Reusable and Single Use Non Sterile Instruments Directions for Use

•

Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff

B. DEVICE DESCRIPTION AND INFORMATION This device may be a reusable or a single-use non-sterile instrument. Or it may be a reusable sterile or non-sterile instrument that may be attached to power. Check the package labeling. Users of this device are encouraged to contact their Arthrex representatives if, in their professional judgment, they require a more comprehensive surgical technique. Arthrex provides detailed surgical techniques in print, video, and electronic formats. The Arthrex website also provides detailed surgical technique information and demonstrations. C. VALIDATION The recommended cleaning, disinfection, and sterilization methods in this DFU have been validated in compliance with federal and international guidance/standards. In accordance with ISO 17665-1, the “overkill” approach was used for sterilization validation and demonstrates a sterility assurance level (SAL) of 10-6. Cleaning, disinfecting, and sterilizing equipment and materials vary in performance characteristics. Therefore, it is the responsibility of the facility/end user to perform the appropriate validation testing for any use beyond recommended performance characteristics. In accordance with ISO 17664-1 and AAMI TIR30, limit values and a means for monitoring chemical residues following cleaning have been established for the product. In assessing the level of cleaning residuals following the cleaning processes, a clinically relevant method was utilized for testing the safety of residuals as part of the validation protocol. Deionized (critical) water was utilized as the terminal rinse water quality to ensure that residuals will not interfere with subsequent processing steps. Repeated processing has minimal effect on these devices. End of life is normally determined by wear and damage due to the intended use. The user assumes liability and is responsible for the use of a damaged and dirty device. D. CLEANING AND DISINFECTION Devices must be adequately cleaned and sterilized prior to use or re-use. All devices are to be cleaned, disinfected, and sterilized prior to each application; this is required as well for the first use after delivery of the unsterile devices. Effective cleaning is an indispensable requirement for

DFU-0023-EOr1_fmt_en

Page 2 of 13

effective sterilization of the devices. Single-use devices must be cleaned separately from soiled devices. A device labeled as a single-use device must never be reused. Used refers to those singleuse devices that have come into contact with blood, bone, tissue, or other body fluids. Any unused single-use device that has been exposed to blood, bone, tissue, or body fluids must not be reprocessed and must be discarded. Reuse may pose health and/or safety risks to the patient that can include, but are not limited to cross-infection, breakage resulting in irretrievable fragments, compromised mechanical performance due to wear, lack of or no function, no guarantee of proper cleaning or sterilization of the device. If possible, the Machine procedure (Washer-Disinfector) should be used for cleaning and disinfection of the devices. The Manual Cleaning procedure should only be used if an automated procedure is not available; in this case, the significantly lower efficiency and reproducibility of the manual procedure should be considered. The Preliminary Cleaning steps are to be performed in both cases. Manual cleaning may require onsite validation by the healthcare facility and appropriate procedures should be in place to avoid human factor variability. I. POINT-OF-USE PREPARATION, CONTAINMENT, AND TRANSPORTATION It is recommended that instruments are reprocessed within a maximum of 2 hours of use. At point of use, soiled instruments must be removed from trays and moistened to prevent debris from drying before transportation to the reprocessing area for cleaning procedures. Soaking in enzyme solutions facilitates cleaning, especially in devices with complex features and hard-toreach areas (lumens, etc.). These enzyme solutions as well as enzymatic foam sprays break down protein matter and prevent blood and protein-based materials from drying on devices. Manufacturer’s instructions for preparation and use of these solutions should be explicitly followed. Devices should be contained and transported in a closed, puncture-proof device to ensure safety. Do not clean soiled instruments while in cases or trays. Instrument cases and trays are considered reusable devices. Trays should be inspected for visible soil and must be cleaned prior to use. II. DETERGENT SELECTION Consider the following points during selection of the cleaning agent: 1. Suitability of the cleaning agent for ultrasonic cleaning (no foam development). DFU-0023-EOr1_fmt_en

