American Journal of Infection Control 48 (2020) 777−780

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American Journal of Infection Control

journal homepage: www.ajicjournal.org

Major Article

Particle control reduces fine and ultrafine particles greater than HEPA
filtration in live operating rooms and kills biologic warfare surrogate
Mark H. Ereth MD a,*, Donald H. Hess MSME b, Abigail Driscoll BS c, Mark Hernandez PhD d,
Frank Stamatatos BEE e
a
Department of Anesthesiology, Mayo Clinic College of Medicine and Science, Rochester, MN
b
SecureAire, LLC, Dunedin, FL
c
University of Minnesota School of Medicine, Minneapolis, MN
d
Department of Environmental Engineering, University of Colorado Boulder, Boulder, CO
e
SecureAire, LLC, Dunedin, FL

Key Words: Background: Controlling indoor air quality and the airborne transmission of infectious agents in hospitals is
Indoor air purification critical. The most hazardous particles and pathogens are not easily eliminated by traditionally passive air
Airborne pathogens cleansing.
Air quality Methods: We studied the effect of a novel particle control technology on airborne particulate matter in 2 live
Hospital-acquired infections
real-world operating room settings and on pathogen survival in a microbiology laboratory.
Operating room air purification
Results: Particle control technology reduced operating room particle and pathogen loads by 94.4% in a com-
munity hospital operating room, and by 95% in an academic medical center operating room. The addition of
particle control technology to a collector loaded with a biologic warfare surrogate resulted in a 95% kill rate
of an anthrax surrogate (Bacillus subtilis) within 3 hours.
Discussion: Deployment of this emerging technology could significantly reduce indoor air contamination and
associated infections in operating rooms, hospital isolation rooms, and intensive care settings, as well as
reduce inflammatory responses to airborne particles.
Conclusions: The particle control technology studied may protect patients from hospital-acquired infections,
reduce inflammatory pulmonary disease, and mitigate exposure to biologic weapons.
© 2019 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All
rights reserved.

New building technologies and regulations, such as tightening America, killing more people than diabetes or influenza combined.2
building envelopes and increased insulation, can increase concentra- Airborne transmission is likely responsible for nearly half of all hospi-
tions of indoor particles, pollutants, and pathogens.1 This is especially tal-acquired infections and most surgical site infections.3-5 Most anti-
relevant in hospitals and health care settings, considering that hospi- infection efforts focus on direct physical contamination between
tal-acquired infections are among the leading causes of death in North patients, providers, surfaces, and devices.6 Increased handwashing,
hand and surface purification treatment, and other quality processes
have indeed reduced direct transmission of pathogens.7,8 Yet there
*Address correspondence to Mark H. Ereth, MD, Anesthesiology, Mayo Clinic Minne- have been few advances in methods to reduce airborne transmission
sota, 1435 Woodview Ln SW, Rochester, MN 55902-1000. of bacteria, viruses, and fungi, or to kill airborne pathogens.
E-mail address: [email protected] (M.H. Ereth).
Contemporary air cleansing relies on high-efficiency particulate
Conflicts of interest: M.H.E. is an unpaid consultant at SecureAire, Inc. D.H.H. is an
inventor, founder, and shareholder at SecureAire, Inc. F.S. is a founder, shareholder,
air (HEPA) filtration, positive and negative pressurization, high air
and CEO at SecureAire, Inc. exchanges, photocatalytic oxidation, plasma cleaning, and ultraviolet

https://doi.org/10.1016/j.ajic.2019.11.017
0196-6553/© 2019 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.
778 M.H. Ereth et al. / American Journal of Infection Control 48 (2020) 777−780

