OperationAIR student team creates working prototype for emergency ventilator
In just three weeks’ time, TU Delft students from the OperationAIR initiative have developed a working prototype for an emergency ventilator for coronavirus patients: the AIRone. Following the success of the first tests using a mechanical lung, permission has been requested from the Dutch Ministry of Health, Welfare and Sport to enter the next phase. For this, intensive care practitioners will carry out clinical tests using the ‘first model’, the first device as it will be produced for use in ICUs. If this results in clinical approval, the ministry can give the order for production.
On Monday 16 March, the TU Delft OperationAIR student team set to work, led by Professor Jaap Harlaar, Director of Studies at Clinical Technology. The team comprises 50 Master’s students from various degree programmes, including Clinical Technology, Mechanical Engineering and Electrical Engineering. Their first design for an emergency ventilator was ready within a week. The design requirements were drawn up in close consultation with specialists from LUMC and Erasmus MC.
Ready for clinical testing
On 3 April, 18 days after the start of OperationAIR, a working prototype, the AIRone, was ready. Marijn Mostert, coordinator of the test team: “In the last few days, we’ve carried out extensive tests with the AIRone. We checked all the functions using a mechanical lung with a range of sensors, to check that the device meets all the performance requirements. We also performed user tests with various intensive care practitioners to check for ease of use. Now that all the necessary documentation has been submitted to the Ministry of Health, Welfare and Sport, we are ready for the next step: clinical approval.” The team will be using the coming days to carry out the necessary safety tests.
Meanwhile, the ministry needs to assess the submitted documents and give the green light for clinical approval. Granting clinical approval means the device will be approved for use on COVID-19 patients during the crisis. In that case, the ministry will give the order for the AIRone to go into production.
The AIRone connected to a mechanical lung.
For production, OperationAIR will be working together with an assembly company in Delft. “Everything is ready and waiting to start production. We have good contact with the suppliers of the various parts for the AIRone, and as soon as the ministry gives the order for production, we can order the parts and start production in collaboration with our partners,” explains Josephine Dumas, coordinator of the production team. It is OperationAIR’s ambition to produce100 devices a week, and to ultimately produce a total of 500. “However, if the situation in the ICUs deteriorates, we can look at scaling up production. We are in close contact with the Dutch Association for Intensive Care (NVIC) and the National Consortium for [Medical] Appliances (LCH) about the current situation in the ICUs and the need for ventilators,” says Jaap Harlaar.
Once the design has been given clinical approval and taken into production, OperationAIR will continue to work, focusing on implementation, service and further development. The team have already drawn up plans for training, with a short training course for medical staff. And when the ventilators are taken into use in a hospital, a team will be on standby to assist in the event of any questions or problems.
The final design and the associated documentation needed to build the device will be shared as open source on the OperationAIR website. “We hope that this will enable the device to be imitated in other countries where there is a shortage of ventilators. In this way, we are also doing our best to make a contribution to the fight against the global shortage of ventilators for coronavirus patients,” concludes Jaap Harlaar.
More information about OperationAIR can be found at www.operationair.org
The OperationAIR team, before current measures were taken.