New York—March 3, 2014
"Most implant mismatches are caught before they go into people, but the parts are expensive, so if you throw one away because you realized the error before you put it in, you have wasted thousands of dollars," said Dr. Steven Haas, M.D., M.P.H., Chief of the Knee Service at HSS, and senior author of the study.
Each joint replacement implant is composed of multiple components. A variety of factors can cause a joint replacement part to be opened and not used. These include contamination of the parts upon opening, damage to the parts by a surgical team member, and the inadvertent selection of mismatched parts. Implantation of a mismatched component is a serious event, which can lead to pain, disability and early failure of the implant. These errors often require further surgeries to correct problems.
"Medical errors have been recognized as an inexcusable source of patient complications and hospital costs," said David Mayman, M.D., orthopedic surgeon at HSS who has had experience with the system. “OrthoSecureTM is an elegant, easy to use electronic system that can minimize or eliminate implant errors in the operating room."
OrthoSecureTM was developed by Sandance Technologies (Princeton, New Jersey) and then tested and validated by, and modified and improved based on input from, surgeon investigators at HSS as well as staff from HSS Perioperative Services, Information Technology, and Operational Excellence. OrthoSecureTM involves a computer program, barcodes, and a barcode scanner. Each implant part box has two barcodes, one that identifies what part it is and another that identifies the lot and expiration date. When a clinician scans a barcode, OrthoSecureTM, which recognizes most knee and hip replacement components now on the market, inputs the product information and displays it in a common label format on a large LCD screen. This "e .Label" includes pertinent information, such as the size, the side (left or right), and how the component is fixed to the bone. As a clinician scans all of the components of the implant (such as, for a knee implant, the tibia, femur, patella, and tibial insert), OrthoSecureTM determines whether the parts are compatible and, if not, displays an error message. In addition, OrthoSecureTM checks compatibility with a barcode that has been added to the patient consent form.
In addition to direct cost savings, the functionality of OrthoSecure lends itself to patient-centered care and greater overall efficiency. HSS has linked OrthoSecure to its inventory control and patient documentation software systems to enhance the workflow of the nursing staff and materials management; this translates to a direct reallocation of nursing time back to the patient, as well as improved inventory management. Further, the recently added web-based ordering module allows surgeons to provide implant orders electronically, thereby reducing errors in the order entry process and enabling delivery of implants directly to the operating room.