This module is designed to provide a review of the technological principles and clinical applications of near patient testing (NPT) in a range of
settings. Students will explore the challenges of translating innovative technology in the complex and regulated environment of
healthcare, and the leading role that NPT plays in transforming healthcare delivery.
Near Patient Testing
The spectrum of near patient testing- Areas of use, analysers and test kits. Technological development – Biosensors, Microsystems and miniaturised detection methods. Factors driving the NPT market/economic drivers – Healthcare personnel; Advances and new applications in NPT; the evolution of personalised medicine and companion diagnostics; emerging markets – infectious and lifestyle diseases. Benefits and challenges of NPT- Cost, accuracy, precision and interpretation of the test, patient care and safety, E-Health and connectivity.
Legislation and regulatory requirements
Medical device Legislation (In-vitro diagnostic Regulation 2017/746/EU), role of the Health Products Regulatory Authority and FDA, the role of the manufacturer and user Accreditation standards. In-vitro diagnostic medical devices (IVD) classification, clinical evaluation and performance characteristics, conformity assessment pathways. In-house manufacture of IVDs. Companion Diagnostics. Risk assessment and adverse incident reporting. User training and certification. Competency management, ISO standards related to NPT such as ISO 15189/22870, National NPT guidelines
Effective clinical governance
Responsibility for NPT- The role of the laboratory. Organisation of NPT- Management and oversight. NPT steering group-Membership and role. Role of NPT operational teams and the NPT. Coordinator/Administrator. Evaluation for NPT requests- Risks/benefit analysis (cost versus quality of care). Implementing a NPT service. Resources and space. Training and standard operating procedures, device access. Quality assurance- QC and EQA. Competency /proficiency testing of NPT operators. Device management - NPT connectivity, data management systems and remote access Operator management. Inventory management. Maintenance and service. Process for Adverse Incident Reporting
Sustainability in NPT
Role of NPT in sustainable development goals, WHO Essential Diagnostics List, Production and consumption history, patterns and value chains of NPT, sustainable solutions for NPT production, NPT as a tool to promote health and well-being.This module addresses UN SDG 3 and 9 Specifically targets 3.8 Quality Care and 9.5 Innovative Technology
On-line recorded lectures and on-line resources. Structured feedback on the Near Patient Testing assignment will be provided via the marking rubric in Brightspace.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |