ASTM F565-04

Standard Practice for Care and Handling of Orthopedic Implants and Instruments

ABSTRACT
This practice covers recommended procedures for the handling of orthopedic implants and instruments. Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage of orthopedic implants and instruments. Many implants are wrapped in special sterilizable or pre-sterilized packages, envelopes, or other containers. These wrappings should not be removed by the receiving personnel. Perform transport in a manner to preclude any damage or alteration to the received condition of the implant or instrument. Store implants or instruments prior to use in such a manner as to maintain the device's surface finish or configuration, or both. Maintain orthopedic implants and instruments of different metals separately to avoid the possibility of mixing during surgery. Prior to initial sterilization and promptly following each surgical procedure, thoroughly and carefully clean all instruments and implants. Dispose of orthopedic implants that exhibit surface or configuration damage. Avoid the reimplantation of previously implanted orthopedic implants.
SCOPE
1.1 This practice covers recommended procedures for the handling of orthopedic implants and instruments.
1.2 Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage of orthopedic implants and instruments.
1.3 This practice does not cover producer level handling and packaging procedures.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 30-Sep-2004
• ICS: 11.040.30 - Surgical instruments and materials
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.21 - Osteosynthesis

Relations

• Replaces: ASTM F565-00(2003) - Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• Effective Date: 01-Oct-2004
• Replaced By: ASTM F565-04(2009) - Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• Effective Date: 01-Apr-2009
• Referred By: ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
• Effective Date: 01-Oct-2004
• Referred By: ASTM F1264-16e1 - Standard Specification and Test Methods for Intramedullary Fixation Devices
• Effective Date: 01-Oct-2004
• Referred By: ASTM F382-17 - Standard Specification and Test Method for Metallic Bone Plates
• Effective Date: 01-Oct-2004
• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 01-Oct-2004
• Referred By: ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
• Effective Date: 01-Oct-2004
• Referred By: ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• Effective Date: 01-Oct-2004
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-Oct-2004
• Referred By: ASTM F2884-21 - Standard Guide for Pre-clinical <emph type="bdit">in vivo</emph> Evaluation of Spinal Fusion
• Effective Date: 01-Oct-2004
• Referred By: ASTM F2721-09(2023) - Standard Guide for Preclinical <emph type="ital">in vivo</emph> Evaluation in Critical-Size Segmental Bone Defects
• Effective Date: 01-Oct-2004
• Referred By: ASTM F2529-13(2021) - Standard Guide for <emph type="ital"> in vivo</emph> Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
• Effective Date: 01-Oct-2004
• Referred By: ASTM F1611-20 - Standard Specification for Intramedullary Reamers
• Effective Date: 01-Oct-2004
• Referred By: ASTM F116-12(2021) - Standard Specification for Medical Screwdriver Bits
• Effective Date: 01-Oct-2004
• Referred By: ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• Effective Date: 01-Oct-2004

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F565–04
Standard Practice for
1
Care and Handling of Orthopedic Implants and Instruments
This standard is issued under the fixed designation F 565; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2 Transport—Perform transport in a manner to preclude
any damage or alteration to the received condition of the
1.1 This practice covers recommended procedures for the
implant or instrument.
handling of orthopedic implants and instruments.
3.3 Storage:
1.2 Hospital receiving personnel, central supply personnel,
3.3.1 Store implants or instruments prior to use in such a
operating room personnel, surgeons, and occasionally other
manner as to maintain the device’s surface finish or configu-
individuals will handle orthopedic implants and instruments.
ration, or both.
All personnel should be informed of recommended care and
3.3.2 Manyimplantsareidentifiedbyaserialorlotnumber,
handling procedures to prevent damage of orthopedic implants
or both, on the package label, package insert, or surface of the
and instruments.
device. Record these control numbers and retain for transfer to
1.3 This practice does not cover producer level handling
patient records, to facilitate inventory, stock rotation, medical
and packaging procedures.
device reporting, and possible traceability to the manufacturer.
1.4 This standard does not purport to address all of the
3.3.3 Stock Rotation—The principle of first in, first out, is
safety concerns, if any, associated with its use. It is the
recommended.
responsibility of the user of this standard to establish appro-
3.3.4 Store implants in the operating room in such a manner
priate safety and health practices and determine the applica-
as to isolate and protect the implant’s surface, sterility, and
bility of regulatory limitations prior to use.
configuration. Keep implants made of different metals sepa-
2. Terminology rated.
3.3.5 Store the implants and instruments in the operating
2.1 Definitions of Terms Specific to This Standard:
room in such a manner as to isolate the instruments from the
2.1.1 orthopedic implant—adeviceintroducedbysurgically
implants.
penetrating the skin or mucosa of the body with the intention
that it remain within or attached to the skeleton within the body
4. Handling
following the surgery. This device is referred to in this practice
4.1 Mixing Metals—Maintain orthopedic implants and in-
as an “implant.”
struments of different metals separately to avoid the possibility
2.1.2 orthopedic instrument—any cooperative device used
of mixing during surgery.
during surgical procedures involving the implantation of or-
4.2 Cleaning and Sterilization:
thopedic implants. This device is referred to in this practice as
4.2.1 Prior to initial sterilization and promptly following
an “instrument.”
each surgical procedure, thoroughly and carefully clean all
3. Receiving Implants and Instruments
instruments and implants. Ultrasonic cleaners, mechanized
washers, or hand scrubbing are suitable methods, if carefully
3.1 Receipt:
done. The method employed should be utilized to prevent
3.1.1 Many implants are wrapped in special sterilizable or
impact, scratching, bending, or surface contact with any
pre-sterilized packages, envelopes, or other containers. These
materials that might affect the implant or instrument surface or
wrappings should not be removed by the receiving personnel.
configuration.
3.1.2 Carefully unwrap and handle non-sterilized implants
4.2.2 Closely follow the manufacturer’s recommendations
and instruments upon receipt to avoid scratching, marking, or
on cleaning. In hand scrubbing, use soft brushes and avoid
abrasion by other implants, instruments, unpacking tools, or by
harsh chemicals or harsh cleaning solutions.
dropping or otherwise endangering the surface finish or con-
4.2.3 After cleaning, rinse the orthopedic implants and
figuration.
instruments completely free of all residuals, soap, detergent, or
1
This practice is under the jurisdiction ofASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.21 on Osteosynthesis.
Current edition approved Oct. 1, 2004. Published October 2004. Originally
approved in 1978. Last previous edition approved in 2003 as F 565 – 00 (2003).
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F565–04
cleaning solutions. Following rinsing, dry them thoroughly. 4.4.3 Reshaping or contouring may cause complete loss of
Devote special atte
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