Operating theatres

Operating theatre control, monitoring and management service

For more than twenty years, Centro Assistenza Ecologica has developed a specific control service for operating theatres, aimed at hospital companies and designed to carry out monitoring activities in the various areas required by the various regulations in force.

Circular no. 5/1989 of the Ministry of Health on occupational exposure to anaesthetics in operating theatres first of all sets maximum limits for anaesthetic gas concentrations in operating theatre environments, both as regards nitrous oxide and halogenated compounds. The same circular sets out the checks to be carried out, which, in addition to measuring the concentrations of airborne gases, also include checking the high-pressure and low-pressure gas circuits in order to identify any critical points from which gas leaks may originate.

In addition to the above-mentioned circular, reference should be made to the ISPESL Guidelines of December 2009 on safety standards, work hygiene and control of operating theatres.

Point 3) of the Guidelines sets out the checks to be carried out in order to guarantee the identified safety and hygiene standards.

In particular, the checks for the control of operating theatres must cover the following aspects:

  • PARTICLE CONTAMINATION
  • MICROBIOLOGICAL CONTAMINATION OF SURFACES
  • MICROBIOLOGICAL CONTAMINATION OF THE AIR
    • Microbiological air contamination in At-Rest conditions
    • Microbiological air contamination under Operational conditions
  • CONTAMINATION BY ANAESTHETIC AGENTS
  • MICROCLIMATIC CHARACTERISTICS
  • PRESSURE GRADIENTS
  • VOLUMES OF INJECTED AIR
    • Turbulent flow
    • Unidirectional flow
  • AIR CHANGES
  • DETERMINATION OF RECOVERY TIME
  • QUALITY OF WATER SUPPLIED IN THE OPERATING DEPARTMENT
    • Standard water
    • Technical water
  • DETERMINATION OF ILLUMINANCE LEVEL
  • DETERMINATION OF NOISE

Services offered:

With regard to the requirements identified by both Circular 05/1989 and the 2009 ISPESL Guidelines, the Ecological Assistance Centre is able to provide the following services:

  • Monitoring and control of operating theatres for the determination of the concentrations of airborne anaesthetic gases, during the entire operating session, in order to also identify any operational procedures to be subjected to improvement interventions.

Control of operating theatres - Environmental monitoring of anaesthetic gases Nitrogen Protoxide and Halogenated Anaesthetics

REFERENCE REGULATIONS CIRC. MIN. N.5/89 ISPESL GUIDELINES 2009
EQUIPMENTMulti-gas IR/photoacoustic detector
Bruel & Kjaer type 1302
METHODOLOGYThe anaesthetic mixture used for anaesthesia in general anaesthesia is composed of nitrous oxide, oxygen and a halogenated anaesthetic (Sevorane, Desfluorane or Isofluorane).environmental monitoring of anaesthetic gases aims at assessing the exposure of healthcare personnel to anaesthetic gases during work activity and searching for possible leaks from high and low pressure anaesthesia circuits. The environmental concentration of anaesthetic gases is measured by means of an automatic detector which uses infrared photoacoustic spectrometry as a measuring principle. The detection probe is placed within a radius of about one metre from the operating table, at a height of about 1.80 metres from the floor. If no operations are performed under general anaesthesia, a simulation of general anaesthesia with a trial balloon is carried out.  Environmental monitoring is preceded by a search for possible leaks from the anaesthesia circuit, which is carried out by monitoring the entire anaesthesia circuit (high and low pressure), paying particular attention to the most critical points such as fittings, vaporiser, evacuation system, etc..
EXPRESSION OF RESULTSEnvironmental concentrations of monitored anaesthetic gases are expressed in parts per million: ppm. In case the anaesthetic gas is not used, the value corresponding to the measured environmental background concentration is indicated.
REFERENCE LIMITSThe Guidelines on Occupational Safety and Hygiene Standards in Operating Departments published in December 2009 propose the adoption of the ALARA (As Low As Reasonably Achivable) principle, i.e. keeping occupational exposure to anaesthetic agents as low as possible. The monitored environmental concentration of nitrogen protoxide is compared with the acceptability limit indicated in Ministerial Circular No. 5 of 14/03/1989 of the Ministry of Health, which provides: N2O: 50 ppm for newly built or renovated operating theatres (T.L.V. value, T.W.A.). The monitored environmental concentrations of halogenated anaesthetics are compared with the limits of acceptability indicated by DGR Lombardy Region n° 6/47077 of 17/12/1999, which establishes: Halogenated: 0.5 ppm for newly built or renovated operating theatres (T.L.V. T.W.A. value).
  • Control in operating theatres of the high and low pressure gas circuits, including the ventilation system, in order to detect any leaks in the system that may contribute to contamination of the operating environment. Checks are carried out with the same instrumentation as that used for determining concentrations of airborne anaesthetic gases.
  • Control of operating theatres for the particle classification of operating compartments to define their compliance with the ISO reference class.