Page 3 of 13

2. Compatibility of the cleaning agent with the instruments. Arthrex recommends the use of neutral pH or enzymatic cleaning agents. Alkaline agents may be used to clean devices in countries where required by law or local ordinance, or where prion diseases such as Transmissible Spongiform Encephalopathy (TSE) or Creutzfeldt - Jakob disease (CJD) are a concern (applies only outside of the US). Arthrex does not recommend the use of a specific brand of cleaning agent. Enzol® and neodisher® MediClean forte were utilized during the validation of these instructions. Caution: Low acid or alkaline solutions are not recommended, as they corrode metal parts and anodized aluminum and compromise polymer plastics. If non-neutral pH cleaning chemistries are utilized, care should be taken to ensure appropriate rinsing, as validated by the end-user facility, and neutralization steps are taken so as to not negatively impact the fit, finish, or function of the device. Pay attention to the instructions of the detergent manufacturer with respect to neutralization and postrinsing. Follow the instructions of the detergent manufacturer regarding use, concentration, and temperature for either manual or automated cleaning. Please use only freshly prepared solutions as well as only purified/highly purified water at least for final rinse, and a soft, lowlinting cloth and/or filtered medical grade air for drying, respectively. III. PRELIMINARY CLEANING Note: No assembly/disassembly of these devices is required unless stated on the labeling, or directions for use pertaining to cleaning, disinfection, and sterilization. Devices that require disassembly are to be disassembled prior to cleaning. 1. Remove excess soil from devices, especially in areas such as joints and crevices, by cleaning the surfaces with a sponge or brush under cold running water or with a nonshedding disposable wipe for a minimum of 1 minute. 2. Rinse the devices at least 1 minute under running utility water (temperature < 35 °C/95 °F). Special attention should be given to lumens, joint, crevices, and other hard-toreach areas. 3. Immerse the devices in cleaning solution inside an ultrasonic bath. While immersed in solution, brush the devices for 2 minutes using a soft-bristled brush. Special attention should be given to lumens, joints, crevices, and other hard-to-reach areas. Lumens

DFU-0023-EOr1_fmt_en

Page 4 of 13

should be brushed with appropriate diameter and length bristle sizes for the particular lumen. Actuate movable parts at least (5) times during soaking, as applicable. 4. After brushing, turn on ultrasonic power and soak and sonicate for 10 minutes at a minimum of 40±5 kHz. Ensure devices are in the open position and that lumens have complete contact with cleaning solution during soaking. 5. Remove the devices from the cleaning solution and rinse at least 1 minute with utility water. Thoroughly and aggressively rinse lumens, joints, crevices, and other hard-toreach areas. 6. After the completion of preliminary cleaning, the end user has the option to perform either Manual Cleaning and Disinfection or Machine (Automated) Cleaning and Thermal Disinfection (preferred). IV. MACHINE (AUTOMATED) CLEANING AND THERMAL DISINFECTION Considerations for the selection of the washer-disinfector: •

Capable of providing an approved program for thermal disinfection (appropriate exposure time and temperature according to A0 concept)

•

Final rinse completed with purified (critical, e.g. RO (reverse osmosis) or DI (deionized)) water and utilizes only filtered air for drying

Cleaning Procedure: 1. After preliminary cleaning is complete, load the devices in the washer-disinfector such that all design features of the device are accessible to cleaning and such that design features that might retain liquid can drain (for example, hinges should be open, and cannulations/holes positioned to drain). 2. If using alkaline cleaning agents, a neutralization step should be utilized as appropriate. 3. Run an automated wash cycle with fundamentally approved efficacy of the washerdisinfector (for example, conformance to the requirements of ISO 15883 series or clearance by the FDA). The following minimum recommended wash cycle parameters were utilized by Arthrex during the validation of these instructions. RECOMMENDED WASHING CYCLE PARAMETERS

