CMS awarded Corporate Exigency Contract (CEC)

Combat Medical Systems LLC*, Fayetteville, N.C., has been awarded a maximum $36,396,530 fixed-price with economic-price-adjustment, indefinite-delivery/indefinite-quantity contract for various medical and surgical surge, re-supply, and sustainment materials.  This contract is a competitive acquisition, and four offers were received. This is a one-year base contract with nine one-year option year periods. Location of performance is North Carolina with a Feb. 17, 2015 performance completion date. Using military services are Army, Navy, Air Force, Marine Corps, and federal civilian agencies. Type of appropriation is fiscal 2014 war-stopper funds. The contracting activity is the Defense Logistics Agency Troop Support, Philadelphia, Pa., (SPE2D0-14-D-0001).

Read more: http://www.defense.gov/contracts/contract.aspx?contractid=5225

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Managing Pre-Hospital Field Trauma

As seen in the Military Medical & Veterans Affairs Forum

Managing Pre-Hospital Field Trauma
Medical advances are succeeding in stabilizing the wounded warrior.
By J.B. Bissell, M2VA Correspondent

Wartime conditions give rise to devastating injuries. That is a harsh—and absolute—reality of the battlefield. And, of course, that battlefield typically is nowhere near comprehensive medical facilities, let alone a full-blown hospital. So when a soldier suffers a gunshot wound, is peppered with shrapnel, or triggers an IED, it’s up to the combat medics, corpsmen and pararescuemen to manage that combat trauma in a pre-hospital environment—and to stabilize the wounded warrior for transportation.

They do this by following tactical combat casualty care (TCCC) strategies. “The TCCC guidelines are the only set of battlefield trauma care guidelines to have received the triple endorsement of the American College of Surgeons Committee on Trauma, the National Associations of EMTs and DoD,” explained Frank K. Butler, M.D., a retired Navy captain and current chairman of the Committee on Tactical Combat Casualty Care. “TCCC is divided into three phases to allow the care provided to be optimally integrated into the evolving tactical scenario. These phases are: care under fire, tactical field care and tactical evacuation care.”

Not surprisingly, hemorrhagic shock remains the number one cause of preventable battlefield death, and so the TCCC principles “focus strongly on external hemorrha ge control using CAT and SOFT-T tourniquets, Combat Gauze, and junctional tourniquets,” Butler said. “These strategies have reduced death from extremity hemorrhage from 7.8 percent of combat fatalities to 2.6 percent, a remarkable decrease.”

Keep It Simple

While the TCCC procedures certainly are to thank for such a substantial reduction in hemorrhage-related fatalities, Corey Russ, president of Combat Medical Systems, the company that supplies the military with Combat Gauze, the Combat Ready Clamp (CRoC) and other pre-hospital emergency equipment, also believes making that equipment as easy to use as possible is immensely important.

“Our mission is to simplify tactical medicine,” Russ said. “The tactical scope-of-practice faced by first responders and combat medics in pre-hospital trauma situations is nothing short of amazing. They are continually challenged with limited supplies and unlimited injury possibilities. This is made even more difficult by operational constraints and enemy action.

“Additionally, there are dozens of nuances, such as treating casualties at night with very limited lighting, contending with a full range of weather conditions, having to work around a soldier’s body armor, evacuation challenges in urban and mountain terrain, and so much more. Experienced medics call this the dark, mud and blood factor.” In other words, first responders have plenty to deal with. They don’t need complicated paraphernalia too, so Russ and his team, which is supported by 10 veterans who have extensive experience with pre-hospital combat care as well as former DoD medical program managers, focus on developing uncomplicated gear that addresses critical medical needs on the battlefield.

“Our people understand that while good science and medicine are critical components of a lifesaving device, the greatest good is achieved when the device is easily—if not intuitively—applied,” Russ said. “We use our expertise to ensure that the capabilities we provide are totally employable by everyone involved during tactical situations—from the most junior first responders to the most senior medics and corpsmen.”

Combat Medical Systems’ products simplify tactical medicine by removing decision points and standardizing the most common protocols for casualty treatment. “This means that anybody who must perform lifesaving procedures during high-stress, under-fire scenarios can use our devices with confidence, delivering improved outcomes in the treatment of the most common causes of preventable combat death,” said Russ.

