On May 10th the Food and Drug Administration (FDA) released a draft report that will lay the groundwork for approving 3D printed medical devices.
‘Technical Considerations for Additive Manufactured Devices: Draft Guidance for Industry and Food and Drug Administration Staff" is a 28 page document that covers the FDA’s current position and possible regulations for future FDA approval for 3D printed devices.
This document does not cover bio-printing organs and tissues. In the future guidelines will have to be written to cover the safety and design of 3D printed organs.
This document focused on low-level medical devices that are used externally. These devices can range from simple IV clips to prosthetic limbs.
3D printed devices to date have not faced any regulatory requirements. Many who develop medical devices make an effort to match them to the medical standards for similar commercially produced devices. However, when you are dealing with a single prototype or specialized device, going through a FDA approval process is just not practical.
These guidelines will however impact organizations that have designed medical devices already and released them open-source to the public.
The following organizations will see an impact from these guidelines.
Under the document guidelines,
The documentation requirement may put a significant damper on anyone who 3D prints for E-Nable. With so many people using desktop 3D printers to make E-Nable hands, it may fall upon the individual printer to document every printer setting used in the print.
Any documentation requirement will require that E-Nable spend significant funding for secure servers and legal advisors to draft FDA compliance forms. This documentation will deter E-Nable volunteers from printing hands if they have to record all the settings and minute details of their print. E-Nable will also have to host and save all documentation from volunteer printers around the world. Ensuring documentation compliance will also require a large staff in E-Nable dedicated just to this part of FDA compliance.
Glia Free Medical Hardware
Glia Free Medical Hardware (GFMH) is an open-source project to develop affordable medical devices for 3D printing. GFMH made medical headlines by producing a medical quality stethoscope for $0.30. GFMH is also developing open sourced pulseox meters, surgical tools, and otoscope. All of these devices have current standards in place for their commercial counterparts. GFMH founder Dr. Tarek Loubani has developed protocols to test his stethoscope, and in the future he will have to ensure that other devices meet comparable standards.
According to the draft document,
Validation of testing methods can be a time and labor intensive process for any organization, and impractical for volunteers. Furthermore validation will have to happen under very controlled conditions, which may not be possible at a home location. This validation bottleneck can severely restrict anyone who can actually work on these projects. This requirement may mean that only college academics in accredited medical schools will have the ability to approve and validate medical devices. This set of guidelines will have a chilling effect on the makers and designers that can work on these medical devices.
Field Ready is a humanitarian NGO that brings 3D printing equipment to disaster areas. They use 3D printing to quickly make needed medical and sanitation items in the field. By using 3D printing they bypass logistic chains that have been destroyed by natural disasters. Field Ready also provides technical training and resources to help disaster areas recover.
However a problem arises with sterilization guidelines given in the document.
In the field, cleaning and sterilizing 3D printed equipment to federal guidelines will be next to impossible. Closer to home, valuable time can be lost sending 3D printed equipment to a specialized facility to sterilize them. Every 3D printer knows that there will be hairs and burs left over after every print, and it is impossible to scrape off ones that happen inside the print. All of these extra surfaces can present a challenge to meeting medical standards in the field.
In the future Field Ready may have serious limits put on them if they cannot document a field-viable method to sterilize prints in a disaster area. To meet this standard, they will have to carry extra equipment into the field with them, or face regulatory sanctions if they cannot meet standards.
3D printing is a paradigm shift for medicine. As it stands now, 3D printing does not fit within current FDA regulations. As it currently stands, the FDA will not have the ability to regulate 3D printing without a massive change in their whole organization.
Current FDA regulations are written for large medical companies that mass-produce medical devices. The open-source movement in 3D printing is threatening to slough through every notion of FDA regulation.
How will the FDA be able to regulate someone in the US who volunteers to 3D print an E-Nable hand for a child in Mexico? Is it even possible for the FDA to regulate what devices someone can print at home?
Medical companies have the financial resources to meet current FDA requirements, as well as the lobbying power to control congressional regulation of their products. When (not if) 3D printing becomes ubiquitous at home, the ability to print medical devices will threaten the very idea of large medical companies.
The future of 3D printing in medicine is going to be turbulent. I foresee medical companies fighting open-source devices with an army of patent trolls. I also see the FDA burying 3D printers in red tape for even the simplest medical device.
There is a lot of good that 3D printers can do for the world. I support FDA regulation for bio-printing and medical devices that go inside a human body. But when it comes to external devices that can be 3D printed by anyone, I have to wonder how the FDA can possibly regulate home printers. With legal experts talking about regulating 3D printers to prevent copyright violation, I worry that similar measures would be established to prevent the general public from 3D printing medical devices. The FDA will have to figure out how to regulate home printers without crossing over into the territory of George Orwell’s “1984”.
The FDA is going to face some serious soul-searching as 3D printed medical devices continue to become popular.
Additional information on the FDA’s policy's can be found here.
The whole FDA document can be found as a .pdf here.
DISCLAIMER: This blog is an opinion article, and not a legal interpretation of the FDA document. Please contact a lawyer before dealing with the FDA.