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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.
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Manufacturing Site: Varian Medical Systems Haan GmbH Bergische Strasse 16 42781 Haan, Germany
Page 1 of 6 PGM11011300_4 EN Date: 2016-07-12
APPLICATORS AND ACCESSORIES REPROCESSING INSTRUCTIONS Cleaning, Disinfection, Sterilization, Inspection, and Storage GM11011300 WARNING: Cleaning caps must be removed from all ClickFit™ connectors before autoclave sterilization is executed to assure the applicator lumens of the affected device are sterilized during the autoclave steam sterilization process. Failure to remove cleaning caps results in a non-sterile lumen which could lead to infection if patient contact occurs.
WARNING: Before Varian BrachyTherapy devices can be disinfected or sterilized, they must be effectively cleaned to allow disinfecting and sterilizing agents to make full contact with all critical (patient contact) surfaces. Failure to comply could result in patient infection.
Note: When sterilizing multiple applicators and
accessories in one sterilization load, ensure that the maximum sterilization load qualified for Varian BrachyTherapy applicator sets (6.0 kilograms or 13.2 pounds) is not exceeded.
These instructions apply only to products that are originally manufactured by Varian Medical Systems.
If a product is supplied without its instructions for use, or if there are concerns or questions about the proper reprocessing and sterilization methods required for Varian BrachyTherapy applicators and accessories, please contact Varian for information. Refer to the “Varian Customer Support” section below for more information.
Varian BrachyTherapy devices require proper cleaning, disinfection and/or sterilization before the first use and before each additional use.
WARNING: Devices labeled "single-use only" shall not be reprocessed for reuse. Failure to comply could result in patient infection.
WARNING: Proper disassembly of applicator parts is required to assure that all parts come in contact with the disinfecting and sterilizing agents. Failure to comply could result in patient infection.
Note: For determining the maximum number of times a device can be reused/reprocessed, check the individual IFU provided for each applicator.
Highly aggressive decontamination agents and methods required to reprocess applicators and accessories that may contact TSE infective agents are not recommended or approved for use with Varian BrachyTherapy applicators and accessories.
WARNING: Disinfecting applicators with Sekusept PLUS and Cidex® OPA without carefully rinsing with flowing purified water for one (1) full minute five (5) times can cause injury to the patient.
WARNING: If any fluid or liquid enters an inner lumen of an applicator during the cleaning process, flush it with purified water and then carefully dry the lumen using compressed air before autoclave sterilization is performed. Failure to comply could result in a non-sterile device and patient infection.
Varian BrachyTherapy devices are not typically used for treatment of patient tissues where they could be exposed to TSE (Transmissible Spongiform Encephalopathies) infective agents as defined by the WHO (World Health Organization) or RKI (Robert Koch Institute).
Reprocessing methods and reagents other than those specifically described in these instructions may be used by the clinical user. However, it is the responsibility of the user to validate the appropriateness of the alternative methods or reagents.
All Varian BrachyTherapy applicators and components require a thorough inspection for damage and/or wear before reuse to assure proper performance of the applicators and accessories is maintained.
General Information Note: A slight green discoloration of applicator parts may occur due to disinfection with Cidex® OPA. This discoloration does not affect the functionality of the applicator. Note: Sterilizer manufacturer operational instruc-
tions should always be followed.
