The medical industry is on high alert: Doctors, hospitals and manufacturers are reporting an impending shortage in medical device supplies. The reason for this lies in the stricter test regulations issued by the European Commission. Despite the efforts of Health Minister Lauterbach, there seems to be no solution in sight.
Berlin, Germany). When a newborn is born with a serious heart defect, such as crossed arteries, prompt treatment is crucial. A balloon catheter is used to widen the space between the right and left atria – a theoretically simple procedure. In practice, however, it is increasingly becoming a problem because the necessary surgical material is not available. Professor Matthias Gorenflo, Medical Director at the Clinic for Pediatric Cardiology and Congenital Heart Defects at Heidelberg University Hospital, complains that “there are individual products that are practically unavailable at the moment”. In such cases, you have to contact colleagues in other clinics to ask “if they have anything left”.
More and more hospitals are desperately turning to politics
Gerald Gass is very familiar with the lawsuits and the need for barter deals. As CEO of the German Hospital Society (DKG), he reports: “We are already receiving alarming news from German hospitals about a lack of medical products, especially niche products, including for children and newborns.” The situation is getting worse “day by day”. The balloon catheters previously used for newborns are no longer available. Gass knows that the hospitals “rely on stocks and a single inadequate alternative”. Cardiologist Gorenflo describes the EU’s Medical Device Regulation (MDR) as “a dead horse not to be ridden”.
EU regulations are well intentioned but badly done
Poorly executed but with good intentions. These stricter regulations are a result of the breast implant scandal. The goal is to get more clinical data and more monitoring. In Germany, medicines are approved by the Federal Institute for Drugs and Medical Devices. The medical products have to go through a test procedure with private providers such as TÜV or Dekra and be certified by them. These certification bodies must now be redesignated in accordance with EU requirements. This is expensive in itself. In fact, according to information from the association, only 29 positions are left from the last 59.
Some small certification bodies have disappeared and the remaining ones are experiencing capacity bottlenecks as the testing effort itself has also increased. Therefore, companies streamline their product portfolio when it becomes uneconomical. According to a survey by the German Hospital Society (DKG) in April, hundreds of products are already no longer available.
Currently, it appears that some medical products are best sourced online. Some medical products that are currently in demand can be ordered from Medmasters, a specialist mail order company for various medical areas such as practice supplies, urology or anatomy.
In the future, even more medical products will become scarce
It is amazing that both existing and niche products are subject to the same high standards as a new instrument. This leads to the absurd situation that a hip implant that has been on the market for 20 years has to be completely re-certified, criticizes Manfred Beeres, spokesman for the German Medical Devices Association (BVMed).
According to Professor Gorenflo, development is silent. “When a manufacturer ends a product line, the products are discontinued. You don’t realize it until you want to backorder them, and then they’re no longer available.” The transition period for the EU regulation ends in May 2024 and the closer that date gets, the more alarming the voices are getting. Professor Ruth Kirschner-Hermanns, urologist at Bonn University Hospital, warns: “Doctors will be surprised at what they will soon be missing on the operating tables.”
There is no doubt that control and security are of great importance. However, apparent over-regulation of new products can no longer be justified as a protective measure for patients. Professor Wolfram Lamadé, deputy head of an oncology center in Pforzheim, warns: “Restricting innovations can lead to deaths.”
Numerous deaths feared
DKG boss Gass has been noting for a few weeks that the concerns are being taken seriously, especially at a meeting of the 27 EU health ministers in Brussels. Nevertheless, he emphasizes: “It is not enough to take the concerns seriously, urgent action must be taken.” And adds: “We mustn’t let the summer break go by unused.”
Health Minister Lauterbach is holding back politically. In a response to a parliamentary question from CDU MP Diana Stöcker, his ministry admits that the European Commission is currently opposed to legislative measures such as extending the transition period, as this would not solve the problems, only shift them.
The ministry assures that Germany has pledged its support in implementing practical solutions. However, it does not look like a political all-clear. It could be that an incident has to happen before action can be taken. At a specialist congress, cardiologist Gorenflo spoke bluntly: “If nothing changes, people will die.”