How safe are pacemakers and implants? The most important questions and answers

According to the “Panama Papers” are now the “Implant Files” for attention. A world-wide research network has seen the authorisation, control and fault management of medical products. The result suggests high waves, even in politics. The most important questions and answers on the topic.

What has researched the network?

In the “Implant-Files” were involved in 60 media, including in Germany, NDR, WDR and “Süddeutsche Zeitung”. They have researched according to their own figures of one and a half years, in 36 countries, and requests filed, thousands of files are spotted, and with hundreds of patients and experts spoke.

What have you found out?

Report: more and more injuries and deaths due to implants

The core allegation: In contrast to medicinal products, which are tested prior to admission carefully, would not medicine controlled products by the government and issues are not systematically recorded. The System was “manipulated, flawed and responsible for countless Deaths,” writes the “Süddeutsche Zeitung”.

How to fix it?

In the broadest sense to medical products – that is, everything which the Sick are treated without drugs, from the wheelchair to the pavement. In a narrower sense, it comes to implants – that is, products that are permanently inserted into the body, such as cardiac catheterization, knee joints, or insulin pumps. The medical products are divided into four risk groups – low risk (Thermometer) up to very high risk (breast implant).

How is the test procedure?

A medical device must go through according to the Federal Institute for drugs and medical devices (BfArM) no official authorisation procedure. The manufacturer only has to prove “that its product is safe and the technical and medical services are also fulfilled by him”. Part of the evaluation process was “always a clinical evaluation, in certain cases, a clinical examination”.

Who checks?

The BfArM is called “notified Bodies” – according to the research network, there are approximately 50 private providers such as TÜV or Dekra. The given, the “CE”mark was “use a seal of quality for the Patient, but rather a Marketing label”, is quoted as a health scientist. Many of the applications will be examined in the research, also only on paper.

And if there are problems later?

According to the BfArM, manufacturers, operators and users “events to report” to the competent authorities. “It’s an obligation and if this obligation is not complied with, then that is a failure of the user,” said a spokesman for the Federal Ministry of health in Berlin.

How often do complications occur?

In Germany had been reported in the past year, about 14,000 cases in which there have been injuries, deaths, or other problems that could stand in connection with medical products, is in the “Implant-Files”. The BfArM reported 2016 of 12,000 cases.

What does the manufacturer say?

“The regulatory System for medical products is thus the same as high, partly higher requirements than medicinal products,” according to the German medical technology Association. The largest German manufacturer Medtronic writes on his website: “Our products are also subject to gifts extensive Tests, reviews and free or of the authorisation by the respective Supervisory authorities.”

What is the reaction of the policy?

“The Federal Ministry of health takes these reports very seriously,” it said on Monday at the Federal press conference. The Minister of health, Jens Spahn (CDU) said the “Rheinische Post” (Tuesday), the BfArM have to change in the event of problems with a medical product, not a total overview of comparable cases and also no Chance to warn patients specifically: “we want to.”

What exactly should be done?

According to the health Ministry of a industry will have to be reported to established independent body, in which all of the installed implants. In addition, the Federal government has been planning this for some time, a national Register, the quality of breast implants, heart valves, and to detect a pacemaker. The Register should show, how long implants to hold – on the basis of data to implant ions, and a result of surgery for corrections, hospitals, health insurance companies and manufacturers is mandatory.

To run it, the German Institute for Medical documentation and Information (Dimdi). From may 2020, a new European medical devices needs to be regulation implemented. That higher requirements apply to the certification bodies; High-risk products must be evaluated in the clinical assessment of international experts.