AAOS Now

Published 2/1/2012
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Kent Jason Lowry, MD; William M. Mihalko, MD, PhD

Will Uniform Information Organization for Arthroplasty Implant Labeling Become a Reality?

A new “implant-selection secondary label” may be the answer

In “The impact of standardized implant labels” (AAOS Now, March 2009), members of the AAOS Biomedical Engineering (BME) Committee observed the wide variability across and within manufacturer’s labels on medical devices, specifically how critical information is organized on arthroplasty implant labels. This observation led the BME Committee to discuss engaging manufacturers in organizing critical information necessary for final implant selection in a uniform manner, similar in nature to the U.S. Food and Drug Administration’s (FDA) food nutrition label.

The BME Committee approached ASTM International, an organization that develops engineering and manufacturing standards for medical devices through a consensus-driven process, to collaboratively confront the issue. A task group was subsequently organized within the arthroplasty subcommittee (F04.22) and included representatives from the BME committee/AAOS, the FDA, major hospital systems, national healthcare participants from other countries, and orthopaedic implant manufacturers such as Aesculap USA; Biomet, Inc.; Consensus Orthopedics, DePuy Orthopaedics, Inc.; Exactech, Inc.; Smith & Nephew; Stryker; Tornier, Inc.; and Zimmer, Inc.

The task group spent 2 years discussing the challenges and barriers to a uniformly formatted device label. These discussions covered the following topics:

  • how to balance the often competing needs of manufacturing and distribution
  • regulatory requirements
  • how to enable end users to accurately identify a chosen implant
  • space availability on the package for label information
  • formatting differences desired by individual manufacturers (often based on limited focus groups held by the manufacturer)
  • the added expenses and challenges of change

After discussing and confronting these competing needs, the task group developed a working draft of the proposed standard. This draft has been put to ballot by the ASTM twice over the past 12 months and received several negative votes, which have kept it from being implemented. The most common theme for the negative votes is an unwillingness to change a given manufacturer’s processes. A revised draft is scheduled for ballot with ASTM International this spring.

A secondary label
The proposed draft standard focuses on development of an “implant-selection secondary label” (ISSL). The ISSL is a secondary area on an implant’s packaging where manufacturers will consistently organize information critical for final implant selection by an end user, such as the treating surgeon, operating room (OR) nurse, OR technician, or product sales representative.

On the ISSL, information will be organized in a consistently logical fashion, regardless of who made the implant. The end user, for example, will always be able to look to the upper right corner for size/side information and to the upper left corner for the name of the manufacturer (Fig. 1), regardless of the type of implant or the manufacturer.

To encourage the voluntary participation by manufacturers in adopting the ASTM standard, the ISSL has been designed to give them considerable flexibility in where to place the label. For example, a manufacturer may put the ISSL on the package side that is most commonly seen, such as on the end of the box that is visible when boxes are stacked on inventory shelves. Or, the label may be relocated “below” the end of the box on the adjacent surface.

The goal of the ASTM standard is to have a secondary label area on every arthroplasty implant package where critical information is always organized in a similar fashion, regardless of manufacturer or implant brand. Organizing this information in a more uniform manner should help individual processes for identifying and selecting implants become more consistent, thus reducing implant selection errors and improving patient safety and operating room quality.

We encourage you to share your comments on this effort with representatives from orthopaedic implant manufacturers. Let them know how important this effort is to hospital systems and orthopaedic surgeons nationwide who use these devices on a daily basis and desire to improve patient safety.

Kent Jason Lowry, MD, a member of the AAOS BME Committee, is in private practice in Rhinelander, Wisc.; William M. Mihalko, MD, PhD, chairs the AAOS BME Committee and is on the staff of the Campbell Clinic, Germantown, Tenn. Disclosure information: Dr. Lowry—Biomet; Dr. Mihalko—Aesculap/B.Braun; Corin U.S.A.; Saunders/Mosby-Elsevier; Journal of Arthroplasty.