Using 3D printing for medical devices is becoming more common amid the COVID-19 pandemic, as demand for critical personal protective equipment (PPE) continues to outpace supply.
As traditional manufacturers’ supply chains struggle to keep up with production, healthcare providers struggle with securing the necessary supply of face shields, facemasks, gowns, respirators, and gloves. In response to the deficiency, the 3D printed medical device market has expanded.
This has brought about many regulatory questions and concerns. Here are some of the most common ones.
Are 3D-Printed Medical Devices FDA Approved?
The FDA acknowledges the need for flexible and creative approaches to meet the high demand for medical devices, specifically PPE, as well as the potential interruptions made to the worldwide supply chain. In addition to the FDA guidance document on technical considerations for manufacturing 3D-printed medical devices, the FDA published FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic.
Due to the circumstances of the COVID-19 outbreak, the FDA has declared several authorizations of emergency use (EUAs) to proactively aim to contain and mitigate further spread. A granted EUA allows unapproved medical devices or unapproved uses of an approved medical device to be emergently utilized to prevent, diagnose, or treat a life-threatening condition or disease, such as the novel coronavirus, when there is no available, adequate, or approved alternative. This determination included circumstances in which personal respiratory devices, ventilators, and protective accessories would be granted a EUA, which the FDA outlined in an enforcement policy.
The FDA also published a standard and an accelerated EUA template for submissions of in vitro diagnostics for the detection and diagnosis of COVID-19. Further enforcement policies have been published to address coronavirus disease diagnostic testing, sterilizers and air purifiers, gowns and gloves, and imaging systems during the COVID-19 public health emergency.
How Should 3D Printing Medical Device Companies Respond?
Based on the FDA’s communications and published guidance, we have the following recommendations for 3D-printing medical device companies and manufacturers:
- 3D-printed PPE have not been FDA-cleared to provide equivalent air filtration or fluid protection as surgical masks and N95 respirators.
- The need for validation, testing, and approved clearance from the FDA depends on the equipment or device’s classification.
- The NIH 3D Print Exchange provides downloadable designs of 3D printing medical device prototypes, which was built by America Makes in collaboration with the FDA, National Institutes of Health, and Department of Veterans Affairs.
- When 3D printing medical device components, parts, or accessories, the same performance quality, device dimensions, and specifications should be utilized, if available.
- The demand for specific products, device component compatibility, and medical, government, and regulatory guidelines should be considered before production.
- Sponsors who are interested in developing in vitro diagnostics related to the coronavirus disease should consider submitting a pre-EUA. Sponsors who are interested in developing therapeutics to treat coronavirus should submit any questions or information to the Pre-IND Consultation program.
- The FDA created an emergency program, Coronavirus Treatment Acceleration Program (CTAP), intending to support clinical trials, new treatments, and possible therapies related to COVID-19, which could include studies related to 3D-printed medical devices.
- 3D printed medical device companies should ensure the well-being and safety of manufacturing personnel. The Center for Devices and Radiological Health have published emergency-situation recommendations.
What Should You Know About 3D-Printed Medical Devices?
In addition, several recommendations have been issued for consumers and healthcare providers:
- 3D-printed face masks or makeshift cloth masks can serve as a protective layer but are not an alternative to FDA-cleared masks.
- Be cautious of products claiming to treat COVID-19. Report any fraudulent, unapproved products that claim to treat, cure, prevent, or diagnose COVID-19 to the FDA’s Health Fraud Program.
- Conventional capacity, contingency capacity, and alternative, crisis strategies for medical glove conservation and surgical mask and gown conservation have been outlined in letters from the FDA.
While 3D printing medical devices may not provide an immediate solution to the increased demand and decreased supply of PPE during the COVID-19 pandemic, the available technology may continue to develop and aid in providing support to the healthcare industry.
What questions do you still have about 3D printing medical devices and PPE during the COVID-19 pandemic? Connect with us to discuss how we can help.