Time versus Event: Preserving Sterile Package Integrity
By Kelly M. Pyrek
A few years ago, a Canadian nurse was rummaging around in her hospital's basement and discovered a trunk containing old bandages wrapped in muslin that she suspected had been packaged for shipment overseas during World War II. Curious as to what effect more than 50 years of storage would have on these once-sterile dressings, the nurse brought the bandages to the laboratory for testing. The packages were cultured and no microbial growth was found. This discovery helped convince several hospitals in British Columbia to convert from time-related sterility protocol to event-related sterility (ERS) protocol without clinical mishap and with improved cost savings.1
Events that can compromise package sterility include multiple handling that leads to seal breakage or loss of package integrity, moisture penetration and airborne contamination.2 According to Barbara J. Gruendemann, RN, MS, FAAN, CNOR, and Sandra Stonehocker Mangum, RN, MN, CNOR, authors of Infection Prevention in Surgical Settings, "Event-related shelf life practice recognizes that the product should remain sterile until some event causes the item to become contaminated. Examples of events are tears in packaging, the package becoming wet, the package being dropped on a contaminated surface such as a floor and any compromise that destroys the barrier effectiveness of the packaged material."
Gruendemann and Mangum say items should be handled three times: when removing an item from the sterilizer cart and placing it on a storage shelf, when placing the item on a case cart or supply exchange cart and when picking it up to open for use.
While most U.S. hospitals have adopted ERS, some healthcare facilities still use time-related expiration dating for sterile packages. Whichever system is used, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) mandates either protocol must have policies and procedures consistent in intent 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 control consultant. "In-house processing is usually time-related, yet the principle of package integrity is inherently event-related. Commercial manufacturers predominantly use ERS. It doesn't matter who processes it; if the package integrity isn't there you don't use it. In the real world, [event-related sterility protocol] may not be followed because of a lack of knowledge or resistance to change among healthcare workers (HCWs). No matter which shelf-life measure is used, from a process assessment standpoint, you must ensure all steps are followed sequentially, correctly and appropriately."
Since the 1990s, ERS has become the accepted standard in the processing of sterile supplies. It's a trend sparked by the need to reduce reprocessing costs and resterilizing devices and supplies that had expired sterility dates but whose packages were still intact. According to Gruendemann and Mangum, "If a sterile item (packaged according to acceptable protocols) and its packaging have not been compromised, the item is considered to be sterile and safe for use. With ERS, length of time since sterilization is irrelevant."4
Recommended practices issued by the Association of periOperative Registered Nurses (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 ensure the oldest items are used first, based on the sterilization date marked on each item. At regular intervals, inventory should be rotated so that items with the oldest sterilization dates are advanced to the front of the shelf. These items should be used first to avoid prolonged opportunity for a contaminating event to occur. AORN says sterile items unused for more than a year should be evaluated as to whether it should be maintained in a sterile state. AORN adds that if a commercially prepared item contains an expiration date, that date should be honored even if the facility has adopted ERS. Expiration dates placed on such packages often refer to product degradation as opposed to loss of sterility of the package contents. Products such as latex gloves, pharmaceuticals and specialized catheters may degrade over time and their shelf life takes precedence over ERS considerations.6
Sometimes HCWs must contend with a shortage of sterile supplies and resort to hoarding or using products whose sterility has been compromised, according to Bjerke. "One must always be suspicious of package integrity, but HCWs can overlook potential breaches of sterility," she says. "Perhaps a package has gotten wet. While there's visible water stains, an HCW might assume there's no damage inside, especially if it's the last one on the shelf. An HCW will 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 of sterility are happening."
Bjerke continues, "Stockpiling and hoarding means a hospital has limited supplies and goes on back order frequently because of budgetary restraints. People have learned that in order to not interrupt patient care, when sterile supplies come in, they will hide them. While the package integrity is jeopardized, their intentions are good -- they will be able to care for their patients."
Bjerke explains that poor understanding of preserving sterile package integrity often is supplanted by the nursing shortage. HCWs on a short-staffed unit tend to take shortcuts that can lead to disastrous results.
"From an infection control perspective, the nursing shortage is a slap in the face to process improvement," Bjerke says. "Even though a root cause of an infection is known to be associated with short staffing, HCWs are taking shortcuts that compromise sterility. They are dealing with sicker patients and are asked to work harder, yet they have fewer resources at their disposal. It's a vicious cycle. For infection control practitioners to say to HCWs, 'This is what you have to do to prevent the spread of infection because we don't want another multiple-resistant organism cluster in the nursing unit,' is to further burden HCWs. The impact of the nursing shortage on patient care is a management issue that needs to be addressed to resulting in less stress, fewer medical errors, better infection control practices and minimal wasted resources. People are doing their best with what they have. Their hearts are in the right place, but preventing infections takes priority and is focused on quality patient outcome.