The Race for PPE: Meeting the Need With 3D Printing
As 2020 began, few people expected a global pandemic. While nations moved to mobilize people and materials against the new virus and care for the sick, a second problem became visible.
According to the World Health Organization there was not enough Personal Protective Equipment to meet the sudden demand created by the Novel Coronavirus, referred to as COVID-19.[600] In one US survey conducted in May 2020, 87% of nurses reported reusing single-use disposable masks or N95 respirators at work because supplies had run out.[7] Nearly 30% said they had been exposed to confirmed COVID patients without appropriate PPE. By the summer of 2020, some 340 nurses, doctors, physicians assistants, medical technicians, and other healthcare workers had died from Coronavirus in the US alone.[7]
The load on healthcare workers and on the system around them was severe. A supply chain that normally delivered PPE on schedule broke down under pandemic conditions. Transportation limits, trade restrictions, border controls, and quarantines cut the global capacity to manufacture and move equipment at exactly the point it was most needed.
Production and distribution of this equipment sits with private producers and suppliers. With demand that sudden and that large, other routes to manufacture and distribute had to be found quickly.
Meeting the demand for protective equipment needed another approach. 3D printing, applied at scale, helped supply the equipment that protected first responders and medical staff from infection. The process is normally slow for certain objects, and most printers use fused deposition modeling. Governments asked large and small businesses, colleges, and medical manufacturers to help produce PPE quickly. Thousands responded.
Devices manufactured by 3D printing through the pandemic included N95 masks, surgical masks, face shields, Controlled Air Purifying Respirator systems, and High Efficiency Particulate Air masks designed for use with a HEPA filter.
Personal protective equipment includes protective clothing, gowns, gloves, goggles, and respirators. Each keeps healthcare workers and first responders away from viral spread, and each protects patients during hospitalization or while seeing a medical professional.[12]
FDA and NIH Guide for New Partners and Contributors
In response to the urgent need for COVID related materials including personal protective equipment, the National Institutes for Health published guidelines for suppliers, manufacturers, and small businesses so that products met federal requirements for safety and efficacy.[8]
Who is coordinating and overseeing the manufacture of 3D PPE?
Public/Private Partnership is created to collaborate on open-source medical products needed for COVID-19 protection.
Agencies involved in the manufacture, quality control, and oversight of 3D Manufacturing of Personal Protective Equipment include:
The Food and Drug Administration (FDA)-Facilitating the use of 3D printing for emergency use
The Veterans Health Administration (VA)-Responsible for “clinically reviewing” PPE to ensure industry standards for safety and quality are met
The National Institutes of Health (NIH)-NIH 3D Print Exchange shares design files necessary to create PPE
America Makes-An online repository for products and equipment for the protection of people
Members of that group continue to evaluate 3D printable parts for safety and efficacy, identifying the designs that prove most useful to patients and practitioners and putting those into use.
3D Printing-What Exactly is It?
The process is also called additive manufacturing or rapid prototyping. A 3D printer builds an object by laying down fine layers of material that bond to one another. The object comes from a computer model or a 3D scan of something that already exists, which is what makes production on demand possible.[1]
3D printing fuses successive layers of raw material into a three dimensional object, each layer bonding to the one below it. The virtual blueprint comes from a 3D file such as CAD or an MRI scan.
The Most Common Process-Powder Bed Fusion
Powder Bed Fusion is the most common process for 3D medical devices and works with several material types. A laser or electron beam melts very fine metal or plastic powder so the particles fuse. Each layer adheres to the one below, permanently bonding the material into the specified object.[4]
3D printing has a wide range of applications. Medical devices, household items, automotive parts, and a range of intricate mechanisms are all built through layering technology.
Medical devices created using 3D technology include
- 3D Manufacturing-The Path to Production
- Creating a 3D object using additive technology requires
- Design-Digital models are used to create a workable design.
Software Workflow-A design is converted to a file that will be sent to a printer.
Material Controls-Procedures, requirements, and supplier agreements are checked for every batch of 3D objects created.
Printing-3D objects are printed based on files created for specific objects.
Post-Processing-3D objects may be trimmed, polished, cooled, sterilized, drilled or subjected to another process after printing.
Process Validation and Verification-3D printed objects may be tested for strength and size, (or another parameter) to ensure performance as intended.
Testing-Testing methods and results for 3D printed medical devices go to the FDA to demonstrate safety and efficacy. These devices are generally subject to the same regulations as ones made by traditional manufacturing.[6]
The benefits of 3D printing, also referred to as “additive manufacturing” are many,
allowing greater flexibility, the ability to manufacture many different parts without additional equipment or tooling, and the production of patient specific devices matched to individual anatomy. 3D printing can also produce objects with very complex internal structures.