As noted, uncontrollable hemorrhaging remains the most preventable cause of combat death. “We focus heavily on that,” Russ said. “For example, the Combat Ready Clamp represents the latest advances in battlefield hemorrhage control. Localized pressure remains the simplest, time-tested way to control severe hemorrhage in a stable and/or coagulopathic patient, and the CRoC is intuitive, easy to apply and controls severe junctional bleeding within seconds of application. With minimal training, every warfighter can deploy the CRoC to instantly treat life-threatening blood loss.

“Combat Gauze and the Combat Ready Clamp continue to prove themselves as the standard of care in hemorrhage control. In addition, we remain engaged with DoD and its recommending bodies, such as the Committee on Tactical Combat Casualty Care, to develop and distribute devices and kits that meet the demands across the spectrum of tactical medicine.”

Besides the gauze and the clamp, that spectrum includes Battle Wrap, a compression dressing and tactical tape designed to stand up to extreme conditions—and, again, simplify the stabilization process. It’s non-slip and self-adhering, and also transparent so field medics can visually monitor underlying wounds even after the dressing has been applied.

Combat Medical Systems also distributes the Sentinel Chest Trauma Kit, which contains the Sentinel Chest Seal, Mojo Dart chest decompression needle and the Mojo Dart Target needle placement guide for treating symptoms of tension pneumothorax. “And it’s all packaged in a low-cube, rugged bundle that is easy to identify, open and deploy,” Russ added.

All these crucial features—the lifesaving capabilities, obviously, but also the smart packaging and the trouble-free deployment—are based on “our team’s personal experiences and constant engagement with combat medics and corpsmen,” Russ said. “Thanks to that kind of interaction, we really understand the unique challenges of tactical medicine.”

Attention on the Junction

One of those very unique challenges is dealing with the rising instances of IED attacks. “The Dismounted Complex Blast Injury [DCBI] produced by dismounted IED attacks has been increasingly prevalent in recent years in Afghanistan,” explained Butler. “The Army surgeon general’s task force formed in 2011 to address this injury complex found that the hemorrhage control emphasis that TCCC provides was very well-suited to maximize survivability from these devastating injuries.”

And devices such as the CRoC and SAM Medical Products’ SAM Junctional Tourniquet (SJT) are very well-suited to control those types of hemorrhages. In fact, “The SJT is designed to control bleeding where standard tourniquets would not be effective,” said Adrian Polliack, president of SAM Medical Products. “Those types of wounds are typically junctional in nature, such as a high-level leg or arm amputation as a result of an IED blast. Time is of the essence for patients with these kinds of injuries, and the SJT’s simple design allows application for hemorrhage control in less than 25 seconds in most cases, and it works in both the axilla and inguinal areas.”

While the SJT certainly can handle most any junctional hemorrhage emergency, it’s a particular standout when it comes to one specifically nasty injury. “The SJT is the only junctional hemorrhage device cleared by the FDA to stabilize pelvic fractures,” Polliack said. “Recent studies indicate that IED-type injuries often have associated pelvic fractures,” he continued. “So we based the SJT on the design of our SAM Pelvic Sling II, and it controls the visible hemorrhage associated with those injuries and also stabilizes the pelvic fracture to prevent further hemorrhaging that could potentially go undiagnosed in the field.”

For such a comprehensive apparatus, it’s surprisingly easy to put to use. First of all, it weighs only slightly more than 1 pound so it’s hardly an awkward or burdensome piece of extra equipment. More importantly, though, it deploys in just four steps, even for those difficult-to-handle pelvic catastrophes. Once a first responder arrives on the scene, he simply places the unit’s belt underneath the fallen soldier so that the target compression device is positioned directly over the area that requires pressure. If bilateral attention is required, two target compression devices can be used simultaneously.

The SJT is outfitted with a simple three-pronged clip buckle that is then snapped together to connect the two ends. Color-coded brown straps are used to properly secure the buckle before the medic inflates the compression device with the hand pump. That’s it. The external—and often unrecognizable internal—bleeding is under control and the patient is ready for transport.