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
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Manufacturing Site: Varian Medical Systems Haan GmbH Bergische Strasse 16 42781 Haan, Germany
Page 2 of 6 PGM11011300_4 EN Date: 2016-07-12
APPLICATORS AND ACCESSORIES REPROCESSING INSTRUCTIONS Cleaning, Disinfection, Sterilization, Inspection, and Storage GM11011300 Cleaning, Disinfection, Sterilization, Inspection, and Storage Instructions General Process Descriptions Point of Use Processing Applicators with ClickFitTM Connectors
Point of Use Processing Applicators without ClickFitTM and Accessories
• Remove gross soil from assembled applicators by
• Remove gross soil from assembled applicators by
using wipe wetted with purified water • Disassemble • Wipe ClickFitTM connectors with wipes moistened with neutral pH cleaner to remove soil • Wipe connector surfaces with wipe moistened with purified water to remove cleaner solution • Wipe connector surfaces dry with dry wipe • Place a cleaning cap onto the clean ClickFitTM connector • Immerse in cleaning solution or disinfectant solution for transport
using wipe wetted with purified water
• Disassemble • Rinse parts under purified water • Immerse in cleaning solution or disinfectant solution for transport
Transport to Processing Area • Avoid damage to applicators parts • Keep applicator parts wet/ moist
Manual Cleaning
Machine Cleaning
• Immerse for 20 minutes in neutral pH cleaner solution • Manually clean with soft brush • Rinse/ flush with purified water • Immerse in sonicator containing neutral pH cleaner • Sonicate for 10 minutes at 40-50 kHz • Rinse with purified water • Dry (if necessary)
or
• Immerse in neutral pH cleaner within sonicator unit • Sonicate for 10 minutes at 40-50 kHz • Manually clean with soft brushes • Rinse with tap water • Load into washer-disinfector • Operate washer-disinfector • Dry (if necessary)
Disinfection (optional) • Immerse in disinfectant solution • Rinse in purified water • Inspect and dry thoroughly Inspection and Packaging • Inspect product for wear, damage or deterioration • Lubricate moving parts (if needed) • Package wrapped sterilization box (single or two layers of wrapping) or package in autoclave pouch
Sterilization • Pre-vacuum steam autoclaving • For applicators with ClickFitTM connectors, remove cleaning caps before autoclaving
Storage • Controlled environmental conditions
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
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Manufacturing Site: Varian Medical Systems Haan GmbH Bergische Strasse 16 42781 Haan, Germany
Page 3 of 6 PGM11011300_4 EN Date: 2016-07-12
APPLICATORS AND ACCESSORIES REPROCESSING INSTRUCTIONS Cleaning, Disinfection, Sterilization, Inspection, and Storage GM11011300 Detailed Processing Instructions
Point of use pre-cleaning instructions for applicators without ClickFitTM connectors and for accessories
Assure air is not trapped within areas to be cleaned during immersion. If necessary, use a syringe to ensure cleaning solution reaches all parts.
Clean by brushing with a soft-bristled brush.
Rinse with purified water one (1) full minute and repeat for a total of three (3) full rinses. Flush holes, grooves, features and lumen of applicators.
Prepare a sonication unit to contain neutral pH cleaner solution (refer to the “Approved Cleaning and Disinfection Reagents” section below).
Immerse and sonicate applicator parts for ten (10) minutes at 40-50 kHz. Assure air is not trapped within the applicator parts during immersion and sonication.
Rinse under purified water one (1) full minute and repeat for a total of three (3) full rinses.
Visually inspect applicator parts for contamination and repeat cleaning if necessary.
Allow applicator/ parts to dry if necessary
Remove gross soil from assembled applicators by using a wipe wetted with purified water.
Disassemble the applicator.
Rinse parts under purified water.
Immerse parts in a bath of water, neutral pH cleaner or pre-cleaner/ disinfectant solution (refer to the “Approved Cleaning and Disinfection Reagents” section below).
Assure air is not trapped within the parts during immersion. If necessary, use a syringe to ensure pre-cleaning solution reaches all parts.
Point of use pre-cleaning instructions for applicators with ClickFitTM connectors
Remove gross soil using a wipe wetted with purified water.
Disassemble the applicator.
Wipe ClickFitTM connector surfaces (if required) with hospital wipes moistened with neutral pH cleaner solution until the soil is fully removed (refer to the “Approved Cleaning and Disinfection Reagents” section below).
Wipe connector surfaces with hospital wipes moistened with purified water to remove cleaner solution.
Wipe connector surfaces dry with dry hospital wipes.
Place a cleaning cap onto clean ClickFitTM connector fittings.
Immerse parts in a bath or water, neutral pH cleaner or pre-cleaner/disinfectant (refer to the “Approved Cleaning and Disinfection Reagents” section below).
Assure air is not trapped within areas to be cleaned during immersion. If necessary, use a syringe to ensure cleaning solution reaches all parts.
Disinfection (optional)
Immerse applicator parts in a neutral pH disinfectant according to the manufacturer’s instructions (refer to the “Approved Cleaning and Disinfection Reagents” section below).
Assure air is not trapped within the applicator part. If necessary, use a syringe to ensure disinfectant solution reaches all parts.
