In the field of #medicaldevices, regulations are nowadays becoming more complex but also stricter, not only for manufacturers but also for users. The basic principle here is #patientsafety, which is an overarching goal that we all pursue.
Under these regulations, the manufacturer is responsible for ensuring that a product meets the performance and safety requirements that apply when it is first placed on the market. According to the #MDR, these performance and safety requirements shall also be available throught the complete life span of the product. These requirements are accompanied by technical drawings, various tests/evaluations, and the appropriate product documentation.
The fulfillment of these safety requirements is made clear in required information such as company logo of the initial marketer and information such as part number, batch or production marking, CE marking and information about the product.
When the product is in use, the operator is responsible for the maintenance of the medical devices.
Repair should therefore always be carried out properly and by authorized service providers in order to maintain its conformity and not lose the validity of the #processinginstructions. This preserves claims under the warranty assumed by the original manufacturer, because refurbishment and modification of medical devices can cause them to no longer comply with the specifications of the initial marketer.
The consequences can be dramatic, as the following pictures show:
Through professional and hygienic #processing and the intended use according to the specifications of the instructions for use of the initial marketer, maintenance measures can be kept low and the quality of the medical devices can be kept high.
An efficient and safe way to retain value!
About the author
Johannes Gulde has been a member of AKI since 2018 and is one of the representatives of the instrument manufacturers in the group. Within the KLS Martin Group, he is responsible for product management for surgical instruments, sterilization containers and related services.