Operating theatres, high-risk wards, laboratories, in-patient areas: controlling biocontamination in hospitals, one of the most pertinent and tragic causes of nosocomial infections today, starts with the ventilation and air-conditioning system for airborne components.
Meticulous design, test and validation phases and the implementation of proper codes of conduct and managerial procedures are the cornerstones of protecting every person needing to enter a hospital, and to ensuring the best outcome of all these phases.
At SagiCofim, we are specialist in the air filtration, diffusion and distributor sector. We provide solution to ensure the optimum and proper performance of HVAC system in hospital buildings, both in their standard and more critical settings.
When designing and implementing hospital systems, the project manager must keep in mind two absolute priorities: patient health and worker safety. this criteria extends right the way through from operating theatres, inpatient wards and laboratories (preparation of radiopharmaceuticals, antibiotics, etc.) To critical wards (for immunosuppressed, infectious, severe burns patients). Over thirty years’ experience in the European market in what has earned us the reputation as confirmed expert in contamination-controlled environment. An example of this experties is our DIF-OT (diffuser for operating theaters) ceiling filtration system, an integrated differential speed air filtration and diffusion system for operating theatres that is capable of guaranteeing maximum sterility levels (ISO 5 Operational), in other words, for during surjery when the surgical team are working. It also guarantees reduced recovery times and low energy consumption
We believe that controlling airborne biocontamination in hospitals, one of the most pertinent and tragic causes of nosocomial infections today, starts and continues with the ventilation and air-conditioning system. In hospital facilities, so-called “contamination-controlled buildings”, the detailed planning and subsequent application of proper codes of conduct and management procedures is essential.
We have the experience and knowledge to successfully direct all of these phases.
Current figures in Italy and Europe for nosocomial infections are shocking. We can help with the design, creation and management of better hospitals, where you can be certain that the air there will serve as a close ally rather than a worst enemy. To do this, choosing a skilled and specialist partner from the outset is paramount.
Even from the early stages of designing the buildings and different zones, the client and the project manager must work together to define their objectives and to make the best technical choices in order to achieve them, guaranteeing as a minimum:
- the quality of internal air to control contamination from the environment;
- the physical and dynamic isolation of individual environments or departments;
- the sustainable adherence to optimum quality requirements.
- Nowadays, LCC (Life Cycle Cost) analysis is a determining factor, both on a design and management level, when assessing the quality and suitability of a system or installation.
Our convictions, reflected in our professional practices, have allowed us to collaborate on important design studies (Foster Wheeler, Jacobs, Tecnimont, etc.) and with service providers like Cofely and Siram. We have designed and installed high-level integrated solutions for, to cite just a few examples , the Spedali Civili hospital in Brescia, the Eksjö hospital in Sweden and Malta, Milan’s Sacco Hospital and the CTO Hospital in Turin.
The SagiCofim story, and its collaborations with high profile Italian and European clients, is an eloquent testimony to our abilities and our trustworthiness. We approach every situation and every project on a detailed, “made to measure” basis, paying special attention to the case in hand: not just the products, but solutions and the overall vision.
SagiCofim is capable of ensuring this level of performance because it develops, designs and manufactures at the highest level: it owns its own factories with advanced production processes, equipped with highly automated production lines for building aeraulic components and the whole range of filters and filtering systems. It feeds and updates the production processes through its specialist Research, Development and Testing Centre, that operates in close collaboration with the Polytechnic University of Milan on both the theoretical research phases and on carrying out and validating tests carried out in the field.
At its headquarters in Cernusco sul Naviglio (Milan), it also has its filter and filtration system manufacturing unit; here there is a technologically advanced testing circuit, annexed to the production line, for testing every high and very high efficiency HEPA and ULPA filter in accordance with EN 1822 standards, to further guarantee the quality of every product that leaves the factory.
The aeraulic components are produced at its Bareggio facilities, outside Milan, and in Teglio in Valtellina (Sondrio).
SagiCofim’s international vocation is demonstrated through projects carried out and underway in several European and international locations. Its French branch in Lyon, concerned primarily with the commercial side of the business, is one such example. It also has a presence in other European countries through operative agents with proven technical skills, who are able to evaluate and advise on the situation in hand.
Beyond Europe’s borders, SagiCofim has a particularly well-established, recognised presence in certain areas undergoing rapid industrial development, such as Korea, India and the United Arab Emirates.
What do you do?
Critical issues and benefits
HOSPITALS AS CONTAMINATION-CONTROLLED BUILDINGS
Within this new, broader vision, which views the entire hospital as a contamination-controlled structure, included amongst the environments exposed to biocontamination are chemical and biohazardous laboratories and operating theatre units, which are already subject to specific and extensive guidelines..
