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Dedicated to the Military Medical & VA Community

Special Section Prosthetics

Medical Supplier Maj. Gen. (Dr.) Joseph Caravalho Jr. Commander USAMRMC and Fort Detrick Deputy for Medical Systems to the Assistant Secretary of the Army for ALT

www.M2VA-kmi.com

October 2013 Volume 17, Issue 5

Command Profile

Exclusive Interview with: Maj. Gen. Jimmie Keenan Commander, Southern Regional Medical Command Chief, U.S. Army Nurse Corps Director, SAMHS

Airway Management O Burn Care O Pre-hospital Trauma Medical OS Migration

Military Military medical & Veterans Affairs Forum

2014

Editorial Calendar February [18.1]

March [18.2]

June [18.3]

July [18.4]

Q&A: Maj. Gen. (Dr.) Douglas J. Robb Deputy Director TRICARE Management Activity Special Section: Leadership Insight Roundtable 2014 Features: Radiology Systems Surgical Devices EHR/AHLTA Who’s who: James J. Peters VA Medical Center Tradeshows: AUSA Winter MHS Conference Closing Date: January 16

Q&A: Vice Adm. Matthew Nathan Navy Surgeon General Special Section: RTLS Features: MRI Machines Biomedical Informatics Trauma Kit Equipment Disinfection/Sterilization Who’s who: Walter Reed Army Tradeshows: Medical Center Sea-AirSpace Expo Closing Date: February 28

Q&A: Lt. Gen. (Dr.) Thomas W. Travis U.S. Air Force Surgeon General Special Section: Burn Care Features: Tissue Injury/Wound Care Needles and Syringes Aeromed Technologies Infectious Disease Who’s who: Brooke Army Medical Center Closing Date: May 19

Q&A: Rear Adm. Raquel C. Bono Director National Capital Medical Directorate Special Section: Pain Management Features: Ultrasound Machines Vital Signs Monitors Soldier Carried Medical Gear Defibrillators Who’s who: Theater Hospital Closing Date: June 23

August [18.5]

October [18.6]

November [18.7]

December [18.8]

Q&A: Maj. Gen. (Dr.) Joseph Caravalho Jr. Commanding General U.S. Army Medical Research and Material Command and Ft. Detrick Deputy for Medical Systems to the Assistant Secretary of the Army for ALT Special Section: Combat Casualty Care Features: X-ray Machines Hemorrhage Control Cold Weather Medicine Anesthesia Equipment Who’s who: Landstuhl Regional Tradeshows: Medical Center MHSRS/ ATACCC Closing Date: July 5

Q&A: Lt. Gen. Patricia Horoho Army Surgeon General Special Section: Telemedicine Features: Pre-Hospital Trauma Medical Services Outsourcing Biosurveillance Cardiac Life Support Who’s who: Tripler Army Medical Center Tradeshows: AUSA Modern Day Marine Closing Date: September 12

Q&A: Dr. Jonathan Woodson Assistant Secretary of Defense for Health Affairs Special Section: Pharmacy Automation Features: PTSD Treatment Diabetes Care Medical Surveillance Infant Security Who’s who: Wilford Hall Ambulatory Surgical Center Tradeshows: Joint Forces Pharmacy AMSUS Closing Date: October 15

Q&A: Col. Peter J. Benson Command Surgeon, U.S. Army Special Operations Command Special Section: Combat Search and Rescue Features: Airway Management Mobile Health IT Field Hospital Care SOF Medic Training Who’s who: USNS Comfort USNS Mercy Tradeshows: SOMA I/ITSEC Closing Date: November 17

Military medical & Veterans Affairs Forum

Cover / Q&A

Features Managing Pre-Hospital Field Trauma

Special Section

Tactical combat casualty care strategies are the guiding lights of medics confronted with the shattering injuries of war. These strategies center strongly on the prevention of hemorrhagic shock.

By J.B. Bissell

19 4

Treating the Burn Administering first-aid to victims differs from person to person; however, there are a few rules to follow in each case. Multiple companies have created products to treat burns at the initial “point of injury.”

By Chris McCoy

October 2013 Volume 17, Issue 5

To Walk and To Run Remarkable advances in lower-extremity prostheses have resulted from the nearly 12 years of war and preponderance of IEDs encountered in asymmetrical combat overseas.

By Peter Buxbaum

22 7

Command Profile

Exclusive Interview with Major General Jimmie Keenan, Commander, Southern Regional Medical Command; Chief, U.S. Army Nurse Corps; Director, SAMHS.

Departments

Major General (Dr.) Joseph Caravalho Jr.

12

25

The past few years have seen the development of a range of commercially available airway management devices; however, their optimal placement in the medical setting and role in airway management procedures is not yet fully defined.

By Colonel (Dr.) Alexander S. Niven

The project manager for the U.S. Army’s Medical Information Technology Center Project Management division relates the challenges faced and lessons learned in migrating U.S. Army Medical Command’s end-user devices to the Microsoft Windows 7 operating system.

By Kelly Turner

Controversies in Airway Management

Capturing Information Technology Lessons Learned

Industry Interview

2 Editor’s Perspective 3 People/Program Notes 14 Vital Signs 27 Resource Center

Chris Yerger

President Fort Defiance Industries Inc.

28

16 Commander U.S. Army Medical Research and Materiel Command and Fort Detrick Deputy for Medical Systems to the Assistant Secretary of the Army for ALT

“We understand ongoing budget constraints ... I’ve asked my staff and subordinate commanders to provide me with maximum flexibility to decide how to direct limited resources across the command by defining varying baseline levels of productivity across all of their portfolios.”

—Major General (Dr.) Joseph Caravalho Jr.

EDITOR’S PERSPECTIVE

Military Medical & Veterans Affairs Forum Volume 17, Issue 5 • October 2013

Dedicated to the Military Medical & VA Community Editorial

Editor Chris McCoy chrism@kmimediagroup.com Managing Editor Harrison Donnelly harrisond@kmimediagroup.com Online Editorial Manager Laura McNulty laurad@kmimediagroup.com Copy Editor Sean Carmichael seanc@kmimediagroup.com Correspondents JB Bissell • Peter Buxbaum • Henry Canaday Hank Hogan • Kenya McCullum

Art & Design Art Director Jennifer Owers jennifero@kmimediagroup.com Senior Graphic Designer Jittima Saiwongnuan jittimas@kmimediagroup.com Graphic Designers Scott Morris scottm@kmimediagroup.com Eden Papineau edenp@kmimediagroup.com Amanda Paquette amandak@kmimediagroup.com Kailey Waring kaileyw@kmimediagroup.com

Advertising Account Executive Casandra Jones casandraj@kmimediagroup.com

KMI Media Group Chief Executive Officer Jack Kerrigan jack@kmimediagroup.com Publisher and Chief Financial Officer Constance Kerrigan connik@kmimediagroup.com Executive Vice President David Leaf davidl@kmimediagroup.com Editor-In-Chief Jeff McKaughan jeffm@kmimediagroup.com Controller Gigi Castro gcastro@kmimediagroup.com Trade Show Coordinator Holly Foster hollyf@kmimediagroup.com

Recently my associates at M2VA and I have been regularly traveling to Fort Detrick in Frederick, Md., to cover Vendor Day. Vendor Day is a cooperative venture between the military services logistics agencies based at Fort Detrick.

The military agencies that take part in Vendor Day are the Defense Medical Material Program Office, U.S. Army Medical Material Agency, Naval Medical Logistics Command, Air Force Medical Evaluation Support Activity, Air Force Medical Logistics Office and U.S. Marine Corp Systems Command.

During the Vendor Day events, vendors of medical equipment and Christopher McCoy supplies display their products to all these agencies at the same time.

Editor Vendor Day occurs once a month and the vendors are a diverse group.

There are large multinational companies and many smaller ones as well. There are also old companies that have decades of military medical history and brand-new companies seeking to break into the military and federal market. Due to the spacing limitations on the floor, vendors can only attend one event a year.

Since so many military medical conferences and tradeshows have been canceled over the past year, many contractors, and hopeful potential contractors, are taking advantage of the event to show their wares.

Speaking to some of the organizers, I found that the event is becoming more popular as a result of all the canceled tradeshows and conferences. Over the course of the past year Vendor Day has grown into, as one organizer put it, “a global event.”

Overall, it’s interesting to see how the military medical marketplace is adapting to sequestration and the consequential cancellations of the many military conferences and tradeshows that offer vendors the opportunity to show their technologies to the brass and others involved in procurement.

I would recommend checking out Vendor Day at Fort Detrick to anyone involved in the military medical marketplace. I would also recommend Vendor Day to anyone interested in what modern military medicine has to offer our armed services.

As usual, feel free to contact me with questions or comments for Military Medical & Veterans Affairs Forum.

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PROGRAM NOTES VA Grants Retroactive Benefits for Fully Developed Claims The Department of Veterans Affairs announced on August 1 that veterans filing an original fully developed claim (FDC) for service-connected disability compensation may be entitled to up to one year of retroactive disability benefits. The retroactive benefits, which are in effect August 6, 2013, through August 5, 2015, are a result of a comprehensive legislative package passed by Congress and signed into law by President Obama last year.

“VA strongly encourages veterans to work with veterans service organizations [VSOs] to file FDCs and participate in this initiative, since it means more money in eligible veterans’ pockets simply by providing VA the information it needs up front,” said Allison A. Hickey, Undersecretary for Benefits. “At the same time, it helps reduce the inventory of pending claims by speeding the process.”

Filing an FDC is typically the fastest way for veterans to receive a decision on their claims because FDCs require veterans to provide all supporting evidence in their possession when they submit their claims. Often, this is evidence that VA legally must attempt to collect on the veteran’s behalf, which is already in the veteran’s possession, or is evidence the veteran could easily obtain, like private treatment records.

When veterans submit such evidence with their claims, it significantly reduces the amount of time VA spends gathering evidence from them or other sources–– often the longest part of the claims process. While VA will still make efforts to obtain federal records on the veterans’ behalf, the submittal of non-federal records (and any federal records the veteran may have) with the claim allows VA to issue a decision to the veteran more quickly. Typically, VA processes FDCs in half the time it takes for a traditionally filed claim.

FDCs can be filed digitally through the joint, DoD-VA online portal, eBenefits (www.ebenefits.va.gov). VA encourages veterans who cannot file online to work with an accredited VSO who can file claims digitally on veterans’ behalf. While submitting an FDC provides a faster decision for any compensation or pension claim, only veterans who are submitting their very first compensation claim as an FDC are potentially eligible for up to one year of retroactive disability benefits under the newly implemented law.

FDCs help eliminate VA’s claims backlog because they increase production of claims decisions and decrease waiting times. Also, VA assigns FDCs a higher priority than other claims, which means veterans receive decisions to their claim faster than traditional claims.

VA continues to prioritize other specific categories of claims, including those of seriously wounded, terminally ill, Medal of Honor recipients, former prisoners of war, the homeless and those experiencing extreme financial hardship. As part of its drive to eliminate the claims backlog in 2015, VA also gives a priority to claims more than a year old.

In May, VA announced a new partnership with VSOs and others known as the “community of practice,” an effort that seeks to reduce the compensation claims backlog for veterans by increasing the number of FDCs filed by veterans and their advocates.

VA is continuing to implement several initiatives to meet the department’s goal to eliminate the claims backlog in 2015. In May, VA announced that it was mandating overtime for claims processors in its 56 regional benefits offices to increase production of compensation claims decisions through the end of fiscal year 2013. In April, VA launched an initiative to expedite disability compensation claims decisions for veterans who have a waited a year or longer.

As a result of these initiatives, VA’s total claims inventory remains at lower levels not seen since August 2011. The number of claims in the VA backlog––claims pending over 125 days––has been reduced by 17 percent compared to the highest point in March 2013. www.M2VA-kmi.com

Compiled by KMI Media Group staff

Medical Device Firm Names Exclusive Distributor for Military Market in U.S. 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 U.S. military distributor. Combat Medical Systems will spearhead sales and distribution of iTraumaCare’s iTClamp hemorrhage control system to various branches of the U.S. 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 CEO and Founder Dr. Dennis Filips said, “We selected Combat Medical Systems as our exclusive U.S. military distributor due to their extensive depth of experience and proven track record in working with the U.S. 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 U.S., European Union and Canada.

PEOPLE

Compiled by KMI Media Group staff

Navy Captain Bruce L. Gillingham has been nominated for appointment to the rank of rear admiral (lower half).

Gillingham is currently serving as fleet surgeon to the commander, Fleet Forces Command, Norfolk, Va. Navy Captain Stephen M. Pachuta, who has been selected for promotion to rear admiral (lower half), will be assigned as director, Medical Resources, Plans, and Policy Division, N0931, Office of the Chief of Naval Operations/Chief of the Dental Corps, Washington, D.C. Pachuta is currently serving as executive assistant to the surgeon general of the Navy, Bureau of Medicine and Surgery, Washington, D.C.

M2VA 17.5 | 3

How burn treatment technologies offer a range of options to today ’ s doctors and combat medics .

According to the American Burn Association, more than 700,000 people in the United States are treated for a burn injury each year.

The quality of care during the initial care after a burn injury can have a dramatic and lasting effect on the long-term outcome. This initial “point of injury” burn care is vitally important when you take into consideration how the military is performing its rigorous duties both on the battlefield and back at home.