light to limit contamination or kill pathogens on surfaces.4 Each of general, urologic, orthopedic, and gynecologic surgical procedures. The
these methods has significant limitations and may reduce the pres- existing operating room ventilation system included a prefilter, mini-
ence of larger airborne particles (>2.5 m), but they have limited mum efficiency reporting value (MERV) 14, HEPA filtration, and 16 air
impact on fine particles (<2.5 m) and ultrafine particles (<0.25 m). exchanges per hour during the baseline period.19 These specifications
These very small particles characteristically have low settling veloci- are compliant with ASHRAE (American Society of Heating, Refrigerat-
ties, keeping them resident within spaces even in the presence of ing and Air-Conditioning Engineers) 170 and local state code require-
contemporary air cleansing technologies.9 ments.20 During the subsequent 5 weekday intervention period, a
The majority of airborne pathogens fall into the fine particle or portable particle control device was added (Active Particle Control
ultrafine particle ranges. It is a common misconception that these Technology, SecureAire Inc, Dunedin, FL). The unit was placed within
small particles are effectively cleared from a space (such as an operat- the 4,200 ft3 operating room along with a particle monitor that
ing room) via HEPA filtration. Unfortunately, most very small par- remained within the same location throughout both 5-day phases. The
ticles and pathogens are of insufficient mass to be controlled by bulk ventilation system settings also remained consistent between the
airflow and can remain suspended for days or even weeks.9 Signifi- baseline and intervention period in this experiment.
cant fractions of these suspended particles and pathogens cannot be The second clinical setting was a 300-bed tertiary-care teaching
effectively transported to or removed by conventional air filters (per- hospital with 12 operating rooms located in Pennsylvania. This clini-
sonal communication, Don Hess, April 2, 2019). cal study examined immediately adjacent operating rooms that were
Coarse particles (>2.5 m) are subject to physical forces and are reli- supplied by the same air-handling system. The control operating
ably carried by airflow and deposited on the filter media. Conversely, room was supplied via a prefilter, MERV 14, HEPA filtration, and 16
submicron particles (≤0.4 m) are influenced by electromagnetic forces air changes per hour. The adjacent treated room was served by a pre-
within the environments in which they are suspended. Those with filter and an installed particle control device MERV 15 system with
physical diameter between 2 and 5 m are influenced variably by iner- 16 air changes per hour.
tial and electrostatic forces. Ultralow penetration air filters and HEPA An identical laser-based particle monitor was used at both clinical
filters are only effective on those particles and pathogens that can sites. The device measures particles that are >0.4 m and those that
reach the filter, not those that remain suspended in space. are >2.5 m.21 The mean particle counts were calculated throughout
The inability to eliminate airborne fine and ultrafine particles is the baseline and particle control treatment phases. Airborne fine and
most hazardous to those who have preexisting pulmonary disease, ultrafine particle counts correlate with airborne contamination, and
are immunocompromised, or are in a hospital or other health care have been used and validated as surrogates for airborne patho-
facility. Although particulate matter 2.5 (particulate matter 2.5 m in gens.22,23 At both clinical sites, none of the procedures during the
diameter, PM2.5) is frequently measured, it is particulates < 2.5 m that baseline or study period involved open abdomens, bowel incisions,
are the most harmful.10,11,12 or emergency procedures that would further contaminate the operat-
These very small particles are inhaled and transmitted through ing room environment and potentially compromise results.
respiratory passages, and have the ability to settle deep within the
distal pulmonary alveoli.13 They can remain there permanently, caus- Pathogen inactivation study
ing localized inflammation and/or infection, and even travel through
cell walls into the bloodstream to be disseminated throughout the Airborne pathogen inactivation studies were conducted at the
body.13 The uptake of inhaled microparticles can contribute to gener- University of Colorado Environmental Microbiology Laboratory
alized and localized inflammation, and is directly linked to pulmo- (Boulder, CO). Anthrax (Bacillus anthracis) is a well-characterized
nary disease, cardiovascular disease, myocardial infarction, pathogen, known for its persistence under a broad range of environ-
cerebrovascular events, dementia, and Alzheimer disease.3,14,15-18 mental conditions, including the atmospheric environment.24 A
closely related but less virulent bacterium, B subtilis, was used for
PARTICLE CONTROL TECHNOLOGY controlled disinfection challenges of the particle control system
because these microbes have similar environmental behavior to B
Particle control technology principally works by local electrostatic anthracis, and have been widely used as a model for the environmen-
field manipulation (not ionization). These forces condition the micro- tal behavior of bacterial bioaerosols. In independent and replicated
particles and continuously initiate millions of particle-molecular col- trials, the filter surfaces of the particle control system were loaded
lisions. These collisions lead to rapid and permanent ionically driven viable B subtilis cells at a density of approximately 107 cells/cm2.
aggregations of fine and ultrafine particles into larger particles. Once Direct microscopic counts were concurrently performed with the
the larger aggregates attain a critical mass, they fall under greater standard culturing of eluents from filter coupons embedded in the
influence of physical forces and are carried by air currents to the par- particle control system, as previously described.25,26
ticle collector. Finally, the aggregated fine and ultrafine particles Widely accepted statistical analysis was applied to compared
trapped in the collector are subjected to a strong electric field that mean particle counts before and after the engagement of the particle
kills the previously airborne pathogens by oxidative stress. control system. Differences were considered statistically significant
We sought to determine (1) the effect of particle control on fine at t test alpha level of 0.05.
and ultrafine particle loads in live real-world operating rooms, and
(2) the effect of particle control on the survival of a biologic warfare RESULTS
surrogate, Bacillus subtilis.
In a Minnesota community hospital operating room, the mean
METHODS baseline particle counts throughout the first week (control-HEPA)
were 167,408/ft3 (peak of 629,100/ft3). For the treatment period
Live operating room studies (HEPA plus particle control) the mean particle counts were reduced to
9,313/ft3 (peak count of 22,600/ft3) (Fig 1). The particle control system
Two clinical settings and 1 laboratory setting were studied. One resulted in a 94.4% reduction in fine and ultrafine particles (P < .0001).
was a single operating room within a medium-sized 40-bed Minnesota In a Pennsylvania academic medical center hospital, the control (ie,
hospital with 5 operating rooms. Baseline airborne particle counts HEPA) operating room mean particle counts were 93,351/ft3, and the
were measured for 5 consecutive weekdays during a variety of routine operating room with the particle control ventilation system had mean
 M.H. Ereth et al. / American Journal of Infection Control 48 (2020) 777−780 779

