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03 April 2020

“As far as we are aware, TÜV SÜD is currently testing a design by ULTIMAKER. Generally, designs should be tested according to the applying norms such as EN 166 for face shields.
The most important topics to be tested by a local hospital are mechanical properties (form, fit, function) and disinfectability. New designs should be approved by the local department of hospital hygiene.”

At least after every contact with a patient, who is considered infectious, the shield should be disinfected.

Prusa states they have an approval by the Czech ministry of health. Furthermore, their design has been approved in the US by Michigan Medicine Procurement (PRUSA Protective Face Shield-RC3). Both the high resolution as well as the suggested low resolution settings have been approved, too, and material (PLA, PETG) is not a consideration as of 27 March 2020.

From our perspective, we have not witnessed any supply problems with 3D printing so far. 3D printing is a suitable solution, especially for reproducing the exact geometry of the splinters.

31 March 2020

At present, most of the use cases are focused on polymeric materials. Nethertheless, there are first use cases for metals like holders for disinfection bottles in hospitals.

We notice that right now more attention is being paid to 3D printing. We witness that in Asia, the supply chains have largely collapsed and fast as well as pragmatic solutions with short transport routes are required.

Right now, a lot of such files are being shared in the world wide web. MGA has created a section for use cases on this website where samples can be found. Moreover, our recently launched platform weboostam.com is a possible source to retrieve such data. Please note that both are selections only and – of course – do not reflect the complete scope of Corona use cases available. Please also pay attention to our disclaimer.

For sure, it is ok and makes sense to print own protective masks or shields on a desktop printer for private use. However, for commercial use and especially for the use in hospitals, either a certified process or a certified end product is mandatory as those are medical products for which the related standards must be applied. Also, product reliability must be assumed.

Recently, reports from Italy had communicated that – in an instant need – components for ventilators had been reprinted. This was due to an ad-hoc lack of such parts while high amounts of patients had to be doctered. The OEM of these parts olds a copyright and had not released it. So in a legal sense, the reprinted components have been product piracy, even if they might have saved lives.

Product liability applies to all sorts of applications, no matter whether it is an officially sold product or a donation as these are medical products. For personal use, product liability is not an issue.

As MGA, we are not obliged to make recommendations to policy makers. Our role is to provide information about the feasibility for production, suitable materials, product liability etc. Moreover, we have tested the wearing comfort of individual face shields and arrange matches between hospitals in need of medical products and certified manufacturers.

Please contact TÜV SÜD Product Service Ltd. for more depth. To our knowledge, the tests have been carried out in a clinic in Braunschweig.

Indeed, this makes sense, but as the many approaches on face shield designs are not coordinated yet, this is difficult to realize.

27 March 2020

Decathlon states on their website that they will limit the distribution of their Easybreath-masks to hospitals, research facilities and other institutions.
New information about liabilty of selling and donating medical products will be provided in our next Webex on 3 April 2020.

The FIT AG has a new approach to face masks that can be assembled without glue. It will be demonstrated in our next session on 3 April 2020, as well as other approaches, too.

AgvaHealth has made the following statement on their website:
We would be ready to have the product manufacturing licence to be given to the identified, willing and capable manufacturer.
The company will provide technical drawing details, manufacturing process, machining and software for the development of AgVa Ventilators.
The company will provide the essential raw materials from its OEM in order to build the ventilator.

They are a use case, but the focus is currently more on face shields, face masks, glasses and other safety equipment

PETG can be sterilized using radiation or compatible chemicals but it cannot be autoclaved. Its chemical resistance is inferior to that of the polyolefins with a rating of “fair.” Steam sterilization, carried out in a temperature range of 120-130°C, results mostly in post-crystallization and physical aging effects of PP.

The current directive remains in force or the transitional period is extended until the final entry into force of the new MDR. This affects all producers who have not been able to certify their products right now.

EN 14683 is required for medical masks whereas EN 149 is dedicated to general masks in non-medical jobs.