“Soldiers learn basic combat first aid,” said Dr. Alan Young of the U.S. Army Institute of Surgical Research, chief of Burn Rehabilitation Services and chief of the outpatient burn clinic at Fort Sam Houston, Texas. “Corpsmen are trained to evaluate and triage the severity of the burn, which may be only one component of the injury, stabilize and dress the wound, treat pain, and maintain the patient until the operational environment allows for evacuation.

“Some problems in medicine are routine,” Young said. “Every burn and how each individual responds is unique.”

Pain, infection, breathing problems, scars, loss of function to burned areas, heat intolerance, sensitivity to sun exposure, loss of limbs, nerve injuries and significant psychological issues are common complications of burn injuries. Generally it takes at least one year to resolve all aspects of a major burn.

Young explained that there is also a series of steps to take when administering first aid to a burn. First, one must extinguish or remove the source of the burn and remove any jewelry or constrictive clothes from the burn area unless it tears the burned skin. Then, one should run lukewarm, not cold, water over the area for 10 to 30 minutes. Following that, it is important to elevate the burn area and watch for swelling. A first responder must also keep the patient warm and cover the burn victim with a non-adherent dressing.

Gel-Infused Sterile Burn Dressings Water-Jel Technologies of Carlstadt, N.J., offers a water-based, water-soluble gel called Water-Jel to treat burn injuries. The company’s gel-infused sterile burn dressings and fire blankets have been proven effective in minimizing the debilitating effects of initial burn injuries and have been used by U.S. armed forces over the past 20 years.

“When you consider the military’s role as they perform their rigorous duties both on the battlefield and back at home, Water-Jel’s product lines demonstrate to be an effective patient modality at point of injury burn care, by helping to stop the burning process and beginning the medical treatment of first, second and third degree thermal and electrical burns,” said David P. Dula, National Government Relations Manager, Water-Jel Technologies. “The quality of care during the initial treatment after a burn injury at its point of injury is crucial; because so many of the wounded are in 4 | M2VA 17.5

By Chris McCoy, M2VA Editor

their 20s, they face a lifetime where medical care may be required that is costly, intense and ongoing. Additionally, Water-Jel also has the crucial ability to extinguish and prevent the re-ignition of white phosphorous burns.”

Water-Jel’s burn dressings and fire blankets are sterile and use a medical non-woven carrier that is impregnated with a specially formulated bacteriostatic gel, all inside a foil pouch. The gel consists of 96 percent water, mild thickening agents and preservatives that give the products a five-year shelf life. The gel is thicker than water but not greasy, so it offers cooling pain relief, but does not induce hypothermia. The gel also dissipates heat, covers and protects burns, and helps prevent vital fluid evaporation and infection. Moreover, the gel makes the dressings non-adherent so the dressing carrier and the gel can easily be removed.

More recently, product improvements were made in response to recommendations received from U.S combat medics. “Now all Water-Jel sterile burn dressing products having a national stock number are available in a tactical color, tan foil packaging with easyto-open tabs. Also, these new burn dressings are night vision compatible, lighter in weight, take up less space and are more durable while still being very efficacious,” said Dula. “Water-Jel fire blankets are now also available in tactical color pouches and canisters.”

The company offers a special universal burn dressing that can be employed in various configurations to meet the uncertainties faced by medics during treatment of burn scenarios. First, it can cover a single large burn surface area of 11 by 19 inches. It also can be cut to treat multiple smaller burn surface areas. More importantly, in the treatment of specific facial and hand burns, this dressing has precut holes and flaps that allow medics to quickly apply the dressings and care for these painful and difficult-to-manage burn areas. Due to this design, medics have one universal burn dressing that can used in the

Water-Jel WJ70 Sterile Tactical Burn Dressing is specially designed for hand and face burns and can be used on burns anywhere on the body. [Photo courtesy of Water-Jel]

www.M2VA-kmi.com

delivery of care to any combination of large or small surface areas, facial and hand burns.

“Water-Jel is widely available through the military supply system and other medical supply distributors under several government contracts allowing ease and convenience of procurement, i.e., GSA schedule, electronic catalog, distribution and pricing agreement, and government credit card,” said Paul Slot, vice president of sales at Water-Jel. “Additionally, numerous Water-Jel products have national stock numbers.”

The Navy and the Marines employ Water-Jel products in their shipboard firefighting gear as part of Naval/ Marine Corps aviation gear lists, Fleet Marine Force authorized medical allowance lists and individual first aid kits.

TESTED. PROVEN.

A Special Ingredient Marcy A. Turkos, clinical field Paul Slot manager for Derma Sciences, discussed the Medihoney Wound and pslot@waterjel.com Burn Care dressing product line and its novel ingredient.

Turkos explained that Medihoney products are manufactured with Leptospermum honey harvested from a specific region in New Zealand.

Realized for its beneficial qualities in 1991, the Leptospermum honey used in the full line of Medihoney dressings is controlled against a rigorous set of systems and standards that Marcy A. Turkos demonstrate product consistency from batch to batch. Medihoney products have increasingly found their way into many hospitals today.

“Medihoney Gel, Medihoney Hydrogel Colloidal Sheet [HCS] and Medioney Calcium Alginate dressings have seen recent growth in usage in burn centers in the U.S.,” said Turkos. “Medihoney dressings possess unique qualities that make them ideal for the management of chronic and acute wounds and burns.”

Randomized controlled studies have shown that the dressings are effective on hard-to-heal wounds and burns. The dressings have been used to effectively promote autolytic debridement.

“Medihoney products offer two mechanisms of action that can help clinicians in their wound and burn management. The Medigoney products have a high osmolarity and low pH, which can help create an optimal environment for wound healing,” said Turkos.

Due to their high sugar content, the products have a high osmotic potential. This can help to increase wound fluid at the site of the wound, which helps to support autolytic debridement. The low pH of the product helps to create a less alkaline environment.

Since the products contain a very high percentage of Leptospermum honey, the dressings are able to work in the presence of fluid, blood and tissue, thus promoting an optimal healing environment.

Medihoney Gel contains 80 percent active Leptospermum honey and 20 percent natural gelling agents. The gelling components help to increase the viscosity of the honey, providing greater stability at the burn site. The Medihoney HCS dressings contain 63 percent www.M2VA-kmi.com

WATER-JEL Sterile Burn Dressings and Fire Blankets are easy to use for burns at the initial point of injury, help stop the burning process and are effective on 1st, 2nd and 3rd degree burns.

WATER-JEL provides fast and effective pain relief, helps prevent infection, extinguishes white phosphorus (WP) injuries, won't cause hypothermia and is easy to remove.

Now available in lighter, more durable tactical packaging with NVG compatibility.

Made in the U.S.A. Contact WATER-JEL for more information.

1-800-275-3433 or www.waterjel.com

LEADING THE WORLD IN EMERGENCY BURN CARE

M2VA 17.5 | 5

Leptospermum honey and combine the benefits of Leptospermum honey with a super absorbent polymer technology that allows for increased fluid management and absorption. The honey remains at the site of the wound/burn, while the dressing substrate absorbs exudates and their harmful components that can delay healing.

“Medihoney HCS is also cooling and soothing upon application and non-traumatic upon removal,” said Turkos.

The Medihoney Calcium Alginate dressings offered by Derma Sciences contain 95 percent active Leptospermum honey by weight.

As fluid enters the dressing, an ionic exchange takes place with the sodium ions linking to the alginate, releasing the calcium ions, which allows a controlled and slow release of honey into the wound/burn site. This ionic exchange also allows the alginate dressing to absorb high levels of exudate, forming a gel. Due to patent protection on these dressings, there are no other products with these Mark Gorman technologies available on the market.

Native Collagen Human BioSciences Inc. (HBS) manufactures the burn care product SkinTemp II. These dressings contain 100 percent native

Presents a training summit:

December 9-12, 2013 San Diego, CA

Enhancing and Innovating Care for a New Generation of Wounded Warriors Featuring presentations from distinguished military healthcare professionals including: Dr. Alice B. Aiken Director Canadian Institute for Military and Veteran Health Research Andrea L. Behrman, PhD, PT, FAPTA Professor, Department of Neurological Surgery, Director, Pediatric NeuroRecovery Program Kentucky Spinal Cord Injury Research Center, University of Louisville, Louisville, KY CDR Steve Hanling Navy Pain Management Specialty Leader Naval Medical Center San Diego

Eric Harness Co-Founder/Director of Research and Development Project Walk Spinal Cord Injury Recovery Center Jacqueline Warmuth Vice President of Clinical Development Sitrin Health Care Center Scott Hornbeak, MBA, CPO, FAAOP Program Director, CSUDH O&P Program VA/CSUDH Center for Orthotics and Prosthetics

Santyl Ointment is a selective enzymatic agent indicated for debriding chronic dermal ulcers and severely burned areas. [Photo courtesy of Healthpoint Biotherapeutics]

collagen, in the non-hydrolyzed form. The product is designed to keep the collagen intact so that the bandages comprise a fibrous network.

“Our proprietary manufacturing process maintains the chemical and structural integrity of the original bovine collagen, which is a triple helical structure,” said Mark Gorman, director of Business Development at HBS. “Kollagen technology makes collagen selfaggregating. Hence, the molecules naturally interact together to bond and build a framework. This aggregation occurs naturally with Kollagen technology as a natural function of the molecule.”

SkinTemp II dressings are indicated for the management of first and second degree burns, blisters, sores, scrapes and cuts, ulcers and other wounds.

HBS currently produces and sells SkinTemp II and Medifil II collagen particles, produced in a U.S. FDA-compliant and ISO 13485-certified production facility in Gaithersburg, Md. HBS collagen products are used for treatment throughout the U.S. in VA hospitals, VA medical centers, VA pharmacies, Indian Health Services, wound care centers, burn centers, longterm care facilities, civilian hospitals, private physician offices and internationally.

Selective Enzymatic Debriding Healthpoint Biotherapeutics’ Santyl Ointment is a prescription biologic approved by the FDA to treat chronic dermal ulcers and severely burned areas. The product is a selective enzymatic debriding agent that provides continuous, bioactive removal of necrotic collagen without harming granulation tissue.

“Ongoing, active removal of necrotic debris at the cellular level may help wounds progress from the inflammatory phase to the proliferative phase of healing,” said Collin Hadley, director of product marketing for Santyl. “By breaking the cycle of inflammation which traps many chronic wounds, Santyl Ointment contributes to the formation of granulation tissue and subsequent epithelialization.”

Currently Santyl Ointment is the only enzymatic debriding agent approved by the FDA and Healthpoint has contracts with VA facilities throughout the U.S. Ultimately, the modern military combat medic has many more tools at his or her disposal than in years past. New products and breakthroughs in burn care are leaving combat medics with more options to treat hard to manage burns. Moreover, these same products and breakthroughs are leaving burn care patients with a brighter prognosis and less painful treatment and recovery process. O

EARN 20+ CME CREDITS! www.MilitaryHealthcareConference.com 6 | M2VA 17.5

For more information, contact M2VA Editor Chris McCoy at chrism@kmimediagroup.com or search our online archives for related stories at www.m2va-kmi.com.

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Command Profile

Pioneering A New System

The first San Antonio enhanced multi-service market manager takes the helm at MHS. Major General Jimmie Keenan Commander, Southern Regional Medical Command Chief, U.S. Army Nurse Corps Director, SAMHS Major General Keenan entered the Army as a Nurse Corps officer in July 1986, commissioned through ROTC at Henderson State University.

She has enjoyed a variety of assignments as a staff nurse Oncology/Hematology, Dwight D. Eisenhower Army Medical Center, Fort Gordon, Ga.; charge nurse, Emergency Department, Dwight D. Eisenhower Army Medical Center, Fort Gordon; nurse counselor, 2nd Recruiting Brigade, U.S. Recruiting Command, Fort Gillem, Ga.; AMEDD Officer Basic Course Nurse Advisor, AMEDD Center and School, Fort Sam Houston, Texas; chief nurse, A Co, 168th Medical Battalion (AS), Camp Red Cloud, Korea; head nurse, Emergency Treatment Section, 21st Combat Support Hospital, Fort Hood, Texas; nurse methods analyst, Carl R. Darnall Army Community Hospital, Fort Hood; chief nurse, Department of Outlying Health Clinics, 67th Combat Support Hospital, Wuerzburg, Germany; chief nurse/executive officer, 67th Combat Support Hospital (Forward), Camp Bondsteel, Kosovo; Army Congressional fellow, Senator Kay Bailey Hutchison, (R-Texas), Washington, D.C.; chief, Congressional Liaison Office, Office of the Army Surgeon General; and garrison commander, Camp Bullis, Texas. Keenan served as the deputy commander for Nursing, Dewitt Army Community Hospital, Fort Belvoir, Va., and as the chief of staff, U.S. Army Warrior Transition Command at the Pentagon until May 2009. Following that assignment, she was commander, Evans Army Community Hospital, Fort Carson, Colo. Her last assignment, prior to assuming command of the U.S. Army Southern Regional Medical Command, was commanding general, U.S. Army Public Health Command, Aberdeen Proving Ground, Md. Keenan is also the director of the San Antonio Military Health System.

