Under the guidelines of the Internetauftritt des Bundesinstituts für Arzneimittel und Medizinprodukte (BfArM) of September 17, 2012, the following enforcement applicable to safe restraint systems has been established in healthcare:
The abdominal safety belts for patient securing should guarantee by means of its design that they cannot slide up from the belt. Moreover, they should guarantee that any displacement of the patient above the edge of the bed is avoided.
Although this legislation is currently in force in Germany only, it is expected that it will be applied successively in the other European countries. Consequently, the therapeutic restraint belts manufactured by Medicare System are provided with a sewn perineal band in accordance with the regulations, which have been explicitly monitored by the BfArM and granted approval for marketing.