DFU-0023-EOr1_fmt_en

Page 5 of 13

Phase

Recirculation Time

Temperature

Detergent

Pre-Wash

3 Minutes

Cold water

N/A

10 Minutes

Follow detergent manufacturer’s recommendation

Enzymatic or alkaline detergent

Neutralization Rinse (optional)

2 Minutes

Follow detergent manufacturer’s recommendation

Neutralizing agent (as needed)

Rinse

3 Minutes

Cold water

N/A

Thermal Disinfection Rinse

5 Minutes

90°C (194°F)

N/A

Drying

Minimum 6 minutes or until visibly dry

Minimum 100°C (212°F)

N/A

Cleaning Wash

4. Remove the devices from the washer-disinfector following the completion of the program and check devices for visible soil. Repeat cleaning if soil is visible and reinspect; otherwise, proceed to Inspection and Maintenance section. V. MANUAL CLEANING AND DISINFECTION Following preliminary cleaning, the instructions for Manual Cleaning and Disinfection may be followed as an alternative cleaning method to Machine (Automated) Cleaning and Thermal Disinfection if an automated procedure is not available. 1. After preliminary cleaning is complete, repeat steps 1-5 provided in the Preliminary Cleaning section of this DFU, including rinsing, immersion and sonication, and postrinsing. Final rinsing should be completed with purified (critical, e.g. RO (reverse osmosis or DI (deionized)) water. 2. Check devices for visible soil. Repeat cleaning if soil is visible and re-inspect. 3. Soak the devices for the given soaking time (provided by the disinfectant manufacturer) in disinfectant solution so that the devices are sufficiently covered. Make sure that there is no contact between the devices. Ensure that the device is in the open position during soaking. Actuate movable parts at least five times during disinfection, as applicable. DFU-0023-EOr1_fmt_en

Page 6 of 13

4. Remove the devices from the disinfectant solution and rinse per disinfectant manufacturer’s instructions. 5. Dry devices thoroughly utilizing filtered medical grade air or a soft, clean, and low-linting cloth. E. INSPECTION AND MAINTENANCE 1. Arthrex non-sterile devices are precision medical devices and must be used and handled with care. Inspect the devices for damage prior to use, and at all stages of handling thereafter. If damage is detected, do not use the device prior to consulting the manufacturer for guidance. 2. Devices with cutting functions or sharp points become dull with continuous use. This condition does not indicate a device defect. This condition indicates normal wear. Dull devices may require replacement if they no longer perform as designed. Inspection prior to use should include verifying the cutting ability and sharpness of these points and edges. 3. To protect instruments from staining and rusting, lubricate all moving parts prior to packaging and sterilization with an instrument lubricant that is biocompatible and has given compatibility with steam sterilization up to 138°C (280°F). Apply lubricants in accordance with manufacturer’s instructions. Re-lubrication is critical for devices that contain actuating mechanisms (e.g. ratcheting handles) to ensure continued effective operation. F. STERILIZATION This device may be provided either sterile or non-sterile. Check the package labeling for more information. For devices that are not provided in a terminally sterilized configuration, sterilization is to be performed following cleaning, disinfection, and sterile packaging prior to use. I. STERILE PACKAGING Singly: Single devices should be packed as to ensure that the pack is large enough to contain the device without stressing the seals. Packaging should be completed utilizing a pouch or wrap which conforms to the recommended specifications for steam sterilization as outlined below. If a wrap is utilized, it should be completed following AAMI double-wrap or equivalent guidelines with an appropriate wrap (cleared by the FDA or the local governing body). Devices may also be placed into an approved reusable rigid sterilization container. Aesculap SterilContainer™ and Genesis™ rigid containers with perforated bottoms and lids are approved for use with Arthrex, Inc. devices. DFU-0023-EOr1_fmt_en

