REGU08008 2017 Sterilisation and Biocompatability

General Details

Full Title
Sterilisation and Biocompatability
Transcript Title
Sterilisation and Biocompat
N/A %
Subject Area
REGU - Regulatory Affairs
LIFE - Life Sciences
08 - NFQ Level 8
05 - 05 Credits
Start Term
2017 - Full Academic Year 2017-18
End Term
9999 - The End of Time
Mary Butler, Mary Garvey
Programme Membership
SG_SMEDI_L08 202100 Higher Diploma in Science in Medical Device Regulatory Affairs and Quality

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.

Learning Outcomes

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 Assessments

Repeat assignments will be given.

Indicative Syllabus

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

Coursework & Continuous Assessment
100 %

Coursework Assessment

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

Type Location Description Hours Frequency Avg Workload
Online Lecture Online Lecture 2 Weekly 2.00
Independent Learning Online Independent Learning 5 Weekly 5.00
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
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

Recommended Reading
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

Module Resources

URL Resources

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

eBook ISBN: 9780723436829
Paperback ISBN: 9780702045486
Paperback ISBN: 9780323080583
eBook ISBN: 9780702056666
eBook ISBN: 9780702062407
eBook ISBN: 9780702050282
Imprint: Saunders
Published Date: 17th September 2012
Page Count: 482

Introduction - Biomaterials Science: An Evolving, Multidisciplinary Endeavor. Biomaterials Science (Third Edition) 2013