Cleaning, Sterilization, Inspection for Orthopaedic Medical Devices LSTPI-B Rev2 Aug 2012

Contents 1. Introduction Warnings and Precautions 2. Processing Instructions 3. Cleaning Inspection 4. Packaging 5. Sterilization 6. Storage Before Use 7. References

2

Page 3 3 4 5 8 8 9 11 11

1. Introduction This document is intended to provide detailed instructions for processing reusable surgical instruments manufactured by Stryker Orthopaedics. All Stryker Orthopaedics reusable instruments must be cleaned and sterilized to prepare them for use. This document also gives instructions for inspection to determine when an instrument has reached the end of its serviceable life and must be replaced. This document provides assembly and disassembly instructions for multicomponent instruments which must be disassembled prior to cleaning and sterilization.

Stryker Orthopaedics has validated the processes provided in these instructions to be capable of being effective. Equipment, operators, cleaning agents and procedures all contribute to the efficacy of the processing. The healthcare facility should ensure that the selected processing steps are safe and effective. Alternative methods of processing outside the scope of this document may be suitable for reprocessing; however, these must be validated by the end user. In the event of conflicting national cleaning and sterilization requirements, these shall prevail over Stryker Orthopaedics recommendations.

Warnings and Precautions Single use devices should not be reused, as they are not designed to perform as intended after the initial use, unless they are reprocessed by a reprocesseor expressly authorized by stryker. Only then can it be assured that the device is appropriate for reprocessing, and that the correct method and validation is used. Some devices may develop changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re-sterilization that may compromise the integrity of the design and/or material leading to diminished safety, performance and/or compliance with relevant specifications. Please refer to the device label to identify single or multiple use devices and components.

Stryker Orthopaedics reusable instruments are not normally used in surgical procedures where they contact TSE infective tissue (Transmissible Spongiform Encephalophaties) as defined by the World Health Organization (WHO). Therefore decontamination procedures with highly aggressive agents [i.e. sodium hydroxide(NaOH) or sodium hypochloride (NaOCl)] are not necessary and, for normal processing, are not recommended because material degradation may occur. The sterilization parameters recommended in this document are not intended and not suitable for inactivation of prions.

3

2. Processing Instructions The sequence of steps required to prepare re-usable instruments for re-use or to prepare new devices for initial use are summarized in the chart below. More detailed instructions for each step are given on the following pages.

Point of Use

Remove gross soil

Transport to Processing Area

Avoid damage Minimize time before cleaning

Preparation for Cleaning

Disassemble as required

Manual

Automatic

Manual Pre-Cleaning

Soak in enzymatic solution 15 minutes (minimum) Rinse using agitation under the water level

Manual Cleaning

Soak in ultrasonic bath 20 minutes (minimum) Brush, Operate Rinse using agitation under the water level

Pre-Cleaning

Soak in ultrasonic bath 20 minutes (minimum) Brush, operate Rinse using agitation under the water level

Washer Disinfector

Wash 93°C (200°F) 10 minutes (minimum) Rinse Dry

Inspection

Check soil “traps” Check operation Check straightness Check for damage

Sterilization

Suitable packaging Steam sterilizer

Storage

Control environment Control storage time

4

3. Cleaning Two methods of cleaning Stryker Orthopaedics re-usable instruments are provided in these instructions, a manual method and a method using an automated washer disinfector. Whenever possible the automated method should be used. The automated cleaning process is more reproducible and, therefore, more reliable, and staff are less exposed to the contaminated devices and the cleaning agents used. Whichever method is used, staff should use suitable protective clothing and equipment at all times. In particular, take note of the instructions provided by the cleaning agent manufacturer for correct handling and use of the product. The guidance provided by the detergent manufacturer concerning concentrations and temperatures shall be observed. If these concentrations and temperatures are exceeded significantly, discoloration or corrosion could occur with some materials. This could also happen if rinsing after cleaning and/or disinfecting is insufficient. For cleaning or disinfecting re-usable instruments, only specifically formulated cleaning agents and/or disinfectants should be used.

