Management of surgical instruments

Management of reprocessable surgical instruments: Organization, control, execution, documentation, quality assurance, and tracking of maintenance and repair measures to restore and ensure the functionality, safety, availability, and operational readiness of the instruments in compliance with applicable legal, normative, and manufacturer requirements. This includes identifying and processing repair needs, technical assessment of damage patterns, performing or arranging suitable repair measures considering manufacturer specifications, testing safety- and function-relevant features potentially affected by the measure, performing and documenting quality assurance measures, documented release, return to the supply and reprocessing cycle, and providing evaluations, reports, and evidence for traceability. Optional services include the provision of repair replacements if repair is technically impossible or economically unfeasible, as well as maintenance and repair services for motor systems, drive units, handpieces, angled pieces, and associated accessories. Excluded are flexible and semi-flexible endoscopes, as well as medical products and instruments for which maintenance or repair services may only be provided by the respective manufacturer or manufacturer-authorized companies due to existing manufacturer ties. Contract duration: 4 years, with a unilateral option for extension by 1 additional year.

Tender documents

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