The Need for Lifecycle Evaluations of Orthopedics—An Orthopedic Innovators Q&A

By Sean Fenske, Editor-in-Chief

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 address a couple of things: it can provide information on how the device performs (i.e., the functionality and material compatibility) and the biological safety of the device over multiple uses

Audrey Turley: From a biocompatibility perspective, it is an evaluation of the materials and manufacturing processes throughout the full life of a device. The full life of a device is from the date of manufacture to expiry or the length of expected use. For an orthopedic device, this could include an implant or a tool used for the implantation procedure. This presents a unique scenario where one manufacturer may have, in the same kit, a single-use device (e.g., the implant) and reprocessed devices (e.g., surgical tools). An additional complexity of this scenario is if multiple sizes of implants are included in a surgical tray, but only one is implanted and the remaining sizes will be reprocessed for another surgery. Each scenario requires a different lifecycle evaluation.

For surgical tools, we want to ensure they are free of manufacturing and surgical debris. The manufacturing debris is mainly a concern for the first-time use. After that, the concern is to remove any debris from the surgical procedure. This would require a cleaning validation and a disinfection validation.

For the implants, these would primarily need validations to ensure the cleaning agents are fully removed prior to patient exposure for the predetermined number of cleaning cycles to which an implant may be exposed. If the implant is not included in a surgical tray and reprocessed several times, then it will need to be validated for the expiry date, meaning whether the materials are stable and compatible with the packaging and storage environment.

Fenske: Why is such an evaluation performed? What is its purpose? Who requires the information?

Turley: Considering the different environments an orthopedic device could be exposed to, we want to ensure the final product is delivered to the patient as intended in material and manufacturing. This is a component of a biocompatibility evaluation required in ISO 10993-1 (2025), specifically section 4.3: “The biological evaluation of a medical device shall consider its lifecycle.” As this is an international standard, this is required for any medical device submitted to a regulatory agency that cites compliance with this standard.

Cammack: Just to add, there are two main reasons to perform this testing. The first reason is that it provides information on the functionality and material compatibility of a device as it is used and reprocessed over the course of its lifetime. This helps manufacturers understand when their devices have met their maximum use life and how reprocessing products (i.e., detergents and disinfectants) interact with their devices. However, this is not a required test for reusable medical devices. Manufacturers have two options to determine the maximum use life for their devices.

1. State the number of uses for the device, which will require a lifecycle evaluation.
2. Provide the end user with a method or mechanism to determine whether the device has met its maximum use life. This does not necessarily require a lifecycle evaluation.

The second reason to perform a lifecycle evaluation is that it provides information on the biological safety of the device over multiple uses. It addresses whether the multiple uses affect the surface of a device that may impact its biological safety over the device’s use life.

Fenske: When is this performed? Does it impact the development of the device, or is the information used for a future version?

Turley: This testing is typically performed when a final finished product has been developed. However, consideration of this requirement should be done at the beginning of the design process. When selecting materials for a medical device, fitness for purpose is considered first, but ISO 10993-1 (2025) also states, “The potential for change in the characteristics of the medical device during transport, storage or use (e.g. where there is anticipated degradation or potential for physical failures causing exposure to previously unevaluated materials or constituents) shall be considered.”

Cammack: Also, keep in mind that this testing is performed after the reprocessing procedures have been validated. This ensures the testing accurately represents the cleaning, disinfection, and/or sterilization that will be used by the end users. Depending on the outcome of the testing, it may affect the development of the device. The testing may show that the materials are not compatible with the reprocessing methods, which may affect the current development and any future version of a device.

Fenske: How are sustainability and/or environmental considerations affected by the lifecycle evaluation?

Cammack: Lifecycle evaluations help manufacturers understand how long a device can be used, which will in turn provide information on how often the device needs to be replaced. Lifecycle evaluations can provide this insight so manufacturers can make appropriate decisions on the number of devices to manufacture.

Fenske: Does the lifecycle evaluation drive testing or post-market surveillance activities?

Turley: Yes, lifecycle evaluation drives both testing and post-market surveillance activities. Testing is performed when data are needed to demonstrate the stability and safety of any residuals/leachables over time and processing. Post-market surveillance activities are critical sources of data that can be used to update biological evaluations throughout the full production life of a device.

Fenske: Is there a regulatory impact from the lifecycle evaluation? Does the FDA or the EU’s MDR gain access to this information?

Cammack: The results from this testing may be required by the FDA or another notified body to demonstrate that the device is safe to use over a listed maximum use life.

Turley: To expand a bit, lifecycle evaluation was a large component of the most recent EU MDR update, so this has been on the radar for the EU for some time. While the FDA has had its own approach on this subject, it seems it is receiving more attention in the U.S. during submissions.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?

Cammack: Many orthopedic devices do not have a defined maximum use life and, as such, it can be difficult to know how many cycles to perform for lifecycle evaluations. Additionally, there is no current standard or guidance document that dictates the testing. While this may seem like there is not much guidance out there, it means there may be more than one way to approach the testing. This can allow for creative solutions to potential problems that occur during testing. Ultimately, you will want to ensure that whatever method you choose can be scientifically justified.

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