The following refers to: 3DPX-013306
The FDA has authorized production of protective face shields outside of the normal clearance pathway during the COVID-19 pandemic, based on Part 5, section D of the “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff." This face shield has undergone review in a clinical setting and is recommended when fabricated as instructed.
There is a shortage of protective gear for doctors and nurses, so 3DVerkstan designed a frame for holding standard sized plastic sheets. Quick to print, easy to assemble.
- Using readily available plastic sheets with as little modification as possible, and only common tools used.
- All features printable with nozzle sizes up to 1mm and layer heights up to 0.5mm
- Drip protection above the eyes
- Printable in less than 20 minutes
- No tight tolerances requiring well-tuned printers.
- Design that works equally well with most common materials (PLA, CPE, PETG, ABS etc.)
The visor is tested and approved by staff all over the world but there are a lot of different regulations regarding medical supplies, please make sure to follow authority guidelines that applies within your region.
This model has been approved by Columbia University Medical Center/New York-Presbyterian Hospital staff, who are currently using hundreds of them.
More information can be fonud at the designers web site:
https://3dverkstan.se/protective-visor/
You can also find the files and lisence here:
https://github.com/Cederb/Faceshield.nu/
Comments
bdsearle
Fri, 2020-04-03 12:53
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Approval Status?
Where can we find a status on the approval for clinical use? I have printed samples of this design and provided to nurses for feedback - all feedback has been positive. This design can be printed very quickly, uses less filament than others and does not require a strap. An update or approval would be greatly appreciated!
Beth Ripley
Fri, 2020-04-03 19:52
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We are actively testing this
We are actively testing this design now. We hope to finish assessment in the next 24 hrs.
mrowkitty
Sat, 2020-04-04 03:43
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3 hole punch version
Is the 3 hole punch version also included in the review? it's the same, but is just set up for use with US style 3 hole punch for attaching film.
bernard1988
Sat, 2020-04-04 22:00
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Dont recommend the 3 hole. 6
Dont recommend the 3 hole. 6 hole is more secure. 3 holes may be possible with a redesign.
fledder
Sun, 2020-04-05 02:12
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Can use 3 hole punch for this one
Set the end stop on the 3 hole punch to 10 inch size (basically, 1/2" away from the normal centered location) then punch once, flip, and punch again to get the right pattern.
Nathan
Sun, 2020-04-05 23:26
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Yes this would be very
Yes this would be very helpful in the US
Hilbe
Mon, 2020-04-06 15:38
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Spacer
There's a spacer you can print to put on your 3 hole punch. I'm doing tons of them right now with my 3 hole puncher and spacer. Simple and much better holding the transparency than 3 hole version.
Manfre
Tue, 2020-04-07 21:40
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Link to spacer?
Link to spacer?
dnelms
Thu, 2020-04-09 09:45
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Unfortunately, not all 3 hole
Unfortunately, not all 3 hole punches have a spacer.
blayed
Thu, 2020-04-09 17:40
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3 Hole punch?
How are you getting the 3 hole punch to work? Even with the spacer it is impossible for me. The US 3 hole punch standard is 4 1/4" I have to punch it at 4 5/16" to fit over the pegs and even then double punch to ovalize the hole.
Paul Nord
Tue, 2020-04-07 22:06
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3 hole version is a bad idea
I tried a 3-hole version of this design. Since the end tabs can move around a lot and the bend at the edge is large, the plastic sheeting does not stay in place well.
It works well as designed. It prints effieiently and is very simple. I can print one in about 40 minutes. The visor designs take me 4 hours on the same printer.
Donald The Dinosaur
Sat, 2020-04-11 11:35
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Clever Design
This is a clever design which shifts some of the rigidity burden from the headband to the shield. The benefit is faster printing and the cost is 6 holes instead of 3.
mcss
Sat, 2020-04-04 20:54
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Sheet Material
Suggestions for plastic sheets to use?
mechE_student
Sun, 2020-04-05 00:48
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Nice work. Is there any reason the design couldn't be produced via laser-cutting? This would help with increased production capacity.