Of course, that’s not really it. A tremendous amount of thought, discussion, design and experimentation went on behind the scenes to be sure the SJT would perform simply and efficiently in the field. “We designed the SAM Junctional Tourniquet as an easy-to-use, multipurpose product that can be applied quickly in life-threatening situations,” said Polliack. “We worked directly with key military medical and scientific personnel along the product development and testing pathway to ensure it ultimately met the rigid requirements associated with medical devices used in the challenging combat arena.”

Indeed, even the buckle, which to the untrained eye doesn’t look like anything more than a basic clip fastener, has advanced functionality. “The patented buckle provides the correct force to clinically stabilize a pelvic fracture, taking the guesswork out of tightening the belt,” explained Lance Hopman, director of research and development for SAM Medical Products. “This is vital in high-stress environments where over-tightening or under-tightening could potentially be harmful. Controlled force also is imperative for the inguinal hemorrhage, because it ensures slack is removed before tourniqueting pressure is applied. This overcomes a known problem with standard tourniquets.”

Given its ability to handle all means of junctional hemorrhaging injuries, the SJT can be utilized for several lifesaving field procedures. “Combat medics and first responders would need to carry three separate devices to treat the same indications that the SJT can do with one,” Polliack said.

Beyond the Blood

Even with plenty of Combat Gauze and a Combat Ready Clamp or a SAM Junctional Tourniquet on hand, combat medics have to be prepared for every situation, and not all of them involve the uncontrollable loss of blood. If a wounded warfighter can’t breathe, his or her body fluid deficiency becomes a non-issue.

Enter the Smiths Medical Pneupac VR1 emergency ventilator. It’s barely bigger than the palm of a hand, but it overflows with vital features. Simply put, “it’s designed for use in the most rugged environments, such as those requiring ventilation on short-term or longer-term transports,” said Jeffrey Phillips, senior director, government business development, Smiths Medical. “Traditional bag valve masks require a responder solely dedicated to squeezing the bag, but manual ventilation skills diminish quickly, and studies show that both frequency control and delivered tidal volumes vary. As a result, bag valve device resuscitation has been linked to high incidence of hyperventilation.”

Smiths Medical made it possible for first responders to remove the “manual” part of the equation altogether. Sure, an available combat medic can hold the VR1 in place, but the device also can be attached to a stretcher rail or suspended from an IV pole, and “a single control sets tidal volumes and frequency settings,” Phillips explained. “Ventilation can be delivered either controlled manually or automatically. When a manual button is pushed, a single, controlled ventilation is delivered, not a continuous insufflation, allowing the ventilator to be used during cardiopulmonary resuscitation with a chest compression-ventilation ratio of 30:2.”

The VR1 also is outfitted with a pressure relief valve and a demand valve function that suppresses the continuous automatic ventilation and regulates proper oxygen flow if the patient starts to breathe under his or her own power. And for times when the first responder determines that the patient will not be able to breathe on his or her own without emergency airway access, Smiths’ Portex Cricothyroidotomy Kit has everything needed for a quick, efficient procedure under duress.

“It was originally designed with the help of military medics,” said Phillips, “and comes preassembled with a scalpel, tube holder, and 6 mm Cricothyroidotomy tube with Soft Seal cuff to enable spontaneous breathing. Plus, the package contents are presented in sequence of use to facilitate conclusion of procedure, and the unique Veress needle indicates entry into the trachea and subsequent contact with the posterior wall, allowing qualified medics to efficiently, safely and quickly gain airway access.”

Whether the challenge is obtaining airway access or stopping a massive hemorrhage, one constant is the field medic. “Their success in the face of these formidable obstacles is achieved every day and night around the world because of excellent training, intense focus and reliable equipment,” Russ said.

Fortunately, these companies have all designed the type of reliable equipment that’s proving essential to those medics, corpsmen and pararescuemen who continue to successfully manage seemingly unmanageable pre-hospital trauma and life support situations every day.

www.M2VA-kmi.com M2VA 17.5 | 19

Medical Device Firm iTraumaCare™ Receives Expanded Indication from FDA for iTClamp™ Hemorrhage Control System

Indications for Use Now Include the Scalp

SAN ANTONIO — iTraumaCare, an early-stage medical device firm focused on developing traumatic injury solutions, has achieved its fourth regulatory milestone with an expanded indication for use from the US Food and Drug Administration (FDA). The regulatory body has expanded the indications for the company’s first product, the iTClampTM Hemorrhage Control System, to include the temporary control of severe bleeding of the scalp. Previously, the product’s indications for use in the US included only the extremities (arms and legs), axilla (arm pit) and inguinal (groin) areas.

