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Implant register Germany starts trial operation

The German Implant Register has received the first data on breast implants from clinics. It has therefore successfully started trial operation. Technically, the register has been operational since March 31, 2023. This represents an important milestone on the way to even greater protection of the health and safety of patients. Starting January 1, 2024, all healthcare facilities must report implant-related activities involving breast implants to the registry.

Federal Minister of Health Prof. Karl Lauterbach: “With breast implants, women can regain a better quality of life after breast cancer or with malformations. Patients should be able to rely on the fact that they are receiving high-quality implants and that they will be informed quickly if there are any problems. The implant register creates transparency and improves patient safety. The registry starts with the recording of breast implants. Endoprostheses for hips and knees will soon also be registered there. As part of our digitalization offensive, the data from the implant register will also be evaluated for research in order to systematically improve the supply of implants.”

The establishment of a secure technical platform at the federally owned D‑Trust GmbH and the ITZBund as well as the transport via the telematics infrastructure guarantee information security and the protection of health data. Only the trust at the Robert Koch Institute knows the patient’s health insurance number. The registry office at the Federal Ministry of Health stores the information about the implant and the medical data. She only has pseudonyms for the patients and does not know their identities.

The first expansion stage of the register was set up in close collaboration with the DGPRÄC (German Society for Plastic, Reconstructive and Aesthetic Surgery) and the AWOgyn (Working Group for Aesthetic, Plastic and Reconstructive Surgical Procedures in Gynecology), a section of the German Society for Gynecology and Obstetrics.

A web form in the telematics infrastructure is currently used for reporting. In order to relieve the burden on clinics and practices, the reporting process should be integrated into hospital information systems and practice management software and largely automated. There is close coordination with the Federal Association of Health IT (bvitg) and software manufacturers.

In the consolidation phase that is currently underway, some adjustments are being made to the institutions that are already participating, which result from practical operation. In addition, the registration and authentication of clinics and practices will be converted to a procedure suitable for mass use. All health facilities can then register for trial operation and thus prepare for regular operation from 2024. The opening of the registration platform will be announced in good time on the implant register websites and via the associations.

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