Cost-Cutting at the Expense of the Law: the new single-use devices regime

Recent reports of the repeated use of single-use medical devices in some Czech hospitals have sparked a wave of debate and understandable concerns about patient safety. A closer look at the situation, however, reveals that this is not a matter of isolated failures, but rather a much broader phenomenon. This stems directly from economic pressure on healthcare facilities and likely occurs to varying degrees across the entire sector. Moreover, this clash between the daily reality of hospitals and strict legislation brings us to the threshold of a major European change that could completely overturn the current rules.

The current regulations in the Czech Republic are very strict. The Czech Medical Devices Act currently prohibits any reprocessing of single-use medical devices, as well as their placing on the market and supply in the Czech Republic. This national ban is based on the current framework of the European Medical Devices Regulation (MDR).

While the current version of this regulation does allow for the reprocessing of single-use devices under certain strict conditions, it also explicitly grants member states the right to completely ban this practice within their territory. And the Czech Republic has exercised this right. State authorities, such as the Chief Sanitary Officer or representatives of the State Institute for Drug Control (SÚKL), have long defended the ban primarily on the grounds of the need to protect patients from the risk of spreading infections and potential material failure of the devices. The cases from hospitals that are currently resonating in the public sphere must therefore be viewed primarily in the context of this categorical national ban.

Revision of the MDR and Expected Resistance from Member States

While compliance with the current law is currently being addressed at the national level, a radical change is being prepared at the EU level. The proposed revision of the MDR fundamentally changes the approach to single-use devices. Manufacturers will now be required to provide a professional and verifiable justification for why a given device is labeled as single-use only. All devices for which the manufacturer cannot provide such justification may be reprocessed, strictly in accordance with the manufacturer’s provided instructions. The proposed revision also stipulates that any person or company that performs a so-called full refurbishment of a single-use device will legally become its manufacturer and assume complete responsibility for the newly created product. These new provisions are expected to take effect five years after the revision enters into force.

The most controversial impact of this proposed change, however, is the fact that it will effectively strip Member States of their current right to impose a general ban on the refurbishment of these devices within their territories. Precisely because of the loss of local authority and the inability to regulate this practice within their borders, massive resistance can be expected from many member states, including the Czech Republic. Whether the upcoming European revision will lead to a more rational functioning of the market or merely complex legislative battles remains to be seen in the coming years.

Author: Markéta Hrubá