Batch Control Identification (BCI) in the dental setting allows dental practitioners to demonstrate that any critical dental instruments used on a patient have been through a particular steriliser cycle with verifiable performance data.

1. 92 Australasian Dental Practice March/April 2020
B
atch Control Identification
(BCI) in the dental setting
allows dental practitioners to
demonstrate that any critical
dental instruments used on a
patient have been through a
particular steriliser cycle with verifiable
performance data.
It is required under Australian and
New Zealand standards for instrument
reprocessing and in the ADA Infection
Control Guidelines. BCI helps ensure
infections cannot be spread from patient
to patient from Reusable Medical Devices
(i.e. dental instruments) used during
dental procedures.
Batch Control Identification (BCI)
serves as a link between a specific sterilisa-
tion cycle and dental instruments prepared
for use on a patient. It must be utilised for
all critical items. It also can, and prefer-
ably should, be used with all semi-critical
items used in routine dentistry including
restorative dental handpieces.
A Batch Control Identification number
comprises a simple, unique sequence of
numbers, such as those produced from
a labelling gun or printer, or it can be
barcode combinations for the date, cycle
and the steam steriliser number.
BCI is clearly designated as a manda-
tory requirement in AS/NZS 4815 and
AS/NZS 4187. Both require pouches or
wrapped packages with individual instru-
ments or instrument sets to record the
following batch information for entry into
patient records:
• Steriliser identification number or code
(if there is more than one steriliser within
the office-based health care facility);
• Date of sterilisation; and
• Cycle or load number.
In the case of dental implants, the man-
ufacturer’s batch/lot number must also be
recorded into the patient’s records.
Labelling pouches
and wrapped packages
As an alternative to using barcodes and
label scanners, batch information can
be recorded manually on packs prior to
steam sterilising using non-soluble per-
manent marker ink, or by using adhesive
labels applied with a labelling gun, pro-
vided the inks and adhesives used can
tolerate steam sterilising.
Pencils, water-based markers and ball
type pens should NOT be used for label-
ling packs as these may compromise pack
integrity. Similarly, packs should not be
labelled after sterilisation as this may also
compromise the integrity of the pack.
Instrument traceability
The second in a series of articles with insights provided by Bronie Shvarts,
infection control trainer and auditor from Infection Control Dental
infection | CONTROL
“It is not necessary to place
an expiry date on packs, since
the modern concept of expiry
dates relates to events rather
than a specific time...”

2. March/April 2020 Australasian Dental Practice 93
SomelabellingsystemsincludeaClass1
chemical indicator on the label, which
changes colour in response to exposure to
heat. This provides a useful visual guide
that the item has been processed and is in
addition to the Class 1 indicator already
included on the pack. Under current stand-
ards, it is not necessary to place an expiry
date on packs, since the modern concept
of expiry dates relates to events rather
than a specific time.
At the time of the critical procedure,
the bar codes should be scanned as instru-
ments are removed from their packages.
If the BCI is being manually recorded,
the empty packages should not be imme-
diately placed into the waste, but rather
put to one side in a clean zone of the
operatory. Batch number information can
later be recorded into the patient’s treat-
ment records by the clinician responsible,
as part of writing up the procedure notes.
The final component of BCI is a com-
prehensive log of steam steriliser cycles,
which includes vital information for every
load, even those that do not include any
critical instrument packs.
The log provides the necessary written
documentation that should record:
• Steam steriliser identification code (if
there are several units in the practice);
• Date;
• Time the cycle is started;
• Cycle Parameters (including wrapped,
unwrapped, etc);
• Nature of the load (numbers of packs,
instrument cassettes, etc);
• Batch numbers of packs included in that
load (if any);
• Result of the autoclave readouts or
printout for that cycle;
• Result of the chemical indicators (Class
1, 4, 5 or 6) used in the cycle; and
• Identification of the unloading operator
who has checked the autoclave readouts
and chemical indicator result and who
authorises release of the load for use.
The operator must also check the
wrapped items are dry, have unbroken
seals and are intact.
By completing the cycle record, the
operator is stating the sterilised load is
suitable for use, which is a tangible contri-
bution to quality and safety in the practice.
Automation
of record keeping
Automated systems may reduce the
workload on the operator, but it does
not remove the need for careful manual
checking of all sterilized items to ensure
that they conform to requirements. The
use of barcode label printers and scanners
instead of manually recording BCI data
into patient records reduces the chances
of transcription errors that could prevent
a package of instruments being accu-
rately identified and linked to a successful
sterilisation cycle.
Electronic cycle data can be captured
automatically and also stored off-site (i.e.
on a computer, portable device or App)
for a permanent record and easily made
available for an infection control audit.
The process can be made more secure and
far simpler by using well-designed sterili-
sation equipment with inbuilt data capture
and linked software or an App to assist
infection control workflow in the prac-
tice - right down to tracking individual
sterilised items by a serial number.
infection | CONTROL

3. 94 Australasian Dental Practice March/April 2020
The newly released W&H Lisa steri-
liser features the innovative “EliTrace”
system to record the sterilisation status
of instrument kits by serial number.
Easily identifiable icons in a pre-installed
database make data entry faster and sim-
pler. This information can be entered
directly into the Lisa steriliser Touchpad
or through the W&H Steri App on
smartphones and tablets. Once set up this
way, the user only has to enter any new
items or scroll through and choose the items
already in the database to automatically
produce individualised labels for those
critical and semi-critical items together
with other instruments and instrument kits/
packs in the load. The labels on the steri-
lised instrument pouches are then scanned
chairside before use to automatically link
the sterilisation cycle to the patient, pro-
cedure and clinician on the patient record.
The newest “smart” LISA and certain
Lara sterilisers have built-in Artificial
Intelligence including reminders about
required test cycles, when to replace the
Multidem demineraliser cartridge, and
how to optimise drying cycles and the
status of the vacuum test.
W&H produces the only sterilisers
with a built-in air leak detector which
means vacuum tests are only required on
a weekly and not a daily basis - saving
time and money. The Lisa also features
patented Eco Dry+ technology that adapts
the drying time to the mass of the load.
This reduces cycle time, increases the
lifespan of instruments and optimises
energy consumption.
Other information such as cycle status
can be seen at a glance of the coloured bar
indicator light of the new Lisa steriliser
and visual indicators together with audible
warnings can be sounded when the door is
open and the load is still hot.
Contact Bronie Shvarts at Infection Con-
trol Dental to arrange an audit of your
practice, see infectioncontroldental.com.au
References:
1. ADA Guidelines for Infection Control 2015.
2. National Health and Medical Research Council
(NHMRC) Infection Control Guidelines 2019.
3. Australia Commission on Safety and Quality in
Health Care Standards (NSQHS)
4. AS/NZS4815:2006.
5. AS/NZS4187:2014.
For more info on the smart new range of Lisa sterilisers contact A-dec on 1800-225-010 or see australia.a-dec.com