Additionally, infusion pumps and syringe pumps in the US (including the EU) are subject to the same safety regulations and level of supervision, and the accuracy and safety of syringe pumps is less dependent on material and dimensional deviations of the syringe. Therefore, it is reasonable for infusion pumps (and syringe pumps) to be set at a Class II regulatory level in these developed countries.
Our country's medical device regulatory system is basically a complete reference to the U.S. FDA's establishment, system and regulations, including the principles of medical device management classification and classification catalog are basically the same. Therefore, infusion pumps (and syringe pumps) are also set as Class II regulatory level.
However, hospitals and patients in our country cannot afford the high cost of specialized consumables, and commonly use PVC plastic infusion sets labeled as "suitable for gravity infusion only". These plastic infusers, when used in pressure infusion pumps, pose potential risks of "confusion of labeling, loss of precision, fatigue rupture, and non-reporting of running needles.
As mentioned earlier, unlike syringe pumps, the accuracy and safety of infusion pumps is particularly dependent on the materials, specifications, and sizes of the consumables. According to the actual situation in China at this stage, it is completely appropriate to differentiate the regulatory level of infusion pumps and syringe pumps, syringe pumps can be set up as Class II, while infusion pumps should be categorized and managed according to the Class III level.