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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 validated as more or less effective than other existing implant labels currently in use.
4.5 These recommendations have been developed through the collaboration of an ASTM-sponsored task group with representation from large and small orthopedic implant manufacturers, orthopedic surgeons (specifically the Biomedical Engineering Committee from the American Academy of Orthopedic Surgeons), healthcare facility administrators, operating room nurses, the U.S. Food and Drug Administration (FDA), and the Canadian Healthcare System. The task group utilized “voice of consumer” feedback from previous manufacturer label initiatives combined with input from various end users on the task group. This process did not identify any given implant label format as being more or less effective but only attempts to prioritize information and recommend a universal format for this information. A manufacturer may determine that an alternative format may be more effective for its internal processes and elect not to follow these recommendations.
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 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 ISSLs 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ISO StandardsISO 13485 Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes ISO 15223–1 Medical Devices--Symbols to be Used with Medical Device Lables, Labeling and Information to be Supplied--Part 1: General Requirements
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42320000(Orthopedic surgical implants)