ASTM F2943-13
(Guide)Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty
Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty
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 Current 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 individual stakeholders (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 validated as more or les...
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 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.
1.3 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.
1.4 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.
1.5 It is not the intent of this guide to limit or dictate overall package labeling content.
1.6 It is not the intent of this guide to supplant existing regulatory requirements (only to augment or complement existing regulatory label requirements).
1.7 The use or application of multiple languages is not prevented by this guide; however, 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 cons...
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Designation: F2943 − 13
StandardGuide for
Presentation of End User Labeling Information for
1
Orthopedic Implants Used in Joint Arthroplasty
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 International symbols should also be considered to avoid the
need for multiple ISSL where possible.
1.1 The goal of this guide is to recommend a universal label
format (across manufacturers and various implants) of content 1.8 Use and implementation of this guide is optional and at
and relative location of information necessary for final implant the sole discretion of the implant’s manufacturer. It shall be
selection within an implant’s overall package labeling. implemented with the following considerations:
1.8.1 The content and layout of any orthopedic implant
1.2 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
1.8.2 If internal risk management activities recommend
in the operating room environment.
deviation from this guide, the manufacturer is discouraged
1.3 This goal is achieved by creating a partitioned, second-
from implementing a hybrid label that partially applies the
ary area of an implant’s package label or a separate label to
principles and recommendations in this guide.
uniformly present this information uniformly.
1.9 The values stated in SI units are to be regarded as
1.4 The authors of this guide identified the competing needs
standard. No other units of measurement are included in this
of regulatory requirements, manufacturing/distribution, and
standard.
implantidentification.Itisrecognizedthroughourtaskgroup’s
1.10 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
across manufacturers were identified.
2.1 ISO Standards:
ISO 13485 Medical Devices—Quality Management
1.5 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
1.6 It is not the intent of this guide to supplant existing
Medical Device Lables, Labeling and Information to be
regulatory requirements (only to augment or complement
Supplied—Part 1: General Requirements
existing regulatory label requirements).
1.7 The use or application of multiple languages is not 3. Terminology
prevented by this guide; however, more than one language is
3.1 Definitions:
discouragedontheimplantselectionsublabel(ISSL)definedin
3.1.1 body side, adj—implantsthatareright/leftspecificand
this guide. The language of choice is left to the manufacturer
for which side of the body they are intended.
and should be dictated by the end user and regulatory require-
3.1.1.1 Discussion—This may also include identifiers for
ments in the jurisdictions where the device is marketed.
medial/lateral or anterior/posterior.
3.1.2 company, n—the company that is primarily respon-
sible for providing the product to the end user.
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.
2
Current edition approved April 1, 2013. Published May 2013. DOI: 10.1520/ Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F2943-13. 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
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F2943 − 13
3.1.2.1 Discussion—It is preferred that this is reflective of 3.1.8.1 Discussion—This definition applies to implantable
the company designation that will be commonly used by the medical devices o
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