Regulatory Focus™ > News Articles > 2020 > 3 > FDA Casts Doubts on 3D-Printed PPE, Clarifies Digital Health Policies for COVID-19

FDA Casts Doubts on 3D-Printed PPE, Clarifies Digital Health Policies for COVID-19

Posted 27 March 2020 | By Michael Mezher 

FDA Casts Doubts on 3D-Printed PPE, Clarifies Digital Health Policies for COVID-19

The US Food and Drug Administration has cautioned health care professionals that 3D-printed personal protective equipment (PPE) may not provide the same level of protection as conventional products.
“3D-printed PPE may provide a physical barrier, but 3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators,” according to a new FAQ from the agency.
The explainer comes after companies and hobbyists around the world, including major tech firms such as HP, have begun making 3D-printed equipment and parts in an effort to mitigate PPE shortages at hospitals. Despite the promise of 3D-printing for some applications and the widespread availability of equipment, experts caution that 3D-printing is unlikely to address the most pressing needs during to COVID-19 outbreak.
However, FDA acknowledges that the public and health care institutions may resort to 3D-printed PPE as demand outstrips supply. The new FAQ provides some minimum recommendations for health care professionals to look for when using 3D-printed masks.
Recommendations include checking 3D-printed masks for leaks, confirming that the material is breathable and being extra cautious in surgical environments.
FDA also directs companies to its 2017 final guidance on technical considerations for 3D-printing for a range of recommendations on medical device applications, including device design, software workflow, material controls, post processing and process validation.
Some companies have begun to use 3D-printing to manufacture parts and accessories for more complex medical devices; for example, Italian firm Isonnova reportedly has supplied 3D-printed valves for ventilators for hospitals in Italy.
In FDA’s FAQ, the agency advises health care professionals to first use “original parts or those with the same specifications, dimensions, and performance, if available.” The agency says it may be possible to 3D-print certain parts and accessories, some may be too complex. FDA advises anyone looking to 3D-print parts for medical devices to engage with the original manufacturer and reference plans or drawings if available.
FDA also asks anyone interested in 3D-printing entire medical devices to contact the agency via a dedicated email address,
Digital Health
In a separate statement, FDA clarifies its approach to digital health products amid the COVID-19 outbreak based on its 2019 risk-based policy for regulating software and mobile medical applications.
The agency explains that it “does not consider most apps and software systems for public health surveillance and communication to be medical devices regulated by the FDA,” including patient-tracking software or software to provide educational or reference information to patients and health care professionals.
FDA also explains that it will continue to exercise enforcement discretion for lower-risk software-based devices consistent with its existing policy, including patient screening and counseling tools and software that enables patients and caregivers to send alerts to first responders in the context of COVID-19.
For higher-risk digital health devices, FDA says it is looking to engage with developers that are interested in requesting an emergency use authorization (EUA).
FDA: 3D-Printing FAQ, Digital Health Policy

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