Journal of Hospital Infection (2002) 5l: 79–84

doi:l0.l053/jhin.2002.l2l7, available online at http://www.idealibrary.com on

REVIEW

Environmental controls in operating theatres

S. Dharan and D. Pittet
Infection Control Programme, Department of Internal Medicine, University of Geneva Hospitals,
I2II Geneva I4, Switzerland

Summary: Surgical-site infection is the leading complication of surgery. Normal skin flora of patients or
healthcare workers causes more than half all infections following clean surgery, but the importance of air-
borne bacteria in this setting remains controversial. Modern operating theatres have conventional plenum
≤ µm are removed. For orthopaedic and other implant surgery,
ventilation with filtered air where particles 5
laminar-flow systems are used with high-efficiency particulate air (HEPA) filters where particles ≤0.S µm are
removed. The use of ultra-clean air has been shown to reduce infection rates significantly in orthopaedic
implant surgery. Few countries have set bacterial threshold limits for conventionally ventilated operating
rooms, although most recommend 20 air changes per hour to obtain 50–150 colony forming units/m S of air.
There are no standardized methods for bacterial air sampling or its frequency. With the use of HEPA filters
in operating theatre ventilation, there is a tendency to apply cleanroom technology standards used in
industry for hospitals. These are based on measuring the presence of particles of varying sizes and
numbers, and are better suited than bacterial sampling. Environmental bacterial sampling in operating
theatres should be limited to investigation of epidemics, validation of protocols, or changes made in
materials which could influence the microbial content.
© 2002 The Hospital Infection Society
Keywords: Surgical wound infection; operating rooms; environmental monitoring; quality control; reference
standards; air microbiology.

Introduction of operating theatres has been advocated. There is

Surgical-site infections are still a major problem in
modern medicine. These infections may be deep or
superficial. The superficial ones are easier to deal
with, but the deep ones can be complicated,
leading to re-operation, or even be life threatening.
Factors causing surgical-site infection are
multifarious; type of operation, surgeon*s skill,
insertion of foreign material or implants,
appropriateness of surgical preparation, adequacy
and timing of antimicrobial prophylaxis, the immune
state of the patient and contamination of the
inanimate environment. To reduce these infections,
bacteriological management
Author for correspondence: Professor Didier Pittet,
Infection Control Programme, Department of Internal Medicine,
University of Geneva Hospitals, 1211 Geneva 14, Switzerland;
Tel. (office): ‡ 41-22/SU2 98 28; Fax: ‡ 41-22/SU2 S9 8U.
E-mail: didier.pittet@hcuge.ch
no international consensus on the methods, types
of sampling and tolerable limits of bioburden in
operating theatres. The main parameters
associated with environmental biocontamination in
operating theatres are discussed with a special
emphasis on air quality and its control.
Source and transport of organisms
The control of surgical-site infection requires
a knowledge of the source and transport of the
cau- sative organisms. In today*s operating
environment, more than half of clean surgical-site
infection pathogens originate from normal skin flora
of patients or staff.1–S Bacteria on skin squames, lint
and other dusts get into the air in the operating
theatre and by turbulent air currents deposit on
surfaces. They are also spread by direct contact
between

