According to Cliff Bernier, director of standards at AAMI, it is thanks to the contributions of a diverse cast of professionals—including physicians, researchers, industry and regulatory representatives—that the updated document can build upon existing knowledge while also providing a new level of clarity.
“If somebody who is not 100% familiar with particulate assessment takes a look at this technical information report, it is written in a way that they can still follow,” he said.
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The goal is that readers will be able to better grasp regulatory expectations, what kind of testing should be done, and what you should do with the resulting data.
As for what comes next, this AAMI working group is monitoring other AAMI standardization groups to keep tabs on changes in the intravenous space.
“We’re in touch with the clinicians, pathologists, and industry reps who have interest in continuing to explore knowledge gaps in this area so that AAMI can continue to develop standards that make medical products safer,” Whatley said.
About AAMI
AAMI is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 healthcare technology professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective health technology. AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for health technology and sterilization professionals.
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