When considering how to tackle airborne biocontamination, vital considerations include how and where it comes from and how it is spread through the ventilation and air-conditioning systems, which must, therefore, be designed and installed in accordance with professional standards. These considerations will also highlight the positive impact that can be made by the application of proper codes of conduct. It is worth underlining that to control contamination merely designing and installing state-of-the-art systems is not enough, but addressing operational procedures and the conduct of users is just as essential.
Within this new, broader vision, which views the entire hospital as a contamination-controlled structure, included amongst the environments exposed to biocontamination are chemical and biohazardous laboratories and operating theatre units, which are already subject to specific and extensive guidelines. But these new professional practices in hospital technologies are now also being extended to encompass Contamination Control Ventilation and Air-Conditioning Systems, designed to address the varied range of hospital requirements, which place the control of airborne contamination at the top of the list of priorities: the variety of different environments, from infectious-disease wards to corridors, from casualty departments to waiting rooms, from communal areas to entrance halls, are being scrutinised for their individual, but no less exacting, requirements.
In the European Union 4.1 million patients contract hospital-acquired infections every year. The European Centre for Disease Prevention and Control estimates that this figure is actually closer to 4.5 million, considering that patients may contract more than one infection during the same hospital stay..
As much as a successful surgical operation can put a smile back on a person’s face, an unexpected and avoidable infection can equally alter the course of their life. The statistics on nosocomial infections, particularly those contracted from the site of surgery, continue to indicate alarming data on a global scale. In the European Union 4.1 million patients contract hospital-acquired infections every year. The European Centre for Disease Prevention and Control estimates that this figure is actually closer to 4.5 million, considering that patients may contract more than one infection during the same hospital stay.
This is an increasingly worrying phenomenon, for Italy too, where based on the literature and multi-centric studies performed over recent years, there are estimated between 450,000 and 700,000 nosocomial infections contracted every year, 1% of which are fatal. With 30% of all hospital-acquired infections deemed as potentially preventable, it is estimated that each year between 135,000 and 210,000 cases could have been prevented, and with 1% of those proving fatal, that means between 1,350 and 2,100 deaths could be prevented every year. 35% of such cases can be traced back to the operating site. Contracting an infection will, at the very least, increase the length of a patient’s hospital stay, which means an additional burden on the national health service with associated annual costs exceeding one billion Euros, as well as three million missed working days by patients.
Infections are almost always caused by agent-vehicle-host contact. The most common vehicle for infection is the hands of those working at the site, that is, people involved in administering all forms of treatment and providing assistance, as well as airborne substances that are already present or produced by the activities of the operating theatre.
Hospital-acquired infections are generally caused by opportunistic micro-organisms, present in the atmosphere, which attack the immunosuppressed or other patients with weakened immune systems. For this reason, critical hospital departments, and surgical units above all, must be designed and created using technical solutions, to guarantee superior levels of air quality. Recent studies and guidelines, however, have now extended this requirement to all hospital zones and environments, which are now categorised as a whole as “contamination-controlled buildings”.
In the European Union 4.1 million patients contract hospital-acquired infections every year. 35% are acquired from the operating theatre.
According to the U.S. Department of Health and Human Services, there are over 290,000 surgical infections contracted every year, and over 13,000 fatal cases.
During a surgical operation lasting 4 hours, with a team of 6 people, over 500,000 CFU can be released.
Planning the air in a hospital
During the planning phase, the utmost attention must be paid to the air circulation aspect. In fact, whether in “critical” zones, or in pass-through and meeting areas, the air itself can be a close ally or the most formidable enemy. Designing the air-processing systems must play a leading role, where the selection and installation phases are vitally important, but also the management and maintenance programmes as much so..
Hospitals are places of cures and of hope; they are also businesses, which must be mindful of costs and wastage. Just like when tackling infections, when it comes to costs, prevention is better than cure: that is why maximum attention must be paid to air circulation during the planning phase. In fact, whether in “critical” zones, or in pass-through and meeting areas, the air itself can be a close ally or the most formidable enemy.
Designing the air-processing systems must play a leading role, where the selection and installation phases are vitally important, but also the management and maintenance programmes as much so. Sagicofim maintains that to achieve the desired results, it is absolutely essential to start by considering the entire hospital as a “contamination-controlled structure” and, therefore, the air quality of every single different hospital area must be analysed, based on the specific needs and individual standards of those areas.
Reduce costs, optimise services
If the maintenance side of the equation is planned alongside the system itself, it is possible to gain huge benefits from whatever angle you look at it. If to these concerns we add the system’s flexibility too, we can reduce energy and maintenance costs by up to 70% in the mid-long term..
