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can be used. The majority of expiration dates include the month, day, and year. However, a few may still have only the month and year printed on the labeling. The instructions for use should state whether it is the first day or last day of the month. These include:


• Hang time: Hang time refers to the number of days that a reprocessed endoscope can be stored after drying before it’s reused.


• Open bottle dating: This refers to the prac- tice of assigning a new expiration date based upon the first opening of a bottle. This date gives the maximum time that an item is stable after the bottle is opened and the contents are exposed to air. Water test strips, high level disinfection test strips and some cleaning chemistries have defined open bottle dating rules. pen- bottle dating does not extend the labeled expiration date of the item; it often short- ens the usage time of the contents.


• Period after opening (PAO) date: similar to open bottle dating, this is the amount of time that an item remains safe for human use after opening. lthough  is typi- cally used for cosmetics, it is occasionally seen in instrument processing areas.


• Post-sterilization shelf life: This refers to the length of time after a sterilization process that the sterilized item can be safely used. This dating is independent of product expiration dating. Sterilization pouches are a great example. When manufactured, sterilization pouches are assigned an expiration date. This date is related to the pouch’s ability to seal and the chemical indicator’s performance in the sterilization process. nce the ster- ilization pouch is used in a sterilization process, the pouch expiration date is no longer valid, and the post-sterilization shelf life date is followed. This date is based upon the ability of the pouch to protect the sterile contents from microbial invasion and the stability of the chemical indicators after they have been sterilized.


• Shelf life: This is the time frame within which an item remains fit for use. he shelf life is used to define the epiration date. It can be used to assign the expira- tion date at time of manufacture, at pack- age opening, or after a process. Labels and instructions for use may include directions based on shelf life such as “stable for two years from date of manu- facture” and “use within six months of first opening the bottle.


• Event-related shelf life/expiration: This indicates that the item is fit for use until a specified event makes the item unfit. This type of expiration dating is used


primarily with sterilized packages of surgical instrumentation. Items are safe for use until an event that can potentially allow microorganisms to enter the pack- age and reach the sterilized items occurs. Tears in wraps, popped pouch seals, and evidence of moisture are examples of events that could allow microorganisms to enter the package.


• Endpoint stability: This refers to the time- frame during which a visible test result will remain unchanged. This relates to chemical indicator strips and other test strips that have a visible test result that is interpreted. Although this is not an expiration date, it is often considered in the assignment of expiration dates for sterilized packages that contain chemical indicator strips.


Managing expiration dating he first step when managing epiration dating is to identify all forms of it used in the department and to document them in policies, procedures, and work instruc- tions as appropriate. Four things should be considered when developing expiration dating documents:


1. Inventory rotation/ first in-first out (FIFO)


Inventory rotation is critical when manag- ing expiration-dated items. Practicing a first infirst out approach ensures that the oldest items are used first. orkstations, local storage cabinets and decentralized storage locations should all be included in the rotation schedule.


Monitor how often each item is rotated through inventory. The longer an item sits in an inventory location, the more likely it is to be moved, handled and exposed to environmental contamination such as dust. If an item is exposed to an event that requires reprocessing and the SPD is unaware, surgical delays can result while replacements are sought and reprocessed.


2. Reconciling expiration dates When a pack contains more than one item with an expiration date, the pack’s label should show the expiration date from the item with the shortest time remaining. Remember to consider the endpoint stability for any indicators that are inside sterile packages. Chemical indicators (CIs) within sterile packages may give a false fail or false pass result if interpreted after the endpoint stability timeframe has passed. Technicians may need to understand what the result may be and determine, through a risk assessment, the


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policy for expiration dating of the pack- age to ensure a safe interpretation of the CI before using the sterile items. Chemical test strips are used to ensure


that a disinfectant has the minimum rec- ommended concentration of the active ingredient to obtain disinfection. The result of a test strip cannot be used to extend a disinfectant’s open bottle expira- tion date. Procedures and work instruc- tions should clearly state this.


3.Reprocessing


Items assigned a hang time or expiration date after processing may not be used within the specified hang time. olices should include instructions for reprocess- ing expired items and should include which decontamination steps must be repeated. For example, do expired hang time endoscopes require all steps, includ- ing leak testing, cleaning, and high level disinfection, for expiration reprocessing?


4. Reconcile event-related and post sterilization shelf life of sterilized items


Event-related expiration dating is com- monly used throughout healthcare when labeling sterilized pouches, wrapped items and containers. bservable events include holes and tears in packages, faded external indicators, broken or lifting tape, moisture and spotting, compromised seals, pack- ages showing signs of excessive handling, inappropriate storage and transport, and items dropped on the floor. ther events can happen over time that are not so easy to see, including packaging material deg- radation, loss of adhesive stickiness, and exposure to environmental bioburden. The manufacturers’ post-sterilization shelf life guidance becomes important in these cases. Manufacturers of products such as sterilization wraps must provide a post- sterilization shelf life timeframe so users will know when the effects of time could result in a microbial breach. Each facil- ity should evaluate the vendor-provided post-sterilization shelf life, along with the events that could occur in the facility, to set their policy and procedures for event- related shelf life. A risk assessment may be used to help with this decision.


Expiration dating and regulatory surveys


Credentialing bodies help facilities com- ply with the requirements of the Center for Medicare and Medicaid Services. Compliance allows a facility to treat indi- viduals taking part in these government


hpnonline.com • HEALTHCARE PURCHASING NEWS • September 2022 39


SELF-STUDY TEST ANSWERS: 1. D, 2. D, 3. C, 4. D, 5. A, 6. A, 7. B, 8. B, 9. D, 10. C


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