WRIGHT Instruments Cleaning and Handling Instructions

d.

The potential mechanisms for injury, e.g., migration, infection;

Preparation

• The cleaning process must be conducted so that all parts of the surgical instrument

e.

Procedures or treatments that should be avoided, such as MRI exams in the case of metallic

for Cleaning

are exposed as permitted by instrument design. The cleaning process should include

fragments. This may help to reduce the possibility of a serious injury from the fragment.

an individual properly gowned with appropriate gloves and personal protective equipment.

B. HANDLING & STERILIZATION Warning: Multicomponent instruments that can be disassembled must be

Cleaning Accessories

disassembled for cleaning. Please refer to the corresponding assembly/ disassembly Water

instructions.

Cold deionized or reverse osmosis water should be used, as temperatures above 140°F

Warning: All non-sterile devices must be cleaned and sterilized before use.

(60°C) will coagulate proteins, rendering them difficult to remove from contaminated

Warning: Reusable instruments must be cleaned directly after usage.

items. Detergent

Warning: Users have to ensure the cleanliness of the cannulation of the instrument

Prepare detergent (i.e., LIQUI-NOX®, Alconox, Inc. 8.5 pH) per manufacturer

pre-, inter- and post-operatively to make sure that bone debris does not accumulate

recommendations. Enzymatic

Prepare enzymatic cleaner (i.e., ENDOZIME®, Ruhof Corporation 6.0-7.5 pH) per

Cleaner

manufacturer recommendations.

Manual

Brushes and/or Pipe Cleaners, Syringes, Gloves, Absorbent Disposable Cloth (i.e.,

Cleaning

and to reduce the risk of instruments binding on the guide/ k-wire. Warning: Products not labelled as sterile are non-sterile. Manual

1.

Disassemble all components as per manufacturer instructions (if appropriate).

Cleaning

2.

Rinse with cold tap water to remove gross contamination.

KIMWIPE®, Kimtech Science).

3.

Bathe in an enzymatic cleaning solution prepared per manufacturer directions fo r

Ultrasonic

Ultrasonic Cleaners should be monitored routinely to ensure they are working

4.

Cleaner

properly.

Accessories

5 minutes. narrow lumens with enzymatic cleaning solution using a syringe. 5.

Cleaning/ Disinfection Warnings

Scrub thoroughly with a soft brush and/or pipe cleaner; repeatedly flush any very Rinse with cold tap water for a minimum of one minute; use a syringe to repeatedly flush any very narrow lumens.

When handling sharp instruments use extreme caution to avoid injury: consult with an

6.

Bathe in a detergent solution prepared per manufacturer directions for 5 minutes.

infection control practitioner to develop and verify safety procedures appropriate for

7.

Scrub thoroughly with a soft brush and/or pipe cleaner; repeatedly flush any very

all levels of direct instrument contact.

narrow lumens with detergent solution using a syringe.

Always double-wrap the components in an FDA-cleared CSR wrap or similar type nonwoven, medical grade wrapping material. Flash-autoclaving of individual instruments should be avoided whenever possible. Unwrapped components DO NOT maintain sterility.

8.

Rinse/Flush thoroughly with deionized/reverse osmosis (RO/DI) water.

9.

Sonicate for a minimum of 10 minutes in an enzymatic cleaning solution prepared per manufacturer directions.

10. Rinse/Flush thoroughly/ with RO/DI water. 11. Dry with a clean, soft, absorbent, disposable cloth.

Clean instruments as soon as possible after use. Do not allow blood or debris to dry on the instruments. If cleaning must be delayed, place groups of instruments in a covered container with

12. Visually inspect for cleanliness. All visible surfaces, internal and external, should be visually inspected. If necessary re-clean until it is visibly clean.

cold water or an appropriate detergent or enzymatic solution to delay drying. Clean all instruments

Note: Brushes (i.e., pipe cleaners) can be used for cleaning most lumens, however, the

whether or not they were used or inadvertently contacted with blood or saline solution.

use of a syringe to flush narrow lumens is recommended.

