Revision Rev 6

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Orthopaedic

Reusable

Devices

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 and single-use devices packaged and

sold sterile but removed from packaging and placed

in kits (e.g. screws, plates, etc.). These devices are

single-use but can be reprocessed if not used.

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 and must be discarded.

Always consult the device labeling and instructions

for use for specific recommendations or restrictions

on processing within a health care setting.

Devices that cannot be reused may be labeled with

the following symbol:

ISO 15223-1 5.4.2

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:

ISO 15223-1 5.2.6

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).

Manual cleaning: cleaning without the use of an automated

washer or washer/disinfector.

CJD = Creutzfeldt-Jakob Disease

CSSD = Central Sterile Supply Department

PPE = Personal Protective Equipment

SAL = Sterility Assurance Level

TSE = Transmissible Spongiform Encephalopathy

5. SYMBOLS

ISO 15223-1 5.4.2

Do not reuse

ISO 15223-1 5.4.3

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

ISO 15223-1 5.2.6

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

2015.

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. It is also

Zimmer’s recommendation to thoroughly process nonsterile implants (e.g. plates, screws, etc.) prior to use.

Single-use devices must be removed from the tray or caddy

for the initial cleaning process and returned to the tray or

caddy for sterilization. Upon subsequent reprocessing,

however, unused single-use devices may be left in the tray

or caddy.

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

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

reprocessed and must be discarded.

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.

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.

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.

Hospitals must assume responsibility for cleaning,

disinfection, packaging and sterilization of all loaner

instrument sets before returning them to Zimmer. 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 reprocessing 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 either

the rigorous manual or combination method cleaning

instructions outlined in this reprocessing manual. The

combination method which includes 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

Reprocessing limitations and or restrictions

Preparation for reprocessing at the point of use

Preparation for cleaning (including assembly/

disassembly as necessary)

Cleaning, disinfection and drying

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

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

manual or combination cleaning instructions contained in this reprocessingmanual. The following codes are etched on

some devices and case components and may provide useful information in the selection of cleaning agents as well as

indications for disassembly.

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 neutralization and thorough rinsing. These devices can be treated 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 neutralization and thorough rinsing. These

devices can be treated with rust-removal agents approved for surgical instruments if needed.

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 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

neutralization and thorough rinsing.

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). The use of alkaline cleaning agents might be

corrosive to the surface of these devices.

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.

•

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.

•

Lubricants not specifically designed for compatibility

with steam sterilization should not be used because

they may: 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.

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.

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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 silk-screened 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.

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. Either the

rigorous manual or combination cleaning process is

recommended with the combination process being

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. Single-use devices

must be cleaned separately from soiled instruments.

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: Any unused, single-use device that has been

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

reprocessed 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 devices.

•

Ethylene Oxide (EO), Gas Plasma Sterilization and dry

heat sterilization methods are not recommended for

sterilization of Zimmer devices.

•

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 devices. 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 treated 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), reverseosmosis (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 alkaline 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, neodisher® FA Alkaline Detergent,

neodisher® Z Acid Neutralizer.

• 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).

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 method is preferred and can be used

for all devices.

G. Rigorous 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 enzyme 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.

Table 1. Cleaning/Disinfection Options

Method

Description

Section

Rigorous

Manual

Enzymatic or alkaline soak and

scrub followed by sonication.

G

Combination

Enzymatic soak and scrub with

sonication or alkaline soak with

sonication followed by automated

washer/disinfector cycle.

H

Automated

Only (Washer/

Disinfector)

Washer/disinfector cycle only.

I

• The rigorous manual method is effective for all devices

and may be used when an automated option is not

available.

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.

7. Proceed to Section 8J, Inspection, Maintenance,

Testing, and Lubrication.

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

H. Combination 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 and sonicate for 10 minutes at 45-50 kHz. If

using enzymatic cleaning agents, use a soft nylonbristled 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 nylonbristled brush (i.e. pipe cleaner).

Step

Description

1

5 min pre-rinse with cold tap water

2

10 min alkaline cleaning agent wash at 55°C

3

2 min rinse with neutralizer

4

1 min rinse with cold tap water

5

Disinfection at 93°C with hot purified water

until A0 3000 is reached (approx. 10 min)

6

40 min hot air drying at 110°C

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.

4. Proceed to Section 8J, Inspection, Maintenance,

Testing, and Lubrication.

I. Automated Only Cleaning/Disinfection

Instructions

1. Automated washer/disinfector systems are not

recommended as the sole cleaning method for

surgical instruments that are not of simple design.

Orthopaedic instruments with any features such as

multiple components, lumens/cannulations, blind

holes, mated surfaces, connectors and internal

mechanisms should be cleaned following the

rigorous manual or combination cleaning procedure

outlined in this reprocessing manual except where

specifically indicated.

2. Simple instruments without any features such as

multiple components, lumens/cannulations, blind

holes, mated surfaces, connectors and internal

mechanisms may be successfully cleaned and

disinfected using a typical washer/disinfector cycle

for surgical instruments as outlined in Table 2 or

Table 3 of this reprocessing 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.

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

2. Visually inspect for completeness, damage and/or

excessive wear.

Note: If damage or wear is noted that may compromise

the function of the instrument, contact your Zimmer

Representative for a replacement.

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.

4. If necessary, hinged, rotating, or articulating

instruments can be lubricated with an instrument

product (e.g. Instrument Milk or equivalent lubricant)

specifically designed for compatibility with steam

sterilization.

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.

5. Check instruments with long slender features

(particularly rotating instruments) for distortion.

6. Where instruments form part of a larger assembly,

check that the devices assemble readily with mating

components.

