Incorporating Biocompatibility, Chemistry, and Toxicology into your Biological Risk Evaluation
In the past, biocompatibility consisted of determining the contact of your medical device, looking at the Table A.1 in ISO 10993-1 and running the test prescribed. This approach put too much emphasis on checking boxes of antiquated tests to screen the biocompatibility risk for modern-day complex devices.
The better approach for biocompatibility is to assess the risk of the device through consideration of its materials, geometry, and process residuals. This creates a change to the “Big Three” of biocompatibility which were cytotoxicity, sensitization, and irritation. The “Big Three” for this new risk based approach are:
Biocompatibility assessment can evaluate the impact of the geometry of the device, chemistry results, material research, intended use of the device, and toxicological evaluation to give an overview of risk and safety
Chemistry (e.g., chemical characterization, extractables/leachables) gives an understanding of the compounds that are released from a medical device. It provides insight on what the patient’s exposure would be from the use of the device.
Toxicological principles, chemistry results, genotoxicity, systemic toxicity, and carcinogenicity risks from the device are all evaluated.
Incorporating these new “Big Three” into your biocompatibility assessment will help to truly understand the risk associated with the medical device and allows the evaluation to be done with the least impact to cost and timelines.
For over a decade, Nelson Laboratories has been hosting educational seminars called The Science of Sterilization Validation. The aim of these three-day seminars has been to provide MedTech professionals the opportunity to establish or refresh their fundamental testing knowledge and, thereby, achieve more efficient, accurate, and effective testing outcomes.
As the needs of our customers have evolved, we have continuously updated our seminars to meet those changing needs. To better align with the new, more comprehensive agenda, Nelson Labs is re-naming the seminar to: Introduction to the Validation of Sterile Medical Devices: Sterilization, Packaging, Biocompatibility, Toxicology, and Reprocessing. The program will continue to be RAPS and ASQ approved for 12 RAC and 1.2 ASQ credit hours and may also qualify for AAMI credit hours. Courses are taught by Nelson Labs’ and SteriPro’s scientific experts. Highlights include, but are not limited to:
Introduction to Microbiology & Sterilization:
The introduction offers attendees an opportunity to brush up on the basics of sterilization, microbiology, and important industry terms.
Ethylene Oxide Sterilization Validation:
Learn how to develop, optimize, and validate a successful ethylene oxide sterilization process that delivers the necessary sterility assurance level and ensures repeatability.
Biocompatibility / ISO 10993:
With 24 possible categories, the biocompatibility testing experience can be intimidating. We will help you understand the testing requirements of ISO 10993 and how to choose the correct test methods for your product.
Chemical Characterization / E&L Assessments:
This topic will help you understand the analytical chemistry strategies that can be used to characterize device materials and evaluate extractable/leachable compounds.
Packaging Overview / ISO 11607:
Focused on the requirements outlined in ISO 11607, this subject will help you understand packaging validations and how to successfully navigate the package testing arena.
Radiation Sterilization Validation:
Attendees will learn how to perform radiation validations, review bioburden data, deal with sterility test failures, and understand the various radiation options (gamma, electron beam, and X-ray).
Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Devices:
Our experts will teach attendees the information and processes involved in the validation of healthcare device reprocessing instructions. Highlights include discussion of the guidance documents, standards, industry trends, and the acceptance criteria.
Cleaning Validations for Newly Manufactured Devices and Single Use Implants:
The importance of manufacturing clean devices will be discussed, and how cleanliness should be evaluated in addition to the sterility and biocompatibility of a device.
The full seminar is appropriate for professionals who are new in their role as well as for MedTech veterans. Lectures are presented by industry-leading experts and include case studies, hands-on activities, Q&A, and one-on-one time with the speakers. 100% of post-seminar survey respondents have expressed that they would recommend the seminar to a colleague or friend.