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by Jeannie Akridge

EX-Flow ultra-clean ventilation system distributed by Modern Medical Systems

"In recent years, the U.S. healthcare community has been hyper-focused on contact precautions such as handwashing," said David Lutz, director of marketing, Mintie Corp, Los Angeles, CA. "This has served an important role in combating a number of contact transmissible diseases. But, increasing awareness of airborne dangers and solutions both here and abroad is bringing the subject of airborne precautions and air cleaning technologies back into the forefront of hospital safety conversations." In particular, he noted that recent research in Europe has identified airborne transmission as a potential risk for diseases such as C. difficile. "Not only are airborne HAIs harder to conclusively prove, but the risks are also not always as apparent since airborne particulates can travel from a ‘low risk’ area to a higher one," Lutz continued. "Yet, the growing intolerance for preventable infections, understanding of transmission and expanding list of CMS no-pay events means that healthcare facilities can no longer afford to put off taking action."

"With the new CMS regulations, there’s a lot of focus on ‘let’s keep people coming in healthy, versus having them catch these nosocomial infections or post op infections,’" agreed Pat Meehan, president, Modern Medical Systems, Farmingdale, NY.

Certainly the American Institute of Architects recognized the relationship between air quality and patient care when it called for single-patient rooms in medical/surgical and postpartum units as the standard for all newly constructed hospitals in its 2006 guidelines for healthcare facilities. A recent article in the Los Angeles Times explored the concept of evidence-based design, whose supporters contend that the spread of infections could be greatly reduced with the right physical environment – single patient rooms, well-designed ventilation systems and air filters, easy to clean, non porous surfaces and plenty of sinks for handwashing. The article highlighted renovation projects at Los Angeles County-USC Medical Center and UCLA Medical Center that incorporate elements of evidence-based design: private patient rooms, isolation rooms for highly infectious patients, and emergency departments with negative air pressure, which pulls infectious air away from the rest of the hospital.

In addition to the push to reduce HAIs, Lutz noted that "guidelines for construction and maintenance containment are changing. The recently published 2009 Joint Commission Environment of Care guidelines require healthcare facilities to conduct a pre-construction risk analysis and take action based on it. This is part of a wider recognition that airborne particulates pose an avoidable HAI risk. Unfortunately, it is not uncommon for internal projects which do not undergo intensive review to be implemented without proper containment. The change in regulation makes it even more important to start pushing for better compliance with policies now, before it puts accreditation at risk."

Fiberlock Kontrol Kube Abacus and Topsider isolation units

Not to be overlooked, "pandemic and bio-terror preparedness have received a lot of needed attention over the last several years," said John Pierson, marketing and product manager, Fiberlock Technologies/Kontrol Kube Mobile Containment Solutions, Andover, MA. "One of the key factors in ensuring the best possible outcome during a biological event is a healthcare facility’s ability to deal with a sudden influx of patients. The federal government knows this and has allocated funds to help facilities prepare for such an event. While the full scope of what is involved in federal funding for pandemic and bio-terror preparedness is complex and lengthy, critical benchmark 2-2 of HRSA BHPP Priority Areas and Critical Benchmarks speaks directly about surge capacity. Essentially it states that; in order for a region to qualify for funding, all facilities in the region must have the capacity to maintain at least one suspected highly infectious disease case under negative pressure isolation within three hours post-event. It goes on to state that one regional facility, which is defined by the participating facilities in the region, must be able to support initial evaluation and treatment of at least ten adult patients at a time under negative pressure isolation," he said.

Lutz pointed out that recent studies have shown that in the event of a pandemic the U.S. could only provide airborne infection isolation rooms for ~2-3% of the population and is actively looking for surge capacity solutions.

At the same time, the "greening" trend is also gaining momentum, along with the need to reduce energy consumption costs, said Aaron Ayer, vice president of marketing for StrionAir, Louisville, CO.

The U.S. Green Building Council’s LEED (Leadership in Energy and Environmental Design) certification program includes a focus on improving indoor air quality and maximizing energy savings. Ayer describes LEED certification as "one of the fastest growing trends in construction history. LEED registrations overall have grown at 100 percent every year for the last eight years. And it’s not just new construction by any means. There is a substantial component of LEED that is focused on existing buildings."

