The GKV-SV is conducting manufacturer surveys
Manufacturers of products belonging to product group 11 of the HMV are confronted with an update: The German National Assosciation of Statutory Health Insurance Funds (GKV-SV) has written to manufacturers of anti-decubitus products, asking them to provide a manufacturer query.
If a manufacturer query is triggered, manufacturers are requested to provide test reports, operating instructions or manufacturer's declarations on specific issues, for example.
In the context of the update of PG 11, it covers the topics:
- loudness / volume
- users manual
Humming mattresses? Pressure sore aids can be noisy, too.
The focus is on the volume of the products. How can a mattress be noisy? Especially for patients with pressure ulcers, for whom jumping out of bed is rarely a hobby.
‘Alternating pressure mattress’ is the keyword. These special air mattresses are highly adaptable, particularly gentle and often equipped with electric compressors.
When constantly equalising the pressure in the mattress or aid, the compressors make a noise – anyone who has ever tried to fall asleep in the presence of a housefly knows how annoying a hum that cannot be switched off can be.
The GKV is now calling for manufacturers of PG 11 to provide information on the volume of their products. This should be done by means of a test report and in the operating instructions.a
Because testing this specific aspect of this specific product group is such a specific niche, there are very few testing centres for it in Germany. Fortunately, however, BEO BERLIN has excellent relations with a testing centre that specialises in this niche.
So, if you, dear manufacturer, carry a product in PG 11, please do not hesitate to write to us! Together, we can professionally and efficiently adapt your products to the constantly changing regulatory requirements and ensure your place in the HMV.
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