Germany should receive a digital implant register. This is what the Federal Cabinet decided at the beginning of April, with the bill presented by health minister Jens Spahn.
With the new central database across Germany, medical implants are collected systematically on and in the body of German patients.
The goal is to increase the quality and safety of medical devices. Product errors can then be reported to all affected patients as quickly as possible via the central implant register.
Researchers and manufacturers are also learning about the lifecycle of individual types of implants through the online registry and can draw conclusions about the quality and performance of implanted healthcare facilities.
Central data collection for more patient safety
The German Institute for Medical Documentation and Information (DIMDI) in Cologne is responsible for the central data acquisition of implants as well as explantations. Here, the German telematics infrastructure is used.
From about mid-2021, notifying implants should be technically feasible. Whether hip joint prosthesis, cardiac pacemaker or breast implant: manufacturers, patients, legal and private health insurers, clinics and practices are then subject to the same reporting obligation and must register medical implants mandatory in the register.
It is still unclear from what point in time the individual implant types have to be precisely registered.
It is estimated that hip and knee endoprostheses will be required to be reported as early as mid-2021, according to a press release from the Federal Ministry of Health at the beginning of April. For the extra work involved in the registration, clinics and practices using implants should be reimbursed.
Data transfer from existing registers
In addition, data from the existing implant registries with previously voluntary participation will also be taken over and used. For these data transfers legal frameworks are already under construction. All data of registered implants are processed pseudonymised.
The central, digital recording of the implants enables problematic products to be identified early and removed from the market – this is the objective of the Federal Ministry of Health. Currently, 440,000 hip and knee endoprostheses and 65,000 breast implants, for example after a breast cancer diagnosis, are used in patients annually in Germany.
Anna Engberg is a Wiesbaden-based freelance journalist specialising in health and technology.
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