Manual Orthopaedic Surgical Instruments Rev 5

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Manual

Orthopaedic

Surgical

Instruments

Instructions for Care, Cleaning, Maintenance and Sterilization

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

1. PURPOSE

These instructions are recommended for the care,

cleaning, maintenance and sterilization of reusable

Zimmer orthopaedic manual surgical instruments. This

document is intended to assist health care personnel

in safe handling practices, effective reprocessing and

maintenance of Zimmer reusable devices. It provides

information complementary to the instructions for use

in fulfillment of ISO 17664, ANSI/AAMI ST81, and the

European Council Directive 93/42/EEC, Annex 1, section

13.6 (h).

The instructions are intended to assist the hospital and

central supply management in developing procedures

for safe and effective reprocessing of Zimmer instrument

sets.

Hospital personnel, including those in receiving and

central sterile supply departments (CSSD), as well as

in the operating room (OR), may be directly involved

in handling instruments purchased from Zimmer or

on a loan basis as consignment instruments. Hospital

directors and other management in each of these

departments should be informed of these instructions

and recommendations to ensure safe and effective

reprocessing and to prevent damage or misuse of

reusable devices.

2. SCOPE

This instruction manual provides information on

the care, cleaning, disinfection, maintenance

and sterilization of manual surgical instruments

and is applicable to all reusable medical devices

manufactured and/or distributed by Zimmer, Inc.

This information is also applicable to single-use

medical devices manufactured by Zimmer that are

supplied non-sterile but are intended to be used in

a sterile state. These devices are single-use but can

be resterilized if not used (e.g. screws, plates, etc.).

This also includes single-use devices packaged and

sold sterile but removed from packaging and placed

in kits.

Note: not used refers to those single-use components that have not been in 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

or resterilized and must be discarded.

Devices that cannot be reused may be labeled with

the following symbol:

Do not reuse

This information is not applicable to singleuse devices that are sold sterile and cannot be

resterilized (e.g. osteotome blades).

Devices that cannot be resterilized may be labeled

with the following symbol:

Do not resterilize

This instruction manual is not applicable to air

driven or electrically powered equipment. However,

it is applicable to functional attachments (e.g.

reamers and drill bits) that are connected to

powered equipment for use.

Powered devices included in a manual device

case must be cleaned per specific manufacturer’s

instructions (e.g. Brasseler powered hand pieces).

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

3. GLOSSARY

Chemical: a formulation of compounds intended for use in

reprocessing.

Note: Chemicals include detergents, surfactants, rinse aids,

disinfectants, enzymatic cleaners and sterilants.

Cleaning: the removal of contamination from an item to the

extent necessary for further processing or for the intended use.

Tray: basket, with or without a lid, that has perforated sides

or bottom, that holds instruments, and that is either enclosed

in sterilization wrap or a pouch or placed inside a container for

sterilization.

Washer/disinfector: a machine intended to clean and disinfect

medical devices and other articles used in the context of

medical, dental, pharmaceutical, and veterinary practice.

Contaminated: State of having been actually or potentially in

contact with microorganisms or infectious particles.

4. ACRONYMS

Containment device (case): reusable rigid sterilization container,

instrument case/cassette, or organizing tray and any reusable

accessories intended for use in health care facilities for the

purpose of containing reusable medical devices for sterilization.

BI = biological indicator

Decontamination: the use of physical or chemical means to

remove, inactivate, or destroy blood-borne pathogens on a

surface or item to the point where they are no longer capable

of transmitting infectious particles and the surface or item is

rendered safe for handling, use, or disposal.

OR = operating room

Disinfection: process used to reduce the number of viable

microorganisms on a product to a level previously specified as

appropriate for its further handling or use.

Note: Cleaning and disinfection are often conducted in the

same step (e.g. washer/disinfector equipment).

CJD = Creutzfeldt-Jakob Disease

CSSD = Central Sterile Supply Department

PPE = personal protective equipment

SAL = sterility assurance level

TSE = Transmissible Spongiform Encephalopathy

5. SYMBOLS

Do not reuse

Manual cleaning: cleaning without the use of an automated

washer or washer/disinfector.

Processing/reprocessing: activity including cleaning,

disinfection and sterilization, necessary to prepare a new or

used medical device for its intended use.

Reusable rigid sterilization Container: sterilization containment

device designed to hold medical devices for sterilization,

storage, transportation, and aseptic presentation of contents.

Consult instructions

Do not resterilize

Sterile: free from all viable microorganisms.

Sterilization: a validated process used to render a device free

from all forms of viable microorganisms.

Note: In a sterilization process, the nature of microbiological

death is described by an exponential function. Therefore, the

presence of microorganisms on any individual item may be

expressed in terms of probability. While this probability may be

reduced to a very low number, it can never be reduced to zero.

This probability can only be assured for validated processes.

Caution or Instructions for Use

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

6. CONSIDERATIONS

This instruction manual pertains to all hip, knee, trauma,

and extremity reusable medical devices manufactured

and/or distributed by Zimmer, Inc. This manual also

pertains to all hip, knee, trauma, and extremity single-use

medical devices manufactured by Zimmer that are supplied

nonsterile but are intended to be used in a sterile state.

This manual does not pertain to Zimmer spine or dental

devices. This information should be studied carefully.

This manual supercedes Zimmer, Centerpulse, and Implex

manual orthopaedic instrument reprocessing instructions

and instrument manuals published prior to Revision Date

2013.

The user/processor should comply with local laws and

ordinances in countries where reprocessing requirements

are more stringent than those detailed in this manual.

New and used instruments must be thoroughly processed

according to these instructions prior to use.

