Which of the following medical devices would typically be classified as Class I?Select one:a. Defibrillatorb. MRI machinec. Insulin pumpd. Tongue depressor
Question
Which of the following medical devices would typically be classified as Class I?Select one:a. Defibrillatorb. MRI machinec. Insulin pumpd. Tongue depressor
Solution
The classification of medical devices is based on the level of risk associated with their use. Class I devices are considered to have the lowest risk, while Class III devices have the highest.
a. Defibrillator - This is a life-saving device used in emergency situations to restore normal heart rhythm. Due to its critical function and potential risk if it fails, it is classified as a Class III device.
b. MRI machine - This is a sophisticated imaging device used to visualize internal structures of the body. It is a complex device with significant potential risk if it fails or is used improperly, so it is classified as a Class II device.
c. Insulin pump - This is a device that delivers insulin to patients with diabetes. It is a critical device that, if it fails, could result in significant harm to the patient. Therefore, it is classified as a Class III device.
d. Tongue depressor - This is a simple device used to depress the tongue to allow examination of the mouth and throat. It poses minimal risk to the patient and is typically classified as a Class I device.
So, the answer is d. Tongue depressor.
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