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New Expectations for Biocompatibility Testing: Are You Ready?

Are you aware of the regulatory changes and testing advances involving biocompatibility?

Image of an in vitro irritation test courtesy Nelson Laboratories.

Biocompatibility testing requirements for medical devices are changing. "A lot of things are happening, on all fronts," Thor Rollins, biocompatibility specialist at Nelson Laboratories LLC, told Qmed. "ISO 10993 changed, FDA released a new guidance document for ISO 10993, and Europe issued new medical device regulations. These are all impacting the regulatory environment for medical devices.

"The changes in each are similar and focus on a risk-based approach to biocompatibility testing as the new industry standard," Rollins explained. "This makes sense considering that chemistry is evolving, science applications are getting better, and medical device complexities are increasing."

"The industry is starting to realize that the 'checkbox approach' to biocompatibility testing is no longer sufficient," he continued. "Some of the biocompatibility tests are more than 40 years old, but devices are getting more complex with the use of nanotechnology and other advances. There are newer materials, and people are wearing devices, so there's the need to evaluate user exposure over time. There's the need to understand the risks to the user."

And with new in vitro tests for biocompatibility emerging, regulators and standards bodies are taking steps to consider and include them. For instance, ISO 10993 now includes an in vitro test for irritation. "Applying medical device extracts to reconstructed human epidermis at the cellular level in a plate can predict irritation," Rollins explained.

"The method went through worldwide round-robin tests, and the results will be published shortly," he said. "We believe that FDA might be more comfortable with this. Older tests just expose an animal to an extract, and if the animal is OK, then the extract is considered 'safe.' With the newer tests, we can identify and quantify an extractable or leachable compound and develop a safety profile."

Rollins said that many of the larger medical device companies are aware of such regulatory changes and testing advances because of their involvement in round-robin testing, but many small- to medium-sized companies may not be. "These companies may only have a few products and probably haven't submitted anything to FDA recently. A lot of education needs to happen," he said.

For instance, some of the testing charts in ISO 10993 and FDA's guidance are changing completely to accommodate the risk-based approach.

With several different regulators and standards bodies taking a similar risk-based approach--Rollins says he's also helping the U.S. Pharmacopeia--industry can expect "very unified voices," he said. "They've each been very isolated for a long time, but it's been changing in the last 5 years."

Nelson Laboratories has validated the new in vitro test for irritation and is implementing other new chemistry tests. The contract lab services provider is also offering a "Biological Evaluation Plan" that can help medical device companies evaluate risks and create plans to mitigate those risks. "We can develop a well-thought-out testing plan and provide complete testing reports," Rollins said. "FDA likes it because it likes to see a proactive testing plan."

For more details, Rollins will be available for these types of consultations at MD&M East June 13-15 at Nelson Laboratories' booth, #1933.

Daphne Allen is executive editor of Pharmaceutical & Medical Packaging News and a contributor to MD&DI and Qmed. Reach her at [email protected] and on Twitter at @daphneallen

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