September 2007

Q I work for a state psychiatric facility in the Northeast. I do the sterilizing of instruments except for our dental clinic. The dentist is here for routine work on patients a half day a week. We do no surgery here other than occasional removal of infected ingrown toenails and occasionally some suturing. Most often, the kits and instruments I sterilize expire before they are ever used, and then I have to resterilize them. The largest kits are our suture kits which contain minimal instruments. Is it really necessary or mandatory that I use biological indicators since most procedures we do are not major invasive procedures. We use a steam chemical indicator strip (class 4) in each peel pack. We have a small steam autoclave. Would that be sufficient or is the biological indicator still necessary? Thanks for your help. I await your reply.

A Sterilization monitoring is a very important part of quality assurance. Procedures involved in the reprocessing and sterilization of patient care equipment, surgical instruments and other medical devices must be developed, implemented and enforced to ensure patient and worker safety. In the development of reprocessing and sterilization procedures and policies it is essential that regulations, standards and guidelines be considered and appropriately integrated into hospital procedures. Regulatory bodies that have significant importance in sterile processing include OSHA, FDA, EPA, state and municipal Departments of Health. Other entities that greatly influence reprocessing and sterilization protocols include: JCAHO, CDC, AORN, APIC, and the CS professional associations IAHCSMM and ASHCSP. Most sterilization professionals accept and follow the (Association for the Advancement of Medical Instrumentation) AAMI guidelines.

A First and foremost you want to obtain documentation and instructions for use from the container manufacturer. It is very important to note that many rigid sterilization containers have not been validated or approved for flash sterilization. The documentation you receive should include flash sterilization validation for that specific containment device. This should include the parameters required to achieve sterilization as well as any load or chamber capacity limits such as weight, contents configuration and the like. Never attempt to use a container in a flash cycle that has not been designed for or validated for flash cycles. Do not assume that any containment device is acceptable for use in a flash cycle as long as you leave the lid ajar. There are flash containment devices such as the one you have described that are FDA cleared and do comply with AAMI and AORN flash guidelines and standards. Regarding your concern that contaminated air may enter the sterilizer and the container when the sterilizer door is opened, basic laws of physical science prevent that occurrence. Since both the flash autoclave chamber and the flash-container are exhausting steam when the door is opened this escape of steam outward will continue as long as the temperature inside of the chamber and containment device remain higher than atmospheric temperature. It is important that you slide the lid shut and close the valve prior to removing the container from the sterilizer.

Ray Taurasi is Eastern Regional Director of Clinical Sales and Services for Healthmark Industries.