Tuttlingen – As part of the MDR & IVDR emergency aid BW coordinated by BIOPRO GmbH, MedicalMountains GmbH moderated clinical literature evaluations for product group L06 "Punching/drilling instruments for hard tissue/bones, class Ir". This now receives a second document for processing. Other interested companies can register.
Together with the service provider Karl-Heinz Fischer (Fischer QMS), joint instructions for the professional preparation of reusable surgical instruments are to be created. The aim of this project is to create a uniform template for manufacturers of reusable surgical instruments, with which all aspects and requirements for qualified reprocessing by the user can be met. It should be noted that this is not a processing validation for which each manufacturer is responsible, but a template for non-conforming processing instructions.
The time frame will be around 6 months, since the requirements on the user side are also determined (hospitals, university clinics, external processors...). The input from the participating manufacturers will take the form of working sessions where drafts will be discussed and modified accordingly until the final template is available. Approximately five working sessions are scheduled.
Further information on the consortium and cost sharing from Marena Hauser, hauser@medicalmountains.de, telephone 07461 969721-64. Registrations are still possible until May 12th.
