INSIDE THE CURRENT ISSUE

January 2008

Q We seem to be increasing the volume of items that require flash sterilization. I work in a surgery center and we recently added two new eye surgeons and our case load has increased dramatically. However our OR business manger will not allow us to purchase any additional instrumentation and feels that we can continue to schedule back-to-back cases and flash the instruments sets. I believe that this is dangerous and goes against best practices. Where can I get support to convince the manager we need to curtail this practice and purchase more instruments?

Figure 1

A The use of Flash sterilization does have an appropriate application. When the process is controlled, performed properly and monitored it is not necessarily an inferior process. Scientifically and technically the process is sound. The major concern and problem lies in the inappropriate and excessive use of the process as is the case with any process that is hasty and done under pressure the potential of error, complacency and compromise is heightened. Often times there are breaches in proper cleaning, decontamination, loading and appropriate exposures. Further when using an open tray process there is a great potential for contamination when removing sterile items from the flash sterilizer and transporting to the operating room. The sterilization process requires the strict adherence to protocols and there can be no short cuts. The practice of flash sterilization should be reserved for true emergencies and unanticipated events that may occur intra operatively. Recommendations by CDC, AAMI, JCAHO, AORN state flash should be kept to minimum, not used to compensate for insufficient inventory of instruments, to save time or for reasons of convenience. You may use these recommendations to support your case to purchase the needed instrumentation. The use of proper flash sterilization containers can decease the concerns relative to contamination during removal from sterilizer and transit to OR. (See figure 1)

Q I was of the understanding that there were 5 classes of chemical indicators but recently I heard somewhere that there was a new type of indicator considered a class 6 chemical indicator. I could not find anything about it in the AAMI documents that we recently purchased or in any of the CS technical manuals. What can you tell me about this? Is there a class 6 indicator and is it something we need to be using?

A Class 6 chemical indicators known as an emulating indicator are cycle specific devices. While they are more widely used in the European market to date they are not readily available or used much in the U.S. Class 6 emulators have a very narrow pass / fail window and are specific to a particular sterilization exposure cycle. Labeling on the device clearly delineates the precise sterilization temperature and exposure time for which the CI is effective. Usage of class 6 emulating chemical indicators are currently not included in any AAMI recommended user documents. There are many questions and decisions to be made relative to the appropriate use and benefits of use of class 6 emulators in the U.S. In the states we are already challenged by and trying to deal with the ever increasing number of different extended sterilization cycles required by medical device manufacturers. The use of Class 6 emulators, as they stand now, could very well involve the use of many different CIs each for use in a single specific sterilization exposure cycle. It would not be practical or reasonable to expect users to maintain an inventory of so many different CIs; and it would also be very confusing to CS staff. It might however be likely that in the future a class 6 emulator might be developed that could be used in a range of cycles perhaps with some sort of an advance indicator specific to different exposures. If this would be possible and if the emulator’s response could be correlated to a BI the device would have more appeal and application in the U.S. I believe as class 6 CIs further develop and the benefits of use become more popular you will indeed see AAMI documents created for user guidance.

Q We recently had a BI which was positive; a review of the mechanical print out showed that the items were accidently run on the wrong cycle. We were able to retrieve all of the items that were processed in the load. The OR director and our infection control nurse insisted that we issue a recall of all products that were processed in the sterilizer since the last time we ran a BI with a negative result. To no avail I tried to convince them that that was an over reaction to an identified problem and that it was not necessary to do. We ended up sending out an alert and retrieving what products we could find that had been sterilized in the previous week and a notice was sent to all physicians whose patient may have used questionable products. Do you feel it was appropriate to do such a broad recall?

A Although current recommendations require a biological indicator be run only once weekly in each sterilizer more frequent use of biological indicators would greatly reduce the depth of a product recall when necessary. AAMI user documents state that the daily use of BIs is a preferable practice. AAMI ST79:2006 recommends that if the BI failure was not the result of an identified operator error such as the selection of the improper cycle, than all items processed in the sterilizer since the last negative BI results must be considered unsterile and should be retrieved. Since the incident you described was a result of operator error it was not necessary to do such an extensive recall. Now that this incident is behind you I would suggest that you regroup with your OR director and infection control nurse to revisit and revise your biological monitoring and recall policies using professional guidelines such as AAMI documents to guide you in the development of best practice protocols for your hospital. Having well-defined policies and procedures allows for expedient action when necessary eliminating any misunderstanding and confusion amongst staff.

Ray Taurasi is Eastern Regional Director of Clinical Sales and Services for Healthmark Industries. His healthcare career spans over three decades as an administrator, educator, technologist and consultant. He is a member of AORN, ASHCSP, AAMI and a past president of IAHCSMM and has served on and contributed to many national committees with a myriad of professional organizations, manufacturers, corporations and prestigious healthcare networks. Taurasi has been a faculty member of numerous colleges teaching in the divisions of business administration and health sciences. In addition to this column he has authored several articles and has been a featured speaker on the international scene.