TGA assesses Ballarat-built medical ventilator

THE Therapeutic Goods Administration are in the process of assessing Gekko Systems’ GeVentor for approval.

A mining equipment producer, the company has pivoted expertise and resources to engineer machinery for the COVID-era, including a medical grade ventilator.

Managing director, Elizabeth Lewis-Gray said the GeVentor will take over breathing for those needing help.

“With COVID, some people need to be sedated and anaesthetised. What we’re offering is a mandatory ventilator which completely operates instead of their lungs, providing a mix of oxygen and air,” she said.

“Most Australian ICUs have sympathetic ventilators that cost $100,000. If the patient is trying to breathe, it will sympathetically respond to that.

“But it’s a much faster process for us, through the TGA to get a mandatory ventilator designed and built. That’s the main requirement through COVID at the moment, and a unit will cost closer to $20,000.”

The TGA have provided an exemption approvals process, accelerating assessment with the regulator looking at test work and design protocols, quality, usability and customer surveillance.

“If there are other devices available, fully approved, they will be used first, and this would be used as a secondary requirement.

“We’ll have a choice, once COVID’s over, whether we want to take the unit right through the full approvals process which would normally take one to two years,” Ms Lewis-Gray said.

Ballarat Innovation Research Collaboration for Health have clinically evaluated the ventilator. Humanitarian groups have expressed interest in the “easy-to-use” system for developing nations, so Gekko Systems is exploring export options.

The only other ventilator that has passed the exemption process globally, that Ms Lewis-Gray is aware of, was developed by NASA.

“Approval would be a great feat in its own right. We’d like to think our ventilator will have the opportunity to save peoples’ lives,” she said.