1、Designation: F2943 13Standard Guide forPresentation of End User Labeling Information forOrthopedic Implants Used in Joint Arthroplasty1This standard is issued under the fixed designation F2943; the number immediately following the designation indicates the year oforiginal adoption or, in the case of
2、 revision, the year of 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 variou
3、s implants) of contentand relative location of information necessary for final implantselection within an implants overall package labeling.1.2 This guide identifies the necessary, “high priority” labelcontent and recommendations for the layout and location ofinformation for accurate implant identif
4、ication by the end usersin the operating room environment.1.3 This goal is achieved by creating a partitioned, second-ary area of an implants package label or a separate label touniformly present this information uniformly.1.4 The authors of this guide identified the competing needsof regulatory req
5、uirements, manufacturing/distribution, andimplant identification. It is recognized through our task groupsefforts that, if a manufacturer elects to implement theserecommendations, balancing these competing needs may ne-cessitate changing a manufacturers internal processes, relabel-ing their entire i
6、nventory (either at a single point in time orover a defined time period), or accepting duplicate informationon an implants package label. No additional compromises thatwould allow the primary goal of uniform implant label designacross manufacturers were identified.1.5 It is not the intent of this gu
7、ide to limit or dictate overallpackage labeling content.1.6 It is not the intent of this guide to supplant existingregulatory requirements (only to augment or complementexisting regulatory label requirements).1.7 The use or application of multiple languages is notprevented by this guide; however, mo
8、re than one language isdiscouraged on the implant selection sublabel (ISSL) defined inthis guide. The language of choice is left to the manufacturerand should be dictated by the end user and regulatory require-ments in the jurisdictions where the device is marketed.International symbols should also
9、be considered to avoid theneed for multiple ISSL where possible.1.8 Use and implementation of this guide is optional and atthe sole discretion of the implants manufacturer. It shall beimplemented with the following considerations:1.8.1 The content and layout of any orthopedic implantlabel should be
10、influenced by risk management activities andall label formats should be validated.1.8.2 If internal risk management activities recommenddeviation from this guide, the manufacturer is discouragedfrom implementing a hybrid label that partially applies theprinciples and recommendations in this guide.1.
11、9 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.10 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
12、-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ISO Standards:2ISO 13485 Medical DevicesQuality ManagementSystemsRequirements for Regulatory PurposesISO 152231 Medical DevicesSymbols to be Used withMedical Device
13、Lables, Labeling and Information to beSuppliedPart 1: General Requirements3. Terminology3.1 Definitions:3.1.1 body side, adjimplants that are right/left specific andfor which side of the body they are intended.3.1.1.1 DiscussionThis may also include identifiers formedial/lateral or anterior/posterio
14、r.3.1.2 company, nthe company that is primarily respon-sible for providing the product to the end user.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 appro
15、ved April 1, 2013. Published May 2013. DOI: 10.1520/F2943-13.2Available 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, PO Box C700, West Conshohocken, PA 19428-2959. United State
16、s13.1.2.1 DiscussionIt is preferred that this is 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 F
17、ig. 1).3.1.3.1 DiscussionIn the event a pouch is 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, manufactur
18、ing,distribution, and implant selection.3.1.4 end 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
19、 fold, nbend in the packaging that forms a dividebetween 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 striven to be provided and itmay be used to assist in implant selection by
20、allowing the enduser to differentiate it from other systems.3.1.7 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
21、 to betotally or partially introduced into the human body or 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 int
22、ervention.3.1.8.1 DiscussionThis definition applies to implantablemedical devices other than active implantable medical devices(“implantable medical device” definition from ISO 13485,Clause 3.5).3.1.9 implant description, nbrief, generic description us-ing terminology comprehensible by all end users
23、 regardless ofher/his technical knowledge of the implant.3.1.10 implant selection sublabel (ISSL), nsubset of theprimary label and 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 info
24、rmation for final implant selection presented inclear, uncluttered 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, tech
25、nical description, and use of the medicaldevice, but excluding shipping documents.3.1.11.1 DiscussionSome regional and national regula-tions refer to “labeling” as “information supplied by themanufacturer” (ISO 13485, Clause 3.6 and ISO 152231,Clause 3.4).3.1.12 primary label, n“main” package label
