Selection of the Drugs to be used to Evaluate Compatibility and Leachables for Infusion Devices

May 11, 2018

Before starting to evaluate drug compatibility and leachables from the infusion pump or other medical devices intended to deliver a drug, an FDA approved drug(s) intended for use with the device must be selected.  If the device is intended for just one drug, like an insulin pump, the selection of the drug is obvious.  If the device can be used with multiple drugs and multiple routes of administration, select a total of three drugs that are commonly used from the three most common routes of administration.  For example, if evaluating an infusion pump that is intended to deliver drugs intravenously and as an epidural, pick two common drugs for intravenous infusion and one for epidural infusion. Once the drug(s) has been selected, pick the simplest formulation of the drug to evaluate drug compatibility and leachables.

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