MGA is in contact with several clinics and is working on creating one plattform for fast and straightforward communication of demands and supplies available as well as the respective distribution channels.

24 March 2020

Right now, there is a lot of initiatives to create such databases to support the health system to steer us through this pandemic crisis. Many are fairly general with non-AM relevant, but also AM-relevant cases of need and/or offers.

Databases that we are aware of and which we can access are scanned by us on a daily basis with regard to AM feasibility and then transferred over to our data records. In the case of tangible propositions, we pass on the information accordingly and provide support in establishing contact with the users.

To raise your offer or announce your demand please fill the forms on our webpage.
For needs that have already been addressed to us we have already started matching those with potential offers as well as to review and channel proposed solutions. We kindly ask for patience in case not every inquiry can be answered in short time.

Inquiries regarding regulatory requirements and potential exceptions can only be answered by notified bodies such as TÜV Süd Product Service GmbH or other experts.

At this moment, the demand is mainly focused on items for protective equipment:

  • face masks with appropriate filters,
  • face shields (based on materials that can be disinfected and sterilized),
  • but also bottles into which sterile fluid can be filled (compatible with defined dispenser holders),
  • up to parts for respirators and their components (e.g. splitters etc.).

Thus, it is of vital importance to make your offer visible for quicker and easier retrieving in case the demand arises. Transparency across the AM market will be key when the time may come to match demand and offer in an instant. It goes without saying that we must be able to fulfill the needs of different target groups: not only highly complex ventilators and intensive care units, also more simple, affordable solutions for average consumers to support the public infrastructure (e.g. bus drivers, bakery or security staff).

To raise your offer or announce your demand please fill the forms on our webpage [LINK].
For needs that have already been addressed to us we have already started matching those with potential offers as well as to review and channel proposed solutions. We kindly ask for patience in case not every inquiry can be answered in short time.

Naturally, the best choice are certified / approved materials for medical applications. For broader applications such as face shields which are not to be used in hospitals suitable plastics with the following requirements are sufficient:

  • transparent,
  • scratch-resistent,
  • non-fogging,
  • not absorbing toxic fumes and
  • easily disinfectable.

Please find more information about materials on our website. There are a couple of tenders.

A number of different fundings have recently been released.
Generally, hospitals are provided with financial resources allowing them to purchase additional materials autonomously. However, there are also initiatives by networks to provide financial support to companies, for example 3DHubs.

At this moment, the demand is mainly focused on items for protective equipment. Moreover, the number of masks required varies from state to state, amounts vary from several hundred thousand to several million. At times, some of them could be supplied as sterilizable, reusable variants, but the majority will most likely be used as single-use variants.

It is not possible to tell how high the demanded volume is going to be, even harder it is to foresee when exactly what is needed and where. Thus, it is of vital importance to make all offers visible for quicker and easier retrieving in case the demand arises. The aim should be to arm AM forces and be prepared to being able to deliver in shortest possible time as soon as the ad-hoc need is there.

At this moment, the demand is mainly focused on items for protective equipment: face masks, face shields, but also bottles into which sterile fluid can be filled and which are compatible with defined dispenser holders up to parts for respirators. Thus, it is of vital importance to make your offer visible for quicker and easier retrieving in case the demand arises. Transparency across the AM market will be key when the time may come to match demand and offer in an instant. It goes without saying that we must be able to fulfill the needs of different target groups: not only highly complex ventilators and intensive care units, also more simple, affordable solutions for average consumers to support the public infrastructure (e.g. bus drivers, bakery or security staff).

To raise your offer or announce your demand please fill the forms on our webpage.
For needs that have already been addressed to us we have already started matching those with potential offers as well as to review and channel proposed solutions. We kindly ask for patience in case not every inquiry can be answered in short time.

Needless to say that this is surely an ethical question. At the end of the chain is the clinical staff who has to make a decision due to a shortage. However, it is also a legal or regulatory question whether this shortage had to arise at all as there could have been alternatives to certified components, even if not certified – this question is for the bodies to decide upon.