Trigger Warning: This blog article is based on the author's personal experience as a trained physician, US military veteran, EMT/Paramedic who, since 2012, has been working in and teaching tactical and operational medicine primarily in the SWHEM, working with many resource-limited teams, units, and corps. There are many in the world who have never heard of, care about, nor are subject to DOD or CoTCCC regulations or opinions and make equipment decisions based on cost and local availability.
What is CoTCCC?
The Committee on Tactical Combat Casualty Care (CoTCCC) is a group of medical professionals, including trauma surgeons, emergency medicine physicians, combat medics, and other experts, dedicated to improving trauma care in combat and tactical environments. Established in the 1990s to address preventable deaths in military settings, CoTCCC reviews scientific literature, analyzes data, and develops evidence-based recommendations for medical devices and techniques, such as tourniquets. Their work has made them a respected authority in tactical medicine, particularly within military and law enforcement communities.
However, CoTCCC is not a regulatory body. Unlike the U.S. Food and Drug Administration (FDA), which has legal authority to approve medical devices for use in the USA, CoTCCC lacks the power to enforce regulations or legally approve or disapprove products. Instead, it serves solely as an advisory group, providing guidance based on its research and expertise, primarily for military and tactical contexts.
Investigating the Claims
The claims that CoTCCC-approved tourniquets are "better" or "legal to use" in the USA compared to other tourniquets stem from misunderstandings about CoTCCC's role and the meaning of their recommendations. Let’s break these claims down:
Are CoTCCC-Approved Tourniquets "Better"?
CoTCCC evaluates tourniquets based on their performance in tactical combat scenarios, prioritizing factors like rapid deployment, one-handed application, and durability in extreme conditions. Their recommended tourniquets—such as the Combat Application Tourniquet (CAT) and the SOF Tactical Tourniquet (SOFTT)—are backed by rigorous research and testing tailored to these settings. This makes them highly effective for military and tactical use, which contributes to their reputation as "better" in those contexts.
However, this does not mean they are universally superior:
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Context Matters: CoTCCC’s focus is on tactical environments. In civilian settings (e.g., urban EMS or hospitals), other tourniquets might perform equally well or better, depending on the situation. For instance, a tourniquet optimized for prolonged use or ease of training might be more suitable for civilian first responders.
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Not All Tourniquets Are Reviewed: CoTCCC does not evaluate every tourniquet on the market. Newer, foreign, or less well-known models might be just as effective but absent from their recommended list simply because they haven’t been assessed. (Think SnakeStaff, Spain's TIE, and the Ukranian DNIPRO & SICH tourniquets)
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Evolving Recommendations: CoTCCC’s list has changed over time. Until 2019, only a few tourniquets were recommended, but that year, they expanded their list based on new evidence. This shows that "better" is a moving target, and non-recommended tourniquets aren’t necessarily inferior—they may just lack CoTCCC’s review.
Thus, while CoTCCC-recommended tourniquets are highly regarded for tactical use, they are not inherently "better" than all other tourniquets, especially outside military contexts.
Are CoTCCC-Approved Tourniquets the Only Legal Option?
In the USA, the legal use of tourniquets is governed by FDA approval, not CoTCCC recommendations. The FDA evaluates medical devices to ensure they meet safety and efficacy standards, and any FDA-approved tourniquet can be legally marketed and used, regardless of CoTCCC’s stance.
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FDA vs. CoTCCC: An FDA-approved tourniquet that isn’t recommended by CoTCCC is still legal for use by civilians, EMS, or hospitals. Conversely, a CoTCCC-recommended tourniquet must also be FDA-approved to be legally sold in the USA.
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No Legal Mandate: There is no law or regulation requiring tourniquets to be "CoTCCC-approved" for legal use. CoTCCC’s recommendations are influential but not legally binding.
The claim that CoTCCC-approved tourniquets are the only legal option is false. Legality hinges on FDA approval, not CoTCCC’s advisory guidance.
The Fallacy of "Approved" vs. "Recommended"
A key misunderstanding fueling these claims is the conflation of "approved" and "recommended." This fallacy has significant implications:
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"Approved" Implies Regulation: In a regulatory context (e.g., FDA approval), "approved" means a device has met legal standards for safety and efficacy, granting it official authorization for use. CoTCCC does not have this authority.
