3rd Dec 2020


EU patients need safer and better rules

It is common knowledge that the EU, referring to the subsidiarity principle laid down in the Treaty, does not have an original competence for health policy – hence many regulations at EU level concerning health issues have been implemented in the past, and health systems and health policies across the EU are becoming more and more interconnected.

This is caused by many factors, including for example the increased movement of patients, the dissemination of new medical technologies such as pharmaceuticals and medical devices as well as the enlargement of the Union. Health issues do not respect the borders of Member States and raise several questions: How can certain health care quality standards be ensured EU-wide? How can patients get access to cross-border care? And how can national policies be reconciled with the obligations of the EU's internal market?

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  • "How can certain health care quality standards be ensured EU-wide?" (Photo: Wikipedia)

The EU Commission is aware of the recent developments and has decided to take a new strategic approach: a coherent framework shall set out broad health objectives for the future in order to address the current and future challenges. Cross-border matters and the idea of mainstreaming health into all Community policies will not only be dealt with by the health unit in the Commission, other Commission services will also be working towards the same health goals.

Access to healthcare

This EU framework aims at helping Member States improve efficiency and effectiveness within their own national health care systems whilst respecting both Community law as well as the social and health values on which those systems are based.

European health policies are generally focused on the patient, his safety and right for proper treatment: Having access to high-quality healthcare when and where it is needed is a priority issue for European citizens, which is also recognised in the Charter of Fundamental Rights of the EU.

National authorities welcome European support in achieving a high level of quality and safety in healthcare, such as through the development of binding guidelines and indicators. This support has proven to work out well in the past. At the same time, fundamental aspects of the Treaty have to be taken into account. To sum up, a comprehensive combination of both the European principles and legally binding measures has to be found – especially when it comes to patient safety.

Legal patchwork

At the interface of these specifications stands the reprocessing of medical devices. This is one of the topics regulated in detail at EU level; the review of the so-called Medical Devices Directives has recently been adopted under the German presidency. From the patient safety's perspective, the EU has again failed to ensure binding guidelines concerning the quality of the reprocessing of medical devices. Instead, the legal patchwork is still in force throughout Europe.

In order to evaluate the gap between the Member States, the European Commission will submit a report on medical device reprocessing within the next three years and will explore whether further proposals are needed. For this purpose, the Commission had launched a public consultation which was closed in mid August. This consultation will be followed by the setup of an experts group which will work on the report.

The market of professional third-party reprocessing service providers has only been established during the last decade due to recent economic and political developments as well as scientific and technological opportunities, while reprocessing of medical devices has been carried out for many years within hospitals. Thus, reprocessing must not primarily be seen as an issue for cross-border professional service providers since the focus should remain on patient safety.

Against this background, the combination of the specifications named above could be assured by implementing the "German model": Germany is one of the few countries to have early on recognised to benefit from the technical advances being made in the field of medical device reprocessing as a means of achieving comprehensive patient protection through binding legal framework conditions. Since 2001 it is allowed to reprocess medical devices, regardless of their manufacturer's designation as being ‘single' or ‘multiple' use, applying the processes set out in the recommendation by the competent hygiene body.

Although it is the sole decision of the manufacturers to declare their medical devices as either ‘single-use' or ‘multiple-use' which in fact says little about the actual reprocessability of a medical device, many national regulations recommend following this label. Throughout the last decades, more and more medical devices have been declared ‘single-use', either because the manufacturer aims at limiting his liability to one use only, that he has not developed a validated procedure for reprocessing or just for economic reasons.

Both the medical device industry and the medical device reprocessing industry are highly innovative and dynamic. Therefore, the reprocessing industry will advance rapidly which means that the number of devices labeled as ‘single-use' that will be made reprocessable by the reprocessing industry will increase over time.

Compared to the situation in Germany, uncontrolled reprocessing in hospitals without mandatory quality standards poses significant risks to patient safety. The prohibition of reprocessing is not reasonable as it has not been proven to enhance patient safety. On the contrary: prohibiting the reprocessing of ‘single-use' devices leads to a grey market outside the regulatory regime, outside the supervision by public authorities.

Patients, hospitals as well as health insurance funds can profit from reprocessing. Throughout Europe, national systems are urging the partners in the health care market to seize their economic advantages, and especially hospitals are given more and more opportunities to generate surpluses. Due to a longer life cycle of reprocessed medical devices more patients have access to innovative medical devices and are therefore guaranteed better and safer treatment.

Given the fact that reprocessing is carried out throughout Europe – regardless of whether it is strictly prohibited or allowed under certain quality standards – one cannot turn back the clock or ignore technical and scientific progress. What European patients need is a 360 degree approach through binding regulations on medical devices altogether – not only when the original product is leaving its manufacturer, but also when it comes to reprocessing the device in a safe way.

The author was formerly minister for health in Germany


The views expressed in this opinion piece are the author's, not those of EUobserver.

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