26、of animplant, which includes all labeling needs such 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
27、 at the discretion of themanufacturer based on regulatory requirements.3.1.13 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,FIG. 1 End of BoxF2943 132component capabil
28、ity, and so forth) that aid in appropriateselection 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 joint arthroplasty, nfor this guide, this terminologyshall to include all implant types that are int
29、ended to replacethe function of an existing joint, including total jointarthroplasty, hemiarthroplasty, or unicompartmental arthro-plasty.4. Significance and Use4.1 Implantable medical device labeling often results in avariety of label formats and information prioritization. Thisvariability can be s
30、een not only across different manufacturersbut also across different implant types.3Current 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 u
31、ser needs (as identified by individualmanufacturers performing “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 variablepri
32、oritization of label information and highly variable labeldesigns. 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.34.3 N
33、o 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 individual stakehold-ers (surgeons, operating room nurses, hospital administrato
34、rs,product representatives, and manufacturers) suggests apotential, although unproven, benefit for an increased standard-ization of implant labeling.3Lowry, K. J., McGrath, M. S., Mihalko, W. M., “The Impact of StandardizedImplant Labels,” AAOS Now, March 2009, (http:/www.aaos.org/news/aaosnow/mar09
35、/clinical12.asp).FIG. 2 Visual Representation of Guide Using ISSL as Primary Identifier on End of BoxFIG. 3 Another Visual Representation of Guide Using ISSL as Primary Identifier on End of BoxF2943 1334.4 The authors of this guide believe it is important tohighlight that no universally accepted met
36、hod for validation ofa labels effectiveness 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 re
37、commendations pre-sented within this guide have not been validated as more or lesseffective compared with other existing implant labels currentlyin use.4.5 These recommendations have been developed throughthe collaboration of an ASTM-sponsored task group withrepresentation from large and small ortho
38、pedic implantmanufacturers, orthopedic 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 g
39、rouputilized “voice of consumer” feedback from previous manu-facturer label initiatives combined with input from representedend users on the task group. This process did not identify anygiven implant label format as being more or less effective butonly attempts to prioritize information and recommen
40、d auniversal format for this information. A manufacturer maydetermine that an alternative format may be more effective forits internal processes and elect not to follow these recommen-dations.5. General Considerations5.1 Labeling needs are often driven by competing regula-tory requirements, manufact
41、uring/distribution needs, and finalimplant selection 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-t
42、ered manner (see examples in Figs. 2-4).5.3 The ISSL has been developed with the ability to satisfythe needs of implant selection along with a manufacturersdistribution and packaging needs.5.3.1 The following general considerations are to be appliedto the ISSL and a manufacturer is encouraged to con
43、sider 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 published validation meth-ods of package labeling for orthopedic implants do notcurrently exist. Therefore, manufacturers a
44、re encouraged tovalidate this guides recommendations, or any alternativeformat, against a stated users needs for a particular label. It is4Haene, R. A., Sandhu, R. S., Baxandall, R., “Reading the small printlabelingrecommendations for orthopaedic implants,” Ann R Coll Surg Engl, Vol 91, No. 8,Nov 20
45、09, pp. 653657.FIG. 4 Additional Example of Guide Using ISSL as Primary Identifier on End of BoxF2943 134recommended that validation for a users needs include theimpact of other formatted labels in an operating roomenvironment, which is out of the individual manufacturerscontrol.5.3.3 Use of symbolo
46、gy should comply with existing stan-dards (such as ISO 152231).5.4 All information shall be presented with good visualcontrast and with adequate space between information toprevent clutter. Suggested color contrasts are as in Table 1(with black and white being preferred).5.5 Additional regulatory ne
47、eds or requirements, such ascompany address and so forth, shall be placed outside of theISSL.5.6 Package seams should not obstruct information withinthe ISSL.5.7 Use of multiple languages within the ISSL is discour-aged. If multiple languages are necessary, a separate, additionalISSL label located o
48、n a different surface than the primary ISSLis recommended. The primary language should be dictated bythe end user and regulatory requirements in the jurisdictionswhere the device is marketed. International symbols shouldalso be considered to avoid the need for multiple ISSLs wherepossible.6. ISSL Lo
49、cation6.1 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 needs.6.3.1 It is recognized that placement of the ISSL below thefold of the end of the box may necessitate duplication ofinformation on the implants
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