The iTClamp™ is designed to control severe bleeding – a leading cause of death in traumatic injury – in seconds. The iTClamp™ seals the edges of a wound closed to create a temporary pool of blood under pressure, which forms a stable clot that mitigates further blood loss until the wound can be surgically repaired.

iTraumaCare’s CEO and founder, Dr. Dennis Filips, said, “The scalp is often one of the bloodiest wound sites, with uncontrolled bleeding becoming a major issue in patient treatment. This expanded indication will allow first responders and medical professionals to use the iTClamp in even more meaningful ways to improve patient care.”

Incorporated in 2010 and based in Edmonton, Canada with its global commercialization headquarters in San Antonio, Texas, iTraumaCare is addressing unmet needs in the field of emergency medicine by developing, manufacturing, and commercializing solutions to treat common causes of preventable death in traumatic injury scenarios.

Read more here: http://www.heraldonline.com/2013/10/29/5350177/medical-device-firm-itraumacaretm.html#storylink=cpy

Medical Device Firm iTraumaCare Names Combat Medical Systems Exclusive Distributor for Military Market in US

[San Antonio, Texas]  iTraumaCare, an early-stage medical device firm focused on developing traumatic injury solutions for first responder and military medicine applications, has selected Combat Medical Systems as its US Military distributor. Combat Medical Systems will spearhead sales and distribution of iTraumaCare’s iTClampTM Hemorrhage Control System to various branches of the US Military and Federal Government.

“The iTClamp fills the gap that currently exists in the Care Under Fire phase of tactical medicine. It’s intuitive and easily applied, and its impact on the challenges we face in hemorrhage control is significant,” said Corey Russ, President, Combat Medical Systems.

iTraumaCare’s CEO and founder, Dr. Dennis Filips, said, “We selected Combat Medical Systems as our exclusive US Military distributor due to their extensive depth of experience and proven track record in working with the US military.”

The iTClamp is designed to control severe bleeding – a leading cause of death in traumatic injury – in seconds.  The iTClamp seals the edges of a wound closed to create a temporary pool of blood under pressure, which forms a stable clot that mitigates further blood loss until the wound can be surgically repaired. It is available in the US, European Union and Canada.

Combat Medical Systems, founded by a team of military medical personnel and industry specialists, has a straightforward goal: simplify tactical medicine and decrease pre-hospital mortality. Combat Medical Systems is located outside Fort Bragg, N.C., which strategically positions the company to stay current on military medical trends.

Incorporated in 2010 and based in Edmonton, Canada with its global commercialization headquarters in San Antonio, Texas, iTraumaCare is addressing unmet needs in the field of emergency medicine by developing, manufacturing, and commercializing solutions to treat common causes of preventable death in traumatic injury scenarios.

Vidacare Corporation launches the T.A.L.O.N. Intraosseous Vascular Access System

[San Antonio, Texas] At the 2013 Military Health System Research Symposium (MHSRS) in Fort Lauderdale, Vidacare Corporation will be launching the T.A.L.O.N.TM (Tactically Advanced Lifesaving Intraosseous Needle) Intraosseous Vascular Access System for military use.

The T.A.L.O.N. system is a groundbreaking single needle solution for vascular access that provides combat life savers and medics with rapid and accurate manual IO access to seven FDA cleared  IO sites – proximal tibia (below the knee), distal tibia (ankle), proximal humerus (shoulder) and the sternum.  The T.A.L.O.N. system is the first IO system to meet all Committee on Tactical Casualty Care (CoTCCC) recommendations for IO devices.

T.A.L.O.N. provides rapid vascular access through the intraosseous (inside the bone) space and helps deliver vital fluids and drugs through this space, the body’s largest non-collapsible vein, to injured soldiers safely and quickly.  T.A.L.O.N. is a non-powered vascular access option that complements Vidacare’s powered EZ-IO® Intraosseous Vascular Access System that is widely utilized in combat medicine today.

