Implant Files

from Wikipedia, the free encyclopedia

A research published at the end of 2018 by the International Network of Investigative Journalists is referred to as Implant Files , which uncovered gaps in the control of implants worldwide .

publication

The publication took place in December 2018 with the cooperation of ICIJ , BBC , WDR , NDR , Das Erste and Süddeutscher Zeitung . This was preceded by a two-year research with more than 250 journalists from 36 countries. This was preceded by a (successful) attempt by the Dutch journalist Jet Schouten , in which she had taken the first step towards the approval of a fruit packaging net for mandarins as a vaginal net . She turned to the ICIJ and thus initiated further research.

Problem

The research showed that medical devices are often too easily approved. New medical devices usually have to undergo clinical trials before they can be approved. However, if this has already been done with a similar product, the equivalence principle applies and the manufacturer then only receives a CE mark for approval , whereby the first step is an assessment of the technical documentation and the second step is an assessment of the factory of the manufacturer. The independence of the test center, in Germany e.g. B. Dekra or TÜV , is questioned because the manufacturer is both the client of the test and also pays for it. When testing, the testing company often only decides on the basis of the documents provided by the manufacturer and not on the basis of the product itself. However, if the product is rejected, the manufacturer also has the option of having the product tested by another of around 50 testing companies . It is also criticized that manufacturers often have to recall medical devices themselves and that this is rarely ordered by the authorities .

The Federal Institute for Drugs and Medical Devices (BfArM) is responsible for monitoring medical devices. However, it can only make recommendations itself and not issue ordinances or bans . This can only be done by an appropriate state authority , which it rarely does. In addition, if there is a suspicion of a fault in the product, a doctor reports this to the manufacturer. According to a study by the BfArM, the latter only reacted in about half of the cases.

Another criticism is that there is no Germany-wide or Europe-wide database on implanted medical devices, a so-called implant register . Only 20% of countries around the world have public databases with information on safety warnings and medical device recalls. The BfArM only has a non-public database of all problems with medical devices. The criticism is that there is a lack of transparency . The research also showed the strong connection between lobbyists and politicians.

This article or the following section is not adequately provided with supporting documents ( e.g. individual evidence ). Information without sufficient evidence could be removed soon. Please help Wikipedia by researching the information and including good evidence.
The second part of the paragraph lacks precise information on the sources, e.g. the following statements:
  • "More than 10 dissertations and several habilitation theses have been written on this topic."
  • "For 80% of the prostheses worldwide there is no data on quality and for the remaining 20% ​​of the prostheses the reoperation rate by a factor of 3 to 10 (depending on the product) between reality in the registers of the state health systems and the publications of the developers"
Sources for this can be found here: https://www.ncbi.nlm.nih.gov/pubmed/?term=pabinger+c+OR++labek+g

The problem was already examined in 2007 in the EU project EUPHORIC, a project initiated by the European Commission and the Directorate-General for Health and Food Safety . As a result, all orthopedic medical products (hip, knee and ankle prostheses) were analyzed in the QoLA project. QoLA was a project of the European Orthopedic Association, in which professors from large parts of Europe and internationally collaborated. More than 10 dissertations and several habilitations have been written on this topic. The project manager, Gerold Labek, and the scientist responsible for public health, Christof Pabinger, then published international specialist articles which showed that there is no data on quality for 80% of the prostheses worldwide and the reoperation rate by factors of 3 to for the remaining 20% ​​of the prostheses 10 (depending on the product) lie between reality in the registers of the national health systems and the publications of the developers (or other publications): The publications of the developers are obvious and often incomprehensible. The causes are economic pressure and inadequate approval criteria. The result was political discussions and the development of the EU Medical Device Directive (MEDDEF) 2.7 / 1 Rev4 (see clinical evaluation ), which was finally implemented in national laws in all EU countries in 2017 and significantly tightened the approval process to avoid scandals like these in the future to avoid. At the time, all politicians and scientists involved did not consider informing the general public to be expedient. The starting point is Directive 93/42 / EEC on medical devices , which should not be confused with MEDDEF.

