Tuttlingen – Internal and external input form a reliable template: MedicalMountains GmbH moderated the creation of joint preparation instructions for surgical instruments as part of the MDR & IVDR immediate aid BW. 15 medical technology companies took part.
"If you look at the requirements for the companies and enter into dialogue with them, you will find a number of starting points for joint solutions," says Marena Hauser, who accompanied the project at MedicalMountains GmbH. So there were immediately enough interested parties to form a consortium for the topic of "reprocessing instructions". Karl-Heinz Fischer (Fischer QMS) was brought on board as a service provider. The basis was formed by the normative and regulatory requirements, including those from DIN EN ISO 17664 and Annex I of the EU-MDR, as well as the processing instructions currently used by the companies involved. Marena Hauser names two essential aspects that emerged as essential in the course of the joint work: "On the one hand, surgical instruments are also becoming more and more complex and therefore more difficult to clean. This must be taken into account in the accompanying information.” On the other hand, the focus is more on the later users of the instruments. In order to fill this point with life and content, the design of four clinics was subjected to a "practice check". "That was very valuable for obtaining well-founded assessments and additions," says Marena Hauser.
The heart of the package is the template for the preparation instructions. The framework is largely predetermined; only manufacturer-specific information such as values for drying, packaging or sterilization must be added. Additional documents include explanations, an editable template for risk assessment, a laboratory checklist and accompanying literature. On behalf of the companies involved, Dr. medical Taalke Schlatterer from Magonovum® GmbH & Co. KG summarized the result as follows: "I find it extremely useful to involve central sterile supply departments of different sizes in order to take their actual processes and requirements for processing instructions from the user side into account." Very supportive in fulfilling the The risk analysis and the accompanying publications are also required. "All in all, a well-founded, standard-compliant and very comprehensive project," she says.
As with the other basic documents created as part of the MDR emergency aid program, the joint reprocessing instructions for surgical instruments can be purchased from other medical technology manufacturers. The price is EUR 840 (plus VAT) for companies from Baden-Württemberg and EUR 1,500 (plus VAT) for companies outside of Baden-Württemberg. Additional information is available from Marena Hauser, hauser@medicalmountains.de, or via this link .
