How do you determine the expected life of a medical device?

The device has passed its recommended replacement date

During their life cycle, most medical devices are regularly maintained and inspected, for performance and safety. Even if the device is working properly when tested, a fault may occur when the device has passed its recommended replacement date. This will then cause a continued usability issue, as parts may have become obsolete, or you discover that due to age of the device, the manufacturer may have deemed the device to be nonserviceable and/or non-upgradeable, therefore causing liability challenges.

Wear and Tear

Some devices have moving mechanical parts, that with time and depending on the frequency of use, may show premature signs of wear and tear. Damage that occurs prior to expected replacement date, may also bring forward the replacement date, as the device may become unreliable, or unsafe to use.

Based on Commercial Decisions

Sometimes, equipment vendors may shorten life expectancy from original statements, based on commercial decisions, such as short supply and cost of materials to manufacturer ongoing parts, or the preferred use of newer technology or more innovative designs. A short-life statement also benefits the vendor by limiting liability for devices that remain in service for a long time.

So, how can you best determine the replacement date for your device?

Do you use the device up to the last day of the expected life as stated by the manufacturer, stop using it early as a measure of caution, or continue to use it past that date with some level of risk assessment and extra scrutiny? In conclusion, determining the expected life of new medical devices is not easy. However, using the manufacturers recommended replacement date as a guide, combined with a live and accurate asset management system, that can provide customised analytical reports, will provide the best means of determining serviceability and life expectancy of a medical device.

DISCLAIMER: Information and resources found on the U-Tech Medical website is intended to educate, inform, and motivate readers to make their health decisions after consulting with their healthcare provider. U-Tech Medical is a Biomedical Technical Device Services Company.

The authors are not healthcare providers. NO information on this site should be used to diagnose, treat, prevent, or cure any disease or condition.