nosocomial infection control__white paper__greg luther - biowarn llc

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p. 1 Copyright © 2005 BioWarn, LLC I. Background It's estimated that in the United States alone there are about 2 million nosocomial (i.e. hospital-acquired) infections each year, of which about 90,000 result in a patient's death. That places nosocomial infection at number five in the list of the top ten leading causes of death in the U.S. in 2002, ahead of diabetes at about 73,000 deaths, and close behind accidents at 107,000 deaths i . From 1975 to 1995 the rate of nosocomial infections per 1,000 patient days increased 36% - from 7.2 to 9.8. It is estimated that in 1995 nosocomial infections cost $4.5 billion and contributed to one death every 6 minutes. ii The current incidence of BioWARN, LLC Perspective on Nosocomial Infection Control Gregory D. Luther, VP—Product Development September 19, 2005 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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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. BioWarn's real-time, hands-free pathogen surveillance technology 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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Page 1: Nosocomial Infection Control__White Paper__Greg Luther - BioWarn LLC

p. 1Copyright © 2005 BioWarn, LLC

I. Background

It's estimated that in the United States alone there areabout 2 million nosocomial (i.e. hospital-acquired)infections each year, of which about 90,000 result in apatient's death. That places nosocomial infection atnumber five in the list of the top ten leading causes ofdeath in the U.S. in 2002, ahead of diabetes at about

73,000 deaths, and close behind accidents at 107,000deathsi.

• From 1975 to 1995 the rate of nosocomialinfections per 1,000 patient days increased 36% -from 7.2 to 9.8.

• It is estimated that in 1995 nosocomial infectionscost $4.5 billion and contributed to one deathevery 6 minutes.ii The current incidence of

BioWARN, LLCPerspective on Nosocomial Infection ControlGregory D. Luther, VP—Product Development

September 19, 2005

Introduction

BioWarn, LLC, has discovered a breakthrough method for the detection of dangerous pathogens and is working on a finalproof-of-concept to be completed during the summer of 2005. This revolutionary, patent-pending technology—calledSmartSand™—integrates proven bio-science and micro-electronics in a new way that provides immediate alerts to thepresence of toxins, bacteria, or viruses and relays their identity to a local area network—all from a unit the size of a grainof sand. The potential applications for SmartSand™ are numerous and are of interest to any enterprise, industry, orpublic 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 orplay. Initial target markets for SmartSand™ are healthcare, food processing, and bio-defense. Potential productsinclude:

• 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 inhealthcare facilities. If nosocomial infection were tracked by the Center for Disease Control, it would rank number six onthe list of leading causes of death in the U.S. in 2002—ahead of diabetes, influenza, pneumonia, and Alzheimer's. Thealways-on pathogen surveillance capability of SmartSand™ represents a quantum leap for the field of infectioncontrol and could transform the state of patient safety in our hospitals.

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p. 2Copyright © 2005 BioWarn, LLC

nosocomial mortality is most likely higher becauseof the tremendous increase in antibiotic-resistantbacterial infections.

• Morbidity and Mortality Report found thatnosocomial infections cost $5 billion annually in1999iii, which represents a $500 million increase infour years. The annual cost of nosocomialinfections might now be on the order of $5.5billion.

• It is estimated that nosocomial infections haveincreased the system-wide average length of stay(ALOS) by between 7.4 to 9.4 days, increasedICU stays by 8 days, increased morbidity by 35%,and increased total cost per patient for thosepatients who survived by approximately $40,000.iv

A key driver of this problem is the rise of multi-drugresistance and the continued ascendancy of"superbugs" such as methicillin-resistant Staphylococcusaureus (MRSA), vancomycin-resistant enterococci (VRE)and penicillin-resistant Streptococcus pneumoniae (PRSP).MRSA infection rates, for example, have doubled in adecade and represent half of all S. aureus infections. Asystematic literature review covering 55 studiespublishedbetween1990-2000calculatedthe averageattributablecosts ofinfection(i.e. directlyresultantexcess costsincurredversus acontrolgroup ofpatients)and compared them to the costs of infection controlv:As shown in Table 1, the costs of an infectionoutbreak are very substantial and far out-weigh thecosts of infection control.

An effective program to combat infections includescontact precautions, as recommended by theCenters for Disease Control and Prevention (CDC),which are used when an infectious agent is presentthat can be spread by skin-to-skin contact or bycontact with contaminated surfaces. According tonoted infectious disease expert Barry M. Farr, MD,hospital epidemiologist for the University of VirginiaHealth System, contact precautions are a necessarycondition for the control of infection outbreaks, butthey are probably not sufficient in themselves.Neither, for that matter, are measures based onantibiotic restriction, substitution, and cycling. Inorder for these measures to be effective, hospitalsshould adopt active culture surveillance measurestogether with contact precautions in a concertedinfection control program. Active culturesurveillance involves the detection and tracking of allpatients who are asymptomatically colonized withMRSA, VRE, or some other infectious agent (i.e."colonization" means the microorganism is present inor on the body but does not cause illness; whereasinfection means the organism is present and diseasehas been caused).