Hilbe
Sun, 2020-04-05 07:20
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3 hole punch
Would love to use this design in 3 hole punch version. Is there a model somewhere?
cgenco
Sun, 2020-04-05 14:50
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Using a 3 hole punch
All you need to do for a 3 hole punch is put the paper against the edge stop, move it over 1/2 inch and punch. Then flip it and do the same. You end up with 6 holes. You can test that you are doing it right with a plain piece of 8 1/2 x 11 paper.
paulemccabe1
Tue, 2020-04-07 00:30
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Agree
Agree. Once you line it upproperly and test with paper this process works really well with a standard 3 hole punch.
ZedAxisLLC
Sun, 2020-04-05 20:51
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Product lifetime recommendation?
Are these intended to be single use or can they be sanitized and re-deployed?
mtitus83
Fri, 2020-04-17 17:21
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The hospital that we are
The hospital that we are providing these to (PLA) are able to properly disenfect and redeploy these for reuse. I do not have specifics on their disinfection method however.
Hilbe
Mon, 2020-04-06 20:49
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Looking for a stacked version
Looking for a stacked version for single extruder.
mtitus83
Fri, 2020-04-17 17:24
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The 3DVerkstan group advises
The 3DVerkstan group advises against stacked printing for single extruder printers. It does offer a STL for dual extruder machines. You can find that information on their site at the link below;
https://3dverkstan.se/protective-visor/faceshield-faq/
niisanraul
Wed, 2020-04-22 17:15
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Also need this
I would also like a stacked single extruder version, I have to print 200 of them and I only have 1 Printer that is in good working condition.
laurent90
Sun, 2020-04-26 13:37
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I successfully used these
I successfully used these stacked STL files:
https://retrolabs.com/3d-prints/3d-printed-face-shield-with-10-mil-pvc
Beth Ripley
Tue, 2020-04-07 13:22
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CLINICAL REVIEW
What tests does the VA run for face shields?
Faceshields are used to prevent fluids from hitting the wearer’s underlying face mask or, if not wearing a face mask, the wearer's mucous membranes (mouth and nose).
Tests that we ran were:
Additional quality checks: Are the manufacturing instructions clear? Is it easy to assemble the device? Are there instructions for use?
Akomaria
Thu, 2020-04-09 10:37
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Will you share your test results?
Beth,
I am also looking for the approval document for this model and found your posting in the comment section. Will you share your testing results for the assessment you guys conducted?
Was it submitted to NIH?
I am distributing this headband to local healthcare workers and would like to tell them that this model is approved by NIH but I can't seem to find a document to back the claim.
Thanks
MetaS
Fri, 2020-04-10 11:59
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Does anyone have feedback
Does anyone have feedback after several days of use on the pros and cons of this design?
SLIPHX
Thu, 2020-04-23 20:17
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Thank you, for sharing your
Thank you, for sharing your results. From your testing, is the faceshield adequate enough for casual contact without a mask? For example, seeing outpatients? or in the community?
Moore3dprints
Tue, 2020-04-07 15:44
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ultimaker s5
I cannot get the supports to stay on the inside of the print it want to outline the entire print, when trying to print the stacked version. I have s5 with cpe and breakaway supports.
Moore3dprints
Tue, 2020-04-07 16:10
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ultimaker s5
I cant seem to get the supports to only be on the inside of the print, it does a perimeter that i do not want does anyone know how to get rid of it? im tryin to print the stacked.
CM3D
Tue, 2020-04-07 21:14
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PLA and ABS M30
Successfully printed this design in both PLA and ABS M30 and have units available in stock.
