ASTM F2943-14
(Guide)Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
SIGNIFICANCE AND USE
4.1 Implantable medical device labeling often results in a variety of label formats and information prioritization. This variability can be seen not only across different manufacturers but also across different implant types.3 At present label design and layout is developed by a given manufacturer and represents balancing internal needs (such as manufacturing, distribution, and marketing), regulatory requirements within various markets, and end user needs (as identified by individual manufacturers performing “voice of the consumer” feedback on their label designs).
4.2 At no fault to any given manufacturer, this process, along with the manner in which label information competes for available “real estate” on a package, often leads to variable prioritization of label information and highly variable label designs. The impact of this variability on patient care is not well documented within the published literature. An article from AAOS Now in 2009 described potential issues around label variability and gave anecdotal evidence of its impact.3
4.3 No published literature demonstrating a clear and conclusive impact on patient safety resulting from implant label variability was identified. Despite this lack of evidence, anecdotal observations and input from various involved individuals and organizations (surgeons, operating room nurses, hospital administrators, product representatives, and manufacturers) suggests a potential, although unproven, benefit for an increased standardization of implant labeling.
4.4 The authors of this guide believe it is important to highlight that no universally accepted method for validation of a label’s effectiveness exists. Current validation methods consist of varying methods of customer feedback on an existing label design using formal customer questionnaires, informal customer feedback through individual polling, and internal manufacturer-driven studies. The label recommendations presented within this guide have not been valida...
SCOPE
1.1 The goal of this guide is to recommend a universal label format (across manufacturers and various implants) of content and relative location of information necessary for final implant selection within an implant’s overall package labeling.
1.2 This guide recommends package labeling for musculoskeletal based implants individually processed and packaged with the intent of being opened at the point of use, typically in the operating room.
1.3 This guide identifies the necessary, “high priority” label content and recommendations for the layout and location of information for accurate implant identification by the end users in the operating room environment.
1.4 This goal is achieved by creating a partitioned, secondary area of an implant’s package label or a separate label to present this information uniformly.
1.5 The authors of this guide identified the competing needs of regulatory requirements, manufacturing/distribution, and implant identification. It is recognized through our task group’s efforts that, if a manufacturer elects to implement these recommendations, balancing these competing needs may necessitate changing a manufacturer’s internal processes, relabeling their entire inventory (either at a single point in time or over a defined time period), or accepting duplicate information on an implant’s package label. No additional compromises that would allow the primary goal of uniform implant label design across manufacturers were identified.
1.6 It is not the intent of this guide to limit or dictate overall package labeling content.
1.7 It is not the intent of this guide to supplant existing regulatory requirements (only to augment or complement existing regulatory label requirements).
1.8 The use or application of multiple languages is not prevented by this guide; however, use of more than one language is discouraged on the implant selection sublabel (ISSL) defined in this guide. The langua...
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Designation: F2943 − 14
Standard Guide for
Presentation of End User Labeling Information for
1
Musculoskeletal Implants
This standard is issued under the fixed designation F2943; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope language is discouraged on the implant selection sublabel
(ISSL) defined in this guide. The language of choice is left to
1.1 The goal of this guide is to recommend a universal label
the manufacturer and should be dictated by the end user and
format (across manufacturers and various implants) of content
regulatory requirements in the jurisdictions where the device is
and relative location of information necessary for final implant
marketed. International symbols should also be considered to
selection within an implant’s overall package labeling.
avoid the need for multiple ISSLs where possible.
1.2 This guide recommends package labeling for musculo-
1.9 Use and implementation of this guide is optional and at
skeletal based implants individually processed and packaged
the sole discretion of the implant’s manufacturer. It shall be
with the intent of being opened at the point of use, typically in
implemented with the following considerations:
the operating room.
1.9.1 The content and layout of any orthopedic implant
1.3 This guide identifies the necessary, “high priority” label
label should be influenced by risk management activities and
content and recommendations for the layout and location of
all label formats should be validated.
information for accurate implant identification by the end users
1.9.2 If internal risk management activities recommend
in the operating room environment.
deviation from this guide, the manufacturer is discouraged
1.4 This goal is achieved by creating a partitioned, second- from implementing a hybrid label that partially applies the
principles and recommendations in this guide.
ary area of an implant’s package label or a separate label to
present this information uniformly.
