Theatre and CSSD Issues in

Infection Control

By
Dr. Ranganathan N Iyer
MD FRCPath DNB DPB MAMS
Consultant Clinical Microbiologist
Global Hospital
Hyderabad
 Types of operating rooms

• Conventionally ventilated operating suite

• Ultraclean ventilated ( UCV) operating
suite
• Unventilated theatre
• Treatment rooms
 Principles of OR Ventilation
• Prevent airborne contaminants from
entering surgical wounds.
• Source of contamination- skin squames of
the operating team
• Differs at different times
• Depends on the traffic in the operating
room
 Other sources of contamination
• Improperly filtered outdoor air
• Contaminated fabrics for the staff
• Backtracking of contaminated air from the
outside
• Aerosols from power tools used during the
procedure
 Commissioning of a theatre
• Done before the OR is used
• After modifications have been made to the
OR
• ICT is involved in the pre- design stage till
the final hand over
• Important for time slots for discussion and
surveillance
 Parameters that need a check
• Theatre interior for obvious defects
• The air distribution within and between
rooms of the theatre
• The Air Handling unit of the theatre
• Setback ventilation and indications
• The air change rates in the theatre
• Airborne microbiological surveillance in an
empty theatre
 Theatre interior
• Pressure release dampers- open when the door is
shut and closed when the door is open
• Cracks and gaps in the wall/ flooring
• Minimal fixtures
• Painted surfaces and finishes should be smooth
• Minimum shelves, closed windows, solid ceiling
 Engineering controls

• Filtered outside air

• Reduce the contamination of the air in the
OR
• Prevent entry of contaminated air into the
OR
 Air distribution in an Operating
room
•The theatre actual
•The preparation room ( lay up room)
•The anaesthetic room
•The disposal room
•The corridor
The air flow is important from 1& 2 to the
others and not in the reverse direction
 What are these?
Preparation room:-
• Lay up of surgical instruments
• Sterile pack store

Short circuiting of air :-

Must go out in one direction without
entraining contamination
 What happens in an UCV
Theatre

• Laminar flow of air

• Unidirectional flow onto the clean
zone( sterile surgical zone)
• Recirculation of air – large volumes
• Filtration – HEPA filters ( 6 months)
 Check for the Air flow
Smoke testing :
• Turbulent airflow in and around the OR
Table
• Air flow indicators- the direction of the
room air from the theatre to the prep room-
the anaesthetic room- outside
( helps for large vols of air)
* Unidirectional flow of air
 Set Back Ventilation
• Ventilation when the theatre isa not in use
• Done manually / sensors
• Indicators in the theatre mandatory
• Routine working times – no set back
• Pressure relativities maintained
• Give 15 mins set back- normal flow rates
 Air Changes
• One air change- vol of air= vol of the OR is
supplied or removed
• Expressed as Air changes per hour( ACH)
• ACH= Vol of the room, ventilation rate
• Cubic metres/ second
• ACH= Air supply rate/ vol of the room
 Air Change Rates
Ventilated theatre
Operating room: 20
Prep room or area: 37
Prep / sterile pack stores-11
 Microbiological sampling
• When to sample
• How to sample
• What to use
• What medium, incubation times
• How much to sample
• How often to sample……..
 When to sample
• Before commissioning – recommisioning
• In- depth cleaning -dust free
• Normal flow rates- 24 hours
• All engineering aspects have been dealt
• Inspection of the interiors
• Air change rates/ velocity are in order
 How to sample
Source of contamination:-
Dispersal of skin squames from personnel
• The OR needs to be empty
• All air flow areas need to be empty
• Give sufficient time for dilution of contamn
• Preferably remote operated sampler
 How much to sample?

