Technology has dramatically changed every aspect of life as we know it, with medicine being one of the most important aspects. Medicine has been revolutionized through medical imaging, drugs, implants and more. What happens, however, when the medical device industry fails? The International Consortium of Investigative Journalists (ICIJ) conducted a year-long global study on this and published their findings.
Tight regulations surround the pharmaceutical industry, requiring a large amount of clinical testing before being approved. While there are regulations put in place for medical devices, they aren’t as rigid as for drugs. As a result, medical devices are put on the market faster and have a higher chance of causing harm, such as puncturing organs, delivering errant shocks, poisoning blood and more, leading to “explant operations” or permanent harm. So, what could have led to such mistakes?
Firstly, it is hard to find reports on defective devices. Some regulations, such as the ones in practice in the US until 2017, allowed breast implant companies to bury evidence of harm by not publicly disclosing their reports. When this practice stopped, the number of injuries reported skyrocketed. Outside of the US, it is even harder to obtain information. For instance, in Europe many reports cannot be disclosed or are never collected in the first place. Detailed data such as the number of devices on the market and their use are also unknown. In other words, there is no way to do statistical analysis on a device behaviour, and neither patients nor their doctors can take informed decisions.
Secondly, we would expect regulations surrounding the health domain to be extremely rigid. The reality is, regulations are a bit more lenient in the medical device industry. Some devices sold on the market have never been tested on humans and only need to provide “reasonable assurance” of the product’s safety and effectiveness. For some devices, it is enough to be “substantially equivalent” to devices already on the market or to an earlier version of the product. They also do not need to demonstrate that the device delivers a benefit to the patient.
Moreover, Europe, with some of the lightest regulations in the developed world, is seen as a “testing ground” for big corporations, waiting to see the success of their products on the market before selling it in the US. From the data that the ICIJ journalists could gather during their investigation, it is expected that the number of reports of injuries due to medical implants will dramatically increase, doubling in the UK in nine years, either due to improved report practice or an increase in injuries.
Thirdly, lobbyism plays a role as well. When a market is concerned by regulations, the companies involved intervene with representatives to attempt to have their viewpoint protected by politicians. For nine years, lobbyists put pressure on representatives during the rewriting of plans to reform Europe’s safety rules. During the whole process, as the ICIJ journalists claim, lobbyists fought to keep as much as possible from the “light-touch safety regime”.
Currently, the regime in Europe uses a range of for-profit certification firms, the “notified bodies”, to approve new devices for market release on behalf of the European Union if they conform with the regulations. They are supposed to look through technical files that truthfully describe the devices, including issues and testing, and then decide whether they meet the regulations. Sometimes, notified bodies might have never seen these files and might have loosely awarded the CE certificates to unsafe implants for the companies that pay them for their services. The European Commission proposed to transfer responsibility for assessing high-risk devices to a new department within the European Medicines Agency. In 2012, however, a centralized regulator was deemed “inappropriate”. According to the Journalists investigators, the commission repeated lobbyist’s arguments: increased costs for hospitals with no increased safety to European citizens. Although there is no fundamental change in the structure, new regulations will push for a stricter control of medical devices.
It is important to note, however, that despite the harm that has been caused by faulty medical devices, the general effect of the devices on health is massively positive. Nothing is black and white. Health manufacturers don’t focus primarily on increasing revenue and decreasing costs, but it is a consideration they need to have to keep the company up and running, which will then allow them to produce more devices that can revolutionize the healthcare domain. Regulations do fail, but they still protect us from many mistakes.
We can decide to leave things as they are, but as the next generation of scientists and engineers, we believe it is our role to positively contribute. Moral issues and fairness to stakeholders should be considered when creating any device. When regulating them, ethical behaviour is important because finding dangers in a truthful description of a device is easier than analysing lies. Finally, even after devices have been released, follow-up is essential, and we believe this area is dramatically under-developed and would have massive impacts in the long run. Scandals and criticism are central to raise awareness but constructively working with all parties involved is even more vital.