K. Sterile Packaging

Packaging instrument sets in rigid trays and cases with

lids

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. Consult the Zimmer website

www.zimmer.com or your Zimmer representative for the

full list of approved sterilization containers. The total

weight of the instrument set, case, and sterilization

container, must not exceed 11.4kg/25lbs (other local

limits below 25 lbs may apply).

•

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.

•

Follow the sterilization container manufacturer’s

instructions for inserting and replacing sterilization

filters in sterilization containers.

Instrument trays and cases with defined, preconfigured

layouts

•

Areas designated for specific devices shall contain

only devices specifically intended for these areas.

•

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.

•

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.

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.

Note: If sterilization wraps are used they must be

free of detergent residues. Reusable wraps are not

recommended.

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.

•

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.

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.

•

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.

•

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.

L. Sterilization Instructions

•

See Table 4 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 reusable devices.

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.

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.

•

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:

•

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.

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

•

Gravity displacement sterilization cycles are not

recommended because cycle times are too long to be

practical.

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.

•

Sterile instrument packages should be carefully

examined prior to opening to ensure that package

integrity has not been compromised.

Table 4. Recommended Steam Sterilization

Parameters

Exposure Time1,5

Cycle Type

Temperature 2

UK Prevacuum/

Pulsating Vacuum3

134°C / 273°F

3 minutes

Prevacuum/

Pulsating Vacuum3

132°C / 270°F

4 minutes

Prevacuum/Pulsating

134°C / 273°F

Vacuum4,11,12

18 minutes

Wrapped6,7 and

Unwrapped8

Minimum Minimum

Dry Time9 Cool Time10

30 minutes 30 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

AAMI/AORN steam sterilization cycles with longer times than those

listed are also acceptable.

6

Medical grade steam sterilization compatible wrap equivalent to four

thicknesses of 140-thread-count muslin.

7

Approved rigid sterilization container per the Zimmer website

www.zimmer.com.

8

Flash (immediate-use) steam sterilization by exposure at 132-134°C

/ 270-273°F should only be used as an emergency procedure.

Instruments must be cleaned and disassembled.

9

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

larger loads

10

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.

11

This cycle is not for use in the United States.

12

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.

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.

•

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.

13

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

•

The instructions provided in this reprocessing

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) 58 854 80 00

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

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

Reprocessing Medical Devices Federal Health Gazette,

10/2012

1.

AAMI TIR12, Designing, testing, and labeling reusable

medical devices for reprocessing in health care facilities: A

guide for medical device manufacturers

2.

AAMI TIR30, A compendium of processes, materials, test

methods, and acceptance criteria for cleaning reusable

medical devices

3.

AAMI TIR34, Water for the reprocessing of medical devices

4.

ANSI/AAMI ST67, Sterilization of health care products –

Requirements for products labeled “Sterile”

21. UK Department of Health, published by The Stationary

Office, London: Health Technical Memorandum (HTM) 0101: Decontamination of reusable medical devices. Parts A

and B

5.

ANSI/AAMI ST77, Containment devices for reusable

medical device sterilization

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

200.3, WHO Infection Control Guidelines for TSE

6.

ANSI/AAMI ST79, Comprehensive guide to steam

sterilization and sterility assurance in health care facilities

7.

ANSI/AAMI ST81, Sterilization of medical devices –

Information to be provided by he manufacturer for the

processing of resterilizable medical devices

23. Reprocessing Medical Devices in Health Care Settings:

Validation Methods and Labeling Guidance for Food and

Drug Administration Staff, 2015

8.

ANSI/AAMI/ISO 15223-1, Medical devices – Symbols to be

used with medical device labels, labeling, and information

to be supplied – Part 1: General Requirements

9.

AORN, Standards, Recommended Practices and Guidelines

10. Association for Applied Hygiene (VAH) Verbund für

Angewandte Hygiene, List of Disinfectants

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

Orthopedic Implants and Instruments

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

June 1993 concerning medical devices

13. German Instrument Working Group (AKI) Arbeitskreis

Instrumenten-Aufbereitung, Proper Maintenance of

Instruments, 10th Ed,2012.

14. IAHCSMM, Central Service Technical Manual

15. ISO 15883, Washer/Disinfectors: Requirements, Terms

and Definitions and Tests

16. ISO 17664, Sterilization of medical devices –

Information to be provided by the manufacturer for the

processing of resterilizable medical devices

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

heat, Part 1

18. 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), Hospital Supplies and

Instrument Sterilization in Light of CJD Patients and

Suspected CJD Cases, Federal Health Gazette, 7/1998

15

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Zimmer Instrument Care, Cleaning, Maintenance and Sterilization Instructions

Appendix 1- Cleaning/Disinfection/Sterilization Validation Process

Zimmer rigorous manual 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 sign of remaining blood soil.

Bioburden extractions are performed to determine the number of spores remaining on the test samples. The data are

compared to positive controls to determine if the acceptance criteria are met.

Zimmer combination (with automated process) cleaning and disinfection methods are developed using total protein,

total organic carbon, and visual inspection criteria to determine critical cleaning parameters. The reusable devices or

device features are exposed to blood soil and allowed to dry for 24 hours prior to cleaning/disinfection. After cleaning,

test samples are inspected for any sign of visible soil and extracted to determine the quantitative amount of extractable

protein and organic soil. The data are compared to test protocol requirements to determine if the acceptance criteria

are met.

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

ISO 17664, Sterilization of medical devices – Information to be provided by the manufacturer for the processing of

resterilizable medical devices

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

Administration Staff

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 approved rigid steam sterilization containers. 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:

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

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

Page 20

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.

MC138865 5-26-15

97-5000-170-00 Rev. 6 ©1987, 1988, 2002, 2006, 2010, 2012, 2013, and 2015, Zimmer, Inc.