Technology & Services

Nosocomial Infections and Air Filtration in Operating Theatre Suites Application of French Standard NFS90-351:2003
a report by

Fabrice Dorchies
Corporate Product Manager Clean Concept, Camfil Farr

The Problem

The incidence of nosocomial infections in the hospital environment ranges from 5% to 8%. It is estimated that almost 20% of these infections are contracted in an operating theatre suite with possible irreversible consequences for patients. According to the etymological meaning of the word (nosos illness and komein treat), the term nosocomial is used to describe infections contracted following treatment. When this type of infection is diagnosed, therefore, cause and responsibility rest with the healthcare facility. The media give regular reminders of this issue, e.g., the sports clinic scandal. The increasing involvement of the public should also be noted, who not only increasingly demand more transparency, but also wish to understand how the health system works. At the same time, they are less willing to accept risk, which they cannot control, or have not chosen. Against this backdrop of public pressure and increased public awareness, healthcare professionals are justified in paying ever-closer attention to nosocomial infections. Each year in France, 60,000 to 100,000 patients admitted to hospital contract nosocomial infections, which corresponds to a prevalence in the range of 6% to 10%. Five thousand to 10,000 people die of the infections. In terms of public health, these figures are as alarming as the statistics for road-traffic accidents (7,800 deaths in 2002). To this picture must also be added the aspect of cost for the healthcare structures and, therefore, for the local authorities nosocomial infections extend not only the list of treatments to be provided but also the length of stay in hospital. Faced with this issue, many European countries are currently drawing up documents intended to standardise the most reliable solutions. The recent French standard, NF S90-351:2003, relative to clean rooms and similar controlled environments in healthcare facilities, provides

recommendations for the development of the project, as well as the construction and maintenance of air-treatment facilities. For its part, Spain has also adopted a new standard UNE 100713:2003: air conditioning in hospitals with the same objectives. In the UK, hospital air conditioning is now under scrutiny from the Association of Local Authority Risk Managers (ALARM) the UK national forum for risk management in the public sector. This body has stated that failing to manage the risks associated with heating and ventilation systems in premises, particularly hospitals, could have catastrophic results. Their view is that failure to control or minimise exposure to dust fumes, airborne contaminants and bacteria could leave anyone in the building at risk of developing a range of illnesses. The containment of the risk of Legionella has now been coupled with increased emphasis on the containment of methicillin resistant stephalococcus aureus (MRSA) and all hospital-acquired infections. Although cleanliness programmes are often aimed at contact spread, airborne spread is now being treated increasingly seriously and appropriate filter systems, particularly for recirculated air flows, are fundamental to the hospitals infection control team. Camfil offer consultative advice to prioritise the fitting of correct filter systems and on-going advice on hygienically focused preventative maintenance. The emphasis is placed on the air handling unit (AHU) section and the operating theatre suite.
Filters Compliant with European Standards
The EN 779:2002 Standard

This standard deals with air filters used to trap particles in the general ventilation system. It includes a protocol for evaluating their gravimetric efficiency so that filters can be classified and compared. In particular, this standard enables evaluation of the filters capacity for the filtration

BUSINESS BRIEFING: HOSPITAL ENGINEERING & FACILITIES MANAGEMENT 2005

Technology & Services

of fine particles (0.3m to 3m) and to assess its dust-holding capacity. It applies only to filters with an initial efficiency of less than 98% for particles of 0.4m.
The EN 1822-1 to 5 Standard

Table 1
Pr P 1 2 3 4

Part 1 of this standard supplements the previous standard, as it specifies a method for the classification of high efficiency particulate air (HEPA) filters and ultra-low penetration air (ULPA) filters. Part 2 concentrates on describing the measurement methods and instruments. Parts 3, 4 and 5 describe the testing systems.
The EN-ISO 14698-1/2 Standard (March 2004)

1 2 3 4

1 2 3 4

2 4 6 8

3 6 9 12

4 8 12 16

Pr = risk factor associated with the procedure P = risk factor associated with the patient Score of 1216: zone 4 (very high risk zone); score of 69: zone 3 (high risk zone); score of 24: zone 2 (moderate risk zone); score of 1: zone 1 (low risk zone).