In most cases, maintenance is usually addressed after the system is completed. This can lead to considerable disruption to operations, with additional costs being incurred for the time required for said operations and their related costs. If the maintenance side of the equation is planned alongside the system itself, it is possible to gain huge benefits from whatever angle you look at it. If to these concerns we add the system’s flexibility too, we can reduce energy and maintenance costs by up to 70% in the mid-long term.
An essential part of reducing costs is optimising the day-to-day system management, by both planning the maintenance as best as possible, and by instructing healthcare workers on the correct codes of conduct. This way, the hospital’s primary goal of optimising services is guaranteed, whilst at the same time waste and damage caused by errors and carelessness is kept under control.
Amongst the considerations involved in using contamination control HVAC systems, we recommend installing a pre-filtration system upstream of the final filter. The efficiency of this system must be evaluated based on the role of the final filter and scheduled maintenance activities. The pre-filtration system should keep the ventilation equipment clean and ensure the proper working life of the final filter, by optimising energy costs associated with system clogging over time.
Filtration systems should be chosen and dimensioned in such a way that their Life Cycle Cost is also taken into account by way of a Life Cycle Assessment.
– Using inefficient contamination control filtration systems will increase energy costs and system maintenance duties.
As a general rule, we do not recommend using filters with an efficiency rating lower than F7, because:
– it will not provide any significant advantages in terms of guaranteeing a longer service life of the subsequent filtration stages;
– it does not guarantee the long-term cleanliness and performance of the APU components;
– it wastes energy in circulating the air.
See: Ricci R., Bruschi R., Martini E., Tantucci L., Esposito E. “La ventilazione dell’aria in sala operatoria, flussi turbolenti o flussi unidirezionali? Quali vantaggi, quali benefici e quali costi?” [Air ventilation in operating theatres, turbulent flow or unidirectional flow? What are the advantages, benefits and costs?] Documents from A.I.C.O. Congress XII, 2009.
The reason why a vertical airflow is the best solution when choosing a ceiling filtration system for operating theatres
The issue of nosocomial infections is an increasingly worrying phenomenon, Italy included, where hospital-acquired infections total between 450,000 and 700,000 every year, 1% of which are fatal. 35% of such cases can be traced back to the operating site. For this reason, critical hospital departments, and surgical units above all, must be designed and created using technical solutions, to guarantee superior levels of air quality..
The issue of nosocomial infections is an increasingly worrying phenomenon, including in Italy, where hospital-acquired infections total between 450,000 and 700,000 every year, 1% of which are fatal. 35% of such cases can be traced back to the operating site. This lengthens hospital stays and weighs heavy on hospital budgets, with annual costs soaring to over one billion Euros.
Hospital-acquired infections are generally caused by opportunistic micro-organisms, present in the atmosphere, which can attack immunosuppressed patients. For this reason, critical hospital departments, and surgical units above all, are being designed and created using technical solutions, to guarantee superior levels of air quality.
At the end of the 1990s, the Italian Higher Institute of Health (Istituto Superiore di Sanità) identified three classes (A, B and C) of microbial air contamination based on the air-conditioning system present in operating theatres. Class A applies to operating theatres with particularly stringent airborne contamination control requirements, (theatres for cardiac, orthopaedic, neurological and vascular surgery, for example) and prescribes a maximum value of 10 CFU/m3, achieved through unidirectional airflow and absolute filtration; Class B applies to operating theatres with absolute filtration and turbulent airflow and prescribes a maximum value of 200 CFU/m3; Class C applies to operating theatres with simple filtration and turbulent airflow, and accepts a maximum value of 500 CFU/m3 (Sabatini L. “Controllo della biocontaminazione ambiente: orientamenti per una normativa italiana.” [Controlling ambient biocontamination: guidelines on Italian legislation.] 3rd International Congress on Hospital Safety, Monza, 29-30 October 1992).
More recently, the guidelines on workplace safety and hygiene standards for surgical departments, published by the Italian Institute for Occupational Safety and Hygiene (2009), state: “The indications provided in the United Kingdom’s National Health Service specifications – Health Technical Memorandum 2025  – shall be used as the reference values on biological contamination, which stipulate the following limits for the air surrounding the operating table, for conventional operating theatres under active conditions:
< 180 CFU/m³ with turbulent flow contamination-control HVAC system
< 20 CFU/m³ with unidirectional flow contamination-control HVAC system.”
