Applicators and Accessories

Applicators and Accessories GM11011300 Reprocessing Instructions

6 Pages

APPLICATORS AND ACCESSORIES REPROCESSING INSTRUCTIONS Cleaning, Disinfection, Sterilization, Inspection, and Storage GM11011300      Each health care facility is responsible for assuring that their reprocessing methods provide safe and effective reusable applicators and accessories for use in their associated clinical settings.    Where conflicting national reprocessing requirements are encountered, these shall take precedence over the Varian methodologies specified herein. This is especially true for nationalized procedures or methods required for the inactivation of prions.  These instructions also provide directions for inspection of reprocessed applicators and accessories to determine when they have reached the end of their serviceable life and require replacement.  Introduction   These instructions are intended to provide general guidance for reprocessing Varian BrachyTherapy reusable applicators and accessories to prepare them for clinical use.  Cautions and Warnings CAUTION: Cleaning and disinfectant reagent instructions provided by the reagent manufacturer(s) must be strictly followed. Failure to follow the manufacturer’s instructions can be expected to degrade or damage the device materials and their ability to perform effectively and safely when reused.  The reprocessing instructions described herein have been validated for use by Varian Medical Systems. The validations were conducted according to the current relevant medical device regulatory standards and have demonstrated that Varian BrachyTherapy applicators and accessories processed according to the conditions specified within this document can be safely and effectively reprocessed for clinical use and reused as specified for use according to each product's labeling (or Instructions for Use (IFU)).  CAUTION: Cleaning caps are single use devices that can be used only once and then they must be discarded. A reused cleaning cap might not securely protect the applicator lumens, so liquid could enter which could lead to malfunction of or damage to the Varian afterloader.  Note: Instructions for Use for individual applicators  CAUTION: Cleaning caps are required for closing ClickFit™ connectors before manual cleaning and disinfection or machine cleaning operations can be performed to avoid liquid entering the lumens which could lead to malfunction of or damage to the Varian afterloader.  and accessories are included on the Varian BrachyTherapy Applicators and Accessories Instructions for Use CD (GM11010400).     Additional and specific reprocessing method details and precautions for individual applicators and accessories are also provided in the IFUs for those individual applicators and accessories. These instructions apply only to those applicators and accessories for which this document is referenced in the “Cleaning, Disinfecting and Sterilization” section of the individual IFUs.  CAUTION: An applicator that is not completely disassembled might become damaged beyond repair during cleaning, disinfection and sterilization. CAUTION: Varian BrachyTherapy devices are not suitable for exposure to highly basic (such as NaOH) or highly acidic (such as HCl) cleaning or disinfectant reagents. These conditions can be expected to degrade or damage the device materials and their ability to perform effectively and safely when reused.  The personnel, methods, equipment, and reagents used for reprocessing of reusable applicators and accessories all provide impact upon the levels of performance and effectiveness delivered by the reprocessing system employed.   Alternative methods for applicators and accessories reprocessing may be equally suitable for the reprocessing of Varian's reusable BrachyTherapy applicators and accessories.  EU Authorized Representative: Varian Medical Systems UK Ltd. Gatwick Road, Crawley West Sussex, RH10 9RG United Kingdom  Legal Manufacturer: Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 USA  CAUTION: Applicator lumens of Varian BrachyTherapy devices must not become contaminated by liquid, moisture or other contamination as this could lead to malfunction of or damage to the Varian afterloader.  0086  Manufacturing Site: Varian Medical Systems Haan GmbH Bergische Strasse 16 42781 Haan, Germany  Page 1 of 6 PGM11011300_4 EN Date: 2016-07-12
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File Name: Varian - PGM11011300_4 EN - Applicators and Accessories GM11011300 Reprocessing Instructions - 2016-07.pdf

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