Farr explains that colonized, asymptomatic patientsare far more important than infected patients in theevolution of an epidemic. He says, "The hospitalthinks it will deal with (an infection) when they get an

mean mean + 1 std dev mean mean + 1 std dev mean mean + 1 std dev

Nosocomial Infection (in general) 13,973 31,971 1,138 2,580 12X 12X

by Body Site#1 - Bloodstream 38,703 41,825 5,622 14,688 7X 3X#2 - Pneumonia 17,677 38,132 was cost-saving n/a#3 - Surgical site 15,646 29,466 27 n/aUrinary tract infection No studies available 1,962 n/a

by PathogenMRSA 35,367 38,282 4,808 8,176 7X 5X

Tuberculosis No studies available 61,446 148,338Measles No studies available 41,087 n/aVaricella zoster virus No studies available 27,377 52,689Other No studies available 27,497 62,065

Table 1 - Costs of nosocomial infections and infection control interventions - based on 55 published studies from 1990-2000 (Source: AJIC)

Times Return on Intervention $

Note: MRSA accounted for 54% of all S. aureus infections in ICUs in 1999, and- 24% of nosocomial S. aureus pneumonias- 40% of nosocomial S. aureus bloodstream infections- 49% of nosocomial S. aureus surgical site infections

Attributable Costs of Remediation (US$ per bacteremia) Intervention Costs (US$)

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Bacteria or Virus

Ligand

BioPore

Bio-Sensor

Electrochemicalsignal

(Note: Depicts SmartSand detector at grain-of-sand scale.)

outbreak, get the results from clinical microbiology,and put (infected) patients in isolation. (But) themajority of colonized patients will not be identifiedwith that approach… Patients who are recognized byclinical microbiology represent the tip of theiceberg."vi Active surveillance gets past the tip anddetects the much larger, invisible portion of the"iceberg"—those patients and healthcare workers whoare asymptomatically colonized. Most of an infection'sspread comes from these clinically inapparent,colonized patients, who represent most of thereservoir for transmission. Surveillance cultures toidentify this reservoir are, therefore, criticallyimportant to the control of spread—together witheffective barrier precautions—and such a concertedapproach has been shown to reduce the spread ofMRSA by 16-fold compared with standardprecautions.

Many studies confirm that contact precautions workwhen sufficient active-surveillance cultures areundertaken to detect the reservoir for spread. Thelargest and most important was the Study of theEfficacy of Nosocomial Infection Control (SENIC) astudy done by the Centers for Disease Control andPrevention in the 1970s and the 1980s on aprobability sample of hospitals throughout thecountry. It showed that the intensity of surveillancewas the most powerful predictive factor withrespect to the control of infections to a lowerlevel.vii

The Problem and the Opportunity

As was illustrated in Table 1 above, hospitaladministrators recognize that nosocomial infectionscreate longer hospital stays and generate costs threetimes greater than normal. But in spite of researchdata indicating that contact precautions used ontheir own have little or no impact on controllinginfection, most health-care facilities have not yet triedthe concerted approach. Instead, many hospitals areopting for low-frequency use of culture surveillance(e.g. monthly rather than weekly), or no use at all. Ahigh impact improvement opportunity in anyhealthcare facility's infection control process,

then, is to reduce the cost—and so reduce thebarrier to adoption or usage—of active culturesurveillance. And that is the promise of BioWarn'sSmartSand technology.

II. BioWarn and SmartSand™

BioWarn's mission is to bringfull-time, always-on pathogensurveillance and protectionwithin the reach of everyhealthcare facility by embeddingits SmartSand™ technology infamiliar healthcare systems anddevices and by providing newcategories of highly affordabledetection products thatsafeguard patient safety.

1. What Is SmartSand?

SmartSand™ is a patent-pending bio-chip technologythat can detect dangerous substances in real time—and at a fraction of the cost of alternativetechnologies or techniques. Its characteristics include:

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• Each detecting unit can be as small as a grain ofsand.

• Each unit has a bioscience component and amicroelectronics component.

• The bioscience component contains complexorganic molecules (ligands), discreetly “waiting.”

They “wait” for “targets” (toxins, bacteria, orviruses) to appear and interact.

Interactions release a very smallelectrochemical signature unique to the“target.”

Multiple “target” types can be detected by asingle detector.