During musculoskeletal surgery, instruments become

contaminated from blood, tissue, bone fragments and

marrow. The instruments may also become contaminated

with body fluids containing hepatitis virus, HIV or other

etiological agents and pathogens. All health care workers

should become familiar with the necessary Universal

Precautions of preventing injuries caused by sharp

instruments when handling these devices during and after

surgical procedures and during reprocessing.

However, the next user must also inspect the set upon

receipt to verify that instruments have, in fact, been

adequately cleaned and decontaminated before repeating

reprocessing procedures to prepare the loaner set for

subsequent reuse. Zimmer cannot guarantee that sterility

was attained by the previous user and has been maintained

during transit. Zimmer representatives often open and

inspect instrument sets between users, which will, of

course, compromise cleanliness and sterility and require

complete reprocessing prior to subsequent use. Zimmer

requires certification of cleaning and disinfection prior to

return of loaner sets to Zimmer

This manual includes instructions for Zimmer reusable

devices marked with reprocessing category codes [a,

a+, b, b+, c]. See Section 7 of this manual for further

explanation of reprocessing codes. All Zimmer devices

may be safely and efficiently reprocessed using the manual

or combination manual/automated cleaning instructions

outlined in this manual. The combination with an automated

process is preferable.

Core orthopaedic instrument sets must be complete and in

good condition to be used correctly. Optional devices may

be available on request from your Zimmer representative.

To maintain instruments properly it is important to consider

the following information and processing instructions:

• Warnings and precautions

• Instrument set completeness and functionality

It should be noted that saline and other irrigation fluids

such as Ringers Solution are often used in copious amounts

during surgical procedures and may cause corrosion of the

instruments.

• Reprocessing limitations and or restrictions

Orthopaedic surgery requires instruments which are heavy

and have multiple components, articulating or rotating

parts, removable handles, plastic replacement parts, and

series of gauges or other measuring devices in graduated

sizes. Devices are usually supplied in sets and subdivided

into trays and cases in which the devices may be arranged

by size or in the order needed for a specific surgical

procedure.

• Cleaning, disinfection and drying

Hospitals must assume responsibility for cleaning,

disinfection, packaging and sterilization of all loaner

instrument sets before returning them to Zimmer.

• Preparation for reprocessing at the point of use

• Preparation for cleaning (including assembly/

disassembly as necessary)

• Maintenance, inspection, testing and lubrication

• Sterile packaging

• Sterilization

• Storage

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

7. PROCESSING CATEGORY CODES

The following codes are etched on some devices and case components and provide information useful in the selection

of cleaning agents with appropriate pH as well as indications for disassembly as well as manual reprocessing.

Zimmer recommends that all reusable devices (regardless of etching) be processed in accordance with the manual or

combination manual/automated cleaning instructions contained in this reprocessing instruction.

Note: Codes on trays and cases apply only to those components noted and do not apply to the contents of the tray or

case.

a

Metal devices (excluding aluminum and titanium) and case components without features posing

a cleaning challenge or non-metal/polymer handles, or other components (e.g. retractors,

drills, testing trays, rasps, scissors, clamps, exploring hooks, compression forceps, skin bridge

elevators, guide wires, etc.). These devices are tolerant of alkaline cleaning agents when followed

by acidic neutralization and thorough rinsing. These devices can be cleaned with rust-removal

agents approved for surgical instruments if needed.

a+

Metal devices (excluding aluminum and titanium) and case components with features posing a

cleaning challenge but without non-metal/polymer handles or other components (e.g. drills with

elongated holes, belt tensioning pulleys, bone joint reamers, extractor cases). These devices are

tolerant of alkaline cleaning agents when followed by acidic neutralization and thorough rinsing.

These devices can be cleaned with rust-removal agents approved for surgical instruments if

needed. Features posing a cleaning challenge must be cleaned manually.

b

b+

c

Devices and case components without features posing a cleaning challenge made of polymers or

metal instruments paired with polymer components (e.g. testing trays for flat profiles, chisels with

non-metal handles, awls, dissectors, femur dilatators, pyramidal chisels/rasps). These devices

are tolerant of alkaline cleaning agents when followed by acidic neutralization and thorough

rinsing.

Devices and case components with features posing a cleaning challenge, made of polymers or

metal instruments paired with polymer components (e.g. tibial mallets, flex screwdrivers, tibial

dilatators, etc.). These devices are tolerant of alkaline cleaning agents when followed by acidic

neutralization and thorough rinsing. Features posing a cleaning challenge must be cleaned

manually.

Devices and case components made of titanium or aluminum alloys and/or having assembly/

disassembly or other reprocessing aids (e.g. torque spanners, tibial aiming devices, pad cutters,

instrument cases, trays and sterilization containers). These devices should be cleaned using the

manual or combination manual/ automated cleaning procedures provided in this manual. These

devices should not be exposed to alkaline cleaning agents.

Note: Features posing a cleaning challenge include; lumens/cannulated bores, tightly mated surfaces, rough surfaces,

ball detents, springs, and multiple component designs.

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

8. PROCESSING INSTRUCTIONS

These processing instructions are intended to assist the

hospital and central supply management in developing

procedures to attain safe and effective devices, both

for hospital-owned and for loaned instrument sets. This

information is based on Zimmer testing, experience

and material science, as well as widely accepted

recommendations of the following organizations:

• American National Standards Institute (ANSI)

• American Society for Testing and Materials (ASTM)

• Association for the Advancement of Medical

Instrumentation (AAMI)

• Association for Applied Hygiene (VAH)

• Association of Operating Room Nurses (AORN)

• Canadian Standards Association (CSA)

• Centers for Disease Control (CDC)

• Federal Institute for Drugs and Medical Devices

(BfArM, Bundesinstitut für Arzneimittel und

Medizinprodukte)

• German Instrument Working Group (AKI)

Arbeitskreis Instrumenten-Aufbereitung

• International Standards Organization (ISO)

• International Association of Healthcare Central

Service Material Management (IAHCSMM)

• National Health Service (NHS)

• Robert Koch Institute (RKI)

• Swissmedic

• World Health Organization (WHO)

Note: These instructions describe the necessary

processing steps that new and used instruments must

undergo to attain sterility.