With regards to the methods of use, the standard focuses on the air flow systems for the area to be protected (unidirectional or non-unidirectional flow), the air exchange rate in the room and the decontaminable aspects of the exposed materials. The following types of operating theatre suites are normally classified as level 4 risk areas traumatology, ophthalmology (OPH), major burns, cardiovascular surgery and neurosurgery, etc. The procedures carried out in these operating theatre suites combine the risk factors associated with the procedure (duration and complexity of the procedures, etc.) and the risk factors associated with the state of the patients health (age, effectiveness of the antibiotic therapy and immunedeficient condition, etc.).
Level 4 Risk Areas

The scope of this future standard will cover the biocontamination control of clean room air. Furthermore, this standard introduces the idea of risk assessment.
The ISO 14644-1 to 4 Standards (Classification Index X44-101 to 104)

Although not specific to the healthcare environment, the classification system proposed by this standard means that the clients requirements and aims can be incorporated. This dimension can prove to be a determining factor in the design, operation and construction of clean rooms in a hospital environment.
Industrial Analysis and Know-how

According to NFS90-351, level 4 risk areas must fulfil the following criteria: minimum filtration chain F6 (AHU input), F7 (AHU outlet) and H13 (ceiling diffusion); ISO 5 particulate classification (ISO 14644-1); CP10 particulate decontamination kinetic classification; target bacteriological classification B10; use of easily decontaminable materials; unidirectional flow; and air exchange rate of the room > 50vol/h.
2 Types 1A /1B

The contamination control requirements vary in healthcare facilities according to the medical procedures carried out and the areas allocated to these activities. In response to these requirements, the NF S90-351 standard points out the need to initially conduct a risk assessment to define the particulate cleanliness classification appropriate to the specific needs of each area. Two factors determine the infection risk in an operating site. The first concerns the surgical procedure itself, the other the patients state of health. The combination of these two factors determines the biocontamination risk specific to the procedure (see Table 1). Having completed this procedure, the required performance efficiency for the facility can then be analysed and the most appropriate equipment selected in line with the surgical procedures carried out. From risk 4 (the highest) to risk 1 (non-specific areas), each risk area will be classified and linked with a target technical efficiency level.

Rooms for operating theatre suites (according to UNE100713:2003) must fulfil the following criteria: three-stages of filtration, (F6 and F9) in AHU and H13/h14 (ceiling diffusion); filters F6 and F9, according En 779; filters H13 according EN 1822; two types of air flow for classes 1, A or B; type 1A unidirectional flow; type 1B unidirectional flow or nonunidirectional flow;

BUSINESS BRIEFING: HOSPITAL ENGINEERING & FACILITIES MANAGEMENT 2005

Nosocomial Infections and Air Filtration in Operating Theatre Suites

air exchange rate of the room > 30vol/h; 100% fresh air; and roomside access for filters controls.
The Solutions
Figure 1

With a view to providing a point-by-point response to this new standard as regards to level 4 risk areas (and/or 3), Camfil has developed a unidirectional flow filtration ceiling, the CamHOSP Screentek finish. As a result of Camfils 40 years of experience and knowledge of the hospital environment, their engineering department has concentrated on: frequent replacement). swift implementation with guaranteed results (class B seal, according to EN 1886, EN-1822and En779:2002-certified filters); reduced maintenance costs through the use of universal mechanical seal filters, providing the operator with a guarantee that filters can be replaced very easily and independently (unlike gel-seal filters, which are not suitable for This system is particularly suitable for hospitals, as it allows frequent and efficient cleaning and disinfection; The CamHOSP complies perfectly with Appendix D paragraph 1.2 of standard NF S90-35, as it is free of surface unevenness and porosity that could promote the retention of particulate and chemical contam-ination or the development of micro-biological contamination.

BUSINESS BRIEFING: HOSPITAL ENGINEERING & FACILITIES MANAGEMENT 2005