Research

What you need to know about
Biological Monitoring

The use of autoclave sterilization has been an indispensable method of assuring that today's equipment is sterile and safe, but what assurance do you have that your autoclave is functioning properly?

The Centers for Disease Control (CDC) vol. 42/No. RR-9 -
“Proper functioning of sterilization cycles should be verified by the periodic use (at least weekly) of biological indicators (i.e. spore tests).”

For many years the medical and dental fields as well as body arts studios have been monitoring their sterilization process regardless of state mandated requirements. For the safety of the facility and clients, the use of single service needles, autoclave sterilization, disposable supplies and latex gloves have been indispensable in the fight against infection. These practices along with universal precautions protect the practitioners and their clients against infection and possible cross contamination.

One regulation that is being implemented into most local health code law is the requirement for third party autoclave monitoring. Spore testing and consistent up to date record keeping might seem like overkill to some, but remember… an autoclave is a mechanical instrument. Small moving parts, gaskets and valves can malfunction and consequently put your business at great risk. (The CDC encourages testing regardless of whether or not it is mandatory in your state. “Sterilizer monitoring will greatly reduce your exposure to infectious diseases and other blood-borne pathogens.” ) It is a proactive way to reduce legal liability while providing a safe environment for yourself, your staff and your clients.

Companies like Global Autoclave Compliance, LLC have made the process of accurate testing and log keeping simple. A spore test sample is mailed to the establishment on a recurring basis determined by the facility ’s needs or local health department. The sterilization clinician places the sample into the autoclave for a complete sterilization cycle in the effort to kill the spores (Bacillus stearothermophilus) contained in the ampoule. The sample is then allowed to cool and return to the monitoring laboratory for incubation. After a full 48 hour incubation period the sample is examined and a pass or fail result is determined. The client is then informed of the outcome and the collected data can now be maintained for an accurate and up to date record book.

It is important to note that heat sensitive chemical indicators (e.g. those that change color after exposure to heat) alone do not ensure adequacy of a sterilization cycle. Their sole use is to identify packs that have been processed through the heating cycle. Spore Testing is the ultimate assurance that
all microbial life has been destroyed.