Finer control of the drug flow rate through an administration set can be obtaine

Question

Finer control of the drug flow rate through an administration set can be obtained using an infusion
controller, which was invented in 1970 (Georgi, 1974). The administration set tubing interfaces
with the controller directly, for the control and adjustment of fluid drops. An external drop
sensor is also clamped to the administration set drip chamber for direct measurement of the flow
rate through the counting of fluid drops. The optical drop sensor has a reference beam that is
transmitted and received through the drip chamber. An amplified pulse train, with each pulse
representing a drop, is output from the drop sensor. This sensor pulse train is compared to a
pulse train representing the desired flow rate, which has been input by the user. This comparison
is used to adjust the actual flow rate through the tubing until it matches the desired flow rate.
(a) Is an infusion controller a medical instrument? Explain your answer.
(b) Over time, infusion controllers were replaced by volumetric infusion pumps to overcome
the controller’s pressure limitation. What is the specific pressure limitation of an
infusion controller?
A typical infusion pump uses a special administration set, in which the section of tubing in
contact with the infusion pump mechanism is made of silicone, rather than traditional PVC.
The more pliable silicone enables the pump mechanism to output much more accurate flow
rates, so that a drop sensor is no longer needed. In the Carefusion Alaris SE infusion pump,
the catheter pressure is measured as an input for estimation of catheter impedance (Voss
et al., 1997). Catheter impedance changes have been linked to the onset of the patient drug
infusion complications (Scott et al., 1996).
(c) Is the Alaris SE pump a medical instrument? Explain your answer.

Explanation / Answer

a). Yes, Infusion controllers are medical instruments. It controls the inward fluid rate or nutrients into a patients circulatory system.

c). SE Is a medical device but SE pump is not a medical device.

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