For more than 5 years, the AAOS Biomedical Engineering Committee has been working with an international standards-setting group (ASTM-International) and multiple other stakeholders to establish uniform labeling standards for orthopaedic implants. Members of the committee, as well as representatives from the U.S. Food and Drug Administration (FDA) and various orthopaedic implant manufacturers, were part of a task group charged with developing an internationally recognized standard addressing joint replacement implant label.
It wasn’t an easy task. A package label must meet several competing needs; for example, it must include information required by regulatory bodies, it must reflect the manufacturer’s branding and marketing, and it must include sufficient information to enable correct implant selection in the operating room.
Although incorrect implant identification in the operating room rarely occurs, these events may be underreported “near misses.” When they happen, they represent a significant negative patient care experience. The Biomedical Engineering Committee has reviewed several cases that highlight the impact of variable implant labeling practices on patient safety and believes that a uniform labeling standard would not only improve patient safety but also contribute to a more efficient, effective operating room.
The ASTM standard
The task group sought input from various stakeholders, including regulators, manufacturers, and end-users. It followed the ASTM-International process for standards development, which relies on openness, transparency, and consensus-building processes. In April 2013, it achieved its goal with the publication of the ASTM standard guide—Presentation of End-User Labeling Information for Orthopaedic Implants Used in Joint Arthroplasty.
The stated purpose of this standard 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.” What this means is that when someone reaches for an implant package, he or she would readily be able to spot the necessary information, because it would always appear in the same relative position, regardless of the type of implant or the manufacturer.
The standard achieves this goal by creating an Implant Selection Sub-Label (ISSL) within an implant’s package label. The ISSL is a partitioned, secondary area of an implant’s package label, divided into four distinct zones, each of which contains specific, necessary information for correct implant selection (Table 1).
Impact on safety
Root cause analyses of adverse events and “near misses” in joint replacement patients involving incorrect implant identification have identified lack of consistency in product labeling and an inability to properly assess data such as a product’s expiration date as contributing factors. A standard presentation of necessary, high-priority information would be especially helpful in smaller and community hospitals where multiple joint replacement implants are used or where operating room nurses may not have orthopaedics as their primary responsibility.
In addition, because manufacturers may change or update a label, a standard ISSL would enable easy identification of information when implants from the same manufacturer have slightly different packaging.
The attempt to develop a universal labeling standard for orthopaedic joint replacement implants is a laudable effort to help ensure patient safety for orthopaedic patients. The goal is to ensure that the implant placed in a patient is the correct implant of the correct size and side, and that its manufacturer and expiration date are appropriate. A universal labeling standard is a basic, pivotal step in achieving that goal (Fig. 1).
Despite the fact that the ASTM standard was published more than a year ago, it has not yet been implemented on a widespread basis. As it is currently published, the standard is voluntary and implementation “is optional and at the sole discretion of the implant’s manufacturer.”
And, although orthopaedic manufacturers participated in the development of the standard, a recent survey found that more than half are not planning to implement it into the product labeling practices for joint replacement. Only one third said they would support expanding the concepts of this labeling standard to other orthopaedic implant packages (such as spine, trauma, or biologics).
These attitudes persist despite the publication of the standard and the support of the Canadian Health System, the FDA, and the AAOS for a uniform labeling standard. While industry delays implementation to “assess” the impact of the labeling changes required to meet the standard, end-users continue to be confronted with a variety of confusing and inconsistent labels, and patients are at risk of an inadvertent error.
Orthopaedic surgeons and their operating room teams understand the importance of standardization in labeling and its positive impact on patient safety. It is the absolute responsibility of the operating surgeon to ensure that the correct implant is used. For this reason, we, as orthopaedic surgeons, should support improvements in any part of the selection process—including a standardized label that makes it easier to identify the appropriate implant—that can improve the safety and efficiency of joint replacement procedures.
In discussions with hospital purchasing agents, implant manufacturing sales representatives, and others, we need to become more vocal about the benefits of uniform labeling practices—benefits that have been clearly realized in other industries. The AAOS committees Biomedical Engineering, Biological Implants, and Patient Safety encourage our colleagues to actively participate in this effort.
Disclosure information: Dr. Lowry—ASTM International; Dr. Wilkinson—no conflicts; Dr. Mihalko—Aesculap/B.Braun, Medtronic, Smith & Nephew, Stryker, Saunders/Mosby-Elsevier, Springer, American Board of Orthopaedic Surgery, Inc., American Orthopaedic Association, ASTM International.
Kent Jason Lowry, MD, is in private practice with Northland Orthopedics in Rhinelander, Wisc.; Joe B. Wilkinson, MD, is a member of the AAOS patient safety committee, and William M. Mihalko, MD, PhD, is the J. R. Hyde Chair of Excellence in Biomechanical Engineering at the department of orthopaedics, University of Tennessee Health/Campbell Clinic.