Recent investigations into faulty medical device regulation have highlighted the need to broaden the scope of pharmacovigilance, to include more than just medications.
The International Consortium of Investigative Journalists (ICIJ) started releasing the Implant Files in late 2018. Their collection of investigative articles, researched by over 250 journalists worldwide, digs deep into the regulation of medical devices. Numerous examples of patient harm from across the globe paint a bleak picture of insufficient testing and regulation of medical devices, and of regulatory processes that are less than transparent and lend themselves to conflicts of interest.
The category of devices includes anything that is placed inside the human body: breast implants, vaginal mesh, pacemakers, artificial hips, stents, heart valves, contraceptive devices, and so on.
Data from the US suggest that, in the last decade, around 80,000 deaths and 1.7 million injuries were possibly attributable to devices; in Europe, with ‘light-touch’ regulation, there has been a steep rise in incident reports in recent years. The ICIJ summarise its findings as follows: “Patients around the world have become unwitting test subjects for new medical technology. Often following the trusted advice of their doctors, they have been injured, maimed and killed by poorly-tested implants.”
At Uppsala Monitoring Centre, we believe that transparency in all matters relating to the safety of medicines and devices is an essential element of ethical regulatory practice. Health professionals, patients and society at large have a right to full information about all matters that affect their health.
In their 2016 article ‘Pharmacovigilance is…vigilance’, Ralph Edwards and Rachida Soulaymani Bencheikh argue that medical devices are the proper concern of pharmacovigilance as much as medications; that the growing focus on individual patient welfare, alongside epidemiological perspectives, demands the adaptation of traditional methods and the development of new expertise. Many countries in the world rely on approvals in the US or Europe and have no local system for reporting device failures.
The ICIJ report makes it clear that the same stringent regulatory principles for medicines should also apply to medical devices and that there is an urgent need for reform.