CSSD Basics Chemical Indicators, Biological Indicators and Recall Process

The Basics of Quality Assurance in the Central Sterile Service Department

2. •A Chemical Indicator is a device that monitors the presence of
one or more of the parameters required for an effective
sterilization process or to monitor the sterilizer equipment
•The device is designed to respond with a characteristic
chemical or physical change to one or more of the physical
conditions within the sterilizing chamber. CIs are intended to
detect potential sterilization process failures that could result
from incorrect packaging, incorrect loading of the sterilizer, or
malfunctions of the sterilizer. The "pass" response of a CI does
not prove that the item accompanied by the indicator is
necessarily sterile.
•AAMI ST79, ST41, and ST58 have defined six classes of CIs:
Class 1 (process indicators), Class 2 (Bowie-Dick tests), Class 3
(single-variable indicators), Class 4 (multivariable indicators),
Class 5 (integrating indicators), and Class 6 (emulating
indicators).

3. •Process indicators are intended for use with individual units
(e.g., packs or containers) to indicate that the unit has been
directly exposed to the sterilization process and to distinguish
between processed and unprocessed units. They are designed
to react to one or more of the critical process variables.
•These types of indicators are called external CIs and should
be used on the outside of each package unless the internal CI
is visible. Examples are sterilization indicator tape, an
indicator label, or printed legend as seen on the outside of
peel pouches, and load cards.

5. •Class 2 indicators are intended for use in specific test
procedures as defined in relevant sterilizer or sterilization
standards. An example of this type of indicator would be the
Bowie-Dick test that is designed to test for air removal in
dynamicair-removal steam sterilizers.

8. •A single-variable indicator is designed to react to one of the
critical variables and is intended to indicate exposure to a
sterilization process at a stated value (SV) of the chosen
variable.
•An example of a single-variable indicator is a temperature
tube that contains a chemical pellet that melts at a specific
temperature.
•Single-variable indicators may be used as internal CIs for pack
control monitoring but would not provide as much information as
a Class 4, Class 5, or Class 6.

10. •A multivariable indicator is designed to react to two or more of
the critical variables and is intended to indicate exposure to a
sterilization cycle at SVs of the chosen variables.
•These CIs are usually paper strips printed with a color change
CI and are used as internal chemicals for pack control
monitoring.

13. •Integrating indicators are designed to react to all critical process
variables.
•The SVs are generated to be equivalent to or to exceed the
performance requirements published in the ANSI/AAMI/ISO 11138
series for BIs.
•The results of Class 5 integrating indicators are more closely aligned
with BI performance and are the most accurate of the internal CIs but
do not replace the use of BIs.
•Class 5 integrating indicators may be used as internal CIs for pack
control monitoring. Class 5 CIs may be used as an additional
monitoring tool in process challenge packs to monitor non-implant
loads. The CI should be in the BI process challenge device used to
monitor implant loads.

15. •Emulating indicators are cycle verification indicators that are
designed to react to all critical variables for specified
sterilization cycles.
•The SVs are generated from the critical variables of the
specified sterilization process. Class 6 CIs may be used as
internal CIs for pack control monitoring.
•Class 6 CIs may be used as an additional monitoring tool in
process challenge packs to monitor non-implant loads. This CI
cannot replace the use of a Class 5 CI in the BI process
challenge device used to monitor implant loads or the use of a
BI.

17. •CIs should be used outside of each healthcare-prepared
package, tray, or containment device unless the internal
CI is visible. These external CIs are used for exposure
control to determine if the item has been processed. The
external CI should be read when unloading the sterilizer,
dispensing or issuing the item for use, and before the item
is opened in the OR.
•If the external CI suggests inadequate processing, the
package should not be used.
•CIs should also be used inside of each healthcare-
prepared package, tray, or containment device in the
area considered the most challenging to sterilant
penetration. The containment device manufacturer should
be consulted about where to place the internal CIs.

18. •These internal CIs are used for pack control to determine that
the sterilant penetrated each package. The internal CI should
be read before the package is placed on the sterile field.If
the internal CI suggests inadequate processing, the package
should not be used and should be returned to SP, and the
supervisor should be informed to determine if the load should
be recalled.
•Class 5 and Class 6 CIs may also be used inside PCDs as an
additional monitor tool for nonimplant loads. Class 5 CIs
should be used inside of the BI PCDs to monitor implant loads
and can be used in defined emergency situations to release
implants
•More details about the use of CIs can be found in Section 10
of AAMI ST79 and ST41 and Section 9 of ST58. Always
follow the CI manufacturer's written IFU for proper usage,
interpretation of results, and storage conditions.

