| Conference
Wednesday, January 30, 2008 - 9 a.m. to 4 p.m.
Abstract While it may not be obvious why chemical and material characterization is an essential part of biological evaluation, ISO standards clearly link the two together. Part 18 seem to be taking on even more emphasis, as it becomes an integral part of the biological evaluation of medical devices. The international standard 10993 has been and continues to be a major driving force behind the biological safety evaluation of biomaterials and medical devices. An important step in the process is that of characterizing the material and identification of chemicals that can migrate or extract from the polymer components. Such basic information is critical to understanding biological response and risk management of the device since adverse effects caused by materials are generally chemical effects. This presentation will give guidance on how to conduct a chemical characterization evaluation of materials used in medical devices. About the Instructor Dr. David Albert has over 27 years of medical device related experience. Dave has been at NAMSA for 12 years. During this time, he has served as a Corporate Staff Chemist, Manager of the Chemistry Department and most recently as a Senior Scientist. Prior to joining NAMSA, he served as a Senior Scientist at Anatrace, Inc. where he supervised research and developed projects involving new and existing medical devices. His primary expertise is in the areas of pharmacology and biochemistry. Dave has been a faculty member in the Department of Chemistry at Lourdes College for over 10 years and an adjunct professor in the College of Pharmacy at the University of Toledo. He holds several degrees: a B.S. in Pharmaceutical Sciences, an M.S. with an emphasis in Endocrinology and Biochemistry, a Ph.D. in Chemistry and a Doctorate in Pediatric Medicine. He has presented and published numerous papers. He is currently a member of the American Association for Clinic al Chemistry (AACC), the American Chemical Society (ACS), American Association of Pharmaceutical Scientists(AAPS), Association for the Advancement of Medical Instrumentation (AAMI), Parenteral rug Association (PDA) and the Ohio Academy of Science.
Dealing with Material Equivalency and Change Control Using ISO 10993— Part 18 Abstract ISO 10993-18 addresses requirements for providing information about the chemical components of materials and plays a pivotal role in the selection process. The focus of this guidance document is on the chemical characterization of materials as an essential part of the overall biological safety of a device, but can also help in dealing with material changes and verification of equivalency. When a change is made, these same tests can be used to evaluate material equivalency. These tests provide a powerful way to evaluate and confirm equivalency with respect to mechanical, physical, chemical, and toxicological properties for any proposed material. When performed regularly, chemical characterization tests can also serve as quality control measures and test methods to evaluate and control change.
Chemical Characterization of Implantable Medical Devices Abstract While implantable medical devices are often subjected to a variety of physical and biological tests, chemical testing should be considered at least as important. The individual chemical species present in a device contribute to its physical properties, and when these species interact with the body, or are released from the device, a biological response is observed. So, it is critical that we have as much information as possible about the chemical compounds that are present. Fortunately, analytical chemists have developed a wide array of tools that we can use to chemically characterize devices. This presentation will introduce many of those tools and provide suggestions on how to select the best analytical tool to help you characterize your device.
About the Instructor Dr. Allen L. Noreen is a broadly experienced organic chemist who has mastered many analytical tools to help him solve industrial problems during his 35+ year career. He currently supervises the Investigative Chemistry Department for Legend Technical Services, where his group finds innovative ways to chemically characterize and improve polymer systems used in medical devices. He holds a B.S. degree in Chemistry from The University of St. Thomas, and a Ph.D. in Organic Chemistry from the University of Colorado. Toxicological Risk Assessment as a Part of Materials Characterization Abstract Toxicological hazard is a property of the chemical constituents of the materials from which a medical device is made and should be considered in relation to the assurance of biological safety. Therefore, for a biological safety assessment, the first step comprises chemical characterization of materials using the principles set forth in ISO 10993 Part 18. Toxicological hazards can be identified from knowledge of the toxicity of materials or extracted chemicals. The manufacturer, analytical chemists, and toxicological risk assessor, must all have input and be significant contributors to the assessment process. This type of collaborative approach will be described in this presentation along with defining the role of toxicological risk assessment and ISO 10993, Part 17 for medical devices.
