We circulated a survey last week, to see who is making things like face shields and other personal protective gear and actually delivering it to hospitals in need. This survey yielded some interesting results, giving us a peek into how different areas are handling the production and distribution of these products.
One topic that keeps coming up is whether or not something is “Medically Approved”. When people tell us that, we’re seeing two distinctly different things.
- The official National Institutes of Health page has vetted their design and it has been approved for certain uses in a medical field.
- They talked to a doctor or nurse, who said that they could use it.
Both of these are serving equally important roles right now.
On one hand, you should absolutely submit any design you have to the NIH site for testing and approval. This is the smart thing to do, and can give medical professionals a way to easily select a design that they know has been reviewed.
On the other hand, the most important thing is that you find what your local needs are, and meet those needs. Get a connection with your local hospital (or maker group that already has a connection) and find out what they will accept. If you are simply producing things with the hopes that you’ll find someone to accept them, you’re likely wasting your time. Some hospitals have come up with or decided on a design already, regardless of the progress of the NIH and you’ll have the greatest impact by simply creating and delivering what the hospital is asking for.
One thing to keep in mind is that a medical professional may not be intimately familiar with 3d printing, and may not be aware of the downsides or limitations. If the facility has not yet decided on what designs they’re willing to accept, the NIH approved list is a very good place to start.
Note: The only mask (not shield) that has been approved may appear to be a simple fdm printed mask from the thumbnail. However, if you click on it you will find that it is actually powder fusion. At this point, no standard filament based 3d printed masks have been approved by the NIH.
3D printing presents problems not only with sterilization and reuse due to the porous nature of FDM, but also with fitting accurately to the face. While some are claiming that something is better than nothing, others have suggested that a false sense of security can be extremely harmful, especially in a medical environment.
With that said, however, we’ve heard of some medical facilities using home FDM printed face masks. Again, the most important thing is to find out what your local needs are and meet those needs.
How do we get approved?
In short, submit your design to the NIH for review and approval. It was announced on March 27 that the NIH would partner with the Department of Veterans Affairs and America Makes to get open source and diy solutions reviewed and approved (or denied).
The review process involves the design being sent to a few different professionals for review in a medical setting. There is no official timeline for how long this review takes, and you can see that the list of items under review is growing very quickly. It may be more efficient to simply pivot your production to an already approved model than to wait for your design to become approved.