Operating theatre control - Particle classification of the operating theatre

REFERENCE NORMATIVEISPESL GUIDELINES 2009UNI EN ISO Series 14644
EQUIPMENTParticle counter CLIMET CI–500 EC –02
METHODOLOGYAir sampling by means of an isokinetic probe positioned at a height of about 1 metre above the floor in the positions and operating modes indicated by the technical standard.
EXPRESSION OF RESULTSNo. of particles ≥ 0,5 mm/m3
REFERENCE LIMITSOperating theatres served by unidirectional flow aeraulic system: ISO Class 5 < 3.520/mc
Operating theatres served by turbulent-flow aeraulic system: ISO Class 7 < 352,000/m3
  • Microbiological classification of surfaces by performing environmental swabs on walls, floors, operating tables, trolleys. The control of operating theatres is carried out by using slides for contact sampling on surfaces for the determination of the Total Bacterial Load.

Control of operating theatres - Microbiological classification of surfaces

REFERENCE STANDARDISPESL GUIDELINES 2009
EQUIPMENTRodac contact plates 24 cm2
METHODOLOGYSampling with contact plates (24 cm2 surface area. Standard Plate Count Agar culture medium) in 5 different surfaces of the operating theatre (walls, floor, mother table, operating theatre, operating bed). The samples are transported with a suitable system and delivered to the microbiology laboratory. To ensure complete growth of the microorganisms, the plates are incubated at 36 °C for 48 hours. At the end of the incubation period, the CFU (colony forming units) are counted.
EXPRESSION OF RESULTSNumber of Colony Forming Units (CFU) per plate
REFERENCE LIMITSCompliant: ≤ 5Acceptable:5 < CFU ≤ 15
  • Performing environmental monitoring for the control of operating theatres and for the evaluation of the level of microbiological contamination of the air, both in "At Rest" conditions, i.e. before the start of the operating sessions, and in "Operational" conditions, i.e. for the entire duration of the operating session

Operating theatre control - Microbiological validation of the operating theatre in AT-REST conditions (monitoring of airborne mesophilic microbial load)

REFERENCE STANDARDISPESL GUIDELINES 2009
EQUIPMENTSAS (Saurface Air System) sampler
METHODOLOGYAir sampling with SAS positioned at a height of about 1 metre from the floor near the operating theatre bed. Three consecutive samples of 200 litres of air each are taken, using for each sample a different 24 cm2 rodac plate containing Standard Plate Count Agar (PCA) culture medium. To ensure complete growth of the micro-organisms, the plates are incubated at 36 °C for 48 hours. At the end of the incubation period the CFU (colony forming units) are counted.
EXPRESSION OF RESULTSNumber of colony forming units (CFU) per m3 of air
REFERENCE LIMITSOperating theatres served by unidirectional flow aeraulic system: ≤ 20 CFU/m3Operating theatres served by turbulent flow aeraulic system: ≤ 35 CFU/m3

Operating theatre control - Microbiological validation of the operating theatre in OPERATIONAL (monitoring of airborne mesophilic microbial load)

REFERENCE STANDARDISPESL GUIDELINES 2009
EQUIPMENTSAS (Saurface Air System) sampler
METHODOLOGYAir sampling with SAS positioned at a height of about 1 metre from the floor near the operating theatre bed. A series of samples are taken by aspirating 200 litres of air onto a 24 cm2 rodac plate containing Standard Plate Count Agar (PCA) culture medium. Sampling begins at the first cut of surgery and continues at 5/10 minute intervals for a total monitoring period of 60 minutes. To ensure complete growth of the microorganisms, the plates are incubated at 36 °C for 48 hours. At the end of the incubation period, the CFU (colony forming units) are counted.
EXPRESSION OF RESULTSOperating theatres served by unidirectional flow aeraulic system: ≤ 20 CFU/m3 Operating theatres served by turbulent flow aeraulic system: ≤ 180 CFU/m3
REFERENCE LIMITSOperating theatres served by unidirectional flow aeraulic system: ≤ 20 CFU/m3 Operating theatres served by turbulent flow aeraulic system: ≤ 180 CFU/m3
  • Execution of microclimatic surveys for the evaluation of thermal comfort indices inside operating theatres.

Control of operating theatres - Microclimatic assessment and determination of the PMV and PPD thermal comfort indices.