Examples

The company Rainer Technology , based in England, has tested a spinal column prosthesis on baboons . Even if the tests on them failed, a study with only 19 patients over three months was later carried out and the British Standards Institution then awarded the CE mark in 2010. The authority did not receive any documents on the study with monkeys.

Database

In the course of the research, the international network of investigative journalists created and published a database including a website for accessing information about recalls and warnings from individual countries regarding medical devices. The data was made available as open data under a Creative Commons license. In December 2019 the database contained more than 120,000 entries from 46 countries.

Reactions

At the same time as the reporting, the Süddeutsche Zeitung published a book entitled “Danger in the Body” and previously held discussion events in various German cities.

The Federal Association of Medical Technology (BVMed) pointed out in its statements that the new European Medical Device Regulation (MDR), which was passed in 2017 and will apply from May 2020, will bring about numerous tightening and abolish the principle of equivalence. The test centers are also named by the state, with the involvement of the EU Commission , and monitored by the state. The central implant register planned by the federal government would be supported by the industry.

The Implant Files won the Mumbai Press Club's Red Ink Awards in 2019 in the Health & Wellness category.

Web links

Individual evidence

  1. ↑ a b c d Implant Files reveal deficiencies in medical devices . In: Süddeutsche Zeitung . ( sueddeutsche.de [accessed on December 2, 2018]).
  2. ^ The Implant Files: a global investigation into medical devices. ICIJ , accessed December 2, 2018 .
  3. ^ The Implant Files. tagesschau.de , accessed on December 2, 2018 .
  4. ^ A b Antonius Kempmann, Britta von der Heide: Animal experiment failed - tested on people. tagesschau.de, November 28, 2018, accessed on December 2, 2018 .
  5. ↑ a b Katrin Langhans , Frederik Obermaier : This is how the research went . In: Süddeutsche Zeitung . November 25, 2018, ISSN  0174-4917 ( sueddeutsche.de [accessed December 2, 2018]).
  6. ↑ Daniela Prugger: You didn't even ask about the safety of our ridiculous product . In: Süddeutsche Zeitung . November 26, 2018, ISSN  0174-4917 ( sueddeutsche.de [accessed December 2, 2018]).
  7. ↑ The EUPHORIC Project. (No longer available online.) Archived from the original on March 25, 2018 ; accessed on March 9, 2019 (English).
  8. ↑ EUPHORIC Project - Attachment 4 - Deliverable N. 4 Indicators submitted to ECHIM To be considered in the short list. (PDF) Retrieved March 9, 2019 .
  9. ^ Quality of Publications regarding the Outcome of Revision Rate after Arthroplasty. Retrieved March 9, 2019 .
  10. ^ European Federation of National Association of Orthopedics and Traumatology. Accessed March 10, 2019 .
  11. ^ Quality of Publications regarding the Outcome of Revision Rate after Arthroplasty - Final Report of the QoLA Project. (PDF) (No longer available online.) Archived from the original on July 21, 2013 ; accessed on March 9, 2019 (English).
  12. ↑ MEDDEV 2.7 / 1 revision 4 - Guidelines on Medical Devices. (No longer available online.) Archived from the original on July 2, 2018 ; accessed on March 9, 2019 (English).
  13. ↑ Explore the only International Medical Devices Database. Retrieved December 2, 2018 .
  14. ↑ International Medical Devices Database. Retrieved December 2, 2018 .
  15. ↑ Safety data from 20 countries added to Implant Files database. In: ICIJ . November 25, 2019; Retrieved December 5, 2019 (American English).
  16. ↑ Implant Files - Danger in the Body - Frankfurt. In: Süddeutsche Zeitung. Accessed December 2, 2018 (events).
  17. ↑ BVMed on #ImplantFiles: The industry is strictly regulated. BVMed - Federal Association of Medical Technology, November 25, 2018, accessed on December 6, 2018 .
  18. ↑ BVMed supports implant registers. BVMed - Federal Association of Medical Technology, November 27, 2018, accessed on December 6, 2018 .
  19. ↑ Mumbai Press Club: RedInk Awards 2019. Retrieved July 9, 2019 .