0l95–670l/02/060079 + 06 $35.00/0 © 2002 The Hospital Infection Society

80
carrier and wound, but the importance of airborne
bacteria as a source of infection remains a subject
of debate among professionals in infection
control.S–6 The inanimate environment is probably
one of the factors that can be managed efficiently
by the infec- tion control team.
Several studies, including experience at our
institution, have shown a reduced number of infec-
tions when orthopaedic surgery is performed in
operating theatres with ultra-clean air facilities. U–14
Thus, it can be assumed that for this type of
surgery, higher bacterial counts in the air correlates
with a higher risk for surgical site infection.
To reduce prolonged morbidity and healthcare
costs associated with these infections, airborne
bac- teria and other sources of contamination must
be reduced to the minimum. This can be achieved
by the choice of staff theatre dress, patient
preparation and draping, education of personnel
and design and controlled ventilation of operating
theatres.15–2S The infection control team*s role
should be that of a consultant where expertise in
materials and methods in asepsis are shared
among the other professionals involved in the
design, layout and functioning of operating
theatres.
Clothing and healthcare
worher education
Surgical drapes and the fronts and sleeves of
surgical gowns should be impregnated with a fluid
repellent and made of a non-woven or close-woven
fabric.18 In the European Medical Devices
Directive, these articles are considered as medical
devices, and as such they should pose no infection
risk for the user and the patient. The requirements
for surgical drapes and gowns have been defined
(resistance to bacterial penetration wet and dry,
linting, tensile strength, etc.) and should be met by
the manu- facturers and distributors. Surgical staff
should wear hoods and masks although the
wearing of masks is controversial.19,21,24 Operating
theatre dress made of non-woven fabric or
impermeable material can be uncomfortable so
climatic conditions in the operating theatre should
compensate for this. Staff should be educated in
the maintenance of sterility of instruments by no-
touch behaviour, covering of sterile instruments
with a sterile drape until use, and movement and
number of persons in the operating theatre should
be kept to the minimum.20,22
S. Dharan and D.
Pittet
Ventilation
Most modern operating theatres have conventional
plenum ventilation with filtered air, using filters with
an efficiency of 80–95% to remove airborne
≤ particles 5 µm [DOP test25]. Laminar air-flow
systems with HEPA filters which remove
airborne particles of
0.S µm and above with 99.9U% efficiency are
generally used for orthopaedic and other implant
surgery. HEPA-filtered laminar air-flow can be
supplied to the operating area by ceiling-mounted
(vertical flow) or wall-mounted (horizontal flow)
units. Both systems have their inconveniences and
the unidirectional flow of air can be disrupted. With
the vertical flow system, heat generated by surgical
lamps creates minor air turbulence. A horizontal
laminar air-flow system was developed to overcome
the problems associated with vertical air-flow.
However, this system has a major inconvenience in
that the operating team usually disrupts the uni-
directional air-flow. Some studies have shown that
vertical laminar air-flow generates less bacteria at
the operating site.8,26 To overcome the problems
asso- ciated with both horizontal and vertical flow
systems, a combination of vertical and horizontal
flow has been developed, known as exponential
laminar air- flow with the form of an upside-down
trumpet.2U,28 Few countries have set bacterial
threshold limits
in conventionally-ventilated operating theatres,
although most recommend 20 air changes per hour
in order to obtain 50–150 colony forming units
(cfu)/mS of air. In the United Kingdom, the limit is
S5 cfu/mS for an empty operating theatre and in
activity it should not exceed 180 cfu/mS for an
average 5 min period. In an ultra-clean air
operating theatre the
limit is set at c10 cfu/mS sampled within S0 cm of
the wound using conventional clothing. The limit
is set at c1 cfu/mS of air when total body exhaust
gowns are used (UK Department of Health docu-
ment, Health Technical Memorandum 2025).
These limits are not always easy to achieve
during an
operation as various factors influence the
bioburden in the air during the surgical procedure.
There are no standardized methods for air sam-
pling in operating theatres or for its frequency. In
addition, a variety of instruments are used in volu-
metric air sampling which renders correlation of
results difficult due to variability.
With the use of HEPA filters in operating
theatre ventilation, there is a tendency to apply
clean- room technology standards used in industry
for hospitals. Most of the industrialized countries
have
Environmental controls in operating 8l
theatres

