Oswab: 3D printed swabs for testing COVID-19

The Oswab is the result of an existing local Dutch partnership, of which all partners are certified to develop and produce medical products. Thanks to this project, the supply of swabsticks for testing can be secured quickly and “testing, testing, testing! can be realized. The official press release:

Ede, Roden, Hoogeveen – At this time, swabsticks are seriously needed to collect samples for COVID-19 tests in potential patients. These nasal swabs are used to test for influenza and respiratory infections. With the Oswab, a 3D printed version of the swabstick, the supply can be secured quickly.

To safeguard supply of swabs, The Netherlands has started with the development and production of swabsticks, required for certain COVID-19 tests. Starting with a prototype, developed on behalf of the Ministry of Health, Welfare & Sport (VWS) 2 weeks ago, the Oswab is ready for the market, as a 3D-printed alternative to the existing swabsticks.

Corona swabs from The Netherlands
The production of the Oswab is the result of a collaboration between three Dutch companies. With a local supply chain and certification for the development and production of medical products, Oceanz 3D printing, DEAM and Almed produced, packaged, sterilized and validated the 3D printed swabsticks within two weeks, with a quality level that enables safe use.

Tested & validated
3D printing is a very suitable method to get this started quickly. After a few days, the first prototypes of the Oswab were delivered for testing and validation by Netherlands National Institute for Public Health and the Environment (RIVM). RIVM is one of the parties in the diagnostics task force that was set up under the direction of the Ministry of Health, Welfare and Sport. This task force is part of the National Consortium on Resources. At the same time, DEAM organized the supply chain and ensured that the product and production process complied with European directives. After the 3D printing process, the swabsticks are safely packed by Almed, sterilized and distributed to test locations. All tests have shown that the 3D printed swabsticks perform as well as standard nasal swabs used for COVID-19 testing. Nursing staff also indicate that the 3D printed swabsticks are comparable in use.

3D printing and ISO 13485
Now that this validation has been completed, the 3D printed swabs are put into mass production. The 3D printing technology enables fast scale up in numbers. Swabs are medical devices and must be manufactured according to the EU guidelines for medical devices. These are also the guidelines urged by the European Commission in the reports of late March regarding 3D printing for COVID-19 tests. For the production of the Oswabs, only ISO 13485 certified partners are involved to comply with the guidelines.

 “3D printing these swabsticks is a good example of rapid prototyping and 3D printing; the ability to quickly switch from prototype to large series with this technology. This is done according to ISO 13485, the correct guidelines for the production of medical devices– Erik van der Garde, CEO Oceanz 3D printing.

“In addition to the technical side, medical product development also requires an extreme focus on product quality, and safety, and medical use. DEAM develops products according to ISO 13485 and can therefore realize a medical product according to EU guidelines in a very short time. We do this together with our production partners in one local supply chain” – Wimold Peters, CEO DEAM – Steerable Medical Devices.

“We are delighted to be able to contribute to the production of enough test capacity” – Paul van Rooijen, General Manager – Almed

What is a swab?
The swabsticks are flexible with a bristly end. These are inserted into the nose up to the back of the nasal cavity to collect a specimen, which sticks to the bristles. The swab is then placed in a collection container. Swabsticks have a weak spot at 7-8 cm from the bristle tip, which can break the stick to the correct length when placed in the collection container. In this way, the container can be closed before transport to a laboratory for testing.

Who can be tested with a 3D printed swab?
The swabs are used for COVID-19 testing on healthcare personnel, among others. When primary schools reopen in mid-May, teaching staff should also be tested.

For more information contact:
Wimold Peters

April 24, 2020 News
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