(1) Compared with infusion pumps that use specialized infusion sets, infusion pumps that use common infusion sets as consumables increase the following risks:
1) Common consumables have a variety of brands and specifications, and the characteristics of the parameters vary greatly among them, which are easy to overlook and confuse during clinical use.
2)Common infusion sets are generally made of PVC plastic, which is prone to fatigue rupture after prolonged peristalsis and extrusion; fatigue rupture parameters are not tested and controlled, and the risk of line rupture increases with the increase of infusion time.
3) The ability of different infuser lines to store pill doses in the event of obstructed access varies greatly, and without accurate testing and control, it is easy to cause excessive pill dose shock to the patient.
4) The elasticity of the common PVC plastic material infusion set decays with the peristaltic extrusion process, and the infusion accuracy can only be maintained for 3 to 5 hours if the traditional fully extruded peristaltic mechanism is used.
(2) Both to use ordinary infusion set for consumables, but also to ensure the safety of the infusion process, infusion pumps must take some of the following measures:
1) infusion pumps should display the current selection of the brand, specifications and registration number of the infusion set, to avoid the risk of mis-selection and misuse.
2) The number of squeezes before fatigue rupture of each infusion line should be measured at the factory, and an alarm should alert the clinical operator during use to change the squeeze site in a timely manner.
3) Determine the pressure parameter for storing and releasing dangerous pill doses after obstruction of each infusion line before leaving the factory, and accurately alarm the termination of perfusion during use, so as to avoid pill dose shock.
4) For the characteristics of PVC plastic piping, the use of semi-squeeze mechanism, temperature compensation and drip rate compensation to overcome or compensate for the sharp attenuation of accuracy due to extrusion.
(3) recently promulgated and implemented "GB9706.27-2005 infusion pump safety requirements" for the control of dietary use of common infusion device for the following risks:
(1) the introduction of "only when the relevant consumable parts, especially piping and system matching, in order to ensure the safe use of equipment"
(2) 6.1 aa) (3) Article 6.8.2, paragraph 9) "A statement of the maximum infusion pressure and blockage alarm pressure generated by the equipment, if patient lines of the specified size or marking are required to maintain the safe and normal use of the equipment"
(3) Article 6.8.2, paragraph 9) "A statement of the maximum infusion pressure and blockage alarm pressure generated by the equipment ".
(4) 6.8.3 clause ee) "The manufacturer must describe the infusion lines applicable to all tests of this standard"
(5) 51.101 in the special standard "The equipment must maintain the accuracy described by the manufacturer during the recommended infusion line replacement intervals "
(4) It is not difficult to see that as long as the relevant conditions in point (2) above are met, infusion pumps using ordinary gravity infusion sets as consumables can also meet the safety specifications of GB9706.27-2005 Infusion Pump Safety Special Requirements. Product examples can refer to the HOAIE996 infusion pump of Beijing Houai Medical.