Page 7 of 13

Sets: Where appropriate, cleaned, disinfected, and inspected devices should be placed into trays/cases as provided or in general-purpose sterilization trays. The total weight of trays/cases should not exceed 11.4 kg/25 lbs. (other local limits below 11.4 kg/25 lbs. may apply). Trays/Cases should be double wrapped following AAMI or equivalent guidelines with an appropriate wrap (cleared by the FDA or the local governing body). Sets may also be placed into an approved reusable rigid sterilization container. Aesculap SterilContainer™ and Genesis™ rigid containers with perforated bottoms and lids are approved for use with Arthrex, Inc. sets. Areas, or bracketed positions, designated for specific devices shall contain only devices intended for those areas. Devices should not be stacked or placed in close contact. Only Arthrex devices should be included in the trays or cases. These validated instructions are not applicable to trays or cases that include devices not intended to be used with Arthrex trays or cases. II. STEAM STERILIZATION Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in the table below. Sterilizers vary in design and performance characteristics. Cycle parameters and the load configuration should always be verified against the sterilizer manufacturer’s instructions.

RECOMMENDED STEAM STERILIZATION PARAMETERS

1

Cycle Type

Exposure Temperature

Exposure Time

Minimum Drying Time1

Minimum Cooling Time2

US Prevacuum Cycle3

132°C (270°F)

4 Minutes

30 Minutes

30 Minutes

UK Prevacuum Cycle3

134°C (273°F)

3 Minutes

30 Minutes

30 Minutes

Prevacuum Cycle4 (Prion Cycle)

134°C (273°F)

18 Minutes

30 Minutes

30 Minutes

Drying times vary according to load size and should be increased for larger loads.

DFU-0023-EOr1_fmt_en

Page 8 of 13

2Cooling times vary according to the sterilizer used, device design, temperature and

humidity of ambient environment, and type of packaging used. Cooling process should comply with ANSI/AAMI ST79. 3For markets outside of the US, the cycle parameters listed for exposure time and

temperature can be considered as minimum values. 4

For markets outside of the US, reprocessing parameters recommended by the World

Health Organization (WHO) where there is concern regarding TSE/CJD contamination. III.

SPECIAL PRECAUTION – TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY AGENTS It is outside the scope of this document to describe in detail the precautions that should be taken for Transmissible Spongiform Encephalopathy (TSE) Agents. The agents for transmission of Creutzfeldt-Jakob disease (CJD) are believed to be resistant to normal processes of disinfection and sterilization and therefore the normal processing methods of decontamination and sterilization as described above may not be appropriate where CJD transmission is a risk. In general, the tissues that come into contact with orthopedic surgical instruments are those of low TSE infectivity. However, particular precautions should be taken when handling instruments that have been used on known, suspected, or at-risk patients. Refer to ANSI/AAMI ST79 for further information. G. PACKAGING AND LABELING 1. Arthrex devices should be accepted only if the factory packaging and labeling arrive intact. 2. Contact Customer Service at

+1 800 934-4404 if the package has been opened, altered

or damaged. H. STORAGE Sterile devices must be stored in the original unopened packaging, away from moisture and temperature/humidity extremes and should not be used after the expiration date. Sterile device packages should be carefully examined prior to opening to ensure that package integrity has not been compromised. Non-sterile metal devices should be stored in a clean, dry environment. The shelf life of nonsterile devices is not limited; the devices are manufactured from non-degradable material, which does not raise any question of device stability when stored under recommended conditions. It is the responsibility of the end-user to ensure devices, once sterilized, are stored in such a way as DFU-0023-EOr1_fmt_en

Page 9 of 13

to maintain the sterility of the device until use. Sterile, packaged devices should be stored in a designated, limited access area that is well ventilated and provides protection from dust, moisture, insects, and temperature/humidity extremes. Sterile device packages should be carefully examined prior to opening to ensure that package integrity has not been compromised. Maintenance of sterile package integrity is generally event related. If a sterile wrap is torn, shows any evidence of tampering, or has been exposed to moisture, the device or set must be cleaned, repackaged, and sterilized. I.