Keenan is a Distinguished Military Graduate from Henderson State University with a Baccalaureate of Nursing. She also holds a Master of Science in nursing administration from the Medical College of Georgia and a Master’s in Strategic Studies from the U.S. Army War College. Her military education includes the Army Medical Department Officer Basic and Advance Courses, the U.S. Army Command and General Staff College and the U.S. Army War College.

Her awards and decorations include the Legion of Merit, the Meritorious Service Medal with four Oak Leaf Clusters, the Army Commendation Medal with Four Oak Leaf Clusters and the Army Achievement Medal. She has earned the Expert Field Medical Badge, the Parachutist Badge, the Air Assault Badge, and the Army Staff Identification Badge. Keenan was the General Douglas MacArthur Leadership Award winner for the Health Services Command in 1988, a Regional Finalist, White House Fellowship Program in 1992 and an Army Congressional Fellow for fiscal year 2001. She is a member of the Order of Military Medical Merit and a Fellow in the American College of Healthcare Executives. www.M2VA-kmi.com

Q: Can you explain to us what the eMSM is, and what your goals and plans with respect to this increased responsibility are?

A: Earlier this year, the deputy secretary of defense directed the establishment of a Defense Health Agency to assume shared functions, services and activities of the Military Health System [MHS], and I have been given the great privilege and responsibility of being the first market manager of the San Antonio Enhanced Multi-Service Market.

The San Antonio MHS was a Multiservice Market. Effective October 1, SAMHS received enhanced authorities and is now an eMSM. With respect to my duties as the commanding general of the Southern Regional Medical Command and the eMSM market manager, I plan to continue to focus on the health of our servicemembers and their beneficiaries as DoD works through sequestration. One of the biggest problems in U.S. health care today is the amount of money wasted. The Institute of Medicine estimates that $750 billion is wasted annually on health care, which is 30 cents of every dollar. Money is lost in areas such as unnecessary services, disproportionate administrative services, inefficient delivery and in prevention failure. My goal is to reduce that 30 percent loss as much as possible while still delivering high-quality care to ‘America’s sons and daughters.’

Some of the goals of the Affordable Care Act of 2010 most important to Army Medicine and military health care overall are to treat patients in integrated health systems and to develop a national quality improvement strategy: improve health care delivery services, patient health outcomes and population health. This correlates with MHS’s three goals: experience of care, population health and per capita cost.

As the market manager, I will have direct authority to create and sustain a high-quality health system; manage the allocation of the budget for the market; direct the adoption of common clinical and business functions; optimize readiness to deploy medically ready forces; and direct the movement of workload and workforce among market military treatment facilities. My authority and responsibilities as the market manager include: optimizing the enhanced multi-service market in support of readiness; executing a five-year performance plan; allocating and managing the enhanced multi-service market budget; implementing best practices and managing cost containment. These enhanced markets will be provided additional authorities to assist in managing the entire market regardless of service affiliation.

Currently, the San Antonio market is unique to MHS, as our private sector costs are less than our direct care costs. Compared to other areas, more of our beneficiaries have chosen to use military treatments facilities, as opposed to getting their care from non-military medical providers. I want to continue that trend as it demonstrates that military medicine is fully capable of providing cost-effective care.

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Command Profile The San Antonio eMSM will drive efficiencies and optimization of the direct care system and use of the purchased care network by providing improved health care services, supporting graduate medical education and training, and supporting basic/clinical biomedical research. All of these work to support sustaining readiness skills.

Q: Twelve years of war have been tough on soldiers. What are your military treatment facilities doing to help them cope?

A: One of the programs that the Southern Region has implemented to assist soldiers is called intensive outpatient programs. There are currently nine intensive outpatient programs that have been put into operation by military treatment facilities to help soldiers deal with a myriad of issues ranging from PTSD, depression, anxiety, insomnia, substance use disorders, traumatic brain injury [TBI], stress and pain.

Across the Southern Region, these programs range in duration from two to eight weeks. [There is] also a spectrum of care, whether they are partial hospitalization programs or traditional outpatient therapy, which excludes 24-hour programs that operate over the weekend. Fort Gordon has also implemented a residential treatment facility, which is a 24-hour, live-in setting specifically targeting addiction treatment. The residential treatment facility also provides treatment for dual diagnosis for detoxification and psychiatric services.

In 2008, the Warrior Resiliency Program was implemented to build and restore resiliency among warriors and their families. Additionally, the Warrior Resiliency Program provides clinical care via tele-medicine to soldiers across the region to enhance access to care, provide quality care, reduce referrals to the purchased care network, and improve cost effectiveness of behavioral health services within the region, through the coordinated and efficient use of an integrated tele-behavioral health system. Tele-behavioral health creates access to care and enhances readiness by surging specialty providers virtually to geographic areas with a shortage of resources.

We have also implemented embedded behavioral health; child and family assistance centers; school behavioral health; internal behavioral health consultants in primary care; behavioral health case management in primary care, known as RESPECT-MIL; marriage and family therapy; behavioral health services, which include psychiatry, psychology and social work; and the Behavioral Health Data Portal in all active duty servicemember behavioral health clinics.

The Southern Region has also established TBI clinics to offer comprehensive treatment programs to promptly identify and treat soldiers suffering from invisible wounds such as concussion/mild TBI, post-traumatic stress, and other related co-morbid conditions associated with deployment and non-deployment injuries. Our clinics are staffed with a robust specialty trained multidisciplinary team consisting of medicine, behavioral health and rehabilitation clinicians. TBI staff use evidence-based strategies in a holistic approach to help soldiers address, cope [with] and recover from symptoms of chronic headaches and musculoskeletal pain, sleep deficits, speech and cognitive dysfunction, and vestibular and dizziness complaints. Additionally, we provide various psychosocial programs to assist soldiers and family members work through behavioral health stressors.

The Southern Region’s military treatment facilities provide soldiers care from the point of injury, whether evacuated from theater or garrison, to the time they return to duty or transition from active 8 | M2VA 17.5

duty, thus maximizing their function and quality of life. Moreover, the region has two of six Army military treatment facilities to receive an Intrepid Fallen Hero Fund proffer to build a National Intrepid Center of Excellence Satellite treatment facility. We are leveraging existing TBI, behavioral health and pain management augmentation team staff and introducing complementary alternative medicine modalities, such as acupuncture, yoga, massage therapy and art therapy, to enhance the exceptional TBI-care provided to our beneficiaries.

Military treatment facility staff implemented the Army’s concussion/mild-TBI management strategy ‘educate, train, treat and track’ lines of efforts to increase TBI awareness for all soldiers and medical personnel assigned to our installations through annual and pre-deployment training. Clinics host numerous brain injury awareness activities and support the 2012 Army and National Football League initiative to promote prevention and decrease stigma of seeking care through installation and local community outreach programs.

In many cases, chronic pain is one of our patients’ greatest hurdles.

Part of our comprehensive pain management campaign plan includes reintroducing nontraditional forms of pain management, such as acupuncture, massage therapy and biofeedback, into the spectrum of care for these patients. We have developed and implemented specialized pain management augmentation teams at several military treatment facilities to help move this campaign forward. We have much more work to do in this area, but these efforts are already making real differences in the lives of our soldiers.

The Army comprehensive pain management campaign plan offers integrated pain management services that are consultative and collaborative for acute, chronic and cancer pain. Treatment is holistic, multidisciplinary and multimodal in its approach for a consistent patient and provider experience. The common objectives are to minimize pain and suffering while maintaining focus on maximizing function, quality of life and wellness. The comprehensive pain management campaign plan is implemented in a tiered model, designed for a network of clinical services, referral, and/or consultative support, as well as pain education and training for patients, families and patient centered medical home [PCMH] personnel. There are two primary clinical components of the comprehensive pain management campaign plan to support the PCMH, the pain management augmentation team and the interdisciplinary pain management clinic.

The pain management augmentation team serves as the PCMH primary point of contact for pain management education, training and practice standards for staff, patients and their families. These teams are supported by designated interdisciplinary pain management centers, and serve as conduit/facilitator of information and support between local PCMH and designated pain management clinics.

The interdisciplinary pain management clinics serve as the hub for Army Medicine’s pain management synchronization, and support designated military treatment facilities and pain management augmentation teams within their regional medical command. Interdisciplinary pain management clinics provide pain management specialty referral and consultation services, patient and provider education, and coordination of research initiatives. The interdisciplinary pain management clinics work collaboratively as part of an interdisciplinary team to evaluate and treat patients using a multimodal pain management treatment plan that may incorporate integrative treatment modalities, such as acupuncture, bio-feedback, yoga and medical massage. www.M2VA-kmi.com

Q: Could you explain to our readers the role played by embedded behavioral health teams?

A: Before I discuss the embedded behavioral health teams, I want to make sure everyone knows a very important telephone number: The Military and Veterans Crisis Line, 1-800-273-8255. I cannot stress enough how important it is to prevent suicide, and providing the best behavioral health services is very important to me.

The embedded behavioral health team initiative is among several actions by the U.S. Army Medical Command to improve soldier access to behavioral health care, and provide more direct support to unit commanders for addressing soldier behavioral health issues. These teams are being established at several installations across the Army, and are comprised of 13-member teams of providers and support staff that are attached to brigade combat teams and operate small clinics within the brigade’s footprint. The teams are multi-disciplinary, including psychiatrists, social workers, psychologists and psychiatric nurses, to allow a wide range of behavioral health services. The embedded behavioral health teams assign a behavioral health provider to each battalion within a brigade so that the team can become well integrated in brigade operations, and provide a highly accessible consultant to each battalion and subordinate company command cadres.

The embedded behavioral health model is an early intervention and treatment model that promotes soldier readiness throughout the entire Army force generation cycle. The program has made it easier and more convenient for soldiers to seek help. The teams work with the units to proactively identify and manage behavioral health risks before they become a serious problem. This approach to care maximizes diagnostic accuracy, removes barriers to care, reduces stigma, and improves treatment outcomes largely due to patient trust and consistency in care.

Barriers are removed because brigade and battalion commanders are supportive of embedded behavioral health and word gets around that the team knows what they are doing. Embedded behavioral health teams have demonstrated positive impact on specific behavioral health targets such as reduced psychiatric hospitalizations and reduced incidence of suicide behaviors. We currently have embedded behavioral health teams at Fort Campbell, Fort Hood, Fort Stewart, Fort Polk and Fort Benning.

Q: What measures is the Army taking to promote better health within the life space?

A: Army Medicine is responding to the challenge by empowering our best talent and creativity to leverage health as an enabler for optimal soldier performance and resiliency. We are harnessing technology, research and innovation to increase the number of opportunities to influence healthy choices and enhance soldier performance. Initiatives will create a solid foundation for comprehensive, standardized and sustainable efforts that promote healthy behaviors and environments for soldiers and the military family.

To this end, Army Medicine has developed the performance triad.

The performance triad pilot program supports the Army’s Ready and Resilient campaign, and began this September at three U.S. Army Forces Command units located at Fort Bragg, Fort Bliss and Joint Base Lewis McChord. The intention is to motivate individuals and www.M2VA-kmi.com

M2VA  17.5 | 9

Command Profile units to reach their peak performance, readiness and health through good habits of activity, nutrition and sleep. There is substantial scientific evidence to support sleep, activity and nutrition as a means to better health and performance. These three areas directly impact our patients’ lives, regardless of their current health status. The pilot program will use a tiered prevention strategy to ensure the Army family receives the education and/or services to help them maintain, improve or restore health.

The first opportunity is to maintain health. This describes the efforts that go on across Army Medicine every day that help our soldiers and their families. Some of maintaining health happens in deployed units, laboratories and research facilities, teaching facilities, medical and dental treatment facilities, and garrisons around the world. More commonly, however, maintaining health occurs in the personal life space of our soldiers and families.

The second opportunity is to restore health. This guides our deliberate and disciplined approach, once illness or injury occurs. This is where we actively intervene and treat patients, and includes medical and dental therapies and public health interventions. It’s also research and teaching modern techniques and materials that speed restoration of health and return quality of life.

The third opportunity is to improve health, which describes our efforts throughout Army Medicine to turn the ‘health dial’ of our patients to the right. To help soldiers and their families become better, healthier and stronger—physically, psychologically and spiritually.

Q: What advantages will the new Wilford Hall Ambulatory Surgical Center offer?

A: San Antonio is among the 10 largest cities in the nation. Driving from neighborhoods near Sea World to Brooke Army Medical Center can take an hour in heavy traffic. Wilford Hall Ambulatory Surgical Center ensures that the geographic footprint of clinical services for a significant number of our active duty airmen, soldiers, family members and retirees who reside and work in southwest San Antonio remains readily accessible. The current structure formerly housed Wilford Hall Medical Center, which is not the most efficient building to use for ambulatory surgical procedures.

Designed and outfitted with the latest technologies, the new facility will provide a replacement for the aging infrastructure of existing buildings that will be more efficient to operate and maintain. It will contain four operating rooms and one procedure room. The facility is being constructed in three phases. A fourth phase will be executed in fiscal year 2016, which includes demolition of the existing Wilford Hall structure.

The first phase includes a 1,000-space, three-story parking structure, a new central energy plant and the first wing of the new facility.

