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Archive for the ‘Medical’ Category

DOD utilizes 3D-printing to Create N95 Respirators in the Battle Against COVID-19

Thursday, January 14th, 2021

In response to the COVID-19 global pandemic, the U.S. Army Medical Materiel Development Activity’s Warfighter Expeditionary Medicine and Treatment Project Management Office, as part of the U.S. Army Medical Research and Development Command’s Additive Manufacturing Working Group, has played an integral role in the ramped-up effort to produce N95 respirators for healthcare and frontline workers across the nation. As stated on the U.S. Food and Drug Administration’s website, an N95 respirator is “a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles.” Compared to a surgical mask, which is loose-fitting, the edges of the N95 mask are designed to form a very tight seal around the individual’s nose and mouth, providing the highest levels of protection against infection from COVID-19.

U.S. Air Force Maj. Daniel Williams serves as product manager of the WEMT PMO’s N95 respirator efforts at USAMMDA. These include coordinating programmatic and regulatory support, leveraging existing government resources, and developing synergies within the Department of Defense’s organic industrial base to successfully generate N95 respirator products. He explained that his primary task is to ensure the medical device meets military needs and regulatory requirements, and that development of the product remains on schedule and within budget.

In a recent interview, Williams offered a great deal of insight with regard to USAMMDA’s N95 respirator efforts, and the work to produce and distribute these products as quickly as possible in the battle against the spread of COVID-19 throughout our nation and the world.

JS: As product manager within the WEMT PMO, please describe your responsibilities in regard to the N95 respirator effort.

DW: The N95 effort is a slightly atypical experience, in that we are primarily working with DOD partners who have never manufactured medical devices. However, they have extensive experience in various methods of manufacturing, including additive manufacturing, also known as three-dimensional, or 3D, printing. So, our primary responsibility is assisting these DOD manufacturers in navigating the medical device world, including compliance with U.S. Food and Drug Administration and National Institute for Occupational Safety and Health regulations. Further, we facilitate test and evaluation of their products, by leveraging DOD laboratories and government partners to obtain performance feedback on respirator prototypes.

JS: Please describe the features of the N95 respirator, and why this device is superior to others currently on the market. What is its significance, especially with regard to COVID?

DW: It’s not so much superiority, as it is availability. One of the highest levels of respiratory protection for medical purposes, to include viral infection, is a NIOSH-certified N95 respirator. These come in multiple forms, but all are held to the same standard of filtering at least 95 percent of relevant particles, such as the Sudden Acute Respiratory Syndrome Coronavirus-2 virus. Most people are familiar with what is called an FFR, or a Filtering Facepiece Respirator. These are the standard disposable, one-time-use products typically worn by our healthcare workers. However, at this time, these types of masks are nearly impossible to 3D-print. Our group has been working on what is called an elastomeric half-mask respirator, which is a reusable frame produced by a 3D printer, with a disposable media or cartridge that filters at the 95-percent level.

When the pandemic hit, the on-hand supply of N95 respirators, specifically FFRs, was quickly exhausted and traditional N95 manufacturers were not prepared to meet this new demand. Therefore, the primary purpose of the N95 working group is to develop N95 respirators to supplement existing supplies of respirators, as well as to develop new manufacturing capabilities within the DOD’s organic industrial base, which consists of military arsenals, maintenance depots and ammunition factories. Ensuring the DOD has the capability to independently manufacture protective respiratory devices will help to protect frontline workers during the COVID-19 pandemic, and it will also help to maintain our military readiness in the face of future pandemics or biothreats.

JS: Please detail the current status of the N95 program, and explain what lies ahead.

DW: Currently, we’ve partnered with multiple organizations across the DOD including the Army, Navy, Coast Guard, and the Defense Logistics Agency to support N95 respirator design, manufacturing and distribution through existing logistics. To date, we’ve facilitated testing of 18 iterations of respirator design, and two have successfully passed preliminary evaluation at the Army’s Combat Capabilities Development Command’s Chemical Biological Center. Our next steps will be to assist these manufacturers with the NIOSH application and process, to obtain an N95 certification for these respirators. Further, we are continuously seeking new partners within the DOD who have N95-related efforts, so that we may be able to assist.

