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Conclusion The use of the T-DOC traceability software has enabled the specific determination of sterilization costs for each product. This new approach to the structure of costs enables a more accurate accounting overview for real activities in each surgical unit than that provided by analytical cost accounting. For hospital pharmacists, being aware of costs per product and per process stage is both useful for the management of costs and for improving quality and thus services rendered to the patient. There are also new possibilities with regard to subcontracting (the creation of a tool to support strategic decisions by the management), internal contracting, and – in the long term – billing by patient and operation. Moreover, since the method and its application are also feasible for use in other health establishments, the definition of new external benchmarks for the comparison of activity costs can be envisaged. At present, the benchmark used by the ENC, which is used to compile the prices of the homogenous hospital stay groups (GHS), is still the cost per cubic meter resulting from analytical cost accounting. This is not particularly representative of the real costs. To conclude, the information on costs per product resulting from this method will enable the pricing of the sterilization process for the surgical units and also for the managing entities of health establishments;
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Introduction This guidance provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable1 medical devices. This guidance document also provides recommendations for the content and review of premarket notification submissions [510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests and investigational device exemption (IDE) applications, concerning the labeling instructions for reprocessing reusable medical devices. Please note that exemption from 510(k) does not mean a device is exempt from compliance with labeling or Quality System (QS) requirements. Manufacturers of 510(k)-exempt devices should follow the recommendations of this guidance pertaining to such requirements, unless, for example, the device is specifically exempted by regulation from specific QS requirements. Manufacturers of reusable medical devices are responsible for having labeling that bears adequate directions for use, including instructions on preparing a device for use. While FDA recognizes the critical role and responsibility of the device user community to follow the validated reprocessing instructions in the device labeling, the focus of this document is to provide guidance to medical device manufacturers in the complex activities involved in crafting and validating reprocessing instructions that ensure that the device can be used safely and for the purpose for which it is intended. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should 1 While the scope of this guidance also includes single-use medical devices that are initially supplied as non-sterile to the user and require the user to process the device prior to its use, the majority of the devices addressed by this guidance are reusable devices. Accordingly, this document uses the term “reusable devices” for editorial convenience.