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Medical Device Lifecycle Testing: More is Better

thoracoscope Medical Device Lifecycle Testing

Life-saving surgeries rely, more and more often, on increasingly complex surgical tools. Meanwhile, the global climate crisis increasingly demands we rely less on single-use surgical instruments and medical supplies. This has made medical device lifecycle testing more important than ever. 

But shifting to reusable medical instruments can be tricky. There is no risky calculus when going into surgery with a single-use . That can’t be said for doing surgery #199 with a reusable duodenoscope that has been designed to be used 200 times.

As a medical device engineer once noted:

“If we design a tool to 200 uses, that means 200 trips through the autoclave. If we can get it to 300 autoclave cycles and it’s still working perfectly, we could stop. But we really prefer to just keep autoclaving it until it fails, because that’s a nice data point to have.”

This is why Priorclave has worked to make this sort of medical device lifecycle testing as easy as possible:

When testing is easier, product development teams can run more test cycles. When lives are on the line, more product testing is always better. 

Medical Device Lifecycle Testing with Priorclave Autoclaves

In 2015, Priorclave worked with a Minnesota-based medical device manufacturer specializing in robotic-assisted surgical systems. They’d developed a suite of tools that could improve accuracy and precision during orthopedic surgery while eliminating the need for repeated CT scans during pre-surgical planning.

This set of surgical tools included a specialized electrical sensor encased in a metal and plastic enclosure assembled with epoxy. The medical device manufacturer had concerns about how this device would hold up to repeated uses and sterilization. There were so many potential points of failure: the sensor itself, the wiring, the plastic case, the epoxy holding it all together, etc.

One might assume that the ideal solution would be to get the most common hospital autoclave and simply run the surgical tool through repeated cycles until it fails. But FDA-approved medical-grade autoclaves are not ideal for research. They are expensive, high-maintenance devices built around a high-throughput steam-jacketed design that makes them extremely resource consumptive.  

On top of that, few hospital-grade autoclaves can be programmed to run a complete sterilization cycle, sit idle until the chamber has cooled to room temperature, and then automatically initiate another sterilization cycle with no further operator action. Because the process needed a “babysitter,” this medical device maker could not run more than two or three tests each day. It would take them months to confirm that their device was practical and any substantive change would necessitate starting the sterilization durability testing over again from scratch.

Repeat Programmable Priorclave Autoclaves Give Labs More Sterilization Cycles with Less Hands-On Time

All Priorclave autoclaves allow the operator fine control over every operating parameter (e.g., pressure, temperature ramps, dwell times, vacuum initiation, etc.). Our engineers worked with the lab, outfitting them with a non-jacketed, programmable research-grade autoclave, and helping them sort out a program that would run a repeatable cycle emulating hospital autoclave sterilization conditions—including a complete cool-down period prior to automatically initiating another sterilization cycle.  

The medical device maker’s testing throughput soared. Previously, they’d topped out at three cycles per day. Once they had their Priorclave programmed, they were regularly setting it up at the end of the workday and running it overnight, arriving in the morning to find 10 to 15 sterilization cycles complete.

As their mechanical engineer noted at the time, “When it’s less work to do tests, you do more testing. When it was me pushing the button, draining and filling the autoclave, I can tell you that we did the minimum number of tests that our quality group would agree was safe. But now that it’s easy, we find ourselves hitting that minimum number of cycles, then saying ‘Well, it didn’t fail; just keep running it for another week, another two weeks, and see how high we can get.'”