1.10 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
1.5 The authors of this guide identified the competing needs
of regulatory requirements, manufacturing/distribution, and standard.
implantidentification.Itisrecognizedthroughourtaskgroup’s
1.11 This standard does not purport to address all of the
efforts that, if a manufacturer elects to implement these
safety concerns, if any, associated with its use. It is the
recommendations, balancing these competing needs may ne-
responsibility of the user of this standard to establish appro-
cessitate changing a manufacturer’s internal processes, relabel-
priate safety and health practices and determine the applica-
ing their entire inventory (either at a single point in time or
bility of regulatory limitations prior to use.
over a defined time period), or accepting duplicate information
on an implant’s package label. No additional compromises that
2. Referenced Documents
would allow the primary goal of uniform implant label design
2
2.1 ISO Standards:
across manufacturers were identified.
ISO 13485 Medical Devices—Quality Management
1.6 It is not the intent of this guide to limit or dictate overall
Systems—Requirements for Regulatory Purposes
package labeling content.
ISO 15223–1 Medical Devices—Symbols to be Used with
1.7 It is not the intent of this guide to supplant existing
Medical Device Labels, Labeling and Information to be
regulatory requirements (only to augment or complement
Supplied—Part 1: General Requirements
existing regulatory label requirements).
3. Terminology
1.8 The use or application of multiple languages is not
prevented by this guide; however, use of more than one
3.1 Definitions:
3.1.1 body side, adj—implantsthatareright/leftspecificand
1
for which side of the body they are intended.
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.22 on Arthroplasty.
Current edition approved April 1, 2014. Published June 2014. Originally
2
approved in 2013. Last previous edition approved in 2013 as F2943–13. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2943-14. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F2943 − 14
3.1.1.1 Discussion—This may also include identifiers for orifice, or to replace an epithelial surface or the surface of the
me
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2943 − 13 F2943 − 14
Standard Guide for
Presentation of End User Labeling Information for
Orthopedic Implants Used in Joint
1
ArthroplastyMusculoskeletal Implants
This standard is issued under the fixed designation F2943; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 The goal of this guide is to recommend a universal label format (across manufacturers and various implants) of content and
relative location of information necessary for final implant selection within an implant’s overall package labeling.
1.2 This guide recommends package labeling for musculoskeletal based implants individually processed and packaged with the
intent of being opened at the point of use, typically in the operating room.
1.3 This guide identifies the necessary, “high priority” label content and recommendations for the layout and location of
information for accurate implant identification by the end users in the operating room environment.
1.4 This goal is achieved by creating a partitioned, secondary area of an implant’s package label or a separate label to uniformly
present this information uniformly.
1.5 The authors of this guide identified the competing needs of regulatory requirements, manufacturing/distribution, and implant
identification. It is recognized through our task group’s efforts that, if a manufacturer elects to implement these recommendations,
balancing these competing needs may necessitate changing a manufacturer’s internal processes, relabeling their entire inventory
(either at a single point in time or over a defined time period), or accepting duplicate information on an implant’s package label.
No additional compromises that would allow the primary goal of uniform implant label design across manufacturers were
identified.
1.6 It is not the intent of this guide to limit or dictate overall package labeling content.
1.7 It is not the intent of this guide to supplant existing regulatory requirements (only to augment or complement existing
regulatory label requirements).
1.8 The use or application of multiple languages is not prevented by this guide; however, use of more than one language is
discouraged on the implant selection sublabel (ISSL) defined in this guide. The language of choice is left to the manufacturer and
should be dictated by the end user and regulatory requirements in the jurisdictions where the device is marketed. International
symbols should also be considered to avoid the need for multiple ISSLISSLs where possible.
1.9 Use and implementation of this guide is optional and at the sole discretion of the implant’s manufacturer. It shall be
implemented with the following considerations:
1.9.1 The content and layout of any orthopedic implant label should be influenced by risk management activities and all label
formats should be validated.
1.9.2 If internal risk management activities recommend deviation from this guide, the manufacturer is discouraged from
implementing a hybrid label that partially applies the principles and recommendations in this guide.
1.10 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.11 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.
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.22
on Arthroplasty.
Current edition approved April 1, 2013April 1, 2014. Published May 2013June 2014. Originally approved in 2013. Last previous edition approved in 2013 as F2943–13.
DOI: 10.1520/F2943-13.10.1520/F2943-14.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F2943 − 14
2. Referenced Documents
2
2.1 ISO Standards:
ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
ISO 15223–1 Medical Devices—Symbols to be Used with Medical Device Lables,Labels, Labeling and Information to be
Supplied—Part 1: General Requiremen
...
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