3D Printing

Ventilation devices from the 3D printer – what needs to be considered

The dramatically increased demand for ventilators in the wake of the Corona crisis poses a particular challenge for industrial production. It is therefore all the more obvious that car manufacturers, as well as engineers and researchers from a wide range of technical disciplines, should also get involved in the design and construction of ventilators. 3D printing offers the ideal solution for producing various individual parts in a timely and cost-effective manner.

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Special requirements

However, it is by no means as easy as it might sound to switch production from (e.g.) cars to ventilators almost overnight. One challenge is getting the necessary medical technology know-how after all, these are devices for a highly sensitive purpose. If in doubt, developers should therefore seek cooperation with experts from the medical technology industry.

On the other hand, it must be remembered that medical devices are subject to a legally clearly regulated approval process.

The admission process

In Germany, the responsibility for the approval of medical products and medical devices lies with the Federal Office for Drugs and Medical Devices, BfArM for short.

Normally, there are fees for the necessary approval of new medical devices, and applications must also be filled out correctly. Due to the current crisis situation, however, the hurdles at the BfArM have been lowered, which means that the usual fees are no longer applicable for the time being. Manufacturers are also advised so that the applications are correct.

In the case of the approval of ventilators, the BfArM should, in the broadest sense, be guided by the requirements of the US Food and Drug Administration, FDA summarized in a nearly 25-page document. It states, among other things, that the ratio of inhalation and exhalation must be one to two. The device must allow at least 10 and a maximum of 30 breaths per minute, adjustable in steps of two. In addition, the devices must be able to withstand continuous operation for at least 14 days. Stable control software is also required.

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In addition to these technical requirements, the hygiene standards a crucial role for approval. The device must be easy to clean if it is splashed with respiratory secretions or blood. Finally, any risk to both the intensive care patients to be ventilated and the medical staff should be excluded.

Pay attention to certified materials

A crucial prerequisite for the 3D printing of ventilators (or at least their accessories) is the use of biocompatible materials. Of course, this primarily applies to those components that are inserted directly into the patient’s body. At 3D Activation you will find a considerable selection of appropriately certified materials. You can also read more information about biocompatible plastics in our blog.

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