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Automated

Pre-Cleaning

Automated

Thermal Disinfection

Cleaning

Both manual pre-cleaning and automated cleaning must be performed prior to

Cleaning

A thermal disinfection at ≤95°C is recommended and should take place according to

sterilization. A soft nylon brush (not a metal brush) should be used to remove visible

the A0 concept.

impurities. A brush or syringe can be used to clean the cannulated parts and/or

General Recommendations for the Automatic Cleaning Cycle

complex surfaces. The aim of pre-cleaning is to reduce the number of microorganisms, prevent any

Phase

pathogenicity that may result and facilitate subsequent cleaning. It should also protect personnel when handling instruments and avoid contamination of the environment. All

Pre-wash 1

Phase Time

Water Type &

Detergent Type

(Minutes)

Temperature

and Concentration

≥2 min

Tap or Purified

N/A

<45°C

reusable instruments must be manually cleaned and treated in a washer-disinfector. Pre-cleaning is carried out by immersing the instruments in a neutral or alkaline

Cleaning Step

≥10 min

Tap (≤60°C)

enzymatic cleaning solution that contains neither aldehyde nor ethanol. All parts of the Rinse 1

≥2 min

The use of brushes is permitted for cleaning the parts from all contamination. The instruments should then be carefully rinsed. Automated Cleaning Dried-on or fixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Consequently, no fixing pre-cleaning temperatures >45°C should be used and no fixing disinfectants (active substance basis: aldehyde, alcohol) should be

Alkaline Detergent (pH: ≤11)

instruments must be covered. The duration depends on the manufacturer's specifications for the product used.

Enzymatic and

≥ Room

N/A

Temperature Rinse 2 with Thermal Disinfection Drying

≥15 min with a minimum of 3 min

Purified water

N/A

80 ± 5°C

N/A

at 93°C ≥20 min

used. Only chemicals that have been tested and approved (e.g., FDA, VAH, CE marking) and recommended by the chemical manufacturer with regard to material compatibility may be used. It is recommended to use a cycle in which in the first step the instruments are rinsed with deionized water at a temperature of ≤ 45°C (no fixing pre-cleaning temperatures). The cleaning step should include washing with an alkalotic, enzymatic cleaning solution at a maximum of 60°C and a pH of ≤ 11.00. The cleaning solution selected should be

Adhering residual soiling is fixed during further treatment and may not be removable in later reprocessings. It also promotes the formation of corrosion and forms a potential source of germs. Residual contamination can impair the sterility of the entire sterilization batch and hinder the functioning of the instrument. Check each instrument for cleanliness (recommended: illuminated magnifier with 3.5x magnification) and, in the event of any abnormalities, subject it to renewed cleaning and disinfection.

approved for medical use and should have no known residual toxicity to the patient. The cleaning cycle must include a final rinse with purified water (deionized water). Time, water flow, and rinse volume must be sufficient to remove all cleaning solution residues on the product surface. Instruments should be dried carefully to avoid contamination.

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Automated Cleaning

To minimize damage, the following should be done: The cleaning conditions validated by Tornier are listed in the following table: Step

• For devices with hinged/mated surfaces or moving components, a biocompatible, surgicalgrade lubricant intended for heat sterilized medical instruments (Miltex® Spray Lubrication or equivalent) should be used per the manufacturer’s guidelines. Apply spray lubricant to the

Cleaning

Cleaning

Agent

Agent Type

Conc.

pH

Temp(°C) Dwell Time

moving components and/or hinged/mated components where appropriate prior to the sterilization process. Particular attention should be paid to:

Pre-Rinse Tap or

Room

Purified

≥ 2 min

Temperature

• Recessed features (Holes, textured surfaces, and cannulations); • Features where soil may be impacted into the device, such as drill flutes adjacent to the

Water

cutting tip and sides of teeth on broaches and rasps;

Cleaning

Neodisher

Alkaline/

0.5%

10.4 –

Step

MediClean

Enzymatic

V/V

10.8

55 ± 5°C ≥10 min

• Cutting edges should be checked for sharpness and damage; • Mating devices should be checked for proper assembly. instruments with moving parts should be operated to check correct operation (medical grade lubrication suitable for steam

Forte

sterilization can be applied as required). Rotating instruments, such as multiple use drill bits

Rinsing 1 Tap or

≥ 2 min

and reamers, should be checked for straightness. This can be achieved by simply rolling the

Purified

instrument on a flat surface.

Water

Note: Wright Medical does not define the maximum number of uses appropriate for reusable

Purified

≥ 15 min

Rinsing 2 Water

with minimum at 93°C for 3 min.