The parking structure is already complete. The entire phase is nearly complete and the project team is performing final commissioning. This phase also includes family health, cardiology, and TRICARE operations and patient administration. Phase two includes two more wings to the new facility and is currently 73 percent complete. This phase includes operating rooms, internal medicine, mental health, ophthalmology, physical therapy, radiology, lab and pharmacy.

Phase three includes the construction of the remaining areas and is currently 35 percent complete. This phase includes specialty 10 | M2VA 17.5

clinics, medical logistics and administrative areas. Occupancy of the new facility is expected to occur in summer 2015. The new facility will be roughly half the size of the existing structure, and will be Leadership in Energy & Environmental Design Silver certified. All health care services will continue to be provided at the existing facility until the new structure is fully furnished in 2015.

Q: Can you discuss what pharmacy innovations have been implemented to better serve your beneficiaries?

A: We are working on many initiatives to serve our patients more efficiently. One new program is Army Medicine’s secure messaging service.

For the first time, patients will be able to communicate directly with their provider and care team. For example, patients can use this system to let their provider know they need to renew their prescription. To register for online services, beneficiaries should visit with their health care team administrator or call their primary care clinic for more details. By the end of 2014, our goal is to offer this service to 100 percent of our beneficiaries in the direct care system.

TRICARE Pharmacy Home Delivery is your least expensive option when not using a military treatment facility pharmacy. There is no cost for TRICARE Pharmacy Home Delivery for active duty servicemembers. For all other beneficiaries, there is no cost to receive up to a 90-day supply of generic medications. For more information, the website is www.tricare.mil/homedelivery, or call 1-877-363-1303.

I also encourage all our beneficiaries to register for TRICARE online at www.tricareonline.com. TRICARE beneficiaries who receive care at a military treatment facility can access appointments and refill prescriptions online.

Automation has been a key innovation in pharmacy services. Pharmacy departments have incorporated automation and workflow solutions to improve the efficiency and safety in delivering the pharmacy benefit. Additionally, we use radio frequency identification, known as RFID, to store refills and use this in addition to other technologies to improve service excellence efforts. A computer web-based software system enables pharmacy staff to collect more data on such important issues like wait times, possible deviation of prescription levels and effective monitoring for the number of needed staff members. It also tracks the increased number of people waiting to get their prescriptions and allows us to track patient times, and in the near future will allow us to notify them when their prescriptions are ready via text messaging.

Increased interactions with patients through discharge counseling, medication review and medication management mark some of the most valuable improvements in terms of improving patient care and outcomes. Having an emergency department and Wounded Warrior pharmacy right off the emergency room is a best practice as noted by The Joint Commission. Again, it provides patients direct access to pharmacists who are experts in these areas. Our military treatment facilities have robust clinical pharmacy staffs that work directly with patient and providers to ensure medication management is optimized.

Q: How would you define the operating company model for Army Medicine as it pertains to Southern Regional Medical Command?

A: When operating company model concepts were introduced to Army Medicine, Southern Regional Medical Command was already leaning www.M2VA-kmi.com

Compiled by KMI Media Group staff

forward with initiatives that put us well down the path to having a robust operating company model approach to command management.

The model is well suited to the region since we are responsible for a large, complex system of health where we collaborate with our military treatment facilities while providing solid, central guidance and control for medical planning and execution, as well as providing well-developed management tools for the military treatment facilities.

One example is our core business operating metrics dashboard.

The dashboard pulls together 22 critical metrics that are borrowed from both the Army Medicine Business Bowl, a competition which tests readiness, quality, access to care, and financial management and the balanced score card. It provides the military treatment facility command sections with a single indexed ranking of their overall performance based on a composite of these 22 metrics. This allows them a ‘manage by exception’ opportunity to focus their attention to areas where they are most needed. They do not have to go to dozens of other tools and sites to gather this data themselves and it gives them a monthly snapshot of how they are doing compared to the other military treatment facilities across the command.

The Army’s medical logistics enterprise provides a good example of the operating company model. Across the Army and DoD, medical logistics utilizes the same prime vendor contracts, business processes and information management systems. Key stakeholders in medical logistics formed a council that synchronize strategic goals across the enterprise and provide a centralized steering committee for logistics information systems.

The vision for medical logistics is to expand the enterprise architecture information system that allows for greater centralization of management functions and greater standardization of materiel and processes. The vision is consistent with the operating company model and with the emerging best practices in the commercial industry. The Southern Region’s logistics staff actively participates in the Army medical logistics enterprise through a collaborative system of data collection and performance metrics, and through numerous workgroups that continue to develop enterprisewide business processes. The enterprise approach in medical logistics not only promotes standardized business processes, but encourages feedback and transparency from the experts in the region back to Army and DoD policy development.

Q: If you could solve any three medical ailments, commonly faced by those in the services, what would they be?

A: I'm glad you didn’t use the term cure, because many of the Army’s most significant problems really do need to be thought of in terms of prevention or solutions, rather than cures. From the perspective of health and well-being, our active duty population is relatively young and active, and faces risks associated with that demographic. More servicemembers received medical care for injuries than any other morbidity-related category in 2011. So injury prevention has to be very high on the list.

A related condition that accounts for significant lost duty time and a high volume of medical encounters is back pain. Many people may not consider musculoskeletal disorders such as back pain to be a medical ailment, but the impact on our soldiers and the medical resources dedicated to treating these disorders is significant. Also very high on the list would be substance abuse disorders. The impact of these preventable www.M2VA-kmi.com

and treatable problems on our fighting force and our families can be devastating and can even end the careers of good soldiers.

If I could add a fourth, for its impact on our readiness as a fighting force, I would add obesity. Clearly, this is having an impact on all aspects of health care across the nation, as well as in the military population. And it creates so many other health issues. All of these are too common. And the important thing to keep in mind is that prevention is far better than treating the after effects.

Q: Can you explain the difference between the MHS and the move to a system for health?

A: Current health systems are more focused on treating conditions once they present themselves. A system for health sets the focus clearly on prevention of injury and disease by becoming involved in the everyday life space of our beneficiaries. A health care provider only has very limited contact with patients throughout the average year and community involvement is the only way to influence the life space. A system for health encourages community involvement to as a way to improve the health of our beneficiaries.

The PCMH is the center of gravity of U.S. Army Medical Command’s transformation from a health care system to a system for health. The PCMH embodies the operating company business methodology, which is one that provides consistency, clarity, accountability of services and value. The PCMH is designed around one core principle: putting patients first. PCMH is Army Medicine’s gateway to influence the life space where beneficiaries make decisions on the key determinants of health and wellness––activity, nutrition and sleep.

The PCMH is defined by the ability to provide comprehensive primary care, promote wellness through active patients, and seamlessly coordinated care within the ‘medical neighborhood’ to achieve optimal health for our beneficiaries. It is a multidisciplinary approach to deliver evidence-based, comprehensive primary care, coordinating care delivered outside of the primary care setting and proactively engaging patients as partners in health.

Moving patient care closer to the communities where our soldiers and our families live and work, as is occurring in our patient-centered and soldier-centered medical homes, represents a major step we have taken to provide medical expertise where it can have an impact early, and provide the support that they need both for convalescence and to improve the quality of their lives. This is part of the process of changing our health care system into a system for health. A key benefit of maintaining a more healthy force and healthier beneficiaries is better utilization of resources that will help us absorb the effects of reduced DoD funding.

Q: Is there anything else that you would like to add that we haven’t discussed?

A: Military treatment facilities are a strategic asset; they provide far more than just health care to servicemembers and eligible beneficiaries. The military treatment facilities provide unique military requirements for soldier readiness. They are the generating force for medical personnel. They provide direct logistics and administrative support to deploying and deployed units and provide capabilities for contingency operations. O M2VA 17.5 | 11

Controversies in Airway Management Has technology changed the approach and training requirements to trauma airway management ?

Airway compromise remains a small but significant cause of preventable death in military casualties, based on recent analysis from the Joint Theater Trauma Registry, and effective airway management continues to be vital in the successful resuscitation and management of seriously injured casualties. Despite extensive training of medical personnel involved in tactical evacuation from the battlefield and ongoing care in Level 2 and 3 facilities, operational conditions and patterns of injury can make the lifesaving procedure of intubation challenging to successfully perform.

In a recent large retrospective review of the Israeli Defense Forces Trauma Registry, for example, only 45 percent of first intubation attempts were successful and 22 percent of patients required either a surgical airway or had further airway management efforts discontinued due to difficulty.

Is Better Technology the Answer?

Current tactical combat casualty care guidelines and the Joint Theater Trauma System clinical practice guidelines on trauma airway management still feature endotracheal intubation and rapid sequence induction as a primary approach to airway management. Recent years have seen the development of a wide array of commercially available indirect optical devices and videolaryngoscopes, all with varying characteristics and technical considerations for use. These devices have gained significant popularity despite limited data supporting their utility over traditional direct laryngoscopy. Videolaryngoscopes typically provide a better view of the glottis than direct laryngoscopy, but current literature suggests that these tools offer little advantage in the average patient without difficult airway risk factors [See Table 1]. Because these tools provide only indirect glottic visualization and do not always require alignment of patient upper airway axes, time to intubation in some studies has actually been increased using videolaryngoscopy due to difficulties appropriately directing the endotracheal tube.

In contrast, high rates of intubation success have been shown in small studies including patients with risk factors for difficult airways or following failed direct laryngoscopy attempts using the McGrath Series 5, C-MAC and Glidescope videolaryngoscopes. This advantage does not appear to be uniform across all indirect optical devices; the Airtraq optical laryngoscope, for example, has performed less favorably in difficult airway management in the prehospital setting.

Although expert opinion strongly supports these limited data that videolaryngoscopy offers significant advantages in the management of 12 | M2VA 17.5

By Colonel (Dr.) Alexander S. Niven

difficult and failed airways, considerable controversy remains regarding in which clinical situations and practice settings they can be best utilized. Comparative data examining the performance characteristics of different devices, their utility and appropriate placement within the military evacuation chain are also very limited at this time.

Improving Airway Management Training If advanced technology does not provide a universal solution to maximize intubation success, perhaps better training is the secret to improvements in provider performance. Currently, formal training on airway anatomy and management is integrated into medical and deployment training for medical personnel ranging from combat medics to deploying providers, including hands-on simulation-based experience with direct laryngoscopy and endotracheal intubation in the latter group.

Airway management in emergency situations is associated with significant increases in difficulty and risk, and several recent large studies of consecutive emergency intubations at single civilian institutions have credited their low complication rates to the early involvement of an experienced airway manager. Given the risk associated with unsuccessful airway management, many experts advocate training and proficiency in a relatively comprehensive set of skills for “basic competence� in airway management [see Table 2].

Unfortunately, evidence to support specific training strategies is frustratingly limited. In one small but well-designed study, 20 novice airway managers received formal airway instruction followed by simulation-based practice performing 20 intubations using airway task trainers. Following this training, they performed sequential endotracheal intubations in the operating room under the direct supervision of an experienced anesthesiologist, who evaluated their performance with the aid of a standardized checklist. The authors demonstrated that the probability of a good intubation reached the 90 percent threshold after approximately 50 intubations.

Using a videolaryngoscope to assist in initial airway instruction may accelerate progression to competence based on other small studies, likely because this tool provides learners with better visualization and subsequent understanding of anatomic structures involved in the procedure.

Incorporating simulation-based training clearly improves learner satisfaction and confidence with airway management skills, but has not been clearly associated with more rapid psychomotor proficiency in these procedures even when human cadavers have been employed. www.M2VA-kmi.com

On the other hand, there is growing evidence supporting the use of a simulated clinical environment to build teamwork skills and gain experience with a systematic approach to patient and equipment preparation using realistic clinical scenarios. Careful preparation—including airway assessment, preoxygenation and a preplanned management strategy—is recommended by the American Society of Anesthesiologists to maximize intubation success, and several intensive care unit studies have shown that implementation of a standardized “intubation bundle” significantly reduced the rate of complications and the need for emergent surgical airways. A carefully designed iterative performance improvement program in airway management at a New York hospital also demonstrated that a combined team approach that included intensive simulation-based airway skills for physicians, crew resource management training, use of a mandatory checklist during each intubation, and post-event debriefing to significantly improved the safety of airway management in that facility.

Rethinking Common Approaches to Airway Management Repeated intubation attempts place patients at risk for prolonged hypoxemia, the primary cause of many serious complications of airway management. Extraglottic airways (EGAs, such as the Laryngeal Mask Airway and King tube) can be placed in the upper airway to re-establish adequate oxygenation and ventilation without significant technical expertise in many cases, and some experts have advocated early use of these devices in situations when an initial intubation attempt with direct laryngoscopy is unsuccessful. A large prospective study using this approach in over 12,000 patients demonstrated no adverse outcomes and a very low incidence of hypoxemia.

EGAs clearly play an important role when bag-mask ventilation is inadequate, initial intubation attempts are unsuccessful, or medical personnel lack adequate skill to perform definitive endotracheal intubation. In a systematic review, no differences in patient outcome were found in 1,559 patients managed with either endotracheal intubation or alternative airway techniques (bag-mask ventilation or EGA) in a series of heterogeneous trials. Based on extensive favorable experience with these devices within the military trauma system and the growing prominence of these devices in published airway management algorithms, EGAs are now featured prominently as an airway management option in the tactical combat casualty care guidelines.

