Reliability Testing of a Single-Use (Disposable) Medical Device

[NicoleinFlorida]

Hello cove,

My company has a Single-Use device that composes with two parts, the handle and component A. The component A is a real single use device. The handle can use 8 times by changing the component A.In other words, during one surgery, one handle can utilize 8 component A's at a maximum.

Right now, we would like to perform a reliability testing of the handle to prove that the handle can successfully fire 8 times. However, I am confused about the testing method.

The initial plan: 30 handles with 240 A, each handles fire 8 times. But I don't think this is reliability test.

Could you give some advice about this test?

Thanks.

 

[NicoleinFlorida]

Any one can help?

 

[Bev D]

First I am not an expert in the regulatory requirements for this type of device.

That said, most reliability tests of electrical and mechanical devices have two aspects: length of test (time or number of uses) and conditions.
Typically you would test more than the expected life/uses until failure or until you have reached a life (or number of uses) that simply wouldn't happen in the real world.
You would also test under worst case conditions. what is the worst - but not foolish - conditions that the arm will experience? think about temperature humidity, contamination, component A 'fit' that makes it more difficult for the handle to fire...

 

[pkost]

What happens to the device as it is used multiple times?
What risks have you identified if the device is used multiple times?
What could fail from excessive re use?....

Determine the characteristics that are required to ensure that the device functions effectively

Test that the product is still within these criteria after eight (probably simulated worst case) uses.

You will need sufficient confidence in your study, you may achieve this through going beyond 8 uses or increasing your repeats....Statistics isn't my area!

 

[Steve Prevette]

I'd suggest testing the handle to failure. Keep replacing with component A's until failure. Perhaps you might be able to reuse component A's so you don't waste a bunch of them. Do a test, remove and reinstall the same component A (assuming age of component A does not affect failure of the handle) and test to failure of the handle. Repeat enough times to get a good data distribution of number of times to failure, then estimate the failure rate if you stop at eight.

A lot of assumptions need to be verified, but this may be a less expensive way to do the testing.