Content area
Full Text
A process challenge device is the International Standards Organization (ISO) term that is now being used in the Association for the Advancement of Medical Instrumentation (AAMI) recommended practices and standards. This term replaces the word challenge or test pack that has been used in the past. For short it is referred to as a "PCD".
You will not routinely find the term PCD used in the labeling of commercially available challenge or test packs because it is a new term but be aware that the term "test" or "challenge pack" on that product is interchangeable with the term "PCD".
In 2003, AAMI published a Technical Information Report TIPv, AAMITIR31, Process challenge devices/test packs for use in health care facilities. This TIR provides technical information to health care facilities in the selection and use of process challenge devices (PCDs). This TIR specifically addresses biological indicator (BI) PCDs but does have Annex B which discusses the Bowie-Dick test pack. In addition, at the time this TIR was published, there were no test or challenge pack or PCD standards for hydrogen peroxide gas plasma or ozone sterilization. Information about the use of test or challenge packs/PCDs in these processes is provided by the sterilizer manufacturer.
The AAMmRSl, 2003 defines a process challenge device (PCD) as1:
"Item designed to simulate product to be sterilized and to constitute a defined challenge to the sterilization process, and used to assess the effective performance of the process."
For this inservice the term PCD does refer to test or challenge pack and will discuss biological indicator PCDs (BI PCDs), Class 5 integrating indicator PCDs (Class 5 CI PCDs), and Bowie-Dick PCDs (BD PCDs).
Biological Indicator PCDs
A BI PCD consists of a BI and may include a chemical indicator. These indicators are placed inside a package that creates a challenge to the sterilization process and that is representative of the most difficult item to sterilize in the load.
The BI PCD is the greatest challenge to the sterilization process because spores are the only currently accepted system capable of integrating all the physical parameters responsible for lethality of a sterilization process to tell you spores were killed.2,3 Chemical indicators, such as Class 5 integrating indicators are not an acceptable monitor for determining the...