The COVID-19 pandemic has clearly illustrated that civilian medical supply chains were unprepared to rapidly scale-up production of critical medical supplies such as medical personal protective equipment, including N95 respirators. Although this crisis will end, the next one could come along at any time. Additionally, the impact of critical medical supply shortages on military readiness could occur again in future battlefields from natural pandemics or biothreat agents. By continuing to focus on producing medical devices within the DOD organic industrial base, we can translate the lessons we’ve learned with medical PPE shortages into better preparedness for the next medical crisis, as well as for future conflicts in a Multi-Domain Operational environment.

JS: Why was the WEMT PMO tasked with the N95 respirator effort?

DW: The WEMT PMO’s everyday mission is to develop and deliver medical devices to our Service partners in the Army, Navy, Air Force and Marines. In response to the COVID-19 pandemic, our program office was able to naturally pivot and leverage our staff’s medical product development expertise and apply it to the crisis at hand. This is truly what project managers do – we find creative ways to deliver effective, suitable and timely medical solutions when and where they are needed most.

JS: Please list the other members of the N95 respirator program team, and detail their responsibilities in the overall effort.

DW: The team has been phenomenal and is comprised of many professionals. However, the N95 program is actually a subgroup of the USAMRDC’s Additive Manufacturing Working Group, and nothing could have been accomplished without its assistance and guidance. The AMWG oversees three specific product lines: diagnostic swabs, ventilator parts and accessories, and the N95 respirator. As the lead for the N95 line of effort, I was tasked with outlining FDA and NIOSH requirements, initiating agreements between organizations, and leading an N95 working group to facilitate collaboration amongst all of our partners.

The N95 team specifically, can really be split into three different components, and we’d be nowhere without the ongoing collaborative effort from each component. First are our manufacturing partners, the U.S. Navy Underwater Warfare Center-Keyport, U.S. Forces Korea, Defense Logistics Agency, and the U.S. Coast Guard Academy. These organizations have the technical and subject matter expertise to not only design an N95 respirator, but actually to produce it through additive manufacturing methods.

Second is our AMWG team members at USAMRDC, comprised of the Office of Regulated Activities, Office of the Principal Assistant for Acquisition, Legal office, and USAMMDA’s Office of Research and Technology Applications and the WEMT PMO. The USAMRDC ensures all regulatory requirements for the respirator have been met, appropriate agreements are in place between organizations, and that any concerns with patents or intellectual property on the respirator designs have been addressed. It also provides clinical expertise on potential products, and facilitates test and evaluation of N95 respirator prototypes.

Last, but certainly not least, is the Army’s Combat Capabilities Development Command Chemical Biological Center. The CCDC CBC has been evaluating all forms of respirators for decades, and has an unparalleled knowledge of respirator design and evaluation. Once our manufacturing partners have produced a prototype, it is sent to CCDC CBC for evaluation, to determine whether it will meet the NIOSH standards for an N95 respirator. The CCDC CBC has been critical in providing performance feedback and offering design suggestions for our manufacturers, allowing iterative prototyping to expedite development of respirators.

JS: Other than for the current pandemic, what are some other (future) uses of the N95 mask?

DW: The N95 was thrust into the spotlight as COVID-19 is an airborne respiratory illness. However, the N95 respirator has long been used as medical PPE to prevent against other airborne illnesses, as well as in industrial settings to protect workers against airborne environmental toxins. Therefore, even when the COVID-19 pandemic ends, the N95 respirator will still be a much-needed product in these types of situations.

JS: Is there anything else you would like to say regarding the N95 working group?

DW: Tireless effort is put in on a daily basis, from N95 working group members internal and external to USAMMDA and USAMRDC, USAMMDA’s higher headquarters. It has been such an honor to work with such an amazing group of professionals, spanning the medical and non-medical communities, and a truly unique experience to see so many different specialties come together for a common goal. I am extremely grateful to have been a part of it, and I would like to say a sincere “Thank you” to everyone involved!

USAMMDA is a subordinate command of the U.S. Army Medical Research and Development Command, under the Army Futures Command. As the premier developer of world-class military medical capabilities, USAMMDA is responsible for developing and delivering critical products designed to protect and preserve the lives of Warfighters across the globe. These products include drugs, vaccines, biologics, devices and medical support equipment intended to maximize survival of casualties on the battlefield.

