Endoprosthesis Register

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An endoprosthesis register (implant register) records all initial implantations and revisions of endoprostheses . The first such registers were created in 1979 in Sweden and Finland after problems with hip joints.

Purpose and functionality

As soon as an endoprosthesis has to be removed, this data is merged with the installation, which may have been years ago. An endoprosthesis register enables quality assurance in the field of endoprosthetics . A register reduces revisions over the years.

Endoprosthesis registers record the brand and model of the implant and the bone cement. The registry thus serves as an early warning system for products that do not work in the patient's body. Long-term results thus allow an assessment of the quality of the products used. With the hip joint implant register (Swedish National Hip Arthroplasty Register) introduced in 1979, for example, follow-up operations could be reduced by around 70 percent.

By recording every single operation, statements can also be made about the quality of the hospitals. In Sweden there is an active dialogue between the registry and the hospital. Hospitals with poor results are contacted and an analysis is made of the circumstances that caused the results.

The issue became explosive after a recall of metallotic hip joints by DePuy Orthopedics , a Johnson & Johnson subsidiary, in 2011, where tens of thousands of patients worldwide were affected by a possible exchange, including 5500 in Germany. Therefore, in addition to medicine, implant manufacturers are now also interested in this quality assurance tool.

National regulations

Most European countries, Australia and Canada keep a register. The establishment of a register has been discussed in the USA for years.

Germany

In Germany, the first endoprosthesis register was set up by Hans-Georg Willert . Successors have been discussed for years,

The German Society for Orthopedics and Orthopedic Surgery (DGOOC) has been running the German Endoprosthesis Register (EPRD) in a test phase since October 2011 . According to their information, it is the largest database in Europe on artificial hip and knee joints (of the approx. 400,000 knee and hip prostheses used annually in Germany, around 35,000 are replacement prostheses). Regular operation of this central register for Germany is to run from April 2012. The EPRD has so far cooperated with the AOK and the Association of Substitute Funds. The integration of the data from private patients has not yet been clarified.

Austria

Basic data
Title: Establishment of an implant register for the field of hip endoprosthetics
Long title: Ordinance of the Federal Minister for Health, Family and Youth regarding the establishment of an implant register for the field of hip endoprosthetics
Type: regulation
Scope: Republic of Austria
Legal matter: Administrative law
Reference: BGBl. II No. 70/2007
Legal text: as amended (RIS)
Please note the note on the applicable legal version !

In Austria, there is no provision for a central implant register for all of the endoprosthetics; However, numerous decentralized specialist databases have been in development and use since the 1990s.

It was already regulated in Section 73 of the Medical Devices Act (MPG) of 1997 that Health Austria  (ÖBIG) was allowed to keep an implant register (and in particular for data protection reasons such as), and since 2007, Section 10 of the Medical Device Operator Ordinance (Austria) has stipulated the Implant Register in Section 10 that all Austrian hospitals have one thing to run.

The Austrian Society for Orthopedics and Orthopedic Surgery and the ÖBIG had already started an Austrian register for hip endoprosthetics . Since February 2008, on the initiative of the Association for Trauma Surgery , individual trauma surgery departments have also taken part. This is also due to the fact that the Minister of Health according to § 74 is required to prescribe specialist registers “taking into account serious public health interests and with a view to gaining improved knowledge about the benefit / risk assessment of certain types or groups of medical devices” . J. also enshrined in law.

There are also smaller databases for other departments. Such voluntary-based projects are well proven, find material and construction defects - which are rare in Austria anyway - and trace them back to the individual patient. From the Metallosis -Affaire spring 2011. Austria was only affected to a range of 50 possible cases.

Finland and Sweden

After problems with the so-called Christiansen hip prosthesis arose, Sweden and Finland founded the world's first prosthesis registers in 1979. In Sweden, the data is recorded nationwide in The Swedish National Hip Arthroplasty Register ( Svenska Höftprotesregistret ) , which is maintained by the Joint Replacement Unit (JRU) in the Department of Orthopedics at the Medical Faculty of Gothenburg University .

Switzerland

In Switzerland, over 21,000 artificial hip joints and 18,000 artificial knee joints are implanted in around 150 hospitals every year.