There are a number of current EGAs that also provide the option of one-step intubation through the device (Ambu Aura-i, CookGas LLC Air-Q/ILA, LMA Fastrach and Classic Excel, i-Gel). These devices may provide significant benefit in patients following failed direct laryngoscopy or even as a primary approach in patients with a predicted difficult airway, and are frequently available at level 3 facilities.

Surgical cricothyroidotomy is also prominently featured in deployment guidelines and included in medical and pre-deployment training of military medics and providers. This procedure is recommended in casualties who cannot maintain a patent airway during initial tactical field care or with more definitive airway interventions as the patient is moved through the military medical evacuation chain. Outside of the deployed military environment it is an uncommon procedure generally reserved for the emergency airway situation when an extraglottic airway cannot be effectively employed due to upper airway abnormalities, blood, or secretions that obviate proper placement and function. It is also an important early rescue strategy in the setting of the failed airway when definitive endotracheal intubation www.M2VA-kmi.com

Table 1: Risk factors associated with a difficult airway

»» Previous noted difficulties »» Male, age 40–59, obesity »» Diabetes, obstructive sleep apnea »» Upper airway trauma, swelling, or infection »» Large tongue, receding jaw, high arched palate, prominent upper incisors »» Short thick neck, large breasts, fixed or ‘high’ larynx »» Small mouth opening, significant jaw protrusion »» Reduced head/neck mobility Table 2: Recommended Skills for “Basic” Airway Management

»» Face mask ventilation, airway positioning »» Extraglottic airways (including intubating laryngeal mask airway) »» Oral endotracheal intubation (direct laryngoscopy) »» Simple maneuvers to improve glottis visualization »» Use of stylet, gum elastic bougie »» Rapid sequence induction »» Fiberoptic intubation via conduit (oropharyngeal airway, laryngeal mask airway) »» Percutaneous cricothyrotomy cannot be established, especially when ventilation and oxygenation are inadequate. Cricothyroidotomy can be performed most rapidly using a rapid four step technique (RFST), and a modified RFST performed by inserting a bougie through the neck incision and into the trachea to serve as a guide for a standard endotracheal tube has also been shown to be very successful in the hands of the novice non-surgeon. Although invasive, it can be an important and rapid lifesaving measure when used early to prevent prolonged hypoxemia and its complications.

Conclusions Although recent years have seen the development of a wide array of commercially available airway devices, their optimal placement in the medical environment and role in airway management procedures continue to be actively defined. Recent literature underlines the importance of a systematic approach and teamwork to the success of this high-risk procedure, and training should clearly emphasize these areas in addition to the acquisition of procedure skills.

Use of videolaryngoscopy may accelerate progression to proficiency during airway training, and although this technique provides better glottic visualization its early use in airway management protocols remains an area of active investigation. Maintaining oxygenation is even more important than definitive intubation to the avoid life-threatening complications of airway compromise, and the increased emphasis of early EGA use in current military trauma guidelines underline their ability to reduce the risk of prolonged hypoxemia in difficult airway situations and in the hands of providers with a wide variety of airway management skills. O Colonel (Dr.) Alexander S. Niven is an associate professor of medicine at the Uniformed Services University of the Health Sciences and program director, Internal Medicine Residency at Madigan Army Medical Center.

The views expressed in this review are those of the author and do not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. government.

For more information, contact M2VA Editor Chris McCoy at chrism@kmimediagroup.com or search our online archives for related stories at www.m2va-kmi.com.

M2VA 17.5 | 13

VITAL SIGNS Innovative 8.4-inch Medical-Grade LCD Monitor Tru-Vu Monitors, a supplier of medical, industrial and commercial LCD monitors, has announced the release of a new medical-grade 8.4-inch LCD monitor.

The new MM-8.4S complies with UL 60601-1, enabling it to be used in surgical operating rooms, and in close proximity to patients.

The monitor’s medical display features VGA, S-Video and composite video inputs; 800-by-600 resolution; a 4:3 aspect ratio

screen; 450 nits brightness and more in a rugged, white and powder-coated steel enclosure. It is designed to operate 24/7 and is backed by a full three-year warranty.

The MM-8.4S is built for use in a wide range of medical applications, including operating rooms, diagnostic systems, patient monitoring, mobile carts, endoscopy, remote monitoring and more.

Non-Invasive Intracranial Pressure Monitor Award The National Science Foundation (NSF) has awarded Third Eye Diagnostics Inc. $500,000 to advance development of the CerePress, a non-invasive, handheld intracranial pressure (ICP) monitor. The monitor is targeted for use in combat theaters, hospital ERs, medical transport vehicles and sports events for the rapid diagnosis of brain injury.

ICP monitoring is critical for early diagnosis, earlier intervention and improved outcomes in patients with brain injury, e.g., concussion, traumatic brain injury, stroke, hydrocephalus and other neurological disorders. The phase II grant will enable the company to further develop the technology and prepare it for commercialization.

In 2010 the NSF awarded the company an SBIR phase I grant to develop and perform early trials of a prototype CerePress system. “The successful phase I prototype demonstrated the ability to rapidly and non-invasively measure central retinal

venous pressure and correlate it to ICP,” said Anthony Bellezza, Ph.D., chief operating officer of Third Eye Diagnostics and the grant principal investigator. “Independent clinical trials of the CerePress technology against invasive measures demonstrate an excellent correlation.”

According to Terry A. Fuller, Ph.D., chief executive officer of Third Eye Diagnostics, “The non-invasive, handheld and portable CerePress ICP monitor will enable medical practitioners and first responders to rapidly monitor and triage patients with potential head injuries. The present standard of care requires surgically inserting a sensor into the cranium through an access hole drilled through the skull. As a result, invasive techniques are limited to patients who are critically ill. We believe that the CerePress will provide an early medical intervention option that will lead to better patient outcomes and reduce unnecessary procedures and payer costs.”

$75 Million Prime Contract to Support U.S. Air Force CACI International Inc. has been awarded a $75 million prime contract (one base year and four option years) by the U.S. Air Force to sustain expeditionary contingency medical materiel (ECMM) support services. The contract continues work performed in support of medical logistics services in the U.S. at all levels of the Air Force, Army and the Air National Guard, with coverage now including Alaska, Japan and Guam. This award expands CACI’s growth in its health care and logistics and material readiness market areas.

ECMM support services are responsible for identifying and communicating medical manpower and equipment planning data for all Air Force combat and support forces.

14 | M2VA 17.5

CACI will deliver a comprehensive range of contingency medical logistics support for forces serving in theater and deployed DoD and service personnel in various locales within the U.S. and overseas. This support includes building and maintaining deployable medical assemblages across the globe; fulfilling urgent medical requirements in combat zones; sustaining medical logistics for deployed units and forces; and augmenting medical logistics to meet requirements for natural and man-made events within the U.S. With this award to CACI, the Air Force benefits from the company’s highly experienced personnel, proven processes and extensive capabilities to provide

medical requirements necessary to support U.S. forces as well as to build and deploy medical logistics solutions as assembled units. At the Air Force’s 340,000-squarefoot facility in San Antonio, Texas, CACI builds, maintains and deploys medical assemblages varying in size from portable backpack sets to fully equipped hospitals. CACI provides staffing at 29 sites where assemblages are stored across the continental U.S. and deploys them to support operations anywhere in the world, at any time. In addition, assemblages can be deployed in support of humanitarian relief efforts for disasters such as the 2004 Asian tsunami and the 2010 earthquake in Haiti.

www.M2VA-kmi.com

Compiled by KMI Media Group staff

Hydrogel Wound Dressing

High-tech Tinnitus Treatment Device

In essence and in practice, the proper management of a battlefield wound requires immediate and accurate diagnosis, followed by the appropriate course of treatment. The far-forward soldier often receives delayed treatment and is most likely alone when the injury occurs. He could use a wound dressing kit that is very portable and conformal, eliminates the need for wrapping, allows for self-treatment and protects the wound from foreign particles, particularly bacteria.

BioCure’s GelSpray wound dressing technology is a state-of-the-art hydrogel wound dressing that was developed by DoD for military applications. A non-active version of the GelSpray dressing was approved by the FDA in 2008.

Since 2008, GelSpray has been tested successfully in a porcine study in a collaboration with the U.S. Institute of Surgical Research, and has received strong interest in global markets in Asia and Europe, in both human and animal health.

GelSpray is projected to be a revolutionary product that greatly speeds up the recovery of external injuries in the battlefield, saving lives and preserving post-war zone quality of life along the way. The dressing can be self-applied with one hand, conforms to the wound site, serves as a barrier to infections shows excellent antimicrobial and wound healing properties and with a further development, GelSpray will be able to deliver drug actives such as pain relief medicine and be able to address a wide variety of wounds, including burns. Injuries that would prohibit a far-forward soldier from completing a mission could now be managed by the soldier in the battlefield, without interrupting the mission.

Larry McDonald Jr.; lmcd.jr@mcdonaldandconsultants.com

Members of the military who suffer from mild to moderate tinnitus now can benefit from a new device designed specifically for their condition––and funded by a U.S. Army development grant.

Neuromonics Inc., the maker and distributor of the FDA-cleared, patented and clinically proven Oasis medical device designed for long-term significant relief of tinnitus, has introduced the Neuromonics Sanctuary. With funds received from a U.S. Army Medical Research Acquisition Act in fall 2011, the company has developed and brought to market this first device helping individuals suffering from mild to moderate tinnitus.

“With the introduction of the Sanctuary, Neuromonics can provide effective, simple treatment for the full range of tinnitus that particularly affects members of the military,” said Curtis Amann, Neuromonics’ vice president of marketing and sales. According to the American Tinnitus Association, more than 50 million people in the United States alone suffer from tinnitus, described as buzzing, ringing, hissing, humming, roaring or whistling that someone hears in the absence of any external sound. Usually brought on by exposure to loud noise, the problem is especially significant in the military, with more than 34 percent of returning veterans from Iraq and Afghanistan suffering from tinnitus.

Curtis Amann; curtis.amann@neuromonics.com

DARPA Contract to Build Medical Device to Treat Sepsis A team consisting of Battelle, NxStage Medical Inc. and Aethlon Medical has won a contract from DARPA to develop an innovative medical device that may save the lives of soldiers and civilians by treating sepsis.

As many as 10 percent of combat wounds result in life-threatening infections that ultimately lead to septicemia and/or sepsis. “This device could not only save many of our soldiers’ lives, it could be profoundly important in saving thousands of civilian lives each year in the United States alone,” said Martin Toomajian, president of Battelle Energy, Health and Environment.

DARPA created the Dialysis-Like Therapeutics (DLT) program to develop a portable device that creates a holistic treatment for sepsis.

The device is intended to remove blood from the body, separate harmful “dirty” agents from the blood and return “cleaned” blood to the body in a www.M2VA-kmi.com

manner similar to dialysis treatment for kidney failure. DARPA has made significant investments in its DLT effort to date to multiple contractors for the development of key blood purification and diagnostic technologies that could contribute to the ultimate device.

The project calls for Battelle and key subcontractors NxStage and Aethlon to design, develop, test and validate an advanced, portable medical device and coordinate integration of key technologies developed during the overall DLT program.

Beyond the military need for sepsis therapies, the DLT device may play an important role in saving the lives of civilian patients, as infection leading to sepsis is a significant cause of mortality. When sepsis is complicated by shock, approximately half of patients do not survive for 30 days, even if effective antibiotics are used.

M2VA 17.5 | 15

Medical Supplier

Q& A

Transitioning U.S. Army MRMC to a Post-War Footing Major General (Dr.) Joseph Caravalho Jr. Commander U.S. Army Medical Research and Materiel Command and Fort Detrick Deputy for Medical Systems to the Assistant Secretary of the Army for ALT

Major General Joseph Caravalho Jr., M.D., graduated in 1979 with a Bachelor of Arts in mathematics from Gonzaga University in Spokane, Wash. He was commissioned a second lieutenant through the Army ROTC Program. In 1983, he graduated with a medical doctorate from the Uniformed Services University of the Health Sciences School of Medicine, and was commissioned a captain in the Medical Corps.

Clinically, Caravalho held positions as a staff internist, nuclear medicine physician and cardiologist. He served as chief of cardiology at Tripler Army Medical Center (AMC), Honolulu, Hawaii, and as deputy commander for clinical services at Womack AMC, Fort Bragg, N.C. His operational medical experience includes assignments as surgeon, 1st Battalion, 1st Special Forces Group (Airborne), Okinawa, Japan; physician augmentee, Joint Special Operations Command, Fort Bragg; surgeon, 75th Ranger Regiment, Fort Benning, Ga.; deputy chief of staff, surgeon, U.S. Army Special Operations Command, Fort Bragg; and as the assistant chief of staff, Health Affairs, XVIII Airborne Corps, Fort Bragg. He also commanded the 28th Combat Support Hospital and the 44th Medical Command (Rear) (Provisional), both at Fort Bragg. He has two deployments in support of Operation Iraqi Freedom, most recently serving as the surgeon for both MultiNational Force-Iraq and Multi-National Corps-Iraq. After his last deployment, he served as the commanding general for Great Plains Regional Medical Command (RMC), and then, following USAMEDCOM reorganization, for both Southern RMC and Brooke AMC, both at Fort Sam Houston, Texas. Before coming to the U.S. Army Medical Research and Materiel Command, Caravalho served as commanding general, Northern RMC, Fort Belvoir, Va. Caravalho is a graduate of the Command and General Staff College and the Army War College. He earned the special forces and ranger tabs and was awarded the Expert Field Medical Badge.