set their own standards, usually modifying the
American Federal Standard 209E to their local
needs (Table I).29 These standards are based on
measuring the presence of particles of varying
sizes and number [British standard 5295, Table
II(a); German VDI 208S, Table II(b)]. S0,S1 Many of
these are presently being amended to align with
the International Standards Organization (ISO)
14644 [Table II(c)].S2
The European Standard, ³Cleanroom technol-
ogy*, is presently in its draft form. This document
covers methods of analysing and measuring
aero- biocontamination in zones at risk, classified
accord- ing to risk categories 1 to 4. This
document does not set limits in bioburden or
frequency in sampling; the decision is left to the
individual institution. Systems (ultra-clean air)
should be maintained to standards that will fulfil
their desired functions. However, to measure
these, controls have to be instituted. At present,
there is no international consensus on the
methods, types of samples (settle plates vs.
volumetric air sampling), frequency of sampling,
and tolerable limits of bioburden in operating
theatres.26,SS–S8 Based on experience at our
institution, we consider that a standard
established on measured particle size and
number, similar to the American Federal
Standard 209E (Table I) would be better suited
than bacterial sampling. It is less demanding,
results are immediate, and it can be used for on-
site teaching. The interval
between sampling should be decided by each insti-
tution based on the means available.
We are not proponents of routine bacteriological
surveillance of air and surfaces in conventionally-
ventilated operating theatres due to the fact that
results obtained are valid only for the moment and
location where they were obtained. Different
factors influence the results and we cannot
presume that results will be the same an hour or a
day later. Fur- thermore, in a clinical setting not just
the quantity of bacteria is important, but also its
quality. Taking these factors into consideration, it
would be a waste of resources to routinely take
bacterial samples on a regular, i.e., monthly basis.
Rather, we recommend annual maintenance of
ventilation systems by the engineering department.
Bacteriological sampling has its place in the
investigation of epidemics, validation of changes in
products and procedures in the maintenance of
operating theatres (cleaning, disinfection, and
ventilation) and education. Volumetric air sampling,
either particle or bacterial counts, should be carried
out in an empty operating theatre after any main-
tenance work carried out in the ventilation system
and should meet previously set target limits. The
limits set in Table III are not based on scientific
evidence of the relation between contamination
of the environment and surgical-site infection
risk, but on local evaluation of contamination in
empty operating theatres. When surgical
techniques

Table I Limits of air particle contents according to standardized norms (adapted from FS209 E◆)

Superior limits in measured particle size (particle per volume unit) (equal to, or greater than stated size)

Class †
0.l µm volume unit 0.2 µm volume unit 0.3 µm volume unit 0.5 µm volume unit 5 µm volume unit

SI FS 209 m3 ft3 m3 ft3 m3 ft3 m3 ft3 m3 ft3

Ml 350 9.9l 75.7 2.l4 30.9 0.875 l0 0.283 – –

Ml.5 l l240 35.0 265 7.50 l06 3.00 35.3 l.0 – –
M2 3500 99.l 757 2l.4 309 8.75 l00 2.83 – –
M2.5 l0 l2 400 350 2650 75.0 l060 30.0 353 l0.0 – –
M3 35 000 99l 7570 2l4 3090 87.5 l000 28.3 – –
M3.5 l00 26 500 750 l0 600 300 3530 l00 – –
M4 75 700 2l40 30 900 875 l0 000 283 – –
M4.5 l000 35 300 l000 247 7.0
M5 l 00 000 2830 6l8 l7.5
M5.5 l0 000 3 53 000 l0 000 2470 70
M6 l0 00 000 28 300 6l80 l75
M6.5 l 00 000 35 30 000 l 00 000 24 700 700
M7 l 00 00 2 83 000 6l 800 l750
000
◆ Reference 29.
†
Refers to the engineering classification of cleanrooms. SI: International system (metric); column l is the metric equivalent
of the US standard FS209 (column 2).
82 S. Dharan and D.
Pittet

Table II Limits of air particle contents according to different international standards

(a) British Standard 5295◆: classification and requirements of cleanrooms

Superior limits in measured particle size per m 3 (equal to, or greater than stated size)

Class† 0.3 µm 0.5 µm 5 µm l0 µm 25 µm

C l00 35 0 NS NS
D l000 350 0 NS NS
E l0 000 3500 0 NS NS
F NS 3500 0 NS NS
G l 00 000 35 000 200 0 NS
H NS 35 000 200 0 NS
J NS 350 000 2000 450 0
K NS 3 500 000 20 000 4500 500
L NS NS 2 00 000 45 000 5000
M NS NS NS 4 50 000 50 000

NS = Not specified.
◆ Reference 30.
†
Refers to the engineering classification of cleanrooms.