Portable, collapsible containment units can help facilities to safely isolate airborne contaminants during construction/renovation and maintenance projects as well as help fill in the gaps in isolation surge capacity.

The Association for Professionals in Infection Control and Epidemiology (APIC) has developed the APIC Threat matrix for Risk Assessment, which Pierson described as "a tool that can be used as a starting point for developing an ICRA (Infection Control Risk Assessment). Basically the matrix gives you a method of looking at what type of work is going to be done, ranging from Type A – Type D (A having least environmental impact, D being most) and then cross reference it with the risk assessment regarding patients in the area (Low, Medium, High, Highest) the work will be done in to establish a threat level. For example changing a light bulb in a waiting area far away from any patients or critical care areas may be quantified as a low-risk task in a low-risk area making it a class 1 threat. A facility may decide that the procedure they take for a class 1 threat is simply changing the bulb and vacuuming up any dust that might fall. Conversely, if this same light bulb change is being done in a burn ward or other sensitive area, it could be considered a class 3 or 4, which would require negative pressure containment around the area that is being disturbed. Once a classification of threat has been established a course of action is then determined," said Pierson. "For example, the APIC document states, Complete all critical barriers i.e. sheetrock, plywood, plastic, to seal area from non work area or implement control cube method (cart with plastic covering and sealed connection to work site with HEPA vacuum for vacuuming prior to exit) before construction begins."

Fiberlock’s Kontrol Kube Topsider provides a mobile, temporary negative pressure environment for facilities maintenance/construction, accommodates an 8’ ladder on a solid working platform and allows for ceiling access up to 10’. 

Pierson suggested buyers look for "true mobility from a solid wheel base with four locking casters. The basic concept of the unit during maintenance is the ability to contain dust and particulate while moving from one location to another without removing your ladder, tools and equipment. If you have to disassemble it to move it down the hall, you might not be getting your money’s worth."

Mintie’s comprehensive range of airborne containment solutions include those that offer the ability to address multiple needs with a single product. Numerous accessories allow for additional applications, increased efficiency and ease of use. The first generation ECU-CC (Ceiling Cavity) is used for ceiling penetrations during construction and renovation projects, while the ECU-AR (Anteroom) contains wall-based penetrations and individual patient room isolation. The ECU2 combines these functions with a larger footprint, providing greater versatility. Add the Corridor Flange Accessory to the modular ECU2 to isolate larger areas for mass cohorting in pandemic preparedness or larger construction area isolation.

The new ECU Mobile Platform from Mintie allows for easy and safe repositioning of the containment unit during construction projects – leaving tools, ladders and other equipment inside. "The single greatest barrier to instituting infection control programs during construction, maintenance and renovation is compliance," said Lutz. "Airborne particulate containment is extremely important due to both the risk posed and the growing prevalence of projects. Yet, the policies and guidelines necessary to protect staff and patient safety often come at the expense of workflow, ergonomics and comfort. As a result, proper procedure is not always observed and tension can build between the Facility and Infection Control departments. The ECU Mobile Platform ensures staff and patient safety by aligning compliance and workflow goals. Compliance with ICRA guidelines also becomes hassle free."

Mintie’s IcoRoom was designed to meet the needs of isolating a patient with an infectious disease, such as tuberculosis, during surgery or invasive procedures. "In addition to preventing the positive pressure of an OR from pushing potentially contaminated air into public spaces, a recent pilot study by Russ Olmsted published in AJIC has shown it to be extremely effective at removing airborne particulates from the OR itself, which has practitioner safety implications," said Lutz.

Fiberlock’s Kontrol Kube Abacus unit, featuring a beveled base and wall flanges, can be used as an anteroom for whole room containment or patient isolation.  "A portable anteroom gives a facility the ability to isolate a patient essentially wherever they are, be it the ER or the OR," said Pierson, for example, when an ER patient shows symptoms of TB. "The Kontrol Kube Abacus gives a facility the ability to turn any room into an airborne isolation room by developing a negative pressure barrier on the doorway. This is just one of many situations that a fast, mobile and easy isolation method is needed in a healthcare facility; another common situation where portable, mobile containment is needed is smaller facilities that do not have permanent airborne isolation rooms."