He completed the Army Airborne and Flight Surgeon schools, as well as the Navy Dive Medical Officer and SCUBA courses. He holds current certification in nuclear cardiology. His military awards include the Distinguished Service Medal with Oak Leaf 16 | M2VA 17.5

Cluster (OLC), Legion of Merit (OLC), Bronze Star Medal, Defense Meritorious Service Medal, Army Meritorious Service Medal (6 OLC), Joint and Army Commendation Medals, and the Army Achievement Medal (3 OLC). He is also a member of the Order of Military Medical Merit.

Q: As commander of U.S. Army Medical Research and Materiel Command [USAMRMC], what are your top priorities?

A: I would like to ensure USAMRMC remains relevant as an Army medical command in a drastically changing post-war environment. To this end, I have three priorities: shaping the organization to meet and exceed the research demands in support of the nation’s focus in the world; promoting advocacy within DoD, interagency, Congress and the nation for continued requirementsdriven medical research; and developing leaders at all levels—both military and civilian—to inspire those around them to work and live by values of professionalism, self-discipline, and dignity and respect for others.

Q: What new challenges does the pivot to the Pacific bring to your command? www.M2VA-kmi.com

A: Although we face many challenges in overt combat operations, the greatest medical challenges to our warfighters, in my opinion, come by way of endemic infectious diseases and the long distances over which the echelons of casualty care must be arrayed. As history has repeatedly shown, endemic tropical diseases will challenge our ability to sustain an effective war fighting capability on the ground, and we will need to provide casualty care capabilities currently available only at major medical centers farther forward in the battlespace.

Q: How is USAMRMC preserving its capabilities and prioritizing in these austere times?

A: We understand ongoing budget constraints will impact military, let alone medical, research. I’ve asked my staff and subordinate commanders to provide me with maximum flexibility to decide how to direct limited resources across the command by defining varying baseline levels of productivity across all of their portfolios. This will range from ‘minimum sustainable operations’ to an as-yet-to-bedefined level of quiescence. This, along with our estimate of fixed costs to operate our infrastructure, will give me a clear estimate of a baseline operating budget during austere times. On this I can then overlay appropriate combinations of program, personnel and equipment costs to address varying focus areas of military importance across the command.

Q: Could you tell us about USAMRMC’s work regarding the noninvasive brain stimulation device called PoNS? A: In January 2013, the USAMRMC signed a cooperative research and development agreement. This exciting agreement leverages a unique private-public partnership by collaborating with University of Wisconsin-Madison and NeuroHabilitation Corporation. We will be able to maximize our resources to explore a potential real-world treatment for injured servicemembers and civilians with a variety of health conditions.

The battery-operated PoNS device is placed on the patient’s tongue and held against the roof of his/her mouth. The patient then performs a set of physical, occupational and cognitive exercises. A typical session with the PoNS device lasts from 20 to 30 minutes; during this time the device sends specially patterned nerve impulses to the patient’s brain. The impulses improve the brain’s organizational ability and allow the patient to regain neural control.

Testing will include a collaborative study with researchers and clinicians at the Blanchfield Army Community Hospital at Fort Campbell, Ky. The hospital is home to the Warrior Resiliency and Recovery Center, which is dedicated to the treatment of soldiers with physical and neuropsychological problems due to service-related trauma.

Additional patient testing will be conducted at other veterans facilities and civilian medical institutions. Concurrently, the U.S. Army Medical Materiel Agency and the U.S. Army Medical Materiel Development Activity [USAMMDA] will conduct environmental testing, such as temperature and humidity limitations for the device, to better understand potential constraints. At the conclusion, USAMRMC hopes to seek FDA clearance for the PoNS device.

Q: What motivated the research for the SOLX whole blood collection system? www.M2VA-kmi.com

A: We wanted to improve the quality of stored red blood cells [RBCs] and reduce the amount of RBCs that expired on the shelf before ever being used. This motivation continues to drive blood research and continues providing medical advances to save our wounded servicemembers.

In partnership with USAMMDA, Hemerus Medical LLC received FDA approval of the new drug application for its SOLX system [LEUKOSEP HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with Citrate Phosphate Dextrose Solution Anticoagulant and SOLX Additive] on April 25, 2013.

The SOLX system is a whole blood collection system that produces leukoreduced RBCs and plasma. The FDA approved this system in the United States to store RBCs for up to six weeks; it was approved previously in Europe for up to eight weeks of storage. Haemonetics Corporation, which recently acquired Hemerus Medical, also plans on seeking an eight-week RBC storage indication in the U.S. The significant part of the SOLX system is the additive solution that was co-developed by Walter Reed Army Institute of Research and the University of Cincinnati. The additive solution has been shown to reduce storage lesions, thus improving the quality of the RBCs and extending the storage period, potentially improving outcomes among transfusion patients. An initial calculation that was performed at the onset of the research showed that an additional two weeks of storage time could save DoD millions of dollars in transportation costs and decrease product loss due to outdating during military deployments. However, it was soon realized that longer storage time could only occur with better-quality cells. The SOLX system achieves both.

Q: Could you give us some background information concerning the requirement for an advanced modular manikin [AMM]?

A: The USAMRMC’s Joint Program Committee-1, Medical Training and Health Information Systems Research Program, in coordination with the Telemedicine and Advanced Technology Research Center, are leading the research and development of an AMM. The goal of the AMM is to advance the state-of-the-art in medical simulation-based training. The intent is that the AMM be a platform upon which future technologies can reside through development of advanced add-ons and upgrades.

The creation of the AMM platform will allow for a usable manikin system that can easily incorporate future advances, from a variety of sources, into military medical training.

Current medical manikin training systems have a number of significant limitations. Existing full-body manikins possess relatively fixed configuration options and lack end user customization functionality. In addition, no general purpose manikin yet exists that equals or exceeds live tissue training fidelity.

Q: How do USAMRMC personnel stay current with what is going on in the commercial marketplace?

A: The USAMRMC’s advanced development efforts are just one of the ways that the command stays up-to-date on the current standards and trends within the medical community. The advanced development process reviews promising technology from the industry and academia, and enables the transition to U.S. forces.

M2VA 17.5 | 17

It encompasses the testing required for FDA approval or licensing, to fielding of the finished product.

Additionally, many of the senior leaders and scientists at the USAMRMC are doctors and researchers by trade. Like any respected doctor or researcher, they are expected to stay up-todate on trends and developments within their fields of expertise.

To this end, many of them are members in professional associations; contribute regularly to journals and scientific papers; and attend industry meetings and events.

Q: How is USAMRMC confronting the issues of PTSD and TBI within the military population?

A: PTSD and mild TBI are priorities for the U.S. Army as well as the USAMRMC. To meet the demand for research and treatments, the command has several programs, staffed with the most talented doctors and scientists, addressing this important topic.

Within USAMRMC’s combat casualty care research program, there are two major subdivisions that study very different forms of TBI. ‘Neuroprotection’ focuses on penetrating brain injury, damage to the brain caused by shrapnel, bullets, or other projectiles passing through the skull and physically lodging in or passing through the brain matter. ‘Neurological effects of blast’ studies the effects of acute exposure to blast waves, or ‘blast overpressure,’ on the brain. The goal of each is to increase understanding of the etiology of TBIs to develop new treatments and to arrive at evidence-based solutions.

The command’s military operation medicine research program is working to address the psychological health problems related to PTSD. Researchers develop strategies and advise policymakers to enhance and sustain mental fitness throughout the servicemembers’ career. These include validated prevention and treatment interventions that address psychological health issues, enhanced screening and identification of concussionrelated health concerns and improved clinical guidelines for health care providers.

The blast injury research program is working to address critical medical research gaps for blast-related injuries. The program leverages extramural partnerships with DoD medical research laboratories to achieve a cutting-edge approach to solving blast injury problems. One of the program’s major areas of focus is the improvement of battlefield medical treatment capabilities to mitigate neurotrauma and hemorrhage.

USAMRMC also operates two congressional programs that support the ongoing research on PTSD and mild TBI. The congressionally directed medical research programs’ psychological health and traumatic brain injury research program, Defense Centers of Excellence, was established in 2007. Its goal is to complement current and ongoing DoD research efforts as well as support the DoD Psychological Health and Traumatic Brain Injury Center of Excellence in its efforts to advance and spread knowledge, enhance clinical and management approaches and facilitate other vital services to best serve the needs of servicemembers impacted by PTSD and mild TBI. The psychological health portfolio within the Telemedicine and Advanced Technology Research Center focuses on studies examining the mental health impact and consequences of military service. The portfolio gives special attention to the underlying causes, risk factors, consequences, symptoms and treatments of 18 | M2VA 17.5

psychological trauma. Studies range from explorations of biological mechanisms in PTSD to innovative remote deployments of psychological treatments in austere environments.

Q: How does USAMRMC work with private industry to achieve its goals?

A: The USAMRMC has several avenues for working with private industry groups, both large and small.

The three-phase small business innovation research [SBIR] program directly funds up to $1.15 million in early-stage R&D by small companies. Eligible projects must fulfill an R&D need identified by DoD and have the potential to be developed into a product or service for commercial or defense markets.

The three-phased program works in the following manner.

Phase I [project feasibility] determines the scientific, technical and commercial merit and feasibility of the ideas submitted. Phase I contracts are typically $150,000 over a period of six months. Phase II [project development to prototype] is the major R&D effort, funding the prototyping and demonstration of the most promising Phase I projects. Phase II contracts are up to $1 million and usually span 24 months. Phase III [commercialization] is the ultimate goal of the SBIR program. Small businesses are expected to obtain funding from the private sector or government sources outside the SBIR program to commercialize the Phase II project for sale in the military and private sector markets.

The small business technology transfer [SBTTR] program provides up to $850,000 in early-stage R&D funding directly to small companies working cooperatively with researchers at universities and other research institutions. The DoD STTR program is also a three-phased program and is funded at over $100 million annually.

The USAMRMC medical technology transfer office uses cooperative research and development agreements, material transfer agreements, patent license agreements and interagency agreements to engage in opportunities with industry.

Grants and funding opportunities are also available through the congressionally directed medical research program. These are announced to industry partners in the form of a funding announcement that provides the description and submission requirements for that funding opportunity.

Additional information about each of these programs is available on the USAMRMC webpage.

Q: What does USAMRMC need from private industry to reach those goals?

A: The USAMRMC is always on the lookout for the best and the brightest researchers and medical materiel developers to partner with in order to achieve mission critical goals.

The command makes every effort to follow up on leads and investigate new opportunities, but we rely on regular submissions from those within the industry to keep current with new cuttingedge technologies and applications.

We encourage those in the industry to submit new products and ideas using our developed application channels. This enables our command to keep a record of all submissions. You can find more information about the submission process on the USAMRMC website [https://mrmc.amedd.army.mil] and new product portal [https://mrmc-npi.amedd.army.mil/]. O www.M2VA-kmi.com

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 www.M2VA-kmi.com

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.”

M2VA 17.5 | 19

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

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20 | M2VA 17.5

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 www.M2VA-kmi.com

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. O

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 Adrian Polliack 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.”

Jeffrey Phillips 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.

For more information, contact M2VA Editor Chris McCoy at chrism@kmimediagroup.com or search our online archives for related stories at www.m2va-kmi.com.

PREPARE FOR A FUTURE IN HEALTHCARE U.S. Air force photo. USe of militAry imAgery doeS not imply or conStitUte dod endorSement.

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M2VA 17.5 | 21

Special Section

A decade of advances in lower-extremity prostheses has enriched the lives of amputees .

By Peter Buxbaum, M2VA Correspondent amputees to fit artificial limbs and then train amputees in their use.

Lower-extremity prostheses have Such specialists usually have earned a master’s degree in the subject. advanced to the point that U.S. warfighters “War provides opportunities to make improvements to prosthetic who have lost a leg can actually return to devices,” said Mike Link, vice president of College Park Industries and active duty, perhaps even to combat. It’s hard a certified prosthetist. “It draws attention to the needs of amputees to decide which aspect of this phenomenon is and it gives us a decent-size population of high-impact, high-activity the most remarkable: that an amputee would amputees who are looking to push the bounds of the current state want to return to active duty, that the U.S. of technology.” military would allow them to return, or that Working with that type of population allows companies to introprosthetic devices have advanced to the point duce improvements quicker. “It might take us a couple of years that this is a possibility. under ordinary circumstances to find weaknesses in designs because The precise number of warfighters who patients aren’t testing the limits of the device,” said Link. “But put it have returned to active duty under these on an 18 or 19 year old who wants to go back to active duty and you circumstances is hard to come by. Reliable will find weaknesses quickly because he is testing the limits of the sources say that at least a handful of wounded design and the materials. This accelerates the process of developing warriors have returned to active duty after having a leg amputated— high-end products.” thanks to the availability of these advanced prosthetic legs—and that The Brooke Army Medical Center is one of three military facilities a few have been deployed. What is certain is that the Department of hosting an amputation center; the others are at Walter Reed Army Defense funded research and development on these next-generation Medical Center in Bethesda, Md., and at Balboa Navy Hospital in San devices that allow for the possibility of a return to active-duty.

