A Case of Mistaken Identity: Do You Know What Material You're Using for Your Medical Device?

The ISO 10993-18 standard for chemical characterization of materials is an essential guideline for evaluating the overall safety and biocompatibility of a medical device and its associated materials. But one critical component of the standard is often overlooked, according to David Albert, senior scientist and chief chemist at NAMSA.

In a presentation at the MEDevice Forum in San Diego last week, Albert stated that the standards document "presents to be a framework for the identification of the material and identification and qualification of the chemical constituent." However, it's important to note, he says, that many medical device manufacturers forget to actually identify the material they plan to use.

This statement, upon hearing it, sounds rather silly and obvious: Of course medical device manufacturers know what material they are using for a proposed device. But the fact is, they don't always know, Albert says. He notes that NAMSA has had numerous instances in which companies have sent polypropylene material samples, for example, for testing. Yet once the sample was infrared scanned by NAMSA, the consulting company discovered that the material was not the stated polymer at all; it was a completely different polymer.

"I think that's something we need to be cognizant of," Albert cautions. "We need to make sure that the material we think we have and that we can document is the material we [actually] have. You don't want to find out [otherwise] once you've already manufactured or gone through some process."

Albert's presentation was full of interesting tips and nuggets of advice for medical device manufacturers in regards to material characterization. For more information, check out Albert's clarifications on extractables versus leachables in material characterization. --Shana Leonard