Caution: Stryker Orthopaedics trays and cases are intended for transport and storage of re-usable instruments. They are not designed for cleaning and disinfection in the fully assembled state. The instruments must be removed from the tray for adequate cleaning results. Point of use

After use (within a maximum of 2 hours post-operatively) remove gross soil using absorbent paper wipes. Intensive rinsing of the re-usable instruments with fluent water or transfer of the medical devices into a bath with an aldehydefree disinfectant solution is highly recommended. Transport to processing area

Avoid mechanical damage by ensuring that heavy devices do not get mixed with delicate ones. Pay particular attention to cutting edges, both to avoid personal injury and prevent damage to the re-usable instrument. Transport the re-usable instruments to the point where cleaning is to be performed as soon as practical. If transfer to the processing area is likely to be delayed, consider covering the re-usable instruments with a damp cloth to avoid drying of soil.

As not all cleaning agents and disinfectants may be available around the globe, Stryker Orthopaedics does not recommend any specific cleaning and/or disinfection agent.

Preparation for cleaning

The quality of the water used for diluting cleaning agents and/or disinfectants and for rinsing re-usable instruments should be carefully considered. Application of freshly prepared purified water/highly purified water or sterile water for rinsing purposes with less than 100 cfu/ml and 0.5 EU/ml is highly recommended. Mineral residues from hard water, as well as higher contamination with microorganisms and endotoxins, can result in staining of the device or prevent effective cleaning and decontamination.

Pre-Cleaning

Disassemble instruments as required. Specific instructions for instruments that require disassembly are provided in Appendix 1.

The pre-cleaning step can be omitted in case of direct subsequent manual cleaning and disinfection. In the event that highly contaminated re-usable instruments are to be subjected to an automatic cleaning process, pre-cleaning in an ultrasonic bath is recommended.

5

Equipment required: • Cleaning bath or vessel large enough to allow complete immersion of the instruments • Freshly prepared cleaning solution using a cleaning agent intended for manual cleaning • Brushes – soft and firm, bottle brushes or cleaning wires for cannulations • Personal protective equipment as recommended by the cleaning agent supplier • Absorbent paper • Syringes (volumes 1 to 50 ml depending on the size of the channels to be rinsed) Caution: Never use metal brushes or steel wool for cleaning.

3. Cleaning Pre-Cleaning • • • •

•

•

Remove gross soil using wipes and solution of cleaning agent. Immerse re-usable instrument in solution of cleaning agent. Ensure that all surfaces are thoroughly wetted. Use a syringe to ensure that the cleaning solution reaches all parts of cannulations. Ensure that air is not trapped within features of the device when immersing in the solution. Soak for minimum recommended time by the detergent manufacturer’s instructions.

•

•

•

•

Using suitable soft bristle brushes, clean the re-usable instrument thoroughly, paying particular attention to rough surfaces and features where soil may be impacted or shielded from the cleaning process. Use a firm bristle brush for cleaning bone-cutting features such as drill tips, reamer flutes and the teeth of broaches. Use a bottle brush of appropriate diameter and length for cannulations. Ensure that the brush passes the whole length of each cannulation. Operate articulating devices and those with moving parts.

Manual cleaning and disinfection Equipment required: • Ultrasonic bath large enough to allow complete immersion of the re-usable instrument. (A frequency of 25 – 50 kHz is recommended. Do not exceed the temperature stated by the detergent manufacturer.) • Cleaning agent intended for manual cleaning and suitable for ultrasonic treatment. Do not exceed the concentration specified by the detergent manufacturer. • Suitable brushes or cleaning wires to reach all parts of the device. • Syringes (volumes 1 to 50 ml depending on the size of the channels to be rinsed) • Fresh purified water, highly purified water or sterile water for rinsing purposes.

Procedure: • Prepare an ultrasonic bath with a cleaning solution at the concentration and temperature specified by the detergent manufacturer. • Immerse the device completely and activate the bath for minimum of 15 minutes. • Using suitable brushes or cleaning wires, clean the device paying particular attention to rough surfaces and features that may be shielded from the brushing action. • Rinse for at least 1 minute in running water until all traces of cleaning solution are removed. Pay particular attention to cannulations, blind holes, hinges, and joints between mating parts. Rinse cannulations at least three times with a syringe (volume 1-50ml). • If, after completion of the cleaning step in the ultrasonic bath, encrusted soil remains on the device, the cleaning step must be repeated as described above.

