A recent BBC Panorama programme has highlighted the need for stricter regulations around the use of medical devices in the healthcare sector.
The BBC investigation worked alongside the International Consortium of Investigative Journalists and 58 media organisations around the world. It found that medical devices, such as implanted contraceptives, pacemakers and hip replacements, were being put into people after failing in clinical trials. Currently, Europe does not have a governmental body that checks medical devices before introducing them to market, instead a Notified Body (in which there are 58 in the EU) issue CE marks. Approval by just one of them means that they can be used anywhere in the European Economic Area (the EU, Iceland, Liechtenstein and Norway). Mr Dalvi Humzah, consultant plastic, reconstructive and aesthetic surgeon recognises that this is also a issue for the aesthetic sector too. He said, “Although a CE mark is helpful the devices and products used in aesthetics rarely undergo formal clinical trials to asses their efficacy in this specialty. What we need is a more rigorous testing of products before and after they enter the UK market.”
Souphiyeh Samizadeh, dental surgeon and aesthetic practitioner, added, “Stricter regulations around the use of medical devices in the field of aesthetic medicine are essential. Although such devices in this field are mainly used for non-medical and purely cosmetic purposes, their use involves medical procedures.”
She uses the examples of dermal fillers, threads and lasers that are under the umbrella of medical devices. She continued, “This has meant that people without a healthcare background are buying and using/injecting/implanting these devices on or in patients’ faces and bodies. This is disastrous as it immediately puts the public in great danger. Such individuals with no medical/healthcare background have no understanding of patient care and ethical medical practice, anatomy, physiology and pharmacology, nor can they manage medical emergencies, or recognise and manage complications. Such devices, in wrong and untrained hands can result in catastrophic complications that can be life threatening and life-changing including infection, permanent blindness, and burns.”
At the time of publication, the government has said it will look at what changes may be required.