To avoid damage, do not leave applicator parts in disinfectant longer than recommended by the manufacturer of the disinfectant.
Rinse under purified water one (1) full minute and repeat for a total of five (5) full rinses.
Dry for a minimum one (1) hour at ambient conditions.
Machine cleaning
Immerse applicator parts within a sonication unit in neutral pH cleaner/ disinfectant prepared according to the manufacturer’s instructions (refer to the “Approved Cleaning and Disinfection Reagents” section below).
Sonicate applicator parts for ten (10) minutes at 40-50 kHz.
Clean all surfaces and any challenging features (cannulations, grooves, lumen, etc.) by brushing with a soft-bristled brush.
Manual cleaning
Immerse applicator parts for 20 minutes in a new bath of neutral pH cleaner solution prepared according to the manufacturer’s instructions (refer to the “Approved Cleaning and Disinfection Reagents” section below).
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
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Manufacturing Site: Varian Medical Systems Haan GmbH Bergische Strasse 16 42781 Haan, Germany
Page 4 of 6 PGM11011300_4 EN Date: 2016-07-12
APPLICATORS AND ACCESSORIES REPROCESSING INSTRUCTIONS Cleaning, Disinfection, Sterilization, Inspection, and Storage GM11011300
Rinse under tap or purified water for one (1) full minute.
Place in washer-disinfector and wash with very mildly alkaline or neutral pH detergent (refer to the “Approved Cleaning and Disinfection Reagents” section below) using the following parameters (or equivalent):
If desired, new cleaning caps can be sterilized as loose items so that a sterile cleaning cap can be placed on the ClickFitTM connector prior to patient insertion.
Pre-vacuum autoclave cycles have been validated for use in the health care facilities as follows:
2 minute pre-wash using cold tap water (10°C or 50°F)
132°C (270°F) exposure temperature set-point, 4 minute exposure time, 25 minute drying time
5 minute cleaning cycle (45-55°C or 113-131°F)
2 minute rinse using cold tap water (10°C or 50°F)
134°C (273°F) exposure temperature set-point, 3 minute exposure time, 25 minute drying time
5 minute thermal disinfection (90°C or 194°F)
15 minute drying cycle (100-110°C or 212-230°F)
134°C (273°F) exposure temperature set-point, 5 minute exposure time, 25 minute drying time
Remove from washer-disinfector and inspect for cleanliness. Inspect the applicator parts for visual contamination and repeat cleaning if necessary.
Dry any wet applicator parts at ambient conditions if necessary.
Inspection, lubrication, and packaging
Under well-lighted conditions, inspect all applicator parts for cleanliness before sterilization. Repeat cleaning of any parts that exhibit residual soil or other cleaning residues.
Inspect all applicator parts for damage or deterioration (deterioration includes corrosion, discoloration, cracking, etc.).
Remove all cleaning caps.
Lubricate any moving parts, hinges, or threaded interfaces with a non-silicone based and biocompatible surgical lubricant as needed.
Package applicator parts in sterilization boxes and wrap in no more than two (2) layers of steam permeable/ hospital autoclave wrap. Refer to AAMI ST79 for guidance for applicators and accessories wrapping methods and materials.
Single applicator and accessory components can be packaged in sealable autoclave pouches.
Sterilization
Pre-vacuum (dynamic air removal) autoclave (moist-heat) sterilization cycles are recommended for reusable Varian BrachyTherapy applicators and accessories.
Cleaning caps must be removed from ClickFitTM connectors before autoclave sterilization.
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
All sterilization cycles listed above have been validated to achieve a sterility assurance level of 10-6 or better by Varian Medical Systems.
It is the responsibility of each health care facility to assure that its autoclave sterilization processes provide a sterility assurance level of 10-6 or better for the reprocessing of reusable medical applicators and accessories.
Applicator specific sterilization boxes are recommended if available (see individual applicator IFUs). For other applicator sets, the Universal Sterilization Box (GM11010340) is recommended for use. Small components can be stored in the small component box (GM11012300) and the needles can be stored in the needle box (GM11012340). The component box and the needle box must be placed inside the Universal Sterilization Box for sterilization. Both boxes (GM11012300 and GM11012340) are also suitable to store the components during cleaning and disinfection. All sterilization boxes are qualified to use for 500 autoclave cycles.
