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Nosocomial Infection Control - White Paper - Greg Luther - BioWarn LLC
Nosocomial Infection Control - White Paper - Greg Luther - BioWarn LLC
Introduction
BioWarn, LLC, has discovered a breakthrough method for the detection of dangerous pathogens and is working on a final
proof-of-concept to be completed during the summer of 2005. This revolutionary, patent-pending technology—called
SmartSand™—integrates proven bio-science and micro-electronics in a new way that provides immediate alerts to the
presence of toxins, bacteria, or viruses and relays their identity to a local area network—all from a unit the size of a grain
of sand. The potential applications for SmartSand™ are numerous and are of interest to any enterprise, industry, or
public authority involved in assuring the safety and health of large numbers of people and the air, food, water,
mail/packages, environmental surfaces, and/or equipment they come into contact with in the normal course of work or
play. Initial target markets for SmartSand™ are healthcare, food processing, and bio-defense. Potential products
include:
• Hand-held units for use by nursing staff, inspectors, infectious disease specialists,
• Point-of-care bedside diagnostics in hospitals and clinics,
• HVAC inserts to monitor buildings for outbreaks such as Legionnaire’s Disease or bio-terror agents,
• Surgical dressings, monitoring for bacterial infection,
• Surgical gloves, monitoring for presence of contagion during procedures or routine patient care,
• Contagion monitors embedded in food processing plants—ahead of where the public is placed at risk,
• Inserts in the walls of shipping containers to monitor for terrorist threats,
• Inserts in dental prosthetics or surgical implants (e.g. hip replacements) for long-term infection monitoring,
• Face masks or breathalyzers to screen international travelers for contagious diseases.
In this paper we focus on just one area, but one of critical importance: reducing or eliminating nosocomial infections in
healthcare facilities. If nosocomial infection were tracked by the Center for Disease Control, it would rank number six on
the list of leading causes of death in the U.S. in 2002—ahead of diabetes, influenza, pneumonia, and Alzheimer's. The
always-on pathogen surveillance capability of SmartSand™ represents a quantum leap for the field of infection
control and could transform the state of patient safety in our hospitals.
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nosocomial mortality is most likely higher because An effective program to combat infections includes
of the tremendous increase in antibiotic-resistant contact precautions, as recommended by the
bacterial infections. Centers for Disease Control and Prevention (CDC),
which are used when an infectious agent is present
• Morbidity and Mortality Report found that that can be spread by skin-to-skin contact or by
nosocomial infections cost $5 billion annually in contact with contaminated surfaces. According to
1999iii, which represents a $500 million increase in noted infectious disease expert Barry M. Farr, MD,
four years. The annual cost of nosocomial hospital epidemiologist for the University of Virginia
infections might now be on the order of $5.5 Health System, contact precautions are a necessary
billion. condition for the control of infection outbreaks, but
they are probably not sufficient in themselves.
• It is estimated that nosocomial infections have
Neither, for that matter, are measures based on
increased the system-wide average length of stay
antibiotic restriction, substitution, and cycling. In
(ALOS) by between 7.4 to 9.4 days, increased
order for these measures to be effective, hospitals
ICU stays by 8 days, increased morbidity by 35%,
should adopt active culture surveillance measures
and increased total cost per patient for those
together with contact precautions in a concerted
patients who survived by approximately $40,000.iv
infection control program. Active culture
A key driver of this problem is the rise of multi-drug surveillance involves the detection and tracking of all
resistance and the continued ascendancy of patients who are asymptomatically colonized with
"superbugs" such as methicillin-resistant Staphylococcus MRSA, VRE, or some other infectious agent (i.e.
aureus (MRSA), vancomycin-resistant enterococci (VRE) "colonization" means the microorganism is present in
and penicillin-resistant Streptococcus pneumoniae (PRSP). or on the body but does not cause illness; whereas
MRSA infection rates, for example, have doubled in a infection means the organism is present and disease
decade and represent half of all S. aureus infections. A has been caused).
