Start Consumer protection Register for implants to improve patient safety

Register for implants to improve patient safety


After reports of an increase in injuries and deaths due to poor medical implants, Federal Minister of Health Jens Spahn wants to ensure greater transparency in medical devices. For this, an implant register should be created. „We set up an industry-independent office, where all installed implants must be reported,“ said Spahn the Rheinische Post. At the same time, the minister acknowledged deficits. In the case of problems with a medical device, the Federal Institute for Drugs and Medical Devices (BfArM) has „no overall overview of all comparable cases“ and thus no chance of deliberately alerting patients to errors.

According to the results of an international search in which the broadcasters NDR and WDR and the Süddeutsche Zeitung were involved in Germany, injuries and deaths associated with implants have increased sharply. In Germany alone, 14,034 suspected cases were reported last year. The leader in medical technology, the US company Medtronic, could be associated with up to 9,300 deaths and 292,000 injuries in the US alone, reports said.
A health ministry spokesman said the reports were taken very seriously. „Every single case described there is tragic and one too many.“

The SPD health politician Karl Lauterbach called on the government to act. „We have to significantly improve patient safety,“ he told the Neue Osnabrücker Zeitung. For potentially dangerous side effects of implants, „human examinations“ would have to be „significantly more important.“ In addition, a complete implant register and its publication is necessary. Stricter rules would have to ensure that implants that showed abnormalities „are immediately removed from the market“. Lauterbach accused Union and FDP of having prevented such stricter requirements in the past.

Sparkle innovations and harmful products

The statutory health insurance also called for improvements. „For medical devices, dummy innovations and even harmful products are far too easy to supply, and there are no safe rules and regulations that prevent this,“ said Doris Pfeiffer, the CEO of the GKV Spitzenverband. Examples ranged from „self-dissolving stents to metal-on-metal hip replacements“. The policy had „for many years despite many reminders too little done“, although the statutory health insurance repeatedly pointed to the problems.