Diego. Brooke treats around 100 patients at any given time, on an High-tech lower-extremity prostheses have been around for a outpatient basis, for limb loss. number of years. Advanced knee joints, embedded with microprocesVHA operates 70 centers around the country that provide prossors, can control movement under varying conditions. This allows thetic and orthotic devices to the 460,000 veterans. During fiscal year the amputee to perform different kinds of activities without having to 2012, VHA centers saw 22,739 patients for artificial legs, according provide manual input. What distinguishes the latest of these devices to Dr. Joseph Miller, the VHA’s prosthetics program director. Those from their predecessors is that they have been made waterproof and patients were not necessarily all being fitted for new limbs. Many had are able to withstand other harsh environmental conditions that made appointments for repairs and adjustments. might be found in combat.

The VHA also maintains an intramural research program to Leg and foot prostheses have made other advances in recent develop and test prosthetic devices. “We have over 100 VA centers years. Wartime directs attention to the problems faced by amputhat have the capacity to do research and [we have] between 3,000 tees and boosts government funding of research into this area. and 4,000 investigators working on projects of all kinds,” said Dr. While many of the advances have been at the high end, most ampuRobert Jaeger, VHA’s prosthetics director of research. tation cases seen at Veterans Health Administration “We don’t do head-to-head comparisons of devices.

(VHA) came about as a result of disease processes such The question for us is which device is best for an as diabetes and cancer; amputation caused by trauma individual veteran.” The VA also operates a technolis a relative rarity. ogy transfer office that licenses government-develGovernment and industry research has improved oped technologies to private companies interested in the fit and weight-bearing capabilities of the socket— commercializing them. where the prosthesis interfaces with the limb stump— “The thing to remember about prosthetics,” said and advances in prosthetic feet have allowed the Fergason, “is that the biggest cause of amputations devices to be made stronger and lighter at the same around the country is not trauma or war but disease time. Powered prostheses—which give a patient an processes, particularly vascular problems associated extra push when needed—have recently been introMike Link with diabetes. If we see advancements in the treatment duced, while direct attachment of a prosthetic limb to of diabetes you will see the amputation rate drop off.” a patient’s skeletal system is expected in the future.

“The percentage of our patients who have lost limbs due to “We performed some of the beta testing for the battle-hardened trauma, whether combat related or as a result of a motor vehicle knee,” said John Fergason, chief prosthetist at the Brooke Army accident, is very small,” said Miller.

Medical Center at Fort Sam Houston, Texas. “DoD funded developWith the latest in advanced prostheses, warfighters can return to ment of this knee, then tested it, and we are now providing this to active duty in as little as two months after being fitted with the device, patients regularly.” Prosthetists are the professionals who work with 22 | M2VA 17.5

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“The use of multiple springs produces a proporaccording to Byron Backus, a prosthetist at Ottobock, tional loading response,” said Link. “The vertical shock the maker of the combat-hardened knee. “These absorption technology of the Soleus helps dissipate guys were in peak fitness when they went into battle, forces, providing improved comfort and control. All of so they rehabilitate quickly,” he said. “After several this combined created a foot that is 40 percent stronmonths in the hospital to get through their medical ger and 40 grams lighter than its predecessor.” Since issues, they are fitted with a prosthesis and within a College Park launched the Soleus six years ago, it has month they are ambulating pretty well. Within two made 1,500 changes to improve the performance of months they can get back to active duty. These guys the foot. aren’t looking for a ticket out. They don’t want to let WillowWood, located in Mt. Sterling, Ohio, is an injury get in the way of what they are passionate involved in several innovations in prosthetic limb about doing.”

Byron Backus design, function and manufacturing. Among the com“The device is not getting anyone deployed,” said pany’s many innovations have been improvements to Fergason. “The self-determination, drive and motivasocket design, the area where the prosthesis attaches tion of these warfighters are getting them back to to the remainder of the leg. active duty.”

“The general issue with prosthetics for generations It was around six years ago that the governhas been the ability to hold the prosthesis to the residment approached Ottobock about developing a battleual limb,” said Andy Marsland, a certified orthotist and hardened prosthetic knee, reported Backus. Knees prosthetist at WillowWood. “Since 2007, we have been equipped with microprocessors that operate in difworking on an electronic version of a vacuum pump ferent modes based on input from the environment, that would provide a better fit to the socket. Advances rather than the user, were already on the market. in vacuum technology hold the prosthesis better to the Ottobock was already working on improvements to its residual limb.” latest products and used government grant money to Andy Marsland Another area WillowWood has been working on develop the kind of knee the military was looking for. is skid protection. “Over the last 12 months we’ve introduced a new “In order to develop a microprocessor knee that could go family of silicon liners,” said Marsland. “These provide greater cominto a combat situation, it needed to be made dustproof and waterfort and allow for the interchange between different materials so that proof,” said Backus. “The new X3 knee was made waterproof up amputees can change their activities without changing prostheses.” to 1 meter in depth. The military version of the device was also WillowWood won a competition in 2012 in partnership with The equipped with a mute mode, so that the device didn’t vibrate or beep Ohio State University and The University of Akron for a Department of when it had to send an error message. That could be a bad situation Veterans Affairs Innovation Initiative contract. The project will develop in combat.” a more comfortable and useful prosthetic system to help patients at VA The X3 was very recently made available to the military, and only medical centers who have an above-knee (transfemoral) amputation. to the military. Once those orders are satisfied, the knee will be made VA’s competition revolved around solutions that provide improveavailable to veterans and only after that to the general public. In the ments in the fit, function and comfort of prosthetic sockets for vetmeantime, the X2 knee, which is water resistant but not waterproof, erans with amputations that involve removal of the leg at the thigh, is available to veterans and the public. leaving part of the femur intact. “The proposed solution involves Ottobock’s line of advanced knee joints are equipped with a developing an improved suspension system and a socket system remote control device so that the user can program the knee to opermade from polymer materials that draw heat away from the limb for ate in modes other than normal walking. “One of the big advantages enhanced performance and comfort,” said Marsland. of the microprocessor knee is that the user doesn’t have to think The project, which spans 26 months, is intended to provide transabout every step,” said Backus. “Earlier versions worked 99 percent femoral amputees with a more comfortable and durable prosthetic of the time, but patients always had to be thinking about the other 1 socket system that maintains fit and performance across a wide range percent because otherwise they could take a fall and get hurt badly. of activities. “We plan on using 3-D laser printing technology to create The microprocessor takes that out of the equation.” a socket design that will solve the problems of comfort and suspenCollege Park Industries specializes in designing and producing sion and allow patients to do whatever they want,” said Marsland. prosthetic feet, which are then incorporated into a leg assembly by WillowWood and its partners will also be conducting extensive clinical prosthetists. The company’s line of eight models was engineered to research through the course of the project. provide function and comfort across different ranges of activities, Recent innovations to lower-extremity prostheses include incordepending on individual needs. poration of a power generation unit to help patients push off in difCollege Park’s Soleus foot is a high-end product for high-activity, ficult situations. “These units provide power to the foot and ankle to high-impact situations such as tactical military environments. “The push off instead of relying on a passive device,” said Fergason. “This structure of the Soleus foot was optimized for strength-to-weight will help amputees get up out of chairs, climb up and down stairs in ratio based on extensive machine and real-world testing,” said Link. addition to their ground level walking. It substitutes for some of the “We were able to remove unnecessary weight while retaining superior muscle power that is missing since the amputation.” These power strength. We made some changes to structural components to shift devices were beta tested at Brooke Army Medical Center two to three mass around and make the design more durable.” years ago and have been commercially available for about a year.

The Soleus was recently re-engineered to be lighter and stronger.

“Powered ankles put energy into the gait to help propel patients Advancements include new heel springs, a new mid-spring design and forward,” said Backus, “especially when walking on uneven ground or a new belt attachment. www.M2VA-kmi.com

M2VA 17.5 | 23

Special Section uphill and downhill or doing other things requiring the ankle to flex.

Some of these improvements are in the market already and I expect to see more advances in this area.”

“The powered prostheses are getting us into the area of bionics,” said Miller. “We are just now beginning to experience and to see what it means for veterans to be using these types of technologies.”

“The most exciting area of innovation in lower-extremity prostheses involves oseo-integration,” said Jaeger. “This would eliminate the need to fit a prosthesis over a leg stump with a socket. One of the biggest problems with lower extremity prostheses is that the body doesn’t want to be in a container for very long. There are also the problems of sweating and the breakdown of skin tissue.”

Oseo-integration involves the attachment of the prosthetic device directly to the patient’s skeletal system. This is accomplished by screwing a titanium rod directly into the bone of the residual leg and designing the prosthesis to attach to the rod.

“Direct skeletal attachment is not a new technology,” said Link.

“It has been used in Scandinavian countries and has been limited to patient who could not be fitted with a conventional prosthesis. But there are risks of breaking the titanium implant and infection, which could result in deeper or further amputation.”

“Sometimes the procedure fails,” acknowledged Jaeger. “We hope to find a way to close the skin over the titanium rod and to develop a procedure that is safe and effective.”

The benefits to oseo-integration would be that the device would allow weight to be borne throughout the limb, making for a more

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natural gait, and taking pressure off the socket and eliminating the complications associated with that area. “With conventional prostheses all of the weight goes down into the socket,” said Jaeger. “That can cause the leg to pop out of the socket, which is disruptive to walking.

The rod would be customized to the patient and the device would make walking easier and more symmetrical.”

“Direct skeletal attachment would allow weight to be supported over the leg,” said Fergason. “Now much of the weight has to be supported in soft tissues around the pelvis. Much of my work is to teach people to bear weight on portions of their bodies that were not designed for that purpose. If we can eliminate that and go to skeletal weight bearing, it would be a tremendous advancement.”

Progress on the oseo-integration front would also impact designers of prosthetic feet like College Park Industries, because the feet are designed to accommodate the weight-bearing scheme of conventional prostheses. “Especially for high-impact activities, we would have to mitigate the shock being transmitted up the leg to the rod,” said Link.

Other future developments foreseen in this area include a greater role for computers in the prosthetic design and manufacturing processes. Laser measurement devices can be integrated with computer aided design software to craft the prosthesis in the virtual world instead of having to make a physical plaster cast. The end result could then be sent to a 3-D printer that could produce the prosthesis on the spot.

“This is a cleaner and more accurate way of producing a socket,” said Marsland, “and it is definitely where the future is going.”

Backus expects some of the innovations developed for upper body prostheses to be applied to the lower extremities. “There has been experimentation in using nerve signals and muscles to control devices,” he said. “Surgery has been done to take nerves that normally control the knee and ankle function and embed them in the thigh.

The nerves and muscles can then send signals to the knee joint to allow control of the knee through the body’s nervous system.”

Many of the recent advances in lower-extremity prostheses have come as a result of an infusion of federal dollars galvanized by the return of casualties from the wars in Iraq and Afghanistan. These advances have benefited the population of veterans and the general public as well.

As the wars come to an end, and regardless of the sequestration of federal budget funds, the question arises whether the same level of funding for prosthetics research—and thereby the advancements in the technology—can be sustained. “There has been a history of federal funding for prosthetics research because there have been significant numbers of amputations in these conflicts,” said Fergason. “Without war, there will be fewer new amputations and it stands to reason that funding to support research in this area will be significantly reduced.”

That could have a negative impact on the general public and the health care system, noted Backus. “Amputees could have a much more functional and active life,” he said. “This would reduce the burden on the health care system and even probably reduce insurance costs.”

“What is holding innovation back,” said Fergason, “is the question of who is going to pay for these things once they get developed. It is already a small market and these new devices are typically very expensive to develop. Because it is a very small market, a lot of technological advances need to be federally funded.” O For more information, contact M2VA Editor Chris McCoy at chrism@kmimediagroup.com or search our online archives for related stories at www.m2va-kmi.com.

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Capturing Information Technology Lessons Learn The story of a medical enterprise

operating system migration effort .

After 10 years on the Microsoft Windows XP platform, the U.S. Army mandated that the U.S. Army Medical Command (MEDCOM) enterprise migrate all of its end-user devices (EUDs) to the Microsoft Windows 7 operating system (OS). Reimaging or migrating over 100,000 EUDs to the Windows 7 OS in a manner that minimizes the disruption of health care delivery to clinical operations and to end users is a tremendous task. So, this task should have been somewhat seamless, right? After all, we have learned valuable lessons from past migrations, right?

This migration was anything but graceful, and previous lessons learned were not planted in a time capsule to help us in 2011 and 2012. We have discovered and learned many valuable lessons along the way that are definitely worthy of documenting this time around.

This is what we discovered along the way.

Application Compatibility Deserves Attention First, with such a large number of EUDs, we had to get a handle on all the applications that were installed on those EUDs, and then we separated those applications into major categories, or types: business, medical, utility and other.

To do this, we created functional divisions for those categories. Then we utilized our business intelligence team to create a database to populate and manage this. The business intelligence team went so far as to ‘cold call’ vendors to determine compatibility.