6

• •

•

•

Rinse in running water until all traces of cleaning solution are removed. Pay particular attention to cannulations and blind holes, as well as hinges and joints, between mating parts. Visually inspect for any remaining soil and repeat the steps above if necessary. Allow to drain on absorbent paper or transfer immediately to cleaning step.

3. Cleaning Disinfection Equipment required: • Bath large enough to allow complete immersion of the re-usable instrument, temperature according to detergent manufacturer’s instructions. • Disinfectant intended for manual disinfection and compatible with the applied cleaning detergent; concentration according to the detergent manufacturer’s instructions. • Syringes (volumes 1 to 50 ml depending on the size of the channels to be rinsed). • Freshly prepared purified water/ highly purified water or sterile water for rinsing purposes. • Filtered medical compressed air (if available) or clean and lint-free single use wipes.

Procedure: • Prepare a bath with a disinfectant solution at the concentration and temperature specified in the detergent manufacturer’s instructions. • Immerse the device completely for at least the time specified in the detergent manufacturer’s instructions. • Rinse cannulations at least three times with a syringe. • Rinse for at least 1 min in running water of the specified quality until all traces of disinfectant solution are removed. Pay particular attention to cannulations and blind holes as well as hinges and joints between mating parts. Rinse at least five times with a syringe (volume 1-50ml).

•

•

•

Dry the re-usable instrument using filtered, compressed air or clean, lintfree wipes If additional drying is required, arrange instruments in a clean area or heat in an oven below 110°C. Visually inspect and repeat complete manual cleaning and disinfection if necessary.

Automated cleaning and disinfection using washer-disinfector Equipment required: • Washer-disinfector with fundamentally approved efficiency (e.g. CE mark or FDA approval according to ISO 15883), properly installed, qualified and regularly subjected to maintenance and testing. • Approved thermal disinfection Program with sufficient rinsing steps (A0 value > 3000 or application of at least 5 min at 90 °C). Caution: Chemical disinfection programs are not recommended due to the potential for chemical residues to remain on the instruments. These residues could interfere with sterilization efficacy.

•

Cleaning agent intended for use in washer-disinfector. Do not exceed the concentration and temperature recommended by the detergent manufacturer.

Procedure: • Load the re-usable instruments into the washer-disinfector. • Connect cannulations to the rinsing ports of the washer-disinfector. If no direct connection is possible, locate the cannulations directly on injector jets or in injector sleeves of the injector basket. • Avoid contact between devices as movement during washing could cause damage, and washing action could be obstructed. • Arrange re-usable instruments so that cannulations are not horizontal and blind holes incline downwards to assist drainage. 7

• • •

•

Articulating devices should be in the open position. Operate the washer-disinfector cycle. Upon completion, unload the washer-disinfector. Visually inspect each device for remaining soil and dryness. If soil remains repeat the cleaning process. Remaining wetness may be removed with filtered, compressed air or clean, lint-free wipes. If additional drying is required, arrange instruments in a clean area or heat in an oven below 110°C.

3. Cleaning Inspection Before preparing for sterilization, all re-usable instruments should be inspected. Generally un-magnified visual inspection under good light conditions is sufficient. All parts of the devices should be checked for visible soil and/or corrosion.

Functional checks should be performed at all times: • •

Particular attention should be paid to: • • •

• •

Soil “traps” such as mating surfaces, hinges, shafts of flexible reamers. Recessed features (holes, cannulations). Features where soil may be impacted into the device, such as drill flutes adjacent to the cutting tip and sides of teeth on broaches and rasps. Cutting edges should be checked for sharpness and damage. For devices that may be impacted 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.

•

•

Mating devices should be checked for proper assembly. Instruments with moving parts should be operated to check correct operation (medical grade lubricating oil suitable for steam sterilization can be applied as required). Rotating instruments, such as multiple use drill bits, and reamers, should be checked for straightness. This can be achieved by simply rolling the instrument on a flat surface. “Flexible” instruments should be checked for damage to the spiral element.

4. Packaging Where appropriate, the cleaned, disinfected, and checked re-usable instruments should be assembled into the dedicated trays provided. Stryker Orthopaedics cases/trays should be double wrapped according to AAMI/ CSR technique. The packaging for terminally sterilized re-usable instruments should meet the following requirements: • • • •

ISO 11607-1 CE Mark or FDA clearance Suitable for steam sterilization Grade appropriate for weight of instrument case

8

Note: Stryker Orthopaedics does not define the maximum number of uses appropriate for re-usable instruments. The useful life of these devices depends on many factors, including the method and duration of each use, and the handling between uses. Careful inspection and functional test of the instrument before use is the best method of determining the end of serviceable life.

