3D Printing for COVID-19, Part Six: Government Regulations and Outreach

As a country with a strong centralized government, China was able to enact a quarantine and manufacture supplies quickly compared to nations with weaker or decentralized governance structures. From that we might conclude that, while numerous small businesses, 3D printer users, and large corporations have begun utilizing their 3D printing skills and equipment to produce medical supplies for the COVID-19 outbreak, governments may be those most necessary to coordinate an effective response. Interestingly, we are seeing government bodies incorporate additive manufacturing (AM) into their emergency relief efforts, setting yet another precedent within this unprecedented pandemic. 

The European Commission (EC), for instance, reached out to the European association for AM, CECIMO, to see if its network of members can manufacture medical equipment for hospitals confronting the coronavirus outbreak. The EC said that it would facilitate companies wishing to aid in relief efforts to protect them from a legal standpoint, given the regulatory constraints associated with manufacturing medical goods. CECIMO has a form that AM companies can fill out in order to be considered for possible assistance in manufacturing goods for possible use in dealing with the virus. 

Vincenzo Belletti, CECIMO Innovation Policy Manager, has said that the trade group is providing daily reports to the EC, acting as an intermediary between the EC and companies, national trade associations and universities with AM capabilities. CECIMO is facilitating these parties as they deal with the “financial, legal and intellectual property issues” associated with individual nations within the European Union. Among the financial issues is the fact that, while AM companies are providing their services free of charge, there are associated transportation and material costs that may need to be covered through an emergency fund. 

The trade group is hoping that national governments and hospitals publish information related to what equipment is needed and what guidelines should be followed.

Belletti told 3D Printing Media Network, “In the UK, the guidelines for the production of tools such as fans have been published by the government; it would also be important to have an official reference model in Europe, so as to simplify the work.”

Like the EC, the Canadian government has sent out a request to educational institutions to provide resources to fight the coronavirus outbreak, including N95 masks and surgical masks, nitrile and vinyl gloves, hand sanitizer and hospital gowns, disposable surgical masks, nitrile gloves, vinyl gloves, hospital gowns, hand sanitizer.

In a post on LinkedIn, Prime Minister Justin Trudeau wrote: “To every university, college, polytechnic, and CEGEP in the country: We need your expertise and your resources. If you have masks and ventilators we can use, or if you think you can help with things like 3D printing of medical supplies, let us know.”

In addition to the aforementioned hospital items, Canada is looking for providers of nursing, IT support and security services. To provide goods or services, individuals, institutions and businesses are instructed to fill out a submission form on Buyandsell.gc.ca, the government’s procurement information service.

As discussed in previous posts, including our article on DIY ventilators, there are complicated health and safety considerations to take into account with all of these projects. This means that, even if we don’t have time to 3D print devices according to regulatory approval processes, guidelines should at least be put in place to ensure the maximum level of safety possible. 

Fortunately, the U.S. Food and Drug Administration (FDA) has published a letter that includes information related to medical devices for the COVID-19 outbreak. The letter, meant to complement existing health guidelines, highlights the use of FDA-approved ventilators whenever possible, but states that modifications to such devices can be made without FDA approval due to the ongoing health emergency. In such cases, the regulatory body suggests that FDA indications for these devices to be clearly distinguished from those that are not yet approved.

When FDA-approved devices are not available, medical teams can rely on alternative breathing devices as necessary, such as home ventilators or emergency transport ventilators, anesthesia gas machines, and noninvasive ventilation patient interfaces (e.g., CPAP, auto-CPAP, BiPAP machines for sleep apnea). 

Hopefully, these devices will be more immediately available than experimental 3D-printed devices, for which there is not yet any regulatory approval. The FDA has not yet put out criteria related to 3D printed parts for responding to the outbreak. With that in mind, we would like to list just a few that should give people pause about how 3D printing can help. 

As our editor Joris Peels points out, there are numerous risks that can be associated with 3D printed parts, many of which we have not yet discussed in this series. Here is a brief breakdown about the potential health issues to be considered:

• Porosity: 3D-printed parts have microscopic pores where bacteria can grow
• Particles: Microscopic debris from the surrounding environment can be embedded in a printed part during the fabrication process. 
• Additives: Ingredients within a material can be carcinogenic, can cause allergies, or can be toxic to cells (cytotoxicity).
• Proper functionality: We don’t know that these designs will function as intended. Most printed parts suffer from weakness in the Z-axis. Therefore, critical parts may break during operation, potentially causing even more issues. 

As Joris explains, “We could be making things that increase the spread of the virus rather than contain it. Rather than be a solution for someone who has no mask, we could infect their entire family.” This does not mean that all of the efforts to support the medical supply effort are fruitless, but that they aren’t something one should embark on hastily and without aid from existing medical staff.