Abstract:
OBJECTIVE To explore the influence of hydrogen peroxide residue on the monitoring effects of three types of hydrogen peroxide chemical indicators and chemical process challenge devices (PCD) so as to provide guidance for quality control of low-temperature hydrogen peroxide sterilization.
METHODS The hydrogen peroxide residue resistance test was performed. The color changes of the different chemical indicators and chemical PCDs were observed without initiating a new sterilization procedure after the completion of the first, three consecutive, and five consecutive sterilization cycles. The statistical analysis was performed by means of Fisher's exact test.
RESULTS After the first sterilization cycle, the qualified color change of the three types of hydrogen peroxide chemical indicators occurred without starting the sterilization procedure, indicating that there were potential safety risks, especially for the class 4 indicators and PCDs. The residue resistance stability ranked as C1 superior to C2 and C3, and PCD1 superior to PCD2 and PCD3, with PCD2 more stable than PCD3. After three consecutive sterilization cycles, the hydrogen peroxide residue in the sterilization chamber increased, resulting in qualified color changes of the class 1 indicators of all the three brands; the discoloration degree of the class 4 indicators and PCDs was significantly increased compared with that after the first cycle. After five consecutive cycles, hydrogen peroxide accumulated continuously, and even the most stable PCD with the strongest discoloration resistance achieved fully qualified discoloration; the statistically significant differences were observed among the groups (
P<0.05).
CONCLUSIONS Hydrogen peroxide residues remain in the sterilization chamber and inside the PCDs after the low-temperature hydrogen peroxide sterilization, and the residual volume increases with the number of consecutive sterilization cycles. The residual hydrogen peroxide may cause false qualification of chemical indicators, leading to potential medical safety hazards. It is necessary for medical institutions to rigidly standardize operational procedures, avoid releasing sterilized items merely based on the color change of chemical indicators, and preferentially adopt chemical indicators and PCDs designed to resist hydrogen peroxide residues so as to improve the accuracy and safety of the sterilization monitoring.