Can you really stop the bleeding? The availability of illegal, untested and old tourniquets:
• U.S. Military issued their 1st warning about “fake” tourniquets in May, 2010
• U.S. Federal Food and Drug Administration (FDA) issued their 1st warning in August, 2010
• EU regulatory departments have been aware for years and admit to having this information, but to my knowledge there have been no official EU government warnings issued
• Many individual states in the U.S. have issued warnings
→ → → However, these tourniquets remain easily available for any consumer to purchase from the many e-commerce websites and also direct from companies who claim to specialize in medical products.
3 tourniquets were recommended by a U.S. military committee in 2004, now called the Committee on Tactical Combat Casualty Care (CoTCCC) . These 3 tourniquets are referred to as the “CoTCCC recommended limb tourniquets” and this remains unchanged today.
Let’s think about that. There has to be a good reason why their recommendation has remained constant for so many years.
The 3 recommended tourniquets are:
C-A-T® Tourniquet – C-A-T Resources, LLC, South Carolina, USA
SOF® Tactical Tourniquet – Tactical Medical Solutions, South Carolina, USA
E.M.T. – Delfi™ Medical Innovations, Inc., British Columbia, Canada
1) Why is it important to learn from the U.S. military?
– Their experience in the field has provided them with extensive and real life-saving use of peripheral tourniquets
– Over many years they have conducted extensive tourniquets testing in their laboratories, compiling comprehensive and qualitative results in the use of peripheral tourniquets
2) These 3 recommended tourniquets are designed and manufactured by medical companies certified by the International Organization for Standardization (ISO).
– Why is ISO certification important for the manufacturing of medical product?
– ISO requires a quality management system be maintained during the manufacturing process
– Why is quality management important?
– It certifies that the finished products are tested using qualified testing methods
– It certifies that each individual component, that makes up the final product, is tested, registered and tracked during the manufacturing process
– These individual components are what make up the specific lot or serial numbers of the final product as it comes off the production line
3) Peripheral tourniquets are a Class I CE product based on EU Council Directive 93/42/EEC.
– How do manufacturers get their Class I products CE certified?
– If manufactured within the EU, a Declaration of Conformity (DoC) Letter is required, which is written by the manufacturer, stating they follow EU Council Directive 93/42/EEC → → → it can’t get much easier than that!
– If manufactured outside the EU, the DoC letter is required but also the appointment of an “EU Authorized Representative” (E.A.R.). The E.A.R. provides the “outside” EU
manufacturer with an inside EU person or company who is responsible to act as their legal agent.
– The E.A.R. has very specific legal responsibilities but there are many examples of these responsibilities not being followed.
– Whether it is a company or a private person assigned E.A.R. status by the outside EU manufacturer, there is the possibility their focus may be that of self-interest (money!)
and not the quality of the product.
– Through-out Europe there are “real” companies who are “real” E.A.R. agents. These are the ones you should trust to follow the EU laws.
– Based on a statement by the European Commission, the purpose of Council Directive 93/42/EEC is to enhance “the safety, quality and efficacy of healthcare in the EU”.
→ → → makes you wonder how it’s possible there are so many illegal and untested tourniquets available
What can you do?
– Never buy a tourniquet just because you get a cheaper price. Before buying think about asking the supplier for the following:
– The year of product manufacturing
– any company with tracking capability should have this information
– ISO certificate from the manufacturer
– A copy of their Declaration of Conformity
– If the manufacturer is from outside the EU, who is their E.A.R.?
– Go with your gut feeling – do you believe this supplier and E.A.R. are concerned with your best interest or are they putting their own interest 1st?
– If the E.A.R. is also the seller then perhaps you should be suspicious of their motive
– Look out for the following – the manufacturers and sellers of these illegal and untested tourniquets use very clever techniques to get you to buy:
– They may use the same name for their tourniquets as those tourniquets you are familiar with – sounds crazy but they often get away with this
– They may make a slight change in the name of the tourniquet so that you do not notice you are not buying the real thing
– They often copy and imprint onto their tourniquets the very same imprints that the “real” tourniquet manufacturers use – again this sounds crazy but they get away with
this unless consumers act responsibly
Many court cases have been won by the “real manufacturers” of tourniquets and many cases are still ongoing. Thousands of illegal tourniquets have been confiscated by law enforcement agencies all over Europe but there are still many of these tourniquets available.
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