The microelectronics component within a SmartSandunit is comparable to chips in disposable cameras.

• More mature than nano-technology, i.e. it's 1000times larger.

• Electrodes acquire the “target’s” signature.

• The signature is processed, identifying the“target.”

• False-alarms are sorted and discarded beforealerts are transmitted.

• The wireless alert transmission is facilitated viaother circuitry in the unit.

• The unit uses background energy (cell phones,RF, etc.) as a power source.

• Only communication devices are required asexternal equipment.

2. SmartSand™ Benefits

Unlike other sensor technologies that detectsubstances using tags, “labels”, and secondary effects(e.g. like chemiluminescence), SmartSand™ performsdirect measurement of a target pathogen’s chemicalreaction within the detector.

• By detecting, digitizing, and storing the uniquevoltage patterns produced by each targetpathogen, SmartSand™ enables a precision andsensitivity of detection not possible with

competing technologies.

• By integrating target protein detection,digitization, and voltage pattern-matching intoone device, SmartSand™ removes the typicalseparation of the bio-chip from its reaction-detection hardware and eliminates laboratoryprocess steps requiring human intervention.

• By combining pathogen detectors with wirelessnetwork communications features, SmartSand™enables the deployment of automated, on-line,real-time pathogen surveillance systemsanywhere that the presence or spread of disease isa major concern.

When fully developed, SmartSand™ will deploy all ofthese capabilities in a unit no larger than a grain ofsand.

III. Product Design Goals

As implied by BioWarn's mission statement, theprimary goal to be considered is that of increasing theusage-intensity of active culture surveillance inhealthcare facilities, and enhancing infection controlprocess performance generally wherever failure pointscan be found. As illustrated in Chart 1, a common

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source of failure across the infection control processis the absence of a feasible control step that assuresthe quality of the infection counter-measures. But aSmartSand™-based device can be designed andproduced to fill this gap at multiple points in theinfection chain, for multiple pathogens, and formultiple types of disease vectors. For example,SmartSand devices couldtake the following forms:

− SmartSand™"breathalyzer" forscreening ofrespiratory illnesses athospital admissions;

− USB-enabledSmartSand™sampling probes foruse with laptopcomputers in wards orin the field;

− Secure Digital- orBluetooth-enabledSmartSand™sampling probes forpersonal digitalassistants (PDAs);

− SmartSand™ -enabled surgical/examinationgloves, gowns, and masks; or

− SmartSand™-enabled general purpose wipes.

Because a SmartSand™ unit is an integrated circuitchip, it can be mass-produced at the low cost per unitcharacteristic of such chips. Depending on thespecific features, it may be possible to provide aSmartSand™ detection product at no more than thecost of a standard stethoscope, i.e. around $150 perunit. And as is the case for stethoscopes, at that pricethere is no reason that any healthcare worker —orpatient—should be without a SmartSand™device.

By deploying such SmartSand™-based devices ahealthcare facility would be achieving three keyobjectives all at once:

1. SmartSand™ devices would increase theeffective frequency of culture sampling to"always-on," and so the coverage of afacility's infection reservoir could be

increased substantially.

2. The cost of sampling and infection detectionwould be dramatically reduced, and so a keybarrier to the adoption of active culturesurveillance would be removed.

3. The efficacy of infection controlcountermeasures—like hand hygiene orenvironmental surface sanitation—would forthe first time be made measurable andverifiable, allowing the rapid identificationand reduction of infection control errors.

The targeted outcomes listed in Table 1.1 provide abasis for comparing SmartSand™-based pathogensurveillance with a conventional laboratory-basedapproach, which is discussed in Section V below.

Hospital

The InfectionReservoir

Infected Individuals

Colonized Individuals

The Infection Reservoir

Infected Individuals

Colonized Individuals

Community

Counter-measures

PatientIsolation

PersonalProtectiveEquipment

HandHygiene

Sanitation/Sterilization

ActiveSurveillanceof Cultures

GlovesMask

Gown

Points ofFailure

Usually only appliedto infected patients,

not colonized patients

Inconvenient for staffand no ready way to

verify efficacy

Staff fall back to oldhabits and no readyway to verify efficacy

No ready way toverify surfaces are

clean

Other measuresineffective without

this, but generally notused due to expense.

Infection Vectors

Patients

Visitors

Health-care

Workers

Environ-mental

Surfaces

Equipment& Devices

BioWarnImprovementOpportunities

Use SmartSand™devices to identifycolonized patients

Use SmartSand™devices to flag PPE

failures

Use SmartSand™devices to verify

compliance

Use SmartSand™devices to flag

surface contamination

Use SmartSand™devices to reducecost and increase

usage of activesurveillance.

