Implant register
An implant register (in Austria the implant register ) serves to protect the health and safety of patients when providing healthcare with implants. In Germany , it has been listed at the German Institute for Medical Documentation and Information under the name Implantateregister Deutschland since January 1st, 2020 . Previously, various registers of medical professional societies operate, as it so far there is no National implants register or German implants register in Germany, as the European Medical Device Regulation ( - Medical Device Regulation MDR provides, in the EU Member States measures to promote) should take appropriate registers (see Article 108 sentence 1 MDR).
Implant Register Establishment Act
On December 12, 2019, the Implant Register Act (IRegG) was enacted as Article 1 of the Implant Register Establishment Act ( EIRD ; Federal Law Gazette I p. 2494 ). Accordingly, the Robert Koch Institute is setting up an independent trust agency (Section 8 IRegG) that pseudonymises all personal data (Section 9 IRegG). The telematics infrastructure in accordance with Section 291a (7 ) sentence 1 of the fifth book of the Social Security Code (Section 18 IRegG) is used to transmit the data records . In order to ensure the informative value of the register, reporting to the register for health facilities, statutory and private health insurances (§ 25 IRegG) and all patients (§ 24 IRegG) is mandatory. Manufacturers are obliged to register their products in the register's product database. In the event of reporting violations by the implanting device or the use of implants not registered in the product database, the draft law provides for a remuneration exclusion. It contains comprehensive requirements for transparency, such as annual reports by the registry and the Federal Institute for Drugs and Medical Devices (BfArM). The additional expenses incurred by the health facilities as a result of the mandatory reporting to the registry will be reimbursed. The framework conditions for the data transfer from existing registers are regulated. The actual start of the reporting obligation for the individual implant types depends on the existence of all technical requirements for the registration to receive the report and is specified in a statutory ordinance.
The following implant types are recorded in accordance with the annex (to Section 2 No. 1) of the IRegG:
- Joint endoprostheses (for hip, knee, shoulder, elbow and ankle),
- Breast implants,
- Heart valves and other cardiac implants,
- implantable defibrillators and pacemakers,
- Neurostimulators,
- Cochlear implants,
- Vertebral body replacement systems and disc prostheses and stents.
Dental implants are therefore not recorded in the German implant register.
The law also contains regulations with which the procedure of the Federal Joint Committee (G-BA) for the evaluation of examination and treatment methods in contract medical care is to be accelerated. For this purpose, the previous deadline for the G-BA will be shortened from three to two years.
In addition to the law, a statutory ordinance is being drawn up that regulates the details of the operation of the implant register (Section 37 IRegG).
Overview of the existing registers in Germany
| Name of the register | carrier | Registered implants / treatment |
|---|---|---|
| German Aortic Valve Registry (GARY) | German Aortic Valve Register GmbH by the German Society for Thoracic, Cardiac and Vascular Surgery (DGTHG) and the German Society for Cardiology - Heart and Circulatory Research (DGK) | Transcatheter Aortic Valve Implantation (TAVI) |
| Abdominal Aortic Aneurysm Register (BAA Register) | German Society for Vascular Surgery and Vascular Medicine (DGG) | Endovascular aneurysm treatment (EVAR) and open surgery to eliminate the abdominal aortic aneurysm (OAR). |
| Breast Implant and Network Register (AWOgyn) | Working group for aesthetic plastic and restorative surgical procedures in gynecology (AWOgyn), Asthemis GmbH | Breast implants , meshes and tissue matrices |
| Endoprosthesis Register Germany (EPRD) | German Society for Orthopedics and Orthopedic Surgery (DGOOC) | Endoprostheses (hip and knee joints) |
| Histopathological implant registry | German Society for Orthopedics and Orthopedic Surgery (DGOOC) | Joint endoprosthesis and implant pathology cases (ICD T84.0, T84.5, T84.9, A49.8, M10, M11, M19, M86). |
| Hernia Register | Herniamed gGmbH to Vivantes Hospital Spandau | Mesh implants hernia surgery |
