Medical Device Classification Quiz

Overview of Medical Devices and Their Classification

• Medical devices include instruments, machines, implants, and software intended for human use in diagnosis, prevention, treatment, or monitoring of diseases or injuries.
• Healthcare activities involve prevention, diagnosis, curative, rehabilitation, and palliative care.
• In vitro diagnostic medical devices are used for examination of human specimens, such as blood or urine, to provide diagnostic or monitoring information.
• In vivo medical devices are used for internal examination within the human body.
• Medical laboratory devices include equipment for sample separation, microscopy, clinical chemistry, and hematology analysis.
• Medical imaging devices include X-ray, CT, ultrasound, MRI, and nuclear medicine imaging.
• The classification of medical devices depends on factors such as duration and degree of invasiveness, intended action on the body, and whether it delivers medicines or energy to the patient.
• The World Health Organization classifies medical devices into four levels of risk: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk).
• The FDA classifies medical devices into three regulatory classes: Class I (low risk), Class II (moderate risk), and Class III (high risk).
• The EC classifies medical devices into four classes: Class I, Class IIa, Class IIb, and Class III.
• Medical devices used in pediatric intensive care include physiological measurement devices, radiotherapy devices, and physical therapy devices.
• Point of care (POC) devices are designed to provide rapid access to information to support critical care decisions, such as portable ultrasound imaging devices and blood tests at the patient's bedside.