Manufacturing technology 28
Before the Altobelli twins were
separated, CHOP had only performed 28 heart printing procedures in more than 60 years.
CHOP
Double vision It’s often the exceptional cases that introduce hospitals to the potential of 3D printing at the point of care. “One of the running jokes is most people either start with kidneys, hearts or conjoined twins,” says Silvestro. “Every printing lab has a conjoined twin story because it’s such a unique case for what printing can do.” That’s not to say it’s the only one. Implemented properly, in-house AM can help hospitals take better care of almost any patient. As well as surgical models like those used for the Altobelli twins, the CHAMP lab also produces educational toys for young patients and their families; simulation and training tools for trainee physicians; and replacement and patient-specific devices that can’t be sourced from external manufacturers. The other main application for onsite AM is in the creation of surgical guides – plastic templates that enable surgeons to carry out joint replacements and corrective bone surgeries according to plans determined on computer screens. Most impressively, these guides enable off-the-shelf components like replacement joints (which come in a range of sizes) to be personalised for specific patients. “Each guide is produced to cut the bone in a specific way, so the implant fits exactly as planned,” explains Andy Christensen, current chair of the Radiological Society of North America (RSNA) 3D Printing Special Interest Group. As he puts it, “it’s an elegant way of doing personalisation without having to personalise the implant,” bringing all the advantages of custom implants for patient outcomes at a fraction of the time and cost.
At first, guides and models were almost always provided by external 3D printing specialists like Medical Modeling, the company Christensen founded in 2000. That process was expensive and could take time, so as certain types of 3D printers became more affordable, what Christensen calls “surgeon-tinkerers” began to explore what they could achieve by bringing the capabilities into their workplaces. “They get complicated anatomies and they love to see things in their hands,” Christensen says, referring in particular to maxillofacial and orthopaedic surgeons, as well as cardiologists dealing with heart deformities. And that brings us back to CHOP in 2011, when a group of radiologists and cardiologists decided to invest in a 3D printer that they could use in planning for heart surgeries. It could have gone better. “A very nice printer was bought and put in a room six floors away from everybody with the idea that the physicians would have time to run it,” says Silvestro. “A few years later, they realised that wasn’t the most productive plan.” CHAMP only began to transition to what it is today when Silvestro, and her radiologist colleague Dr Raymond Sze, were given the full-time jobs of running it in the mid-2010s.
60 A rarity
Since then, every hospital in the US has been exposed to a different type of “extreme, once-in-a- lifetime case”: Covid-19. Although Silvestro and Sze have always used the CHAMP lab’s position in the radiology department to avoid being siloed, even they weren’t prepared for the sudden spike in interest. “We were able to put devices all over the hospital,” Silvestro says. “Even making simple ear- savers for masks got the word that there was a printing lab out there further than we ever thought we could reach.” That’s particularly important in a paediatric hospital like CHOP because so few medical devices are specifically tailored to the needs of children – masks and PPE included. “A lot of paediatric devices are just scaled adult devices, which isn’t a good representation of the paediatric anatomy,” explains Silvestro, “but by having the lab inside the hospital, we’re able to help fill some of those gaps.” Indeed, with the whole hospital newly aware of what the CHAMP lab could offer, Silvestro and her team received a flood of requests about replacing child-friendly devices that were either unavailable because of supply chain issues or had simply been discontinued. Their work on creating mask adapters, airway devices and guidewire tools for young patients even began to attract attention from outside the hospital’s walls. The Philadelphia Paediatric Device Consortium, which is funded by the FDA to improve the supply of devices suitable for children, has met with the CHAMP team to talk about facilitating partnerships that might enable their designs to be mass-produced by external manufacturers. That could be a real boon for less well-resourced hospitals. They can’t all afford their own labs, and, at present, even those that purchase 3D printed guides and models from specialists do so without much hope of reimbursement. “The hospitals are doing this because they know that it helps provide better patient care,” explains Christensen. “But there isn’t a direct financial connection between the provision of this service and some funding that would come back to pay for it. And it’s been that way forever.”
He should know. Having repeatedly tried and failed to get US reimbursement codes for 3D-printed surgical tools established while at Medical Modeling. Christensen’s now leading the RSNA’s attempts to put things right. So far, the 3D Printing Special Interest Group has secured a set of temporary codes, which means certain 3D-printed tools no longer need to be filed as miscellaneous (and completely ignored by insurers), but there is still work to be done before they become permanent, paid-for parts of the system. “In order for these labs to stay afloat, they have to
Medical Device Developments /
www.nsmedicaldevices.com
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