00011386 - Transport Infusion Pump

1.         Introduction
As the publicly funded provider of air ambulance and critical care transport for Ontarians, Ornge has unique requirements for biomedical equipment that can operate safely in the dynamic transport environment.  Specifically, for the purpose of delivering infusions of medications, fluids and blood products, Ornge requires transport-focused infusion pumps for use in fixed-wing and rotor-wing aircraft and critical care land ambulances. For use in the transport setting, such infusion pumps must be lightweight, provide software features including medication libraries and smart medication safety options, while providing the ability to deliver, as a single unit or in combination, up to 8 simultaneous infusions.  For the purpose of transport, Ornge is seeking vendors with currently available, or forthcoming infusion pumps which are designed for the unique challenges and rigors of the out-of-hospital transport environment.  Considerations must include access to certified mounting options for aircraft and ambulances, battery life and power management solutions and safety in temperatures and operating conditions outside of normal in-hospital environments.

This Request for Information (RFI) is issued by Ornge for the purposes of gathering information only and does not constitute a commitment.  The intention is to explore the marketplace in order to assist in the determination of future purchasing options or requirements.  Any decision would be contingent upon the products meeting Ornge’s unique needs, including the ability to successfully mount the devices in a manner that meets Transport Canada aviation requirements.  Respondents are asked to respond to Ornge and provide the information requested below.
Ornge provides air and land ambulance services under an agreement with the Ontario Ministry of Health. Additional information about Ornge is available at: www.ornge.ca.

3.         Background
Ornge’s air ambulance and critical care land ambulance fleet is made up of PC 12 fixed wing and AW 139 rotor wing aircraft, and Crestline Commander land ambulances, operating out of thirteen base locations across the Province of Ontario.
Ornge has over 650 employees, including paramedics, pilots, aircraft maintenance engineers, transport medicine physicians and dispatch communications officers both medical and flight.

Ornge’s advanced and critical care paramedics provide medical care in transport at among the highest level in North America, including ICU-to-ICU level transports of the highest acuity patients.  Reliable and easy to use biomedical devices are key to the success of these life-saving operations. 
With respect to infusions, Ornge teams provide infusions of medications, including high-alert medications and controlled substances, fluids and blood products across all age ranges (neonate to adult).  In a typical transport, patients may have 6-8 unique medications or fluids requiring simultaneous infusion.  Each of the infusion pumps supporting these infusions must be available at arms-reach within an aircraft or ambulance, be visible and easily operable in a variety of lighting conditions, and be light enough to support both mounting on various platforms and the requirement to hand carry the pumps, often over distance, to either an accident scene or patient bedside. 

The requirement to mount and operate the infusion pump in aircraft also poses unique challenges.  OEM mounting brackets or pole-mount mechanisms do not typically meet the requirements for aviation pull testing, typically at 20G or greater. Thus, specially engineered mounting solutions that meet Transport Canada certification requirements are often necessary.  Additionally, power management solutions are necessary as the number of available power outlets and the available power consumption limit the number of devices that can be plugged in to AC power at any given time. A transport infusion pump thus provides sufficient battery life to remain operational for the duration of transport, sometimes four hours or greater. Any solution that proposes multiple separate infusion pumps grouped together to provide the necessary number of unique infusions must have a robust and compact power management solutions that enable the powering and/or charging of multiple pumps with a single AC power connection. 

The provision of critical care in the transport environment also challenges the typically operating conditions of biomedical equipment. Ornge paramedics provide care at emergency scenes on roadsides, shorelines, densely wooded remote areas, industrial sites and other locations in addition to the traditional hospital setting. These outdoor care locations necessitate equipment that can safely operate in operating temperature ranges well outside published norms for in-hospital equipment. Exposure to elements including rain and snow is also not uncommon. 
Finally, as a healthcare organization accredited by Accreditation Canada with Exemplary Standing, Ornge seeks infusion pump solutions which in addition to transport-specific capabilities also provide smart medication safety features including advanced medication libraries and user interfaces designed to identify and prevent medication errors. These libraries must be programmable for different age groups and be easily updatable as medication requirements change or adapt. Ideally, libraries will have warning zones and hard limits for infusions outside of set parameters.  

4.         Minimum Requirements
Parameter                                Minimum Requirement
Battery Life                               8 hours active use
Flow Rates                               0.1 – 999ml/hr
Programmable Drug Library    Programmable library with  hard limits
Standards                                Certified for electromagnetic compatibility and other standards suitable to Canadian aviation regulations
Approvals                                 Currently approved by Health Canada for use in Ornge’s clinical setting, or with active plans to obtain such approval

Ornge envisions that an appropriate transport infusion pump solution will have the following features or capabilities:

• Lightweight;
• Rugged design;
• Multi-channel, allowing 2-4 simultaneous infusions using as single pump;
• Ability to operate indoors & outdoors in a variety of environments;
• Highly visible graphic user interface, readable and operable in both high and low light conditions;
• Human factors driven design to ensure ease and accuracy of setup and operation;
• Satellite based command and control, including tracking;
• High-precision infusion accuracy in all modes;
• Advanced drug library which incorporates medication safety processes;
• Extensive battery life in real-world operational conditions (high flow rates, low ambient temperatures, backlighting systems activated, continuous setting changes);
• Power management solutions for charging and operation of multiples pumps with a single power supply;
• Ability to mount single or multiple pumps in a lightweight, user friendly configuration that meets aviation certification requirements; and
• A variety of disposable infusion sets for standard infusions, blood product infusion and specialty infusions.