The BfArM points out critical vulnerabilities in the real-time operating systems of various venders.

BfArM has redacted its updated recommendation from 2019 concerning height-adjustable therapy tables.

BfArM has received several incident reports about fractures in the neck area of the stem hip implant made of titan alloy.

BfArM refers to a publication about potential cybersecurity vulnerabilities in operating systems of different manufacturers issued by FDA.

The BfArM points out critical vulnerabilties in the real-time operating system VxWorks of the company Wind River.

Possible contamination of carrier trays made of moulded fibre materials (e.g. disposable kidney dishes) after sterilisation

Severe hypersensitivity reactions caused by dialysis filters

The surgical mesh implant Rebound HRD / HRD-V is a device for treatment of abdominal wall hernias. Fractures of its ring component may lead to in part severe complications, in these cases requiring explantation. Originally, the devices were not distributed in Germany. However, according to actual information to BfArM, an indirect distribution cannot be excluded.

According to new clinical study results, the Raindrop implant (Brand name: Raindrop Near Vision Inlay; manufacturer: ReVision Optics) may lead to an increased occurrence of corneal haze.
The BfArM would like to refer to a recent FDA Safety Communication and publication by the medical society GSCRS in this context and strongly recommends against further implantation of the implant (§ 11 Abs. 2 MPSV).

The manufacturer Bayer Vital GmbH stops distribution for CE marked devices Essure ESS 305 in Europe. The manufacturer points out that implanted devices may stay implanted safely.

Cleaning and Disinfection of heater-cooler-units (HCUs): possible influence on oxygenator integrity

The BfArM would like to draw attention to the recent SCENIHR publication regarding the use of surgical meshes in urogynecological surgery.

Advices for the application of NaCl basin liners

The German Cardiac Society (DGK) has published recommendations regarding patients with silicone insulated defibrillation leads Riata and Riata ST of St. Jude Medical.

Weld control of the hoist Omnilift G2 of the former manufacturer Weiner Innovative Medizintechnik