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:
Installation Qualification (IQ):
requires that when a sealing device is firstused, assuming it is operated correctly, the vital parameters to ensure efficient sterilisation (sealing temperature, sealing pressure and ?sealing time) can be monitored and verified.
Operational Qualification (OQ):
is a test to determine whether in practical, everyday use the vital parameters can be easily and routinely delivered for each sterilisation cycle.
Performance Qualification (PQ):
refers primarily to staff training, and is achieved by conducting regular checks to ensure that the sealing equipment is continuing to deliver optimally sealed sterile barrier systems.
To fully comply with ISO 11607-2, each heat-sealed packaged must meet all three of the above qualifications in-practice, while self-seal pouches are only subject to the PQ in-practice, as the other two have been achieved at manufacture. Again, this would suggest that selfseal pouches are more convenient than heat-seal pouches, however this is not to say that the safety of safe-seal should be taken for granted, as the emphasis here is very much on the PQ element and continued compliance of dental practice staff.
Recontamination risk
All dental practices will be familiar with the HTM 01-05 document published by the Department of Health. In the updated document (March 2013), shelf-life of wrapped instruments was extended from 21 days for non-vacuum autoclave and 60 days for vacuum autoclave, to a maximum of one year. With the extended shelf life, team members should be aware that truly aseptic storage can only be achieved if pouches have been correctly sealed. If they have not been completely sealed in line with manufacturer guidelines then there is a significant risk of recontamination – even more so given the possibility of instruments being left in storage for anything up to a year. This presents a problem for dental practice teams. Self-seal pouches are clearly the most convenient form of sealing instruments – however not all self-seal pouches can be sufficiently validated to ensure a complete seal has been achieved.
New developments
To address the risks associated with self-seal pouches, a number of leading manufacturers are now taking steps to ensure that absolute hygiene standards cannot be compromised by a failure to properly secure the pouch seal. Some sterilisation pouches even now include ‘closure validators’ to provide peace of mind that the pouch has been correctly sealed. High quality systems, such as PeelVue+ sterilisation pouches from Dux Dental, utilise such closure validators to guarantee an effective seal, as well as boasting medical grade paper to reduce the risk of tearing and both internal and external process indicators to ensure optimum conditions were achieved throughout the process.
Sterilisation is an important part of the decontamination cycle, but though it can be a time-consuming and laborious process, it doesn’t have to be. With the latest developments in sterilisation pouches, dental team members are able to complete sterilisation protocol quickly and efficiently, while also demonstrating to patients an on-going commitment to the highest standards of hygiene within the practice.