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Assessing Sterility of Packaged Items at Point of Use (4.1.20)

Assessing Sterility of Packaged Items at Point of Use (4.1.20) - Policies, Clinical, UW Health Clinical, Infection Control

4.1.20


UW HEALTH CLINICAL POLICY 1
Policy Title: Assessing Sterility of Packaged Items at Point of Use
Policy Number: 4.1.20
Category: UW Health
Type: Ambulatory and Inpatient
Effective Date: October 23, 2017

I. PURPOSE

To define the parameters for determining the suitability for use of purchased or reprocessed sterile
packaged patient care items with regard to maintenance of sterility.

II. POLICY ELEMENTS
A. Items which are reprocessed and sterilized at UW Health locations may be placed in packaging for which
indefinite sterility is presumed unless packaging becomes compromised (see section III.B. for definition of
compromised packaging), or alternatively, in packaging for which a temporal limit to sterility applies.
B. Items which are reprocessed and sterilized at UW Health locations, and which are packaged using a product
which has a time limit of presumed sterility (e.g., self-sealing peel packs, some impervious containers, some
specific grades of paper wraps, linen wraps) will be labeled with an expiration date appropriate to the
limitations of the packaging. Items which are reprocessed and sterilized at UW Health locations and
packaged in a manner providing indefinite sterility unless packaging becomes compromised will not require
an expiration date. If potential for ambiguity about an expiration date exists, a label stating "indefinite shelf
life unless damaged, opened or wet," or similar language, may be affixed to the packaging.
C. Sterile single-use peel packed items which are purchased from vendors and which do not have a
manufacturer's expiration date noted on the package or product insert will be presumed sterile indefinitely
unless the packaging materials have been compromised.
D. Before using any sterile packaged items, UW Health employees will inspect the packaging to ensure that it
has not been compromised, and to ensure that any applicable expiration date has not been exceeded. For
items which have been reprocessed and sterilized within UW Health, employees will also inspect any
process indicators (described in III.C.3.) which are present within trays or which are placed on, or
manufactured into, packaging materials to ensure that the item has been subjected to a sterilization process.
E. Regardless of appropriate packaging, dating, and process indicator review, surgical instrument trays
prepared at an off site location not under direct oversight of the reprocessing staff at the surgical location,
and then transported to the location of surgery (e.g. instrument trays from a vendor, outside hospital, or an
off site UW Health location) will not be used until the receiving location opens, inspects, cleans, packages
and sterilizes the contents of the surgical tray.

III. PROCEDURE
A. Presumption of Sterility.
i. Sterile items processed by UW Health or contracted through Madison United Hospital Laundry
(MUHL).
a. Items which do not have an expiration date will be presumed sterile indefinitely unless the
package is compromised.
b. Items labeled with an expiration date will be presumed sterile through the expiration date
unless the package is compromised.
ii. Purchased Sterile Peel Packed Items.
a. Sterile single-use peel packed items which are purchased from outside vendors will be
presumed sterile indefinitely unless the package is compromised, or unless the
manufacturer deems it appropriate to place an expiration date, or other limit of safe use,
on the item.
b. For items with manufacturer determined limitations on safe use, the manufacturer's
limitations, as indicated on the package or insert information, shall be used to determine
the item's suitability for use.
c. Items within unopened manufacturer's packaging which are found to be damaged or
soiled, or of uncertain sterility for any reason, will not be used. Notify Risk Management at
261-1327 during office hours and deliver all of the packaging and accompanying
documentation to Risk Management for further investigation and reporting. See
Administrative Policy #12.40, Reporting of Device-Related Adverse Events and Other



UW HEALTH CLINICAL POLICY 2
Policy Title: Assessing Sterility of Packaged Items at Point of Use
Policy Number: 4.1.20

