Integrated Medical Systems, Inc. (IMS), has received CE mark approval to market MedEx 1000 suitcase intensive care unit (ICU) in Europe. This certification is administered by the company's Notified Body, VTT (Finland).
The MedEx 1000 is a portable unit intended to supply ICU functionality for adult and pediatric patients. The MedEx 1000 combines the medical device capabilities into a single platform which include physiological monitoring (electrocardiogram, invasive pressure monitoring, non-invasive blood pressure monitoring, temperature, blood oxygen saturation, and heart rate), low rate and high rate infusion pumps, a fluid warmer, a ventilator with carbon dioxide monitoring capabilities and the ability to deliver oxygen to a patient. The functions of the MedEx 1000 are controlled from a central user interface. The MedEx 1000 may be operated using either hot-swappable battery power or an external source. The unit can accept external high pressure or low pressure sources of oxygen. A USB Port provides connectivity to an external printer, and allows for a connection of a USB flash drive to off-load (download) logged data. An Ethernet Port allows for Local Area Network (LAN) connectivity. The MedEx 1000 is intended to be used in hospitals, aircraft, ambulances, field hospitals, and extended care facilities. A future upgrade will allow additional medical devices to be added using the Auxiliary Device Port and be controlled and displayed through the MedEx 1000.
The purpose of the MedEx 1000 is to help support continuous patient care during transport from outside of the hospital or within the hospital environment. Current practice includes frequently disconnecting and reconnecting a patient from therapy and monitoring when a patient is transported. During transport, caregivers have to juggle multiple medical devices and when they arrive at a destination, connect the devices to a central computer. Use of the MedEx 1000 not only increases patient safety, but caregiver efficiency, as well. Clinical studies with the predicate device, the LSTAT stretcher-based integrated patient care platform, demonstrated the need for fewer caregivers during transport, faster response time to adverse events, faster time to go between wards, and potential reduction in the hospital length-of-stay.