Rollators support people in their basic need for movement and mobility
Rollators are a type of walking aid used all over the world. They are used to compensate for walking disabilities, both in clinical and institutional settings and in the home. Rollators are part of the ubiquitous cityscape. They are used by the majority of older people. With the installation of baskets, cane holders and umbrellas, rollators are not only used for walking, but also offer the possibility of carrying many necessary items or simply going shopping with them. A rollator supports people in their basic need for movement and mobility.
The medical indication must be examined individually and in detail and the aid selected with appropriate care. The aid may need to be customised in order to provide physiologically correct care. Furthermore, customisation serves to eliminate undesirable problems with the fitting and to enjoy the full benefit of the aid. Individual adaptability can be achieved by adjusting the height of the handles or the frame on the one hand and by using various accessories or variants with additional functions on the other. As already mentioned, great care is required when selecting the right aid. Finally, in order to be able to use the selected and customised aid extensively and safely, it is essential to complete appropriate application training. Only then is it possible to use the walking aid at a high level of safety, as only through training can the probability of ‘incorrect use’ be reduced accordingly.
The rollator as a medical aid
In the list of medical aids of the GKV Spitzenverband over 250 rollators can be found in the PG (product groups) 10.50.04.1xxx and PG 10.50.04.2xxx (increased load capacity). The BfArM database contains 24 reports on measures following incidents.
The path that a rollator has to take to end up in the list of medical aids is a long one. Manufacturers must first go through the CE mark and thus the conformity assessment procedure for medical devices with their products. As with all other medical devices, this includes the preparation of technical documentation with the following documents.
Steps of a technical documentation
- Product description and specification
- Information to be provided by the manufacturer
- Information on design and manufacture
- Basic safety and performance requirements
- Risk-benefit analysis and risk management
- Verification and validation
- Declaration of conformity
- Post-market surveillance
Verification of the technical requirements is provided by successful testing in accordance with DIN EN ISO 11199-2:2005-07 ‘Ambulation aids for ambidextrous use - Requirements and test methods - Part 2: Rollators’ .
Risk analysis, Clinical Evaluation Report, usability aspects etc. are also an essential part of the documentation for rollators in order to prove the basic safety and performance requirements or, in short, to be able to affix the CE mark. Only now can applications be considered at all promising, because without CE there is no way forward. Which is a good thing, because according to Section 139 (5) SGB V, medical devices within the meaning of Section 3 No. 1 of the Medical Devices Act (MPG) are generally deemed to have fulfilled various requirements through CE labelling. This also applies to accessories within the meaning of Section 3 No. 9 MPG. In particular, this includes the functional suitability and safety of the products.
However, one look at the requirements according to SGB V also shows that the CE mark is a necessary but not sufficient condition. In addition, there are required documents regarding:
requirements according to SGB V
- Indication/use-related properties
- Quality requirements with regard to service life
- Quality requirements with regard to reuse
- Requirements for the product information
- Requirements for the services to be provided in addition to the provision of the aid
The latter were added as part of the last update of rollators. Some of the required evidence is provided by further verifiable manufacturer declarations, others must be confirmed by recognised testing facilities in the form of test reports.
Knowing how and knowing where are decisive criteria for avoiding double testing. The aid configuration must be observed and the information in the instructions for use must be cross-checked, i.e. consistency must be ensured. If I enter the race with the wrong equipment, even the best test results will not help. For this reason, at least as much care and attention is required when preparing an application for an aid number as in the conformity assessment procedure itself or, as mentioned at the beginning, in the subsequent selection of the aid for the user.
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