Theatre Classification and Air Particle Count Is that Surveillance?

Codes and Specifications for Theatre Installations The South African National Standards Wiring Code - SANS 10142-1:2006. Occupational Health and Safety Act and Regulations (85 of 1993) SANS 10147:2011 Refrigeration Systems including plants associated with air-conditioning systems. Rev 6 The Local Authority Fire Regulations ICASA Regulations SANS 10400 Code of Practice for the Application of the National Building Regulations R158 ASHRAE

Operating Theatre Design Constant volume systems shall be employed at a positive pressure (15% excess air) with respect to any adjoining rooms. Temperature range shall be 18ºC to 24ºC. Separate / individual temperature controllers to be installed in each theatre. No on and off switching of air handling plant to be done from within the theatres. Recirculation of up to 70% of air with the inclusion of 30% fresh air. Delivery of the conditioned air shall be by downward movement from the ceiling to four exhaust outlets located at low level on opposite walls /corners. All ductwork beyond the Hepa filter housing shall be in solid ducting to the air terminal. New operating theatres and where possible, theatre upgrades, shall be provided with mezzanine floors to necessitate ease of access to plant, filter housings and ductwork. Filter housings shall be positioned such to provide easy access to filter media for servicing and visual inspection purposes. No internal air duct insulation is permitted. Condensate water discharge shall go to sewer by means of a trap.

Operating Theatre Design

Operating Theatre International Design Criteria

Why Air Filtration? Today s air is contaminated with dust, fumes, gases, fog pollen, bacteria and viruses. We as human beings use the outside air to live. To live we have to breathe, and with every breath we take in 40,000-70,000 particles, 20,000 times per day. Dust particles can function as carriers of bacteria and viruses and may thus be a hazard to our health. It is therefore imperative that in hospitals, where human resistance is at its lowest, there is a need for air filtration. Hospital operating theatres need clean air to the highest degree to reduce the chances of infection after operations. ICU, NICU, CTICU, etc, also need a correct level of air cleanliness to maintain the health condition of the patients. But also industries, directly or indirectly related to our health, have a need for contaminant free air. The list is endless of the type of applications needing filtration and at what grade.

Types of Air-Conditioning Systems We typically use two types of air-conditioning systems 1- Dedicated Air-Handling Unit ISO Class 5,6,7 A detailed name plate shall be included on the air handling units with design air volume, fan speed, cooling / heating capacity, filter data and heating capacity. The air-handling unit is to be supplied from the emergency electrical supply and the chillers from the normal electrical supply. No sewer pipes are permitted through an air-handling unit plant room. Each operating theatre shall be air-conditioned by a dedicated air-handling unit, or individual package unit. A separate air-handling unit shall serve other areas in the theatre complex. This is the preferred system. 2- Blended Fresh Air and Re-circulation Air Type System ISO Class 8 A detailed name plate shall be included on the air handling units with design air volume, fan speed, cooling / heating capacity, filter data and heating capacity. The air-handling unit is to be supplied from the emergency electrical supply and the chillers from the normal electrical supply. No sewer pipes are permitted through an air-handling unit plant room. This system utilises one central air-handling unit with a variable speed drive for a number of operating theatres / procedure rooms. 100% outside air is drawn into the A.H.U, filtered and cooled and delivered via sheet metal ducting to constant volume and variable volume boxes within the system.

Filtration Filtration Air filtration shall be as specified in accordance with the Department of Health s Filtration and Air Flow Requirements for Operating Theatres. High Efficiency Particulate Air (Hepa) Filters shall be utilised and be situated at the supply air terminals /diffusers before the air enters the theatre or as close to the air terminals as possible. These filters shall be accessible from the Service Areas. Hepa Filters shall be side or top entry fitted to seal in the direction of airflow against a neoprene gasket, and shall be secured by mechanical means to ensure no air bypass. Primary and secondary filters shall be secured by means of no less than four (4) holding stainless steel clips. Secondary and Hepa filters housings shall be fitted with Magnehelic manometers marked with the filter s operating parameters.

Filter Types

Validation of Operating Theatres Each Operating Theatre shall be validated on completion to ensure compliance with Filtration and Air Flow Requirements for Operating Theatres by means of a particle count and air flow measurement. Particle count shall be undertaken prior to Practical Completion and prior to final delivery. The Particle Count shall conform to ISO 14644 1 (Clean-room Classification Standard) and the Standard Specification Particle Count Testing of Operating Theatres.

When do we perform Particle Counts? Particle counts is to be performed: Once a year in ISO Class 8,7,6 Theatres Every 6 Months in ISO Class 5 Theatres Hepa Filters are replaced Increase in reported theatre infections If any alterations or construction were done within the Theatre **Nine points should be tested within each theatre s red line area.

Airborne Particulate Cleanliness Classes

Report Detail The report shall contain the following details: Date & Time of test Location of test Number of test points Particle readings Airflow readings Test results in a numerical and graphical format Test Certificate confirming compliance

Procedure to be followed if a Theatre fails a Particle Count Test Request report and calibration certificate of equipment used. Inform Hospital Manager, Nursing Manager, Infection Prevention Specialist, QSSS and Theatre Matron. Shut down the affected Theatre and arrange for cases to be moved to similar ISO Classed Theatres. Shut down the AHU and change the primary and secondary filters. Re-start AHU, Deep Clean Theatre and re-test the Theatre after 24 hours. If the particle count still does not comply, arrange for Hepa Filters to be changed and re-test the Theatre. At Facilities or Hospitals where no other theatres are available, a contingency must be put in place to only continue with Theatre Cases applicable to the particle count standard passed. ISO Class 5 Neuro surgery, Orthopedic, Cardiac ISO Class 6 Plastics ISO Class 7 Minimum Invasive surgery ISO Class 8 Dental, Labour Where this is not possible, cases should be referred to other facilities or re-scheduled.

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