After the revelations of growing risks posed by implants and other medical products, the largest statutory health insurance provider calls for much stricter laws in Germany. “The 2017 adopted at EU level and medical products regulation is, in our view, inadequate,” said the AOK-Federal Executive Board Chairman Martin Litsch of the “Augsburger Allgemeine”.
Germany must make for a more effective protection for the patient is strong, he stressed. Instead of a Europe-wide authorisation of private testing organizations such as TÜV, it had to be for the protection of patient safety, a Central approval, called for Litsch. Regardless of the laws need to be strengthened at the national level, said the army chief.
Penalties against the manufacturer and the delivery stops for more liability
Litsch called for, in particular, that in the future, each medical equipment manufacturers should not need to have protection in the case of impending bankruptcy, product liability insurance, in order to enable patients to go out in case of damage or empty. So-called high-risk medical devices, in particular implants such as artificial joints and pacemakers, should be also included only in the payroll catalog of the statutory health insurance funds, if the required quality was proved, on the Basis of high-quality studies.
As an immediate measure for more transparency Litsch called for a Register for the use of high-risk medical devices. Pacemakers, breast implants, and prostheses should be marked on the billing data of Physicians and hospitals, so that equal to about a defective product series can be informed, proposed to the army chief. And finally, there is a need for more effective sanctions, called for Litsch, a strengthening of the Federal office for pharmaceuticals and medical technology (BfArM). More liability, you must also fines against a manufacturer, delivery stops, or prohibitions for the provision of services by the BfArM imposed.
Unreported because Doctors do not comply with reporting obligation
So far, the authority turns on only when a suspected product defect. In this case, a recommendation is made to the manufacturer. This does not comply with the recommendation, may order the competent land authority for a recall. In practice, the recalls are but only vanishingly small. Since 2010 in Germany there were only six statutorily mandated recalls for medical devices.
In many cases, Doctors and hospitals of their reporting obligation not to come. We regularly point out, because we know that there is a high dark number“, the BfArM spokesman Maik Pommer to the Bild newspaper.
14.034 reported suspected cases in the past year
Broadcasters NDR and WDR and the Süddeutsche Zeitung had in common with international media colleagues reported, suspected cases of injury or fatal consequences of faulty medical products proliferated. For example, it is not durable Hip implants or prostheses. In Germany had been reported in the past year 14 034 suspected cases.