Validation of effectiveness of sterilization for different weighted surgical instrument packages and their impacts on operators

Objective: To investigate the effectiveness of sterilization of different weighty surgical instrument packages and their effect on packing experience such as operators’ working satisfaction and acceptance. Methods: Orthopedic surgical instruments of the same material were grouped into 8 different weight groups: 7 kg, 9 kg, 11 kg, 13 kg, 15 kg, 17 kg, 19 kg, 21 kg. Class 4 multi-variable CI, Class 5 integrating indicator and biological indicators were put at the least favorable position for sterilization within the packages and the monitoring results were interpreted after normal sterilization cycle to assess the sterilization performance. The operators packed the instrument with the same packaging materials, and then investigators evaluated the acceptability of the instrument package weights to the operators. Results: Instrument packages weighing between 7 kg and 11 kg produced acceptable results in chemical and biological monitoring using the normal sterilization procedure. Package weight exceeding 11 kg indicated uneven color change in Class 4 multi-variable CI, while Class 5 integrating indicator and biological monitoring produced acceptable results only with some wet packs. Instrument packages exceeding 11 kg made packing difficult for operators and resulted in low satisfaction. Conclusion: Package weights not exceeding 11 kg were associated with effective sterilization in normal sterilization procedures, and with good operator satisfaction.