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Rollators – Towards a Reimbursement Listing in Germany (HMV) With Only the CE Marking

Rollators support people in their basic need for movement and mobility.

Rollators are a type of walking aid used worldwide. They are used to compensate for walking disabilities, both in clinical-institutional and domestic settings. Rollators are part of the ever-present cityscape. They are overwhelmingly used by older people. By installing baskets, cane holders and umbrellas, rollators are not only used for walking but also offer the possibility to carry many necessary things in them or to simply go shopping with them. A rollator supports people in their basic need for movement and mobility.

In medical technical aids register of GKV (The National Association of Statutory Health Insurance), more than 250 rollators can be found in the PG 10.50.04.1xxx and PG 10.50.04.2xxx (increased load capacity). In the BfArM database (Federal Institute for Drugs and Medical Devices) there are 24 reports of measures taken after incidents.

The safety depends on many factors. The medical indication has to be checked individually and in detail and the choice of the aid has to be made carefully. An individual adaptation of the aid may be necessary in order to provide physiologically fitting care, to eliminate undesirable problems during care and to enjoy the full benefit of the aid. Individual adaptability can be covered by height adjustment of the handles or the frame on the one hand and by various accessories or variants with additional functions on the other. As already mentioned, great care is required when selecting the appropriate assistive device. In order to be able to use the selected and adapted aid extensively and safely, it is indispensable to complete an appropriate application training. Only then is the use of the walking aid possible at a high safety level, since only through training can the influence factor “incorrect use” be reduced in its probability of occurrence.

Rollators as Medical Technical Aids

The path that a rollator has to take to end up in the HMV is long. The CE mark and thus the conformity assessment procedure for medical devices must first be passed by manufacturers with their products.

Required Documents for CE Marking

As with all other medical devices, this includes the preparation of the technical documentation with the documents:

  • Product description and specificationtion
  • Information to be supplied by the manufacturer
  • Design and manufacturing information
  • General safety and performance requirements
  • Benefit-risik analysis and risk management
  • Verification and validation
  • Declaration of Conformity
  • Post-market surveillance

Verification of the technical requirements is provided by successful testing according to DIN EN ISO 11199-2:2005-07 ” Walking aids requiring both arms – Requirements and test methods – Part 2: Rollators”. Risk analysis, clinical evaluation, usability, 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 allowed to apply the CE mark. Only then can applications be considered promising at all, because without CE mark, there is no way forward. This is good, because on the basis of § 139 paragraph 5 of the German Social Code, Book V, the proof of various requirements for medical devices in the sense of § 3 no. 1 of the Medical Devices Act (MPG) is basically considered to be provided by the CE mark. This also applies to accessories within the meaning of § 3 no. 9 MPG. This includes, in particular, the functional suitability and safety of the products.

However, a look at the requirements according to SGB V also shows that the CE mark is a necessary but insufficient condition. In addition, there are required proofs regarding:

Requirements according to SGB V

  • Indication/use-related properties
  • Quality requirements regarding service life
  • Quality requirements regarding reuse
  • Requirements for the product information
  • Requirements for the services to be provided in addition to the provision of the assistive device.

The latter have been added within the framework of the last HMV update. While some of the required verifications are provided by further manufacturer’s declarations that can be substantiated, others must be confirmed by recognised testing facilities in the form of test reports. Knowing how and where are decisive criteria to avoid double testing. The aid configuration must be observed, 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 highest quality test result will not help. Therefore, at least as much care and attention is required in the preparation of an application for medical aid number as in the conformity assessment procedure itself or, as mentioned at the beginning, in the later selection of the aid for the user.

 

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