By Stephen Wood
The State of Massachusetts is currently reviewing a new protocol for the pre-hospital (i.e., ambulance) administration of blood products to patients with acute hemorrhagic shock.
In the pre-hospital setting, hemorrhagic shock, which is characterized by rapid blood loss that results in potentially fatal oxygen depletion of the vital organs, is traditionally managed by the administration of intravenous fluids. But there is a growing body of evidence spanning several decades that this is not beneficial and, in fact, can be harmful.
In the hospital setting, blood loss is treated by replacing blood, most commonly in the form of packed red blood cells, plasma, and platelets. There is strong data supporting the use of replacement blood products for the management of life-threatening hemorrhagic shock, specifically a reduction in all-cause mortality. Moreover, research has demonstrated the safety, efficacy, and feasibility of pre-hospital blood transfusion. Several states have implemented protocols for pre-hospital blood administration based on this supporting data. There are barriers, however, to initiating this practice at several regulatory and non-regulatory levels. The result is that access to a potentially life-saving intervention is inequitably distributed.
As one example, under Massachusetts Regulation 105 CMR 135.410, blood transfusions can only occur outside of a hospital in unusual circumstances, and only if deemed necessary by the blood bank director. There are several other requirements that make administration of blood products outside of the hospital setting difficult. Notably, Massachusetts paramedics already are able to transport blood product transfusions that were started before transport. This most often occurs in the setting of a hospital-to-hospital transfer. This has been demonstrated to be safe, given that providers receive the appropriate education on this practice, and that there is a quality assurance program in place. Despite this, the current proposal is meeting some resistance from several non-regulatory bodies, including some hospital systems and the regional air medical transport service.
The current proposal would allow for the administration of blood products by specially trained pre-hospital providers. It is a shift from allowing paramedics to transport blood products that were already initiated, to initiating them in the field setting. The proposal includes recommendations on storage and oversight, as well as indications for the administration of these products and quality assurance practices. This would enhance the management of critically ill and injured patients, especially in the setting of penetrating trauma. This progression would provide equity across the state by allowing ambulance services operating at an advanced life support level to provide this life-saving treatment that might not otherwise be available.
There are logistical challenges, as the administration of blood typically requires a process called typing, screening, and cross-matching to ensure the donor products and recipient are compatible. However, in the setting of an emergency, the universal donor of low titer O negative blood can be used, although there are some risks to this as well. Additionally, storage and accountability have been barriers to the pre-hospital administration of blood products. There are several ways to overcome these issues, however, with a well-regulated and monitored system involving the blood bank, local EMS systems, and the appropriate regulatory bodies to oversee the process.
In short, the logistical issues have or can be addressed to allow for this proposal to proceed. The reluctance and resistance to the proposal is more about control than about clinical care. At present, only one regional air medical service is permitted to initiate blood transfusions through a special waiver. What results is an inequitable distribution of a potentially life-saving intervention, most often affecting already marginalized communities. The new proposal would enhance the ability of paramedics to administer blood, which has the potential to decrease call volumes for the air service, which may lead to ensuing financial implications. The rapid, in-field administration of blood could have a similar impact on the need for transfer to a trauma center in some circumstances. These concerns do not, however, address the equity, justice, and beneficence afforded to patients who may require this intervention. Thus, it is imperative to examine the ethics of blocking this proposal, and the impact that would have on the community.
There is a duty to ensure that the care of patients with hemorrhagic shock in the prehospital environment is congruent with the current evidence-based research for the most appropriate care of this potentially life-threatening condition. Similarly, access to this intervention should be equitably distributed to all patients; policy makers should recognize the potential injustice when this resource is otherwise limited to only certain populations. Decisions to increase access to blood products also are a matter of public trust, as such policy changes should underscore that the EMS system is providing the best possible care to all populations. This is the public duty of emergency medical services.
The pre-hospital administration of blood products should be a priority for policy makers and regulatory bodies both in Massachusetts and in any state considering this intervention. The implementation of this intervention will need to be coupled with thoughtful implementation and rigid oversight, coupled with ongoing research on the safety and efficacy of this practice. Political barriers should not overshadow the ethics of providing optimal care to patients across the spectrum. Arguments against the implementation of this practice are in direct opposition to the improvements in mortality that have been widely demonstrated by multiple studies on this intervention. It is unethical to limit this resource when the difference in patient outcomes is so clear. Politics need to be set aside and the State of Massachusetts, and others that follow, must come together to create a system that is equitable to all patients.
To provide some clarification, this post is not a criticism of the current process, nor of any agency, medical facility or system. It is a call to consider the ethical and equitable distribution of a life-saving intervention. This post is not about process or politics, but instead an invitation to consider the ethics of distributing medical care. I have written on this topic previously, during the COVID-19 pandemic, highlighting the inequitable distribution of ECMO and antivirals. As an ethicist and a medical practitioner, I feel it is important to consider equity and justice as part of the medical system. Too often, marginalized communities and people have inequitable access to care. It is the role of all of us, as healthcare practitioners to consider these issues. I am a proponent of expanding the delivery of blood administration, and think that this can be thoughtfully and successfully achieved with cooperation and collaboration.