Can PC Plastic Material be used in Medical Device Cases?

[maple68]

Thanks Kuyakut.

You mentioned handheld device. I was reading an artical discussing if biocompatibility is nessassary for handheld casing. From your experience, what do you think?

Thanks again,

Maple

 

[JeantheBigone]

Skin contact is skin contact.

I had a funny discussion one time when I was on the phone with someone at the FDA. It was concerning a device with a part approx 4" diameter which was to be placed on the patient's body for a total of about 20 minutes / day. The FDA employee said we needed biocompatibility because of the skin contact. As I was talking with him, I realized that I was holding the phone under my chin. I said "you know, I spend about an hour on the day with this phone receiver touching my face. Is that biocompatible?"

He replied, "we're not responsible for phones, only medical devices."

You can try getting clearance without it if you can't get the datasheet from the plastic supplier, your worst case fallback is to put a caution on the label to wear gloves while handling it.

 

[maple68]

Thanks a lot.

Is the caution on label sufficient, or we have to get the material tested?

Also I have another question. When a material is classified as medical grade, does it mean it passed the IEC 10993 test?

Thanks again,

 

[JeantheBigone]

I dug a little bit on the internet and found myself back in the Cove!

"Medical Grade" is a loose definition. Apparently it refers to testing to USP Class VI, which is not the same thing as the battery of ISO 10993 test which may be required.
http://elsmar.com/Forums/showthread.php?t=16152

That makes sense to me, since "medical grade" can take on different meanings depending on on whether the device has skin contact, bone contact, blood contact, etc and correspondingly the required ISO 10993 tests are different.

So the short answer is "no" they are not the same thing.

As far as how you proceed, I cannot say what is best for you. What happened to us is we got a deficiency letter because we had not demonstrated biocompatibility in our 510(k). Rather than spend the $10,000 or whatever to get it done, we simply added a caution in the labeling to wear clothing. You can try submitting it and see what happens. If you get a deficiency letter you can add the caution. Maybe in the future if you submit a modification you can change your polymer to one where the supplier has done the testing and can give you a datasheet.

 

[kuyakut]

Hi Maple,

For biocompatibility we do for most of our handheld device on my current company . Not that it is necessary but because someone from RA department drafted the procedure that all medical device components - including handheld device must comform biocompatibility. With my previous company we dont do biocompatibility on our medical handheld device components whether it has skin contact to the patient.

Kuyakut

 

[maple68]

Thanks a lot, JeantheBigone. This is very helpful.

 

[maple68]

Kuyakut,

Thanks a lot! It looks this is a case-by-case requirement...

Maple