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    April 2020

    Risk Management Guidance for 3D Printing

    As the medical community copes with gear and equipment shortages due to the coronavirus (COVID-19) pandemic, many educational institutions are considering using their 3D printing capabilities to help. This additive manufacturing ─ or 3D printing ─ raises risk management and legal issues that schools should keep in mind.

    Establishing Oversight

    • Appoint leaders for the 3D printing project and determine their levels of authority, responsibility, and oversight. These leaders, or others they authorize, should identify who will participate in the design and production process.
    • Gather all resources that will be used in the process, keeping in mind that 3D printers are used across disciplines ─ from engineering to art ─ and across campus, from graduate schools to makerspaces.
    • Seek out scientists or medical experts from inside or outside the institution to consult on items to produce. Some schools have leaders in health care innovation, biomedical engineering, or medicine who are particularly well suited to advise on these efforts.
    • Involve your institution’s legal counsel in the project to ensure institution policies and legal issues are properly addressed.

    Choosing the Product

    • Work directly with health care facilities or government aid agencies to identify needed supplies. Coordinating your production with the end user is important to avoid unnecessary effort and unhelpful products. Some 3D printing businesses and communities, such as America Makes, are connecting medical centers and government agencies with volunteers who can manufacture needed parts.
    • Review the lists of needs and determine which supplies your machines can safely produce. Due to the varying capabilities of 3D printers, some institutions are choosing to produce items with straightforward designs, like face shields, rather than complex equipment or sensitive protective gear. Consider the porosity of 3D-printed items, which can be problematic for some medical equipment.
    • Review your institution’s 3D printing policy to ensure that all relevant requirements are met. Update the policy to fit the emergency pandemic situation, as needed. If your institution requires proper approval from its medical review board, get it prior to manufacturing.

    Designing the Product

    • Use product designs from a reputable source that already have passed the required approval and certification requirements. Use of open source designs may help avoid patent infringement and other intellectual property issues. When possible, reach out to medical device manufacturers for use of their designs. Consult legal counsel specializing in medical devices for guidance on approved designs and intellectual property issues.
    • Review all certification and regulatory requirements for the product, as some products cannot be accepted by health care centers without proper certification. The Food and Drug Administration (FDA) regulates medical devices and has issued guidance on 3D printing and FAQs addressing the pandemic.
    • Ensure that the chosen design and its digital file are not defective.

    Reviewing Insurance and Legal Obligations

    • Understand that product liability issues surrounding additive manufacturing of medical devices are complicated. Consult with legal counsel and your broker to ensure compliance with all design, contract, and insurance requirements.
    • Enter into a contract with the recipient hospital or agency when products are offered for sale. Include a description of the goods, payment obligation, timelines and duration of the contract, insurance obligations, appropriate waivers, assumption of risk provisions, and indemnification language that ensures the manufacturer will not be responsible for any losses. For more information, see United Educators' (UE’s) contract review checklist and confer with legal counsel.
    • Require the recipient hospital or agency to sign an acknowledgement and waiver if the product will be donated. Describe the product and explain that it is being provided at no charge and without conveyance of intellectual property rights. Include an “as is” clause, product liability disclaimers, a statement that the school will not be liable for damages of any kind, and that the recipient hospital or agency is responsible for compliance with laws and regulations related to the donation. Include indemnification language, if possible; some institutions have received protection from liability through agreements with state or federal emergency management agencies.
    • In March 2020, the Public Readiness and Emergency Preparedness Act (“PREP Act”) was passed to provide limited immunity to colleges and universities manufacturing and distributing PPE for use during COVID-19 response efforts. Consult with legal counsel to determine whether the immunity may apply to your institution.

    Preparing for Production

    • Ensure that before manufacturing occurs, the production process meets the recipient hospital or agency’s requirements and any other standards.
    • Understand that procurement of appropriate materials is critical to meet medical standards. Consult with medical professionals and legal counsel to identify any obligations around standards and use of appropriate materials.
    • Train participants in the production process so they understand all policies, processes, and safety procedures, including any new procedures to protect from COVID-19.
    • Confirm the printing environment meets all health and safety standards, including proper ventilation or air filtration.

    Manufacturing the Item

    • Work in a sterile environment. All individuals should wear gloves and masks.
    • Perform regular inspections of the printers to confirm good working order.
    • Seal items immediately, to the extent possible.
    • Consider storing the product for 72 hours before distribution to reduce possible contamination. The COVID-19 virus has been shown to survive on plastic for some time.
    • Have items checked by a medical professional for quality control. Include adequate disclaimers and warnings disclosing foreseeable risks (including adverse reactions), where necessary. There are potential dangers and inherent risks in medical devices and supplies. Consult legal counsel regarding appropriate language and to evaluate whether to attach labels with instructions or warnings.

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    by Christine McHugh, senior risk management counsel

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