FAQ

[vc_row][vc_column][vc_empty_space][dt_button link=“https://mobilitygoesadditive.org/divisions/medical-goes-additive/3d-printing-fights-corona/“ size=“medium“ bg_color_style=“custom“ bg_hover_color_style=“custom“ text_color_style=“custom“ text_color=“#ffffff“ text_hover_color_style=“custom“ text_hover_color=“#ffffff“]About[/dt_button][dt_button link=“https://mobilitygoesadditive.org/divisions/medical-goes-additive/3d-printing-fights-corona/use-cases/“ size=“medium“ bg_color_style=“custom“ bg_hover_color_style=“custom“ text_color_style=“custom“ text_color=“#ffffff“ text_hover_color_style=“custom“ text_hover_color=“#ffffff“]Use Cases[/dt_button][dt_button link=“https://mobilitygoesadditive.org/divisions/medical-goes-additive/3d-printing-fights-corona/sessions/“ size=“medium“ bg_color_style=“custom“ bg_hover_color_style=“custom“ text_color_style=“custom“ text_color=“#ffffff“ text_hover_color_style=“custom“ text_hover_color=“#ffffff“]Sessions[/dt_button][dt_button link=“https://mobilitygoesadditive.org/divisions/medical-goes-additive/3d-printing-fights-corona/faq/“ size=“medium“ bg_color_style=“custom“ bg_color=“#2b79ac“ bg_hover_color_style=“custom“ bg_hover_color=“#2b79ac“ text_color_style=“custom“ text_color=“#ffffff“ text_hover_color_style=“custom“ text_hover_color=“#ffffff“]FAQ[/dt_button][dt_button link=“https://mobilitygoesadditive.org/divisions/medical-goes-additive/3d-printing-fights-corona/links/“ size=“medium“ bg_color_style=“custom“ bg_hover_color_style=“custom“ text_color_style=“custom“ text_color=“#ffffff“ text_hover_color_style=“custom“ text_hover_color=“#ffffff“]Links[/dt_button][vc_empty_space][/vc_column][/vc_row][vc_row][vc_column width=“1/4″][vc_column_text]

03 April 2020

[/vc_column_text][/vc_column][vc_column width=“3/4″][vc_tta_accordion gap=“10″ c_icon=““ active_section=“123″][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Face shields: Which designs is TÜV SÜD currently testing? What topics will be tested? What should be tested on prototypes at least by a local hospital?“ tab_id=“1586941193366-d6a6792b-db2e“][vc_column_text]“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.“[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Face shields: Is there any recommendation how often a face shield with 3D printed holders should be disinfected?“ tab_id=“1586941167147-b6d25a58-e182″][vc_column_text]At least after every contact with a patient, who is considered infectious, the shield should be disinfected.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Face shields: At the last call it was mentioned that Prusa design is under test, not in Germany. Where? Which design? Can you provide some info?“ tab_id=“1586941308430-1b2984d5-1fca“][vc_column_text]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. [/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Do you have info on the Fraunhofer initiative from Janis Winzer? Is the platform already announced?“ tab_id=“1586941325919-621cf683-c833″][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“The last week mentioned splitters manufacturing will block 3d printing resources, which might be required for complex geometrical parts. Is it possible to make it just out of nylon block with only drill holes? It could save short 3d printing resources.“ tab_id=“1586941359746-857c44df-e6fe“][vc_column_text]The latest information we have is that the platform is still in progress of being set up. Yet, it does not seem to be online.[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row][vc_row][vc_column width=“1/4″][vc_column_text]

31 March 2020

[/vc_column_text][/vc_column][vc_column width=“3/4″][vc_tta_accordion gap=“10″ c_icon=““ active_section=“123″][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Do you see any use for metal parts? As an OEM we are looking to help, but most parts seem to be Polymer material. If yes, what kind of metal would you think is most suitable?“ tab_id=“1586941255148-d03534e6-b9a8″][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Do you see that 3d printing being adopted much faster in hospitals or pharmacies coming out of the crisis?“ tab_id=“1586941255250-782fc2c6-91f0″][vc_column_text]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. [/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Where can one find STL files for masks or valves to self-print?“ tab_id=“1586941255381-b7904afa-454c“][vc_column_text]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. [/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Does it make sense for people to privately purchase a basic 3D printer for helping to produce components for various service industries (assuming basic technological understanding)?“ tab_id=“1586941255502-99d9c2fe-99a2″][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“There are reports of OEMs threatening to sue Makers for creating valves and adapters for existing medical devices. Has this already been an issue for anybody?“ tab_id=“1586941255668-c0c66374-93fd“][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“We print the Materialise door openers and the Prusa face shields and want to donate them. What about product liability?“ tab_id=“1586941255811-7880365c-1c22″][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Could MGA make recommendations to policy makers at European level to relax some regulations regarding, for example, 3D printed face shields to allow healthcare professionals to use it given the shortage of PPE?“ tab_id=“1586941255971-9936165b-e75c“][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“What additional information do you have if you are analyzing 3d printed splitters for ventilators? They are not recommended in the USA due to potential cross-contamination, complexity to regulate simultaeously etc.“ tab_id=“1586941256118-5622f59e-be97″][vc_column_text]TÜV SÜD Product Service Ltd. is currently testing the splitters and will inform us as soon as results are available.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Which Dräger models were tested with splitter by TÜV SÜD? We have access to SLS and a local hospital wants to test them.“ tab_id=“1586941256274-cdb6c21c-f8f2″][vc_column_text]Please contact TÜV SÜD Product Service Ltd. for more depth. To our knowledge, the tests have been carried out in a clinic in Braunschweig.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“We are working on a stamping device for the transparent PETG shield. Doesn`t it make sense to use the same fixing points / holes on all faceshield holders?“ tab_id=“1586941256392-6a725580-9221″][vc_column_text]Indeed, this makes sense, but as the many approaches on face shield designs are not coordinated yet, this is difficult to realize.[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row][vc_row][vc_column width=“1/4″][vc_column_text]

