A doctor who treats critically ill babies is warning that new EU quality control rules for medical equipment are so stringent they force manufacturers to discontinue the supply of devices used in lifesaving operations.
In a plea to the European Commission to resolve the issue quickly as EU institutions ramp up after the summer recess, Damien Kenny, a congenital cardiologist in Dublin, said equipment shortages are leaving his colleagues no option but to perform more risky procedures on newborns and he fears that one day, a baby will die because they have no equipment to help them.
“I’m afraid it will come whereby we have no solution,” Kenny told POLITICO. “In other words, there will be no therapy available and some will die as a consequence,” he said.
In the meantime, a large group of children’s doctors faced with the daily grief of managing without well-established and effective products, such as catheters, stents and tiny balloons, have published a strategy for overcoming the shortages.
At issue is the EU’s Medical Devices Regulation (MDR), which requires all medical devices to be re-certified under a more stringent system — a more costly and time-consuming process. The idea is to protect patients from faulty and unsafe products following the PIP breast implants scandal, and low-standard hip replacements.
But the rules are particularly onerous for devices produced in low volumes, such as those used in newborns or people with rare diseases, with some manufacturers deciding instead to withdraw products.
Earlier this year, the EU delayed the entry into force of the rules to give companies more time to comply, and Health Commissioner Stella Kyriakides has acknowledged that more changes to the rules are most likely needed for rarely used but lifesaving products.
But this has done little to stop manufacturers from withdrawing their products from the market, said Kenny.
Higher risks
Kenny helps newborns and children born with heart defects. Before the arrival of the MDR, many of them would undergo a minimally invasive procedure at the bedside to open up heart valves and vessels and correct congenital problems. His team would use a tiny catheter inserted into a baby’s leg vein and fed up into the heart, where a small balloon is inflated to create space for a stent. But all of these products are now in short supply.
Increasingly, over the last year, his colleagues have been left with no option but to perform open heart surgery on newborns requiring a heart valve or vessel opening. That requires the chest cavity to be opened, the babies’ hearts stopped and connected to a heart-lung bypass machine, and the correction done surgically.
But in some cases, even switching to this higher risk, more invasive option isn’t easy because the tiny cannulas required to attach the baby’s heart vessels to the heart-lung bypass machine are also affected.
“The surgeons are struggling to get them for small babies now because the companies are not making them because, again, they’re having to go through MDR,” Kenny said.
In some cases, companies have applied for national derogations from the rules. But these are time limited exemptions, Kenny said, and manufacturers must have already submitted their product for assessment under the new rules.
The EU has attempted to address this critical shortages of devices, especially those used rarely and in infants. A Medical Devices Coordination group was set up in 2021 to assist in the uptake of the new rules, and in November 2022 Commissioner Kyriakides said the group had established a task force on orphan devices — ones used in very low volumes — to overcome these issues.
But to date, no one has reached agreement on how rarely a device should be used to qualify as an orphan device, despite correspondence from clinicians pleading with Kyriakides to deal with the problem.
“Pick a number, guys, and just let’s go with it,” Kenny said. Then, the expert group can identify orphan products and work can begin on finding measures to protect them, he said.
Recommendations
In an article published in child health journal Acta Paediatrica in late July, experts across pediatric fields presented a raft of recommendations for how the EU can overcome these issues.
These include establishing an expert panel to advise on pediatric devices, identifying those that should be classified as orphan products; and exempting devices that have been used safely for many years from the requirement to generate new evidence.
They also want a priority regulatory pathway to review and certify orphan devices quickly and at a lower cost, ideally carried out by an EU body, such as the European Medicines Agency or a group of private notified bodies.
A spokesperson for the Commission told POLITICO they were aware of the doctors’ concerns and further meetings are planned to resolve the issues. They added that not all products have been withdrawn from the market due to the MDR; two catheter manufacturers recalled their products due to urgent safety issues.
In the meantime, the decision to delay the new rules “addressed the immediate urgencies to avert the risk of shortages,” the spokesperson said, allowing more time for the assessment bodies to build up capacity to operate more effectively. National derogations are also a means to allow continued access to products, the spokesperson added, and in exceptional cases, this could be extended EU-wide.
Kenny, speaking on behalf of his colleagues, pleaded with the Commission to act now.
“We don’t want to change Medical Devices Regulation … What we’re asking for is an acknowledgement of the fact that it can’t all be under the same umbrella,” he said.