Bio Safety & MonitoringCentral Sterile Supply DepartmentCSSD by Dr.T.V.Rao MD

1. Bio Safety & Monitoring
Central Sterile Supply Department
CSSD
Dr.T.V.Rao MD
Dr.T.V.Rao MD 1

2. Biosafety and Monitoring
the CSSD is Priority and
responsibility of everyone
in Health care
• The central sterile supply
department (CSSD) plays a key role in
providing the items required to
deliver quality patient care. To
support infection control within the
healthcare facility, the CSSD staff
members must be well-trained and
skilled, and committed to “doing
what’s right” The shortcuts are never
made and that processes and
practices are consistently followed.
• Dr.T.V.Rao MD
Dr.T.V.Rao MD 2

3. What is Central
sterile supply
department
• Central sterile supply department(
CSSD) is a service unit in a hospital
that processes, issues, and controls
the sterile stores supply to all
departments of the hospital. It can be
defined as that service, with in the
hospital, catering for the sterile
supplies to all departments , both to
specialized units as well as general
wards and OPDs
Dr.T.V.Rao MD 3

4. We Need constant
Monitoring of the Biosafety
of the Instruments and
materials used in Hospitals
• The most common method
for sterilization of medical
instruments worldwide is
steam sterilization.
However, steam sterilization
or autoclaving may not be
100% effective at killing all
microorganisms under all
circumstances. Therefore,
the quality of sterilized
products should be assessed
by physical, chemical, and
biological indicators.
Dr.T.V.Rao MD 4

5. What CDC
Recommends
• According to CDC and other
medical associations, to ensure
heat penetration to all
instruments during each cycle, a
chemical indicator should be
placed inside and in the center of
a load of unwrapped
instruments, routinely in every
sterilization process. Finally,
biological indicators are used
periodically for monitoring of the
quality of sterilization processes
Dr.T.V.Rao MD 5

6. Monitoring CSSD
• The sterilization
procedure should be
monitored routinely by
using a combination of
mechanical, chemical,
and biological
indicators to evaluate
the sterilizing conditions
and indirectly the
microbiologic status of
the processed items.
Dr.T.V.Rao MD 6

7. Care of Mechanical
Monitors
• The mechanical monitors
for steam sterilization
include the daily
assessment of cycle time
and temperature by
examining the
temperature record
chart (or computer
printout) and an assessment
of pressure via the pressure
gauge.
Dr.T.V.Rao MD 7

8. Monitoring
Ethylene Oxide
Monitors
• The mechanical monitors for
EO include time,
temperature, and pressure
recorders that provide data
via computer printouts,
gauges, and/or displays.
Generally, two essential
elements for EO sterilization
(i.e., the gas concentration
and humidity) cannot be
monitored in healthcare EO
sterilizers.
Dr.T.V.Rao MD 8

9. Why Chemical Indicators
are Preferred
• Chemical indicators are
convenient, inexpensive which
indicate that the item has been
exposed to the sterilization
process. But, Chemical
indicators were more likely
than biological indicators to
inaccurately indicate
sterilization even during very
short sterilization times (e.g., 2
minutes).
Dr.T.V.Rao MD 9

10. Criteria of
Classification
• These classifications
are based on
Spaulding’s
classification of
criticality of
materials with
regard to infection
control and cost
considerations
Dr.T.V.Rao MD 10

11. Earle Spaulding Defines the Criteria of
classification
• A young doctor from Philadelphia, Earle Spaulding, took on the task
of testing germicides, antiseptics, soaps, and cleansers against
specific germs. In a paper he published in 1939, he proposed a
classification system that is still used today: The Spaulding
Classification Scheme. He proposed that classifying medical devices
based on the degree of risk for infection would lead to a better
understanding of the degree of cleanliness required, and as a result,
improve compliance and reduce infection. His simple and logical
categories are "Critical," "Semi critical," and
"Noncritical."
Dr.T.V.Rao MD 11

12. Dr.T.V.Rao MD 12

13. Still We Need
Biological
Indicators
• Chemical indicators
should therefore only be
used in conjunction with
biological indicators. It
should not replace
them, because they give
incorrect indication of
sterilization even at
marginal sterilization
time.
Dr.T.V.Rao MD 13

14. Biological monitoring system
• The biological monitoring system
depends on live nonpathogenic
bacterial spores and stringent
sterilization requirements.
• The biological indicators are
prepared using a live bacterial
spore strip containing a minimum
of 1 million live spores.
Dr.T.V.Rao MD 14