A. Warnings and Precautions

• Universal Precautions should be observed by all

hospital personnel that work with contaminated or

potentially contaminated medical devices. Caution

should be exercised when handling devices with sharp

points or cutting edges.

• Personal Protective Equipment (PPE) should be

worn when handling or working with contaminated

or potentially contaminated materials, devices and

equipment. PPE includes gown, mask, goggles or face

shield, gloves and shoe covers.

• Metal brushes or scouring pads must not be used

during manual cleaning procedures. These materials

will damage the surface and finish of instruments. Softbristled, nylon brushes and pipe cleaners should be used.

• Cleaning agents with low foaming surfactants should be

used during manual cleaning procedures to ensure that

instruments are visible in the cleaning solution. Manual

scrubbing with brushes should always be performed

with the instrument below the surface of the cleaning

solution to prevent generation of aerosols and splashing

which may spread contaminants. Cleaning agents must

be completely rinsed from device surfaces to prevent

accumulation of detergent residue.

• Do not stack instruments or place heavy instruments on

top of delicate devices.

• Dry soiled surgical instruments are more difficult to

clean. Do not allow contaminated devices to dry prior to

reprocessing. All subsequent cleaning and sterilization

steps are facilitated by not allowing blood, body fluids,

bone and tissue debris, saline, or disinfectants to dry on

used instruments.

• Saline and cleaning/disinfection agents containing

aldehyde, mercury, active chlorine, chloride, bromine,

bromide, iodine or iodide are corrosive and should not

be used. Instruments must not be placed or soaked in

Ringers Solution.

• Mineral oil or silicone lubricants should not be used

because they: 1) coat microorganisms; 2) prevent direct

contact of the surface with steam; and 3) are difficult to

remove.

• Only devices manufactured and/or distributed by Zimmer

should be included in Zimmer instrument trays and

cases. These validated reprocessing instructions are not

applicable to Zimmer trays and cases that include devices

that are not manufactured and/or distributed by Zimmer.

• Descaling agents that include morpholine should not be

used in steam sterilizers. These agents leave residue

which can damage polymer instruments over time. Steam

Sterilizers should be descaled in accordance with the

manufacturer’s instructions.

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

B. Receiving Inspection – Instrument set

content and functionality verification.

• Upon receipt in the hospital, instrument sets should

be inspected for completeness. Inspect for thumb,

wing, set, or other types of screws; screw-in or other

detachable handles; and auxiliary exchangeable

parts such as blades, right/left attachments or heads.

Many organizing cases have shadow graphs, outlines,

catalog numbers, and instrument names or sizes silkscreened or otherwise marked on the case or tray.

• Orthopaedic surgical procedures follow a precise

order in which the instruments are used. Also, many

instruments have dimensional features which govern

bone resections, determine implant sizes, and measure

intramedullary canal sizes, depth of drill holes,

angles of tube/plate, acetabular cup placements, etc.

Therefore, it is very important that all requested sizes

of a specific instrument series are available (specific

instruments are routinely omitted from instrument

sets due to infrequent use unless requested by the

user). Contact your Zimmer representative if requested

instruments have been omitted but are required for

surgery.

• Markings on instruments used for measuring

anatomical dimensions must be legible. These

may include gauge markings, angles, inner or outer

diameters, length or depth calibrations, and right/left

indications. Notify your Zimmer representative if scales

and other markings are not legible.

C. Limitations and Restrictions

• Neutral pH, enzymatic, and alkaline (pH ≤12) cleaning

agents are recommended and preferred for cleaning

Zimmer reusable devices. Alkaline agents with pH ≤

12 may be used to clean stainless steel and polymer

instruments in countries where required by law or

local ordinance; or where prion diseases such as

Transmissible Spongiform Encephalopathy (TSE) and

Creutzfeldt-Jakob Disease (CJD) are a concern. It is

critical that alkaline cleaning agents are thoroughly

neutralized and completely rinsed from devices.

Note: Drill bits, reamers, rasps and other cutting devices

should be carefully inspected after processing with alkaline

detergents to ensure that cutting edges are fit for use.

Note: It is important to select enzymatic solutions intended

for breakdown of blood, body fluids and tissues. Some

enzymatic solutions are specifically for breakdown of fecal

matter or other organic contaminants and may not be

suitable for use with orthopaedic instruments.

• Repeated processing, according to the instructions in

this manual has minimal effect on Zimmer reusable

manual instruments unless otherwise noted. End of life

for stainless steel or other metal surgical instruments

is normally determined by wear and damage due to the

intended surgical use and not to reprocessing.

• Automated cleaning using a washer/disinfector alone

may not be effective for complex orthopaedic instruments

with lumens, cannulations, blind holes, mated surfaces

and other features. A thorough, manual or combination

manual/automated cleaning process is recommended.

The combination with an automated process is preferable.

• Where applicable, multi-component instruments should

be disassembled for cleaning. Disassembly, where

necessary, is generally self evident. More specific

instructions can be found in the instructions for use

and at www.zimmer.com. Care must be taken to avoid

losing small parts. If a part is lost, notify your Zimmer

representative when the instrument set is returned.

