 Dr. Jerry Nelson Nelson Laboratories Chief Science Officer Visit Website |
Jerry R. Nelson, Laboratory Director at Nelson Laboratories, has a PhD in microbiology and immunology from the University of Utah. He is a member of numerous standards-writing committees and associations, including the New York Academy of Sciences, American Society for Quality, Parenteral Drug Association, American Society of Testing and Materials, Association for Advancement of Medical Instrumentation, Society for Pharmaceutical Engineering, and the American Society for Microbiology. In addition to having published dozens of articles, he is also an adjunct professor of bioengineering at the University of Utah and an adjunct assistant professor of microbiology at Brigham Young University. Jerry was named by MPMN's sister publication, MD+DI, as one of the Top 100 Notable Individuals in the medical device industry.
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Sterilization and Biocompatibility Q&A
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When manufacturing an end product that comes into contact with the patient, is it sufficient to test the materials for biocompatibility, or must a full sample of the final product be tested? Can an assembly or a plastic molding process affect the biocompatibility of the final product? If yes, how can I ensure that the manufacturing process does not affect biocompatibility?Answered May 17th, 2011 by Expert:According to ISO 10993 guidelines, devices that make either direct or indirect contact with the patient should be tested in their final configuration and through all of their processes. Because of residuals, the processing of a device can impact its biocompatibility. Thus, mold, cleaning agents, oil, or other processing substances on the device can have a negative impact on it.