From Condoms to Brain Implants: Protecting Patient Safety Across the Device Spectrum Through Biological Assessment

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Event Information

Event Topic:
From Condoms to Brain Implants: Protecting Patient Safety Across the Device Spectrum Through Biological Assessment

Date/Time:
Date(s) - 12/05/17
8:30 am - 10:15 am

Event Location:
Sunnyvale City Council Chambers- 456 West Olive Ave., Sunnyvale,

Speaker Information

Event Speaker:
Audrey Turley, RM(NRCM), CBA(ASQ)

Event Speaker Title:
Biocompatibility Expert

Event Speaker Company:
Nelson Labs

Event Speaker Bio:

Audrey Turley has 20 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert having performed all the in vitro tests offered at Nelson Laboratories, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM and NIH methods), and genotoxicity (Ames and chromosome aberration). Audrey also has experience performing, consulting and training on bioburden, microbial IDs, sterility and bacteristasis/fungistasis testing. She trains staff within the biocompatibility department and works on a company- wide level to trouble shoot problems. Audrey was responsible for the development of the in vitro mammalian chromosomal aberration assay at Nelson Laboratories. This included connecting with industry experts who developed the assay under OECD. She is also on the team at Nelson Laboratories for developing the in vitro skin irritation assay for medical devices. Audrey is collaborating with ISO members around the world to approve a procedure for round robin testing in order for this assay to gain acceptance by regulatory bodies in Europe and then in the United States. Audrey is an active committee member of many working groups with the Association for the Advancement of Medical Instrumentation (AAMI).

Event Details

Cost:
$0

Event Details:
Using a risk-based approach to address biocompatibility has become mainstream, and actively encouraged by the FDA. This strategy allows manufacturers to leverage previous testing knowledge of device materials and chemistry to reduce their testing burden while improving patient safety. The caveat? Manufacturers have to better understand their materials and how they interact with the body. This presentation will cover assessment of biocompatibility through case studies focusing on real medical devices (including condoms). Bullet Points (what will be covered):  Updates to guidance documents that emphasize using a risk-based approach to biocompatibility  Options and strategies to address biocompatibility with an emphasis on different classes of devices  Examples of where material assessment has dramatically reduced testing burden