• At point of use, soiled instruments must be removed from

metal or polymer trays and moistened to prevent debris

from drying before transportation to the reprocessing

area for manual and/or automated cleaning procedures.

Do not clean soiled instruments while in polymer or metal

trays. Instrument trays, cases and lids must be cleaned

separately from soiled instruments.

• Non-sterile, single-use plate and screw implants should

not be cleaned but must be returned to the tray or caddy

for sterilization.

Note: Any unused, single-use device that has been

exposed to blood, bone, tissue or body fluids must not be

reprocessed or resterilized and must be discarded.

• Polymers used in Zimmer instrument sets can be

sterilized using steam/moist heat. Polymer materials

have a limited useful life. If polymer surfaces turn

“chalky,” show excessive surface damage (e.g. crazing

or delamination), or if polymer devices show excessive

distortion or are visibly warped, they should be replaced.

Notify your Zimmer representative if polymer devices

need to be replaced.

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

• Most currently available polymers will not withstand

conditions in washers/sterilizers that operate at

temperatures equal to or greater than 141°C / 285°F,

and use live-steam jets as cleaning features. Severe

surface damage to polymer devices may occur under

these conditions.

• Soaking in disinfectants may be a necessary step to

control certain viruses. However, these agents may

discolor or corrode instruments (household bleach

contains or forms chlorine and chloride in solution and

has a corrosive effect similar to saline). Disinfectants

containing glutaraldehyde, or other aldehydes may

denature protein based contaminants, causing them

to harden and making them difficult to remove. Where

possible, soaking in disinfectants should be avoided.

• Steam/moist heat is the recommended sterilization

method for Zimmer instruments.

• Ethylene Oxide (EO), Gas Plasma Sterilization and dry

heat sterilization methods are not recommended for

sterilization of Zimmer reusable instruments.

• Instruments with removable polymer sleeves must be

disassembled for sterilization (e.g. acetabular reamer

shaft with sleeve, side cutters, etc.)

• During initial steam sterilization runs some

formaldehyde from polyformaldehyde surfaces may

vaporize and become noticeable. This should not

cause concern. After a few sterilization cycles, the odor

should be no longer evident.

• While ethylene oxide sterilization may prolong the

service life of certain polymers (e.g. polysulfone), this

method of sterilization is not recommended for Zimmer

surgical instruments. Large polyformaldehyde items

(Delrin®, Celcon®) have been found to require excessive

outgassing times (a minimum of five days at elevated

temperatures in a mechanical aerator); therefore,

gas sterilization for polyformaldehyde products is

contraindicated.

• Titanium and titanium alloy devices are especially

susceptible to discoloration from steam impurities and

detergent residues which form multi-colored surface

layers of oxide deposits. Upon repeated sterilization

these oxide layers, while not harmful to the patient,

may become dark and obscure graduation marks,

item and lot numbers, and other stamped or etched

information. Acidic, anti-corrosion agents may be used

to remove this discoloration as needed.

• Stainless steel instruments may be cleaned with rustremoval agents approved for surgical instruments if

needed.

• Use of hard water should be avoided. Softened tap water

may be used for initial rinsing. Purified water should be

used for final rinsing to eliminate mineral deposits on

instruments (e.g. ultra-filter (UF), reverse-osmosis (RO),

deionized (DI), or equivalent).

D. Point of Use Preparation for Reprocessing

• Remove excess body fluids and tissue from instruments

with a disposable, non-shedding wipe. Place instruments

in a basin of distilled water or in a tray covered with

damp towels. Do not allow saline, blood, body fluids,

tissue, bone fragments or other organic debris to dry on

instruments prior to cleaning.

Note: Soaking in proteolytic enzyme solutions or other

precleaning solutions facilitates cleaning, especially in

instruments with complex features and hard-to-reach

areas (e.g. cannulated and tubular designs, etc.). These

enzymatic solutions as well as enzymatic foam sprays

break down protein matter and prevent blood and

protein based materials from drying on instruments.

Manufacturer’s instructions for preparation and use of

these solutions should be explicitly followed.

• For optimal results, instruments should be cleaned

within 30 minutes of use or after removal from solution to

minimize the potential for drying prior to cleaning.

• Used instruments must be transported to the central

supply in closed or covered containers to prevent

unnecessary contamination risk.

E. Preparation Before Cleaning

• Symbols or specific instructions etched on instruments or

instrument trays and cases should be strictly followed.

• Where applicable multi-component instruments should be

disassembled for appropriate cleaning. Care should be

exercised to avoid losing small screws and components.

If a part is lost, notify your Zimmer representative when

the instrument set is returned.

• Instructions for instrument assembly/disassembly

and device specific cleaning aids can be found at www.

zimmer.com.

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

F. Preparation of Cleaning Agents

• Neutral pH enzymatic and cleaning agents with low

foaming surfactants are recommended by Zimmer.

• Alkaline agents with pH ≤ 12 may be used in countries

where required by law or local ordinance. Alkaline

agents should be followed with a neutralizer and/or

thorough rinsing.

• Only agents with proven efficacy (FDA approved, VAH

listed, or CE mark) should be used. As a large variety

of cleaning agents and disinfectants exists around the

globe, Zimmer does not recommend any specific brand.

• Agents used during the validation of these processing

instructions are:

Steris®, Prolystica™ 2X Enzymatic Pre Soak and Cleaner,

Prolystica™ Ultra Concentrate Neutral Detergent

• All cleaning agents should be prepared at the usedilution and temperature recommended by the

manufacturer. Softened tap water may be used

to prepare cleaning agents. Use of recommended

temperatures is important for optimal performance of

cleaning agents.

