In the third installment of our series on preparedness, Gavin Harris, MD, discusses the principles and challenges of biorisk management, focusing on infectious disease threats and containment strategies.
In early fall 2014, a patient walked into a Dallas, Texas emergency department with largely gastrointestinal complaints after having recently returned from Liberia and was sent home with supportive care measures. He returned, was found to have Ebola Virus Disease (EVD) and succumbed to his illness but not before infecting 2 emergency department nurses. Numerous clinical, infection prevention and control, logistic, and institutional lapses were found to have contributed.
Then again in late fall 2024 a patient also returning from Liberia presented to an Iowa emergency department with primarily abdominal complaints and rapidly declined leading to transfer to a tertiary medical facility. It was there, in Iowa City, that the patient, 48 hours into hospitalization, was found to have Lassa Fever (LF), another viral hemorrhagic fever. This patient also died as a result, and thankfully, no secondary infections occurred.
But what do these 2, very similar events, separated by a 10-year span, say about the state of the traditional approach to biocontainment for special pathogens, or high-consequence infectious diseases (HCID)?
At a basic, fundamental level, mechanisms of assessment, mitigation and performance contribute to the management of biorisk, or the potential harm (including potential severity) from a biologic agent. It includes mechanisms and activities to protect, direct, and control an organization, institution, or community. The traditional 3 pillars of biorisk management include biosafety, the combination of practices, procedures and equipment that protect lab workers, the public and the environment; biosecurity, measures taken to protect infectious agents from loss, theft, or misuse; and finally, biocontainment, which addresses the design of safety equipment and specific units to effectively contain infectious agents to prevent accidental release (Figure 1). This is, in essence, one of the traditional last means of defense, especially for HCIDs, which may not have effective medical countermeasures.1
On average, one billion people cross through international borders each year. This includes about 350 million travelers arriving in the US through more than 300 points of entry. What this ultimately means is that a threat anywhere is a mere flight, boat ride, or automobile ride away. Early disease detection, from the emergence of an outbreak within 7 days (part of the 7-1-7 WHO target from start-end assessment of infectious diseases threat) mean that by the time an event is recognized, containment may no longer be an option.2
In response to the West African Ebola Outbreak from 2014-2016, the White House Office of the Assistant Secretary for Preparedness and Response (now known as the Administration for Strategic Preparedness and Response or ASPR) established the National Emerging Special Pathogens Training and Education Center (NETEC) and the Regional Ebola Treatment Network, which has since expanded to 13 Regional Emerging Special Pathogens Treatment Centers (RESPTCs) that are able to maintain a specialized biocontainment unit in each designated region in the US and a tiered coordinated structure known as the National Special Pathogens System of Care (NSPS) that is modeled on the national trauma system. Each RESPTC is required to be able to care for up to 2 patients with a suspected or confirmed viral hemorrhagic fever and up to 10 patients with a potential respiratory pathogen in their biocontainment unit.3
This means that the entire US capacity to care for patients in with suspect or confirmed viral hemorrhagic fever in biocontainment units is less than 30 (the National Institutes of Health Clinical Center has its own biocontainment unit that is separate, and there are some pediatric facilities with their own biocontainment capabilities). And the entire US capacity to care for a potential airborne or respiratory special pathogen such as Middle East Respiratory Syndrome (MERS) is approximately 130 biocontainment beds. These singular numbers only reflect the number of physical beds, a number that likely could change depending on other factors such as staffing or supply constraints. With the WHO responding to approximately 200 epidemic events each year, the sheer frequency demands a more nuanced and realistic approach than biocontainment.4
As mentioned above, the NSPS, modeled on the tiered levels of the national trauma system, is designed to fill this gap. Regardless of the level of resources of the initial facility or NSPS tier (1 through 4, with Tier 1 being RESPTCs and tier 4 any frontline healthcare facility) at which a patient may present, basic principles can effectively initiate a system of care and reduce strain on the healthcare system. NETEC has referred to this as the Identify Isolate Inform algorithm and it has been the cornerstone of approach to care for suspect or confirmed patients with HCIDs. First, these patients need to be properly screened and identified (through symptoms, travel history, etc). Then, if there is concern, they can be quickly isolated and subsequent care performed with appropriate transmission-based PPE. Lastly, appropriate local, state and regional agencies and experts should be notified to provide guidance and logistical support on determination of additional steps.5
But several studies have shown patients experience worse outcomes when placed in isolation, regardless of the type (airborne, contact, etc.). Hospital lengths of stay increase, patient-care team interactions decrease, time spent between the care teams and patients also decreases and mental well-being of patients worsens.6-8 Lack of proper healthcare system preparedness and training and healthcare worker fear can also contribute to suboptimal patient care. Thus, early intervention (the fourth “I”) must be initiated, and it must be clear that the intake and initiation of care does not end when an agency has been informed. In fact, early, optimized and quality critical care is the only countermeasure that has consistently shown improvement in mortality in patients with viral hemorrhagic fevers, especially if instituted early.9
In 2014 Emory University reported the first case of a patient with EVD successfully undergoing renal replacement therapy with documented renal recovery.10 And in late 2024 during the first Marburg Virus Disease outbreak in Rwanda patients were successfully intubated and extubated upon recovery after being placed on mechanical ventilation. And thus, if these patients can be properly identified early, or “ruled out” from having an HCID quickly and appropriate care initiated, the capacity and strain on the healthcare system can be kept to a minimum.
It is not feasible, nor appropriate preparedness, to solely rely on a thin network of small-capacity biocontainment units to protect the United States’ healthcare security. As the world learned with SARS-CoV-1, MERS, H1N1, EVD, and SARS-CoV-2, it is that biocontainment is, at best, a temporizing measure, and at worst, a misguided approach during a potential outbreak. Additionally, identification, isolation and informing work are important principles to initiate the care continuum but work only until a point. We must not forget that in the room where a patient has been placed on likely multiple forms of isolation and who has not seen a provider for several hours while the medical team awaits additional input, is a person who is in dire need of care. When performed properly, it is safe to provide necessary and proper care, and it may be essential to their survival.