Hospital in Paris 3D prints medical equipment using Artec Space Spider for quality control
Challenge: To ensure quality of 3D-printed medical equipment in a French hospital.
Solution: Artec Space Spider, CT Scans, Avizo data processor
Results: Amid the Covid-19 outbreak, medical equipment has been in short supply for many hospitals. Led by a surgeon in Paris, a new operation was launched: to 3D print more medical supplies on demand, with the Artec Space Spider 3D scanner for the rigorous quality control needed.
When the first case of Covid-19 – then known as a mysterious pneumonia-like disease – occurred in Wuhan, China late last year, most of us had little idea of the pandemic that was about to change the world as we knew it. By January 2020 more than 40 people in China had been infected and a name had been assigned – Coronavirus, or Covid-19. Over the next few months, a global pandemic would halt local and international travel, businesses would shut down, widespread quarantines would be imposed, and for most of the world, only essential services would be allowed.
Delivery of 3D printed medical devices to patients preparing for deconfinement. (Photo from Dr. Roman Khonsari / Instagram)
As of mid-May 2020, almost 5 million cases have been reported internationally, with 1.7 million recoveries and more than 300,000 deaths. In France, as of mid-May, more than 180,000 cases have been reported with 28,000 deaths and 60,000 recoveries. At its peak, it stood as the country with the fourth highest number of cases – higher than China, where the outbreak first began.
In countries around the world and especially in countries where numbers were rising and hospital beds were running out, more than any other essential services, medical care was crucial. Medical workers would be stretched thin in both time, numbers, energy, and resources.
That’s when Covid3D.org, a new initiative led by Paris-based surgeon Dr. Roman Khonsari with Paris hospital authority APHP (Assistance Publique – Hôpitaux de Paris), and funded by University of Paris and luxury group Kering, would take shape, with 3D technology forming the backbone of this initiative. The operation needed to be a big one, and one that worked accurately and quickly.
The plan: To set up a 3D printing operation in Paris, where medical equipment could be designed and printed quickly, cheaply, and on demand. The challenge: Starting from scratch, and in unchartered waters.
On top of that with rising numbers and factories around the world shutting down, time was of the essence. With the support and mobilization of fifty doctors, engineers, developers, entrepreneurs and members of both public and private sectors, Covid3D was launched in just 10 days.
“There’s no textbook for 3D printing medical devices during a global pandemic,” Dr. Khonsari says. “And a big challenge as the large amount of legal work involved – this is something we wouldn’t normally be able to do, and we were now creating a brand new framework for the purpose of printing medical supplies.”
And it wasn’t just that hospitals in Paris were running out of medical supplies, Dr. Khonsari explains. With manufacturing hubs like the US and China slowing down operations or keeping what they were producing for domestic use, there was now a need for medical supplies beyond what Covid-19 cases required. Items of critical importance include valves, intubation equipment, respirators, syringe pumps, masks, and medical connectors.
This device, usually imported from the US and now short in supply, is used to hold thread for suturing during heart surgery.
What’s important to remember here is that the items being printed and scanned aren’t necessarily complicated – “We’re not building spaceship parts here!” Dr. Khonsari adds – but because they are for medical use, the highest levels of quality, accuracy, and safety are required.
To ensure submillimeter precision, Artec Space Spider has been put to work. A portable 3D scanner made for capturing small objects in high resolution with consistent accuracy and in intricate detail, Artec Space Spider is ideal for molding parts, keys, computer parts, or in this case, specific medical equipment. Using blue-light technology, Space Spider doesn’t miss any edges no matter how sharp or thin, from the tiny details of a coin to the ins and outs of a human ear.
The biggest challenge for the Covid3D team – legal regulations. “It was killing us, we were working all day and all night working on the quality of what we printed,” Khonsari says. Given the urgency of the situation, the legislation that allowed this printing was expedited, and the team today has the necessary regulations in place, on condition that a strict protocol is adhered to.
“First,” Dr. Khonsari explains, “we have to demonstrate that we have a shortage of the item, and that no other product is able to meet the same need.” Once a real shortage is established, printing of the item is allowed on condition that the protocol is strictly enforced – not only to ensure that the item had been printed to satisfactory standards, but that it can endure cleaning and quality control without being destroyed. Medical cleaning methods include sterilization and disinfection by means of rigorous methods that might damage items not made to last.
The 3D printing factory has been set up near the hospital and operates 24/7. (Photo from Stratasys 3D printing)
In just three weeks, an entirely new system was set up in Port-Royal Abbey, a historic building next to the Cochin Hospital. Here, 60 3D printers churn out various forms of medical equipment round the clock and with a supervising team of five engineers working in shifts. Items printed are separated into batches of 100. For each batch, one is 3D scanned with Artec Space Spider to check the quality.
The designs to be printed are either adapted from scans of existing equipment, or drawn from scratch by the engineers. The scans allow a comparison between the newly printed items and their more traditionally produced predecessors. For data comparison, general-purpose software such as Avizo, an application specializing in industrial data, is used.
If the scan proves that the new item meets the requirements and that the key characteristics of each item are maintained, the batch passes the quality control test. If it fails, the whole batch is thrown out. For equipment where the accuracy of interior tubes are required, CT scanning is used in partnership with Space Spider.
Batch monitoring for emergency medical devices is used for quality control. (Photo from Dr. Roman Khonsari / Instagram)
Today, with the legal hurdle crossed and a protocol in place, the team is confident that their operation can continue – and they’re ready for the future, too. And because the items are cheap to print and can be printed in bulk, they provide a new way of dealing with emergency situations.
Sélim Amrani from Artec 3D’s certified partner CADvision says that while 3D technology can provide an answer quickly, quality is more important still. “What we saw in the first two months was a lot of companies who tried to help by printing visors, or valves,” he says. “But it’s not so easy to print those kinds of parts. We need to respect very specific standards.” With that in mind, quality control 3D scanning takes center stage.
“CADvision is, of course, happy to play a part in finding solutions while creating these parts,” Amrani adds.
For Dr. Khonsari, this is just the beginning. “In the future, a similar 3D-printing solution can be built, in war zones, or in the face of another epidemic,” he says. Already, the team has been contacted by organizations in other parts of France and Europe, and as far as Mexico and countries in Africa.
But even as Covid-19 numbers in France drop and more and more patients move from intensive care to post-intensive care – Dr. Khonsari adds that they’ve got 3D-printed ventilation masks ready for that stage too – the team is prepared.
With restrictions on daily life easing up in France, Dr. Khonsari and his team are already anticipating another rise in cases, possibly in the near future. “At least for what’s medically necessary, we have enough production capacity that our hospitals can rely on,” Khonsari says. “We’re ready in the event of a second wave.”