• Dry powdered cleaning agents should be completely

dissolved prior to use to avoid staining or corrosion of

instruments and to ensure correct concentration.

• Fresh cleaning solutions should be prepared when

existing solutions become grossly contaminated

(bloody and/or turbid).

Table 1. Cleaning/Disinfection Options

Method

Description

Section

Manual

Enzymatic soak and scrub

followed by sonication.

G

Combination

Manual/

Automated

Enzymatic soak and scrub

followed by automated washer/

disinfector cycle

H

Automated

(Washer/

Disinfector)

Washer/disinfector cycle - not

recommended for use without

manual precleaning.

I

• The manual method is effective for all devices and may

be used when an automated option is not available.

Note: Manual cleaning may require onsite validation

by the healthcare facility and appropriate procedures/

documentation should be in place to avoid human factor

variability.

• The combination manual/automated method is

preferred and can be used for all devices.

• The automated method should only be used on simple

devices without multiple components, lumens/

cannulations, blind holes, mated surfaces, connectors

and internal mechanisms or other complex features

G. Manual Cleaning/Disinfection Instructions

1. Completely submerge instruments in an enzyme

or alkaline (pH ≤12) solution and allow to soak for

20 minutes. Use a soft-bristled, nylon brush to

gently scrub the device until all visible soil has been

removed. Particular attention must be given to

crevices, lumens, mated surfaces, connectors and

other hard-to-clean areas. Lumens should be cleaned

with a long, narrow, soft-bristled brush (i.e. pipe

cleaner brush).

2. Remove the instruments from the cleaning solution

and rinse in tap water for a minimum of 3 minutes.

Thoroughly and aggressively flush lumens, holes

and other difficult-to-reach areas.

3. Place prepared cleaning agents in a sonication unit.

Completely submerge device in cleaning solution and

sonicate for 10 minutes at 45-50 kHz.

4. Rinse instrument in purified water for at least 3

minutes or until there is no sign of blood or soil on

the device or in the rinse stream. Thoroughly and

aggressively flush lumens, holes and other difficultto-reach areas.

5. Repeat the sonication and rinse steps above.

6. Remove excess moisture from the instrument with a

clean, absorbent and non-shedding wipe.

Note: If stainless steel instruments are stained or

corroded, an acidic, anti-corrosion agent in an ultrasonic

cleaner may be sufficient to remove surface deposits.

Care must be taken to thoroughly rinse acid from devices.

Acidic, anti-corrosion agents should only be used on an

as needed basis.

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

H. Combination Manual/Automated Cleaning

and Disinfection Instructions

Table 3. Typical European Automated Washer/

Disinfector Cycle for Surgical Instruments

1. Completely submerge the instruments in an enzyme

or alkaline (pH ≤12) solution and allow to soak

for 10 minutes. Use a soft nylon-bristled brush

to gently scrub the device until all visible soil has

been removed. Particular attention must be given

to crevices, lumens, mated surfaces, connectors

and other hard-to-clean areas. Lumens should be

cleaned with a long, narrow, soft nylon-bristled brush

(i.e. pipe cleaner).

Step

Description

1

5 min pre-rinse with cold tap water

2

10 min wash with 0,7% cleaning agent at

55°C

3

1 min rinse with cold tap water

4

Disinfection at 93°C with hot purified water

until A0 3000 is reached (approx. 10 min)

5

40 min hot air drying at 110°C

Note: Use of a sonicator at 45-50 kHz will aid in

thorough cleaning of devices.

Note: Use of a syringe or water jet will improve flushing

of difficult to reach areas and closely mated surfaces.

2. Remove instruments from the cleaning solution and

rinse in purified water for a minimum of 1 minute.

Thoroughly and aggressively flush lumens, blind

holes and other difficult-to-reach areas.

3. Place instruments in a suitable washer/disinfector

basket and process through a standard instrument

washer/disinfector cleaning cycle. The following

minimum parameters are essential for thorough

cleaning and disinfection.

Table 2. Typical U.S. Automated Washer/

Disinfector Cycle for Surgical Instruments

Step

Description

1

2 minute prewash with cold tap water

2

20 second enzyme spray with hot tap water

3

1 minute enzyme soak

4

15 second cold tap water rinse (X2)

5

2 minutes detergent wash with hot tap water

(64-66C/146-150F)

6

15 second hot tap water rinse

7

2 minute thermal rinse (80-93C/176-200F)

8

10 second purified water rinse with optional

lubricant (64-66C/146-150F)

9

7 to 30 minute hot air dry (116C/240F)

Note: The washer/disinfector manufacturer’s instructions

should be strictly adhered to. Use only cleaning agents

recommended for the specific type of automated washer/

disinfector. A washer/disinfector with approved efficacy

(e.g. CE mark, FDA approval, and validation according to

ISO 15883) should be used.

I. Automated Cleaning/Disinfection

Instructions

1. Automated washer/disinfector systems are not

recommended as the sole cleaning method for

surgical instruments. Orthopaedic instruments

should be cleaned following the manual or

combination manual/automated cleaning procedure

outlined in this manual except where specifically

indicated.

2. Simple instruments without multiple components,

lumens/cannulations, blind holes, mated surfaces,

connectors and internal mechanisms or other

complex features may be successfully cleaned and

disinfected using a typical washer/disinfector cycle

for surgical instruments as outlined in Table 2 of this

manual. Devices should be thoroughly inspected

prior to sterilization to ensure effective cleaning.

J. Inspection, Maintenance, Testing and

Lubrication

1. Carefully inspect each device to ensure that all visible

contamination has been removed. If contamination

is noted repeat the cleaning/disinfection process.