Mintie’s ECU2 with corridor flange

Versatile solutions are also easy on the budget noted Lutz. "Mintie helps healthcare facilities meet their needs within the constraints of limited budgets by providing them with multipurpose solutions. The same product that can isolate a single tile ceiling penetration can be used with accessories to isolate an entire ward for mass cohorting during a pandemic event. This comes at a fraction of the price of permanent solutions, fixed isolation rooms can run up to 500K, and without the ongoing maintenance and testing costs."

Durability is key, noted Pierson. "Look for all metal construction with as few moving parts as possible; less moving parts means less things to break during repeated use. Kontrol Kube offers a simple, solid, all metal construction that is easy to assemble and even easier to move from place to place."

"If the product is a hassle to use it will end up living in a closet and be a waste of resources," emphasized Lutz. "This makes quality a major concern. Mintie products are single piece external frames, making them easy to set up from the outside and easier to clean after a job. In addition to a 15-minute setup, they collapse for easy storage."

"One of the major missed opportunities is product purchased for Pandemic Preparedness which is left in trailers," said Lutz. "These could easily be used to meet the daily containment needs of many facilities. This would also serve as practice deploying solutions in low-stress situations. Although most hospitals have plans for increasing capacity, we see many infection preventionists are concerned with the feasibility of these plans. The gap we see in many pandemic preparedness plans is practice to ensure that [those plans] and the technology being used can be deployed under realistic conditions."

Modern Medical Systems specializes in helping hospitals find solutions to problems that reduce the cost of care and improve patient outcomes. One such solution is the Hepaport Medical Air Sterilization System. "The Hepaport systems were born out of the TB isolation era," said Meehan. "In the late ‘90s the CDC was talking about drug resistant tuberculosis and there was a big push to make sure hospitals had sufficient isolation space for patients that were of some infectious type nature. We’re an engineering firm, and our customers came to us and said, ‘I can’t go out and spend over a hundred thousand dollars revamping my HVAC system to put in these special directly exhausted type isolation systems – so what are some alternatives?’"

With models that provide HEPA filtration at 500 or 700 cu. ft. per min., the Hepaport system can be installed in a window or mounted into the ceiling as a "mini air handler", exhausting potentially contaminated air to create an inexpensive airborne isolation room. Modern Medical’s Pressure Watch unit can be mounted on the wall of the negative pressure isolation room or an anteroom to monitor the pressure relationship between the hallway and the room. "Pressure Watch is linked to the Hepaport, so that if someone opened the door and violated the pressure in the room, the unit would cycle up to maximum exhaust to keep the air moving into the room versus out of the room into the general population," explained Meehan.

When it comes to protecting patients from surgical site infections (SSIs), another target of CMS quality initiatives, you can never be too careful or too clean. Modern Medical Systems is also a distributor for Howorth’s EX-Flow Ultra Clean ventilation system, which was designed primarily for use in the OR with orthopedic surgeries. "Bone infection is a very painful and difficult infection to get rid of," explained Meehan, adding that multi-drug resistant TB, MRSA, and other stubborn pathogens are putting the focus on cleaning the air to help prevent a surgical site or nosocomial infection versus using antibiotics to treat the infection after the fact.

Featuring a unique exponential air flow pattern which provides an enlarged 10’ x 10’ clean zone compared to conventional laminar flow systems, the EX-Flow helps protect surgical patients from contaminants that come primarily from the surgeons and surgical staff as they shed skin flakes into the air. 

For the most part cleaner air usually comes at a higher energy price. For example, HEPA (High efficiency filtration particulate air) filters are able to remove 99.97% of the hardest to capture airborne particles – those that are 0.3 microns in diameter. However they not only cost quite a bit more than the average filter, "the energy penalty of a HEPA filter is very high," said Ayer, "because they are big, dense filters and the fan has to work very hard to push air through them." This "pressure drop" only increases as the filter gets more loaded with contaminants, resulting in an extremely costly proposition for hospitals.  

With its electrically enhanced filtration technology the StrionAir system is much less resistant to air flow, and thus more energy efficient, plus provides the added benefit of being germicidal. Ionized particles are both captured and killed in the StrionAir filter, without the use of chemicals or ultraviolet light.