5. Sterilization Sterilization Steam autoclave (moist heat) sterilization using a pre-vacuum (forced air removal) cycle is recommended. Autoclaves should comply with the requirements of, and be validated and maintained in accordance with EN 285, EN 13060, EN ISO 17665, and ANSI/ AAMI ST79. Stryker Orthopaedics has validated an autoclave cycle for sterilization of complete re-usable instrument cases/ trays. Instruments shall be sterilized in the assembled state as stored on the tray (i.e.: if the brackets or recessions in the tray are designed to accommodate multi-component instruments in their assembled state, there is no need to disassemble these instruments for sterilization.) The process parameters shown at the right are validated and recommended by Stryker Orthopaedics for sterilization. Caution: Stryker Orthopaedics does not recommend the use of ‘flash’ sterilization for re-usable instruments.

USA

Method

Moist heat sterilization according to ANSI/AAMI ST 79

Cycle

Pre-Vacuum (Pre-Vac)

Temperature

132°C (270°F)

Exposure Time1

4 minutes (minimum)

Drying Time²

30 minutes (minimum, in chamber)

Outside USA

Method

Moist heat sterilization according to ISO 17665

Cycle

Saturated steam with fractional forced air removal

Temperature

132-137°C (270-277°F)

Exposure Time1

4 minutes (minimum)

Drying Time²

30 minutes (minimum, in chamber)

Warning: Single-use implants and instruments should not be re-sterilized. Warning: Stryker Orthopaedics does not recommend the use of rigid containers for steam sterilization. This configuration could limit steam penetration and prevent effective sterilization of the instruments.

1 E xposure time:

Period for which the load and entire chamber is maintained at the sterilization temperature. ² D  rying time: Period during which steam is removed from the chamber and the chamber pressure is reduced to permit the evaporation of condensate from the load either by prolonged evacuation or by the injection and extraction of hot air or other gases. The drying time varies due to load configuration, wrapping method and material.

9

6. Storage before Use After sterilization, re-usable instruments should be stored the in the sterilization wrap in a dry and dust-free place. The shelf life is depending on the sterile barrier employed, storage manner, environmental conditions and handling. A maximum shelf life for sterilized re-usable instruments before use should be defined by each health care facility.

10

7. References 1.

ISO 11607: Packaging for terminally sterilized re-usable instruments

2.

ISO 17665: Sterilization of health care products, moist heat

3.

ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities

4.

ISO 17664: Sterilization of re-usable instruments Information to be provided by the manufacturer for the processing of resterilizable re-usable instruments

11

Appendix 1: Instruments Requiring Disassembly for Cleaning Total Hip Arthroplasty Instruments

Catalog Number

Instrument Name

Surgical System

6278-1-100

Version Control Stem Inserter

Restoration Modular

Depress the circular button on the body of the impactor and pull away from stem inserter

6266-0-140

Head Impactor

Restoration Modular Accolade

Unthread the white plastic tip in a counter-clockwise manner to separate the impactor tip from the handle

6260-4-070

Proximal Body Steady Handle

Restoration Modular

Unthread the white plastic tip in counter-clockwise manner to separate the impactor tip from the handle

1104-1000

Femoral Head Impactor

Cutting Edge Advantage

Unthread the black plastic tip in counter-clockwise manner to separate the impactor tip from the handle

1235-0-008

ADM Press

ADM MDM

Unthread the black handle in counter-clockwise manner to separate the handle from the press

2102-0410

Acetabular Reamer Handle

Trident

Remove white plastic sleeve by pulling it up and over the end of the shaft

1126-XXXX

Cutting Edge Broach

Cutting Edge

Unthread the cylindrical or tapered distal extensions from the broach in counter-clockwise manner

6278-9-070

Body/Stem Separator

Restoration Modular

2199-20xx

Constrained Liner Inserter Impactor Tip

Trident

6278-1-200D

Distal Stem Inserter

Restoration Modular

12

Disassembly Instructions

1) Unthread the split collet from the puller by twisting the collet in a clockwise manner 2) Unthread the jackscrew from the puller by twisting the jackscrew in a counter-clockwise manner

Unthread the metal adapter from the plastic impactor tip by turning it counter-clockwise

1)Unthread the handle from the outer sleeve by twisting the outer sleeve in the direction of the arrows laser marked on the instrument while holding the flats on the outer sleeve. Note: Threads between the handle and outer sleeve are left-handed. 2)Remove the threaded rod from the outer sleeve by holding the hex end and sliding the threaded rod from the outer sleeve.

