Question: Could you please tell me if there are any specific requirements for maintaining service records for sterilizers?

Answer: It is indeed necessary to maintain accurate and complete records of all service performed on your sterilization equipment. This information provides data for process verification and can be useful in the assessment and analysis of malfunctions. Relative records and data can be maintained via electronic or manual paper methods. Service tracking records are also useful in projecting and planning for equipment replacement and routine expense budgeting. Maintenance records should include sufficient data identifying each specific piece of equipment with a continuous history of all scheduled and unscheduled service which has been performed on the equipment. At minimum the following data should be included in the record.

Answer: In accordance with AAMI ST 46 7.2.1, each item or pack intended for use as a sterile product should be labeled with a lot control identifier. The lot control identifier should designate the sterilizer identification number or code, the date of sterilization and the cycle number. The policy of the individual health care facility determines when the lot control label is affixed to the package. If labeling is done pre sterilization it should not be done until the sterilizer to be utilized and cycle run is determined. If post sterilization labeling is to be done the sterilized packages must be first cooled and dried to prevent contamination. Loaded sterilization carts must be carefully monitored and maintained in a secure environment pre and post sterilization to obviate the potential of mix up of sterile and unsterile goods or lots prior to affixing lot control labels. Lot identification allows for product tracking and enables retrieval of items in the event of a recall and the tracing of problems, such as wet packs, to the problem source. Regarding your not placing lot control stickers on the small packages because they are done in bins and "most" of the items will not be used aseptically - I feel this is not a wise practice as the term "most" implies that some will be used aseptically and since your packaging technique closures etc. are recognized as sterile you have no assurance the devices will not be used for sterile procedures. These sterile goods need the same level of QA as all your other sterile packages including lot control labeling. If you want to package and label processed devices that have been cleaned and sterilized for use in non aseptic procedures differently than those to be used strictly in aseptic procedures then your packaging and labeling should clearly identify the devices as clean, not sterile. For example some hospitals or clinics may process vaginal speculums for clean procedures/exams. Often after cleaning and decontamination the speculums are run through a sterilizer unpackaged or in bulk and then are packaged post sterilization to protect and keep them clean. The packaging materials and protocol clearly differentiates the devices from sterile packages. The speculums maybe placed in a clear plastic bag closed by non-autoclave tape or a twisty and labeled accordingly.

Answer: There is no essential reason or recommendation requiring that absorbent towels be placed in the bottom of instrument baskets or trays. Many CS departments do this for no apparent reason other than that’s the way they always did it and the practice has become a ritual and just another sacred cow. On the other hand, some use the towel as a wicking device to disperse the moisture remaining in the set following sterilization to facilitate better drying. Towels or tray liners are also used to protect delicate instruments as a packaging aid or to prevent instrument tips from protruding through the base of the basket. The use of towels as tray liners is not necessarily a good or bad practice it all depends on the variables and how one looks at it. Some things to be mindful of and to consider:

• There are packaging accessories (brackets, posts, racks, and mats) which are specifically designed to organize, position and protect instrumentation during sterilization which will facilitate sterilization efficacy and produce dry contents. HPN