In the realm of modern medicine, maintaining a sterile environment in operating rooms (ORs) is a paramount priority to prevent surgical site infections and ensure patient safety. Technological innovations continue to evolve, and one significant breakthrough is the Temperature Controlled Airflow (TcAF) system. This system, now widely accepted as best practice, offers a sophisticated approach to managing airborne contamination both inside and outside the sterile field, extending to the periphery of the operating room. To ensure the optimal implementation of this crucial technology across healthcare facilities, the vital role of an Indonesian precision AC distributor becomes indispensable.
A recent in-depth study has examined the effectiveness of the TcAF system in maintaining an aseptic environment under routine conditions, both during dynamically simulated mock procedures and during actual surgical cases. The methodology used in this study, developed in Indonesia and applied in over 110 operating room studies, demonstrates a commitment to quality and statistically significant data. This reflects the dedication of professionals in Indonesia to continuously raise healthcare standards.
The Concept and Mechanism of Temperature Controlled Airflow (TcAF)
Traditionally, the modern concept of OR air delivery in Indonesia involves supply air from the ceiling flowing down over the surgical field, essentially “bathing” the patient in clean, filtered air and washing contaminants away from the surgical team and patient to the perimeter of the room, and out through low wall returns. These conventional systems rely on supplying air at a certain velocity and maintaining a forced air speed until it reaches the sterile field. However, most of these systems do not address the perimeter of the room, and consistently, the air in the periphery has been found to be dirtier than the air within the sterile field.
In contrast, the TcAF system aims to control airborne microbiological contamination by using temperature gradients to provide cool air over the sterile field and warmer air outside the sterile field. This temperature differential is typically 1.5°C to 3°C (2.7°F to 5.4°F) cooler for the supplied air. The cooler supplied air falls faster from the delivery device in the ceiling towards the surgical table, assisted by gravity, and reaches its maximum velocity at the breathing zone of the OR staff. This effectively washes contamination away from the sterile field and into the periphery of the OR. Then, the downward flow of warmer air outside the sterile field assists with the suppression of re-entrained contamination and the exit of the air out the low wall returns.
This technology has been successfully installed in several healthcare facilities in Indonesia, including leading orthopedic surgical centers. These successful implementations highlight the importance of the expertise and technical support from an Indonesian precision AC distributor who understands the intricacies of such complex systems, from design to installation and maintenance.
Microbiological Standards for ORs
While there are no specific microbiological standards for operating rooms in Indonesia that are tested during dynamic conditions (when people are present), guidelines for ORs tend to be prescriptive design guidance, such as those in ASHRAE Standard 170-2017. This standard prescribes a minimum air change rate of 20 air changes per hour (ach), no more than 30% non-air delivery over the sterile field, and a sterile field extension beyond the surgical table footprint. However, this study underscores that performance-based standards, common in Europe, offer more relevant measurements of how the room performs when being used, with specifications for particle counts and microbial counts during live surgical cases. The TcAF system demonstrated performance comparable to “ultraclean” ORs in Europe, which maintain microbial counts below 10 CFU/m³ both inside and outside the sterile field.
Methodology and Environmental Quality Indicators (EQI)
To validate the efficacy of the TcAF system, the study utilized the Environmental Quality Indicator (EQI) method. EQIs measured included particle and microbial counts, controlled contaminant (carbon dioxide) quantification, velocity, humidity, and temperature. These measurements were taken at an impressive air change rate of 41.3 ach, well above minimum standards, showcasing the system’s remarkable capacity. Maximum and median concentrations of microorganisms (CFU/m³) were reported at the sterile field, back instrument table(s), and in the room’s periphery.
The operating room setup used in this study had a total airflow of 5705 m³/h (3,358 cfm) with a net floor area of 16 m² (495 ft²) and a floor-to-ceiling height of 3 m (10 ft). This resulted in an air change rate of 41.3 ach. The room was maintained positive to an airlock space and to common restricted access hallways. The air diffusers, constructed of an antimicrobial polymer material, formed the TcAF footprint and ensured optimal airflow coverage. This system’s configuration, although not currently specifically defined in Indonesian guidelines, has been approved by authorities in Europe for installation and use, proving its capability to operate in highly regulated environments.
