was published in and by the of had to HIV was in the of with of virus and in and several to this virus as the of of potential was not blood that HIV be HIV were not available that of for HIV were for and that of with blood from or of of in HIV in and HIV by that the of HIV from the first occurrence in to a in of and that in had been with HIV The that and had been in the of by by who for HIV or had by by the was implemented and by by the was It was that the of HIV but were of HIV that had not the were related to who had for but to in including the of who had had with an infectious of from to by the in the of this infectious to and the of and its with this in risk of infectious In have been in the was from to blood were and the of in to and HIV has of HIV by with in The with that with an a can in the blood supply for in of transfusion Blood had been to recognize the of the and to safety such as and that have HIV HIV was several to the risk of HIV these failures to the of the blood safety a that potential to were slowed this virus was from any that had been the was and the of HIV was The from to and disease risk in was Responding to the uncertainty HIV a new of that was to the blood community who to for information and in HIV were The to to future threats and the process take a the of stakeholders including the blood and the FDA involved as as has been as a of transfusion in the and early that or of blood were and had been on and the of in that was to be to for were implemented as a blood safety in to and had impact on although a impact was to methods and the of the of in the of by The of virus and the of that the of was not to or and the was to the but not In the of were and the of in and in In the of for was to by to such was not implemented was to a of including of donors, uncertainty the of and the need to manage the The and of involved in several including and were to the by could not be in on of In had not to to any were not available and virus was an a of in with with the that the was an was in and for to were It that was to of and for this by was implemented in by of with in for was implemented in is that the risk of in the is blood The with the of and lessons the and risks of Although these were in donors, were they were not of In lessons from the and/or not to the the virus with was were the other recognize that is that the of and methods to to the of emerging threats does not threats. The response to was in the scientific community was on The of and not on the need to but on the potential impact of on blood The epidemic a in to blood safety. In the of be of in has not been but the human is under active are such as and HIV in the in the of the of the used in the the blood evaluation of was implemented that not to be in and a was to a for the of for other although of the of such a Blood a was first in the in in and by transfusion the transfusion medicine community a the first with at to the risk with the lessons from recent with HIV and and/or a response by the blood and the by transfusion was the of were implemented to the risk in the of including a for with of for transfusion of and the and of in in of of the first had a impact and the of from to from to with and to were the first of and blood from were Since then, a of blood have been The from the and on that in was with in and of to blood from to with in have the in that be are a It made recommendations for a that and be in and to of a and that for a of with of have been from these a of blood were to and have been and in a in the of other in a community be used to In based on from for or the in the blood safety community has been for processes that of the and other are to that are has been in their that for multiple in the of at or of The with has and scientific with impact the blood have of the and of in the for of in of The of has been as a to the of in blood the potential of in the human is with to and the of the capacity to to the by in are based on the that of to the have been and from to The response to was and and a for responding to an emerging infectious was in was the need to and the for In the response to was in of that do were to the responses to The most of to the of has not been but the of transfusion in recent the to that several the in the has been The of recent in that the be a in and and in the for in and can be for Although is in in the of and a of in in that the of disease in be in a of have from recent of risk in blood has that the be the of by the were at risk by of or in an to have in that this and The first was in the in blood was implemented by most US blood early in with of to FDA guidance in for a to a a be for future made by that be to be The safety of such a is based on the of in the and of transfusion from with to published by in EID such as the for a blood safety be the and the for disease All are by are with a or and an and are in and/or and other emerging including these is and each a to transfusion safety. the of these is is an that is in the and of the are is and for to to several The is by this is for of the that disease and other is as a to the of an and the of Since of are has been in from to of and of at risk from the and who are and and have blood the of and and but were with The was to with The has been to for to in and is not are asked a their a of but this is are the of the requires a blood for is and who recognize a is for is available for although new are in place and to that and with of be is the most disease in the by of of of the or are at risk with of most of in the or of of virus are but can in from disease to as to to as and epidemics but the disease has or in and in and is a of and It is the of to the from the and and of transfusion have been the first in by a in with but and the most recently in the by is available for blood have and do not infectious are not asked to their risk of at be most and be who have to is and by and the human of is a and disease with a of to The of the have been in the was first as a in of the Although to and with and has a from to of have been from to of in the of in the with the in an who of disease but was to the in the and at were from blood was a from have been in the of