2. Visually inspect for completeness, damage and/or

excessive wear.

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

Note: If damage or wear is noted that may compromise

the function of the instrument, contact your Zimmer

Representative for a replacement.

Note: If sterilization wraps are used they must be

free of detergent residues. Reusable wraps are not

recommended.

3. Check the action of moving parts (e.g. hinges, boxlocks, connectors, sliding parts, etc.) to ensure

smooth operation throughout the intended range of

motion.

Packaging instrument sets in rigid trays and cases with

lids

4. Hinged, rotating, or articulating instruments should

be lubricated with a water soluble product (e.g.

Instrument Milk or equivalent lubricant) intended

for surgical instruments that must be sterilized.

Some water-based instrument lubricants contain

bacteriostatic agents which are beneficial. To

remain effective, the expiration date specified by the

manufacturer should be adhered to for both stock

and use-dilution concentrations.

Note: Mineral oil or silicone lubricants should not be

used because they 1) coat microorganisms; 2) prevent

direct contact of the surface with steam; and 3) are

difficult to remove.

Note: These lubrication instructions are not applicable

to air-powered or electrical instruments. These devices

have different requirements and should be lubricated

according to the manufacturer’s instructions.

Safety Precaution: The total weight of a wrapped

instrument tray or case should not exceed 11.4kg/25lbs.

Instrument cases may be placed in an approved

sterilization container with gasketed lids at the user’s

discretion. The total weight of the instrument set,

case, and sterilization container, must not exceed

11.4kg/25lbs.

• Trays and cases with lids may be wrapped in standard

medical grade, steam sterilization wrap using the AAMI

double wrap method or equivalent.

• Trays and cases with lids may also be placed in an

approved sterilization container with gasketed lid for

sterilization.

Note: Follow the sterilization container manufacturer’s

instructions for inserting and replacing sterilization

filters in sterilization containers.

Instrument trays and cases with defined, preconfigured

layouts

5. Check instruments with long slender features

(particularly rotating instruments) for distortion.

• Areas designated for specific devices shall contain only

devices specifically intended for these areas.

6. Where instruments form part of a larger assembly,

check that the devices assemble readily with mating

components.

• Optional Zimmer instruments should not be added

to a preconfigured instrument tray or case unless a

dedicated universal space or compartment has been

included in the design and the guidelines described

below for trays and cases without defined layouts or

universal spaces can be applied.

K. Sterile Packaging

Packaging individual instruments

• Single devices should be packaged in a medical grade

sterilization pouch or wrap which conforms to the

recommended specifications for steam sterilization

provided in the table below. Ensure that the pouch

or wrap is large enough to contain the device without

stressing the seals or tearing the pouch or wrap.

• Standard medical grade, steam sterilization wrap

may be used to package individual instruments. The

package should be prepared using the AAMI double

wrap or equivalent method.

• Only devices manufactured and/or distributed by

Zimmer should be included in Zimmer instrument

trays. These validated reprocessing instructions are not

applicable to Zimmer trays that include devices that are

not manufactured and/or distributed by Zimmer.

Instrument trays with reconfigurable layouts

• Brackets designated for specific devices shall contain

only devices specifically intended for them.

11

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

• Optional Zimmer instruments should not be added to a

reconfigurable tray unless a dedicated universal space

or compartment has been included in the layout and the

guidelines described below for universal trays without

defined layouts or universal spaces can be applied.

• Only devices manufactured and/or distributed by

Zimmer should be included in Zimmer instrument

trays. These validated reprocessing instructions are not

applicable to Zimmer trays that include devices that are

not manufactured and/or distributed by Zimmer.

• Brackets designed to force disassembly of a complex

device must not be altered to allow the assembled

device to be inserted into the tray or case.

• To ensure devices are fully seated in their

corresponding brackets and to prevent damage to tray

contents, individual brackets should not overlap one

another when inserted into the tray floor.

Note: Some individual brackets may be designated for

assembly onto other “host” brackets. In these instances,

the mating relationship between the brackets will be

graphically depicted on the face of the “host” bracket.

• Bracket fasteners should be fully engaged with the tray

floor to prevent unintended migration, damage and/or

loss of tray contents.

• Wave springs positioned over the shaft of the

bracket fasteners are intended to stabilize brackets

by minimizing free-play between them and the tray

floor. To ensure intended function, periodically

inspect brackets for damaged and/or missing springs

which can be replaced by contacting your Zimmer

representative.

• Identification tags and associated labels on trays

should correspond to tray contents to ensure correct

trays are available for use in surgery.

• Any manual tools provided by Zimmer to aid in the

removal of individual brackets must not remain in

the instrument trays during reprocessing and are not

intended for use in surgery.

Universal instrument trays and cases without defined,

preconfigured layouts or containing undefined universal

spaces or compartments should only be used under the

following conditions:

Safety Precaution: The total weight of a wrapped

instrument tray or case should not exceed 11.4kg/25lbs.

Instrument cases may be placed in an approved

sterilization container with gasketed lids at the user’s

discretion. The total weight of the instrument set, case

and container must not exceed 11.4kg/25lbs.

• Any device capable of disassembly must be

disassembled prior to placement in the case.

• All devices must be arranged to ensure steam

penetration to all instrument surfaces. Instruments

should not be stacked or placed in close contact.

• The user must ensure that the instrument case is not

tipped or the contents shifted once the devices are

arranged in the case. Silicone mats may be used to

keep devices in place.

