Meeting Customers’ Demands
Written by Marty Kauchak
MMT 2010 Volume: 14 Issue: 5 (August)
Driven by wartime lessons learned and influenced by dramatic technology advancements, the U.S. Department of Defense is equipping its health care providers with a new generation of patient monitoring devices and cardiac defibrillators. A combination of the two capabilities into one sophisticated unit has gained favor with medical providers, in particular, in the aero evacuation community and some battlefield medical facilities. At the same time, battlefield medics assigned to SOF and regular ground components units are seeking these devices in smaller form factors, capable of providing lifesaving medical care at the point of injury.
ONE SERVICE’S PERSPECTIVE
Steven Hawbecker, project manager, Medical Devices, United States Army Medical Materiel Agency, provided one service’s perspective on these developments. Hawbecker pointed out that patient monitoring and cardiac defibrillation capability is necessary to health care support operations at Army Role II (Forward Surgical Team) and Role III (Combat Support Hospital) echelons of care. “This capability includes such technology while the patient is transferred from one facility to another through medical evacuation.”
Lessons learned from Iraq and Afghanistan point to a growing desire for merging patient monitoring and cardiac defibrillation into smaller/single devices. In response to this feedback from battlefield health care providers, “USAMMA is supporting an ongoing Technology Review process, including multiple market analyses to capture current and evolving trends in related technology. Additionally, battery technology has significantly improved in terms of weight, charge capacity and shelf-life,” observed Hawbecker.
The market analyses are joint in nature, with the Army fully engaged with the other services. If the results of the market analyses indicate significant technological advancements in form factor or capability are available in a reliable platform, a request for proposal will be initiated. Hawbecker further explained, “Any devices received under such a request will be required to undergo extensive environmental, rough handling and operational testing as part of the source selection decision. The selection would be ‘best value’ to the Army, based on technology performance, cost and vendor past performance.”
Asked to provide his office’s vision of future capabilities in the two families of devices, Hawbecker remarked, “Lightweight, portable devices and/or merged devices capable of both vital signs monitoring and cardiac defibrillation supporting the patient from within the military treatment facility and between MTFs.”
COMBINED CAPABILITIES
Zoll Medical Corporation has a history of over 30 years in partnership with the U.S. military and is a well-established supplier of products to the services. “By understanding the demanding requirements of the military health care provider, Zoll continues to provide innovative solutions to improve health care from the point of injury to definitive care,” said Barnie Howell, senior director of Military Sales at Zoll.
Recent technology advancements within the defibrillator and monitoring product lines include the Propaq MD, the next generation Propaq monitor, which offers the combined capabilities of defibrillation and pacing, all in one 10 pound box (three pounds lighter than the current Propaq) with enhancements that include a third invasive pressure line and advanced capabilities like 12-Lead monitoring. “The other significant element is the battery life. We have doubled the operating time, giving you a full six hours of monitoring all the parameters, taking pressures every 15 minutes plus delivering 10 shocks,” Howell added. “The Propaq MD is also compatible with the approximate 100,000 Propaq monitors’ accessories, which are in the field. Our other new offering for deployable military medicine is the Propaq M, which is the first vital signs monitor to have the same user interface as the Propaq MD transport defibrillator. This feature will greatly reduce future training requirements.”
Weighing less than two pounds is the Propaq LT, which has allowed frontline DoD caregivers to monitor their patients in the harshest environments. Designed to support all levels of care, in particular Level 2 (i.e., battalion aid station), the Propaq LT comes equipped with essential continuous monitoring capabilities (HR, 3, 5-Lead ECG, Sp02, NIBP & Respirations), all in a compact yet rugged design.
The Propaq LT and the airworthy Zoll AED Pro have been packaged in a rapid deployment kit to aid military caregivers in far forward environments. The AED Pro, which is designed to perform in any environment from the battlefield to the hospital, provides the ruggedness, portability and advanced functionality that professional rescuers and services require from an AED.
In other industry developments, Physio Control’s Lifepak 15 monitor/defibrillator was unveiled in spring 2009 with the military medical community in mind. “The Lifepak 15 monitor/defibrillator is designed to withstand the harsh and rigorous environments of military medical units.
There is not another monitor/defibrillator that meets our standards for dust, water, vibration and shock,” said Aric Vacchiano, national manager, Strategic and Government Accounts. “The goal of this device is to integrate the power of defibrillation with an extensive array of monitoring functions, enabling military medical personnel to assess patients’ status and make timely, appropriate treatment decisions.”