• No standard recommendation
• At least 250 L – 1000 L
• More will be wonderful, but not practical
 Which device to use
• Settle plates
• Air samplers

Both are acceptable with their own

advantages and disadvantages
 Settle plates Vs Air samplers
Settle Plates
• Cheaper
• Sterility testing assured
• Manysamples taken from
different points at the
same time
• Contamination of a
critical surface
• Valid qualitative results
• Air flow is not disturbed
Air samplers
• Sample collection is rapid
• Defined volume of air can
be collected
• Air flow is disturbed
• Not easy to clean or
sterilise
• Cannot be used near the
surgical field ( UCV OR)
 1/1/1 Rule
Standardisation of passive air plates :
9 cm plate blood agar
24 hours incubation
At 37c aerobically
Results normalised to cfu/dm2
1 hour, 80-100cms from floor, 100-150 cms
from the wall- microbial fall out from the
environment
 Index of Microbial Air
contamination
( IMA)
• Use settle plates
• Use the 1/1/1 rule
• Count the nos of colonies after 48 hours
at37 c aerobic incubation
• Express the nos of CFU
• Nos of cfu= IMA
 Selection of a Air sampler
• Can it sample 2l of air ( UCV) for 10 mins
• Can it be remotely operated
• Ease of use and cleaning
• Cost of individual strips
• Cleaning and sterility of media
• Closeness to the wound in a UCV theatre
 The choice of medium
•Nutrient agar medium
•Blood agar medium
•Brain Heart Infusion Medium
•Fungal media
No standard recommendation for this- blood
agar and a enriched medium
 Sampling points
• One at each corner of the unidirectional air
flow zone perimeter
• Halfway along each side of the perimeter
• One at each corner of the inner zone
• One in the centre
 Sampling in a working Theatre
Conventional Theatre UCV Theatres
• Random sampling • Sampling close to the
• 5 min period wound ( <300 mm-<10cfu)
• 180 cfu/ m3 • Sampling at the perimeter
• > 180- look for ventilation of the clean zone( <20cfu)
issues Personnel, theatre practices
and secondary
requirements
 Failed Microbiological Testing
• Conventional Theatre( empty)
• UCV Theatre( empty)
• Conventional Theatre( working)
• UCV Theatre ( Working)
• Clusters of infections
• Theatre staff “ uncomfortable”
• Engineering defects
 Swabbing of surfaces
• Swabs to be taken from areas that come
into close contact with the patient’s skin and
mucosae
• Collection of swabs from floor, walls and
ceiling of the OR
• How often do we report a NG from the lab?
 Theatre Discipline
• The nos of personnel in the theatre
• The noise produced with everyone chatting
• Universal precautions
• Shaving of patients
• Removal of Jewellery
 Double gloves
• Protective against blood and body fluids
Disdadvantages :
• Reduces manual dexterity
• Uncomfortable
• Reduces Tactile sensitivity
 Face Masks & Caps
• Protects against blood and body fluid
splashes
• Protects from laser plums and surgical
smoke
• Fresh mask for each procedure
• Discard masks on exit from the theatre
 Re- use of Theatre gown
• Theatre gowns worn outside the theatre
complex.
• Change of clothes on return
• Overcoats or aprons on top while leaving
the theatre
• Foot wear to be left in the OT complex
before leaving the place
 Visitors to the OR Complex
• Those entering the OR room need to change
• Others do not need to change
• Do not cover them with a plastic apron and
slip on shoe covers- useless
 Scheduling of cases
• Clean after a dirty case
• Time gap after a dirty case
• Surface cleaning and decontamination
• Preferably in a separate theatre
• Air changes
• Ventilation of the theatre
 Central Sterile Services
Departmen ( CSSD)
* A department that deals with preparing,
processing, storing and distributing medical
and surgical hospital supplies required for
patient diagnosis, treatment and care.
* This involves both sterile and unsterile
material
 CSSD
Why do we need one?
1. All materials come from one area after
complete processing.
2. Helps maintain high standards of quality
control.
3. It is economical to do so.
4. Training of a set of people is sufficient for
the purpose.
 Working of a CSSD
Depends on;
1. Efficacy of the sterilisation process.
2. Layout of the CSSD
3. Effective quality control procedures.
4. Good infection control
5. Employee training and motivation from
time to time.
 AREAS OF A CSSD
1. Receiving area.
2. Cleaning and decontamination area.
3. Preparation and packaging area.
4. Sterilisation
5. Sterile storage area
6. Distribution of the material.
 Requirements of a CSSD
Ventilation system;-
Clean to soiled areas, not in the reverse direction
Clean areas- positive pressure
Soiled areas- Negative pressure
Exhaust should be working efficiently to duct the used
air from the soiled areas to the outside or to a re-
circulating duct system.
 STEAM STERILISATION
• Universally accepted form of
sterilisation. Alternative methods are
sought only if this method is not
possible.
• Autoclaving of articles- steam under
pressure, achieves very high
temperatures that can kill all bacterial
spores.
 STEAM STERILISATION

