1、Designation: F2943 14Standard Guide forPresentation of End User Labeling Information forMusculoskeletal Implants1This standard is issued under the fixed designation F2943; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of
2、 last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 The goal of this guide is to recommend a universal labelformat (across manufacturers and various implants) of content
3、and relative location of information necessary for final implantselection within an implants overall package labeling.1.2 This guide recommends package labeling for musculo-skeletal based implants individually processed and packagedwith the intent of being opened at the point of use, typically inthe
4、 operating room.1.3 This guide identifies the necessary, “high priority” labelcontent and recommendations for the layout and location ofinformation for accurate implant identification by the end usersin the operating room environment.1.4 This goal is achieved by creating a partitioned, second-ary ar
5、ea of an implants package label or a separate label topresent this information uniformly.1.5 The authors of this guide identified the competing needsof regulatory requirements, manufacturing/distribution, andimplant identification. It is recognized through our task groupsefforts that, if a manufactu
6、rer elects to implement theserecommendations, balancing these competing needs may ne-cessitate changing a manufacturers internal processes, relabel-ing their entire inventory (either at a single point in time orover a defined time period), or accepting duplicate informationon an implants package lab
7、el. No additional compromises thatwould allow the primary goal of uniform implant label designacross manufacturers were identified.1.6 It is not the intent of this guide to limit or dictate overallpackage labeling content.1.7 It is not the intent of this guide to supplant existingregulatory requirem
8、ents (only to augment or complementexisting regulatory label requirements).1.8 The use or application of multiple languages is notprevented by this guide; however, use of more than onelanguage is discouraged on the implant selection sublabel(ISSL) defined in this guide. The language of choice is lef
9、t tothe manufacturer and should be dictated by the end user andregulatory requirements in the jurisdictions where the device ismarketed. International symbols should also be considered toavoid the need for multiple ISSLs where possible.1.9 Use and implementation of this guide is optional and atthe s
10、ole discretion of the implants manufacturer. It shall beimplemented with the following considerations:1.9.1 The content and layout of any orthopedic implantlabel should be influenced by risk management activities andall label formats should be validated.1.9.2 If internal risk management activities r
11、ecommenddeviation from this guide, the manufacturer is discouragedfrom implementing a hybrid label that partially applies theprinciples and recommendations in this guide.1.10 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.11
12、This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Docum
13、ents2.1 ISO Standards:2ISO 13485 Medical DevicesQuality ManagementSystemsRequirements for Regulatory PurposesISO 152231 Medical DevicesSymbols to be Used withMedical Device Labels, Labeling and Information to beSuppliedPart 1: General Requirements3. Terminology3.1 Definitions:3.1.1 body side, adjimp
14、lants that are right/left specific andfor which side of the body they are intended.1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved April 1, 2014. P
15、ublished June 2014. Originallyapproved in 2013. Last previous edition approved in 2013 as F294313. DOI:10.1520/F2943-14.2Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive,
16、PO Box C700, West Conshohocken, PA 19428-2959. United States13.1.1.1 DiscussionThis may also include identifiers formedial/lateral or anterior/posterior.3.1.2 company, nthe business that is primarily responsiblefor providing the product to the end user.3.1.2.1 DiscussionIt is preferred that this is
17、reflective ofthe company designation that will be commonly used by theend user to identify the implant.3.1.3 end of the box (EOB), nthe surface of an implantspackaging that is most commonly visible when the product isplaced in inventory/storage (see Fig. 1).3.1.3.1 DiscussionIn the event a pouch is
18、used instead ofa box, this would be the most often visualized surface of thepackage. It is often the same surface used for identification andselection of the implant by the end users and attempts tobalance the competing needs of regulation, manufacturing,distribution, and implant selection.3.1.4 end
