A regulation that came into effect last year with the aim of improving the oversight of medical devices in Ireland is leading to unintended consequences which may put some surgeries for children at risk, new research by Trinity College Dublin (TCD) has found.

The regulation may also put the treatment of rare diseases at risk, the researchers have warned.

Medical devices are evaluated and approved in the EU according to a revised law - the Medical Device Regulation or MDR (EU 745/2017) - that came into effect on May 26, 2021. It replaced the previous rules which had been in place since the 1990s.

It has a transition period that allows products that were approved under the previous rules, the EU Medical Device Directives, to continue to be marketed until May 26, 2024, at the latest.

However, as a result of a series of unforeseen factors, there is a possibility that the MDR may result in products becoming unavailable, with the consequent risk of a loss of some interventions that are reliant upon those devices.

Devices that are used for orphan or paediatric indications are particularly vulnerable to this.  

“Due to a series of challenges in implementing these new rules, there is a risk that devices used for the treatment of rare diseases and children may be withdrawn from the market. If even a handful of devices leave the market, this can lead to serious implications for the surgical options that are available and in some cases, this may lead to avoidable harm,” explained Tom Melvin, associate professor of medical device regulatory affairs at TCD’s School of Medicine.

The researchers provided an example of one device, the Rashkind balloon catheter, which was first developed by Dr William Rashkind in 1966 to open the upper chambers in the heart in neonates with congenital heart disease.

A number of these balloons were once available in Europe and now there is only one. This device may become unavailable next year. If this happens, it will not be possible to continue this procedure and alternative surgeries or treatments are far less optimal.

The researchers said that there is now an urgent need for policy to be developed to protect essential medical devices for orphan indications and for use in children. This is necessary to ensure that key interventions can continue and to ensure a more sustainable system in Europe over the longer term.

They emphasised that clinicians in Europe need to be aware that particular medical devices may become unavailable over the next two years and they should contribute to plans to mitigate this risk to ensure their patients receive appropriate care.

“Medical devices are essential tools needed to treat many types of congenital and structural heart diseases in children. Although this regulation was introduced to improve the safety of these technologies, we have seen a number of important devices withdrawn from the market, which is already limiting some treatment options. There is also a real risk that more will follow,” commented Prof Damien Kenny, a consultant in paediatric cardiology in Children’s Health Ireland.

This research is published in the journal, Pediatric Cardiology.