Don’t take safety for granted

Verifiable hygiene procedures are a critical requirement in all healthcare facilities, and multi-use instruments involved in even the smallest invasive procedure must be sterilised after each use, or even after merely being exposed to the atmosphere.

As part of the decontamination cycle, instruments should be packed and processed in a validated steam steriliser, and should then be stored in such a way as to minimise the risk of microbiological recolonisation. There are three options available for the packing of instruments, these are: heat-seal rolls, heat-seal pouches, and selfseal pouches. Typically, heat-seal options are more inconvenient than self-seal as these require a heatsealer to be used in the closure of each pouch. This is a time consuming and therefore costly task, which has led many practice teams to turn to the self-seal option. However as with any sterilisation pouch, the safety of self-seal should not be taken for granted.

Validation requirements

All packaging processes are subject to validation requirements under BS EN ISO 11607-2. It is therefore a crucial element within the sterilisation process that the individual packets, or packaging for each unit to be sterilised, can always be proven to have maintained their integrity at all times. To meet the ISO requirements both the manufacture and use of the sterilisation packaging must either separately or jointly show compliance in three distinct phases: