Professional Documents
Culture Documents
REVIEW
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.
set their own standards, usually modifying the between sampling should be decided by each insti-
American Federal Standard 209E to their local tution based on the means available.
needs (Table I).29 These standards are based on We are not proponents of routine bacteriological
measuring the presence of particles of varying surveillance of air and surfaces in conventionally-
sizes and number [British standard 5295, Table ventilated operating theatres due to the fact that
II(a); German VDI 208S, Table II(b)]. S0,S1 Many of results obtained are valid only for the moment and
these are presently being amended to align with location where they were obtained. Different
the International Standards Organization (ISO) factors influence the results and we cannot
14644 [Table II(c)].S2 presume that results will be the same an hour or a
The European Standard, ³Cleanroom technol- day later. Fur- thermore, in a clinical setting not just
ogy*, is presently in its draft form. This document the quantity of bacteria is important, but also its
covers methods of analysing and measuring quality. Taking these factors into consideration, it
aero- biocontamination in zones at risk, classified would be a waste of resources to routinely take
accord- ing to risk categories 1 to 4. This bacterial samples on a regular, i.e., monthly basis.
document does not set limits in bioburden or Rather, we recommend annual maintenance of
frequency in sampling; the decision is left to the ventilation systems by the engineering department.
individual institution. Systems (ultra-clean air) Bacteriological sampling has its place in the
should be maintained to standards that will fulfil investigation of epidemics, validation of changes in
their desired functions. However, to measure products and procedures in the maintenance of
these, controls have to be instituted. At present, operating theatres (cleaning, disinfection, and
there is no international consensus on the ventilation) and education. Volumetric air sampling,
methods, types of samples (settle plates vs. either particle or bacterial counts, should be carried
volumetric air sampling), frequency of sampling, out in an empty operating theatre after any main-
and tolerable limits of bioburden in operating tenance work carried out in the ventilation system
theatres.26,SS–S8 Based on experience at our and should meet previously set target limits. The
institution, we consider that a standard limits set in Table III are not based on scientific
established on measured particle size and evidence of the relation between contamination
number, similar to the American Federal of the environment and surgical-site infection
Standard 209E (Table I) would be better suited risk, but on local evaluation of contamination in
than bacterial sampling. It is less demanding, empty operating theatres. When surgical
results are immediate, and it can be used for on- techniques
site teaching. The interval
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
Superior limits in measured particle size per m 3 (equal to, or greater than stated size)
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.
Superior limits in measured particle size per m3 (equal to, or greater than stated size)
0§ l50 33 l4 – l0 0
(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)
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
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.
Achnowledgement
or theatre dress are to be evaluated, both volu-
metric air sampling and settle plates may be used The authors thank Rosemary Sudan for editorial
together. Plates should be placed as near as assistance.
possible to the operating team and on the
instrument trolley in order to obtain any meaningful
results. How- ever, this may create practical References
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