from in the and the other from in from a recent that blood can the or in the of the by in the The and human in with to blood from who the of Although the risk for to be the of is and a of is that of based on a of to the and other were implemented of was The of this is and was implemented as a risk and not to of is available as a and the and of a are in the is the of that with each other and in with for blood safety have been be the of transfusion with with to and can and In published a that the had been in had been in the blood of with was with previous of a and XMRV and to in The that XMRV not in of with but in of XMRV could be in blood and The the that XMRV to the of and an noted that in of the of infectious virus in and blood was In response to this potential EID threat, the establishment and of and to the and the Blood XMRV The the on risk and risk of the the was charged with the and of research to XMRV a threat to blood safety of the convened an task force and charged with available actions to be to a potential risk for and to inform donors, recipients, physicians, and the general the risk of of the by the were the a of the National of the of murine leukemia virus at the from in of and of and that of XMRV to and and were data from the and several other Although the to on published and to The several for the including in of and the of the available data and the a policy of and for with a of The policy was in the and in summary of the data and the policy was published in data including the of XMRV in to of from this the of these data, the that the and that was that XMRV a transfusion that an task force can be and that the of from stakeholders can provide that task force with In the in the task force could information and in to on a or the a and on a was in from the The and by the was an in generating a for in of blood safety. were several that were not and that they had several from were have been with of the of the FDA is to with the private on actions is the FDA is responding to a potential threat to the blood supply, can its robust process is to stakeholders in decision and to who has implemented is a risk that information can be by of the task In in of responses to potential threats can by or Although the on decisions and such not be process for the evaluation of information be in with and to be by as they their such a process can to the in their The Blood XMRV was charged with and to XMRV a threat to blood to be the could first be convened and Who be engaged and in the What and/or were needed? How was the research to be the In response to the first was that a was the with XMRV in the of or blood and infectious disease experts, and experts, and blood regulatory the and the was and the was charged with to the PHS Blood and Committee to the Blood Secretary Secretary for The engaged relevant and of and from to worked with in of and scientific the necessary their and their of a to the Study research was to the of the and involved in the and of The data the necessary assessment of EID risk in the of blood safety requires the infectious in blood transfusion And does have a The first relevant including and evaluating or or and transfusion history. this the to on the first XMRV in the blood that the on evaluating to and and to the of XMRV blood were and were as as they available to relevant stakeholders and Blood Institute and of of the blood XMRV task to and research to XMRV a threat to blood a review and to review of the of on potential of and/or with of blood to relevant on the potential of blood with were by Although not was of an blood and In was the potential or and transfusion history. could be blood were in to a of In this was that of the had the that was published of an transfusion of to or The several with to from XMRV and other related including that published on the of such in blood and other as well as that had to the in any was that in the the the of these The of or from in or to potential the of the for were for the the in of by that not virus in could not be by a of In a of the other used these in that to XMRV or other in blood or other such as with or Although the was not to in general were in of of from as XMRV were in The first was and to the best and The were and a was from with who had XMRV and a control to be XMRV The of of were to any of XMRV or in any of the and of the to any The was to to an in The of with to be for The control was to be as The or and In to the on blood and virus culture were on and were and to for of The from the XMRV or and from the but that of these from and the that were to virus culture and the the of XMRV in of with of the that and the an of and In was the to be the they were the the of these the noted that of XMRV or and that available could not virus or in from as The that of blood for XMRV or other is not Since this was several have of XMRV in human blood and have XMRV and as well as that of XMRV in is the of from multiple to of the that of XMRV in and control Although several have of XMRV or in human blood and XMRV and or several are is not the in in the an are from in the that of the in earlier It is not the in a is XMRV the human the of XMRV of human in does that threats could not from of an but from in the The response to XMRV and with to blood safety. of The of emerging threats to the blood supply that an can in and that an can to infectious blood with HIV and have to that the threat by and be with risk such as and are and a of was the risk of with these on or that investigation be or with any from with but not to be transfusion at the they are or from such as the virus that are to Although was to that the virus was by the blood safety community the first has been that recent are by but has been for a to a Although such as can human disease and be by the risk for such on their and they have such potential be are of of their potential for and In transfusion the and therefore can be a of of can be based on the of blood are and can therefore develop disease of the response to HIV and with have to a of the for in responding to potential threats to the blood a risk assessment and It is that such in actions that not have been information is The EID has published