REFERENCE LEGISLATIONPresidential Decree 14.01.1997 ISPESL GUIDELINES 2009 Regulatory Council Decision no. 221 of 26 July 1999.
EQUIPMENTBabuc A microclimatic control unit (L.S.I.)
MEASUREMENT OF ALL MICROCLIMATIC PARAMETERS NECESSARY TO THE EVALUATION OF THE THERMAL WELL-BEING INDICES PMV AND PPD (temperature, radiant temperature, air speed, relative humidity, etc.)The microclimatic control unit is positioned during the operating activity near the operating field with the sensors at a height of about 1.5 metres from the floor. After about 10 minutes of conditioning, the microclimate parameters are recorded for a period of about 60 minutes. Through the elaboration of the measured microclimatic parameters, in relation to the thermal insulation of the clothing worn by the operators and to the estimated metabolic expenditure related to the operating activity, the PMV (Predicted Average Vote) and PPD (Percentage of Dissatisfied) indexes are calculated, which are necessary for a correct evaluation of the degree of thermal comfort felt by the operators.
EXPRESSION OF RESULTSAir temperature (Ta):°CRadiant temperature (Tr):°CRelative humidity (RH):%Air speed (Va):m/sPMV:dimensionlessPPD:%.
REFERENCE LIMITSAir Temperature:(20 - 24)°CRadiant Temperature:± 2°C TaRelative Humidity:(40 - 60)%Air Velocity:(0.05 - 0.15)m/sPMV:± 0.5PPD:≤ 10%.
  • Determination of the pressure gradient between the interior of operating theatres and their surroundings.

Control of operating theatres - Measurement of the differential pressure of the operating theatre with respect to neighbouring environments.

REFERENCE STANDARDUNI EN ISO 14644 ISPESL GUIDELINES 2009
EQUIPMENTDifferential manometer
METHODOLOGYAll the doors and windows of the operating theatre bordering on the adjacent environments are closed for a sufficient time to stabilise the environmental pressures. At this point, by means of the differential manometer, the difference in pressure between the operating theatre and the adjacent environment (e.g. operating theatre/presence room) is measured.
EXPRESSION OF RESULTSPascal (Pa)
REFERENCE LIMITS≥ 5 Pa
  • Determination of the volumes of injected air, both in the rooms with turbulent circulation and in the rooms with laminar circulation and determination of the hourly air changes

Control of operating theatres - Measurement of the supply air flow rates of the VCCC system and calculation of the number of air changes/hour

REFERENCE NORMSPresidential Decree 14.01.1997 Regulatory Council Resolution 26 July 1999, no. 221 ISPESL GUIDELINES 2009
EQUIPMENTVane anemometer Accubalance TSI
METHODOLOGYAccubalance TSI: The instrument is placed directly on the air supply diffuser. The air coming out of the diffuser is conveyed through the collection cone into the measuring section.Vane anemometer:The vane anemometer is placed at a distance of about 10 cm from the absolute filter (if terminal) or from the diffusion grid if the absolute filters are not terminal. A number of measurements are taken according to a grid representative of the entire delivery section.
EXPRESSION OF RESULTSThe air flow rates are expressed in m3/h. The total air flow rate into the operating theatre is obtained from the sum of the individual air flow rates of each supply section. The ratio between the total air flow rate and the cubature of the operating theatre expresses the number of air changes per hour.
REFERENCE LIMITS≥ 15 vol/h
  • Determination of recovery time.

Control of operating theatres - Determination of recovery time

REFERENCE NORMATIVEISPESL GUIDELINES 2009 Series UNI EN ISO 14644
EQUIPMENTParticle counter CLIMET CI-500 EC -02
METHODOLOGYAir sampling by means of an isokinetic probe positioned near the operating bed at a height of 1.5 m from the floor. Programming of the sampler in "continuous" mode with sequential sampling. Stabilisation of the minimum value.Pollution of the operating theatre with an aerosol generator until a contamination > 100 times the class limit is reached, referring to particles with a diameter ≥ 0.5 microns.Calculation of the Recovery time from the moment the contamination reaches 100 times the class limit until the class limit is reached.
EXPRESSION OF RESULTSMinutes
REFERENCE LIMITSrecommended ≤ 20 minutes
  • Quality of water supplied in the operating room

Control of operating theatres - Cold water

REFERENCE STANDARDISPESL GUIDELINES 2009 Series UNI EN ISO 14644
EQUIPMENTIncubator thermostats or PCRs
METHODOLOGYSampling of water in sterile containers and subsequent determination of microorganisms in the laboratory using microbiological analysis techniques
EXPRESSION OF RESULTSColony-forming units on predefined sample volumes
REFERENCE LIMITSTotal bacterial load at 22 C100 CFU/ml Total bacterial load at 37 C20 CFU/ml Total coliforms0 CFU/100mlPseudomonas aeruginosa0 CFU/250ml

Control of operating rooms - Hot water and/or humidification technology

REFERENCE STANDARDISPESL GUIDELINES 2009 Series UNI EN ISO 14644
EQUIPMENTIncubator thermostats or PCRs
METHODOLOGYSampling of water in sterile containers and subsequent determination of microorganisms in the laboratory using microbiological analysis techniques
EXPRESSION OF RESULTSColony-forming units on predefined sample volumes
REFERENCE LIMITSLegionella < 100 CFU/litre
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