Mayo Clinic: Considerations & Cautions in Pandemic Times Regarding 3D Printed PPE

William Clifton, Aaron Damon, and Archer K. Martin, all medical researchers from the Mayo Clinic in Jacksonville, FL, discuss the lack of medical devices during the COVID-19 pandemic, as well as more resourceful measures taken almost immediately.

In the recently published ‘Considerations and Cautions for Three-Dimensional-Printed Personal Protective Equipment in the COVID-19 Crisis,’ we learn more about the requirements for digitally fabricated medical devices, and the potential that lies in assistance from the inspiring and often tight-knit 3D printing community.

There has been considerable coverage regarding the need for devices like ventilators, beginning with a shortage in Italy as they were stricken with the COVID-19 pandemic, and then even more so in the US as hospitals were in need and controversy has continued over whether such devices should be provided on the federal or state level.

Larger manufacturers have not been quick to produce devices and personal protective equipment, leaving engineers and makers to take matters into their own hands, producing face shields and masks, ventilators, connectors, and other parts.

Connector valve – from “3D Printing During COVID-19: More Information on ISINNOVA 3D Printed Connectors for CPAP Masks.”

Investigating the idea that ‘3D printing is better than nothing,’ in terms of products being fabricated and handed out without being held to normal standards, the researchers venture into heavily un-navigated territory—something that seems to be in plentiful supply as the human race has suddenly been cloistered away in fear of what can be a deadly virus.

The FDA has issued statements regarding 3D printed PPE during the pandemic as questions arise over safety:

“3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators.”

However, they do also allow for ‘emergency use authorization guidelines’ in the case that 3D printed connectors and other parts are needed. The researchers point out that even though such guidelines are offered, there is no information regarding how 3D printed PPE should be used to protect individuals from COVID-19.

3D printed ventilation splitters. Image courtesy of Dr. Alexander Clarke. From ‘3D Printing for COVID-19, Part Three: Open Source Ventilators.’

The Centers for Disease Control and Prevention (CDC) has been clearer in stating that ‘home-made face wear’ is considered non-PPE and wearers should ‘exercise caution’ in using such items even as a last resort. The National Institutes of Health (NIH) has even gone so far as to create a repository of 3D printed prototypes, but they do recognize ‘limitations of safety claims due to the heterogeneity of rapid prototyping methods across different printer types and users, even with standard testing.’

As other groups have continued to release files for the public to use, with efforts of ‘noble intention,’ there must be standards in terms of safety—especially in the face of a virus that can kill.

“The greatest danger with continuing to broadcast unvetted PPE production mechanisms is the possibility of hindering transmission curve flattening. There is no doubt that a prompt solution must be implemented, and the prevalent usage of 3D printing has the potential to help solve the PPE crisis across the globe using robust methodology and concentrated vetting,” concluded the researchers.

“It is reasonable to propose that this can be accomplished by a concerted effort between 3D printing innovators and regulative authorities. Together, thorough investigation of proposed models can be achieved in a standardized manner before dissemination and claims of benefit. In this way, true innovation can prevail over brief notoriety and avoid unintentional harm from good intentions led by poor science.”

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