Product Problems, for more information regarding voluntary reporting of device related
failures.
B. Definition of Compromised Packaging.
i. Various types of packaging material are used to enclose items during the sterilization process.
These packaging materials then protect and maintain the sterility of the items until the time that
they are used. Any breach in the integrity of the packaging material results in the loss of sterility of
the enclosed items. In such an event, the items will not be used for patient care. If there is any
doubt as to the integrity of the package, and therefore to the sterility of the item contained therein,
the item is not to be used for patient care. Compromised packaging materials include those which
are:
a. Opened
b. Torn or punctured
c. Heavily soiled
d. Wet or show signs of previous wetting (i.e. water stains or discoloration/wrinkling
consistent with contact with liquids)
C. Inspection of Packaging and Process Indicators Prior to Use of Sterile Items. Prior to using a sterile wrapped
or peel-packed item for patient care, the person who opens the package containing the item is responsible
for checking the following parameters. A failure in any one of these criteria renders the packaged item
unsuitable for use in patient care.
i. Expiration Date: Before opening the package, check to see if it has an expiration date printed on, or
affixed to it. If an expiration date is present, and it has been exceeded, the item cannot be used for
patient care. If an expiration date is present, but is illegible or not definitively clear, the item cannot
be used for patient care.
ii. Package Integrity: If the packaged item has no expiration date or it has an expiration date which
has not been exceeded, inspect the packaging carefully to ensure that it has not been
compromised. If the packaging is found to be compromised, as defined in section III. B., the item
cannot be used for patient care.
iii. Process Indicators: Process indicators are a visual means of verifying that the packaged item has
undergone a sterilization process based on a color change in the indicator. These indicators do not
assure sterility, but allow for a rapid determination that the item has indeed been subjected to a
sterilization process. If the process indicator has not undergone the appropriate color change, or if
the color change is incomplete, the items will not be assumed to be sterile and the item cannot be
used for patient care.
a. Indicator Tape: Most items reprocessed in UW Health locations will have indicator tape
affixed to them. In the presence of ethylene oxide (ETO) gas or steam autoclave
temperatures, diagonal bands of color (red for ETO exposure, black for steam autoclave
exposure) appear on the tape. In the presence of hydrogen peroxide (H
2
0
2
) the word
Sterrad will appear in yellow.
b. Packaging Component: Paper/plastic peel packs typically have dual process indicators for
ETO and autoclave exposure manufactured into them. These indicators consist of colored
arrows, along with a printed legend which describes the color change which will occur
upon exposure to ETO or steam autoclave conditions. Peel packs, utilized with the
Sterrad system have process indicators for H
2
0
2
manufactured into them. These indicators
consist of a red stripe, along with a printed legend which describes the color change which
will occur upon exposure to H
2
0
2
conditions.
c. Packaged Indicator Strips: Wrapped and packaged items reprocessed in UW Health will
have a class 5 integrator included among the items within the container. This indicator
consists of a strip of paper which will undergo a color change upon exposure to ETO gas,
H
2
0
2
or to steam autoclave conditions. Separate strips are utilized to indicate ETO, H
2
0
2
or
steam autoclave exposure, and each indicator strip has a legend which describes the
color change which accompanies adequate exposure to the process in question.
D. For items which cannot be used for patient care because of a failure in any of the criteria described in
section III.C above:
i. Single use items will be discarded.
ii. Reusable items (metal instruments, durable goods) should be returned to CS for reprocessing or
salvage.
IV. COORDINATION



UW HEALTH CLINICAL POLICY 2
Policy Title: Assessing Sterility of Packaged Items at Point of Use
Policy Number: 4.1.20


Author(s): Infection Control Practitioner
Senior Management Sponsor: SVP/Chief Nursing Executive
Reviewers: Hospital Epidemiologist; Director of Central Services
Approval committees: Infection Control Committee; UW Health Clinical Policy Committee
UW Health Clinical Policy Committee Approval: October 16, 2017

UW Health is a cohesive, united and integrated academic medical enterprise comprised of several entities.
This policy applies to facilities and programs operated by the University of Wisconsin Hospital and Clinics
and the University of Wisconsin Medical Foundation, Inc., and to clinical facilities and programs
administered by the University of Wisconsin School of Medicine and Public Health. Each entity is
responsible for enforcement of this policy in relation to the facilities and programs that it operates.

V. APPROVAL

Peter Newcomer, MD
Chief Clinical Officer

J. Scott McMurray, MD
Chair, UW Health Clinical Policy Committee

VI. REFERENCES

Central Services Policy 1212:R:10.0, Expiration Dating.
Administrative Policy #12.40, Reporting of Device-Related Adverse Events and Other Product Problems.
UW Health Clinical Policy #4.1.7, Cleaning, Disinfection and Sterilization of Patient Care Devices and
Equipment.

VII. REVIEW DETAILS
Version: Revision
Last Full Review: October 23, 2017
Next Revision Due: October 2020
Formerly Known as: Hospital Administrative policy #13.18