By Norbert Sparrow, Editor in Chief at PlasticsToday, UBM Canon

This article was originally published in Plasticstoday.com on April 12, 2017.

3DHEALS2017 UCSF, April 20th, 2017

If you’re interested in the intersection of 3D printing and medical technology and happen to be near San Francisco, CA, next week, you might want to carve out some time to attend the 3DHEALS 2017 Global Conference: 3D Print Life. 3D HEALS is dedicated to the proposition that great things can happen if you bring together technologists from the start-up culture of Silicon Valley and the Bay Area and healthcare stakeholders under one roof.

The organization has been around for a couple of years and has produced five successful events during that time. By reaching out to various stakeholders in the healthcare system, technology, regulatory affairs and more, “it made us realize that it takes a village to make revolution happen, and many challenges can only be overcome by a well-organized ecosystem,” write event organizers on the website. “We are hoping that by organizing this global event, 3DHEALS will contribute to fostering this burgeoning yet still fragile ecosystem.”

Event organizers expect more than 400 attendees and approximately 40 speakers addressing all aspects of 3D printing in the medical space. It is scheduled for April 19 and 20 at the Mission Bay Conference Center at the University of California San Francisco. For more information, go to 3d-heals.com.

Find out what’s new and what’s coming in 3D printing at the 3D Printing Summit at this year’s PLASTEC East event in New York City in June. Go to the PLASTEC East website to learn more about the event and to register to attend.

Bedside printing: Who’s liable when things go horribly wrong?

One aspect of the medical 3D-printing ecosystem that will become a hot topic when healthcare establishments start printing medical devices in house is the question of liability. The Legal Intelligencer published an enlightening article about this recently, “ The liability of hospitals and doctors printing 3D medical devices .” Traditionally, a manufacturer producing a 3D-printed device is subject to product liability claims. “But, when a hospital or doctor prints the device at their own facility, who is responsible if that device causes a patient harm?” writes Marion Munley, who offers well-informed insights into this looming legal conundrum.

I use the word “looming” advisedly. While “bedside printers” are not yet a reality, the notion of printing personalized medical devices that conform to individual patient anatomies or other patient-specific medical needs is beyond tantalizing. The technology, for the most part, is available; what is standing in the way are the regulatory hurdles and, as Munley cogently notes, the legal thickets.

For now, hospitals and doctors probably can’t be held strictly liable as suppliers of medical products, writes Munley. “They are considered to be akin to a consumer or user of a product when the product’s use is incidental to the provision of medical services, and are shielded from being held strictly liable.” The line between manufacturer and service provider will blur, however, “as hospitals and doctors begin to print 3D devices in bulk quantities and sell them to their patients,” Munley adds.

Under current law, practitioners and medical establishments could be liable for negligence if a patient is injured by a defective in-house 3D-printed device, notes Munley, but that is difficult to prove. Depending on the circumstances, patients could also file a malpractice claim.

There is a bit of a vacuum in this area of the law, which is concerning to Munley, “since it is widely anticipated that hospitals and doctors will significantly increase their production of 3D medical devices on-site, [and] patients injured by these 3D devices will face legal hurdles.” In the meantime, Munley concludes, the “FDA will have to continue to ensure that these products are safe, as well as properly regulated, until the law catches up with this rapidly evolving technology.”

Mark your calendar for 3DHEALS2018, April 20–21st, 2018