Major issues in steam sterilisation:-

1. Removal of air from the autoclave.
2. Superheating.
3. Load wetness.
4. Material damage.
 Removal of air from the
autoclave
Methods :-
1. Gravity displacement.
2. Dilution by mass flow
3. Dilution by pressure pulsing.
4. Pressure pulsing with gravity
displacement.
The last is by far the best accepted method
for removal of air.
 Efficacy of Steam Sterilisation
Factors influencing are :-
1. Air tightness of the steriliser.
2. Atmospheric pressure.
3. Quality of the steam.
4. Characteristics of the load.
 Problems and Pitfalls
1. The use of vacuum to let in the steam.
2. Leaks at or below the atmospheric
pressure.( Pressure pulsing)
3. Quality of the steam- depends on the
weight of dry steam in the mixture of
saturated steam and water in the
system. 100% sat steam is desirable
 Problems and Pitfalls
Poor quality steam ( steam separator and a baffle)
What happens with excess moisture:
1. The air becomes trapped in the wet load.
Circulation stops and the steam does not
penetrate.
2. The loads do not dry very easily after
sterilisation when they are initially wet.
 SUPER HEAT
This is the temperature excess above the
temp of saturated steam at the same
pressure.
Most of the superheat comes from the
jacket heat of the autoclave.
It reduces the efficiency of the autoclave./
 FLASH STERILISATION
Used for instruments that have become
contaminated in the OT and are required
very urgently for the next case.
Non porous items- 132c for 3 minutes
Porous items- 132c for 10 minutes.
The efficacy depends on the bioburden and
the presence of organic matter.
 FLASH STERILISATION-
Pitfalls
1. Inability to monitor the process
accurately- commercial indicators and
time constraints.
2. Implants should not be sterilised by
this method- dangerous for clinical use.
Use sparingly and not for all instruments.
 Preparation and Packaging
The material used should be compatible with the
process of sterilisation.
Evaluate a material according to its utility rather
than its woven, unwoven nature, whether it is
reusable or disposable.
140 thread count muslin is the preferred fabric.
Other materials have also been tried.
 Sterile Storage Area
• The total air changes per hour is at least 4
changes
• The humidity should be less than 50%
• Well designated areas for storage
• Certain height from the floor, distance form the
walls and the ceiling desired
• All articles should be labelled with a load number,
date sterilised, date of expiry and the steriliser
used.
 Indicators of Sterilsiation

• Physical Indicators
• Chemical Indicators
• Biological Indicators
• Biologically modified P/ Ci Indicators
 Biological Indicators
Place the BI in the most challenging part of
the load.
At the front at the bottom
Near the door
How many BI’S to use in each run?
Will a positive result always indicate
instrument failure?
 Biological Indicators
Commercially available BI’S have about 104 to 106 spores of
B. stearothermophilus.
The probability of the no sterility of items in the load when the
BI’S are sound is less than 1 in 1,000,000.
The sterility assurance level is 10-6
BI does not mean sterility, but provides additional means of
ensuring monitoring of the sterilisation.
 GAS STERILISATION

• Ethylene oxide sterilisation

• Low Temperature Steam formaldehyde
• Vapour Phase Hydrogen peroxide
• Plasma Gas sterilisation.
 Ethylene Oxide ( ETO)
Prevention of toxicity
1. Proper aeration should be allowed ( 8 hours at
60c)
2. Aeration should not be carried out in the open.
Use biosafety cabinets designed for the purposes
with proper air exchanges.
3. The type of item and the nature of the material
used makes a difference( external application or
implants)
 To put in a nut shell
• Theatre and CSSD issues are one of most
volatile issues in Infection control
• Myths and beliefs rather than true scientific
outlook
• Dynamic process with a lot of work done
continually