15. Criteria for Selection of Biological
Indicators
• All of the biological indicators are approved by theAmerican
Type Culture Collection and are also tested using the
biological indicator evaluator resistometer. The D-value of
biological indicator is defined as “the time required in
minutes at a certain temperature (121°C) to reduce the
number of viable microorganisms by a factor of 10,”5 and
the Z-value of a biological indicator is defined as “the
number of degrees in Centigrade to reduce the D-value with
a factor of 10,
Dr.T.V.Rao MD 15

16. What is
Sterilization
Assurance Level
The sterilization assurance
level is the “probability of a
single unit being non-sterile
after it has been subjected to
sterilization.”
Finally, the entire set of
biological indicators after
sterilization is sent to the
microbiology department
for sterility assurance
testing.
Dr.T.V.Rao MD 16

17. Why Still we Need Biological Indicators
•Only a biological indicator consisting of resistant spores
can measure the microbial killing power of the
sterilization process. Chemical indicators are affixed on
the outside of each pack to show that the package has
been processed through a sterilization cycle, but these
indicators do not prove sterilization has been achieved.
Preferably, a chemical indicator also should be placed on
the inside of each pack to verify sterility penetration.
Dr.T.V.Rao MD 17

18. What are
Chemical
Indicators
• Chemical indicators usually
are either heat-or
chemical-sensitive inks
that change color when
one or more
sterilization parameters
(e.g., steam-time,
temperature, and/or
saturated steam; EO - time,
temperature, relative
humidity and/or EO
concentration) are present.
Dr.T.V.Rao MD 18

19. Chemical
Indicator
Classes Defined:
Dr.T.V.Rao MD 19

20. Classification of
Chemical
Indicators
• Chemical
indicators have
been grouped into
five classes
based on their
ability to monitor
one or multiple
sterilization
parameters
Dr.T.V.Rao MD 20

21. Class 1 : Process
Indicators
• “Process indicators are
intended for use with
individual units, (e.g., packs,
containers) to indicate that
the unit has been directly
exposed to the sterilization
process and to distinguish
between processed and
unprocessed units. They
shall be designed to react to
one or more of the critical
process variables.”
• .
Dr.T.V.Rao MD 21

22. Process
Indicators
Applications
• Applications : Indicator
tapes, indicator labels,
and load cards are
examples of externally
visible Chemical
Indicators that are
Process Indicators used
for exposure control.
Dr.T.V.Rao MD 22

23. Class 2 :
Indicators for use
in Specific Tests
• “Class 2 indicators are
intended for use in specific
test procedures as defined in
relevant
sterilizer/sterilization
standards.”
• Applications : Bowie-Dick
type tests are specific tests
used for equipment control
to evaluate the sterilizer
performance.
Dr.T.V.Rao MD 23

24. Class 3 : Single
Variable Indicators
• “A single variable
indicator shall be
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.”
Dr.T.V.Rao MD24

25. Applications
• 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 for pack
control monitoring but would
not provide as much
information as a Class 4 or Class
5 Chemical Indicator.
Dr.T.V.Rao MD 25

26. Class 4 : Multi-variable
Indicators
• “A multi-variable indicator shall be 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 variable.”
• Applications : Multi-variable Chemical
Indicators are used for pack control. These
internal Chemical Indicators are usually
paper strips printed with a Chemical
Indicator.
Dr.T.V.Rao MD 26

27. Class 5 : Integrating
Indicators :
• “Integrating indicators shall be designed to
react to all critical variables. The SVs are
generated to be equivalent to, or exceed
the performance requirements given in the
ISO 11138 series for BIs.”
• Applications : Integrating Indicators are the
most accurate of the internal Chemical
Indicators. Integrating Indicators are used
for pack control monitoring. They can also
be used as an additional monitoring tool to
release loads that do not contain implants.
Dr.T.V.Rao MD 27

28. Class 5 : Integrating
Indicators
• For this additional monitoring
the Class 5 Integrating Indicator
must be used in the appropriate
challenge test pack or Process
Challenge Device (PCD). These
indicators must now have SVs at
121°C/250°F, 135°C/276°F, and
at least one more temperature
in between. Also, the SV at
121°C MUST be greater than
16.5 minutes to ensure
performance is comparable to
BIs in saturated steam.
Dr.T.V.Rao MD 28

29. Class 6 : Emulating Indicators
• Emulating indicators
are cycle verification
indicators which shall
be designed to react
to all critical variables
for specified
sterilization cycles.
The Svs are generated
from the critical
variables of the
specified sterilization
process.”
Dr.T.V.Rao MD 29

30. Biological
Indicators
• Biological indicators are
recognized by most authorities
as being closest to the ideal
monitors of the sterilization
process because they measure
the sterilization process directly
by using the most resistant
microorganisms (i.e., Bacillus
spores), and not by merely
testing the physical and
chemical conditions necessary
for sterilization
Dr.T.V.Rao MD 30

