Full Title Design Assurance, Sterilisation and Biocompatability

Short Title Design Assur, Sterlis'n :-:- Bio

Code REGU09011
Level 09
Credit 05

Author Butler, Mary
Department Life Sciences

Subject Area Regulatory Affairs
Attendence N/A%
Fee

Description
This module is taken by Level 9 students in Medical Technology Regulatory Affairs. It aims to provide students with a detailed knowledge and understanding of the design assurance process, common sterilization techniques for medical devices, associated standards and validation. It aims to provide a basic understanding of common biocompatibility testing methods and interpretation of results.

Indicative Syllabus
The following is a summary of the main topics included in this particular module: DesignAssurance, sterilization techniques for medical devices; sterilization standards; packaging and sterilization; factors to consider in sterilization method choice; Biocompatibility standards; Biocompatibility test methods; Report generation; Characterization of materials/devices.

Learning Outcomes
On completion of this module the learner will/should be able to
  1. Demonstrate an ability to develop verifiable design inputs and understand the links to risk management activities

  2. Design a test protocol including risk based acceptance criteria, sample sizes and use of appropriate statistical methods.

  3. Develop a test report strategy and demonstrate ability to generate reports.

  4. Critically assess the use of standard and non standard test reports.

  5. Illustrate they have a detailed knowledge and understanding of the common sterilization techniques for medical devices.

  6. Critique procedures and standards currently regulating medical device sterilization and validation requirements.

  7. Source and interpret ISO10993-1 for evaluation of the biocompatibility of medical devices. Apply classification of the device as outlined in the standard

  8. Demonstrate an understanding of the common biocompatibility testing methods and interpretation of the test results.

  9. Formulate and communicate an understanding of the rationale and benefit of product characterization.

  10. Evaluate sterilization methods under various headings to include packaging, products effects, costs etc.

  11. Formulate and communicate an ability to generate biocompatibility reports to meet regulatory requirements


Assessment Strategies
The module will be assessed on the basis of 100% continuous assessment. Some or all of the following assessment modes may apply: examinations, practical work, projects, essays, vivas, seminars, and assignments. These assessments may be organised at different centres throughout the country and a selection of assignments may be assessed.

Sample Technologies in use during assessments
Moodle
Adobe connect
Turnitin
Panopto
Microsoft office
Multimedia including DVDs, webinars, youtube video clips, online videos

Assessment Facilitites
Moodle access

Module Dependencies
Pre Requisite Modules
None
Co Requisite Modules
None
Incompatible Modules
None

Coursework Assessment Breakdown %
Course Work / Continuous Assessment 100 %

Coursework Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Assignment written assignment 5,6,7,8,10 60 Week 9
Case Study workshop scenarios (formative) 4,9,11 20 Week 12
LAQ 1,2,3,5 20 Week 3


End Exam Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week


Distance Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Part Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Online Lecture Not Specified Lecture 2 Weekly 2.00

Total Average Weekly Learner Workload 2.00 Hours

Full Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Independent Learning Online Independent Learning 5 Weekly 5.00

Total Average Weekly Learner Workload 0.00 Hours

Resources
Book Resources

Other Resources
None
Url Resources
http://www.elsevier.com/books/regulatory-affairs-for-biomaterials-and-medica
l-devices/amato/978-0-85709-542-8
Additional Info

ISBN BookList

Book Cover Book Details
Stefanos Zenios 2009 Biodesign: The Process of Innovating Medical Technologies Cambridge University Press
ISBN-10 0521517427 ISBN-13 9780521517423
Elaine Whitmore 2012 Development of FDA-Regulated Medical Products: A Translational Approach, Second Edition Quality Press
ISBN-10 0873898338 ISBN-13 9780873898331