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AABB Statement before the Advisory Committee on Blood Safety and Availability

Decision Making Process for Transfusion and Transplantation Safety Policies

May 1, 2009

AABB appreciates the invitation to speak before the Advisory Committee on Blood Safety and Availability regarding our country's decision making process for transfusion and transplantation safety policies. Our association believes that the time is overdue to create a new, more achievable, paradigm under which blood safety policies are adopted in the United States.

AABB is an international association dedicated to advancing transfusion and cellular therapies worldwide. Our members include approximately 1,800 hospital and community blood centers and transfusion and transplantation services as well as 8,000 individuals involved in activities related to transfusion, cellular therapies and transplantation medicine. For more than 50 years, AABB has established voluntary standards for, and accredited institutions involved in, these activities. AABB is focused on improving health through the advancement of science and the practice of transfusion medicine and related biological therapies, and developing and delivering programs and services to optimize patient and donor care and safety.

As we face an increasing number of potential threats to the blood supply, AABB believes there must be a careful assessment of where the largest risks are and where the greatest benefit to patient care can be gained from the implementation of new technologies or safety interventions. Prioritizing these risks is particularly important now as our country enters a new recognition that our resources, both financial and human, are not endless and must be allocated to the most urgent risks. AABB believes that we must begin to consider other than the current "zero-risk" approach to blood and transfusion safety, which in its purest form can actually hinder the introduction of important new blood safety technologies such as pathogen reduced blood components or prevent the elimination of redundant or unnecessary screening measures or tests.

AABB understands that making this transition requires that we have in place a mechanism to accurately assess risks. As this committee has discussed in the past, the United States needs a robust, well-funded biovigilance program to collect data about the risks of transfusion, as well as the effectiveness of safety interventions, both proposed and existing, to reduce these risks. Adequately funded biovigilance can help us to make more evidence-based policy decisions about which transfusion risks the community should focus our limited resources on. In addition to a viable biovigilance system in the US from which prioritization of efforts would result, continued funding should also be directed to donor- and patient-oriented research from which the majority of blood safety interventions in place today have resulted. In prioritizing risks and developing new transfusion safety policies, AABB urges that we continue to focus on the non-infectious risks of transfusion. Our community has made great progress in reducing the risk of contracting infectious diseases via a transfusion. And as we continue to address potential transfusion-transmitted risks, we must also remember that today, the far greater risk is that a patient will be harmed by transfusion-associated circulatory overload (TACO), the transfusion of the wrong unit of blood, transfusion-related acute lung injury (TRALI) or another non-infectious complication.

AABB also believes that voluntary standards and guidance will continue to play an important role in transfusion safety, particularly in the absence of regulatory action. For example, in the past few years, AABB has adopted standards and issued guidance aimed at reducing the incidence of bacterial contamination as well as TRALI. Following AABB's November 2006 recommendation that blood collection and transfusion facilities begin implementation of TRALI risk reduction measures for high plasma-volume components, FDA fatality reports indicate that deaths due to TRALI fell dramatically from 34 in FY2007 to 16 in FY2008. In making our policies, AABB examines the current science and aims to assist our members – blood centers as well as hospital transfusion services – in establishing the best use of their resources to improve patient care.

AABB understands that the adoption of a new blood safety paradigm cannot be accomplished within the blood community alone. A multi-disciplinary approach is needed. The public must be meaningfully engaged in this dialogue to determine the prevailing tolerance for risk associated with new advances and the necessary prioritization of healthcare resources. Representatives of the public and the patient community, physicians, blood centers and hospitals must all be included in these discussions. In addition, representatives from government agencies including the Department of Health and Human Services, FDA, Centers for Disease Control and Prevention, National Institutes of Health, Armed Services Blood Program and Centers for Medicare and Medicaid Services must be at the table. Lastly, we need to encourage the participation of industry, on which we depend to bring forward next generation technology needed to continually advance transfusion and transplant safety.

Engaging in this dialogue may require the use of mechanisms not previously implemented in the blood community. Possible avenues for obtaining wide-spread public discussion need to be thoroughly explored. Town hall meetings are one possibility. For example, recently, HHS held a series of meetings across the country to garner public views about which populations should have access to limited supplies of pandemic influenza vaccines and antivirals. HHS officials have stated that they learned a great deal from these open discussions and at times were surprised by the "ethical" choices the public was willing to make relating to that public health question. The process for establishing community consent for blood substitutes may serve as another example. HHS, at its highest levels, must explore how best to obtain broad public input into this critical public health matter.

AABB understands that next spring Canada will sponsor a Consensus Conference on the topic of risk-based decision making as it relates to blood safety. In the past, Canadian consensus conferences such as this, which use the NIH consensus forum model, have proven extremely valuable in addressing critical blood safety issues and developing productive work products; the TRALI consensus conference is a prime example. The U.S. has, in large part, adopted the definitions of TRALI adopted at that conference and in turn has taken initial successful steps in educating clinicians about this life-threatening condition and reducing TRALI incidence. The goal of the Consensus Conference is to bring together industry, regulators, blood providers, and consumers (patients) to work toward a common decision making process that would allow for more appropriate decisions that consider concepts such as ALARA (risk as low as reasonably achievable), rather than zero-risk. It is recognized that any system / jurisdiction may make a different decision from another (taking into account differing political, economic, epidemiological factors). The Conference aims to explore, through the consensus forum, whether a consistent process for decision making could be defined that would be both transparent and would result in building greater trust between the blood community and the public. The Canadian Consensus Conference will undoubtedly suggest a valuable process for developing public consensus around risk acceptance. Ideally, around the same time our own biovigilance program will begin providing us with critical data specific to risks in the United States.

For some time there has been considerable discussion about the need to move away from the zero-risk paradigm and the time is now for widespread discussion and action in moving toward a new decision-making process. AABB urges the Secretary of HHS to work with the transfusion medicine community in establishing forums to gain information about the public's risk tolerance relating to blood safety. Drawing from such public discussions as well as the best available scientific information, including that gained through biovigilance, we should all work together in prioritizing risks and the most beneficial safety measures to advance patient care.