Developing/Validating Critical Cleaning Protocols and Optimizing Surface Quality for Medical Devices Abstract This presentation will cover:
About the Instructor Barbara Kanegsberg, President of BFK Solutions LLC, is a recognized consultant and expert in the field of industrial cleaning and manufacturing processes. She is a founder and ongoing developer of modern industrial contamination control. As President of BFK Solutions, she uses her training and expertise in biochemistry, clinical chemistry, analytical chemistry, process development, and failure analysis to assist industry in high precision and general industrial cleaning. She develops high-performance, economically sound, safe, and environmentally preferred processes Barbara was an invited speaker at workshops on Cleanliness of Biomedical Devices at the 2003 and 2005 meetings of ASTM; she is a member of the associated ASTM committee. She has conducted numerous seminars and tutorials and has well over 50 publications in cleaning and contamination control. Barbara is the editor-in-chief of the acclaimed "The Handbook For Critical Cleaning," CRC Press, 2001. She co-authors a column in surface characterization and contamination control which regularly appears in Controlled Environments Magazine ( formerly A2C2 Magazine). Barbara Kanegsberg received the 1996 U. S. EPA Stratospheric Ozone Protection Award. She is a member of the University of Massachusetts Lowell Toxics Use Reduction Institute (TURI) Surface Cleaning Laboratory Advisory Committee. Prior to establishing BFK Solutions LLC, Barbara managed and coordinated the replacement of ozone depleting chemicals at Litton Industries. She also designed clinical laboratory tests at BioScience Laboratories. Barbara has a B.A. in Biology from Bryn Mawr College and an M.S. in Biochemistry from Rutgers University.
Sample Preparation for Biocompatibility and Chemical Characterization Testing of Medical Devices Abstract The starting point for most biocompatibility tests and chemical characterization evaluations is the creation of extracts of a medical device. The process for making these extracts is based on several guidelines such as ISO 10993 Part 12, USP General Chapter <661> and the Japanese Ministry of Health, Labor and Welfare's Guidelines for Basic Biological Tests of Medical Materials and Devices as well as others. These horizontal standards along with vertical standards cover the majority of preparations that are needed, but there are exceptions as well as devices that present unique challenges for a standard extraction process that must be addressed. Knowing how to correctly conduct the preparation of medical devices for extraction is essential for completing the overall biocompatibility assessment as well as the basis for chemical characterization. Different preparation options will be discussed as they pertain to the standards mentioned as well as how to approach the extraction process for those samples that do not allow for standard preparation techniques.
Bringing Tissue Engineered Products From Lab Bench To Market Abstract Tissue engineering integrates the fields of biomaterials, cell biology, biochemistry, biomedical engineering and clinical medicine to create living substitutes that function to repair or replace damaged or diseased tissues and organs. Unlike traditional devices, tissue constructs are engineered to remain bio-interactive after implantation, thereby offering structure as well as the physiologic functions of the replaced tissue. Often the cell-scaffold approach has been combined with the use of completely closed bioreactor systems, which maintain sterility while mimicking a physiological environment in which cells divide and secrete all human growth factors, and extracellular matrix proteins (ECM) to form a functional tissue. The human ECM secreted by neonatal fibroblasts contains collagens type I and III, fibronectin, and various sulfated glycosaminoglycans which can be used as an alternative to bovine and porcine matrix proteins for device coatings, hemostatic sponges, and repair patches. When neonatal fibroblasts are grown under hypoxic conditions the ECM also consists of embryonic proteins including collagens 4, 19, and 20. This presentation will cover the challenges and best practices for the development and approval of human cell-based tissue engineered products as well as how engineered human ECM can be used to enhance traditional devices. About the Instructor Gail K. Naughton, Ph.D., has been the Dean of the College of Business Administration at San Diego State University since August 2002. Prior to that, she spent more than 15 years at Advanced Tissue Sciences, where she was the company’s co-founder and co-inventor of its core technology. During her tenure there, Dr. Naughton held a variety of key management positions, including president. While serving as an officer and director of the Company, Dr. Naughton oversaw the design and development of the world’s first up-scaled manufacturing facility for tissue engineered products, established corporate development and marketing partnerships with companies including Smith & Nephew, Ltd., Medtronic and Inamed Corporation, was pivotal in raising over $350M from the public market and corporate partnerships, and brought four fibroblast-based products from concept through FDA approval and market launch. Dr. Naughton holds over 90 U.S. and foreign patents and has been extensively published in the field of tissue engineering. In 2000, Dr. Naughton received the 27th Annual National Inventor of the Year award by the Intellectual Property Owners Association in honor of her pioneering work in the field of tissue engineering. Dr. Naughton has continued her research in cell based products for the last 5 years and in June of 2007 founded Histogen, a regenerative medicine company focused on insoluble human extracellular matrix proteins and soluble protein products manufactured by human neonatal fibroblasts under embryonic (hypoxic) conditions.
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