CAUTIONS

1.

Users of this device are encouraged to contact their Arthrex representatives if, in their professional judgment, they require a more comprehensive surgical technique or more information. Arthrex provides detailed surgical techniques in print, video, and electronic formats. The Arthrex website also provides detailed surgical technique information and demonstrations.

2.

To avoid damaging the instruments, do not impact or subject to blunt force any instruments that are designed to be turned or screwed in. When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.

3.

Do not use Arthrex instruments for any purpose other than their intended use. Manipulating soft tissue or bone with an instrument not intended for that use may result in damage to the instrument.

4.

Instruments with adjustable components must be handled with care. Overtightening or rough handling of the instrument may damage the locking mechanism. Locking mechanisms with internal polymer components may become weakened after repeated autoclaving.

5.

Do not use an instrument that is intended to be used with a specific implant on another implant.

6.

Flexion of the joint with the instrument in position in the joint may result in bending or breakage of the instrument.

7.

Do not overstress the device or use device to pry tissue.

DFU-0023-EOr1_fmt_en

Page 10 of 13

I.

Instrument-Specific Cautions Depth Guides: When noted on the depth guide, disassemble the device into

•

components prior to cleaning, disinfection, and sterilization. Staple Driver: Do not use the end of the Staple Driver’s jaws to seat the staple.

•

This will result in the jaws breaking or bending. Do not use a mallet to strike the end cap of the Staple Driver. Radiolucent Retractors: Use only to retract soft tissue. Do not use as a shield to

•

protect soft tissue from saw blade, osteotome, and/or other surgical instruments. J.

WARNINGS

1.

Caution: Federal law restricts this device to sale by or on the order of a physician.

2. After insertion of the instrument into the joint, do not apply additional flexion to the joint. A piece of a broken instrument can become lodged in soft tissue and/or disappear from the arthroscopic view of the surgical field resulting in possible fragments being retained in the patient. 3.

This device is intended to be used by a trained medical professional.

4. Biohazard waste, such as explanted devices, needles and contaminated surgical equipment, should be safely disposed of in accordance with the institutions policy. 5. Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred. K. INFORMATION 1. In CE Accepting Countries: Procedures carried out using these devices may be used on the general population. 2. In CE Accepting Countries: The clinical benefits associated with the use of these devices outweigh the known clinical risks. 3. In CE Accepting Countries: There are no unacceptable residual risks or uncertainties associated with the clinical use of these devices.

DFU-0023-EOr1_fmt_en

Page 11 of 13

L. CONTACT INFORMATION Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the health authority where the incident occurred.

Arthrex, Inc. 1370 Creekside Blvd. Naples, FL 34108, USA +1 800 934-4404 arthrex.com arthrex.com/eDFU

Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 Munich, Germany +49 89 90 90 05-0 arthrex.de [email protected]

Arthrex Distribution Hub EMEA B.V. Ampèrestraat 9 5928 PE Venlo, Netherlands +31 88 712-9800 arthrex.nl [email protected]

DFU-0023-EOr1_fmt_en

Page 12 of 13

Emergo Consulting Limited Compass House, Vision Park Histon Cambridge CB24 9BZ +44 0 1223 772 671

confinis ch-rep ag, Hauptstrasse 16, 3186 Düdingen, Switzerland +41 26 494 8 494

Manufacturer’s Australian Sponsor Arthrex Australia Pty Ltd Suite 501, 20 Rodborough Road Frenchs Forest, NSW, 2086 Australia +1 800 950 637 arthrex.com.au [email protected]

Trademarks are owned by their respective owners. This is not a warranty document. For all warranty information, including disclaimers, exclusions, terms, conditions and related provisions, refer to the “Arthrex U.S. Product Warranty” section of the Arthrex, Inc. website, found at www.arthrex.com whose provisions are incorporated herein by reference.

DFU-0023-EOr1_fmt_en

Page 13 of 13