The maximum loading mass qualified for autoclave processing of Varian BrachyTherapy applicators and accessories 6.0 kilograms (13.2 pounds).
Always follow the autoclave manufacturer’s operating instructions.
Proper maintenance is required to assure autoclave performance is attained.
Steam autoclaves used in health care facilities must comply with all applicable local and international standards (refer to the “Standards Reference for Reprocessing of Reusable Devices” section below).
Storage
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Store all applicators and accessories under dry conditions.
Manufacturing Site: Varian Medical Systems Haan GmbH Bergische Strasse 16 42781 Haan, Germany
Page 5 of 6 PGM11011300_4 EN Date: 2016-07-12
APPLICATORS AND ACCESSORIES REPROCESSING INSTRUCTIONS Cleaning, Disinfection, Sterilization, Inspection, and Storage GM11011300
The sterile shelf-life of reprocessed applicators and accessories is dependent upon the packaging methods and storage conditions employed at each health care facility. It is the responsibility of each health care facility to validate, determine, and actively maintain the shelf-life of their inventory of reprocessed applicators and accessories.
Approved Cleaning and Disinfection Reagents All cleaning and disinfection reagents listed here have been qualified for use by Varian Medical Systems for the reprocessing of reusable devices (as referenced within each product’s specific labeling, or instructions for use, according to the standards listed in the “Standards Reference for Reprocessing of Reusable Devices” section below).
Cleaning reagent for manual cleaning
Sekusept Activ® from Ecolab, a peroxide based cleaner/ disinfectant. For use in pre-cleaning/ disinfection (when desired) for transport of applicators and accessories from the patient treatment areas to the reprocessing areas. (2.0% concentration)
Post-cleaning disinfectants (optional)
Sekusept PLUS® from Ecolab, a glucoprotamin based disinfectant. For disinfection (when desired) after manual cleaning has been completed. (2.5% concentration)
Cidex OPA® from Advanced Sterilization Products (Johnson & Johnson), an ortho-phthaladehyde based disinfectant. For disinfection (when desired) after manual cleaning has been completed. (100% concentration)
Cleaning reagent for machine cleaning
Dr. Weigert neodisher® MediClean, a mildly alkaline enzymatic detergent. (0.5% concentration)
Standards Reference for Reprocessing of Reusable Devices
AAMI TIR-30 - A compendium of processes, materials, test methods and acceptance criteria for cleaning reusable medical devices.
ANSI/AAMI ST77 - Containment devices for reusable medical device sterilization.
ANSI/AAMI ST79 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Consolidated text of ST79 and Amendments 1 and 2).
ANSI/AAMI ST81 - Sterilization of medical devices Information to be provided by the manufacturer for the processing or resterilizable medical devices.
FDA (2011 CDRH) - Labeling of reusable medical devices for reprocessing in health care facilities: FDA reviewer guidance.
EN ISO 17664 - Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices.
EN ISO 17665-1 - Sterilization of health care products Moist heat - Part1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
EN 285 - Sterilization, Steam sterilizers - Large sterilizers
DIN EN 13060 - Small Steam Sterilizers
Pre-cleaner/ disinfectant (optional)
Dr. Weigert neodisher® MediZym, a neutral pH enzymatic detergent. (0.5% concentration)
AAMI TIR-12 - Designing, testing and labeling of reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.
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
Varian Customer Support Varian Customer Support is committed to providing the latest brachytherapy technology in applicators and accessories. For assistance in selecting the components or for technical questions relating to this applicator and its use or for reporting any incidents involving the applicator, please contact Varian Customer Support. Refer to the Varian Customer Support Contacts sheet for contact information.
E-Mail Your Questions To submit a question, please send an e-mail with a blank subject line to [email protected]. Please indicate the name of your institution, your name and phone number, the product you are commenting on, and your system number, if known, as well as the description of the problem or question.
MyVarian.com Soft copies of this Instructions for Use and the individual applicator Instructions for Use are available on the MyVarian.com web site. You can request a user account on the home page.
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Manufacturing Site: Varian Medical Systems Haan GmbH Bergische Strasse 16 42781 Haan, Germany
Page 6 of 6 PGM11011300_4 EN Date: 2016-07-12