infection prevention
By Diane Cullen , MSN , MBA , RN , CIC
How Healthcare Organizations Can Better Manage Commercially Prepared Sterile Supplies
Managing commercially prepared sterile supplies is an essential task and can be challenging for many healthcare organizations . As part of their effort , healthcare organizations must identify optimal locations within their facilities to store supplies so that staff can readily access them . Healthcare organizations must ensure supplies are being stocked to peak levels while keeping alert to expiration dates so that items do not expire . Additionally , storage areas must be properly maintained so that supplies are stored safely and kept in good condition while protecting them from contamination .
The Joint Commission receives multiple inquiries every week related to sterile supply storage concerns . By recognizing some of the following practices , healthcare organizations can better understand The Joint Commission ’ s expectations for managing and storing packaged sterile supplies within healthcare facilities .
Device Labeling
According to the Food and Drug Administration ( FDA ), manufacturers of certain medical devices and products must include labeling on or within their devices . ‘ Labeling ’ includes all actual labels and other written , printed , or graphic information located on equipment , devices , or wrappers . This includes but is not limited to instructions for use ( IFU ). Additionally , The Joint Commission requires that healthcare organizations follow manufacturer ’ s written instructions for use ( IFU ) to ensure the end-user understands how to properly use , clean , disinfect , reprocess , and store medical devices .
Below are six criteria manufacturers generally include in device labeling :
➊ Reflect the intended use of the device ( e . g ., single use , single patient use )
➋ Advise the end-user on how to thoroughly clean the device
➌ Indicate the correct microbiocidal process ( e . g ., sterilization , high , intermediate , or low- level
disinfection ) for the device based on intended use
➍ Include technically feasible Instructions
➎ Provide comprehensive Instructions
➏ Offer understandable Instructions
Device Labels
In 2016 , the FDA published a final rule ( 21 CRF Parts 660 , 801 and 809 ) which revised its medical device labeling regulations to allow for optional inclusion of symbols in labeling without additional explanatory text ( e . g ., ‘ stand-alone symbols ) if certain criteria were met . A device label may include important symbols that help end users easily understand key information about an item at a glance . For example , many commercially prepared sterile devices will include a manufactured date ( the date the item was manufactured ) which should
SYMBOL MEANING SYMBOL MEANING
Medical device manufacturer date .
Device must be protected from moisture .
Expiration date . Biological risk .
Batch or lot code .
Indicates device has been subjected to a sterilization process .
Indicates device has been sterilized using aseptic processing techniques .
Do not re-sterilize , which indicates the device should not be re-sterilized after it once has been sterilized .
Single patient , multiple use . Indicates the device may be used multiple times on a single patient .
not be confused with the expiration date ( the date the item may no longer be used ).
A single-use device intended to be used on an individual patient during a single procedure and then discarded may be represented by the number “ 2 ” with a horizontal slash across . Conversely , a medical device intended for a single-patient use , meaning it may be used on one patient but may be reprocessed between use per IFU is indicated by a completely different symbol ( see table below ). Another symbol with infection prevention implications on device packaging is the symbol for ‘ Do not re-sterilize ,’ which indicates the sterile medical device within the package must not be re-sterilized after being sterilized once . Additionally , the label may also include symbols that indicate temperature and humidity requirements for storage .
Included below are examples of common symbols that may be included on your packaged sterile products and their meanings .
Lower temperature limit that device can be exposed .
Upper temperature limit that device can be exposed .
Indicates device has been sterilized using ethylene oxide .
Device is intended for one single use only . Do not reuse .
Indicates a medical device that has not been subjected to a sterilization process .