systematic literature review covering 55 studies
published
Table 1 - Costs of nosocomial infections and infection control interventions - based on 55 published
between studies from 1990-2000 (Source: AJIC)
1990-2000 Attributable Costs of Remediation
calculated mean
(US$ per bacteremia)
mean + 1 std dev
Intervention Costs (US$)
mean mean + 1 std dev
Times Return on Intervention $
mean mean + 1 std dev
the average Nosocomial Infection (in general) 13,973 31,971 1,138 2,580 12X 12X
attributable by Body Site
costs of #1 - Bloodstream 38,703 41,825 5,622 14,688 7X 3X
#2 - Pneumonia 17,677 38,132 was cost-saving n/a
infection #3 - Surgical site 15,646 29,466 27 n/a
resultant by Pathogen
MRSA 35,367 38,282 4,808 8,176 7X 5X
excess costs Note: MRSA accounted for 54% of all S. aureus infections in ICUs in 1999, and
- 24% of nosocomial S. aureus pneumonias
incurred - 40% of nosocomial S. aureus bloodstream infections
- 49% of nosocomial S. aureus surgical site infections
versus a
Tuberculosis No studies available 61,446 148,338
control Measles No studies available 41,087 n/a
group of Varicella zoster virus No studies available 27,377 52,689
Other No studies available 27,497 62,065
patients)
and compared them to the costs of infection controlv: Farr explains that colonized, asymptomatic patients
As shown in Table 1, the costs of an infection are far more important than infected patients in the
outbreak are very substantial and far out-weigh the evolution of an epidemic. He says, "The hospital
costs of infection control. thinks it will deal with (an infection) when they get an
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outbreak, get the results from clinical microbiology, then, is to reduce the cost—and so reduce the
and put (infected) patients in isolation. (But) the barrier to adoption or usage—of active culture
majority of colonized patients will not be identified surveillance. And that is the promise of BioWarn's
with that approach… Patients who are recognized by SmartSand technology.
clinical microbiology represent the tip of the
iceberg."vi Active surveillance gets past the tip and
detects the much larger, invisible portion of the
"iceberg"—those patients and healthcare workers who
Bacteria or Virus
are asymptomatically colonized. Most of an infection's
spread comes from these clinically inapparent, Ligand
Electrochemical
colonized patients, who represent most of the signal
• Only communication devices are required as When fully developed, SmartSand™ will deploy all of
external equipment. these capabilities in a unit no larger than a grain of
sand.
Environ-
− Secure Digital- or The Infection Reservoir
mental Sanitation/
Sterilization
No ready way to
verify surfaces are
Use SmartSand™
devices to flag
Surfaces clean surface contamination
Bluetooth-enabled Infected Individuals
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Table 1.1 — SmartSand™ Advantages Targeted Outcomes
• People — By combining pathogen detection with wireless • Increased patient safety (lower
network communications, SmartSand enables the observed rates of infection)
deployment of automated, on-line pathogen surveillance
• Reduced cost and drain on staff time
systems that a) greatly reduce the cost of staff time and
training, and b) substantially reduce the scope for error.
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Based on data Table 2 - Costs of Active Surveillance of Cultures
culled from this (Source: "Cost-effectiveness of controlling MRSA," Journal of Hospital Infection (2002) 51: 126-132)
Estimated Costs of
study, for many Description Quantity/Work Labor/Materials Estimated Costs per Unit
Negative Positive Culture
hospitals the key Culture
barrier to adoption Nurse sample collection time 3.0 minutes per sample 20.00 dollars per hour $ 1.00 $ 1.00
(wages)
of active culture
Disposable lab supplies 1.0 negative culture 2.74 dollars per negative $ 2.74
surveillance may culture
1.0 positive culture 4.62 dollars per positive $ 4.62
simply be the high culture
cost. As shown in Lab technician time 10.0 minutes per 17.00 dollars per hour $ 2.83
Table 2, the cost of negative culture (wages)
15.0 minutes per 17.00 dollars per hour $ 4.25
active culture positive culture (wages)
materials—85% to
90% in this case.
500 bed facility, for Total weekly cost for 100 patients surveilled weekly $6,918
example, would Estimated annual cost for 100 patients surveilled weekly $ 360,000
spend about $1.8 Estimated annual cost for 500 patients surveilled weekly $ 1,800,000
million per year in
staff time and
laboratory materials to support a weekly regimen of 1. SmartSand-based, always-on pathogen
detection
active culture surveillance. Similarly, a hospital
wishing to spend less than $500,000 per year could Given the high cost of lab-based active culture
only afford a monthly surveillance regimen, and the surveillance, three of the SmartSand™ features are
cost of a daily surveillance regimen would exceed $12 particularly valuable: its small size, its always-on
million per year—a cost no hospital could afford. capability, and its low cost.
