EpiGuard Approved by TGA in Australia

EpiGuard just announced that the EpiShuttle is approved by the Therapeutic Goods Administration (TGA) and is now fully available for use in the Australian market.

“Even though The EpiShuttle has been with RAAF for some time now, we are happy to see that the safe isolation and transport system is now fully available to the civil Australian market,” Michael Eimstad, CEO at EpiGuard said.

Australia is known for its long distances which often require the use of air ambulances.

“We have all experienced how contagious viral diseases are and how they occur more frequently. We know that the EpiShuttle is the best, safest, and most efficient way to transport contagious patients by air. The EpiShuttle is finally available to front-running Australian players like CareFlight in their H145, and especially LifeFlight Australia, with their Challenger 604 in service, which is the same aircraft as FAI air ambulance recently received their supplementary type certification (STC) by the European Union Aerospace Safety Agency (EASA) on.

“The same goes for MedSTAR and their Bell412 which is the helicopter the Royal Norwegian Air Force fitted for use with the EpiShuttle. Furthermore, Toll Ambulance Rescue can benefit from both the Northern Norway Regional Health Authority and Abu Dhabi Police’s experience from using the EpiShuttle in the AW139. Also, the Royal Flying Doctor Service (RFDS) may benefit a lot from Pilatus Aircraft Ltd’s own integration of the EpiShuttle, into their four medevac PC-24s.”

During trials to certify the PC-24’s impressive unpaved runway capabilities, aircraft manufacturer Pilatus prioritized the requirements of the Royal Flying Doctor Service of Australia. A key early customer for the Swiss twinjet, the RFDS helped establish the PC-24’s credentials as an air ambulance.

TGA is Australia’s regulatory authority for therapeutic goods such as medicines, medical devices, and diagnostic tests. This approval adds to the approvals of the EpiShuttle isolation and transport system and demonstrates that the EpiShuttle meets the high standards required by the Australian regulatory authorities.

“The approval allows the EpiShuttle to be an important asset to Australian medical providers, enabling them to transport infectious patients safely and efficiently in emergency situations”, Eimstad said.

Viral outbreaks occur more frequently now than before. During epidemics, there are hotspots with ICU capacity brought to their knees. Safe isolation and transport are therefore kernels to the strategy of pandemic preparedness.

“During outbreaks, we must be able to transport patients out of hotspots to where ICU capacity is available. Only when safe transport is in place can we utilise the full capacity of the entire healthcare system and ensure treatment for everyone,” Eimstad concluded.

EpiShuttles are used by WHO as well as first responders in Germany, Belgium, Denmark, Peru, Ireland, Greece, Norway, and the UK. Also, national air forces like the Australian, Canadian, Danish, Norwegian and others are equipped with EpiShuttles. In the private sector, EpiShuttles are a common sight amongst companies like FAI air ambulance, Air Alliance Medflight, DRF Luftrettung, Keewatin Air, Luxemburg Air Rescue and others. The EpiShuttle is NATO stock listed and CE-marked as a class one medical device.