Infusion Safety Management Software

What Is It?

Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission.

What Is FDA Product Code PHC?

Infusion Safety Management Software is FDA product code PHC, Class 2, 21 CFR 880.5725.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 13 recalls under this product code since 2015. None was by a company in China. 6 are Class I, the most serious grade.

The root causes the FDA records most often are Software design (3), Software Design Change (3) and Employee error (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.