Always Ready: 86th Aeromedical Evacuation Squadron Executes Negatively Pressurized Conex-Lite Training Mission

Tuesday, January 5th, 2021

RAMSTEIN AIR BASE, Germany (AFNS) —

The 86th Aeromedical Evacuation Squadron held a COVID-19 patient movement training using the Negatively Pressurized Conex-Lite at Ramstein Air Base, Dec. 14-18.

The week-long training ended with a proof-of-concept flight on a C-130J Super Hercules, solidifying the entire process of U.S. Air Forces in Europe and Air Forces Africa COVID-19 patient transfer capabilities for the 86th Airlift Wing.

“It was the first time an NPC-L has taken off, at least in U.S. European Command, having a training mission on it, all the assets, and coordinating the integration from the ground piece to the in-flight piece,” said Capt. JD Pilger, 86th AES training flight commander. “Previously, everything was done on the ground, so this is a big deal. The capstone for the week was getting this thing airborne and proving this concept and capability for EUCOM.”

Operations such as these are historically placed within the Air Mobility Command, specifically at Joint Base Charleston, South Carolina. The initial force training was only conducted there for the entire Air Force, which would then piece together teams and send on deployments to provide this capability operationally.

In July, however, AMC started a flagship initiative to send certified trainers to Ramstein AB to certify 86th Medical Group and 86th AES personnel to be the initial cadre on the NPC-L. This established an organic capability located overseas, therefore widening the pool of certified personnel to the force, said Maj. Josh Williams, 86th AES operations flight commander.

From the 721st Aerial Port Squadron, loading the NPC-L onto the aircraft to the 86th MDG and 86th AES infectious disease team ensuring proper personal protective equipment was worn during each scenario, multiple units were called upon to contribute to the training.

“The training was for developing another force package for the 86th AW, to enable us to move COVID-positive patients utilizing the NPC-L,” Pilger said. “The force package entails members from the 86th MDG, the 86th AES and additional folks over at Landstuhl Regional Medical Center, such as our Critical Care Air Transport Team.”

The NPC-L is a smaller version of the Negatively Pressurized Conex, an isolated containment chamber intended to transport individuals with infectious diseases like COVID-19. While the NPC is used on C-17 Globemaster III, the NPC-L was developed for use on a C-130J.

“Pursuant to a U.S. Transportation Command joint urgent operational need request, (the NPC) was fielded, and the follow on to that was the NPC-L,” Williams said. “That is what we’ve now developed our teams and force packages within the 86th AW to support. (The NPC) is actually loadable on a C-130 and can transport patients in EUCOM, as well as U.S. Africa Command.”

Up to nine ambulatory patients, four litter patients, two CCATT critical care patients, or variations thereof, can be transported in the NPC-L.

During the training, Airmen were presented with various patient-transfer scenarios and worked together to execute the mission both on the ground and in the air.

“It was a true team sport throughout the whole thing,” said Capt. Zachary Gooch, 86th AES operations support flight commander. “We could not have done it without the support from Air Terminal Operations Center, maintenance or the medical group.”

Having this organic capability enables Ramstein to provide COVID-19 patient movement overseas without the need for assets deployed from AMC.

“I think we proved that this can be done without having a deployed asset that rolls in and sets up shop,” Gooch said. “We did it, basically, from grassroots.”

By SrA John R. Wright, 86th Airlift Wing Public Affairs

New Medical Device May Change the Face of Battlefield Treatment

Tuesday, December 29th, 2020

The U.S. Army Medical Materiel Development Activity has teamed with one of its commercial partners in the development of a novel medical device that may prove to be a “game-changer” in the frontline treatment of wounded Warfighters. Created by TDA Research, Inc., and funded through the Defense Health Agency’s Small Business Innovation Research program, the Lactated Ringer’s Solution Generator is a lightweight, portable unit that can produce sterile LR solution in austere locations from locally available freshwater sources. The device utilizes proprietary technology to produce one liter-size intravenous bags from a concentrated LR salt solution.

Composed of sodium, chloride, potassium, calcium and lactate, LR solution is used primarily to treat dehydration, deliver medication and restore fluid balance following bodily injury. It is also used to treat moderate hemorrhagic shock, as it has been shown to increase initial survival rates among patients and decrease the chances of organ damage.

