The existing EpiShuttle can accomodate a patient up to 198 cm tall and weighing 150 kg. Anthropomorphic studies indicate that a 95%-ile male can fit inside an EpiShuttle. Given limitations in the size of many ambulances, aircraft, and hospital corridors, the size of the EpiShuttle has been considered to be a good comprimise between maneouverability and patient comfort.
In the US, however, much of the physical infrastructure is larger and designed to accomodate larger equipment. At the same time, there are a greater number of patients for whom the existing EpiShuttle may be too narrow.
The objective of this portion of the project is to develop a larger EpiShuttle and simultaneously look at what other features and capabilities we can implement.
The EpiShuttle is currently validated for reprocessing with soak disintection using peracetic acid. This is a safe and effective procedure for disinfecting the EpiShuttle between transportation of infectious patients.
Peracitic acid, however, is not easily available in all markets. At the same time, many health care providers have equipment, procedures, and trained staff in place to disinfect medical equipment using hydrogen peroxide vapor.
In this project, EpiGuard will develop and validate equipment and procedures to allow for safe disinfection of the EpiShuttle using readily available hydrogen peroxide vapor.
The EpiShuttle is CE-marked as a Class 1 medical device in Europe. Through our US distributor, it is also registered with the Food and Drug Administratino (FDA) in the USA. This allows us to market and sell the EpiShuttle in much of the world.
Although CE-marking facilitates compliance in other markets, it is certainly true that FDA (USA) and CFDA (China) clearance will significantly increase the adressable market for the EpiShuttle. This project aims to identify and close any gaps that may exist between existing standards and requirements in the US and China. The project includes the EpiShuttle XL being developed in parallel.
Copyright © 2019 EpiGuard AS
EpiGuard Production
Torsnesveien 210 B
1634 Gamle Fredrikstad
Norway
EpiGuard HQ
Oslo Science Park
Gaustadalléen 21
0349 Oslo
Norway