• Only devices manufactured and/or distributed by

Zimmer should be included in Zimmer instrument

trays. Zimmer validated reprocessing instructions are

not applicable to Zimmer trays that include devices

that are not manufactured and/or distributed by

Zimmer.

L. Sterilization Instructions

• See Table for recommended minimum sterilization

parameters that have been validated by Zimmer to

provide a 10-6 sterility assurance level (SAL).

• The hospital is responsible for in-house procedures

for the reassembly, inspection, and packaging of the

instruments after they are thoroughly cleaned in a

manner that will ensure steam sterilant penetration

and adequate drying. Provisions for protection of

any sharp or potentially dangerous areas of the

instruments should also be recommended by the

hospital.

• Moist heat/steam sterilization is the preferred and

recommended method for Zimmer orthopaedic

instrument sets.

• Sterilizer manufacturer recommendations should

always be followed. When sterilizing multiple

instrument sets in one sterilization cycle, ensure that

the manufacturer’s maximum load is not exceeded.

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

• Instrument sets should be properly prepared and

packaged in trays and/or cases that will allow steam to

penetrate and make direct contract with all surfaces.

• Ethylene oxide or gas plasma sterilization methods

should not be used unless package inserts for the

applicable product specifically provide instructions for

sterilization using these methods.

• Gravity displacement sterilization cycles are not

recommended because cycle times are too long to be

practical.

Table 4. Recommended Steam Sterilization

Parameters

Cycle Type

Temperature 2

Exposure Time 1

Wrapped7,8 and

Unwrapped9

UK Prevacuum/

Pulsating Vacuum3

134°C / 273°F

3 minutes

Prevacuum/

Pulsating Vacuum2,3

132°C / 270°F

4 minutes

Prevacuum/Pulsating

134°C / 273°F

Vacuum4,12,13

18 minutes

Minimum Minimum

Dry Time10 Cool Time11

132°C / 270°F

8 minutes

Gravity/Gravity

Displacement

121°C / 250°F

90 minutes

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

larger loads.

11

Cooling times vary according to the type of sterilizer used, device

design, temperature and humidity of ambient environment, and type

of packaging used. Cooling process should comply with ANSI/AAMI

ST79.

12

This cycle is not for use in the United States.

13

This cycle is not to be used for the inactivation of prions.

Note: The Sterilizer Manufacturer’s instructions for

operation and load configuration should be followed

explicitly.

M. Storage Instructions

• Sterile, packaged instruments should be stored in a

designated, limited access area that is well ventilated

and provides protection from dust, moisture, insects,

vermin, and temperature/humidity extremes.

30 minutes

Prevacuum/

Pulsating Vacuum5

10

30 minutes

40 minutes

1

Validated exposure time required to achieve a 10-6 sterility assurance

level (SAL).

2

Validated exposure temperature required to achieve a 10-6 sterility

assurance level (SAL).

3

Local or national specifications should be followed where steam

sterilization requirements are stricter or more conservative than those

listed in this table.

4

Disinfection/steam sterilization parameters recommended by the

World Health Organization (WHO) for reprocessing instruments where

there is concern regarding TSE/CJD contamination.

5

For Universal Instrument Cases without defined load configurations.

6

AAMI/AORN steam sterilization cycles with longer times than those

listed are also acceptable.

7

Medical grade steam sterilization compatible wrap equivalent to four

thicknesses of 140-thread-count muslin.

8

Rigid sterilization container that complies with ANSI/AAMI ST77.

9

Flash (immediate-use) steam sterilization by exposure at 132134C / 270-273F should only be used as an emergency procedure.

Instruments must be cleaned and disassembled.

• Sterile instrument packages should be carefully

examined prior to opening to ensure that package

integrity has not been compromised.

Note: Maintenance of sterile package integrity is

generally event related. If a sterile wrap is torn,

perforated, shows any evidence of tampering or has

been exposed to moisture, the instrument set must be

cleaned, repackaged and sterilized.

Note: If there is any evidence that the lid seal or filters

on a sterilization container have been opened or

compromised, the sterile filters must be replaced and

the instrument set resterilized.

9. HOSPITAL RESPONSIBILITIES FOR ZIMMER

LOANER SETS

• Orthopaedic surgical instruments generally have a

long service life; however, mishandling or inadequate

protection can quickly diminish their life expectancy.

Instruments which no longer perform properly because

of long use, mishandling, or improper care should

be returned to Zimmer to be discarded. Notify your

Zimmer representative of any instrument problems.

13

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

• Loaner sets should undergo all steps of

decontamination, cleaning, disinfection, inspection,

and terminal sterilization before being returned to

Zimmer. Documentation of decontamination should

be provided with instruments being returned to

Zimmer.

• Missing or damaged instruments from loaner sets

should be brought to the attention of the operating

room supervisor, to the director of the central supply

department, and to your Zimmer representative to

ensure that the next hospital will receive a complete

set of instruments in good working condition.

• The instructions provided in this manual have been

validated by Zimmer in the laboratory and are

capable of preparing orthopaedic devices for use. It

is the responsibility of the Hospital to ensure that

reprocessing is performed using the appropriate

equipment and materials, and that personnel in the

reprocessing facility have been adequately trained

in order to achieve the desired result. Equipment

and processes should be validated and routinely

monitored. Any deviation by the processor from

these instructions should be properly evaluated

for effectiveness to avoid potential adverse

consequences.

10. CUSTOMER SERVICE INFORMATION

Mailing Address

Telephone

Zimmer, Inc.

1800 West Center Street

Warsaw, Indiana 46580

USA

Inside USA: 1-800-348-2759

Outside USA: local international

access code +1-574-267-6131

Zimmer GmbH

Sulzer-Allee 8

CH-8404 Winterthur,

Switzerland

+41 (0) 52 262 60 70

This Zimmer reprocessing manual and device specific cleaning and

assembly/disassembly instructions can be found at www.zimmer.

com under the “Medical Professional” heading.