Austin Langdon serves as assistant product manager for the LR Solution Generator program within USAMMDA’s Warfighter Deployed Medical Systems Project Management Office. He believes the device will help to save lives on the battlefield, and recently he demonstrated the unit for Army Brig. Gen. Michael J. Talley, Commanding General of the U.S. Army Medical Research and Development Command and Fort Detrick.

“Without question, this small device will dramatically reduce the Army’s logistical footprint of having to ship and store lactated Ringer’s solution, which is the fluid of choice for resuscitation if blood is not available on the battlefield,” said Langdon. “This unit can make LR solution from practically any water source, including ditch water.”

“I truly believe in this device and its application for military use in the near future, although it will probably find its way into civilian medicine as well,” he continued. “For the Army, the LR Solution Generator will increase our life-saving capabilities by helping to reduce our logistical supply chain demands — our ability to make LR solution in the field will also help ensure we’re able to use these critical bags before they expire.”

As a former Army flight medic, Langdon praised the unique qualities of the device, highlighting its size, weight and portability. The unit weighs less than 11 pounds and is stored in a hard-shell case that is approximately 10 inches wide by 18 inches long, and only 6 inches deep. The purification device runs on a rechargeable lithium-ion cell that can produce more than 30 bags of LR solution per single charge.

“Army leadership is continually seeking ways to reduce the logistical strain of getting much-needed resources to the frontline and far forward in Multi-Domain Operations,” said Langdon. “Products such as the LR Solution Generator are far-forward-leaning solutions that can help us think outside of our normal parameters of operation. This device, and others like it, will bring forth new innovation that will change our standard of operation and secure our valuable resources.”

By Jeffrey Soares, USAMMDA public affairs

Mystery Ranch – RFAK & VLAK

Thursday, December 10th, 2020

An essential aspect of preparedness is medical supplies and training. The ability to self-stabilize and package yourself, potential patients, or family members will depend on your ability to respond quickly to any situation. MYSTERY RANCH offers two basic medical pouches.

VLAK in use. Photo by: TacGas

The Removable First Aid Kit (RFAK) and Vehicle Litter Aid Kit (VLAK) are two small medical pouches from MYSTERY RANCH built to handle essential medical tasks with expandable-organization in mind. Their application excels with on-person or vehicle-based missions – from the residential, tactical urban, mission-essential or wilderness backcountry environments.  

RFAK and VLAK both offer quick, one-handed visual access to your essential medical supplies organized inside – allowing for pressure or stabilization while accessing the necessary medical solution stored inside.

The history of MYSTERY RANCH medical kits:

IFAK (Individual First Aid Kit) and VLAK (Vehicle Litter Aid Kit) were initially designed around 2010 in response to an RFP for a SOCOM Tactical Combat Causality Care program. Both pouches were designed with quick one-handed entry, ensuring fast rip-open access to med supplies. This design was based on the previously developed Rip-Zip pockets, turned upside down for this application. 

The Ranch was a sub-contractor on the bid, providing nylon that the prime contractor would kit out with the medical supplies. The prime contractor wasn’t awarded the contract, but SOCOM quickly reached out praising the design built by MYSTERY RANCH. Since then, these have been staples of the Ranch’s in-line program. 

RFAK – Removable First Aid Kit

The original MYSTERY RANCH IFAK was redesigned in 2016 based on user feedback from those downrange. The primary redesign element was the ability to remove the internal medical kit while the IFAK outer stayed attached. As shown below, the internal component are now removable so that with one hand, a user could pull the entire contents out of the shell in a tight little bundle. This allowed self-administration of aid or the ability to toss the bundle to someone else who needs it. With this design change, we re-named the product RFAK (Removable First Aid Kit). The RFAK is a compact, yet expandable and removable, individual first aid kit. It features a MOLLE attach system and is sized to keep a low profile. 

No matter if this is placed on your kit, in your go-bag, or in any of your day-to-day belongings. The RFAK contains enough space for an individual’s essential medical supplies.

VLAK – Vehicle Litter Aid Kit

The VLAK is the next step-up in medical kit size, while maintaining the same single-handed utility and MOLLE attachment as the RFAK. It includes a long, detachable strap connected to the top to sling it over a vehicle headrest, or your shoulder while heading to the X. It can also be attached to an assault vest and body armor. 

