Regulating Medical Devices 3D Printed at Point of Care

3D Printed Where Needed

Medical 3D printing has made such advances as to deliver healthcare directly to patients at the Point of Care or PoC. Now 3D manufactured devices, models, implants, and other health devices can be produced on site, such as in hospitals and clinics. The US FDA, though, sees it fit that such practices are regulated.

Clinical point of care (PoC) is the actual site of patient care. This is the point in time when clinicians deliver healthcare products and services to patients. Since medical 3D printing has amazingly evolved such that medical devices, models, guides, implants, among others, can be readily obtained, patients need not endure a long waiting time for their diagnosis and treatment. These products can be printed at clinics or hospitals enhancing the significance of PoC.

However, the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health, or CDRH, realizes the possible uses of PoC 3D printed medical devices to the public and sees fit to establish regulations for this application.

A discussion paper on the subject, found on the FDA website, aims to generate feedback from the public as the agency develops policy. It is not yet providing specific guidelines. The document includes the background of the technology, its regulation by the FDA so far, and the relationship between a 3D printing facility and the safety and effectiveness of a medical device. Challenges to 3D printing devices at PoC and how regulatory oversight might be applied in different situations are offered.

Back in 2017, the FDa had already started regulating medical 3D printing of products outside of PoC. It already contained some guidelines which regulated the PoC printing initiatives of some of the AM giants, like Stratasys, RIZE, and 3D Systems, including the bioprinted tissues of Poietis. When the Covid-19 pandemic hit, 3D printing was crucial in producing ventilator parts, masks, and nasal swabs, sometimes with the aid of on-site AM laboratories.

When regulations and guidelines are already established, it will not only benefit medical items produced at PoC, but also general goods can be made readily available at the point of use. This will jumpstart the future of distributed manufacturing. Furthermore, some 3D printing companies may open up locations in particular regions to 3D print spares on-demand for pick-up. This is a significant development not only for medical 3D printing but for the industry as a whole.

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3D Printing At Point of Use

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