Kevin Jordan
Wed, 2020-04-08 01:35
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Guide for easier 3 hole punch shifting
I found that many locations wanted a bigger face shield. I made a PDF guide and a youtube video of how to use it:
https://www.youtube.com/watch?v=rz36MhT7p-c
I found that flipping over the shield to try and get symetric holes did not align easily for me. If you have an open area hole punch, it's much easier to print a PDF, punch one set of 3 holes, then shift to the right, and punch 3 more. It lines up a lot easier and more accurate.
https://github.com/CRASHSpace/COVID-19-3dprints/blob/master/Face%20Shield/3DVerkstan/Verkstan-3HolePunch-CRASHSpaceMod.pdf
blayed
Thu, 2020-04-09 17:56
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I can't get the 3 hole punch to work for the 6 hole version
I am using the spacer on a standard american 3 hole punch. The holes are too close together. They need to be at least 4 5/16 or even 4 3/8 apart to work but that's impossible to do on a standard 3 hole punch. I am testingi out scaling down the model to 95%
Donald The Dinosaur
Thu, 2020-04-09 21:26
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Model Cross-Section
Slicing North American 6-Hole version with Prusa slicer.
Why is the cross-section of the side pieces not rectangular? The bottom 0.8 mm gets progressively smaller toward the bottom of the model. This makes it impossible to set parameters which are optimal for all layers.
The model could be printed faster, with more consistent quality, if all the layers were the same width.
PFriar
Thu, 2020-04-09 22:41
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Sheet material suggestions
We're printing this in Austin, TX for masksfordocs, I believe they've been using overhead projector transparency sheets and crystal-clear binder covers like these here: https://www.amazon.com/Fellowes-Crystals-Binding-Covers-5204303/dp/B0196JUY7Y
rwayne22
Mon, 2020-04-13 17:10
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Clinical Material Preference
Is there a clinical preference for the material we use?
Timmyu
Tue, 2020-04-14 18:59
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If any one is in need of
If any one is in need of printing these we have the ability to print over 1,000/ week. We would love to talk about any opportunites to help eachother out.
Brad Baker
Fri, 2020-04-17 09:51
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Simple and effective design
This is the main face shield we have been producing and it is very simple to print and manufacture. A short video of our shield portion is here: https://youtu.be/9F2Wpmzz_64
Paul Nord
Fri, 2020-04-17 13:24
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North America 3 Hole version from Verkstan
Is the North America 3 Hole version an acceptable replacement?
* It seems to hold the sheet very well.
* Sheets are interchanbable with other designs.
* And it simplifies the production process.
Paul
mtitus83
Fri, 2020-04-17 18:29
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Can updates inhereit recommendation or require retesting?
As this model is updated by the upstream maintainer does it require complete retesting by the NIH if its structurally similar? The version available to download here on the NIH3PE is v3 and the maintainer is now at v5; It appear's to be the same model so I suspect they are technical changes and not structural. I have submit a request to the maintainer to include an upstream changelog at least for this model to prevent users obtaining v5 from the official site while seeking the NIH approved version, v3. For those with interest you can view my Github issue request here;
https://github.com/Cederb/Faceshield.nu/issues/25
Is there any official guidance on what deviations require retesting?
crabjoe
Fri, 2020-04-17 23:11
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Anyone else having an issue
Anyone else having an issue with the holes lining up when using a 3 hole punch? I'm using a 1/2inch spacer to punch the holes, and it's real close, but it never lines up right. Sure I can get the shield onto it, but I don't like it.
laurent90
Sun, 2020-04-26 13:33
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Sanitization / Disinfection of the printed parts
Hi,
does anybody have any feedback from healthcare emloyees regarding the methods used successfully to disinfect the face shield and the 3D printed parts, particularly with PLA as printing material ? Also, are there any issues with the mechnical strength of the device dimishing after several disinfections ?
Thank you very much in advance !
BMCEDMD
Sun, 2020-05-17 19:55
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Re-use
Hi All, has anyone had experience with reusing these shields? Can anyone comment on how effective disinfection is, what methods can be used? Also, there are concerns that some filaments are porous and thus can retain Sars-COV-2, making them inappropriate for re-use. Are these concerns valid? I have not seen disinfection or reuse criteria among the approval guidelines. Looking for advice.
PreFab3D
Tue, 2020-07-14 09:48
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Assembly & Replacement Video
Made an assembly/shield replacement video for the 3DVerkstan shields. It's a lot easier/cheaper to ship them unassembled so we did this tutorial to help users assemble themselves. It also includes the 3 hole punch template.