Medical Device Life-cycle Costs
The Corner Office
Wayne Moore
11/4/2025
In the on-going discussion of how to balance the life-cycle cost of medical devices there are five major issues in play:
- The expected useful life of the device
- Extending the useful life of the device
- The right-to-repair
- The end-of-life notification
- The cost of replacement
Over the next few months we will be exploring the five bullet points above in some detail.
The FDA requires the expected useful life of any given probe type/model to be included in the device Instructions for Use (IFU). The expected useful life of a medical device is defined by the original equipment manufacturer (OEM) as a time/usage analysis that factors in variables such as how many times per day the device will be used and does the device require cleaning, low-level disinfection, high level disinfection, or sterilization after use. For example, a transesophageal ultrasound probe (TEE) is used without a sheath and is exposed to gastric fluids for (sometimes) hours at a time. The TEE requires high level disinfection after each use, it is transported after use from the surgical suite to central cleaning/processing and back again, and is, by design, a delicate mechanical device. Most OEMs put the expected useful life of a TEE probe at five (5) years and publish that number in their IFU manual to inform the clinical end users as well as the HTMs. It is important to take note of what the OEM says goes into that calculation and the caveats surrounding the probe’s use and care.
Continuing the example above, a general imaging transabdominal curved array probe used in a much less hostile clinical environment than the TEE probe is often given a seven (7) year expected useful life.
Not generally described in the IFU is what to do with a probe that has passed this useful life span. One OEM instructs the customer to simply perform an electrical leakage test on the probe and visually inspect the cable and housing for defects. This, however, will not provide the information needed to ascertain the probe’s overall efficacy. Perhaps a more quantitative test could be used to determine if the probe remains substantially equivalent to a new transducer before continuing clinical use, and if not, then decide whether it should be repaired or replaced.
Next month we will explore the topic of extending the useful life of the device.
Until Next Month,
Wayne