31. Why Bacillus
spores preferred
• Since the Bacillus spores used
in biological indicators are more
resistant and present in greater
numbers than are the common
microbial contaminants found
on patient-care equipment, the
demonstration that the
biological indicator has been
inactivated strongly implies
that other potential pathogens
in the load have been killed.
Dr.T.V.Rao MD 31

32. Biological Indicators
directly Monitor the
sterilization Process
• Biological indicators are the
only process indicators that
directly monitor the lethality
of a given sterilization
process. Spores used to
monitor a sterilization
process have demonstrated
resistance to the sterilizing
agent and are more resistant
than the bio-burden found on
medical devices.
Dr.T.V.Rao MD 32

33. B. atrophaeus spores used for monitoring
• B. atrophaeus spores are used to monitor EO and dry heat,
and G. stearothermophilus spores ) are used to monitor
steam sterilization, hydrogen peroxide gas plasma, and
liquid per-acetic acid sterilizers. G. stearothermophilus is
incubated at 55-60°C, and B. atrophaeus is incubated at 35-
37°C. Steam and low temperature sterilizers (e.g., hydrogen
peroxide gas plasma, per-acetic acid) should be monitored
at least weekly with the appropriate commercial
preparation of spores
Dr.T.V.Rao MD 33

34. Daily use of
Biological
Indicators
Recommended
• If a sterilizer is used
frequently (e.g., several loads
per day), daily use of
biological indicators allows
earlier discovery of
equipment malfunctions or
procedural errors and thus
minimizes the extent of
patient surveillance and
product recall needed in the
event of a positive biological
indicator
Dr.T.V.Rao MD 34

35. Monitoring essential
in each load …..
• Each load should be
monitored if it contains
implantable objects. If
feasible, implantable
items should not be used
until the results of spore
tests are known to be
negative
Dr.T.V.Rao MD35

36. What is New
generation
Biological
Indicator
• The next generation of
biological indicator was self-
contained in plastic vials
containing a spore-coated
paper strip and a growth
media in a crushable glass
ampoule. This indicator had
a maximum incubation of 48
hours but significant failures
could be detected in ≤ 24
hours.
Dr.T.V.Rao MD 36

37. What is rapid-
readout biological
indicator
• A rapid-readout biological
indicator that detects the
presence of enzymes of G.
stearothermophilus by
reading a fluorescent
product produced by the
enzymatic breakdown of a
non-fluorescent substrate
has been marketed for the
more than 10 years
Dr.T.V.Rao MD37

38. Rapid Readout
• Studies demonstrate
that the sensitivity of
rapid-readout tests for
steam sterilization
parallels that of the
conventional
sterilization-specific
biological indicators and
the fluorescent rapid
readout results reliable.
Dr.T.V.Rao MD 38

39. Super Readout
Biological
Indicator
• A new rapid-readout
EO biological indicator
has been designed for
rapid and reliable
monitoring of EO
sterilization
processes. The
indicator has been
cleared by the FDA for
use in the United
States.
Dr.T.V.Rao MD 39

40. Many Hospitals Going for Rapid Technology
Dr.T.V.Rao MD 40

41. How the Read out
technology works
• The rapid-readout EO
biological indicator detects
the presence of B.
atrophaeus by detecting a
fluorescent signal indicating
the activity of an enzyme
present within the B.
atrophaeus organism,
beta-glucosidase. The
fluorescence indicates the
presence of an active spore-
associated enzyme and a
sterilization process failure.
Dr.T.V.Rao MD 41

42. Rapid-readout EO biological indicator
•The rapid-readout EO biological indicator can be used
to monitor 100% EO, and EO-HCFC mixture sterilization
cycles. It has not been tested in EO-CO2 mixture
sterilization cycles. The standard biological indicator
used for monitoring full-cycle steam sterilizers does
not provide reliable monitoring flash sterilizers.
Biological indicators specifically designed for
monitoring flash sterilization are now available, and
studies comparing them have been published.
Dr.T.V.Rao MD 42

43. VISIT ME FOR MORE
ARTICLES OF INTEREST
IN INFECTIOUS
DISEASES
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44. References
• 1 CSSD CONNECT overview CSSD CONNECT is an Initiative by PCI with
the purpose of spreading awareness about the right practices to be
followed in sterile departments in hospitals:
• 2 Health care improving portals on world wide web
Dr.T.V.Rao MD 44

45. •Program created by Dr.T.V.Rao MD for
Medical and Health care workers in the
Developing world
• Email
• doctortvrao@gmail.com
Dr.T.V.Rao MD 45