At Sagicofim, we believe that it isn’t just the minimum recommended operational levels that we should be aiming for, but the best possible levels to ensure the safety of patients and staff. Unidirectional airflow is, without doubt, the best way to ensure these limits are achieved, but even that can be improved. To combat extremely resistant micro-organisms that can lurk in operating theatres, we have developed a new type of differential speed unidirectional airflow, which envelopes the surgical site, the instrument trays and the entire operating theatre in a sterile flow of air, thereby reducing the bacterial count by 95% through absolute HEPA filters.
DIF-OT (Diffuser for Operating Theatres) is an integrated air filtration and diffuser system, capable of achieving maximum sterility levels (ISO Class 5 Operational) under operating conditions. It also guarantees reduced recovery times and low energy consumption.
Whereas in the past only “inert” contaminants were accounted for in theatres designed for ISO 5 “at rest” classification, now, European legislation prescribes that validation tests must be carried out under ambient conditions that simulate the activities that take place in operating theatres.
In Sweden, a country with some of the strictest legislation in the world, the DIF-OT system has recently been approved for use during live surgery. Ordinarily, during an operation lasting four hours, with a team of six people, 500,000 CFUs (Colony Forming Units, pollutants that can cause infections) can be released into the air. Our solution was not only capable of guaranteeing the required sterility class under “operational” conditions, but it also achieved an unprecedentedly low level of microbial contamination, under 1 CFU/m3, during a real-life surgical operation.
In the European Union 4.1 million patients contract hospital-acquired infections every year. 35% are acquired from the operating theatre.
SagiCofim: clean air for over 50 years
It is the customer, and not the product, that constantly inspires us to create better solutions for a better environment. For us, even the smallest of improvements is another step further towards excellence..
SagiCofim is the undisputed leader in the research and production of air filters, air distribution components and integrated air filtration systems for critical environments. Our clients include pharmaceutical companies, hospitals, research centres, industrial groups, universities and OEMs.
It was during the 60s that Sagicofim first began to develop high efficiency filters, to the extent that within a few years, it had produced a full range of low to high efficiency products, HEPA filters and ULPA filters.
From the very beginning, our technical approach has been directed towards building a solid, open relationship with customers, providing them with the full breadth of our knowledge to provide solutions to their problems whilst meeting the strictest of requirements.
It is working in this way, in close contact with our customers, that we have gained a clear, in-depth view of all the risks involved in planning HVAC systems for critical environments. It is extremely important that air is filtered effectively, but it is also important to properly adjust the movement of the airflow into and out of the critical environment.
It is for this reason that in the 80s, the company entered the air diffusion and distribution market, setting up two new and additional manufacturing centres that still today produce diffusers, grilles, dampers, VAV/CAV devices, silencers and every other accessory that our customers may ever need.
Today, Sagicofim has four manufacturing bases, internal testing laboratories, a highly advanced R&D centre and the experience gained from over half a century of hard work: all of this makes us a “100% Italian” supplier of HVAC system solutions in critical environments and a trustworthy partner for our customers.
We are grateful to all of our customers who, for over 50 years, have and continue to place their trust in us, which is testament to the results we have achieved by staying true to our core values:
It is the customer, and not the product, that constantly inspires us to create better solutions for a better environment.
When assessing a problem, there may be several different solutions. But only a wide breath of knowledge can enable you to assess the problem in-depth and thereby achieve the best solution.
For us, even the smallest of improvements is another step further towards excellence.
Industry standards and guidelines for hospital installations
The “hospital system” is undergoing a rethink, with attention being redirected towards the problem of contamination in all its aspects, so that the whole implementation process, comprising the design, installation and running of the system, is carried out with the aim of producing and maintaining safe environments in mind: when it comes to controlling contamination, maximum attention must be paid to operational procedures and to the conduct of users..
The “hospital system” is undergoing a rethink, with attention being redirected towards the problem of contamination in all its aspects, so that the whole implementation process, comprising the design, installation and running of the system, is carried out with the aim of producing and maintaining safe environments in mind: when it comes to controlling contamination, maximum attention must be paid to operational procedures and to the conduct of users.
We must continue to raise awareness of the “biological” risks associated with airborne particles and of the consequent technical choices that need to be applied. And that is because current pharmacological practices are proving to be increasingly lacking when it comes to combating pathogens embedded in hospital buildings, resulting in long and painful hospital stays for patients, family tragedies and significant costs to society as a whole.
Current standards are full of holes and outdated. Whilst the “critical” situations take up our attention, we are ignoring the systems which single-handedly are conditioning the entire life of a hospital for better or for worse: specifically, the air-conduction systems. In 2015, Aicarr approved guidelines which, for the most part, bridge this gap and introduce obtainable standards that are to be desired.