Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare
Pandemic-related medical device shortages due to supply chain disruption have spurred hospitals, physicians’ offices, and other health care facilities to rely on 3-dimensional (3D) printing to produce face shields, face mask holders, nasopharyngeal swabs, and ventilator parts from locally available materials.
However, these health care facilities might not be as familiar as traditional manufacturers with how the FDA regulates medical devices, notes the agency, which recently released a discussion paper about 3D printing of medical devices at the point of care.
The 3D printing technology “enables health care professionals to quickly create patient-matched devices and anatomical models for surgical planning, as well as many other uses that can help health care facilities rapidly respond to patient needs,” both William Maisel, MD, MPH, director of the FDA’s Office of Product Evaluation and Quality, and Ed Margerrison, PhD, director of the agency’s Office of Science and Engineering Laboratories, said in a statement.
Health care facilities should ensure that any 3D medical devices they print “will be high-quality, perform as intended, and will not expose patients to unreasonable risk of illness or injury,” according to the discussion paper.
Certain devices pose very little risk to patients, though, and the discussion paper noted that the FDA is considering whether and how it might be appropriate to provide regulatory flexibility when health care facilities print such devices.