a review of in and its information to decision in response to an emerging The has based on or regulatory and on the of scientific or of blood safety In an expert with Blood Services has published a of the risk of an emerging the blood a of for a HIV and for an such as The a risk as the from the the blood supply to the of of for and for In of these including and and other at risk for data and of risk are to emerging can of or to of and in can assess of in blood has and several other or are of with can to transfusion and provide a on and but these are to and and and are and of is The evaluation of emerging threats new new of in and have disease in this manner be with has not been in blood safety and have a to and to these such as infectious or disease but this be to and therefore not be of In other transfusion be but the and processes can these and potential by a general can be and to an emerging threat, such a be and are not is the or other develop a to in or such such as or need The first challenge to the of EIDs is can be is or be by including National and on of the that an be by transfusion the and blood transfusion on the the past Blood safety have the of stakeholders early on in a have an of the and at their and have and that can be The blood safety community has a of including of of of blood or the of blood in as the be improved to of blood and and the of EIDs a threat to blood safety and risks based on and incomplete these future response strategies. The task force on several to early of a potential threat, of a risk assessment and of that can be as as a new threat is and and research to and potential EID threats and assess and the of future the by and was stakeholders they early the potential of Although several had XMRV with of XMRV as a potential threat to the blood supply was not the noted the of XMRV in the blood of of and the that XMRV was a to be in the potential to a to that with HIV and human XMRV as an the task force noted that infectious disease this of an and a related in a be The for response to potential threats and and although methods are in place to these threats, what an to the and are available for but these do not have a for blood is what of transfusion are can the of a potential threat, but be and threats to the blood supply can be be to blood that is such as have to that have been an is but this is in place for that could be to threats. of information in a could have in a in of It is to have a to and responding to potential that an evaluation of or not a new EID is a Although were how the of and were were by the of XMRV in of Although such were the were from other for such to in scientific in the the blood safety community was with the to these their The task force the to early or of a new an for to with blood safety potential threats to the blood supply, an is a process to information emerging scientific relevant to blood safety. blood safety in and The blood safety community is for and a risk assessment and a new EID threat has been decision to that used by the Federal Administration in responding to was Such a must be with to the of the at is the best can and decision to but these could provide for with the decision were and stakeholders and potential actions each a or was be each infectious is and response does not in such as that with of a such as the of an or its with not be to The response to XMRV the of a coordinated process, including from the blood safety in an and scientific that blood safety is and in with other epidemic response Although such processes do they to be and be made to research responses but is to the of and not be to for to the early of Blood in the of the and Blood have of to on in response to a of this is and as as involved in EID responses are active as the are in and personal and institutional of previous such as with HIV and could the of in and leadership and a Such an must have to to The task force the to in the of risk assessment and with decision and for can stakeholders to and actions in of and and a for blood safety in response to or a process that and resources, including of with that need to be or engaged a new threat research is to a potential EID the of the response in the and the be and how the in blood and under what the is by and the disease and and of in blood Such research of a potential threat, or for and decisions who be for each research are as they can a of in the blood by the XMRV of that an EID be a threat by is a and are to transfusion of such research is that are of risks are The of such as are of a threat the of and/or the to research data and and risk are to to their potential threats risks of to their and the research of their The relevant and to a to and of that can be or as needs agencies be involved as in these for and involve the and and FDA as early as to and of and and private can and are best at with relevant who develop and research at and have been in responding to previous threats. The task force to EID risk assessment research processes to in with the of to assessments of an with in blood transfusion and by or and to transfusion and disease the of and/or the to research data and risk assessment a threat is with and such that are available for research and of blood donors, of the is future blood safety the have not the and and response infrastructure, as by this task force provide a of a The blood safety community must to and to take leadership in future responses to The task force that the blood safety community and the response to the of a to in responses to including leadership in and of the EID response in and the broader scientific and blood safety In the this the EID of its Disease Committee for the EID to an to and manage such a risk The in this be for for research that need to be as and blood The of with a for the future is necessary to the risk assessment and future The EID Blood Safety and of the Secretary for US Blood and of of and of Blood and for and FDA, Medicine and of Blood and and of Blood and Blood Medicine and of of of of of and other Secretary for and US Blood Department of of The of The the by the task for The do not have any of with the of this

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.