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BfArM Recommendations

BfArM Recommendations include information about risks arising from medical devices and measures recommended by the Federal Institute in order to reduce or eliminate risks. The recommendations mainly derive from the evaluation of incident reports received under the medical devices vigilance system.

Date Title:
19.08.2021 Critical vulnerabilities in the real-time operating systems of various venders

The BfArM points out critical vulnerabilities in the real-time operating systems of various venders.
22.12.2020 Updated BfArM recommendation

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

11.11.2020 Damage of hip stem prostheses (neck area) caused by high-frequency cauterizing instruments (e. g. cautery knife)

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

09.10.2019 Critical vulnerabilities in operating systems of different manufacturers

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

28.08.2019 Critical vulnerabilties in the real-time operating system VxWorks of the company Wind River

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

27.08.2019 Sterilization of disposable carrier trays made of moulded fibre material (kidney dishes etc.)

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

20.08.2019 Hypersensitivity reactions caused by dialysis filters

Severe hypersensitivity reactions caused by dialysis filters

22.03.2019 Device alert: Surgical mesh implant Rebound HRD / HRD-V manufactured by ARB Medical LLC (USA)

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.

07.01.2019 Increased occurrence of corneal haze after implantation of the Raindrop Near Vision Inlay (FDA Safety Communication)

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).

15.05.2018 Discontinuation of the sale of the CE marked device ESSURE for permanent birth control

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.

22.12.2016 Cleaning and disinfection of heater-cooler-units (HCUs): possible influence on oxygenator integrity

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

13.05.2016 Urogynecological use of surgical meshes

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

29.01.2015 Advices for the application of NaCl basin liners

Advices for the application of NaCl basin liners

18.11.2014 Recommendations on the approach to patients with Riata and Riata ST leads (St. Jude Medical)

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

27.08.2013 Weld control of the hoist Omnilift G2

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