Posted by Ali Cloak, Partner
Are medical devices compromising patient safety?
Medical devices have dominated the news this week, following the release of a report by the International Consortium of Investigative Journalists. Ali Cloak takes a look into ‘The Implant Files’ investigation.
The term ‘medical devices’ covers a huge range of products and includes machines, apparatus and implants. The development of these devices has, undeniably, had a positive impact on lives and provided treatment options that didn’t exist in the past.
There can be no doubt that medical devices represent some of the most important advances in modern medicine. From pacemakers to robotic surgical techniques, these devices have not only improved patients’ quality of life but also helped to prolong it. However, the release of The Implant Files suggests that patient safety is being compromised by commercial considerations.
Patient vs Profit – is profit winning?
In the EU, device manufacturers pay ‘notified bodies’ to certify that their devices meet the relevant safety standards. These ‘notified bodies’ are private companies who issue devices with CE marks which allows them to be used anywhere in the European Economic Area.
Vitally, if certification is refused by one ‘notified body’, the device manufacturer can seek a CE mark from an alternative provider. This system, The Implant Files says, leads to a lowering of standards by Notified Bodies as they compete for business from device manufacturers. Inevitably lower standards lead to increased risks for the patients who are being treated using these devices.
The ease of achieving certification effectively means that devices are being trialled on the patients they are being used to treat.
How does this impact upon patient safety?
Unpredicted side effects are common place because of a lack of scrutiny.
For example, rather than assisting with mobility, a hip implant produced by Johnson & Johnson poisoned thousands of people resulting in the need for further surgery to remove and replace the implant. Many of these people had symptoms that persisted even after the implant was removed. Had the testing regime been more rigorous, these injuries might have been avoided.
There have also been dire consequences in relation to pacemakers and implantable defibrillators. Nanostim, the first pacemaker without leads, led to the death of at least two people and 90 incidents of a patient suffering serious harm. Similarly the manufacturer of Sprint Fidelis, an implantable defibrillator, has acknowledged that the device may have caused 13 deaths. Further reports have linked the device to around 2,000 deaths.
The lack of rigorous regulation is leading not only to injuries but also to fatalities, and there is a growing consensus that these deaths are preventable. For example, after investigating Stephen Pettitt’s death following robotic heart surgery, the Coroner acknowledged a risk of further deaths. This was due to a lack of regulation and training on the use of this technology. The inquest heard that had Mr Pettitt had conventional open heart surgery he would likely have survived.
These products have the potential to do so much good but are causing a great deal of harm because they are not properly tested before going on sale. This is compounded by the fact that information on subsequent incidents is not available.
The Implant Files found that requests for incident reports were refused on the grounds that releasing the information would violate the manufacturer’s commercial secrecy. This stance limits the ability of medical professionals to monitor the outcomes of various treatment options and means that they may be unaware of dangerous side effects. This seems to be an instance of commercial interests being put ahead of patients’ wellbeing, with disastrous effects.
Is regulatory change on the horizon?
New regulations on medical devices will come into force in the EU in 2020, however there are concerns that the regulation does not represent a big enough change.
In addition, the highest French court handed down a judgment in relation to the PIP breast implant scandal in October. The implants were approved by TUV Rheinland, a Notified Body in Germany, which failed to identify that the implants were made from unauthorised silicone. The court ruled that TUV Rheinland was liable to pay compensation to the women effected, saying that “vigilance [is] an obligation”.
Time will tell if these developments mark a turning point in the regulation of medical devices, but The Implant Files has brought this issue into the spotlight and added to the pressure to reform the system.
Derek Alderson, president of the Royal College of Surgeons, has commented that “the scale of the problem and the truth of the problem are still not fully apparent” and urged the government to address it. Given that 1,004 deaths between 2015 and 2018 have been linked to medical devices, I sincerely hope that substantial reform is on the horizon.
With the media, the public and the medical profession calling for reform, I hope that a regime can be implemented which will put patients’ interests first. If not, it seems likely that we will see an increasing number of claims in cases where profit has been prioritised over safety.
If you've experienced negligent medical care, whether as a result of an implant or other care, please get in touch with our team to find out more about making a claim.
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