27 March 2020

[/vc_column_text][/vc_column][vc_column width=“3/4″][vc_tta_accordion gap=“10″ c_icon=““ active_section=“123″][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Concerning the Decathlon ventilators distributed in Italy: is this application relevant to Germany as well? Are there any regulatory concerns?“ tab_id=“1586940526319-504bd161-c0f1″][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Can TÜV SÜD make an official statement about the current requirements for certification for AM based equipment? We need clarity about what requirements are now valid.“ tab_id=“1586940526372-f03bc5fc-c655″][vc_column_text]TÜV Süd Product Service GmbH will provide an official presentation to COVID-19 topics as soon as possible.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“We are printing face masks from PLA, adjusting to design for multi-use by sterilization of the plastic part and exchanging the filter. All the solutions I have seen include gluing the filter. Did anyone figure out a solution without glue?“ tab_id=“1586940526416-577eab9a-aff3″][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“What about the software aspect of the AgVa ventilator? Is it closed source and are they willing to share it? Hardware is one thing, but the control software (and also the tablet it runs on) is a potential point of failure and shouldn’t be overlooked.“ tab_id=“1586940526470-a063730f-44b0″][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Are the printed testing sticks by Formlabs a relevant use case which is being followed?“ tab_id=“1586940526509-7c08de00-dc67″][vc_column_text]They are a use case, but the focus is currently more on face shields, face masks, glasses and other safety equipment[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“How about low temperature autoclave (~60ºC) and PETG or PP?“ tab_id=“1586940526548-6d0387e1-90bf“][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“What would be the impact of postponing the MDR update? And if, what does not have to be done?“ tab_id=“1586940526586-e7543641-9581″][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“What kind of bacterial tests are required? Is the EN 14683 and/or EN 149 required?“ tab_id=“1586940526633-76a37169-df51″][vc_column_text]EN 14683 is required for medical masks whereas EN 149 is dedicated to general masks in non-medical jobs.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“We are able to print faceshields, ventilators or medical products in „USP Class VI„ certified PA (nylon), resin and metal materials. We would like to follow the European Commission’s call for help, but the registration and communication seems very complicated. Are there any ideas to help faster here?“ tab_id=“1586941816231-099b82d7-2c40″][vc_column_text]There are several ideas but it all depends on the specific needs as well as the country of origin.
For further information please consult this document from the European Commission regarding the ‚Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19‘[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“What is the best way to distribute face shields to clinics in Europe? Where can we find out who is in need and what is the legally safest way to distribute them (= Inverkehrbringer)?“ tab_id=“1586941879300-fbf5562d-ee3f“][vc_column_text]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.[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row][vc_row][vc_column width=“1/4″][vc_column_text]

24 March 2020

[/vc_column_text][/vc_column][vc_column width=“3/4″][vc_tta_accordion gap=“10″ c_icon=““ active_section=“123″][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“How are needs and offers currently structured enabling a matching in case of shortage/ad-hoc need? Is there a central platform compiling all information, esp. to coordinate who can locally produce what to serve where etc.?“ tab_id=“1585300114120-4c75a82d-0bda“][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“How will regulatory issues be handled during the Corona curve? Are there exceptions to CE marking of parts? Will patents temporarily be overruled to enlarge the possibilities?“ tab_id=“1585300269152-ce4a78a3-e6f1″][vc_column_text]Inquiries regarding regulatory requirements and potential exceptions can only be answered by notified bodies such as TÜV Süd Product Service GmbH or other experts.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“From your point of view, what parts are urgently needed right now and how can the AM industry support?“ tab_id=“1585300114145-bc42f753-5ca7″][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“What kind of materials will be required to make parts?“ tab_id=“1585520582430-a776d670-86bc“][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Are there any discussions going on concerning mechanisms for funding efforts in this area?“ tab_id=“1585520653345-93ee085c-c4f3″][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“What is the amount of masks needed in Germany right now? How many masks or products do we need in general?“ tab_id=“1585549266903-b03472d3-ee0a“][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Are you also considering to print objects like swabs for test kits or respiratory mask adapters?“ tab_id=“1585549319509-1f999833-b11f“][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section i_icon_fontawesome=“far fa-question-circle“ add_icon=“true“ title=“Who is responsible for letting someone die because technology is available but there is no „official„ approval? Is that still an ethical question?“ tab_id=“1585550379245-408e94cb-f7ed“][vc_column_text]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.[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row]

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