Lecture 1 Flashcards
What do additional definitions of POCT/NPT emphasize?
A quality-assured pathology service near the patient, enabling immediate decisions and actions that lead to improved health outcomes.
What are the main goals of NPT?
Centering the patient in the healthcare process, providing quicker responses and reducing complications, improving adherence to treatment, and increasing patient satisfaction.
What additional aims does NPT strive to achieve?
Reduced hospital visits and length of stay, optimized drug treatment, reduced use of staff, equipment, and facilities, earlier treatment initiation, improved patient outcomes, and less reliance on the healthcare system.
What factors drive the demand for NPT?
Aging demographics, chronic disease prevalence, the rise of personalized medicine, potential for long-term savings, improvements in technology, and focus on improved care
Why has POCT/NPT gained prominence?
Emphasis on patient-focused care, changes in healthcare practices, advances in POCT technology, and connectivity of modern POC test systems.
What does the Medical Devices Directive (93/42/EEC) define as a medical device (MD)?
Any instrument or article used for diagnosis, prevention, monitoring, treatment, or alleviation of disease, among other purposes for human beings.
What does Regulation (EU) 2017/746 (IVDR) define as an in-vitro diagnostic (IVD) medical device?
Any device used in vitro for examining specimens derived from the human body to provide information on various physiological or pathological processes.
Category I NPT devices
Small handheld devices for qualitative or quantitative analyte determination, such as glucose biosensor strips.
Category II NPT devices
Larger bench-top devices, like critical care analyzers, often using molecular techniques for infectious disease testing.
Where is NPT used outside of hospital and community settings?
Disaster management, extreme environments, military operations, and space research.