Chance of Identifying an = 1 in 0.4 = 1 in 1.0 The major cost savings that SmartSand™ would bring
Colonized Patient w/ Weekly
Surveillance
is in the reduction or elimination of the laboratory-
based steps from the infection control process, which
account for over 85% of the total process cost. Of
the estimated $260,000 of residual cost in this
example, SmartSand™ devices and consumables only
As was stated earlier, the common point of failure account for 18%. That means that further
across the infection control process is the absence of opportunities for efficiency improvement lie more
a control step that assures the quality of the infection with the methods of sample collection than with the
counter-measure. In other words—short of sampling cost of the SmartSand™ devices, and those
and culturing every surface, device, and person and opportunities may be realizable through products that
sending it to the lab throughout the day—there is no embed SmartSand™ detectors in surfaces and
reasonable way to check that a sanitation or equipment—like hospital bed-rails, respirators, and
sterilization step worked as intended, that hand- catheters—in order to provide continuous sampling.
hygiene has been observed by everyone at a patient's
bedside, or that visitors entering a hospital are not
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VI. Conclusion nosocomial infection from the list of top-10 causes of
death in America.
By removing cost as the key barrier to the adoption of
active culture surveillance, and by improving the
performance level from weekly or monthly
surveillance (or none) to always-on pathogen
surveillance, SmartSand™ has the potential to be the
key innovation allowing our healthcare system to
bring nosocomial infection under control and remove
Conventional Lab-
Targeted based Culture
Outcomes Surveillance SmartSand™-based Surveillance
People
Increased patient • Can reduce the failure • Always-on SmartSand™ pathogen surveillance
safety (lower costs of infection by a increases the chance of detecting a colonized patient
infection rates) factor of 7 to 12 times. to100% for a fraction of the cost of lab-based culture
surveillance.
Reduced cost and • Increases staff costs, • Substantially reduces or eliminates both staff and
drain on staff time particularly in the lab. materials costs in the lab, which account for ~90% of
over all cost.
• May be able to reduce cost of sample collection by
embedding SmartSand™ in existing equipment.
Process
Technology
Reduced time-to-
• Culturing of samples • SmartSand™ detection is immediate, and its high level
diagnosis and
takes 1 to 2 days. of specificity can accelerate time-to-diagnosis.
prescription
Increased patient
• Culturing of samples • The potential for spreading a contagion over a two day
safety (lower rates
takes 1 to 2 days. period is eliminated for every colonized patient
of infection spread)
identified.
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References:
* * * * *
iN C H S - FASTATS - Deaths/Mortality.
BioWarn, LLC, is currently selecting corporate www.cdc.gov/nchs/fastats/deaths.htm (Accessed
partners to collaborate on the design and testing of August 21, 2005). The list is as follows:
SmartSand™-based products. We are looking for 1. Heart disease: 696,947
partners who have a deep understanding of the 2. Cancer: 557,271
3. Stroke: 162,672
markets for pathogen detection, established 4. Chronic lower respiratory diseases: 124,816
relationships with key buyers in this field, experience 5. Accidents (unintentional injuries): 106,742
with developing medical devices/products and gaining 6. Diabetes: 73,249
7. Influenza/Pneumonia: 65,681
regulatory approvals for them, and a strong reputation 8. Alzheimer's disease: 58,866
for innovation and customer-focus. Jointly, we can 9. Nephritis, nephrotic syndrome, and nephrosis:
develop SmartSand™ product prototypes that can 40,974
10. Septicemia: 33,865
be rapidly integrated with existing marketing
channels to tap the multi-billion dollar market
opportunities for rapid pathogen detection Weinstein RA. Nosocomial Infection Update.
ii
This prototype development process will include: Forth Decennial International Conference on
iii
Precautions."
• Estimating production costs to support business
vii Ivanhoe's Medical Breakthroughs -
and marketing strategy development
"Unnecessary Illness: Four Steps to Save Patients'
Lives -- Full-Length Doctor's Interview."
http://search.ivanhoe.com/ (Accessed July 18,
Please contact Dr. Jeff Riggs, President and COO, 2005)
BioWarn, LLC, to discuss your needs and to explore
Karchmer TB, Durbin LJ, Simonton BM, Farr
viii
these exciting market opportunities. (Telephone BM. Cost-effectiveness of active surveillance
number 301-926-9050.) cultures and contact/droplet precautions for
control of methicillin-resistant Staphylococcus
aureus. J Hosp Infect. 2002 Jun;51(2):126-32.
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