Drying

• Soil “traps” such as mating surfaces, hinges, shafts, rotating gears, and lumens;

N/A

80 ± 5°C

≥ 20 min

instruments. The useful life of these devices depends on many factors, including the method and duration of each use and the handling between uses. For devices that are impacted during the surgical procedure, check that the device is not damaged to the extent that it malfunctions or that burrs have been produced that could damage tissues or surgical gloves. Careful inspection and functional testing of the instrument before use is the best method of determining the end of serviceable life. Packaging Wright Medical instrument cases are intended to protect instrumentation during shipping. Health care personnel bear the ultimate responsibility for ensuring that any packaging method

Caution: Inspection, Maintenance, and Testing

or material is suitable for use in sterilization processing and sterility maintenance in a particular

Warning: Ensure that drilling and cutting tools are sharp.

health care facility. Testing should be conducted in the health care facility to assure that

Before and during the surgical procedure, ensure that all components prepared for the

conditions essential to sterilization can be achieved. Wright Medical does not accept

procedure function correctly with each other.

responsibility or liability arising from a lack of cleanliness or sterility of any medical devices

The design of the Instrument must not be modified in any way.

supplied by Wright Medical that should have been cleaned and sterilized by the end user.

Surgical instruments and instrument cases are susceptible to damage from prolonged use and through misuse or rough handling. Care must be taken to avoid compromising their exacting performance.

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Sterilization

Avoid contact with hard objects that may cause damage. These recommendations have been

Instruments containing UHMWPE (Ultra high molecular weight polyethylene) cannot be steam sterilized, as heat is detrimental to the plastic. These instruments should be sterilized by ethylene oxide (ETO) or other validated sterilization methods. Wright Medical instruments labeled as non-sterile must be thoroughly cleaned and packaged appropriately for sterilization. The package must permit contact of the sterilant with the item, while also serving as a barrier to microorganisms during any storage period. Users should wear non-linting gloves, i.e., Latex

developed and validated using specific equipment. Due to variations in environment and equipment, it must be demonstrated that these recommendations produce sterility in your environment. If processing conditions, wrapping materials, or equipment changes occur, the effectiveness of the sterilization process must be demonstrated. Disposal There are no special disposal instructions, please follow local hospital disposal instructions.

or Nitrile, when handling reusable instruments, to minimize bioburden and particulates. Inspect the product packaging for tears, holes, moisture, or other defects. If these concerns are present, segregate these items and reprocess them.

C. STORAGE CONDITIONS

Steam Sterilization

Surgical instruments that will not be utilized within a short time and will not be immediately returned to The minimum recommended steam sterilization conditions for Wright Medical reusable

Wright Medical, should be stored clean, decontaminated, and completely dry. The packaging that items

instruments are as follows:

are sterilized in may offer an effective barrier to prevent contamination of the item. Those items, in a

1.

Double wrap the component in an FDA-cleared CSR wrap or similar type non-woven

sealed paper or polyethylene Tyvek® pouch, may be stored in a sealed polyethylene bag and sterilized at

medical grade wrapping material.

a later date. All instruments returned to Wright Medical must be cleaned and decontaminated before

Ensure that the sterilizing agent has access to all external and internal surfaces (e.g., by

shipping. The four main types of packaging for steam sterilization consist of textiles, nonwovens, pouch

opening valves, screws, suitable packaging).

packaging, and rigid container systems. These packaging types offer various levels of protection from

3.

Do not exceed maximum loading configuration.

contamination, which must be consistent with the final intent of the item.

4.

Autoclave according to one of the following options:

2.

Option 1

D. ADDENDUM

Steam Sterilization Cycle Type

Parameter

Minimum

Prevacuum

Exposure Temperature

269.6˚F (132˚C)

Exposure Time

4 minutes

Dry Time

≥ 20 minutes

Option 2

Please consult the addendum (IFU-010) on www.ifu.stryker.com to identify substance(s) defined as carcinogenic, mutagenic and/or toxic to reproduction (CMR), and/or endocrine disrupting substance, if present. The presence of CMR and/or endocrine disrupting substance(s) is identified on the product label.

E. REFERENCES ISO 17664 Sterilization of medical devices – Information to be provided by the manufacturer for the

Steam Sterilization

processing of resterilizable medical devices. ISO 17665 Sterilization of Health Care Product – Moist heat.

Cycle Type

Parameter

Minimum

Prevacuum

Exposure Temperature

273.2˚F (134˚C)

Exposure Time

3 minutes

healthcare facilities: A guide for device manufacturers. AAMI TIR 30 A compendium of processes,

Dry Time

≥ 20 minutes

materials, test methods, and acceptance criteria for cleaning reusable medical devices.

ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. AAMI TIR 12 Designing, testing and labeling reusable medical devices for reprocessing in

5. After sterilization, remove the component from its wrapping using accepted sterile technique with powder-free gloves.

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