19、 users, nindividuals who participate in the act ofselecting the requested implant from inventory for final im-plantation in a patient; these include, but are not limited to, thetreating surgeon, operating room nurse, and operating roomtechnician.3.1.5 fold, nbend in the packaging that forms a divide
20、between two surfaces of the packaging.3.1.6 graphic, ngeneric schematic of the implant.3.1.6.1 DiscussionWith the schematic, a basic representa-tion of an implants features is provided and it may be used toassist in implant selection by allowing the end user to differ-entiate it from other systems.3
21、.1.7 high-priority information, nsubset of informationrequired on the product labeling that is necessary for accurateidentification of the implant for use in the operating roomenvironment.3.1.8 implant, nimplantable medical device intended to betotally or partially introduced into the human body or
22、a naturalorifice, or to replace an epithelial surface or the surface of theeye, by surgical intervention, which is intended to remain inplace for at least 30 days after the procedure, and which canonly be removed by medical or surgical intervention.3.1.8.1 DiscussionThis definition applies to implan
23、tablemedical devices other than active implantable medical devices(“implantable medical device” definition from ISO 13485,Subclause 3.5).3.1.9 implant description, nbrief, generic description us-ing terminology comprehensible by all end users regardless ofher/his technical knowledge of the implant.3
24、.1.10 implant selection sublabel (ISSL), nsubset of theprimary label that is intended to augment/supplement theprimary label (see examples in Fig. 2, Fig. 3, and Fig. 4).3.1.10.1 DiscussionThis area of the label shall include thenecessary information for final implant selection presented inclear, un
25、cluttered manner and is the only focus of this guide.3.1.11 package labeling, nwritten, printed, or graphicmatter affixed to a medical device or any of its containers orwrappers, or accompanying a medical device, related toidentification, technical description, and use of the medicaldevice, but excl
26、uding shipping documents.3.1.11.1 DiscussionSome regional and national regula-tions refer to “labeling” as “information supplied by themanufacturer” (ISO 13485, Subclause 3.6 and ISO 152231,Subclause 3.4).3.1.12 primary label, n“main” package label of animplant, which includes all labeling needs suc
27、h as regulatoryrequirements, an individual manufacturers needs, and infor-mation for implant selection.3.1.12.1 DiscussionInformation may be included on anyor all surfaces of an implants packaging. Formatting andinformation location of this label is at the discretion of themanufacturer based on regu
28、latory requirements.FIG. 1 End of BoxF2943 1423.1.13 primary size, nmain size designator when selectingthe implant.3.1.14 secondary features, nadditional sizes or character-istics (such as coatings, porous surfaces, groups, offsets,component capability, and so forth) that aid in appropriateselection
29、 of the selected implant.3.1.15 system, nbrand name or “family” to which theimplant belongs.3.2 Definitions of Terms Specific to This Standard:3.2.1 musculoskeletal implant, nfor this guide, this termi-nology shall include all implant types utilized for the care ofmusculoskeletal-based conditions, i
30、ncluding arthroplasty,spine, fracture care, and tissue-engineered products.4. Significance and Use4.1 Implantable medical device labeling often results in avariety of label formats and information prioritization. Thisvariability can be seen not only across different manufacturersbut also across diff
31、erent implant types.3At present label designand layout is developed by a given manufacturer and representsbalancing internal needs (such as manufacturing, distribution,and marketing), regulatory requirements within variousmarkets, and end user needs (as identified by individualmanufacturers performi
32、ng “voice of the consumer” feedbackon their label designs).4.2 At no fault to any given manufacturer, this process,along with the manner in which label information competes foravailable “real estate” on a package, often leads to variableprioritization of label information and highly variable labelde
33、signs. The impact of this variability on patient care is notwell documented within the published literature. An articlefrom AAOS Now in 2009 described potential issues aroundlabel variability and gave anecdotal evidence of its impact.33Lowry, K. J., McGrath, M. S., Mihalko, W. M., “The Impact of Sta
34、ndardizedImplant Labels,” AAOS Now, March 2009, (http:/www.aaos.org/news/aaosnow/mar09/clinical12.asp).FIG. 2 Visual Representation of Guide Using ISSL as Primary Identifier on the End of the BoxFIG. 3 Another Visual Representation of Guide Using ISSL as Primary Identifier on the End of the BoxF2943