Regulatory Controls, 3D Printed Medical Devices
The FDA's Center for Devices and Radiological Health oversees companies that manufacture, repackage, relabel, or import medical devices in the United States. Those regulations apply premarket and postmarket, and 3D printed medical devices are no exception.[5]
Many personalized medical devices can now be produced with 3D printing, which is why FDA device regulation and additive manufacturing have become closely linked.[2]
The idea of building 3D objects from stacked layers was first introduced in Japan nearly 40 years ago. Photopolymers and rapid prototyping let developers turn out prototypes quickly for product development. The material range now covers plastics, metals, ceramics, and concrete.[9]
Additive manufacturing was largely established in the 1980s. Early machines were large and expensive enough that most small businesses could not justify the outlay. Cheaper, smaller, better printers followed, which made the method viable for lightweight applications. That mattered for companies that had been importing small parts for larger assemblies, and for new manufacturing businesses in the United States.[10]
Historical Support for 3D Printing
The FDA, together with then president Barack Obama, backed 3D printing through the formation of the National Additive Manufacturing Innovation Institute in 2012. The institute was set up to encourage hard goods manufacturing to return to the United States.
The additive process suits lightweight applications. PPE can be produced quickly, with less waste and less material tied up in the run. It also removes the overproduction of molds and cores, which saves both cost and time.[2]
3D printers are good at devices with complex geometry. Patient specific items such as prosthetics, cranial plates, and hip joints are built from imaging data matched to an individual's anatomy.
Medical Devices for Emergency Use
Emergency use devices have been approved before under specific circumstances. Those include a life threatening condition, no other acceptable treatment being available, or insufficient time to complete the usual FDA approval process.[3]
Emergency Use-Not the Final Solution
ASTM International currently sets the standard for sterilization and cleanliness of PPE. Those standards are freely and continuously available to the public, but risks specific to 3D printed protective gear remain.
3D printing produced badly needed protective equipment quickly during the pandemic, but technical limitations in the additive process remain unresolved.
Personal protective equipment, from clothing and gowns through gloves, face shields, goggles, masks, and respirators, exists to protect people from injury, infection, or illness. 3D printed PPE does not match FDA approved surgical masks and N95 respirators on fluid barrier or air filtration. Air leaks during movement such as talking, and a mask frame that is too rigid, both create risk for the wearer. In some cases the printed material is too porous to sterilize properly.[11]
Further work on printing techniques, on which materials bond well, and on design will be needed before 3D manufactured protective equipment can get past these limits. Its role in the COVID response was still substantial.
. 3D Printing. (n.d.). Retrieved January 27, 2022, from
https://library.educause.edu/topics/infrastructure-and-research-technologies/3d-printing
2Additive manufacturing/3d printing
. U.S. Consumer Product Safety Commission. (n.d.). Retrieved January 27, 2022, from
https://www.cpsc.gov/Regulations-Laws--Standards/Voluntary-Standards/Additive-Manufacturing-3D-Printing
3Center for Devices and Radiological Health. (n.d.).
3D printers are used to manufacture a variety of medical devices
. U.S. Food and Drug Administration. Retrieved January 27, 2022, from
https://www.fda.gov/medical-devices/3d-printing-medical-devices/medical-applications-3d-printing
4Center for Devices and Radiological Health. (n.d.).
3D printing of Medical Devices
. U.S. Food and Drug Administration. Retrieved January 27, 2022, from
https://www.fda.gov/medical-devices/products-and-medical-procedures/3d-printing-medical-devices
5Center for Devices and Radiological Health. (n.d.).
. U.S. Food and Drug Administration. Retrieved January 27, 2022, from
https://www.fda.gov/medical-devices/3d-printing-medical-devices/fdas-role-3d-printing
6Center for Devices and Radiological Health. (n.d.).
There are multiple steps to printing a 3D device. the number of steps
. U.S. Food and Drug Administration. Retrieved January 27, 2022, from
https://www.fda.gov/medical-devices/3d-printing-medical-devices/process-3d-printing-medical-devices
7Cohen, J., & Rodgers, Y. van der M. (2020, December).
Contributing factors to personal protective equipment shortages during the COVID-19 pandemic
. Preventive medicine. Retrieved January 27, 2022, from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7531934/
8Commissioner, O. of the. (n.d.).
FDA, VA, NIH, and America makes covid-19 public-private partnership
. U.S. Food and Drug Administration. Retrieved January 27, 2022, from
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/fda-efforts-connect-manufacturers-and-health-care-entities-fda-department-veterans-affairs-national
How smaller manufacturers can take advantage of additive manufacturing
. NIST. Retrieved January 27, 2022, from
https://www.nist.gov/blogs/manufacturing-innovation-blog/how-smaller-manufacturers-can-take-advantage-additive
. (n.d.). Retrieved January 27, 2022, from
https://www.bu.edu/jostl/files/2016/08/NISSAN_NOTE_MACROD-PDF.pdf
11U.S. Department of Health and Human Services. (n.d.).
3D printing medical equipment in response to the COVID-19 pandemic
. National Institutes of Health. Retrieved January 27, 2022, from
https://www.nihlibrary.nih.gov/services/3d-printing-service/3d-printing-medical-equipment-response-covid-19-pandemic
12U.S. Department of Health and Human Services. (n.d.).
. National Institutes of Health. Retrieved January 27, 2022, from
https://3dprint.nih.gov/collections/covid-19-response