Technical evaluation of a new sterile medical device to improve anticancer chemotherapy administration.

PURPOSE/OBJECTIVES: To assess the PCHIMX-1 (Doran International), a new sterile medical device intended by its manufacturer to improve the quality and safety of cytotoxic drug infusions, as well as its influence on manipulation times required for pharmacy technicians and nurses and its effect on infusion line outflow parameters. DESIGN: PCHIMX-1 assemblies were compared to standard infusion sets. SETTING: Pharmacy and oncology units of a French general hospital. METHODS: Reference assemblies (an infusion bag connected to an infusion set) were compared to PCHIMX-1 assemblies (PCHIMX-1 connected to two bags and to an infusion set). Two assessments were performed: (a) comparison of the times of manipulation during both preparation and administration of 5-fluorouracil infusion bags (n = 40) and (b) effect of PCHIMX-1 on infusion quality. MAIN RESEARCH VARIABLES: Manipulation times in the pharmacy (TP) and in the ward (TW) were measured, as well as flow rate and infusion efficiency. FINDINGS: The results showed that TW was significantly increased, whereas TP was significantly decreased; total time was unchanged. Results also showed that PCHIMX-1 significantly changed infusion efficiency; flow rate was not affected. CONCLUSIONS: PCHIMX-1 obliges pharmacy technicians and nurses to change their handling procedures. The device does not have any influence on infusion flow rate but considerably improves infusion quality by ensuring that the full quantity of medication prescribed is administered. IMPLICATIONS FOR NURSING: PCHIMX-1 guarantees that the complete prescribed dose of chemotherapy is administered without any change in infusion quality and adheres to the latest recommendations concerning occupational exposure protection.