Lagging behind the rapid advancements within the speciality as a whole, a 2023 study titled ‘Is there really no kit for kids?’ has identified the continuing “unmet need” for paediatric interventional radiology (IR) devices. Although off-label device usage has been standard in paediatric cases, Premal Patel (Great Ormond Street Hospital, London, UK) told Interventional News of “changing regulations” in Europe— with repercussions worldwide—which has forced manufacturers to state a definitive ‘yes’ or ‘no’ in device instructions for use (IFU) in reference to children. In light of recent international device withdrawals and license regulation updates, Patel, Fernando Gómez Muñoz (Netherlands Cancer Institute, Amsterdam, The Netherlands) and Alessandro Gasparetto (The Hospital for Sick Children, Toronto, Canada) surveyed the current state of paediatric IR and the global device deficit.
In May 2021, the European Medical Devices Regulation (MDR) introduced an update stating their intention to “bring EU legislation into line with technical advances, changes in medical science and progress in law-making”, stating that all medical devices must meet “robust”, “internationally recognised” safety criteria and apply for new certification. The directive requires that manufacturers explicitly state whether devices can be used in paediatric patients, as well as additional costs to obtain certification for product lines.
In 2023, the European MDR extended the deadline for manufacturers to comply with the requirements to 2027–2028 depending on the device. “They are making it harder for companies to keep licenses,” Patel said, “the way companies typically got around this is by just not saying anything”.
Looking at this in greater depth, Patel et al’s cross-sectional analysis of device IFU assessed the inclusion of children in vascular access, biopsy, drainage and enteral feeding devices from 28 companies who sponsored the British Society of Interventional Radiology (BSIR), the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) and the Society of Interventional Radiology (SIR) between 2019 to 2020. Their results show that 190 devices with IFUs from 18 medical device manufacturers were assessed—26% mentioned children, 3% explicitly stated that the device was not for use in children, and 29% implied they could be used in children with caution—the most common caution (14%) being the size of the device that could be accommodated in a child.
Patel and colleagues’ conclusion draws attention to the 29% of devices that may be suitable for paediatric use but lack explicit manufacturer support—“typically [IFUs] do not mention children, but manufacturers workaround this by stating ‘use an appropriate size for the patient’ which you can interpret how you want,” Patel explained. Now, however, manufacturers are “specifically saying no to children,” he updated, even stating that their data—collected in June 2023—are inaccurate due to recent Cook Medical withdrawals which have taken many of their device lines “off the shelf” for Patel and his team. “We have already seen the effect, the data in the paper are now out of date,” he said.
Device withdrawals and IFU criteria changes have left paediatric interventional radiologists with little option but to “look for avenues around these regulations” and treat patients effectively via off-label device use. In having to seek these avenues, Gómez Muñoz reflected that “children are being prevented from getting treatment,” in the event of no appropriate device being accessible, as well as “the impact of cost to both the interventional radiologist and the patient”. “You do not want to risk your license or your future doing something that, despite knowing it is completely safe and effective, is not plainly indicated for use in children,” he continued.
Sharing his experiences in treating paediatric patients, Gómez Muñoz stated that it is commonplace to use “homemade solutions” in IR due to the absence of any children-specific devices. “If you have to perform biliary drainage, the size of the drain can sometimes be the same size as the kid. You end up making your own holes or using drains that are not intended for internal use, risking the safety of the procedure,” he conveyed. Additionally, he expanded that placing a stent in a child is “completely different” to placing a stent in an adult— “an adult is not going to grow, but the kid may have an artery of 3.5mm, that, over the course of 18 years, may double in size”.
“This is something we suffer every day,” Gómez Muñoz said, and reading Patel et al’s 2023 research spurred him to write a ‘plea’ to the regulatory authorities and medical device companies, urging them to take action. His letter, titled ‘A plea to solve the unmet needs in paediatric IR devices’ begins by asking: “Are we truly upholding the notion that our children are the most valuable good of our society?” He argues that the lack of adequate medications and IR devices for children “tells a different story” and recalls a summit which took place a few years ago that heard a board member plainly confirm “we have no interest in funding research for children”. Although childhood cancer is thankfully “rare,” Gómez Muñoz’s exposits in his plea, the ”unfortunate” stance of medical device manufacturers that states children are not a “lucrative market” has driven a data deficit, risking interventional radiologists’ licenses in the event of complications when using off-label IR devices in low-complexity cases. For Gómez Muñoz, in some cases merely downsizing an existing adult device “will not suffice”, however he believes that “regulatory bodies should be aware of the situation at hand—if you have a catheter that has been approved for 30+ years in adults, [medical device developers] just need to reduce the size, and it should not need to go through the MDR approval process, as then it is not cost-effective and will take years—I do not see the necessity for that”.
In Canada, Gasparetto is in agreement with Gómez Muñoz that conducting clinical trials to collect data on paediatric IR device effectiveness would be “very difficult”. “It is very tough to run these studies to prove a certain piece of equipment is safe and effective because there are enough treatments that doctors and parents are comfortable with, and to try something new? Using a new device? This would require convincing families to take part, and this is very difficult,” he explained.
“Paediatric IR is an emerging specialty right now, there are not enough paediatric interventional radiologists in the world. We are nowhere near where surgery is or even where adult IR is.” Where “inventiveness” and “[adaptation]” reach their end, however, Gasparetto is hopeful that, as paediatric interventional radiologists grow in “manpower” they will be able to put pressure on manufacturing companies to mass produce smaller and shorter devices. He commented: “As we grow, more evidence will become available, and we will be able to push for paediatric-specific devices. But where we are standing right now, we do not yet have the numbers.”
Indicative of this growth, in 2023, the US Food and Drug Administration established the Paediatric Device Consortia which has funded development of medical devices for children, and brings together “experts from various fields, including clinicians, engineers and researchers, to promote the development and accessibility of paediatric devices”, Gómez Muñoz writes in his plea. Referencing Patel’s research, Gómez concludes that regulatory bodies must “collaborate with the increasing number of paediatric interventional radiologists worldwide” to further research and innovation.
Discussions on this topic are increasing, although “intimate” as Gasparetto put it, the Society of Paediatric Interventional Radiology (SPIR) meeting in recent years has facilitated “more conversations about this issue, gaining a voice”. Patel also relayed SPIR’s significance in the UK, and to the wider international specialty. “It was discussed at SPIR last year, although these are European regulations, once this change is implemented and affects a manufacturer’s ability to sell in Europe, they will withdraw non-viable products from the USA and UK markets too—and this is not just affecting IR worldwide, but interventional cardiology and others”, Patel underlined.
With sights set on the near future, Gasparetto believes that the development of medical devices indicated explicitly for children will occur “soon”, given the “rate of growth [paediatric IR] is experiencing” today. Although, proceeding with more trepidation, Gómez Muñoz stated that “more measures need to be considered”, such as the use of large registries for device clearance and the inclusion of children in IFUs, which will “improve treatment outcomes and patient satisfaction”. Pushing further, however, Gómez Muñoz concluded that the “final answer must come from a common effort from regulatory parties, private companies, public entities and healthcare providers” to support research and device innovation for paediatric IR.
