Time versus Event: Preserving Sterile Package Integrity

April 1, 2002

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Time versus Event: Preserving Sterile Package Integrity

By Kelly M. Pyrek

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

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.