35、 1434.3 No published literature demonstrating a clear and con-clusive impact on patient safety resulting from implant labelvariability was identified. Despite this lack of evidence, anec-dotal observations and input from various involved individualsand organizations (surgeons, operating room nurses,
36、 hospitaladministrators, product representatives, and manufacturers)suggests a potential, although unproven, benefit for an in-creased standardization of implant labeling.4.4 The authors of this guide believe it is important tohighlight that no universally accepted method for validation ofa labels e
37、ffectiveness exists. Current validation methods con-sist of varying methods of customer feedback on an existinglabel design using formal customer questionnaires, informalcustomer feedback through individual polling, and internalmanufacturer-driven studies. The label recommendations pre-sented within
38、 this guide have not been validated as more or lesseffective than other existing implant labels currently in use.4.5 These recommendations have been developed throughthe collaboration of an ASTM-sponsored task group withrepresentation from large and small orthopedic implantmanufacturers, orthopedic
39、surgeons (specifically the Biomedi-cal Engineering Committee from the American Academy ofOrthopedic Surgeons), healthcare facility administrators, oper-ating room nurses, the U.S. Food and Drug Administration(FDA), and the Canadian Healthcare System. The task grouputilized “voice of consumer” feedba
40、ck from previous manu-facturer label initiatives combined with input from various endusers on the task group. This process did not identify any givenimplant label format as being more or less effective but onlyattempts to prioritize information and recommend a universalformat for this information.Am
41、anufacturer may determine thatan alternative format may be more effective for its internalprocesses and elect not to follow these recommendations.5. General Considerations5.1 Labeling needs are often driven by competing regula-tory requirements, manufacturing/distribution needs, and finalimplant sel
42、ection needs.5.2 The goal of this guide is achieved by creating an ISSLarea of an implants primary label which uniformly (acrossdiffering implants and manufacturers) presents information in aconsistently organized format, in an easy-to-view and unclut-tered manner (see examples in Figs. 2-4).FIG. 4
43、Additional Example of Guide Using ISSL as Primary Identifier on the End of the BoxTABLE 1 Suggested Color ContrastsText BackgroundBlackWhiteBlueWhiteWhiteBlueWhiteBlackF2943 1445.3 The ISSL was developed to satisfy the needs of implantselection as well as a manufacturers distribution and packag-ing
44、needs.5.3.1 The following general considerations are to be appliedto the ISSL and a manufacturer is encouraged to consider themwhen developing additional areas of an implants label. Addi-tional information and recommendations may be found in thearticle by Haene.45.3.2 Universally accepted and publis
45、hed validation meth-ods of package labeling for orthopedic implants do notcurrently exist. Therefore, manufacturers are encouraged tovalidate this guides recommendations, or any alternativeformat, against a stated users needs for a particular label. It isrecommended that validation of a users needs
46、include theimpact of other formatted labels in an operating roomenvironment, which is out of the individual manufacturerscontrol.5.3.3 Use of symbology should comply with existing stan-dards (such as ISO 152231).5.4 All information shall be presented with good visualcontrast and with adequate space
47、between information toprevent clutter. Suggested color contrasts are as in Table 1(with black and white being preferred).5.5 Additional regulatory needs or requirements, such ascompany address and so forth, shall be placed outside of theISSL.5.6 Package seams should not obstruct information withinth
48、e ISSL.5.7 Use of multiple languages within the ISSL is discour-aged. If multiple languages are necessary, a separate, additionalISSLlabel located on a different surface from the primary ISSLis recommended. The primary language should be dictated bythe end user and regulatory requirements in the jur
49、isdictionswhere the device is marketed. International symbols shouldalso be considered to avoid the need for multiple ISSLs wherepossible.6. ISSL Location6.1 The preferred or primary location of the ISSL is the endof the box for a given implant.6.2 The alternate or secondary location of the ISSL is belowthe fold of the end of the box, on the adjacent surface.6.3 Selection between the preferred or alternate location ofthe ISSL is at the discretion of the manufacturer based onpackage size restrictions or a manufacturers internal nee
