Process Challenging Devices (PCD) verify proper performance for sterilizers. The technical information report (TIR) provides reference and assistance to healthcare technicians when using PCDs to realize sterilization standards. The new TIR31:2008 updated AAMI guidelines for sterilization PCD protocol just issued replaces the 2003 version. Additional features within this revised edition include sections on ozone sterilization and extended cycles.
PCD manufacturers place a highly sterilization resistant spore within the device as a significant challenge to the mechanism being tested. When the sterilizer kills the hardy spores within the PCD, theory suggests that the apparatus provides adequate annihilation of any less challenging pathogens within the rest of the system. In short, it meets those standards.
Ozone Sterilization
Although criteria for ozone sterilization have not been set (there is only one manufacturer using this method), the AAMI felt that addressing this new process was pertinent because the equipment is available. There are similarities with other processes that use different gases to fumigate. When standards are eventually set, this new section is likely to expand in future editions as more manufacturers utilize the process.
Extended Cycles
Pervasive use of steam is now common for disinfection of complex instruments. A major change within the new publication from the 2003 report is focused upon extended cycles for sterilization, particularly when steam is involved.
Many healthcare facilities require a streamlined approach to sanitization when processing several different pieces of equipment at the same time. The typical cycle is 4 minutes at 270 degrees Fahrenheit. More manufacturers now recommend extended cycles of 5, 8, 10, 18, or 20 minutes at temperature – depending upon the specifics of the situation.
Such differing advice can cause confusion for hospitals. They may not be sure which cycle to use with a combination of instruments. The new section is intended to resolve these discrepancies and lessen any potential misunderstanding.
The TIR now provides advice to device manufacturers. This helps them choose what recommendations they give to the customer regarding which extended cycle is appropriate. Focusing on fewer cycles reduces uncertainty. The committee that produced the new TIR targeted 10 and 20 minute extended intervals at 270 degrees Fahrenheit for pre-vacuum cycles. For gravity cycles they concentrated upon 40 and 60 minutes time frames at 250 degrees Fahrenheit.
About AAMI
The Association for the Advancement of Medical Instrumentation (AAMI) is “dedicated to increasing the understanding, safety, and efficacy of medical instrumentation.” This non-profit organization was founded in 1967. Currently, it has over 6,000 members from around the world with the common goal of improving the standards of use for medical devices.
They offer multidisciplinary leadership to help contain costs, inform the industry of new technologies and policy developments, and improve professional skills to enhance patient care. The organization provides a critical forum for discussion between a variety of healthcare professions. They hold continuing education conferences; facilitate certification for healthcare technical specialists; and publicize technical documents, periodicals, books, and software related to the field.
One of the ‘hot’ topics of discussion within this organization is sterilization standards and procedures. Start your search for the sterilizer or autoclave that best meets your needs with this free report.