We found that in many instances, our application versions were simply outdated and were not compatible with Windows 7.

So what should your strategy be when you find applications that are not compatible with the Windows 7 OS? Ideally, you would have an ‘enterprise solution’ answer for these applications.

One of our core applications that provided data at rest, or EUD-level data encryption, was a big issue for MEDCOM. Due to www.M2VA-kmi.com

By Kelly L. Turner

a database conversion problem, we had to transition to a new major version that included standing up a brandnew database.

Our first lesson learned was that you must understand your applications, the standard or compatible version for these applications, and how the applications exist with Windows 7.

Deliver Transparent Metrics to Enhance Visibility Due to the number of applications and EUDs, clear, accurate and timely communication throughout the enterprise [with ‘live’ current reports] would be vital. Having this ‘live’ data makes a big difference between answering questions based upon timely reports and asking or requesting data via a data call.

The organization hosted a SharePoint portal to share information and enhance visibility for the enterprise. There, we posted ‘live’ reports, displaying the number of Windows 7 EUDs deployed, hardware compatibility and application compatibility reports.

Most of these reports were updated every eight hours, and we could typically drill down to the medical treatment facility [MTF] device level.

The creation of this portal for accurate, timely data and communication was crucial to the success of this project. In the beginning of the OS migration, we wanted to know how many EUDs were transitioned to Windows 7, and at the end of the migration, we wanted to know how many Windows XP EUDs were remaining in the inventory—now that’s progress.

Set a Realistic Schedule When we started the OS migration effort, we were very uncertain how long this effort would take, and how to define the transition phases. The task of requiring that 100 percent of the EUDs need to be reimaged versus

upgraded would require a realistic schedule.

We were able to ‘parse’ the project into three distinct phases: pilot [with technology development], integration and implementation.

The comprehensive Windows 7 pilot phase took six months, and then Windows 7 was released to the enterprise via the Microsoft Systems Center Configuration Manager [SCCM] Operating System Deployment [OSD] process. After that, the integration phase took approximately four months for the IT experts at multiple worldwide hub locations and MTFs to test the OSD image in their environments and to plan the local implementation. The implementation phase lasted another 8-12 months, where the EUDs were migrated to Windows 7.

We learned that it was critical to set a realistic schedule and to clearly define the transition phases. The total project effort spanned across 22 months, achieving 94 percent success for over 100,000 EUDs.

Enhance Communication With a project of this magnitude, it is no surprise that communication on all levels would be a paramount factor.

All documents were posted to a SharePoint portal as stated previously, accessible to all IT personnel across the command.

This communication was critical for the sharing of blogs, newsletters, solutions and specialized configurations—for instance, the Defense Medical Logistics Standard Support System handheld scanner configuration.

Directives to the enterprise laid out the framework, plan, timeline and updates to transition to Windows 7. The project team also provided leadership updates every two to four weeks to the chief information officers and chief medical information officers.

M2VA 17.5 | 25

The project team hosted three key forums, or groups, including an integrated product team, a pilot group and a technical working group. These three groups represented internal staff, limited external staff [by invitation] and unlimited external staff [available to all MTF IT personnel] respectively.

It is important to enhance communication across the spectrum, with leadership, with the customer and with the local team. The addition of the portal and various technical groups, along with regular leadership updates, were key to the success of this project.

Transformation or Migration: Define the ‘Critical Objective’ or End State Generating a standard desktop was our critical objective, and this included establishing guidelines and boundaries from the beginning of the project.

Standardization metrics were defined and measured. Guidelines included consistent parameters, such as defining ‘the deployment strategy.’ We also ensured from day one that ‘XP Mode’ was not allowed due to licensing implications and support issues. Initially, standardization included the delivery of a baseline image using the SCCM OSD Process. Further standardization on the technical level was realized in the delivery of group policy objects, incorporating Defense Information Systems Agency Security Technical Implementation Guide guidelines for the OS, Office Suite and Internet Explorer products.

We have very few opportunities to transform, and this was one of them––it’s OK to have a grander strategy or critical objective.

While the Windows 7 OS migration was the ‘immediate target,’ the larger strategy was to transform to a standard desktop. Wasn’t it Stephen Covey who told us to ‘begin with the end in mind’?

Seek the Experiences of Experts and Peers It is always helpful to learn from others’ experiences when they have completed a similar task. To assist in our planning process it was invaluable to listen to a source like Gartner Inc. host an industry panel discussion, where they candidly talked about their Windows 7 migration experiences. Hearing about their trials was educational and it made one start to think critically about omissions in our own planning process.

26 | M2VA 17.5

As errors, issues and problem areas occurred during migration, such as with the User Access Control, it was imperative to research Microsoft TechNet Articles and other sources.

Another great resource was to tap into my peers. As a project manager, I found it helpful to collaborate and compare notes with my counterparts in the other military services. I reached out to experienced technicians at Army hospitals for ‘sanity checks.’

The reminder here was that ‘it took a village.’ Be open to ideas, feedback, criticism and experiences of others in order to achieve success for your organization.

Explore New Technology When transitioning to a new OS, it is a perfect time to explore new technology and to make some calculated changes. It is imperative to research, utilize and implement new technology at the right time.

With the Windows 7 migration, OS licensing was delivered for the first time in the form of token-based activation.

However, the User State Migration Tool [USMT] provided by Microsoft did not function well for the MEDCOM because of the data encryption issues [described earlier], and due to information assurance issues surrounding the decryption of user data.

It would have been of great benefit to the migration effort if the USMT, or some other migration tool, had functioned properly.

We tried to implement a user profile management solution during the Windows 7 migration and we were not able to achieve success. Ideally, something like this should have been accomplished prior to the migration, as it would have provided immediate relief for dealing with user data migration.

In summary, determine if it makes good business sense to deliver technology transformations or changes while transitioning to a new OS.

Identify Obstacles & Risks Prior to and during migration, it is important to identify and overcome obstacles and risks that could be encountered.

For the MEDCOM, this included FDA approved devices, such as laboratory instruments. During the pilot, we also encountered standalone devices in hot suites, i.e., EUDs were positioned in bacteria-infected controlled space. These use cases required us to provide standalone OS licensing instructions.

Try to identify obstacles and risks early on, even if there are not immediate solutions. While research and FDA devices represent a small minority of the EUDs, they still require support and it is important to effectively address obstacles and risks, such as these.

People As a Key Resource Finally, in hindsight, an important element to the success of a migration effort like this one is people. You can plan, design, schedule and perform all of these steps and lessons learned to the best of your ability. However, without dedicated and empowered personnel in the middle of each of these elements, the project will be negatively affected.

Throughout the life cycle of the project, there were key personnel who inherently understood their role in transitioning to Windows 7. Each person’s role and participation was critical in reaching the end state.

It may have been the SCCM application packager who knew that the Microsoft Visio Package required updates, or the dermatology clinic manager who understood how to coordinate with the IT manager to minimize patient/provider interruption.

We witnessed areas of excellence, with people who excelled at their jobs and propelled the migration effort forward with great success.

Conclusion While Murphy’s Law was fully validated during the Windows 7 migration effort, we know that we underestimated the degree of difficulty of this implementation early on.

The high level of integration required for incompatible applications proved to be a major stumbling block and was well documented by Gartner Inc. We performed better in other areas, like delivering metrics and enhancing communications. We’ve documented our lessons learned, and we know that you will gain from them. O Kelly L. Turner is the project manager for the U.S. Army’s Medical Information Technology Center Project Management division.

For more information, contact M2VA Editor Chris McCoy at chrism@kmimediagroup.com or search our online archives for related stories at www.m2va-kmi.com.

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INDUSTRY INTERVIEW

Military Medical & Veterans Affairs Forum

Chris Yerger President Fort Defiance Industries Inc. Q: Can you briefly tell us about your company and its history with the military?

A: Fort Defiance [FDI] is an ISO certified company that has specialized in innovating, engineering and manufacturing for the U.S. military medical community for over 27 years. Our factory is located in Loudon, Tenn., just an hour’s drive from the Great Smoky Mountain National Park. We have been known as the “can-do” company and we have a long track record of responding to the needs of the military by providing rugged and reliable equipment for combat support hospitals. Some examples of our products include water softeners, water heaters, water recovery systems, water pumps, air compressors, electrical panels and custom medical kits for repairs, tests and diagnostics. FDI has been recognized with two awards from DoD. Q: The medical kits sound interesting.

Can you talk more about them?

A: Medical devices within combat support hospitals often require biomedical equipment technicians [BMET] to perform calibrations, diagnostics, service or repairs.

In normal environments, medical device manufacturers have their own technicians which carry specialized tools and parts to perform these activities. In austere military environments, these factory technicians are often not available. The military BMETs need these original equipment manufacturer tools and parts to be clean, safe and organized. We work with major medical device manufacturers such as Siemens, Draeger, Haemonetics, Ziehm and Abbott Medical Optics to provide custom kits for their tools, parts and consumables. These kits create “a place for everything, and everything in its place,” which helps bring organization and precision to some very critical work.

Q: What makes Fort Defiance different from your competitors?

A: Dependability, agility and quality. The military can depend on FDI to be available 28 | M2VA 17.5

and ready to answer the call. Through the ups and downs of military budgets, we’ve been a steady supplier for 27 years. FDI is well diversified in non-DoD markets, such as high-quality aluminum products for the marine industry, and we have also developed a patented device for the logging and wood cutting markets. In addition, Fort Defiance is one division of our overall business operations. Other divisions include logistics, warehousing and plastic injection molding.

I mentioned earlier that we are known as the “can-do” company. We are tuned-in to the needs and requirements of our customers and we are agile enough to respond to those demands. Often the requirements for the military are unique and low volume, as compared with the commercial and industrial markets. Many larger companies are not agile enough to properly address these requirements. Our team of engineers and technicians can provide rapid prototypes and custom solutions to help support critical and often time-sensitive military projects.

Regarding quality, our equipment has a reputation for standing up to the tests of military duty. We understand how to harden designs and constantly apply a set of “maxims” to every project to ensure that austere environmental conditions, safety, reliability and human factors are considered every step of the way.

Q: Do you have anything new going on at Fort Defiance?

A: Our new Model P2131 Automated Field Steam Sterilizer. Let me provide some background. FDI has been involved in the area of steam sterilization for over 10 years.

We manufacture the Water Recovery System for the 2151 Big Bertha steam sterilizer, a sterilizer design that has been in service since the 60s. We have also been producing other sterilization products such as our Portable Water Softener and our “A-Frame” Electrical Distribution Panel. In 2007, we developed our first gravity steam sterilizer prototype that integrated our Water Recovery System into the overall package. In 2008, the Army performed extensive operational and environmental testing on several different sterilizers. Our device performed well, but the Army decided to upgrade the requirements to include automation and pre-vacuum capability. FDI responded again and produced a second sterilizer prototype in 2012 that was fully automated, included pre-vacuum capability and also met the sterilization requirements of the Association for the Advancement of Medical Instrumentation. For most of 2012, the Army conducted extensive testing with multiple sterilizers. As you might expect, we were very encouraged last month when the United States Medical Research Acquisition Activity awarded Fort Defiance a contract for our new Automated Field Steam Sterilizer. My team is now laserfocused on delivering exceptional results on this contract. Long term, our vision is to be the premiere global supplier for lightweight and rugged field steam sterilization systems.

Q: How have you seen your industry change over the years?

A: What comes to mind first is the military’s objective to compress the supply chain. We all remember years ago when contracts were for higher volumes and many items would be stored in depots. Now DoD awards more purchase orders but for smaller quantities.

They have moved towards the “just in time” supply chain model. Electronic and webbased tools are playing a much larger role in procurement, contract management and finance. For example, most of our products are available on an ECAT contract with DLA’s medical supply chain. This system provides an easy and efficient process for customers to purchase products. O www.M2VA-kmi.com

NEXTISSUE

November 2013 Vol. 17, Issue 6

Cover and In-Depth Interview with:

Lt. Gen. Patricia D. Horoho U.S. Army Surgeon General

Special Section Medical Simulation/Training

Advanced medical simulation technologies are providing health care workers with training for the battlefield.

Features Defibrillators

PTSD

Oxygen Generation and Delivery

Tactical Combat Casualty Care

Supplying oxygen to the wounded warrior is a cornerstone of trauma care.

Advances in trauma care are continuing to mitigate the risk of injuries from combat.

Military Burn Center

Theater Medical Systems

The new director of the U.S. Army Institute of Surgical Research Burn Center, Lt. Col. (Dr.) Booker T. King, discusses the state-the-art work done at the military’s only burn center.

Once a servicemember is stabilized and transported to a hospital setting, a number of powerful imaging systems and other medical equipment can help diagnose the extent of his or her injuries.

Infant Security

Physical Rehabilitation Machines

Both AEDs and internal defibrillators play a role in saving the lives of our servicemembers and veterans.

Military maternity wards make ample use of electronic devices to prevent infant kidnappings.

Medical Surveillance

Medical surveillance is one strategy seeking to minimize the occurrence of threats to the health of our servicemembers.

This disease continues to devastate the military and veteran population; however, advances are being made in its treatment.

The high number of casualties stemming from nearly 12 years of war in the Middle East has increased the demand for physical rehabilitation machines.

Bonus distribution I/ITSEC SOMA

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