Safety Assessment of Disposable Infusion Pump Made up of PVC Used for Anesthesia Drugs

OBJECTIVE To investigate the compatibility of the disposable infusion pump with the local anesthesia drugs and provide reference for its safety. METHODS DEHP, insoluble particle and drug concentration at different time when three anesthesia drugs(bupivacaine hydrochloride injection/ropivacaine mesylate injection/tramadol hydrochloride injection) dissolves in NS and lactated ringer’s solution were tested by LC-MS/MS, light obscuration particle count test, HPLC. RESULTS The dissolving amount of DEHP was lower than the quantitation limit of LC-MS/MS and also far beyond assessment standard intravenous infusion of adults. The drug content in the disposable infusion pump was greater than 96.0% at 48 h compared with 0 h. All kinds of drugs had no obvious adsorption within 48 h. For the insoluble particle, diameter greater than 10 micron was 35.13±14.4 within 1 mL solution; diameter greater than 25 micron was 0.61±0.49 within 1mL solution. CONCLUSION It is safety for disposable infusion pump used in clinical with anesthesia drugs.