Understanding Device Lifetime in Medical Devices
By PMCF Manager, Chris Webb
In the highly regulated field of medical devices, ensuring the safety and effectiveness of products is paramount. One critical aspect that is specified within the Medical Device Regulation (EU-MDR 2017/745), is manufacturers having to provide clinical evidence to show their devices perform as expected over its entire lifetime.
Unfortunately, the MDR does not provide an exact definition for device lifetime, however, subsequent guidance documents, such as the MDCG 2022-21 PSUR Guidance, offer more clarity. According to this guidance, "The lifetime of a device is the time period specified by the manufacturer in the device documentation during which the device is expected to remain safe and effective for use/in use." Additionally, use-related lifetime statements can be considered when determining device lifetime, such as specifying that a device should be used for 5 years or 1000 treatments, whichever comes first.
Key Factors of Device Lifetime
Device lifetime is a critical consideration for various stakeholders, including manufacturers, device users, and customers.
Importance to Manufacturers:
Product Safety and Efficacy: Ensuring that a device remains safe and effective throughout its specified lifetime is crucial for patient safety. Manufacturers must conduct rigorous testing and provide evidence that their devices perform as intended over the entire duration of their use.
Risk Management: Device lifetime is closely linked to risk management processes. By defining the lifetime, manufacturers can better anticipate and mitigate risks associated with device failure or degradation over time.
Market Competitiveness: Devices with well-defined and appropriately long lifetimes can be more attractive to healthcare providers and patients. A longer device lifetime can be a significant selling point, offering better value and reliability.
Post-Market Surveillance: Understanding device lifetime aids in post-market surveillance activities. Manufacturers can monitor device performance in the field and gather data to support future product improvements and regulatory submissions.
Importance to Device Users/Customers:
End of Life: Users should stop using the device at the end of its specified lifetime. This, however, often does not happen due to the cost or risk to the patient when removing a device, which may outweigh the risk of keeping it in service, even if its safety and performance are no longer guaranteed.
Safety and Performance: If a lifetime is not defined, users do not know when the safety and performance of the device are no longer guaranteed.
Purchasing Decisions: Hospitals and customers may prefer devices with longer lifetimes if other factors are equal.
Terms often confused with Device Lifetime
There are several terms that are often confused with device lifetime but are distinct:
Shelf Life: The time period between the product being produced and being used, during which it remains safe to use and performs as intended.
Stability: This can correlate to shelf life if it relates to the amount of time a device remains stable in its original packaging. Some devices also have an in-use stability, which is the amount of time a device is safe to use after the packaging has been opened.
Operating Period: The period of active operation, i.e., the total time the device is actually used. This is not the same as the lifetime, as the lifetime does not necessarily depend on actual use.
Testing Device Lifetime with PMCF Surveys
Can device lifetime be tested within a Post-Market Clinical Follow-up (PMCF) survey? Yes, for some devices!
This is particularly feasible for medical devices with relatively short lifetimes or transient use implantable devices. Here are a couple of examples:
Short-Lifetime Devices: If the end user uses the device for its entire lifetime (e.g., a syringe).
Documented Use: If the placement and removal dates of the device are clearly recorded in patient charts (e.g., PICC catheters).
It is, however, important to note that implantable devices or those with longer lifetimes cannot be accurately tested within a survey.
Conclusion
Understanding and defining the lifetime of a medical device is crucial for ensuring its safety and effectiveness. Manufacturers must provide clear and appropriate lifetime specifications, while users need to adhere to these guidelines to maintain device performance. Differentiating device lifetime from related terms like shelf life, stability, and operating period is essential for accurate communication and evaluation. While PMCF surveys can be useful for testing the lifetime of certain devices, they may not be suitable for all, particularly those with longer lifetimes. By prioritising device lifetime, stakeholders can enhance patient safety and optimise the use of medical devices.
Purdie Pascoe’s Dedicated PMCF Survey Team
Purdie Pascoe has developed a best-practice approach, approved by EU regulators and compliant with ISO requirements and GDPR regulations, and has conducted over 400 PMCF surveys, collecting both Level 8 and Level 4 data. We can support you with the design, implementation, data collection and reporting of your PMCF surveys to ensure you collect appropriate PMCF data to be used within your MDR submissions.