Time versus Event: Preserving Sterile Package Integrity

April 1, 2002

Time versus Event: Preserving Sterile Package Integrity

Time versus Event: Preserving Sterile Package Integrity

By Kelly M. Pyrek

Afew years ago, a Canadian nurse was rummaging around in her hospital's basementand discovered a trunk containing old bandages wrapped in muslin that shesuspected had been packaged for shipment overseas during World War II. Curiousas to what effect more than 50 years of storage would have on these once-steriledressings, the nurse brought the bandages to the laboratory for testing. Thepackages were cultured and no microbial growth was found. This discovery helpedconvince several hospitals in British Columbia to convert from time-relatedsterility protocol to event-related sterility (ERS) protocol without clinicalmishap and with improved cost savings.1

Events that can compromise package sterility include multiple handling thatleads to seal breakage or loss of package integrity, moisture penetration andairborne contamination.2 According to Barbara J. Gruendemann, RN, MS,FAAN, CNOR, and Sandra Stonehocker Mangum, RN, MN, CNOR, authors of InfectionPrevention in Surgical Settings, "Event-related shelf life practicerecognizes that the product should remain sterile until some event causes theitem to become contaminated. Examples of events are tears in packaging, thepackage becoming wet, the package being dropped on a contaminated surface suchas a floor and any compromise that destroys the barrier effectiveness of thepackaged material."

Gruendemann and Mangum say items should be handled three times: when removingan item from the sterilizer cart and placing it on a storage shelf, when placingthe item on a case cart or supply exchange cart and when picking it up to openfor use.

While most U.S. hospitals have adopted ERS, some healthcare facilities stilluse time-related expiration dating for sterile packages. Whichever system isused, the Joint Commission on the Accreditation of Healthcare Organizations(JCAHO) mandates either protocol must have policies and procedures consistent inintent and applied uniformly throughout the hospital.3

"When it comes to package sterility, a double standard exists,"says Nancy Bjerke, RN, MPH, CIC, a Texas-based independent infection controlconsultant. "In-house processing is usually time-related, yet the principleof package integrity is inherently event-related. Commercial manufacturerspredominantly use ERS. It doesn't matter who processes it; if the packageintegrity isn't there you don't use it. In the real world, [event-relatedsterility protocol] may not be followed because of a lack of knowledge orresistance to change among healthcare workers (HCWs). No matter which shelf-lifemeasure is used, from a process assessment standpoint, you must ensure all stepsare followed sequentially, correctly and appropriately."

Since the 1990s, ERS has become the accepted standard in the processing ofsterile supplies. It's a trend sparked by the need to reduce reprocessing costsand resterilizing devices and supplies that had expired sterility dates butwhose packages were still intact. According to Gruendemann and Mangum, "Ifa sterile item (packaged according to acceptable protocols) and its packaginghave not been compromised, the item is considered to be sterile and safe foruse. With ERS, length of time since sterilization is irrelevant."4

Recommended practices issued by the Association of periOperative RegisteredNurses (AORN) support event-related sterility.5 According to AORN,the length of time an item is considered sterile depends on the following:

  • Type and configuration of packaging materials used

  • The number of times a package is handled before use

  • Storage on open or closed shelves

  • Environmental conditions of the storage area (e.g., cleanliness, temperature, humidity)

  • Use of dust covers and method of sealing

AORN advises that hospitals practicing ERS should adopt a protocol to ensurethe oldest items are used first, based on the sterilization date marked on eachitem. At regular intervals, inventory should be rotated so that items with theoldest sterilization dates are advanced to the front of the shelf. These itemsshould be used first to avoid prolonged opportunity for a contaminating event tooccur. AORN says sterile items unused for more than a year should be evaluatedas to whether it should be maintained in a sterile state. AORN adds that if acommercially prepared item contains an expiration date, that date should behonored even if the facility has adopted ERS. Expiration dates placed on suchpackages often refer to product degradation as opposed to loss of sterility ofthe package contents. Products such as latex gloves, pharmaceuticals andspecialized catheters may degrade over time and their shelf life takesprecedence over ERS considerations.6

Sometimes HCWs must contend with a shortage of sterile supplies and resort tohoarding or using products whose sterility has been compromised, according toBjerke. "One must always be suspicious of package integrity, but HCWs canoverlook potential breaches of sterility," she says. "Perhaps apackage has gotten wet. While there's visible water stains, an HCW might assumethere's no damage inside, especially if it's the last one on the shelf. An HCWwill say, 'I need it, so I'm going to take it.' From an economic standpoint,which is the driving force in healthcare, we know these kinds of breaches ofsterility are happening."

Bjerke continues, "Stockpiling and hoarding means a hospital has limitedsupplies and goes on back order frequently because of budgetary restraints.People have learned that in order to not interrupt patient care, when sterilesupplies come in, they will hide them. While the package integrity isjeopardized, their intentions are good -- they will be able to care for theirpatients."

Bjerke explains that poor understanding of preserving sterile packageintegrity often is supplanted by the nursing shortage. HCWs on a short-staffedunit tend to take shortcuts that can lead to disastrous results.

"From an infection control perspective, the nursing shortage is a slapin the face to process improvement," Bjerke says. "Even though a rootcause of an infection is known to be associated with short staffing, HCWs aretaking shortcuts that compromise sterility. They are dealing with sickerpatients and are asked to work harder, yet they have fewer resources at theirdisposal. It's a vicious cycle. For infection control practitioners to say toHCWs, 'This is what you have to do to prevent the spread of infection because wedon't want another multiple-resistant organism cluster in the nursing unit,' isto further burden HCWs. The impact of the nursing shortage on patient care is amanagement issue that needs to be addressed to resulting in less stress, fewermedical errors, better infection control practices and minimal wasted resources.People are doing their best with what they have. Their hearts are in the rightplace, but preventing infections takes priority and is focused on qualitypatient outcome.