Benefits include improved patient safety and reduced costs
During the past 20 years, the success rates of many orthopaedic procedures improved as new materials and techniques developed. Complications and medical errors do occur, however, and surgeons continually seek methods to avoid or reduce them.
Some complications occur from preventable errors by the operating team, such as opening or implanting the wrong medical device. As a result, standardized procedures have been created and sometimes mandated for operating rooms across the country in an attempt to reduce both the risk to patients and the cost to the healthcare system.
The wrong components error
Opening the wrong component during an orthopaedic procedure can have serious consequences. If the error is discovered before the component is implanted, the component is typically discarded as waste under hospital and federal regulations. As a result, additional implant costs are incurred and millions of dollars in unused or incorrect implants are wasted every year. According to one recent study, an estimated $36 million in hip and knee arthroplasty components alone are wasted annually.
If the incorrect component is implanted, the patient outcome can be affected. Using a device that is the wrong size or does not properly match other components can lead to soft-tissue irritation, impingement, pain, decreased motion, poor function, and/or runaway wear; and ultimately, a second operation may be required.
Many hospitals follow an intraoperative standard protocol to decrease the likelihood of opening the wrong implant. Under one such protocol, the surgeon first determines which implant is needed. He or she then informs the company representative, who obtains the requested implant from the inventory and gives it to the circulating nurse. If no representative is available, the circulating nurse obtains the device from the inventory. The circulating nurse examines the label to verify that the correct implant was chosen and shows the label to the surgeon, who confirms the correct device. Only then is the prosthesis opened and placed onto the surgical field.
Most hospitals have additional protocols that occur outside the operating room to decrease such errors. Inventories are checked and rechecked to confirm that the necessary implants are available and appropriately organized. To decrease confusion, color-coded stickers may be added to labels by distributors or operating material managers.
Despite these careful processes, errors can and do occur. For example, the surgical team may open an implant that is the wrong brand, size, or side of the body. As a result, the device goes to waste or the incorrect implant is placed, resulting in substandard care and additional costs for the patient.
Inconsistency in labeling
Labels for hip and knee prostheses typically list the implant manufacturer, type of prosthesis, brand name, size, and side of the body (if applicable). The location, size, font, and even presence of this critical information, however, varies among different implants and manufacturers. The manufacturer and brand name may be large, small, or absent. Abbreviations are often inconsistent. The prosthetic size is prominent on some labels, but small and obscure on others. Additionally, size indicators may be placed among other identifying numbers.
With hundreds of different implant packages stacked on a shelf and increasing economic pressures on hospitals resulting in a shift away from specialty-specific dedicated operating room teams, these labeling inconsistencies may substantially increase the difficulty of quickly and accurately locating the correct prosthesis. Adding to the confusion, some manufacturers place two or more languages on the same label.
The impact on patient safety
Two case reports from a single institution illustrate this problem. In the first case, a 61-year-old patient scheduled for a right total knee arthroplasty mistakenly received a left tibial component, despite the fact that the operating room team followed the appropriate protocol. The surgeon requested a right tibial prosthesis and the company representative selected the device from the inventory. It was visually verified by both the circulating nurse and the surgeon. After the procedure, however, an inventory check revealed that a left tibial component, incorrectly placed in the inventory with right tibial implants, had been implanted.
The patient was promptly returned to the operating room and the correct component was implanted. The patient subsequently did well. If the error had not been discovered in the immediate postoperative period, the patient could have sustained further damage to both components, as well as endured severe pain, or accelerated wear of the implant, necessitating a more extensive revision surgery.
The second case involved a patient with a midshaft tibial fracture treated with intramedullary fixation. Because the guide wire opened for the procedure was from a different manufacturer, the diameter of the guide wire ball tip did not match the inner diameter of the nail. The error was not discovered until the surgeon could not remove the guide wire. As a result, the surgeon removed the nail, identified the error, and obtained the correct guide wire.
In both examples, a preventable error occurred because of device misidentification, which led to extra operating time, component removal, additional hardware placement, and increased risk exposure to the patient.
No wonder it’s confusing
As a result of these incidents, a nonscientific examination of a randomly selected group of 10 prosthetic labels was conducted. The results were as follows:
- Three labels did not include the name of the manufacturer.
- Two labels did not list the type of implant; although the label included a picture, the picture did not clearly indicate what was inside the box (for example, an acetabular cup or liner).
- Four labels used different typefaces and sizes to list the type of implant, which was difficult to locate. Information on implant size and the side of the body (if applicable) also varied in location, font, and character size.
- In five examples, implants by the same manufacturer had differing label structures.
These discrepancies may be associated with opening incorrect implants. Standardization of labels may decrease this incidence. If the critical end user information (manufacturer, type of implant, brand name, size, and side of body) was standardized, prominently displayed in a consistent location, with a consistent font type and size, manufacturing representatives, circulating nurses, and surgeons could easily identify the correct implants.
Color-coding or packaging schematics might also help with identification. The result would be fewer incidents of opening wrong devices, which could lead to more efficient procedures with lower complication rates and cost.
Should standardization be mandated?
Mandating standardization of implant labels should be considered. The potential benefits of standardized labeling are demonstrated in other areas of medicine and society in general. Under the Nutrition Labeling and Education Act of 1990, the Food and Drug Administration (FDA) and the Department of Agriculture redesigned the nutrition label to list the most important nutrients in an easy-to-follow format. This provides an easy-to-read label packed with relevant information for the consumer.
The FDA has stated that medical labels are “necessary for safe and effective use” and has instituted a mandatory structured product labeling system for medications. Some of the principles of this system may be applicable to orthopaedic component or other medical device package labeling. For example, information most important to the end user—the healthcare practitioner—could be at the top of the label so it can be viewed quickly and easily. A specific, logical flow of information would enable healthcare providers to quickly and easily identify relevant information on a label.
In 1983, ASTM International—an organization that provides worldwide standards for various processes related to product design, testing, manufacturing, and production—proposed an international standard for medication package labels to avoid preventable errors in medication administration. Similar recommendations could be used to develop standards for orthopaedic implant labeling.
We believe that if orthopaedic implant labels were standardized, as nutrition and medication labels are, operating room accuracy would improve and economic efficiencies would result. In this era of increasing pressures for improved healthcare quality and zero tolerance for wrong site/procedure/patient surgeries, standardized implant labels represent an easily applied mechanism to improve healthcare delivery and decrease cost. All parties involved (surgeons, manufacturers, company representatives, circulating nurses, scrub technicians, and regulatory agencies) should cooperate in creating a reasonable standard that not only addresses the concerns of each group but also improves the quality of care for the ultimate end user—the patient.
Kent Jason Lowry, MD, and William M. Mihalko, MD, PhD, are members of the AAOS Biomedical Engineering Committee; Michael S. McGrath, MD, is a fellow at the Rubin Institute for Advanced Orthopaedics, Sinai Hospital of Baltimore. The authors report the following disclosures: Dr. Lowry—Biomet; Dr. Mihalko—Aesculap/B.Braun, Johnson & Johnson, Stryker; Dr. McGrath—not available.