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"Recommended" Reflects Expertise: When CoTCCC "recommends" a tourniquet, it means they’ve reviewed evidence and found it effective for tactical combat care. This is an expert opinion, not a legal endorsement.
The term "CoTCCC-approved" is often misused in marketing or casual discussion, suggesting a level of authority CoTCCC doesn’t possess. This fallacy arises because:
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Respect Breeds Confusion: CoTCCC’s expertise in tactical medicine lends their recommendations significant credibility, leading some to assume they carry regulatory weight.
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Miscommunication: Phrases like "CoTCCC-approved" sound definitive, obscuring the advisory nature of their role.
In reality, CoTCCC only recommends tourniquets, and equating this with "approval" overstates their influence and misrepresents the legal landscape.
CoTCCC’s Advisory Role and Limitations
As an advisory group, CoTCCC’s mission is to guide best practices in tactical combat casualty care, not to regulate or comprehensively evaluate all medical devices. This role comes with inherent limitations:
No Regulatory Authority
Unlike the FDA, CoTCCC cannot enforce its recommendations or dictate which tourniquets can be used. Their guidance is voluntary, aimed at informing military units, medics, and other tactical personnel. Regulatory decisions remain the FDA’s domain.
No Mechanism for Submitting New Products
CoTCCC does not offer a formal process for manufacturers to submit new tourniquets for evaluation. Unlike regulatory bodies with clear submission pathways, CoTCCC relies on its own initiative to review products, often based on existing data or devices already in use. This means:
- Innovative or niche tourniquets may go unreviewed, not because they’re ineffective, but because they haven’t caught CoTCCC’s attention.
- Manufacturers have no direct way to seek CoTCCC’s endorsement, limiting the scope of their recommendations.
No Set Schedule for Updates
CoTCCC does not follow a fixed timeline for reviewing or updating its recommendations. Updates occur sporadically, driven by new evidence or committee priorities rather than a structured plan. For example:
- The 2019 expansion of their tourniquet list came after years of relying on a smaller set of recommendations, reflecting a reactive rather than proactive approach.
- There are no publicized plans for when or how future equipment will be evaluated, leaving uncertainty about when new tourniquets might be considered.
These limitations mean CoTCCC’s recommendations are a snapshot of evaluated devices at a given time, not a comprehensive or forward-looking assessment of all tourniquets.
Conclusion
The claims that CoTCCC-approved tourniquets are inherently better or legally required in the USA compared to other tourniquets are rooted in misconceptions about CoTCCC’s role:
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Effectiveness: CoTCCC-recommended tourniquets are rigorously vetted for tactical use, but they aren’t universally "better." Other FDA-approved tourniquets may be equally effective, especially in non-tactical settings, and CoTCCC’s limited review process excludes some potentially excellent options.
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Legality: Legal use in the USA depends on FDA approval, not CoTCCC recommendations. Any FDA-approved tourniquet is legal, debunking the idea that CoTCCC’s list defines legality.
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"Approved" vs. "Recommended": The fallacy of calling CoTCCC’s recommendations "approvals" exaggerates their authority. They advise, not regulate.
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Advisory Limitations: As a non-regulatory body, CoTCCC lacks mechanisms for new product submissions, set evaluation schedules, or plans for future reviews, restricting their recommendations to a subset of available tourniquets.
When choosing a tourniquet, users should consider FDA approval for legality and consult multiple sources—including CoTCCC—for effectiveness, rather than assuming CoTCCC’s recommendations are the final word.
We disagree with James’s logic. First, there are no approved devices on the market, simply recommendations. His logic essentially means that innovation is out the window, that no other company ever in the future can come up with something better…and they already have (DNIPRO and OMNA). Not being on “the list” means absolutely nothing, and it is demonstrably false to state “The devices not on that list failed a test and did so for a reason”. There are/were finite criteria for a device to even be considered for testing, one of them being that the device must be on the GSA schedule and/or have an NSN. What if someone develops a TQ for the civilian market and does not care about DoD status? What if you are a foreign company focusing on NATO or Europe or South America? Further, CoTCCC conducts no testing, they simply review available data on a device, it is strictly an academic review, they are not in a lab somewhere conducting physical tests and rely on what has been published. Additionally, there is no submission mechanism for a device, they decide what to review at their leisure, you can lobby them all you want but good luck with that. Finally, two reviews since 2012? That’s an absolute joke that flies in the face of innovation.