| CODE | PHR2612 | ||||||||
| TITLE | Medical Devices | ||||||||
| UM LEVEL | 02 - Years 2, 3 in Modular Undergraduate Course | ||||||||
| MQF LEVEL | 5 | ||||||||
| ECTS CREDITS | 4 | ||||||||
| DEPARTMENT | Pharmacy | ||||||||
| DESCRIPTION | This study-unit combines aspects of manufacturing, science and technology, policy, regulation, and marketing, as they apply to the development and distribution of medical devices. Topics covered include: - Overview of medical devices including characteristics, applications and functions, for example surgical and infection control devices, cardiovascular devices, orthopedic devices, drug delivery devices, home healthcare devices, diagnostic and monitoring point-of-care testing devices. - Process of medical device development, manufacture, distribution, vigilance and regulation. - Overview of new developments in the medical device industry and companies leading these developments. - Quality assurance, safety and reliability of medical devices. - The role of Notified Bodies in medical devices. - Market background, including supply chain, industry drivers and challenges, emerging trends in the global medical device market, demands of customers, provision of consumer information. Study-unit Aims: The study-unit aims to provide students with an understanding of medical devices including classification, developments, technologies, applications, regulatory frameworks, risks, challenges and post-market surveillance. Learning Outcomes: 1. Knowledge & Understanding: By the end of the study-unit the student will be able to: - define and classify medical devices. - describe the process of medical device development and manufacture including different technologies used. - identify and analyse medical devices used in different settings, their characteristics and functions. - discuss key aspects of the new EU regulations governing the quality, reliability and safety of medical devices. - describe actions and responsibilities of Notified Bodies. - discuss marketing aspects related to medical devices. 2. Skills: By the end of the study-unit the student will be able to: - apply regulatory requirements in the development and distribution of medical devices to improve quality, reliability and safety of medical devices. - promote vigilance and market surveillance of medical devices. Main Text/s and any supplementary readings: Main Texts: - Jacobson B, Murray A. Medical devices: Use and safety. Churchill Livingstone; 2007. - Fiedler BA, editor. Managing medical devices within a regulatory framework. Elsevier Science; 2016. - Pommelin P. The Survival Guide to EU Medical Device Regulations. 2017. - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (available online) - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (available online) Supplementary Readings: - Harman RJ. Development and control of medicines and medical devices. Pharmaceutical Press; 2004. - Chowdhury N. European Regulation of Medical Devices and Pharmaceuticals. Springer; 2014. - Ramakrishna S, Tian, L, Wang C, Liao S, Teo WE. Medical Devices: Regulations, Standards and Practices; 2015. - Ogrodnik PJ. Class 1 devices: Case studies in medical devices design. Academic Press; 2015. - Fitzpatrick D. Implantable electronic medical devices. Academic Press; 2015. - Narayan RJ, editor. Medical biosensors for point of care (POC) applications. Elsevier/Woodhead; 2017. |
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| STUDY-UNIT TYPE | Lecture and Tutorial | ||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | Julian Fearne Karen Farrugia Baldacchino Elaine Gatt Louise Grech Francesca Wirth |
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The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints. Units not attracting a sufficient number of registrations may be withdrawn without notice. It should be noted that all the information in the description above applies to study-units available during the academic year 2023/4. It may be subject to change in subsequent years. |
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