The Lifepak 15 offers enhanced monitoring parameters when compared to its older product siblings. During a product overview, Vacchiano further noted, “We have partnered with outstanding companies to incorporate their exceptional monitoring capabilities into the Lifepak 15 monitor/defibrillator, including Masimo Rainbow SET Technology with SpO2, SpCO, and SpMET monitoring, Oridion Microstream EtCO2, CAS Medical MAXNIBP (noninvasive blood pressure) monitoring, and the Glasgow 12-Lead ECG with interpretation and ST-segment trending.”
The device also has a lot of data capture and transmission capabilities. The Lifepak 15 monitor/defibrillator is capable of communicating ECG and vital sign data to computers, printers, PDAs, pagers and other devices. Essentially this allows us to capture 12 lead ECG data and patient vitals in the field, and transmit that data (via secure internet platform) during patient transport. Field medical teams can alert predetermined caregivers (i.e., ED, interventional cardiology, on-call physicians, etc.) which allows our customers to better manage the patient flow.”
Vacchiano pointed out another unique attribute of the Lifepak 15 is the option to escalate the energy level up to 360J. “Evidence published since the AHA Guidelines 2005 show that some patients are more difficult to defibrillate and higher energy Physio-Control biphasic shocks escalating to 360J can improve shock effectiveness when lower energy shocks fail.
“We are the only device in the marketplace with clinical research demonstrating the benefit of escalating energy beyond 200J up to 360J,” said Vacchiano.
Operational attributes include the ability to switch from full-color to a high-contrast SunVue mode to permit increased sunlight visibility, and the latest lithium-ion battery technology allows for hot swapping without any loss of monitoring or data.
The device’s designed lifespan is 7 to 10 years. The Lifepak 15 is in service with the DoD, FBI and other government organizations.
A third industry member, Philips Healthcare, was awarded a DoD contract in fiscal year 2009 for the HeartStart MRx monitor/defibrillator. Titled the “Medical Equipment Corporate Exigency Contract (CEC),” the agreement establishes a long-term program between the department and Philips to provide sustainment material to meet the services’ requirements in times of contingency operations. This contract may also include providing logistical support to humanitarian, emergency and urgent relief efforts performed under the authority of the military.
The HeartStart MRx is a portable, rugged advanced monitor/defibrillator that meets military airworthiness standards for rotary and fixed wing aircraft. To achieve military airworthiness, the MRx went through a battery of testing, including electromagnetic interference and compatibility, environmental, vibration and in-flight and human factors testing.
The monitor/defibrillator includes Philips’ patented Smart Biphasic therapy and provides several best-in-class advantages, including excellent battery-powered operating time, fast time to shock and large color display.
The HeartStart MRx provides a wide range of monitoring capabilities and is compatible with Philips IntelliVue monitoring systems within hospitals. Key monitoring parameters of the HeartStart MRx include arrhythmia detection for 10 rhythm disturbances and irregularities, continuous temperature monitoring (core and skin) for post-resuscitation hypothermia protocols, vital signs trending and audio recording.
Brian Healey, senior marketing manager for Philips Federal/ Military Healthcare, noted his company is also focused on DoD’s concurrent efforts to field lighter weight, portable, battery-powered devices. “That’s where we have our other product, the MP2 [patient monitor] that we introduced just a couple of years ago. It’s a monitor that is feature rich but you can combine that with an AED.”
Healy noted the multiple product offerings allow Philips to cover almost every echelon of health care. “It’s our unique value,” he said.
OTHER PRODUCTS
Also representative of Zoll is the Power Infuser, the first portable, miniature pump designed specifically for controlled, rapid delivery of IV fluids or blood. Small, durable and easy to use, it works when a lack of personnel or room to elevate the bag impedes treatment during transport or at mass casualty events.
“With our ongoing focus on the advancement of resuscitation and critical care, the Zoll E Series now includes integrated SpCO. This non-invasive Masimo Rainbow SET carbon monoxide measurement allows rescuers to easily and accurately diagnose CO poisoning in the field.”
Zoll’s Intravascular Temperature Management system (IVTM) offers health care providers the power and control they need to rapidly, safely and effectively manage the core body temperature of critically ill or surgical patients. “We are seeing tremendous interest from the U.S. military in our Thermogard XP console which delivers accurate, easy to use and cost-effective control for treating the resulting hypothermia in burn and trauma patients,” said Howell. Additionally, therapeutic cooling is considered a useful tool for ICP management.
“We are pleased to have been selected as the leading supplier of resuscitation products, which are utilized throughout military health care, including special operations medicine, Navy fleet and Marine expeditionary medicine units, Army forward surgical teams and combat support hospitals, critical care air transport teams, and VA and military hospitals. As the current PMI defibrillator supplier to the U.S. military, Zoll has recently been awarded the exigency contract and we look forward to support the U.S. military’s goal, to help save more lives.” ♦