Mobile mass casualty care

The Livengood MPCE defines the patient as the center of care regardless of location. Current planning for mass casualty care in alternate sites accounts for shelter, beds, equipment, and supplies – but the architecture that creates the patient care environment is missing. Placement of equipment and supplies are either on the ground, stacked on boxes, or put on makeshift carts.

Developed out of the clinical experience of Livengood’s trauma surgeon and founder, Joseph Livengood, MD, FACS, Livengood has developed the Mobile Patient Care Environment (MPCE) – a product line to address the need of a mobile patient care solution. Integrating contract manufacturing into the process, Livengood has been able to maintain a focus on design, keep overhead low, and work rapidly through product development.


Defining the Need
Emergency preparedness for healthcare presents many challenges, one of which is to create a hospital in an alternate site without compromising the level of care provided. Expecting a tent or building to accomplish this on its own is unrealistic, though often this plan along with a stockpile of supplies is all that exists. Proper planning will ensure that patients receive a standard-of-care that is expected and will prevent complications that may occur such as electrocution, falls, injury from falling equipment, and premature removal of devices (PROD) such as IV’s, catheters, and breathing tubes.

Providing a hospital environment within 6ft of the patient, known as patient vicinity, has a higher level of safety criteria than found throughout the rest of the hospital. This requirement is all but ignored in mass casualty incident (MCI) planning, with the assumption that this need not apply. However, the same risks exist at alternate emergency sites and ignoring these standards will result in complications and injuries.

Examples include The Joint Commissions guidelines to secure medications including saline. Underwriters Laboratories also has an electrical safety standard for the Patient Vicinity based upon the international standard of IEC60601. Plug strips, daisy-chained extension cords, and unstable equipment mounting are all in violation of these codes, which most hospitals consider mandatory.

Compact equipment is easier to move, but can result in longer setup times if designed more with storage in mind than rapid deployment. Setup of this equipment has resulted in a gap in the number of patients (10 to 30) served in a disaster response, which has proven to be the norm by providers. Management of smaller events occurs in existing emergency departments, while larger ones require deployment of massive amounts of equipment and supplies. A rapidly deployed solution for all events, with a specific focus on the moderate events, is the necessity.


Recognizable Environment
The majority of staff responding to a MCI will not be trained or familiar with the care of patients in an alternate site. Therefore, a great advantage is the recreation of an environment that is familiar to staff – one where immediate attention can be put towards patient care, rather than the orientation and search for supplies.

Currently, the organization of medical equipment and supplies is based upon how it will fit into a truck rather than how it will be used. Large containers, collapsible equipment, and pelican cases make up most MCI kits. This results in long set up times involving multiple staff, supplies that are located centrally and away from the patients, and cases stacked on the ground to double as equipment mounts. This results in clutter – blocking patient access, the inability to move patients without a large number of staff, equipment that is prone to tipping, falling, or breaking, as well as PROD.

 

Design Criteria

The defining MPCE design criterion was Platform use in the Patient Vicinity, according to the IEC60601 standard as interpreted by Underwriters Laboratories. Additional criteria selection was to meet the needs of MCI and Disaster Relief.

• IEC 60601 Electrical Safety for the Patient Vicinity with IPX1 Water Resistance – This needs to apply to the entire platform rather than just the power module to ensure that the entire platform is safe for use in the patient vicinity.
• Compact and Mobile – While storing compactly, it should be readily mobile with minimum setup for rapid deployment.
• Modular and Rapidly Configurable – The platform is capable of use in a wide range of capacities, allowing configuration into a mobile ICU for disaster relief and then reconfigured for use in the hospital during normal operations.
• Universal, Vendor-Neutral Platform
• Intuitive User Interface – The platform should be intuitive to the degree that medical staff can understand its functionality with minimal orientation so focus is on patient care.
• Internationally capable – Modules allow for rapid conversion to worldwide voltages and outlet types.
• Design for the Future – The platform itself can drive the direction of future medical device design into the plug-and-play capabilities found in the computer industry.

Center of Care
The Livengood MPCE defines the patient as the center of care regardless of location. It recreates an emergency department/ICU on a mobile platform that preserves hospital-level safety standards, organization, and capabilities in alternate sites for use in emergency preparedness, MCIs, and disaster relief.

It was determined early in the process to use an approach of roll-off-and-go rather than a collapsible system. Having a pre-configured platform eliminates multiple boxes and additional space required for independently packed equipment and supplies. The time and personnel it takes to setup an alternate site is also greatly reduced, making deployment more effective for a broader range of events. Specifically, the efficiency to respond to the more frequent 10 to 30 patient events improves.

The MPCE immediately transforms any site into an ED/ICU with a single platform providing four power outlets, a ventilator, monitor, suction, oxygen, IV pumps, and supplies separately to two patients. Whether the site is a sports venue, cafeteria, or open lot, the safety standards and organization found in the hospital are maintained.


Using CMs
Contract manufacturing is a fundamental part of business operations. Rather than looking at the process as outsourcing, Joseph Livengood, MD, FACS, and founder of Livengood Medical, views contract manufacturers as part of the design and manufacturing team, which is essential to his company’s growth.

“Start-up companies provide small quantities of work to contract manufacturers and require rapid turnaround times to meet market demand. Establishing a strong relationship is crucial to meet product demands within a budget that fits Livengood’s research and design capabilities,” Livengood states. “Establishing good contractor relations expands our expertise by using the contractors’ knowledge to review designs on a regular basis,” Livengood explains. “They provide valuable insight into materials selected, manufacturability, and cost-saving measures.”


Design / MFG / Assembly
Livengood began with implementation of subscription software from CoCreate, now PTC Creo Elements, to have early access to CAD design. The non-history based system and strong support provided by PTC, also enabled the use of contract designers who can work directly in CAD for short intervals without having to review the design history.

“Underwriters Laboratories was remarkable in its desire to work with Livengood in understanding the UL60601 standard. The team assigned to the project was patient and worked diligently to help design toward a successful project that ensured patient safety,” Livengood explains.

The desire to build a MPCE using off the shelf parts was rapidly met with the reality that these were not available.
“This resulted in an exhaustive process of sourcing and developing parts to meet needs, which is where relationships established with our contract manufacturers have proven to be so valuable,” Livengood states.

Assembly is another important part of the design process.

“The practical decision to do in-house assembly initially resulted in visualizing and experiencing the result of our design for assembly, repair, and use,” Livengood says. “This has contributed to a wide range of modifications to reduce assembly effort and cut cost. It is unlikely that our product understanding would have been as complete without the inclusion of assembly at our site.”

Livengood’s success has hinged on the use of contract manufacturing throughout the product cycle. Specifically for a small start-up company, in-house capabilities and resources are limited. Used effectively, contract manufacturers can provide far more than just acting as a machine shop or offering technical skill.

Innovation originates from non-traditional paths and contract manufacturing enables these alternate paths to bring concepts to reality.


Livengood Medical
Fort Collins, CO
livengoodmedical.com

PTC
Needham, MA
ptc.com