Futura(™)
Clean environment system
Futura(™) is a dynamic system, positive air pressure regulated, for creating clean environment, under dynamic conditions - In other words, Futura(™) system “knows” how to handle and actively respond to changing situations and conditions (e.g. - entry of people into the system interior, movements and actions within the system interior or external changes affecting the system interior).
Futura(™) was designed and developed with the aim to bring significant reduction of bacteria and fungal spores quantities within the unit, this by using paraphernal suction system, designed effective and rapid removal of particles from the system interior, combined with anti-bacterial cladding.
Futura(™) allows its users to fully control, monitor and adjust the cleanliness level within the system, at any given moment – and so to fix and determine the exact cleanliness level according to its needs .
Futura(™) Central control Futura(™) consists of a central control unit and Neo Futura(™), independent & controlled filtration units.
The Futura(™) central control unit acts as the "brain" of the entire system, while, at the same time, each Neo Futura(™) filtration unit serves both as the executive arm of the "brain", as well as sensoring units transferring inputs to the "brain".
Each Neo Futura(™) filtration unit includes independent blower, fast exchange modular filter (that can be modified and characterized according to the user requirements) and sensing and detection technologies, all allowing the independent operation of each Neo Futura(™) filtration unit.
The main control unit displays the Futura(™) system data at any given time and allows the user to control the operation of the Futura(™) system - whether by setting parameters according to specific requirements or by choosing one of a predefined operation profiles.
Simple in mind Simple in operation
The Neo Futura(™) filtration units are mounted on a designated Floating ceiling, which is part of Futura(™) system, under the existing ceiling of the room. Each Neo Futura(™) filtration unit weighs about 7 Kg - allowing for quick and simple plug & play installation over existing infrastructures.
Futura(™) system can be set up and implemented, as a standalone system, at any facility, at any time, regardless of existing
infrastructures and without disruption to the existing infrastructures.
Futura(™) system can be set up and implemented, as a standalone system, at any facility, at any time, regardless of existing infrastructures and without disruption to the existing infrastructures.
Using the Futura(™) system , enables to transforms any room into a controlled and monitored clean environment.
Futura(™) is a modular system and can be adjusted to the specific needs of each client requirements – e.g. antibacterial floor coating, antibacterial walls coatings, return-air ducts, interation with the client existing air conditioning systems (including control), partitioning of
the systems interior (using detached partitions attached to the designated ceiling) to create clean indoor spaces in a matter that allows to set the room occupancy physical separation between hospital beds without damaging its cleanliness.
Futura(™)
Bone Marrow Transplant Unit – Clean Room Project
Aspergillosis is a most life-threatening fungal infection for immunosuppressed patients, especially those with a hematologic malignancy or after a bone-marrow transplantation. With these patients, pulmonary infections lead to Invasive Pulmonary Aspergillosis (IPA). The prognosis in these cases is poor, especially for the latter.
According to the guidelines of the American Center for Disease Control (CDC) and in line with the instructions of the Israeli Ministry of Health, hospitalization rooms for patients after a bone-marrow transplantation must meet the following conditions (ISO-8):
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Positive differences in air pressure compared to adjacent spaces.
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HEPA/H-13 air filtration system with filtration levels of 99.997%.
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Completely sealed-off space.
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More than 12 air exchange in room (fresh air + returning air) per hour.
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Complete separation between areas undergoing construction and areas were patients with transplantations are treated.
While the Bone Marrow Transplantation Institute at the Rambam Health Care Campus does comply with these rules and regulation, a worrying 20% of all patients in the unit still contract IPA.
In light of this fact, Rambam decided to examine a new system, in cooperation with SYS Technologies, that specializes in maintaining a clean and sterile environment. The Clean Room Project in the Rambam Bone Marrow Transplantation Institute included the establishing and integrating of a clean environment system. Users were able to control, monitor and maintain specific levels of cleanliness to meet specific requirements. This system is unique in that it was designed and developed based on a dynamic yet simultaneous environment in which the entire air within the space is sent through a filtering system, resulting in a highly-controlled clean environment; moreover, the system is coordinated to work together with the space's existing air conditioning system.
Methodology
Two rooms were included in the study. Room 12 served as the intervention room, while Room 11 served as the control room. The unique system was introduced in Room 12, while the hospital's standard ventilation system – ISO Class 8 in line with ISO 14644-1 – was maintained. Each week, patients in their attending nursers were asked to complete a questionnaire on undesirable side effects, such as increased ear pressure, background noise, etc.
The study was approved by the Helsinki Committee of the Hospital and by the Israeli Ministry of Health.
Conducted from April 2018 until November 2018, a total of ten patients were hospitalized in the intervention room and seven patients were hospitalized in the control room.
Over the course of the study, a total of 185 air cultures were taken in molds, as follows:
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83 cultures were taken from Room 12.
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75 cultures were taken from Room 11.
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27 cultures were taken from other areas in the Unit.
Only 7% of the cultures taken from the intervention room showed growth of mold, compared to compared to 47% from the control room and 33% from other areas in the Unit [P value <0.005; OR =11.2 (95% CI 4.36-28.93)].
Both rooms were divided into five different testing areas (i.e., particle counting stations), based on test protocol definitions found in clean room inspection regulations.
Throughout the experiment timeframe, particle counts were conducted over a period of about 20 minutes at each station. The aim was to examine the size and movement of the air particles inside each room, at different times of the day, when the room contains the patient, medical staff, and guests.
About 5,000 tests of particle counts in the air were conducted in varying conditions. The results showed significantly lower levels in room 12.
Even in a comparison of "room rehabilitation" time from movement to rest (decrease in the number of particles), the intervention room was at an advantage.
Within each room, the uniformity of cleanliness in the room was examined. In both rooms differences between the five areas were found in terms of the particle count. Therefore, this finding may suggest that not all pollutants can be completely eliminated.
With regards to side effects among patients, no differences were reported between patients in rooms 11 and 12 in relation to feeling pressure in ears. However, 57% of the patients in the intervention room reported hearing background noises, mainly in the morning and in the evening when system activity was increased for ten-minute periods in order to clean the air in the room.
The team mainly reported background noises when opening the door and entering the room, but reported that the noise stopped after they closed the door. Moreover, 21% of the team reported feeling pressure in their ears while they were in room 12.