With the growing concern over blood borne diseases e.g. hepatitis and HIV, all facilities that reprocess instruments need to document the sterility of every load. While biological indicators are considered the highest level of sterility assurance, they are living spores that require incubation at 55-60ºC for 2-7 days after processing before results are known. If the spore grows, the sterilizer has failed and the load is considered non-sterile. Sterilizers that do not pass this important test should be taken out of service until repaired and successfully re-tested. Herein lies the problem - what if the test load was not sterile and the instruments were used? What about all the other loads processed in between the weekly test load? Are they sterile or did they just get hot? How do facilities decide which load each week to check for sterility? And who decides?
Mechanical gauges built into steam sterilizers do provide time, temperature and pressure readings for each load; however, these readings are taken at the drain, not inside the packages within the load. Color change indicators are available for placement on the outside and/or inside of packages, but most turn as soon as the sterilizer gets hot. For this reason, the FDA considers color change indicators only process indicators and not sterility indicators.
Whether you work in healthcare, life insurance or you're a designer of sterilization equipment, ensuring that you have the capability to make equipment safe for use on the next patient is a vital part of good health care.