DISCUSSION

The use of particle control technology in live operating rooms

resulted in approximately 95% reduction in airborne fine and ultra-
fine particles in 2 real-world applications. Further, the application of
the particle control electrical field resulted in a 95% inactivation of
otherwise viable B subtilis vegetative cells within 3 hours of treat-
ment in a laboratory setting.
A strength of this study is that it was conducted in live operating
rooms with real patients undergoing actual operations conducted by
surgeons, anesthesiologists, and nurses. To ensure clinically relevant
results, these works were conducted in 2 distinctly different facilities: a
small Midwestern hospital and a large East Coast tertiary-care hospital.
One critique of this work is that the minor differences in operating
room volume may have altered particle loads between the baseline
and treatment phases of these studies. This is mitigated by the 5
weekday length of each control and intervention period, which
served to reduce the impact of surgery case variability between base-
line and treatment phases. In these live operating room studies, the
number, length, and type of surgical procedures was similar (but not
identical) between control and intervention (particle control) peri-
ods. It would be impossible to structure such a study with identical
Fig 1. Particle control technology resulted in a 94.4% reduction in fine and ultrafine patient and procedure characteristics between control and interven-
particle counts when added to a standard ventilation system in a live 4,200 ft3 commu-
tion groups.
nity hospital operating room. Standard ventilation for the 5-day control and 5-day
study period included a prefilter, MERV 14, HEPA filtration, and 16 air exchanges per In some evaluations of ventilation and air purification technologies,
hour (ASHRAE 170 compliant). Mean particle counts during the control period were highly controlled simulated environments are used to approximate
167,408/ft3 (peak of 629,100/ft3) and were reduced to 9,313/ft3 (peak count of 22,600/ operating room activity.27 Although these represent sound scientific
ft3) with the addition of the portable particle control device (P < .0001). Data are pre-
methodologies, today’s clinicians demand real-world practical evalua-
sented as mean, 25th and 75th percentiles, and ranges. ASHRAE, American Society of
Heating, Refrigerating and Air-Conditioning Engineers; HEPA, high-efficiency particu-
tions of new technology. Simulating clinicians working around the
late air; MERV, minimum efficiency reporting value. operating table does not give an exact representation of the disruption
of airflow and potential for contamination by clinician participants.
particle counts of 3,820/ft3; this corresponds to a 96% reduction of fine Nor does it include aerosolized contamination from preparing the
and ultrafine airborne particles during the period of observation (Fig 2). patient’s incision site or from the incised cavity once opened.
In the pathogen killing study, at least 95% of viable B subtilis (bio- Airborne fine and ultrafine particle counts correlate with airborne
logic warfare anthrax surrogate) cells were killed as judged by their contamination and have been used and validated as surrogates for
recovery on standard culturing media after 3 hours of exposure to airborne pathogens.22,23 Successful mitigation of the short- and long-
the electrical field in the particle control technology unit (Fig 3). term risks of exposure to indoor airborne pathogens requires new

Fig 2. Particle control reduced airborne particles better than standard methods in an academic medical center operating room. The control operating room that was supplied with a
prefilter, MERV 14, HEPA filtration, and 16 air changes per hour had mean particle counts of 93,351/ft3. The operating room with the particle control intervention had a reduction in
mean particle counts by 95% to 3,820/ft3 (P < .0001). Data are presented as mean, 25th and 75th percentiles, and ranges. HEPA, high-efficiency particulate air; MERV, minimum effi-
ciency reporting value.
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