The US FDA or the Food and Drugs Authority is most committed to taking flexible and creative approaches when it comes to addressing access to critical medical paraphernalia and equipment in response to the COVID-19 pandemic.
During this trying time, the odds that the demand for certain medical paraphernalia and devices such as personal protective equipment is going to outpace the available supply we have for health care facilities due to the soaring of demand for them.
Besides, another thing that exacerbates the looming problem on this is the disruptions on the global supply chain due to community lockdown measures in many different parts of the globe. Words of an impending crisis on PPEs and other similar items critical to COVID-19 measures have reached authorities.
This explains the reason why the 3D printing Australian community is proactively initiating efforts to utilize their additive manufacturing technique to assist in meeting this growing demand for several medical products/paraphernalia. In light of these efforts, here are some of the most frequently sought questions concerning 3D-type printing and rapid prototyping for medical products like PPEs or personal protective equipment.
Q. Are there any general recommendations coming from the FDA concerning 3D printing of medical devices?
- Only recently, the FDA issued a structured guide regarding the Technical Considerations for 3D Printed Medical Devices. The said document is intending to give a detailed outline regarding the recommendations of the agency concerning 3D-printed devices, starting from the device stage up to process validation and testing actions for finished devices.
Q. Can we utilize 3D printing technology in the production of laboratory gowns, respirators, face masks, and several other kinds of personal protective equipment or PPEs?
- PPEs are any kind of protective covering used by medical professionals and frontliners as one way to protect themselves against injury or from getting infected with airborne microbes and viruses. While there is no denying to the fact that 3D printing can be taken advantage of in the production of some of these PPEs, coming alongside with some of them are technical hurdles that must be overcome first, otherwise, they won’t be effective enough.
For better understanding, let us cite an example here. A 3D printed PPE may significantly help in providing a physical barrier, but they may not be able to provide the required air filtration and fluid barrier protection that FDA-cleared N95 respirators and surgical masks can deliver.
Q. Can a non-medical professional use 3D printed PPEs?
- Anyone wanting to have a certain level of physical barrier against the surrounding environment can turn to the use of 3D-printed PPEs. But as disclosed earlier they can’t give you the air filtration and fluid barrier protection that FDA-cleared N95 respirators and surgical masks can give.
Q. What best practices should healthcare providers observe when using 3D-printed face masks?
- They should observe the following:
- Carefully inspect the 3D-printed mask seal for any leak.
- Verify that they can still breathe when using makeshift filter materials.
- Observe extreme caution in surgical environments. Such places call for extreme liquid barrier protection at all times.
- Identify if the mask being used is providing enough air filtration to keep the possible transmission of infectious agents at bay.
- Highly infectious materials must be disposed of properly, and parts you are intending to reuse need to undergo a proper sterilization procedure.
Q. Can We 3D Print Entire Medical Devices?
- While the FDA is amenable that 3D printing could be taken advantage of in providing wider availability of devices for the entire duration of this public health emergency, some devices would be much more amenable to additive manufacturing compared to others. The FDA is more than willing to discuss this with the 3D printing Australian industry.