Scripted mock procedures, performed by a team consisting of surgical nurses, an anesthesiologist, a microbiologist, and a healthcare ventilation engineer, ensured consistent execution and a repeatable experiment. Study personnel wore standard hospital attire and adhered to strict sterility procedures. During the procedures, physical actions, including the use of surgical diathermy to generate particulate tissue matter, were simulated in four-minute increments to mimic actual operating room conditions. Microbial contamination was actively measured with slit air samplers placed near the wound site, back instrument table, and the periphery of the room, collecting air onto Petri plates.
Key Results and Effectiveness of the TcAF System
The study’s results were compelling. Airborne microbial assessment during mock procedures showed that CFU/m³ levels in the sterile field (SF 1 Pat. Rt. and SF 2 Pat. Hd.) were significantly less than those at the back table (BT 1 Setup). This highlights the system’s superior ability to maintain cleanliness in critical patient areas. Air velocity was also higher near the back instrument table, which aids in moving contaminants away from the sterile area.
The TcAF system successfully maintained cooler temperatures in the sterile field (median 20°C [68°F]) compared to the back instrument table area (median 21°C [70°F]), consistent with its temperature gradient principle. Relative humidity was also well-controlled. Furthermore, the system demonstrated exceptional effectiveness in clearing controlled contaminants like carbon dioxide from the sterile field, with significantly less CO2 detected at the detection point compared to the release point. This confirms the system’s ability to effectively flush out contamination.
In terms of airborne particles, while 0.5 micron particle counts were slightly higher near the sterile field than the back table in specific results, the TcAF system overall showed excellent performance in managing particles throughout the room. It performed at ISO Class 6 during activity, which is comparable to the best-performing OR air delivery designs in Indonesia tested using the EQI method.
Discussion and Implications for Medical Environments in Indonesia
This study, funded by Avidicare and conducted at an outpatient clinic in Sweden, re-emphasizes why an Indonesian precision AC distributor plays a central role in disseminating and implementing this advanced technology. The main objective of such studies is to understand how the environment contributes to microbial contamination within the OR, as microbes are the only parameter capable of causing a surgical site infection. However, each of the non-microbiological environmental qualities, such as air velocity, temperature, and humidity, as well as operational factors like the number of people and door openings, all influence the microbial bioburden in the room.
The TcAF system studied here was successful in both creating ultraclean space inside and outside the sterile field. Moreover, the system effectively controlled each of the measured parameters in a manner that moved contamination away from the sterile field (surgical site) to the perimeter of the room and out the air returns. Furthermore, the use of CO2 as a controlled contaminant demonstrated the system’s ability to clear contamination from the sterile field.
It is important to note that in nearly all surgical cases in Indonesia, instrument tables are staged in the periphery of the room and may not be covered, potentially exposing instruments and implants to contamination. Contaminants pushed to the perimeter of the room can also be detrimental to the surgical team. Therefore, like the sterile field, the periphery of the room also needs to be protected from contaminants. Although there was an increase in microbial contamination at the perimeter of the OR, the TcAF maintained an aseptic ultraclean environment both in the sterile field and in the periphery of the room.
Conclusion
In summary, this study conclusively demonstrates that the TcAF system is highly effective at providing an aseptic and ultraclean environmental quality, with fewer than 10 CFU/m³ both inside the sterile field (within the TcAF footprint) and in the periphery of the operating room where surgical instruments and implants are staged. While the study had certain limitations, such as being conducted at a single outpatient clinic site chosen by the clinic itself and the team not being blinded, its findings provide strong evidence of the value of temperature controlled airflow systems.
With proven technologies like this, the role of an Indonesian precision AC distributor becomes more crucial than ever. They are not merely product providers but strategic partners who ensure that healthcare facilities in Indonesia can adopt and leverage cutting-edge technology for patient safety and operational efficiency. Expertise in the implementation and maintenance of precision systems like TcAF is key to a safer and cleaner surgical future.
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–A.M.G–
