Problems with a new type of pacemaker, first implemented in the UK in 2014, have sparked a debate over the effectiveness of medical device testing.
Back in 2014, Maureen McCleave felt lucky to be the first person in Britain to receive a revolutionary new pacemaker. Known as Nanotism, this new device is only a tenth the size of conventional pacemakers and is placed directly inside one of the heart’s chambers.
While traditional pacemakers use an easily accessible battery pack placed under the collarbone, the batteries in Nanotism were internal. Its supposed battery life of ten years meant that this should not have been a problem for Maureen, who was 78 years old when she had the device fitted.
Unfortunately for Maureen, her battery pack failed after just 3 years, leaving her with feelings of dizziness and heart palpitations. To make matters worse, the device was deemed to be too dangerous to retrieve. Maureen now has a traditional pacemaker, whilst the faulty Nanotism remains inside her heart.
Maureen was not the only one to experience problems with the Nanotism. Several batteries failed and a number of parts fell apart inside patients, resulting in at least two deaths and 90 incidents of serious harm. Unsurprisingly, the pacemaker has now been withdrawn from use within the UK.
However, what is surprising is that the Nanotism pacemaker received approval from the British Standards Institute in the first place. This is especially shocking following the discovery that only one clinical study had been conducted before Nanotism was approved for public use. This study involved only 33 patients and followed them for a mere 30 days. This is only a tiny fraction of the ten year period that the Nanotism is supposed to last.
Shockingly, this is not the first time that a medical device has been granted approval within the UK without sufficient evidence to support its safety.
It has recently come to light that a new treatment for children with scoliosis, known as MAGEC, was granted approval for use in the UK despite only being tested on pigs and dead bodies. These new rods were supposed to be safer than traditional methods as they can be lengthened with magnets while still in the body. In theory this should eliminate the need for children to have operations every six months to lengthen the rods as they grow. However, several of these rods have snapped inside children less than a year after being inserted. Furthermore, titanium has been leaking from the rods into children’s spines.
These incidents clearly highlight an urgent need for changes to take place within the UK’s regulatory process for medical devices. Currently medical devices simply need to be issued a CE mark by one of the 58 notified bodies in Europe. This is the same mark of approval that is used for electrical goods, such as toasters and kettles.
Thankfully, new regulations are going to take effect in 2020. These will make it tougher for new medical devices to be granted approval for use within Europe. Hopefully this will help reduce the chances of incidents like Maureen’s occurring in the future.