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

11. REFERENCES

1. AAMI TIR12, Designing, testing, and labeling reusable

medical devices for reprocessing in health care facilities: A

guide for medical device manufacturers

2. AAMI TIR13, Principles of industrial moist heat sterilization

3. AAMI TIR30, A compendium of processes, materials, test

methods, and acceptance criteria for cleaning reusable

medical devices

4. AAMI TIR34, Water for the reprocessing of medical devices

5. ANSI/AAMI ST67, Sterilization of health care products –

Requirements for products labeled “Sterile”

6. ANSI/AAMI ST77, Containment devices for reusable medical

device sterilization

7. ANSI/AAMI ST79, Comprehensive guide to steam

sterilization and sterility assurance in health care facilities

8. ANSI/AAMI ST81, Sterilization of medical devices –

Information to be provided by the manufacturer for the

processing of resterilizable medical devices

9. ANSI/AAMI/ISO 15223-1, Medical device – Symbols to be

used with medical device labels, labeling, and information

to be supplied - Part 1: General Requirements

10. AORN, Standards, Recommended Practices and Guidelines

11. Association for Applied Hygiene (VAH) Verbund für

Angewandte Hygiene, List of Disinfectants

12. ASTM F 565, Standard Practice for Care and Handling of

Orthopedic Implants and Instruments

13. European Commission, Council Directive 93/42/EEC of 14

June 1993 concerning medical devices

14. German Instrument Working Group (AKI) Arbeitskreis

Instrumenten-Aufbereitung, Proper Maintenance of

Instruments, 8th Ed, 2004.

15. IAHCSMM, Central Service Technical Manual

16. ISO 15883, Washer/Disinfectors: General Requirements,

Terms and Definitions and Tests

17. ISO 17664, Sterilization of medical devices –

Information to be provided by the manufacturer for the

processing of resterilizable medical devices

18. ISO 17665-1, Sterilization of health care products –moist

heat, Part 1

19. ISO 17665-2, Sterilization of health care products –moist

heat, Part 2

Note: All trademarks are the property of their respective owners.

20. Robert Koch Institute (RKI), Hygiene Requirements for

Reprocessing Medical Devices Federal Health Gazette,

10/2012

21. Robert Koch Institute (RKI), Hospital Supplies and

Instrument Sterilization in Light of CJD Patients and

Suspected CJD Cases, Federal Health Gazette, 7/1998

22. UK Department of Health, Health Technical Memorandum

(HTM) 2010, Sterilization, Part 5 – Good Practice Guide

23. UK Department of Health, Health Technical Memorandum

(HTM) 2030, Washer-Disinfectors – Validation and

Verification

24. World Health Organization (WHO), WHO/CDS/CSR/APH

200.3, WHO Infection Control Guidelines for TSE

15

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

Appendix 1- Cleaning/Disinfection/Sterilization Validation Process

Zimmer manual and combination manual/automated cleaning and disinfection methods are developed using spore

logarithmic reduction and visual inspection criteria to determine critical cleaning parameters. The reusable devices

or device features are exposed to blood soil containing approximately 106 spores per ml. The samples are allowed to

dry for 30 minutes prior to cleaning/disinfection. After cleaning the test samples are visually inspected for any signs of

remaining blood soil. Bioburden extractions are performed to determine the number of spores remaining on thhe test

samples. The data is compared to positive controls to determine if the acceptance criteria is met. The cleaning/

disinfection processes outlined in this manual have been validated per the following standards:

AAMI TIR 12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A

guide for device manufacturers

AAMI TIR 30, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable

medical devices

All reusable devices are reviewed to ensure that the device features are not more challenging than those validated.

As new, more challenging features emerge, the features are validated or the device is modified to a less challenging

design.

Zimmer prevacuum (pressure pulse) and gravity moist heat sterilization cycles are developed using F0 data to establish

critical cycle parameters. Calibrated thermocouples are placed in the most challenging locations within the instrument

cases for heat penetration studies. Moist heat cycles are validated using microbial challenge half-cycle studies to prove

lethality via the “overkill” method to demonstrate a 10-6 or better sterility assurance level (SAL). This method utilizes

biological indicators (BI) inoculated with more than one million (106) resistant spores (Geobacillus stearothermophilus)

placed in the most challenging locations within the instrument set. Studies are conducted using disposable moist heat

sterilization wrap and/or rigid steam sterilization containers (Aesculap). Successful half-cycle microbial challenge

studies result in total kill of all BIs demonstrating a spore logarithm reduction of at least twelve (10-6 SAL or better)

for the most resistant microorganism at a population of greater than one million. Recommended dry time is validated

by demonstrating that pre-sterilization and post sterilization case weight is within  3 percent with no visible moisture

at the end of the full sterilization cycle. Durability studies are also performed using multiple cycles at 135°C for 18

minutes to ensure that the instrument case and contents can withstand repeated processing at maximum parameters.

The sterilization parameters outlined in this manual are validated per the following standards:

AAMI TIR 12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A

guide for device manufacturers

ANSI/AAMI/ISO 17665, Sterilization of health care products – Moist heat – Part 1: Requirements for the development,

validation, and routine control of a sterilization process for medical devices

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

17

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Contact your Zimmer representative or visit us at www.zimmer.com

The CE mark is valid only if it is also printed on the product label.

97-5000-170-00 Rev. 5, ©1987, 1988, 2002, 2006, 2010, 2012 and 2013