Large health risk due to defective medical devices
For many patients, an artificial joint or a pacemaker is the last hope for an independent, mobile life. According to the Bremen health researcher Gerd Glaeske, however, there is a great health risk for thousands of patients because many products have not been adequately tested and are therefore often defective.
Artificial joints, stents and pacemakers insufficiently tested Artificial joints, but also stents, pacemakers or breast implants: According to the Bremen-based health researcher Gerd Glaeske, many of the products used in this country are not adequately tested. This poses a great risk for thousands of patients, because defective medical devices could lead to considerable damage to health, according to the expert when the Barmer GEK health insurance fund presented the new report in Berlin. "With the vast majority of medical devices, which include most of the aids, a self-declaration by the manufacturer is now sufficient to be able to market a product," explains Glaeske. "Instead, a substantial approval is overdue, which demonstrates a specific benefit for certain indications . "
"It is not an isolated case, there are thousands" "We have problems in abundance" because "it is not an isolated case, there are thousands", according to Glaeske. It is about cases in which "metal abrasion from artificial joints contaminates the blood. "Or about non-functioning pacemakers as in the case of the well-known television journalist Dagobert Lindlau, who had implied" a defibrillation electrode from Medtronic with malfunctions but CE marking "in 2007 - as well as hundreds of other patients in Germany.
Demand for a uniform approval procedure Medical devices are theoretically certified by private organizations such as the TÜV, but there is no intensive and careful examination - as is the case with medicinal products, for example. According to the Vice President of the Barmer GEK, Rolf-Ulrich Schlenker, something urgently needs to change here: "We demand a uniform European centralized approval procedure for medical devices."
Official tests should urgently be extended to medical devices. Rolf-Ulrich Schlenker also receives support from Jürgen Windeler, head of the independent Institute for Quality and Efficiency in Health Care (IQWiG) in Cologne. At the Barmer GEK event in Berlin, the expert criticized the fact that "why drugs are treated differently and more strictly than medical devices, which have the same purpose as drugs," was criticized or prostheses were expanded and not only the functionality, but also the effect on the patient were tested, according to Windeler, the previous situation was "bizarre", because although there is a federal institute for medicinal products and medical devices, "practically only medicinal products" have so far been tested.
Expensive new developments without added medical value The work of the Institute for Quality and Efficiency in Health Care also focuses primarily on pharmaceuticals. The IQWiG examines new drugs for possible added value and then gives recommendations with regard to a reclassification. So far, the situation has been different for medical devices: IQWiG will only evaluate them if the Federal Joint Committee of Doctors, Clinics and Health Insurance Funds (GBA) takes action because there are indications of harmful effects or unsuitability. Most recently, "based on our recommendation, the GBA ended the remuneration for antibody-coated stents for certain patient groups, at least in the case of legally insured patients," explains Windeler new products have more complications and heart attacks than with previous cheaper stents.
More and more people rely on medical aids and aids. The problem with faulty medical devices is becoming increasingly acute, because according to the Barmer GEK report, more and more German products such as hearing aids or dressing and gripping aids are needed. 500,000 people with statutory health insurance alone received new hearing aids last year. As a result, expenditures for the statutory health insurance funds increased by two percent to 11.5 billion euros in 2012 - but a significantly larger increase is expected for this year. (No)
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