VLAK is a common acronym for this type of larger IFAK designed to be primarily vehicle based for responders to a mass casualty event. This size adapts to family or crew needs with vehicle mobility in mind. The VLAK is sized to hold two RFAK’s worth of gear, to either refill RFAK’s or triage several patients. The VLAK was designed to address medical resupply storage in vehicles. 

The Litter in the name refers to its ability to carry a compressed and ultra-light litter under the two compression straps on the top of the VLAK. As such, it is larger than the RFAK so that it can carry larger and additional medical items along with standard medical gauze, clotting agent, etc.  

RFAK and VLAK Manufacturing and Distribution

Both of these medical pouches are currently made in the USA and are Berry Compliant, and available for civilian purchase. 

We also manufacture an Asia-sourced version that is supplied to the Norwegian Military, as MYSTERY RANCH is a subcontractor for most of the Nylon on Norway’s current TCCC (Tactical Combat Casualty Care) program. Some version of most of our medical packs and pouches are being issued widely there since 2018. 

We are pleased to collaborate with our friends at North American Rescue for kitting out our medical packs for these photos and videos. Please contact NARescue customer service to order medical contents as shown.

*Contents not included with MR pack. 

CRO Thermal Regulation System

Monday, December 7th, 2020

The Thermal Regulation System is a single unit thermal regulation blood transport container produced in Montana by CRO Medical.

Features:
• 400mL or 550mL single unit blood transport container.
• Temperature data logger for blood cold chain validation.
• Meets AABB hemovigilance standards for whole blood transportation. 
• Tear-away panel included for versatile mounting options.
• Velcro mounting option for inside medbag.
• Instantly and reliably heats to 104 degrees F for two hours. 
• Built-in pressure infuser.
• Insulated line kit for filtered tubing included.

The container can heat to 104F and maintain this temperature for two hours on a single charge. The heat passes through an air barrier surrounding the blood to provide safe and consistent circumferential, indirect, and radiant heat intended to prevent freezing in temps ranging from -64.6F to -54.0F. An insulated line kit for filtered tubing is included to prevent thermal changes in the admin line during resuscitation.

*This product is not intended to be a warmer for blood administration. 

The transport container maintains temperature below 10C for 12 hours at 40C ambient temp using the cold pack provided. Polyethylene closed-cell foam insulation with aluminum radiant backing directs heat inward across the air barrier.

Pressure infuse your blood at the point of injury without removing the blood from the pocket.   

Integrates into the blood cold chain using built-in infrared temperature sensor. The sensor is accurate to + or – 0.4F and logs time-stamped temperature data into the on-board hard drive for simple retrieval in .csv format. This allows the operator to remove blood from the refrigerator and begin data logging temperature readings in real-time. If the blood warms above 10C during transport, an 8-hour countdown begins, indicating viable shelf life. If the temp remains below 10C, the blood can be validated using the temperature data log and returned for the remainder of the cold chain life cycle. This follows the best practices of cold chain validation for resource conservation and hemovigilance.

The LCD screen is preferred for operating in blacked-out conditions. No alarms or audible noise.

MSRP: $480

www.cromedicalgear.com/products/trs 

Please contact customer service at CRO for quotes: [email protected]

Introducing CardoMax

Friday, November 20th, 2020

If you’re familiar with MATBOCK, you know Sean Matson and Zack Steinbok. Zach and Sean have spent over a decade of building innovative products and companies. CardoMax at first glance looks like another supplement company, but it is not.

CardoMax has used research-backed ingredients to develop their first 3 products. An Energy Intensifier, an Immune Booster and a Recovery Accelerant. All of these products will be single-served liquid supplements which are designed to be mixed with 20oz of your favorite beverage.

Energy Intensifier:

Is a sugar and calorie free liquid energy supplement designed to boost your workout with caffeine & BCAAs. The CardoMAX Energy Intensifier is the perfect addition for your gym bag or a portable packet to take out with you on a long patrol / hike.

Recovery Accelerant:

The Recovery Accelerant is slightly larger than the Energy packet, but is chalk full of all the good stuff like BCAAs, Creatine, Citicoline and other ingredients promoting good health . The dosages of Creatine & Citiocline have been shown to support brain function and help people with mild TBI.

