German Technical University of Applied Sciences presented results of tests of Russian Potok air decontamination units in Moscow and German Hospital
The research studies showed, the bacterial burden in the operating room is reduced to ≤5 cfu/m³ with Potok decontamination system. This means that Potok technology meets the Swedish SIS-TS 39: 2015, the EU GMP-Guide, and also Russian SanPiN 22.214.171.12430-10, GOST 52539-2006 “Air cleanliness in hospitals”, and it can be used instead of HEPA-filters.
July 10, 2017 one of the largest universities of Bavaria - Ostbayerische Technische Hochschule Amberg-Weiden and the Russia-based engineering company Potok Inter, a unique technology developer and a manufacturer of patented professional equipment for air decontamination, published study results of efficiency of Potok equipment in operating rooms in Russia and Germany.
The purpose of this work was to evaluate the decontamination potential of the Potok technology both in an experimental setting in the research operating room of the Ostbayerische Technische Hochschule Amberg-Weiden with standalone air decontamination units and in a clinical setting in a real operating theater in Moscow were the Potok system is an integrated part of the ventilation system.
Efficiency was estimated by comparison of values of a bacterial burden in operating room without Potok unit (background level) with a contamination level after working of unit – in twenty-four hours in Germany, and after 2 hours in Russia.
Experiments showed an impact of the Potok unit on the bacterial contamination of the room air (concentration of staphylococcus, streptococcus).
For the measurement directly on the operating room table the activity of the units led to a decrease of the bacterial air contamination from 5 cfu/m³ to 3 cfu/m³ in average. For the instrument table and the periphery of the room this reduction was from 5 cfu/m³ and 12 cfu/m³ down to 4 cfu/m³ and 5 cfu/m³ respectively.
Efficiency of the Potok technology was confirmed by the results of the measurements in the real-life setting of the operating theater in a Russian hospital. For the three different measurement locations results showed a decrease of more than 87%. The initial bacterial burden of 37 cfu/m³ on the operating room table and 39cfu/m³ on the instrument board and the periphery of the room had been reduced to≤5 cfu/m³ in average for every measurement point.
At the first stage of the study two units were positioned in an experimental operating room-setting according to the Swedish standard SIS-TS 39: 2015. Three parallel samplings were performed at predefined measuring points. These are located directly on the operating table (1.2m above the ground and ≤0.5m from the operating site), on the instrument table and in the periphery of the room near an exhaust opening.
Sampling was done by impaction method, in which an air volume of 1000 liters was collected per 10 minutes via a columnar opening onto a blood agar plate. The culture media were then incubated for 3 days at 35 °C +/- 1 °C. After incubationthe plates were photographed and colonies were counted manually and documented as colony forming units per cubic meter of air (cfu/m³).
Already in the pilot studies to this work the impact of the surgical clothing on the germ load in the operating room was investigated. On the basis of these results, Swedish surgical gowns were chosen as standard for further experiments. This so- called "Clean Air Suit" is a disposable product and consists of polypropylene. (Fig. 1)
Fig. 1: Example of Swedish surgical clothing
The measurements were performed during a one-hour surgical simulation (6 measurements a 10 minutes). The simulated surgery was performed by 7 people. In order to simulate as much as possible a reality oriented process, 4 persons represent the surgical team directly at the operating table, one person acts as an anesthesiologist and 2 other persons move through the room during the surgical simulation. (Fig. 2)
Fig. 2: Movement profile of the OR simulation, measurement points of the active air sampling and location of the Potok devices
As a second step, the activity and effectiveness of the Potok system was tested in a real-life setting in an operating theater in a hospital in Moscow, where Potok decontamination units have been operating for more than 9 years. (Fig. 3)
Fig. 3:Russian operating theater with installed Potok system
The operating room is equipped with Potok system. The unit consists of 4 inactivation blocks (to be installed as a part of hermetic false ceiling)with optional space for shadow less lamp.For such research study concentration of microorganisms in the air was measured during two days in Moscow hospital. Indoors there were 7 people (strength of the normal surgical team).
According to the World Health Organization (WHO), 5-10% of hospital patients are infected with healthcare-associated infections (HCAI). They appear across the globe and affect all countries, regardless of the degree of their development. The most important pathogens of HCAI are staphylococcus, streptococcus, Escherichia coli, rotaviruses, etc. They circulate in medical facilities, form strains that are characterized by high virulence, resistance to antibiotics, antiseptics and disinfectants.
2-2,5 million Russians suffer with HCAIevery year. Approximately 1/3 of hospital-acquired infections is connected with aerogenic transmission of pathogens. 30% of HCAI can be avoided.
Potok units are designed to significantly reduce these figures, by enhancing microbiological safety of the air in premises with high hygiene requirements.