On July 10, the FDA issued an advisory to clinicians that Becton Dickinson (BD) had announced a global shortage of their Bactec blood culture bottles — which are essential in the case of suspected bloodstream infections — with resolution likely being months away. Soon after, hospitals using the BD system started to report weekly deliveries of blood culture bottles far below their needs.
On a national briefing call in August, one large hospital system reported that they had received only about 10 bottles for the week, forcing them to implement drastic rationing plans. Only about half of hospital labs have been affected, however. There are two other manufacturers of blood culture systems (bioMerieux’s BacT/ALERT and Thermo Fisher’s SIGNAL systems) that are unaffected, but their bottles can’t be used in the Bactec system, and hospitals can’t adopt an entirely new blood culture system on short notice.
While we won’t have reliable data for some time on how patients are being affected by this ongoing shortage, blood cultures are a critical tool for diagnosing bloodstream infection, identifying the specific bacteria causing an infection so that the optimal antibiotic can be used, and choosing the appropriate duration of antibiotics. Without blood cultures, serious infections can be missed and patients may be over-exposed to overly broad antibiotics, raising the risk of antibiotic resistance and side effects.
As this shortage is having highly variable effects at different facilities across the country, and even different facilities within the same city, there is an urgent need for better care coordination and resource sharing to promote equal access for all patients as we wait for the shortage to abate.
Responding to the Crisis
During the COVID-19 pandemic, when ventilators and hospital beds were in short supply, the concept of Crisis Standards of Care (CSC) was widely discussed. CSC plans envision three levels of strategies to address increasingly severe resource shortages: conventional, contingency, and crisis plans.
Conventional plans start with recognition of a potential looming shortage and include steps to conserve resources, call up reserves, and get ready. No patients are expected to be harmed by implementing these plans.
At the contingency level, the shortage may require significant changes to usual practices, like using alternative treatment strategies or asking some clinicians to operate outside their usual scope of practice. These steps may entail modest additional risk, but the aim is still to avoid any patient harm.
At the crisis level, the shortage has become so extreme that resources must be withheld from some patients who will likely be harmed as a result, such as by limiting the use of mechanical ventilators to patients with a higher likelihood of survival.
Of course, every possible step to avoid having to implement such crisis care strategies should be taken, and at the height of the pandemic many extraordinary steps were, in fact, taken, including transferring patients and sharing key resources across health systems that usually are competitors. There were also emergency declarations and some Governors issued executive orders legally authorizing crisis-level rationing, because hospitals and clinicians, fearing lawsuits, might need legal reassurance before implementing even the most carefully designed rationing strategies.
But the blood culture bottle shortage is not the pandemic. No public health emergency has been declared. In fact, public awareness of the issue is low. But that doesn’t mean the shortage isn’t severe and doesn’t warrant adopting some of the same strategies we used in the pandemic.
In response to a request for a more strategic, regional approach to managing this shortage, our Mountain Plains Regional Disaster Health Response System, supported by the HHS Administration for Strategic Preparedness & Response, convened our rapid response Medical Advisory Panel. The panel compiled and distributed region-wide guidance on how to minimize the harms arising from this shortage using the conventional, contingency, and crisis strategies framework.
Our guidance emphasized conventional strategies for conserving blood culture bottles, like implementing best practices to increase the yield of blood cultures, avoiding contamination, and not drawing blood cultures when they are not indicated. We believe every hospital should be taking these steps today, even those not experiencing a shortage. These initial steps alone can often reduce blood culture bottle use by as much as 30-to-50%.
Meanwhile, hospitals experiencing significant shortages should also be using contingency strategies, such as restricting use of blood cultures to certain higher-risk situations. And if, despite these steps, hospitals reach crisis conditions they will need to ration their use of blood cultures even further, such as by using cultures only for patients with compromised immune systems or critical illness.
Preventing the Crisis Peak and Unequal Access
Before getting to that crisis point, hospitals should be talking to each other about the possibility of transferring patients or blood cultures across systems to avert the avoidable tragedy in which patients in one hospital can get blood cultures as usual while critically ill patients in a nearby hospital must go without.
The ongoing blood culture bottle shortage will likely abate in the next month, and is expected to be resolved by the new year. However, it highlights a key area of ethical vulnerability in how we manage shortages, which has profound impacts on patient health outcomes. Namely, it is unfair and unethical for our healthcare system if patients are disproportionately impacted by a shortage based on which hospital they happen to use.
During the COVID-19 pandemic, it was rare for one hospital to be flush with ventilators while a nearby hospital had an ample supply. This was partly because the shortage was driven by widespread increases in demand, but also because there was sharing of resources and region-wide guidance on how to manage COVID-related shortages.
The blood culture bottle shortage is affecting a single supplier, so its impacts have been extremely heterogeneous. Hospitals using the BD system have been forced to use contingency or even crisis strategies, while some hospitals using alternative systems have made no changes at all. Without better coordination and cooperation among hospitals and health systems, this will inevitably lead to significant inequities in care and outcomes based on which hospital patients are taken to for care, and worse outcomes for the community overall.
With shortages in healthcare becoming increasingly common, local, state, and federal leaders should be tracking those that might be expected to have differential impacts across health systems in a region. Then, to ensure both optimal and equitable health outcomes, we need to implement strategies to facilitate better regional coordination and resource sharing. Even in the midst of a significant shortage, our critically ill patients should be able to trust that they will receive similar care regardless of the hospital to which they present.
Anuj B. Mehta, MD, MS, is an associate professor of Medicine at the University of Colorado School of Medicine and a Pulmonary and Critical Care Medicine specialist at Denver Health and Hospital Authority.
Matthew K. Wynia, MD, MPH, is a professor in the University of Colorado School of Medicine and the Colorado School of Public Health. He directs the University’s Center for Bioethics and Humanities, and he sits on the Forum on Medical and Public Health Preparedness for Disasters and Emergencies of the National Academies of Sciences, Engineering, and Medicine.
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