MCH/HIC/14

DOCUMENT NAME: RECALL POLICY

1.0 PPURPOSE AND SCOPE

To define the responsibility for maintaining sterility of patient care equipment
Scope: Hospital wide

2.0 POLICY STATE MENT

Items dispatched from CSSD towards ICUs/OTs and other patient areas, shall be
recalled immediately if;
· Any breakdown is noticed in sterilization of the batch that was sterilized
· Any evidence suggestive of improper sterilization came into notice.
3.0 TARGET AUDIENCE: CSSD, all patient care units
4.0 RESPONSIBILITY: Receiver and sender

5.0 PROCEDURE

 Central Sterile Supply personnel must assure that medical devices are processed
correctly. If they do not, the affected devices must be recalled before they reach
patients.

 Process failures can occur for numerous reasons. They are discovered when
monitoring tools provide information about the effectiveness of the sterilization
process that has been used. Not all monitoring devices indicate a failure at the
same time, but all do provide clues that alert CSSD technicians that a problem
may have occurred.

 Then, when a process failure is suspected, identified, the failure must be

corrected, and sterilizer efficacy testing is undertaken in compliance with the
Recommended

 Several monitoring tools are used to identify load processing failures that lead
to product recalls. These include: Physical monitors built into sterilizers
Indicators, such as Bowie-Dick tests, that check the efficiency of the air

Issue No.: 01 PREPARED DATE: 01/04/2023 Revision No: 01

Effective Date: 01/04/2023 Revision Date: 21/08/2023
Doc. Prepared By: Doc Reviewed By: Doc. Approved
QUALITY ADMINISTRATOR By: DIRECTOR Page 1
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DOCUMENT NAME: RECALL POLICY

removal system for sterilizers with a pre-vacuum cycle.

 External or internal chemical indicators that routinely monitor each package,

tray or rigid sterilizer container to detect sterilization process failures.

 All monitoring tools must have the appropriate results for loads to be released.
For example, in the case of steam sterilization, loads should not be released
when:

 The equipment’s physical monitors indicate that the required cycle conditions
including time, temperature, pressure, and vacuum were not met, or when the
load was processed in the incorrect cycles. The external chemical indicator
provides evidence that packages were not exposed to the physical conditions
present within the sterilizer.

 The Class 5 integrating indicator in the test pack/PCD shows a reject or

incomplete color change result.

 The BI in the test pack/PCD is positive; in other words, the spores were not
destroyed.

 BIs detect conditions that enable spores that are more sterilization-resistant than
other organisms to remain alive. Therefore, if spores are killed, other less-
resistant microbes will also be killed.

 If a load is released before BI results are known, and the BI then reads positive
to indicate sterilization process failure, all item s processed since the last load
with a negative BI that indicates sterilization success are considered non-sterile.
These loads should, then, be recalled, retrieved and reprocessed.

 A BI is run weekly, in that a steam sterilizer is used. The incubation results

(puts in incubator – rapid readout BI containing enzymes that allow living
spores to be demonstrated in the test device within a shorter time, located in
CSR) obtain in one to three hours (if BI result is positive- in one hour/ if result
negative- in three hours).

 Explain necessary product recall procedures to retrieve products sent to user

Issue No.: 01 PREPARED DATE: 01/04/2023 Revision No: 01

Effective Date: 01/04/2023 Revision Date: 21/08/2023
Doc. Prepared By: Doc Reviewed By: Doc. Approved
QUALITY ADMINISTRATOR By: DIRECTOR Page 2
DEPARTMENT of 12
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DOCUMENT NAME: RECALL POLICY

Departments.

 If the reason for the process failure is immediately identified (these are usually cases
of operator error) and confined to one load or to one item in the load, the problem
should be corrected, and the load should be reprocessed.

 If the reason for the failure is not immediately determined, the load should be
quarantined, and all loads back to the last negative BI should be recalled. The
applicable sterilizer should also be removed from service and inspected to determine
if it could be a root cause of the failure.

 Recalls require immediate contact of the staff members and departments that must
retrieve the devices before they reach patients. Specific steps to manage a recall
follow:
Step-1 Orally report positive BI results to the appropriate CSSSD In- charge and
infection control department personnel. They should then implement the facility’s
recall policies and procedures.
Step 2 – Immediately initiate a recall order for all devices in the sterilizer since the
last cycle processed with a negative BI reading. Provide important information to
affected departments including:
Why devices are being recalled.
Which devices are being recalled?
Indicate load label data, including sterilizer load and number, along with processing
data. To whom, when and how to return the recalled devices to the CSS department.
Step 3 – Retrieve and reprocess all recalled devices.
The recall process is not completed after items have been retrieved. The next steps
are to identify and correct the problem(s) that enabled the positive BI results.

Review procedures to identify and correct reasons for sterilization failure.

There are three general causes of processing errors that created the need for the recall:

Issue No.: 01 PREPARED DATE: 01/04/2023 Revision No: 01

Effective Date: 01/04/2023 Revision Date: 21/08/2023
Doc. Prepared By: Doc Reviewed By: Doc. Approved
QUALITY ADMINISTRATOR By: DIRECTOR Page 3
DEPARTMENT of 12
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DOCUMENT NAME: RECALL POLICY

o Human,
o Equipment and
o Utilities.
Human error includes:

 Incorrect use and/or analysis of monitoring tools

 Improper cycle for load content

 Inappropriate packaging materials or packaging techniques

 Incorrect sterilizer loading

Equipment errors include:

 Malfunctioning equipment

 Utility problems

 Ethylene oxide concentration when this sterilization method is used

Utility errors include:

 Boiler malfunctions

 Clogged steam lines

 Wet steam due to improper insulation of s team lines

 Malfunction of trap in steam line or no trap in steam line

 Malfunction of drain check Poorly engineered piping Excessive utility

demands

 Recalls documented and applicable records must be maintained. The analysis

process is determined why the process failure occurred.

Issue No.: 01 PREPARED DATE: 01/04/2023 Revision No: 01

Effective Date: 01/04/2023 Revision Date: 21/08/2023
Doc. Prepared By: Doc Reviewed By: Doc. Approved
QUALITY ADMINISTRATOR By: DIRECTOR Page 4
DEPARTMENT of 12
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DOCUMENT NAME: RECALL POLICY

 The written report should be circulated to the Infection Control nurse, quality
management personnel and teams, and others who may be identified in the
facility’s recall policy.

6.0 DEFINITION AND ABBREVIATION

· BI: Biological Indicator
· CI: Chemical Indicator
· PCD: Pack Challenge Device
· Sterilization: The use of a physical or chemical procedure to destroy all
microbial life, including highly resistant bacteria spores.
· Products / Items: Surgical instruments, utensils, implantable items and other
supplies need for procedures requiring sterility.

Issue No.: 01 PREPARED DATE: 01/04/2023 Revision No: 01

Effective Date: 01/04/2023 Revision Date: 21/08/2023
Doc. Prepared By: Doc Reviewed By: Doc. Approved
QUALITY ADMINISTRATOR By: DIRECTOR Page 5
DEPARTMENT of 12