Making Science a Priority in Device Testing

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI June 1998 Column

INSIDE MD&DI

Industry talks a lot about trying to avoid unnecessary testing," says Dick Wallin, the coauthor of this month's article on ISO 10993-10. The 10993 standards, he says, offer "a great opportunity for materials characterization testing to provide the solution. Once you know a material's properties, you can fix a formula, establish specifications, and then monitor manufacturing so the next time you test a product it's not because five years have passed, it's because something has changed."

ISO 10993, which addresses the biological evaluation of medical devices, has been in development for the past 10 years by Technical Committee 194 of the International Organization for Standardization (ISO) and numerous working groups. Wallin (pictured left) and his colleagues at NAMSA (Northwood, OH) have helped draft and review a number of the documents. ISO 10993 consists of several standards, including those on materials characterization, systemic effects, cytotoxicity, sample preparation, and the focus of this month's article, irritation. A 12-part series on the standards began appearing in MD&DI in January and will continue into early 1999.

"Part I, the introduction to the standards, is probably of greatest importance to the medical device industry," says Wallin. "It sets the stage for the other sections and sets forth principles for the testing of devices. In the past, the medical device industry and even regulators overlooked the importance of characterizing the chemical, physical, and toxicological properties of materials."

Increasingly, manufacturers must be prepared to answer the question, "What effects will a device—and the materials contained within that device—have on a patient over time?" Wallin and coauthor Paul Upman describe the methods used to detect contact hazards from device-released chemicals that may produce skin, mucosal, and eye irritation.

One reason why Wallin is writing this series of articles on ISO 10993 relates to the complexity of the standards and the tests. "ISO 10993 is probably the best-developed set of standards on this topic around. Some of the parts contain an extraordinary amount of detail. You could give a test outlined in these standards to a technician in any country in the world and get the same results. However, there's a huge discrepancy in the amount of direction provided for tests in other sections. In this series, we'll be able to provide concise information on the ISO biocompatibility approach as well as discuss some of the testing approaches we've taken in some areas where ISO direction is lacking."

Wallin has been involved in materials testing since he started his career at Baxter in the late 1960s. In the years before the Medical Device Amendments were passed, manufacturers simply set their own protocols for product testing and for ensuring that their products were safe.

In 1977, Wallin joined NAMSA as scientific director to expand his materials testing to devices for the entire industry. "It was a good time to broaden my testing opportunities," Wallin says. "The Medical Device Amendments and GLPs had just been passed, and I wanted the chance to do for the industry what I'd been doing for just one company." Wallin is now NAMSA's president, CEO, and chairman of the board.

Meetings continue to be held to refine and finalize the standards, and Wallin believes ISO 10993 will leave a lasting impact. "I'd like to believe this standard will move the industry from an empirical approach to device testing to a more scientific approach. Just as manufacturers follow the GMPs in manufacturing devices, they should now follow ISO 10993 in streamlining their testing processes."

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