| German Pacemaker and Defibrillator Register (German Pacemaker Register) | German Society for Thoracic, Cardiovascular Surgery (DGTHG) and the German Society for Cardiology - Heart and Circulatory Research (DGK) and the specialist group for pacemakers and defibrillators at the Institute for Quality Assurance and Transparency in Health Care (IQTIG) | Pacemakers and Defibrillators (ICD) |
| German ablation register | IHF Foundation - Institute for Heart Attack Research with the Working Group of Leading Cardiological Hospital Doctors (ALKK) | Catheter ablation , electrophysiological examination (EPU), high frequency ablation , cryoablation |
| Coronary Angioplasty Register (PCI Register) | IHF Foundation - Institute for Heart Attack Research with the Working Group of Leading Cardiological Hospital Doctors (ALKK) | Cardiac catheter examinations (with and without balloon expansion) |
| Register of atrial occlusions (Left Atrium Appendage Occluder Register Germany (LAARGE)) | IHF Foundation - Institute for Heart Attack Research with the Working Group of Leading Cardiological Hospital Doctors (ALKK) | Atrial appendage closures (umbrella, LAA occluder) |
| German Heart Failure Register (EVIdence based TreAtment - Heart Failure; EVITA HF) | IHF Foundation - Institute for Heart Attack Research with the Working Group of Leading Cardiological Hospital Doctors (ALKK) | Chronic heart failure and left ventricular ejection fraction, use of CRT systems with defibrillator function , " artificial heart " or left ventricular support system (LVAD), heart transplantation |
| German Carotid Artery Stent Registry (GeCAS) | IHF Foundation - Institute for Heart Attack Research with the Working Group of Leading Cardiological Hospital Doctors (ALKK) | Carotid tentangioplasty |
| Coronary stenosis register (German-Austrian-ABSORB RegIsteR; GABI-R) | IHF Foundation - Institute for Heart Attack Research with the Working Group of Leading Cardiological Hospital Doctors (ALKK) | Coronary stenoses that are treated with ABSORB, a bioresorbable coronary stent from Abbott. |
| European Registry for Patients with Mechanical Circulatory Support (EUROMACS) | German Heart Center Berlin (DHZB) | Mechanical circulatory support systems (MCS) such as the intra-aortic balloon pump (IABP) |
| Ankle joint prosthesis register (DAF register) | German Association for Foot and Ankle Joints (DAF) | Ankle joint endoprosthesis |
| German spine register | German Spine Society (DWG) in cooperation with the Spine Society of Europe and the Spine Tango system and the Institute for Social and Preventive Medicine (ISPM) at the University of Bern | u. a. Spinal fusion , PLIF |
Situation in Austria
The implant register for the field of hip endoprosthetics is in the pilot phase and is managed by Gesundheit Österreich GmbH (GÖGG) in the division of the Austrian Federal Institute for Health Care (ÖBIG). The Austrian Society for Plastic, Aesthetic and Reconstructive Surgery also maintains an implant registry for silicone implants.
According to Section 73a (1) of the Medical Devices Act, Gesundheit Österreich GmbH is entitled to
- for the purpose of protecting the health and safety of patients, users or third parties and to avert the risks of implantable medical devices,
- for the purpose of medical device vigilance and market surveillance of implantable medical devices,
- for the purpose of quality assurance of implantable medical devices,
- for the purpose of statistics as a basis for planning, quality assurance and quality reporting in the Austrian health system and
- for scientific purposes
Maintain implant registries for active implantable medical devices, soft tissue implants, cardiovascular, neurological and orthopedic implants.
Situation in Switzerland
In Switzerland, the Swiss Implant Register SIRIS already exists for the time being for artificial knee and hip joints (endoprostheses), later also for other implants. This serves as an early warning system in the event of implant failure, as an indicator of complications during surgery, as an instrument for benchmarking among industry and hospitals and as a database for long-term results and survival time analyzes. The founding members of SIRIS were the Swiss Society for Orthopedics and Traumatology (member of the umbrella association of the surgical specialist community / Foederatio Medicorum Chirurgicorum Helvetica; FMCH), the umbrella association of the Swiss trade and industrial associations in medical technology (FASMED) and the branch association of Swiss health insurers (santésuisse).
Web links
- Swiss Implant Register (SIRIS)
- Medizin Technologie.de - Federal Ministry of Education and Research (BMBF)
Individual evidence
- ↑ Regulation (EU) 2017/745
- ↑ Federal Law Gazette No. 657/1996.
- ^ The Swiss implant register SIRIS
