The smallest known bacteria measures 0.2 micron so to ensure that no bacteria can make its way from a non sterile environment into a sterilised instrument set there should be no hole larger than 0.2 micron in the wrap or filter protecting the sterilised surgical instruments. This is usually impractical for paper and fibre wraps as there is no way of knowing if all the fibres are lying close enough together to prohibit the movement of bacteria across the wrap and into the set. Hence the need to wrap sets at least twice to ensure a torturous route for the bacteria to take to reach the instruments.
It is obvious that this is not ideal as there is no guarantee that the set will remain sterile post autoclaving.
That is until now!
The new surgical pouch is constructed from three layers. The two outer layers are woven and knitted polyester to provide support and high strength to the pouch, resisting tearing and punctures. The inner layer is a PTFE membrane with a maximum pore size of 0.15 micron across the whole of the membrane. This is tested and certified by using a bubble test method.
These pouches now ensure that any instruments and sterile fields autoclaved within a prepared Surgical Pouch will remain completely sterile. It is physically impossible for any bacteria to pass through the 0.15 micron pores within the internal membrane of the pouch.
These bubble tests can be performed regularly on the pouches to provide a certified guarantee that the sets will remain protected and sterile for use within theatres.
The tough polyester supports for the membrane ensure that the pouch retains its integrity even when being manhandled during transport or being dragged off storage shelving. As it is a single pouch any inspection by theatre nurses is quick and accurate.
A real concern for Surgeons and Sterile services management is the preservation of a moist environment for soiled instruments being returned to sterile services for reprocessing. Blood and proteins should not be allowed to dry onto the instruments as this makes it extremely difficult to remove during washing prior to autoclaving. Health Technical Memorandum (HTM) 01-01 lays out these requirements. Because the Surgical pouch allows steam to pass through the membrane but resist fluids from passing through (the membrane has a hydrostatic head pressure of 1.1meter) any soiled instruments returned to Sterile Services sealed in a surgical pouch will retain its moisture content ensuring compliance with (HTM) 01-01.
All materials used in the surgical pouch are recyclable. There is no landfill or incineration associated with these Sterilisation Pouches. This greatly reduces the cost of reprocessing surgical instruments and directly impacts positively on the environment. Being reusable it introduces extremely large cost savings for the trusts that employ them allowing funds to be diverted to urgent requirements whilst at the same time increasing the service and safety for patients.