While there are certain high-risk areas of the hospital where HEPA filters are required, such as the OR and ICU, other general care areas require a minimum efficiency filtration rating value (MERV) 14 as defined by the American Society of Heating Refrigeration and Air Conditioning Engineers (ASHRAE). Ayer explained that MERV ratings describe how much a filter is able to capture at a specific particle size. Administrative areas in the hospital are generally equipped with lower caliber filters approaching MERV 8 filtration.

The StrionAir system provides LEED-qualifying MERV 13 and above filtration for areas of the hospital that don’t require HEPA filters, and can also serve as a life-extending pre-filter for HEPAs. For example, StrionAir’s A130 filter at MERV 13 could be used as a green filter in the general administrative spaces of the hospital while the A150 MERV 15 filter could be used to replace a facility’s MERV 14 filters on the care floors, both providing higher filtration coupled with energy savings. "Our filters are also  very long lived so we’re green in the aspect of reducing landfill consumption, and what’s more important for hospitals – operations and maintenance costs," said Ayer.

The StrionAir system could also be used as an adjunct filter in negative pressure isolation wards or in construction/maintenance projects to both capture and kill exhausted contaminants. Ayer noted that the system had been tested against both tuberculosis and aspergillus mold. "Probably the toughest stuff to kill is spore form, either mold or bacteria. We’ve tested against both and we’ve killed both very effectively. Those spores tend to settle down in the quiet spaces of the hospital, above ceiling panels, in air conditioning ducts, etc., and any construction, anything that can happen that can disrupt those, puts them back in the air," he added.

As a germicidal pre-filter to a HEPA, the StrionAir system has been shown to extend the life of the HEPA by as much as 20 to 50 times according to testing by the Department of Energy. Ayer described how HEPA filters are suspect to a rather "unsavory" process called ripening – in which they become rotten with mold, bacteria, etc. Organic matter contained in dust and moisture in the air provide perfect nourishment for microbes, "creating an environment where things can actually grow and incubate in a filter." As the HVAC system cycles on and off, vibrating the filter, it can also produce an effect called "filter shedding" and reintroduce the contaminants into the air, he explained. "We can help mitigate that ripening because the StrionAir system kills the biologicals that would otherwise settle in the HEPA filter."

Monitoring for airborne toxins, such as gases used in sterile processing, is also an integral part of ensuring safe air quality in hospitals.

ChemDAQ EtO Monitor

"Sterilant gases are selected for their ability to destroy a wide range of microorganisms and pathogens and as a consequence of our common biochemical makeup, exposure of personnel to sterilant gases is potentially hazardous to humans," said P. Richard Warburton, Ph.D., Esq., chief technology officer & general counsel for ChemDAQ Inc., Pittsburgh, PA. "The Occupational Safety and Health Administration (OSHA) has defined permissible exposure limits (PELs) for all common sterilant gases. The concentrations of gases or vapors used in sterilizers are high (typically low percent by volume) and even though modern sterilizers are made to very high standards, leaks can and sometimes do occur due to wear and tear, user error, etc."

Compounding the problem, added Dr. Warburton is that, "hydrogen peroxide has very little smell and ethylene oxide (EtO) has a distinctive ether like smell (but the odor threshold is close to the National Institute of Occupational Safety and Health (NIOSH) immediately dangerous to life and health (IDLH) level of 800 ppm). Only ozone can be detected by most people at concentrations below its OSHA PEL of 0.1 ppm but, olfactory fatigue makes the sense of smell an unreliable indicator of concentration."2

"A continuous gas monitoring system will provide an alert in the event of a leak of sterilant gases. Depending on the magnitude of the leak, the facility can determine if preventative action is necessary or if the area is unsafe and should be evacuated. A continuous gas monitor should be part of the safety plan for any gas sterilant operation. Other parts of the plan include dedicated ventilation, regular sterilizer maintenance, use of personal protective equipment, employee training, good work practices, and an emergency action plan."

Dr. Warburton described some of the shortcomings of many hospitals’ current sterilant gas monitoring methods. "There are still some hospitals that essentially do not monitor their gas sterilizers or if they do, they only use badges. Badges tell users retrospectively that they have been exposed, they do not warn of imminent exposure. It would be difficult for a facility to promptly alert workers of a major leak, or ensure that they are not exposed to concentration exceeding the OSHA excursion limit or PEL without a continuous monitor. In the last six months we know of two major hospitals’ ETO monitors that went into alarm immediately after being installed because of an EtO leak they were unaware of."

