Defective implants endanger patients

Great health risk due to faulty medical devices

09/19/2013

An artificial joint or a pacemaker are the last hope for an independent, mobile life for many patients. According to Bremen-based health researcher Gerd Glaeske, however, thousands of patients are at significant health risk, as many products have not been sufficiently tested and are therefore often faulty.

Artificial joints, stents and pacemakers insufficiently tested
Artificial joints, but also stents, pacemakers or breast implants: According to the Bremer health researcher Gerd Glaeske, many of the products used in this country are insufficiently tested. Thus, there is a great risk for thousands of patients, because faulty medical devices could lead to significant damage to health, according to the expert at the presentation of the new medical and medical report of the health insurance Barmer GEK in Berlin. "With the vast majority of medical devices, which include most of the aids, today a self-declaration by the manufacturer are sufficient to market a product“, explains Glaeske. „Instead, a substantial approval is overdue, which proves a concrete benefit for certain indications.“

"It's not isolated, it's thousands"
"We have problems in abundance“, because "there are not isolated cases, there are thousands," according to Glaeske's assessment. It's about cases where „Metal abrasion of artificial joints contaminating the blood.“ Or non - functioning pacemakers, as in the case of the renowned television journalist Dagobert Lindlau, the 2007 „a Medtronic defibrillation electrode with malfunction but CE mark“ had been implied - as well as hundreds of other patients in Germany.

Demand for a uniform approval procedure
Although medical devices are theoretically certified by private organizations such as the TÜV, an intensive and careful examination - as is usual, for example, with pharmaceuticals - remains out of the question. According to Rolf-Ulrich Schlenker, vice-president of Barmer GEK, there is an urgent need to change this: "We are calling for a uniform European centralized approval procedure for medical devices."

Official examinations 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. It was „At no point explain why medicines are treated differently and stricter than medical devices that have the same purpose as medicines, "criticized the expert at the Barmer GEK event in Berlin, where the official tests for drugs were extended to pacemakers, implants or prostheses and not only the functionality, but also the effect on the patient are tested.The current situation is according to Windeler „comical“, because even though there is a Federal Institute for Drugs and Medical Devices, so far „in fact only medicines“ checked.

Expensive new developments without medical added value
The work of the Institute for Quality and Efficiency in Health Care is also focused on pharmaceuticals. The IQWiG examines new medicines for any added value and then gives recommendations for reclassification. So far, this has not been the case for medical devices: these are only assessed by the IQWiG when the Federal Joint Committee of Physicians, Clinics and Health Insurance Companies (GBA) takes action, because there are indications of harmful effects or unfitness. Recently, for example, "based on our recommendation, the GBA has terminated the reimbursement of antibody-coated stents for certain groups of patients, at least for those insured under the law“, explains Windeler. The reason: Although the tubes are supposed to prevent constricted coronary arteries from occluding, the new products had more complications and heart attacks than the previous cheaper stents.

More and more people rely on remedies and aids
The problem with faulty medical devices is becoming increasingly acute, because according to the report of Barmer GEK more and more German products such as hearing aids or dressing and gripping aids. Alone 500,000 people insured with statutory health insurance got new hearing aids last year. Expenditure on the statutory health insurance funds increased in 2012 by two percent to 11.5 billion euros - for this year, however, a much larger increase is expected. (No)