22. •Shelf life is event related. With event-related sterility, items
are considered sterile unless the integrity of the packaging is
compromised (i.e., torn, soiled, wet, or showing evidence of
tampering). Conditions that may alter the integrity of the
packaging may include the following:
•1. Environmental sources of contamination (e.g., moisture,
vermin, and air movement associated with traffic)
•2. The barrier properties of the packaging material (e.g., the
integrity of its seals and its resistance to tearing)
•3. Storage and distribution practices (e.g., open versus closed
shelving and transport)
•4. Inventory control (e.g., realistic standards and stock
rotation)
•5. Frequency of handling between distribution and the user

24. •AAMI ST79 addresses recalls in Section 10 under "Action
to take when BIs, CIs, or physical monitors indicate a
failure."In Section 10 of ST79 is Figure 12, which shows a
decision tree for conducting investigations of steam
sterilization process failures, which indicate when a recall
is needed.
•Table 8 shows a checklist for identifying reasons for
steam sterilization process failures.
•A recall is not needed if the cause of the failure is
immediately identifiable, which is usually the result of an
operator error and confined only to one load.

25. •For example, an operator error that is immediately
identifiable is running the wrong sterilization cycle for the
load contents. At that point only the error needs to be
corrected and the load reprocessed. If the error is not
immediately identifiable, which will be the case in the
vast majority of sterilization process failures, actions to
take include recalling all items that have been processed
since the last negative BI. This action would be taken if
the BI, CI, or physical monitor identified a problem. The
advantage of every-load monitoring with a BI and
quarantining until the BI results are known is that only the
one load in question is involved, so there is no patient
involvement. The decision tree also indicates when
qualification testing with BI PCDs is needed.

26. •The Section on Action to take when BIs, CIs, or physical
monitors indicate a failure in AAMI ST79 can be used to
assist in developing a written policy and procedure to
address who, when, and how to recall reprocessed items.
In addition, the policy may include compliance
components of the Safe Medical Device Act if failure is
noted in the reuse of reprocessed items. At a minimum, a
log of items within the sterilized load should be reviewed
along with the monitoring results, unused items in the load
retrieved for reprocessing, a root cause of the
sterilization process failure identified, required sterilizer
testing completed, and surveillance of involved patients
initiated.

27. •The recall process is often collaborative and should
include the IP, risk manager, surgical services manager,
and the surgeon or the attending physician for the
involved patients. The same recall process can be used
for low-temperature sterilization processes also. AAMI
ST58 also has in Section 9 information on actions to take
if a BI test is positive. The information in AAMI ST79
Figure 12 could also be used for low-temperature
sterilization process failures.

31. •General considerations

•Written policies and procedures for the recall of items from issued or stored loads should
be developed in cooperation with the infection prevention and control committee and risk
management of the individual health care facility. These policies and procedures should be
documented, and records should be maintained. The department head or designee should
decide, on the basis of the health care facility’s policies and procedures, when a recall of
processed supplies should be implemented. Whenever there is evidence of a sterilization
failure, the infection prevention and control professional should be notified so that follow-up
surveillance of patients can be conducted. Written policies and procedures should be
developed for compliance with the Safe Medical Devices Act of 1990 as it pertains to
failures of reusable medical devices (i.e., the Medical Device Reporting [MDR] regulations
of 21 CFR 803). For additional information on user facility MDR requirements, see FDA
(1996b).

•Rationale: To ensure patient safety and compliance with the user facility reporting
requirements of the Safe Medical Devices Act of 1990, the health care facility should
establish recall procedures to expedite the retrieval of processed items that are suspected
to be non sterile and to ensure adequate follow-up actions such as quarantine of the
sterilizer, notification of physicians and affected clinical departments, and surveillance of
patients.

32. •Recall procedure
•A recall procedure should
•a) be written;
•b) outline the circumstances for issuing a recall order;
•c) designate the person(s) authorized to issue a recall order; and
•d) designate the person(s) responsible for reporting on the execution of a recall order.

•Recall order
•A recall order should
•a) include all items processed back to the last negative BI;
•b) be immediately communicated to affected departments and followed by a written order;
•c) identify by sterilization lot number the products to be recalled;
•d) identify the persons or departments to whom the order is addressed;
•e) require the recording, in terms of kind and quantity, of the products obtained in the recall; and
•f) specify the action to be taken by the persons receiving the order (e.g., destruction or return of product).

•Recall report
•A report of a recall order should
•a) identify the circumstances that prompted the recall order;
•b) specify the corrective action(s) taken to prevent a recurrence;
•c) state, in terms of the total number of products intended to be recalled, the percentage of products
•actually located in the recall; and
•d) provide verification that the recalled items were reprocessed or destroyed, as appropriate.