Instrument Care , Cleaning and Sterilization Quick Reference Guide

Page 1

• The total weight of a wrapped instrument tray or case should not exceed 11.4kg/25lbs. When

placed in a sterilization container with gasketed lid the total sterilization package should not

exceed 16kg/35lbs.

• 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. Silicon 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.

Sterilization

• Disinfection is only acceptable as a precursor to full sterilization for reusable surgical

instruments. See Table 6 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.

• 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.

Storage

• 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.

Hospital Responsibilities for Zimmer Loaner Instruments

• 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.

Instrument Care, Cleaning

and Sterilization

Table 6. Recommended Steam Sterilization Parameters

Cycle Type

2

3

4

Pressure

6

Exposure Time

7

Dry Time

UK Prevacuum

134°C

273°F

3bar

28.5psi

3 minutes

30 minutes

1,3

Prevacuum

132°C

270°F

1.86bar

27psi

4 minutes

30 minutes

3,4

Prevacuum

134°C

273°F

3bar

28.5psi

18 minutes

30 minutes

132°C

270°F

1.86bar

27psi

8 minutes

30 minutes

1,3

1

Temperature

5

8

Prevacuum

9

Gravity

In accordance with ISO 17664

• Additional information is available in Zimmer document 97-5000-170-00 R3 which should

be used in conjunction with this Quick Reference Guide.

• This guide pertains to all Zimmer reusable instruments and should be studied carefully.

This manual supercedes Zimmer and Centerpulse instrument manuals published prior to

January 2006.

• This guide includes processing instructions for all Zimmer reusable devices including legacy

Centerpulse instruments marked with processing category codes [a, a+, b, b+, c]. All Zimmer

devices may be safely and efficiently reprocessed using the manual or combination manual/

automated cleaning instructions outlined in this manual.

• 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.

Not recommended due to excessively long sterilization cycles which are

not practical.

Minimum validated steam sterilization time

required to achieve a 10-6 sterility assurance

level (SAL).

Minimum validated steam sterilization

temperature required to achieve a 10-6 sterility

assurance level (SAL).

Local or national specifications should

be followed where steam sterilization

requirements are stricter or more conservative

than those listed in this table.

Disinfection/steam sterilization parameters

recommended by the World Health

Organization (WHO) for reprocessing

instruments where there is concern regarding

TSE/CJD contamination.

5

6

7

8

9

Quick

Reference

Guide

Considerations

Sea level

AAMI/AORN steam sterilization cycles with

longer times than those listed are also

acceptable.

Drying times vary according to load size and

should be increased for larger loads.

For Universal Instrument Cases without

defined load configurations.

Gravity cycle parameters are available on

request from Customer Service.

Warnings & Precautions

Note: The Sterilizer Manufacturer’s instructions for operation and load configuration should be followed explicitly.

Important Notice

• The instructions provided in this Quick Reference Guide have been validated by Zimmer as

being 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.

Customer Service Information

Address

Telephone

Zimmer, Inc.

1800 West Center Street

Warsaw, Indiana 46580, USA

Inside USA: 1-800-348-2759

Outside USA: Local International Access Code

+1-574-367-6131

Zimmer GmbH

Sulzer-Allee 8

CH-8404 Winterthur, Switzerland

+41 (0)52 262 60 70

This Zimmer reprocessing manual and the associated Quick Reference Guide can be found at

www.zimmer.com under the “Medical Professional” heading.

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

97-5000-701-00 5ML Printed in USA ©2006 Zimmer, Inc.

• 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.

Note: Areas designated for specific devices shall contain only devices specifically intended for

these areas.

Note: These validated reprocessing instructions are not applicable to Zimmer trays that include

devices that are not manufactured and/or distributed by Zimmer. Instrument trays and cases

without defined, preconfigured layouts or containing undefined universal spaces or

compartments should only be used under the following conditions:

• 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.

• Do not place heavy instruments on top of delicate devices.

• Metal brushes or scouring pads must not be used during manual cleaning procedures. These

materials will damage the surface and finish of instruments. Soft-bristled, nylon brushes and

pipe cleaners should be used.

• Do not allow contaminated devices to dry prior to reprocessing. All subsequent cleaning and

sterilization steps are facilitated by not allowing blood, body fluid, bone and tissue debris,

saline, or disinfectants to dry on used devices.

• 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.

Limitations & Restrictions

• Automated cleaning using a washer/disinfector alone may not be effective for orthopaedic

instruments. A thorough, manual or combination manual/automated cleaning process is

recommended.

• Neutral pH enzymatic and cleaning agents are recommended and preferred for cleaning Zimmer

reusable devices. Alkaline agents with pH < 12 may be used to clean stainless steel and some

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 be completely and

thoroughly neutralized and 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.

• Instruments must be removed from metal or polymer trays for manual and/or automated

cleaning procedures. Instrument trays, cases and lids must be cleaned separately. Non-sterile,

single-use plate and screw implants are an exception to this rule. Plates and screws may

remain in the tray or caddy for reprocessing.