Industry Confronts Challenge from New Testing Standard

Originally Published MDDI October 2002

NEWS & ANALYSIS

Leslie Laine

After several years of discussion, the chemical characterization standard, ISO 10993 Part 18, will soon be released as a final-draft international standard—possibly in early 2003. Once the standard is voted on and then officially published, manufacturers, materials suppliers, and contract testing laboratories will all face changes in how they meet biocompatibility requirements. Will industry be ready?

According to testing laboratories with which MD&DI spoke, some manufacturers are already conducing materials characterization. This type of analysis has actually been required in a general way for more than a decade in Part 1 of ISO 10993, "Biological Evaluation of Medical Devices."

Paul Upman, senior scientist at NAMSA (Northwood, OH), a nonclinical medical device testing laboratory, says that even in advance of the official release of the standard, FDA is in fact already beginning to request chemical characterization data. The agency is flexible, he says. "FDA tends to accept testing methods according to ISO, ASTM, or USP if [one of these standards organizations] addresses the need. So we have already been encountering FDA reviewers asking for characterization testing that will be covered by part 18." NAMSA has seen increased demand for materials characterization and anticipates even greater increases when the standard becomes official It has taken several steps to address the new standard, including expanding its testing capabilities and preparing publications and seminars to educate clients about the new requirements.

For the manufacturers who are already addressing chemical characterization, Part 18 will just provide helpful clarification of how to incorporate the chemical identification of all material components into the safety assessment process. For the many other manufacturers who have thus far ignored the vague language about materials characterization in the existing standard, however, meeting the new standard will be challenging.

For example, the most difficult challenge for manufacturers will probably be negotiating with materials suppliers to obtain adequate information about proprietary formulations and production processes. Without access to this information, individual manufacturers be required to incorporate a variety of new tests into their assessment processes. And the industry as a whole will waste time and effort characterizing the same materials again and again when they are used in numerous devices.

Manufacturers who market their products in Japan, where chemical characterization has been required for the last two years, have already experienced how difficult it can be to obtain enough information to satisfy characterization standards.

In her regulatory affairs position at Polystan A/S (Vaerløse, Denmark), a medical device manufacturer specializing in cardiopulmonary and extracorporeal technology, Dana Olsen has had direct experience with gathering chemical characterization data from suppliers to meet Japan's requirements. "Based on my experience," Olsen says, "suppliers of materials are not willing to act as sources of information on chemical characterization of their materials. I am afraid that medical device manufacturers alone will carry the burden of chemical analysis and, consequently, many analyses will be made on the same materials."

"Most manufacturers can't get the information from their suppliers at all, so if they want to use the materials, they have to take it upon themselves to do the testing," agrees David Ingles, medical business manager at Rapra Technology Ltd. (Shrewsbury, Shropshire, UK). Rapra Technology is a research, technology, and information provider specializing in plastics and rubber that offers contract materials testing. Like NAMSA, Rapra is also noticing an increase in requests for chemical characterization testing in anticipation of the new requirements.

Of course, it is unfair to discuss the new standard only in terms of industry's challenges. No doubt the requirements will also impart important benefits as well. For example, once materials that are already known to be safe for a particular application are characterized, extensive preclinical testing for similar applications will be unnecessary, says John Lang of Smith & Nephew plc (London), convener of the ISO working group on materials characterization. Novel materials, however, will likely require both characterization and preclinical testing.

Will the medical device industry be ready for the new chemical characterization standard when it becomes official? Can suppliers and manufacturers work together to reduce the burden of new testing requirements? And will contract laboratories expand their facilities to meet new demands for testing and to provide education on the requirements to their clients? With the standard rapidly nearing completion, all involved parties will have to be ready.

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