Appendix 1: Instruments Requiring Disassembly for Cleaning Total Knee Arthroplasty Instruments

Catalog Number

Instrument Name

Surgical System

Disassembly Instructions

6776-8-210

Stem Punch Extractor

Duracon Xcelerate

Remove the hammer from the handle by sliding the hammer off the handle

6778-6-xxx

Offset Adaptor Trials Scorpio TS

Remove jam nut by turning it counter-clockwise to separate it from the offset adaptor body Disassemble locking knob by turning it counterclockwise to separate it from the fixture body

8200-0043

Scorpio Tibial Offset Fixture

6776-8-010

Tibial Impactor

MRH

Disassemble plastic tip by turning it counter-clockwise to separate it from instrument body

6633-9-995

Tibial Offset Fixture

Duracon TS

Disassemble locking knob by turning it counterclockwise to separate it from the fixture body

80501060L/R

MIS Tibial Resection Guides

Scorpio MIS

Disassemble locking knob by turning it counterclockwise to separate it from the fixture body

Surgical System

Disassembly Instructions

Trauma Instruments

Catalog Number

Instrument Name

Turn the knob clockwise, as described by the arrow indicating “tighten”, until it spins freely 6704-9-320

Single-Sided Tensioner

Dall-Miles

Twist nose counter-clockwise to remove. (The nose is the silver portion that threads into the green body)

6704-9-350

Double-Sided Tensioner

Dall-Miles

Turn knob clockwise to release the jaws in the tensioner heads from the studs. Turn tensioner head clockwise until they are removed from the device

6704-9-720

Grip Impactor

Dall-Miles

Unthread the white plastic tip in a counter-clockwise manner to separate the impactor tip from the handle

6704-9-420

Cutter

Dall-Miles

Using a wrench, turn the retaining nut loose and remove. Twist tip counterclockwise to unthread the plunger and outer sleeve from the Cutter body

13

Appendix 1: Instruments Requiring Disassembly for Cleaning Upper Extremity Instruments

Catalog Number

Instrument Name

Surgical System

5901-1111

Extramedullay Resection Guide

ReUnion Primary Humeral

5901-0032

Glenoid Impactor

Completely unthread knob from proximal resection guide Unthread impactor tip from impactor shaft

ReUnion Self Pressurizing Glenoid

5901-0029

Peg Locating Pin

5900-0060

Humeral Neck Resection Guide

5900-0020

Humeral Head Impactor

5900-8124 5900-8128

Bone Graft Remover

5100-3600 5100-3601

Torque Limiting Driver

5100-4402 5100-4403

Humeral Drill Guide

5100-3302 5100-3303

Disassembly Instructions

Slide the locating pins along their axis out of the holes in the drill guide Unthread the handle/knob from the resection guide

Solar Total Shoulder

Unthread the impactor tip from the impactor handle

ReUnion Facture Humeral stem

Slide the bone graft remover from the central hole of the bone graft cutting handle Pull hex bit from handle

Solar Total Elbow

Humeral Cutting Guide

Unthread the smaller diameter knob only from the assembly

Unthread both knobs from the assembly

14

Notes

15

Legal Manufacturer Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 t: 201 831 5000

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. The products depicted are CE marked according to the Medical Device Directive 93/42/EEC. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Accolade, ADM, Cutting Edge, Dall-Miles, Duracon, MDM, Restoration, ReUnion, Scorpio, Solar, Stryker,Trident, Xcelerate. All other trademarks are trademarks of their respective owners or holders. Literature Number  : LSTPI-B Rev.2 MS/GS 08/12 Copyright © 2012 Stryker

EC Representative Stryker France ZAC Satolas Green Pusignan Avenue de Satolas Green 69881 - MEYZIEU Cedex, France