(b) German VDI 2083◆: classification and requirements of cleanrooms

Superior limits in measured particle size per m3 (equal to, or greater than stated size)

Class† 0.l µm 0.2 µm 0.3 µm 0.5 µm l.0 µm: 5 µm l0 µm

0§ l50 33 l4 – l0 0

l l500 330 l40 45 l0l

2 l5 000 3300 l400 450 l02
3 – 33 000 l4 000 4500 l03
4 – – – 45 000 l04 300
5 – – – 4 50 000 l05 3000
6 – – – 45 00 000 l06 30 000
7 – – – – l07 30 000 70
000
◆ Reference 3l.
†
Refers to the engineering classification of cleanrooms.
:
Size chosen for classification.
§
This class should be considered when cleanroom is unoccupied.

(c) International norm (ISO I4644–I◆: cleanrooms and associated controlled environments, classification and requirements)

Superior limits in measured particle size per m3 (equal to, or greater than, stated size)

Class† ISO 0.l µm 0.2 µm 0.3 µm 0.5 µm l.0 µm 5 µm

l l0 2
2 l00 24 l0 4
3 l000 237 l02 35 8
4 l0 000 2370 l020 352 83
5 l00 000 23 700 l0 200 3520 832 29
6 l0 00 000 2 37 000 l 02 000 35 200 8320 293
7 3 52 000 83 200 2930
8 35 20 000 8 32 000 29 300
9 3 52 00 000 83 20 000 2 93 000

◆ Reference 32.
†
Refers to the engineering classification of cleanrooms.
Environmental controls in operating 83
theatres

Table III Classification of operating theatre zones according to risk

experience and the increasing use of alcohol-
categories and limits in airborne particles and bacteria◆, University of
Geneva Hospitals, Switzerland based solutions for surgical hand disinfection and
double- gloving, we strongly believe that the use of
Particle sterile water for surgical hand disinfection is not a
size (Particles per m3) Bacterial
counts necessity.
Class Level of risk ≤0.5 µm ≤ 5 µm (cfu/m3)

Conclusion
l. Very high risk, within l0 0 cl
laminar air-flow area There is presently no common standard method
with HEPA filtration used to determine bacterial threshold limits in the
2. High risk, exterior 353 l0 5
laminar air-flow,
operating theatre setting. In this situation, it is
but within the practically impossible to compare results between
operating theatre countries. We recommend the use of cleanroom
3. Medium risk, 3 530 25 25 technology standards based on the measurement
conventionally of the presence of air particles as routine
ventilated operating
theatre with air
procedure. Our opinion is that environmental
filtered through bacterial sampling should be restricted to the
terminal filters with an investigation of epidemics and validation of
efficiency changes in products and main- tenance procedure
of 95% and above NS NS NS of the operating theatre. We suggest that there is a
4. Low risk, areas with
uncontrolled ventilation
need to reach a consensus on the method of
evaluation and also, to differentiate
◆ Sampling is performed in the operating theatre between cleanroom technology developed for
whilst at rest. cfu, Colony forming unit; NS, no specific industry and that used in hospitals.
limit.

or theatre dress are to be evaluated, both volu-
metric air sampling and settle plates may be used
together. Plates should be placed as near as
possible to the operating team and on the
instrument trolley in order to obtain any meaningful
results. How- ever, this may create practical
problems in some circumstances.
Water supply
Another area of environmental control in operating
theatres is the bacteriological quality of water used
for surgical handscrubs for which there are no stan-
dardized limits at present. Some institutions use
sterile water for this procedure. At our institution,
we use drinking quality water, c200 bacteria/mL,
with bacterial counts carried out twice a year on
these water outlets. Counts have never exceeded
400 bacteria/mL with most being below 100
(unpublished data). The exception to this was when
a new operating theatre was built and warm water
(S0–S5○C) was provided via a closed circuit for the
comfort of surgeons. However, the problem was
rapidly rectified by lowering the temperature to 20–
25○C. Organisms recovered from these samples
were mainly environmental, Gram-negative bacilli
and atypical mycobacteria. Taking into account our
Achnowledgement
The authors thank Rosemary Sudan for editorial
assistance.
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