 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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My company manufactures and distributes braces for orthopedic use, such as wrist braces, knee sleeves, and ankle supports. The products are mostly made out of fabrics. I am constantly being asked if biocompatibility testing is really required, considering the low risk of the devices themselves and the fact that the fabrics are used in the clothing industry. Are there any circumstances under which no testing would be performed at all? What tests would you recommend for these types of products?Answered October 5th, 2011 by Expert:There are a few circumstances in which biocompatibility testing is likely not required:
- If the same product is already on the market and has historical use data.
- If the product, device, or materials do not involve patient contact.
Although we would agree that your orthopedic brace is a low-risk device, biocompatibility testing, or at least some type of material characterization demonstrating equivalence to a product already on the market, would be required. The type of testing required for this type of device would be:
- Cytotoxicity testing; agar overlay test. This is a test for skin-contacting devices. If your device could potentially contact breached skin, we would suggest that you perform an MEM elution cytotoxicity test.
- Primary skin irritation test for skin-contacting products.
- Buehler sensitization test for skin-contacting products.