"Many people do not realize that it is necessary to monitor for hydrogen peroxide, even though the OSHA PEL for hydrogen peroxide is the same as for EtO (1.0 ppm) while the NIOSH IDLH (75 ppm) is less than one tenth that of EtO," he added.

Another issue is that "some hospitals use gross leak detectors to monitor for EtO, and while these are better than no monitoring at all, they are not designed to detect down to the OSHA PEL, and so cannot help employers meet the requirements of ensuring their employees are not exposed above the PEL," he added. "Lastly, we see many hospitals that have an EtO monitoring system, but it’s either turned off due to false alarms or it’s in a non-functioning state due to lack of maintenance. All gas monitoring systems require periodic calibration to ensure they are functioning correctly. If the system is not operational, it is worse than having no system at all because of the false sense of security [it can] create for the employees."

With monitors for all FDA approved sterilant gases (currently EtO, hydrogen peroxide and ozone), the ChemDAQ system was designed specifically for use in healthcare and related operations. The system is modular, allowing it to be customized for each facility, easily expanded as additional sterilizers are added or changed if a different sterilant gas is introduced. Modularity also increases system reliability – if for some reason one part of the ChemDAQ system were to stop working, the rest of the system would continue to function and continue to provide protection. Remote displays/repeaters mirror the display of the monitors and are typically located outside entrances to the sterile area to provide a warning to anyone before they enter if there was any sterilant gas leak.

ChemDAQ’s EtO sensor is electrochemical which offers high sensitivity, continuous monitoring and fast response times. The patent pending Spot-On chemical filter selectively allows EtO to pass through to the sensor, while removing common interferences.

ChemDAQ’s data acquisition module (DAQ) calculates time weighted averages from the monitors and activates impending alarms allowing the user to take proactive measures before anyone is exposed to a dangerous condition. Automatic data back up and record keeping allows employers to fulfill the OSHA requirement to keep all exposure records for 30 years for each employee. Reports are easily generated to show if any alarms were activated over what period, at what specific time, and at what specific value. Through its SXP program, ChemDAQ tracks the calibration status of every sensor, contacts users when calibration is due, sends freshly factory-calibrated sensors with new filters that the user easily swaps out (takes only a few seconds) and prepays shipping for the return of expired sensors back to ChemDAQ.

Modern Medical Systems provides environmental testing and trace gas analysis for toxic regulated gases such as waste gas in the OR, or formaldehyde used in lab. The company can also apply its engineering expertise to areas such as the SPD.

Meehan explained, "We give the hospital personnel or administration a ‘map’ of what happens in their environment, and when the gas is at its highest levels, to help produce work habits that prevent them from exposing their employees. We monitor the environment to be sure it’s safe, that air flow patterns are correct so that they are indeed under negative pressure, they have enough air changes to ensure that there’s no build up of gas, and then of course that there’s nothing leaking or no inadvertent exposures."   

He provided the example of a sterilizer that emits ethylene gas when the door is first opened after a cycle. "The concentrations of ethylene gas will go up momentarily, so when they crack the door, they should walk away for 5 minutes, because we’ve now traced out and monitored that it peaks out at 5 parts per million and then within 5 minutes it’s down to zero again. So rather than opening the door and immediately unloading the chamber, walk away for 5 minutes and then come back and do it. This way we create work process that minimizes exposure."

Meehan advised facilities to plan ahead for air quality issues just as they would other design elements such as square footage or color schemes. "When they’re designing spaces, when they start out in this process, they need to be proactive. They need to look at air quality as a whole – the control of contaminants, the control of exposure issues – prior to putting the space up and running. Many times we’re invited in after there’s a problem, whereas when they do the initial design it’s a concept that needs to be considered...Put it on your checklist."   

References:

1. "Hospitals, using single-bed rooms and improved ventilation, work to get healthier", Lisa Zamosky, Los Angeles Times, July 28, 2008, http://www.latimes.com/features/health/la-he-architecture28-2008jul28,0,5907587.story