Immune Booster:

Using natural flavoring, the CardoMAX immune booster packets include contents known for decades to sustain and build a strong immune system. With additional clean ingredients, the Immune Booster will help increase endurance and blood flow.

Zach and Sean said “NEW COMPANY! NEW INDUSTRY! NEW & IMPROVED PRODUCTS! SAME TRUSTED FOUNDERS! Engage with us today and be one of the first for free samples and new products before it hits the market.”

Lastly, they are offering 1000 FREE samples (S&H not included). Click here if you want to get your name on the list: www.energy.cardomax.com/energy1

Social Media Links:

IG: www.instagram.com/cardo_max
FB: www.facebook.com/CardoMaxLLC
Website: www.cardomax.com

ZOLL Partners With US Air Force Research Laboratory to Improve How Combat Medics Treat Their Patients

Wednesday, November 18th, 2020

November 17, 2020 — CHELMSFORD, MASS. — ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, and the U.S. Air Force Research Laboratory announced today the signing of a patent license agreement to make it easier for the deployed medic to document vitals, help administer critical care, integrate patient data and identify exact location of casualties in austere combat environments.

The agreement reinforces the integration of ZOLL’s Propaq patient monitors and monitor/defibrillators into the Battlefield Assisted Trauma Distributed Observation Kit, or BATDOK, point-of-injury software tool. BATDOK is a trademark of the United States Air Force.

According to Dr. Gregory Burnett, airman-machine integration product line lead at the AFRL 711th Human Performance Wing, Wright-Patterson Air Force Base, “The ability to monitor and document care for multiple patients from point of injury all the way through to a definitive care facility can improve quality and continuity of treatment for an injured service member.”

The integration of the Propaq monitors and monitor/defibrillators with the BATDOK software tool enables combat medics to wirelessly and automatically monitor multiple patients’ vitals simultaneously at the point of injury through medical evacuation, and follow-on transfer to the next level of care.

“This facilitates maximum awareness and documentation of in-field patient care while providing state-of-the-art patient monitoring and best-in-class diagnostic and resuscitation capabilities to the wounded service member,” said Jonathan A. Rennert, CEO of ZOLL.

The Propaq M and Propaq MD are ultra-lightweight, airworthy and telemedicine-capable monitors or monitor/defibrillators that provide advanced patient-monitoring capabilities. They are designed specifically for the rigors of military and aeromedical operations. Next to ZOLL´s portable ventilators, the EMV+ and the 330 Multifunction Aspirator, the Propaq M and MD are part of the standard patient movement item equipment for the different branches of the U.S. military and are essential critical care devices for many military medical corps worldwide.

For more than 25 years, ZOLL has been a trusted partner delivering acute critical care technologies to the military, Rennert explained. “ZOLL products are extensively utilized throughout the entire military healthcare system in support of the warfighter and casualty care treatment within all roles of operational En-Route Care System, disaster and humanitarian response.”

“ZOLL’s leading resuscitation and critical care technologies are field-proven in all roles of operational medical care on the battlefield, in aeromedical evacuation and transport, in field hospitals and in garrison for definitive care,” he added.

Imminent Threat Solutions Launches 10-4 Radio Pouch and SHARP

Monday, November 16th, 2020

[Arlington TX, 11/13/20] Imminent Threat Solutions is proud to release two new products featuring the DoubleDuty™ Retractor Pocket, designed to provide dummy-proof retention using either the new ITS FailSafe™ Retractor or a heavier duty retractor.

ITS 10-4 Radio Pouch™

The third generation of the ITS 10-4 Radio Pouch™ now fits additional sized radios, features enhancements to the four built-in levels of retention, a new drawbridge and the all-new DoubleDuty™ Retractor Pocket. It also offers limitless mounting options using the versatile 4-Way Mounting System™.

ITS SHARP™

The all-new ITS SHARP™ (Shears Holster and Retention Pouch) was born out of necessity, the mother of all invention. It sheds traditional bulky storage methods that lack functionality and provides limitless mounting potential to enable quick access with up to two levels of retention for your trauma shears.

For more information visit store.itstactical.com.