Bottleneck in hospitals Patients have to wait a long time for some medical devices

Swiss hospitals are struggling with a shortage of various medical devices, and medtech companies are also affected by new EU directives. Politicians want solutions, but implementation is stalling.

The Medical Device Regulation, or MDR for short, was introduced in the EU in 2017 in response to defective breast implants - and is now the main reason why there is a shortage of various medical devices in Swiss hospitals.

The aim of the MDR was to improve patient safety, which is why all medical devices must be re-examined. This also applies to products that have already been approved.

"We have weekly inquiries about supply problems and have to look for alternatives," Severine Dziergwa, Team Leader of Interventional Radiology at the University Hospital Basel, told SRF. Among other things, catheters are required for minimally invasive operations, but are becoming increasingly difficult to obtain. It means "a great deal of effort to obtain other products", explains Dziergwa. It also requires "a high degree of flexibility on the part of employees".

Medtech companies: High costs for EU approvals

Swiss medtech companies are also affected by the new EU regulations, including the start-up Stimit AG. As reported by SRF, the company has developed a new type of ventilator that is set to revolutionize artificial respiration for patients in intensive care units.

The product was designed in Switzerland and the first clinical trials were also carried out here. It is also manufactured in Switzerland. It is currently in the approval process for the USA and Canada, but not for the EU.

Managing Director Ronja Müller-Bruhn complained to SRF about the high cost of obtaining European approval. Appointments are difficult to obtain and many more documents and studies are required. "I would have to calculate three to five times the budget as a few years ago."

When will the adaptation be implemented?

Several years ago, Damian Müller, President of Swiss Medtech and member of the Lucerne Council of States, submitted a motion calling for medical devices that have been approved outside the EU to be able to be used in Switzerland. Parliament approved the motion a year and a half ago, but it has not yet been implemented.

Ronja Müller-Bruhn thinks this is going too slowly. "Together with the industry, we now need to find a pragmatic way to ensure security of supply and patient safety," says the Managing Director of Simit AG.

The Federal Office of Public Health is responsible for implementing the initiative. In response to an inquiry from SRF, the FOPH stated that payment systems outside the EU are currently being examined "to determine how this motion can be implemented without jeopardizing patient safety". It is not yet possible to say when an adjustment can be expected.