In 2012, Switzerland introduced the “SIRIS” endoprosthesis register in order to be able to guarantee the high quality of products and operations. Since then, Swiss hospitals and clinics have been obliged to record implanted hip and knee joints in this database. By the end of 2013, around 34,000 hip and knee prostheses had already been recorded, which corresponds to 95% of the estimated data volume. The establishment phase of the register was thus successfully completed.

SIRIS provides important information about the individual implants after their market launch; This makes it transparent, among other things, how long it will take until an implant has to be replaced after the initial insertion. The data on knee and hip prostheses collected in SIRIS enable doctors and medtech companies to constantly monitor and improve the quality of the prostheses. The long-term data enable doctors and hospitals to identify and remedy the causes of possible complications at an early stage. Sweden is the best example of this. Since the introduction of the first endoprosthesis register in 1979, the probability of a replacement operation has fallen by half. In this respect, SIRIS serves as an "early warning system", not only for doctors and hospitals, patients and health insurance companies, but also for industry.

In addition to the endoprosthesis register, there are other registers in Switzerland. The Institute for Social and Preventive Medicine at the University of Zurich has maintained the AMIS Plus heart attack register since 1997. From around 40,000 registered cases, the doctors generate important information on prognoses, therapies and costs of heart attacks. According to the Society of Cardiac Surgeons, a new national register of cardiological operations is planned. In the future, all interventions such as bypass and heart valve operations as well as operations on the main artery are to be recorded in the registry. Such a national register for implanted lenses is also planned in ophthalmology. Switzerland is currently still connected to the European EUREQUO register.

literature

Individual evidence

  1. ↑ a b c Harro Albrecht: Dangerous spare parts . In: Die Zeit , No. 44/2011, p. 51
  2. ↑ Årsrapport / Annual Report . Annual reports of the Svenska Höftprotesregisteret. Documents. ( Memento of the original from January 27, 2012 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. jru.orthop.gu.se @1@ 2Template: Webachiv / IABot / www.jru.orthop.gu.se
  3. ↑ Udo Ludwig, Ansgar Mertin, Barbara Schmid: Toxic shops . In: Der Spiegel . No. 16 , 2011 ( online ).
  4. ↑ DIMDI DAHTA Health Technology Assessment: Joint endoprosthesis register for Germany . (PDF; 508 kB)
  5. ↑ Endoprosthesis registry and its contribution to the safety of patient care with joint implants . Federal Health Gazette 52 (2009), pp. 589–593 ( doi: 10.1007 / s00103-009-0854-0 )
  6. ↑ Raphael Held, Sebastian Gaiser: White Paper: Joint Endoprosthesis Register for Germany - Potential Savings in Healthcare.
  7. ^ Marc Meißner: Joint replacement: Register for endoprostheses started . In: Deutsches Ärzteblatt 2011; 108 (15): A-813 / B-665 / C-665
  8. ↑ Medical device operators within the meaning of the ordinance.
  9. ↑ Ordinance of the Federal Minister for Health, Family and Youth on the installation, operation, use and maintenance of medical devices in health care facilities ( Medical Devices Operator Ordinance - MPBV) StF: BGBl. II No. 70/2007 (as amended ris.bka )
  10. ↑ Hip endoprosthesis register , Gesundheit Austria
  11. ↑ Hip endoprosthesis register (1562 / A (E) XXIV.GP , Parliamentary materials
  12. ^ Statements by Univ.-Prof. Reinhard Windhager, head of the University Clinic for Orthopedics in Vienna; Gerald Bachinger, head of the Lower Austrian patient advocacy. Quoted in Carefree Hip Swing with Implants . ( Memento from April 25, 2011 in the Internet Archive ) Courier
  13. ↑ Return campaign for hip prostheses - claims for damages against manufacturers? , oe1.orf.at
  14. ↑ Parliamentary question regarding defective hip prosthesis implants 8683 / J XXIV. GP
  15. ↑ Joint Replacement Unit ( Memento of the original from January 27, 2012 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. jru.orthop.gu.se @1@ 2Template: Webachiv / IABot / www.jru.orthop.gu.se