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Module Title
LM Improving Quality and Patient Safety in novel medical technology use
School
Institute of Clinical Sciences
Department
Institute of Clinical Sciences
Module Code
02 37156
Module Lead
Matthew Campbell-Hill
Level
Masters Level
Credits
20
Semester
Semester 1
Pre-requisites
Co-requisites
Restrictions
None
Exclusions
Description
This module covers the application of quality control systems, processes and regulations used when assessing and using novel medical technologies, whether in early practice or during research, and identify possible areas for improvement. brbrMedical technology safety is a fundamental requirement of healthcare regulation and practices during development evaluation are particularly stringent. Through the use of examples from recent publications from the MTEP programme and wider regulatory research literature, the safety issues and requirements of the western medical regulation are explored.
Students work individually to review multiple individual technologies that have been assessed and identify the relevant factors that influenced the safety protocols and quality by design outcomes. Students present on specific areas of interest within quality and/or safety requirements and engagement practices required. Students also present a walk-through of the regulatory process for two devices that are already on the market, showing a deep understanding of the regulatory pathway for medical devices. The findings are presented in oral presentations and written reports, and feedback is given that students are able to refine their approaches and develop their written reports.
Learning Outcomes
By the end of the module students should be able to:
Describe how new medical technologies are regulated and the relevant regulatory bodies
Describe how requirements for quality drive innovation in medical device regulation
Evaluate the relative merits of alternative approaches for regulation in emerging technologies such as digital/software as a medical device/machine learning, enabling quality and safety in a fast evolving technology landscape; and
Demonstrate an awareness of the different approaches internationally to regulation and quality
Assessment
37156-01 : Overall Module Mark : Mixed (100%)
Assessment Methods & Exceptions
Assessment: 50% Individual presentations 50% individual written report, 2000 words
Reassessment: 100% resubmission of written report, 2000 words