Test housing

Hi everyone,

I would appreciate your advice on this.

We are a small design, development, and manufacturing company holding ISO 13485 certification. .

We have a good amount of plastics that reached their expiry date. Can we use these plastics to assemble our cassettes? as per our design and development scientists these plastics have no impact on the final device performance.

Thanks.

Not a plastics expert, by any means, but tossing this out as food for thought.

What is the effect on the plastic past its expiration date? What properties are changed? Is it more brittle? Does it discolor? (There must be something since it has an expiration date, I would think). What are the effects on the product? Maybe, if more brittle, it no longer passes a drop test?

But what if you can't identify anything and then you use the plastic, a patient is harmed, and it's revealed that a potential cause is the use of expired plastic? Is it going to be worth it?

I doubt I would ever advise a client to use expired materials. If you do, though, I would think you'd want to note it as a deviation and do a thorough (documented) risk analysis before approving it.

Full disclosure: I have no background in medical devices, so do not take any of this as a recommendation, simply as food for thought.

In non-medical device industries, raw material suppliers may not base their expiration dates on any experiential or experimental knowledge but simply because they 1) want to limit the potential liability of unknown issues, 2) only tested it to that time, or 3) want to sell more product.

In one instance, a supplier obsoleted a high temperature grease for which there was no equivalent, but we still had ongoing small-volume annual requirements for the product using that grease. We ended up repeating the design qualification tests on the grease each year and were still using it many years later. We bought 100% of their remaining stock.

Thank you guys. This provides me with an idea of what to take into consideration.