This system is designed to provide battlefield responders a tactical advantage needed in the combat zone via its lightweight and minimal cube design, proven ability to gain vascular access quickly and safely, and its versatility because no additional intraosseous vascular access gear or tools are needed.  As with any vascular access site, the IO insertion site should be monitored frequently and the system should be used only when anatomical landmarks can be clearly identified and in accordance with the T.A.L.O.N. system’s instructions for use.

The T.A.L.O.N. system will be commercially available in the United States starting in early Q4 2013.

“This system is designed specifically to address the needs and concerns of military personnel treating patients under strenuous conditions.  The T.A.L.O.N. system will help achieve vascular access and save lives when seconds count also its design is ideal for the combat zone,” said Mark Mellin, President and CEO of Vidacare Corporation.

T.A.L.O.N. will be sold to the military market through an exclusive relationship with Combat Medical Systems.

“The 7-site access achievable with T.A.L.O.N. will give medical responders a distinct life-saving advantage during casualty resuscitation. We are excited to launch this device with Vidacare, and we are certain it will have an immediate positive impact in tactical medicine,” said Corey Russ, President, Combat Medical Systems.

Established in 2001, Vidacare Corporation is the pioneer of a broad technology platform for accessing the intraosseous (inside the bone) space. Current products include the EZ-IO® Intraosseous Vascular Access System and the OnControl® Bone Access System.  Applications include vascular access, emergency and disaster medicine, oncology and spinal surgery. Vidacare’s focus is on enhancing clinical efficacy, patient safety and comfort, and reducing complications and their associated costs, has resulted in its devices becoming the recognized technology standard. Privately held, the company is based in San Antonio, Texas, and its products are marketed in over 50 countries worldwide.  www.vidacare.com

Combat Medical Systems was founded in 2008 by a team of experienced military medical personnel and industry product specialists with a mission to simplify tactical medicine. Headquartered in Fayetteville, N.C., nearby Ft. Bragg acts as its catalyst to staying current with medical trends and product development. (www.combatmedicalsystems.com)

CMS to Distribute Advanced Circulatory’s Products

Combat Medical Systems (CMS) is proud to announce that effective July 1, 2013, Advanced Circulatory, manufacturers of ResQGARD® and ResQPOD®, has named us its Master Distributor to the US Department of Defense and Federal Agencies.

Advanced Circulatory’s ResQGARD® and ResQPOD® are circulatory enhancement devices designed to treat low blood pressure and improve blood flow to the heart and brain in hypotensive patients. These products are supported with extensive scientific and clinical data.

ResQGARD is for treating spontaneously breathing casualties who are hypovolemic and have symptoms of low blood pressure: candidates include casualties who present with low blood pressure due to blood loss, dehydration, heat stroke, easy sepsis and orthostatic intolerance. The device creates slight resistance when a casualty inhales, effectively increasing blood flow and circulation. When IV or IO access is not practical, ResQGARD provides a therapeutic bridge until the casualty receives definitive treatment. The non-invasive device is easily administered by all skill level providers. It can effectively increase blood pressure by up to 30%.

ResQPOD enhances circulation during basic or advanced life support CPR. This simple non-invasive device regulates pressure in the chest and improves blood flow to the heart and brain. When a casualty is at risk for hypotension, ResQPOD provides Perfusion on Demand (POD). In clinical studies, ResQPOD increased blood flow to the brain by 50% and demonstrated increased survival rates with favorable neurologic outcomes by 25% or more. Timing Lights guide proper compression and ventilation rates ensuring effective CPR is administered. ResQPOD helps circulate drugs more effectively and does not restrict patient ventilation.

For more information and clinical references, visit our product resource pages: ResQGARD or ResQPOD and the Advanced Circulatory website www.advancedcirculatory.com.

Combat Medical Systems receives ISO 13485 Quality Management Certification

Our quality management system has been certified for compliance with ISO 13485 standards for the design, manufacture, and distribution of tactical medical devices. Achieving this certification is just one more way we are continuing our commitment to delivering quality medical products for tactical operators.

Combat Medical Systems received the certification from BSI Group, a leading global independent business services organization providing standards-based solutions in more than 140 countries. BSI Group draws upon over 100 years’ experience to partner with 70,000 organizations in 150 countries from its 65 offices. BSI offers assessment, certification and training services in all critical areas of management systems.