General FAQ’s for the HemCon® Bandage
(addressing the 2 x 2 inch, 2 x 4 inch, 4 x 4 inch)
What was the impetus for the development of the HemCon Bandage?
Out of a need to save lives, the HemCon bandage was developed. In 2001 the U.S. Army and the Institute for Surgical Research (ISR) partnered with HemCon Medical Technologies, Inc. to address the needs of soldiers who were having bleeding issues and dying in the field before they could be triaged for surgical intervention. HemCon received the second fastest FDA clearance within 48 hours and has saved hundreds of lives since.
What is the use of the HemCon Bandage?
The HemCon Bandage is used to save lives on the battlefield and the civilian emergency world by controlling severe bleeding from traumatic injuries. In comparison to other traditional bandages, the HemCon Bandage provides superior control of bleeding, quickly seals wounds and is compatible with multiple wound site usage.
From what is the HemCon Bandage comprised?
The HemCon Bandage is fabricated from chitosan, a naturally occurring, biocompatible polysaccharide derived from shrimp shells. The shrimp shells are processed and chemically treated. Once in bandage form, they are sterilized.
Pandalus borealis (also called Pandalus eous) is the species of shrimp found in cold parts of the North Atlantic Ocean that is used in our chitosan.
Is there a problem using this product on people with shrimp or shellfish allergies?
There have been no known allergic reactions as a result of using the HemCon Bandage since distribution began in 2003 and there have been no adverse effects reported in over 700,000 bandages shipped.
HemCon, Inc. has results from a shellfish allergy study conducted by its chitosan supplier which demonstrates that, out of 221 individuals with suspected hypersensitivity, including 8 individuals with known shellfish allergies, none demonstrated any dermal sensitivity when pricked with a chitosan test solution. However, since chitosan is extracted from the shells of shrimp and other shellfish, individuals with known shellfish allergies should exercise caution in the use of products containing chitosan.
How does the HemCon Bandage work?
The chitosan in the HemCon Bandage has a positive charge, and attracts red blood cells, which have a negative charge. The red blood cells create a seal over the wound as they are drawn into the bandage, forming a very tight, adherent seal. By quickly sealing the wound, the bandage reduces blood loss, and thus the demand for blood transfusion products such as red blood cells or plasma.
Can all HemCon Bandages be used internally?
HemCon Medical Technologies, Inc. also offers a variety of hemorrhage control dressings, but only ChitoFlex™-Surgical is cleared with the FDA as a temporary surgical dressing to control severe bleeding in surgery and can therefore be left on the wound for up to 24 hours. All other HemCon Bandages from HemCon are FDA cleared as an external dressing for the temporary control of bleeding.
Is the HemCon Bandage absorbable?
No, the HemCon Bandage is not absorbable.
Who currently is using HemCon Bandage?
In 2005, the Army Surgeon General mandated that every deployed U.S. Army soldier carry at least one HemCon Bandage and every medic five. In 2007, HemCon Bandages were added to every soldier’s IFAK (individual first aid kit). The product is currently being used in the civilian market by first responders, emergency departments and as of July 2007 is exclusively offered to the acute care and hospital market by Cardinal Health.
Is the HemCon Bandage kosher?
The HemCon Bandage is made from shellfish, a creature that is considered forbidden from consumption by some religious groups. Although the bandage is not technically consumed, it is not considered kosher.
How long does it take for the bandage to control the bleeding?
The HemCon Bandage is durable, easy to use and capable of controlling hemorrhaging until an injured patient can be transported to and stabilized in a hospital. The HemCon Bandage controls bleeding within 2-5 minutes.
If the HemCon Bandage stops the bleeding, how does the wound heal?
The HemCon Bandage is cleared by the FDA for up to 48 hours of use to control severe bleeding and is not intended for long term application to promote wound healing. The bandage provides rapid control of severe bleeding by sealing the wound. The bandage works independently of the clotting cascade, allowing the body’s natural clotting to occur.
How long can the HemCon Bandage be left in place?
The bandage can be left on the wound for up to 48 hours.
How is the HemCon Bandage removed?
The HemCon Bandage can be easily removed with saline or water.
Is there any effect of cold temperatures on the bandage?
Although we would not expect low temperature storage conditions to affect dressing efficacy when used at room temperature and above, we have not conducted low temperature stability studies.
Is there any effect of hot temperatures on the HemCon Bandage?
HemCon Bandages have a long shelf life and are durable in varied temperature because they originally designed for military use. HemCon Bandages are best stored at room temperature:
52 degrees F (11 degrees C) to 78 degrees F (26 degrees C).
Will the HemCon Bandage work on hypothermic patients?
Although we would expect the bandage to work on hypothermic patients, we have not conducted any clinical studies to demonstrate efficacy.
Are there any contraindications for its use?
There are no known contraindications for use of the HemCon Bandage. The warning and cautions on our product labels read as follows:
Do not use if seal is broken and/or contents are wet. Do not apply over eyes. Use promptly after opening. Contains chitosan from shellfish. For external use only, do not implant. Not for consumption, do not eat. Single use only. Do not resterilize.
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