The use life of an orthopedic medical device can vary greatly depending on multiple factors, including its purpose, where it’s used, whether it remains in the body, etc. As such, it can affect numerous aspects of the device’s development as well as other considerations such as its cleaning and sterilization protocols. Therefore, it’s necessary to perform a lifecycle evaluation on the product.

Given the breadth of information associated with this evaluation, ensuring all necessary aspects are included in it can be challenging. In addition, the processes used, when to perform the evaluation, and how it can affect the device’s development are all important considerations. With this in mind, assistance from a professional testing laboratory can prove invaluable to ensure the correct methods are used.

As a result, two representatives from Nelson Labs responded to several questions on use life and the lifecycle evaluation. In the following Q&A, Griffin Cammack, B.S., Expert Technical Consultant, and Audrey Turley, Global Segment Director of Biosafety, provided insights on these topics. They addressed when to perform the evaluation, why it’s necessary, what information it offers, and more.

Sean Fenske: What is an orthopedic device lifecycle evaluation? What information is included in it?

Griffin Cammack: An orthopedic device lifecycle evaluation is testing that simulates a device’s use life by performing multiple cycles consisting of simulating the use of the device and reprocessing (cleaning, disinfection, and/or sterilization). This evaluation can…