Update of Product Group 11, Aids Against Decubitus

Removal of Measurement Readings ​​and Decubitus Ulcer Levels

The National Association of Statutory Health Insurance Funds (GKV Spitzenverband) is in the process of contacting all manufacturers who have listed products in product group 11 (aids against decubitus). Among other things the deletion of individual product features (e.g. removal of measurement readings ​​and decubitus ulcer levels) is indicated and a demand for the current up-to-date status of the product listings.

Up until now, it was necessary to submit test reports on pressure relief and shear force reduction, service life, functional properties and microclimate for seat and rest aids as evidence. As part of the update, these have been dropped. Only the volume test for active resting / lying systems still need to be submitted.

According to the GKV Spitzenverband “it is not possible to make a statement about the effectiveness of a product in real life environements, when it has only been tested in the laboratory”. As part of the update, it has been established that the measurement readings ​​of the tests describe only a partial aspect of the effect and therefore do not reflect the care realities of persons in need of care. Therefore more emphasis was given to the user observation as evidence of the medical benefit by increasing the number of patients (10 instead of 5) and duration of use (6 instead of 3 weeks). The so-called “expert appraisal”, in addition to the above-mentioned aspects, exclusively aims at whether a product is suitable for therapy and / or prophylaxis, without making a classification according to decubitus grades.

If you have received mail from GKV Spitzenverband, you ought to ensure responding within the deadline and addressing all inquiries about the listed products, otherwise there is a threat of deletion of existing product listings. To help not to overlook such information letters from the GKV Spitzenverband and to process them in a timely manner, BEO BERLIN supports manufacturers with current and future inquiries. As “HMV Representative” BEO BERLIN acts as a continuous point of contact and informs the manufacturer about corresponding changes in the German medical technical aids register.

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