Hello all,
We have a client that has a product that fluid flows through and then eventually enters the body. The device is also 'advertised' such that it can be strapped to the body (direct contact with skin, possibly wounds).
When they were first cleared / first developed the product, they chose Lexan 244 for the case (which can contact skin) and for a connector in the fluid path. At the time, Lexan 244 was advertised by GE as cleared for medical devices. Apparently now, though, that claim has been rescinded (by GE). Apparently they are not saying it's not safe, just not saying that it is cleared.
They don't have any biocompatibility testing since it was previously considered safe for use.
Does anyone have any experience with this material in a device? They're a small shop and may not be able to afford biocompatibility testing but they may not have a choice. Any advice? Thanks.
We have a client that has a product that fluid flows through and then eventually enters the body. The device is also 'advertised' such that it can be strapped to the body (direct contact with skin, possibly wounds).
When they were first cleared / first developed the product, they chose Lexan 244 for the case (which can contact skin) and for a connector in the fluid path. At the time, Lexan 244 was advertised by GE as cleared for medical devices. Apparently now, though, that claim has been rescinded (by GE). Apparently they are not saying it's not safe, just not saying that it is cleared.
They don't have any biocompatibility testing since it was previously considered safe for use.
Does anyone have any experience with this material in a device? They're a small shop and may not be able to afford biocompatibility testing but they may not have a choice. Any advice? Thanks.