The Cumulative Impact of “Rare Events” in Healthcare
Gerard J Myers RT, CCP Emeritus
![Gerard J Myers RT, CCP Emeritus]()
Gerard J Myers RT, CCP Emeritus
Cardiovascular Perfusionist, Legal Perfusion Expert Witness, Author, Researcher, Respiratory Therapist, International Speaker/Consultant, Artist
In healthcare, certain hazardous complications are often labeled as “rare events.” Because these events are statistically infrequent (on the order of a few tenths of a percent or less), they tend to receive little emphasis in training and protocol development. Because of this, hospitals and clinicians may over time become complacent during routine procedures, assuming such complications are too unlikely to warrant special attention. However, as the term indicates, even a rare event will occur in some patient, at some time. Modern patient safety standards argue that if an event is preventable, it should be prevented every time ... effectively turning a potential rare event into a “never event” (an event that should never happen in practice).
One example of an underappreciated rare event is venous air embolism from a peripheral intravenous (IV) line. In everyday clinical practice, peripheral IV insertions are ubiquitous, with over 300 million short peripheral IV lines inserted annually in the United States, and roughly 80% of hospitalized patients receiving some form of IV therapy. In high-acuity settings like intensive care units, peripheral IV infusions are often delivered via electronic infusion pumps, which are equipped with air-in-line detectors that alarm or halt the infusion if an air bubble is detected in the IV tubing. This technology gives clinicians a sense of security that air embolisms are being averted when they are not present at the bedside. However, the vast majority of peripheral IV lines in general hospital wards, clinics, and emergency settings are gravity driven and manually regulated by a clinician, with no automatic air-detection safeguards. In those routine cases, preventing air from entering the IV line relies entirely on the diligence of that clinician, meaning that even a small lapse in details (such as an unprimed IV line or an unnoticed air bubble) could unintentionally introduce air into the patient’s circulation.
So first we have to define what a rare event is ... in medical terms? A “rare event” typically refers to an occurrence of some adverse event in a patient, with a very low probability of occurrence. These rare events are believed to be between 0.01% (1 in 10,000 cases), to 0.1% (1 in 1,000) of the total cases. A peripheral IV air embolism fits this definition. Air embolisms from peripheral IV infusions are extremely rare on a per-case basis, and the chance that a small air bubble in any single IV line will cause serious harm to a patient is very low. Therefore, some clinicians may consider this risk negligible during any one IV placement, infusion, or maintenance. Unfortunately, this perceived low risk per procedure tends to lead the care giver to complacency, which leads to an increased risk of that rare event happening.
While an individual patient’s risk of a venous air embolism from a peripheral IV is often considered minuscule, the aggregate risk across all IV patients and IV procedures can be alarmingly high. Consider the following:
It is stated that the occurrence of a morbidity/mortality causing air embolism in peripheral IV lines has a ~0.01% to ~0.1% chance of happening (a rare complication). The total peripheral IV lines placed per year (U.S.) is ~300 million.
Therefore, the projected morbidity/mortality causing air embolism from peripheral IV lines per year would be between 30,000 to 300,000 (0.01% and 0.1% of 300 million). More or less a rough estimate of how many IV related air embolism incidents that could occur annually, given the volume of IV insertions nationally.
Many minor IV air infusion episodes go undetected and/or unreported. However, many small air bubbles can lodge in the circulation without immediate obvious symptoms, so those 30,000 to 300,000 figures would refer to only to the harmful, symptomatic cases that require attention or treatments.
So, what seems like a negligible [1 in 10,000 to 1 in 1,000] risk to an individual patient could actually translate into a substantial number of adverse (rare) events on a national scale. Because even a “0.01% - 0.1% rare complication rate” applied to hundreds of millions of IV insertions could become a massive problem. Therefore, even rare medical complications, by virtue of the sheer volume of routine procedures, can produce an astoundingly large cumulative burden to the patient and the healthcare system.
The consequences of peripheral (and central) IV fluid air embolisms, though rare, can still be severe (as reported in the literature). Intravascular air bubbles are foreign to the bloodstream, and even small volumes of air in the venous or arterial circulation can obstruct blood flow in critical organs. Retrograde venous air emboli can lodge in the cerebral circulation and paradoxical air emboli entering the arterial circulation through the heart and lungs can lead to stroke or cardiac ischemia. Neurologic damage such as seizures, heart failure, or even death can result from significant amounts of intravenous air. These outcomes classify air embolism as a high severity complication, regardless of its entry route to a patient’s circulation (accidental or intentional) or its low frequency of occurrence.
As previously mentioned, beyond the potential harm to patients, there is the potential for major economic costs associated with these rare events. Treating a single venous air embolism case (e.g. emergency resuscitation, hyperbaric oxygen therapy, intensive care stay, hospital stay) is estimated to cost the healthcare system on the order of $8,000 to $12,000 per incident. Multiplying this by the potential number of air embolic ‘rare’ incidents, the annual direct treatment cost for peripheral IV air embolisms could reach into the billions of dollars. For example, 30,000 to 300,000 such rare events (in the scenario above) at roughly $8,000 each could theoretically amount to an additional $240 million to $2.4 billion in healthcare expenditures per year. This would be a staggering (yet potentially avoidable) cost burden on any healthcare system. These costs far exceed the expense that would be required to prevent these rare events in the first place (by using inexpensive air trap devices or air filters in every IV line).
Healthcare institutions also must consider the liability costs associated with any peripheral or central air embolism. Patient injury from an air embolus can lead to malpractice claims and legal settlements. A review of anesthesia related IV-line mishaps found that litigation claims involving air embolism had a median payout of $325,000, with some cases settling for over $1 million. Such litigation costs, along with regulatory penalties (since air embolism is deemed to be a preventable adverse event), provide another strong financial incentive for healthcare institutions to address these potential complications. In other words, beyond the medical treatment expenses associated with any air embolism, the reputational and legal repercussions of an air embolism incident are significant.
Given that rare events like peripheral (and central) IV air embolisms have dire consequences, yet are largely preventable, the goal of every healthcare institution should be to proactively address these risks for every patient. Modern medical technology and simple safety practices can make a potentially rare peripheral IV air event, a potential never event. In fact, intravascular air embolism is officially recognized as a serious preventable adverse event. The National Quality Forum classifies air embolism as a “never event,” and The Joint Commission lists it as a reportable sentinel event. This means that any occurrence of intravascular air embolism (through any route) is considered a major, unacceptable failure in safety protocols.
What may seem to many like a negligible low risk per patient problem, can sometimes translate into a multi-billion-dollar problem when scaled to a single nation’s annual healthcare volume. Rare complications like peripheral IV air embolism underscore the importance of not letting low frequency events lull the medical community into ambivalence, complacency or inaction. Data indicates that when rare events are aggregated, their impact on patients and healthcare systems can be far from rare. By proactively addressing peripheral air emboli rare events by using simple technologies (like air traps or air filters in IV lines) ... a “rare event” may someday become a “never event”.
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2moGerald thanks good work
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2moAll you need is a patient with an undetected ASD..Air can be very dangerous
Not all Consultants are Created Equal! Proven track record of translating the value of infusion therapy technology to clinical practice.
2moThank you for sharing your work, Gerald! Every Infusion & Vascular Access Professional must read your publication! Marlene Steinheiser, PhD, RN, CRNI , Lori Kaczmarek, MSN, RN, VA-BC, Vincent Forde Seth Eisenberg
Retired Clinical Perfusionist, Amphia Hospital Breda.
2moNice review of “the fight continues”. Well done Gerard.