REGU08008 2017 Sterilisation and Biocompatability
The aim of this module is to give students an understanding of the importance of sterilisation of medical devices in order to insure there is no risk of microbial contamination following use. The most commonly used sterilisation methods will be discussed, detailing the theory behind the method, advantages and disadvantages and applications of each. Students will also learn about disease causing pathogens, virulence factors and associated risks to public health. This module also introduces the students to biocompatibility testing of medical devices according to the ISO guidelines, highlighting the aims and requirements for a number of assays. An overview of human anatomy, toxicology and pharmacology will also be given to ensure students are aware of the importance and risks associated with poor biocompatibility of medical devices i.e. patient morbidity, immune system response and associated diseases. Therefore, students will obtain a good understanding of the toxicology and pharmacology aspects relevant to human toxicity following exposure to medical devices and/or leachates e.g. liver and kidney function in metabolism and elimination of toxic materials. Students will gain knowledge and experience (via CA material) in all aspects of sterilisation, sterility testing (SAL, bio-burden etc) and biocompatibility of medical devices according to the ISO guidelines. This module aims to develop the students understanding of experimental procedures allowing them to understand how to conduct experiments and analyze data.
On completion of this module the learner will/should be able to;
Explain and predict the risks associated with medical device contamination, routes of contamination, microbial pathogenicity and prevention methods.
Summarise sterilisation of medical devices, requirements, application of sterilisation methods to specific materials and sterility testing methods.
Evaluate the risks associated with medical device materials from a disease risk and organ biocompatibility view.
Demonstrate an understanding of toxicity testing incorporating both target organ and systemic endpoints.
Show an ability to interpret biocompatibility testing data generated following testing and to use this to determine a materials level of compatibility.
Demonstrate an understanding of the requirements (ISO) to be met and adhered to when ensuring a medical device is both suitably sterilized and biocompatible pre and post sterilisation.
Teaching and Learning Strategies
Content will be delivered primarily via online and blended methods. Additional lecturing, as required, may be provided by outside specialists and practitioners. Learning strategies including evidence based and enquiry based learning also will be used. Resources used will include Moodle, Adobe connect, Panopto, and other multimedia such as youtube, webinars, literature databases.
Module Assessment Strategies
The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ's, project assignments, group reports and essays and oral presentations.
Repeat assignments will be given.
The following is a summary of the main topics included in this particular module: microbial pathogenicity, pathogenic and non-pathogenic bacteria, fungi and viral species, sterilisation of medical devices and biomaterials, biomaterials basic concepts, toxicology and predictive toxicology of materials, pharmacology – metabolism and elimination of xenobiotics/leachate materials associated with medical devices, target organ toxicity, immune system and immunotoxicity as a strong indicator of non-biocompatibility of test materials, conducting ISO recommended experimental procedures and analysis of data, requirements of the ISO’s relating to sterilisation and biocompatibility procedures.
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Scientific analysis- Biocompatability||Continuous Assessment||Written Report||10 %||Week 7||3,4,5|
|2||MCQ/LAQ||Continuous Assessment||Multiple Choice||20 %||Week 3||1,2|
|3||Sterilisation assignment||Continuous Assessment||Written Report||20 %||Week 11||1,2,3,6|
|4||Critical writing||Continuous Assessment||Assignment||30 %||Week 12||4,5,6|
|5||MCQ||Continuous Assessment||Multiple Choice||20 %||Week 6||1,2,3|
Online Learning Mode Workload
|Independent Learning||Online||Independent Learning||5||Weekly||5.00|
Required & Recommended Book List
2014-10-27 Regulatory Affairs for Biomaterials and Medical Devices (Woodhead Publishing Series in Biomaterials) Woodhead Publishing
All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance.
- Addresses global regulations and regulatory issues surrounding biomaterials and medical devices
- Especially useful for smaller companies who may not employ a full time vigilance professional
- Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing
2012-12-31 Biomaterials Science: An Introduction to Materials in Medicine Academic Press
The revised edition of this renowned and bestselling title is the most comprehensive single text on all aspects of biomaterials science. It provides a balanced, insightful approach to both the learning of the science and technology of biomaterials and acts as the key reference for practitioners who are involved in the applications of materials in medicine.
- Over 29,000 copies sold, this is the most comprehensive coverage of principles and applications of all classes of biomaterials: "the only such text that currently covers this area comprehensively" - Materials Today
- Edited by four of the best-known figures in the biomaterials field today; fully endorsed and supported by the Society for Biomaterials
- Fully revised and expanded, key new topics include of tissue engineering, drug delivery systems, and new clinical applications, with new teaching and learning material throughout, case studies and a downloadable image bank
A History of Biomaterials. doi:10.1016/B978-0-08-087780-8.00154-6
Sterilization of Biomaterials of Synthetic and Biological Origin. Volume 4: Biocompatibility, Surface Engineering, and Delivery of Drugs, Genes and Other Molecules.
Immunology, 8th Edition
Authors: David Male Jonathan Brostoff David Roth Ivan Roitt
Introduction - Biomaterials Science: An Evolving, Multidisciplinary Endeavor. Biomaterials Science (Third Edition) 2013