Medical devices and in vitro diagnostics proposals: Information is Power

  • Posted on 03.04.2013

Medical devices and in vitro diagnostics proposals: Information is Power


Sascha Marschang

Policy Coordinator for Health Systems, European Public Health Alliance

health system

World Health Day approaching us on April 7th is meant to raise awareness on the endless host of hurdles that undermines our health and therefore, our quality of life. Public health is about making sure that the external factors that determine our health are governed by policies that have people’s well-being at the very heart of their mandate. EPHA, Europe’s leading NGO advocating for better health, is committed to that very principle.

This year marks EPHA’s 20th anniversary in advocating EU and European policy-makers on public health. Bringing today’s leaders to focus on people’s health is not an easy task. The medical devices and in vitro diagnostics files appropriately represent the juggling effort that advocating for public health usually turns out to be.

As discussions over the Commission’s legislative proposals for Regulations on Medical Devices and In Vitro Diagnostic Medical Devices are becoming more exhaustive, and different stakeholders are bringing forward more tangible arguments, what I usually do is take a step back. On one hand this helps putting into context the slew of information disseminated by the different political actors, and on the other hand distance helps avoid becoming overwhelmed by the intricacy of it all. Working for Europe’s largest public health umbrella network representing the interests of over ninety organisations active at EU, national and regional level, I’m no stranger to complexity; trying to meet competing demands isn’t easy. And given the number of evolving EU files that are sometimes deliberately, at other times involuntarily, linked to each other (in the case of Medical Devices this includes, inter alia, legislation on Clinical Trials, Data Protection, Cross-border Patients’ Rights, Pharmacovigilance and eHealth) it’s easy to lose track of what’s happening.  But while the devil is in the detail, at EPHA we also look at files from a broader angle: what are the potential impacts for public health at large, and what does it mean for certain population groups?

Allow me to answer these questions for medical devices first and in vitro diagnostic medical devices later in the blog post. Medical devices are products most people don’t normally think much about. We tend to take them for granted unless there’s a problem related to access (e.g., shortages) or to reimbursement. Worse, they often only enter into our consciousness when something goes wrong and the devices in question and their manufacturers are publicly denounced. Many of us simply lack the critical knowledge to reflect on their utility.

At the heart of EPHA’s position papers – Medical Devices being no exception – is a deep-seated concern over patient safety, which is shared by all our members. Together we search answers to the burning questions all European health systems are grappling with: how can quality, equitable and sustainable health systems be achieved, and what are the tools and processes required in order to provide quality care?

Thus EPHA is in favour of many of the proposed measures in the Medical Devices revision, such as mandatory identification of the supply chain, improved traceability by way of Unique Device Identification, registration of manufacturers, importers and devices in an EU database, better supervision of the Notified Bodies by the competent authorities and more stringent controls by NBs of manufacturing sites, more transparency of clinical data, and reporting of serious adverse reactions by patients and health professionals, to name but a few of the provisions. It remains to be seen whether a level-headed combination of pre- and post-market assessments and surveillance measures can achieve the right balance between clear, enforceable rules for patient safety and stimulating Europe’s innovation potential.

Medical devices, which are much more numerous than medicines, are more difficult to grasp than the latter; this is due to their sheer variety and complexity. And that’s just the point: they should take centre stage when it comes to debates over patient safety. People – whether current or future patients, but crucially also health professionals – need to be able to better know medical devices according to their function and ability, whether it is to make an appropriate selection or to gauge applicability.  Thus, rather than seeing them as abstract intrusions, we should recognise their quality as potentially life-saving inventions on which our lives may well depend one day. While this is more difficult in the case of tools exclusively deployed in hospitals and other healthcare settings, our relationship with medical devices is more intimate when it comes to in vitro diagnostic medical devices, i.e. those that are primarily used for information provision purposes and that do not come into direct contact with people.

In vitro diagnostic medical devices are extremely varied. Many are commonly and exclusively used in clinical labs and other healthcare settings for varied purposes such as determining blood groups, detecting or diagnosing diseases (e.g. HIV testing) and congenital infections, or for storing blood or tissue samples (e.g. specimen receptacles) that will be used for assessing an individual’s health status or for obtaining genetic information. Others are available over-the-counter and are routinely deployed by individuals themselves, for instance pregnancy tests, inhalers, or blood sugar monitors.

The proliferation of in vitro diagnostic devices designed for self-use creates new challenges for patient safety, which can be compromised by bad design (e.g. difficult to handle), insufficient information (unclear or incomprehensible instructions, incompatibility with other devices, etc.), erroneous use, and ignorance about where to access appropriate support following self-testing. As the Internet is gaining ground in healthcare, and more people take advantage of cross-border healthcare, patients and health professionals will have to be even more sensitised to the advantages and risks of home-use devices. As with all new tools and technologies, what is potentially empowering can also quickly backfire.

From my bird’s eye view perspective, the experiences of users, including health professionals and patients, must be taken into account as providing expertise should not be the prerogative of those habitually involved in the manufacture or assessment of devices. The power to proficiently engage in such discussions does however not arise out of nothing and can only result from better transparency and information, as highlighted in the Commission’s proposal. Therefore, part of the revision process should be raising awareness of the crucial role that medical and in vitro diagnostic medical devices play, as well as building up knowledge amongst all users so they can take co-ownership of the debate.

– Sascha Marschang, Policy coordinator, Health Systems

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