Chart 1 — The Chain of Infection and Points of Control Failure

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IV. Approaches to Infection Control

The cost of conventional infection control

As mentioned above, an effective program to combatinfection includes contact precautions, as describedand recommended by the Centers for Disease Controland Prevention (CDC). They include:

• Patient isolation

• Glove use

• Strict hand hygiene

• Gown use

• Mask use

• Appropriate patienttransport

• Dedicated use of non-critical equipment

• Adequate cleaning anddisinfection of sharedequipment

The following is a description of active culturesurveillance in a neonatal ICU at University ofVirginia Health System in Charlottesville, VAviii:

The average daily census in the neonatal intensivecare unit was 24 infants per day. The estimatednumber of cultures per infant per week was threeand a half. Every infant had three cultures (nares,axilla and groin) and some infants had additionalcultures if a wound was present or the umbilicushad not healed. Active surveillance cultures wereperformed for 46 weeks. The estimated totalnumber of infant surveillance cultures was 3864.Eighteen were positive and the remaining 3846were negative. Three hundred and twenty-fivepersonnel cultures were performed and two werepositive.

Table 1.1 — SmartSand™ Advantages Targeted Outcomes

• People — By combining pathogen detection with wirelessnetwork communications, SmartSand enables thedeployment of automated, on-line pathogen surveillancesystems that a) greatly reduce the cost of staff time andtraining, and b) substantially reduce the scope for error.

• Increased patient safety (lowerobserved rates of infection)

• Reduced cost and drain on staff time

• Process — By integrating target (pathogen) detection,signal digitization, and signal pattern-matching into onedevice, SmartSand™:

Eliminates laboratory process steps requiring humanintervention,

Substantially reduces time-to-detection, and soenhances the ability to isolate infection in apopulation and differentiate it in individuals

• Increased patient confidence inhealthcare facility safety

• Reduction or elimination oflaboratory-based process steps

• Reduced time-to-detection and topatient sequestration

• Technology — By detecting, digitizing, and storingunique signal patterns produced by target pathogens,SmartSand™ provides a precision of rapid-detection notpossible with alternative approaches.

Increased specificity allows for more rapididentification of “drug of choice” remedies that wouldotherwise take hours or days to analyze

• Reduced time-to-diagnosis andprescription

• Increased patient safety (lower ratesof infection spread)

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Based on dataculled from thisstudy, for manyhospitals the keybarrier to adoptionof active culturesurveillance maysimply be the highcost. As shown inTable 2, the cost ofactive culturesurveillance ismostly attributableto laboratory stafftime andmaterials—85% to90% in this case.

And as shown inTable 2.1, whenmultiplied by thenumber of beds tobe surveilled, thecosts of alaboratory-based,full-time, facility-wide active culturesurveillanceprogram can runinto the millions ofdollars per year fora large hospital. A500 bed facility, forexample, wouldspend about $1.8million per year instaff time andlaboratory materials to support a weekly regimen ofactive culture surveillance. Similarly, a hospitalwishing to spend less than $500,000 per year couldonly afford a monthly surveillance regimen, and thecost of a daily surveillance regimen would exceed $12million per year—a cost no hospital could afford.

1. SmartSand-based, always-on pathogendetection

Given the high cost of lab-based active culturesurveillance, three of the SmartSand™ features areparticularly valuable: its small size, its always-oncapability, and its low cost.

Because of SmartSand™'s small size, it can bedeployed as a variety of hand-held or smaller devices,

Table 2 - Costs of Active Surveillance of Cultures(Source: "Cost-effectiveness of controlling MRSA," Journal of Hospital Infection (2002) 51: 126-132)

DescriptionNegative Culture

Positive Culture

Nurse sample collection time 3.0 minutes per sample 20.00 dollars per hour (wages)

$ 1.00 $ 1.00

Disposable lab supplies 1.0 negative culture 2.74 dollars per negative culture

$ 2.74

1.0 positive culture 4.62 dollars per positive culture

$ 4.62

Lab technician time 10.0 minutes per negative culture

17.00 dollars per hour (wages)

$ 2.83

15.0 minutes per positive culture

17.00 dollars per hour (wages)

$ 4.25

Cost per culture $ 6.57 $ 9.87

of which lab-related 85% 90%

Number of surveillance 3.5 per patient-weekNumber of cultures per sampling 3.0 per patient-sampleNumber of cultures per patient- 10.5 Cost per patient-week $ 69.02 $ 103.64

Estimated Costs of Labor/MaterialsQuantity/Work Estimated Costs per Unit

Table 2.1 - Costs of Active Surveillance of Cultures(Source: "Cost-effectiveness of controlling MRSA," Journal of Hospital Infection (2002) 51: 126-132)

DescriptionNegative Culture

Positive Culture

Beds to be surveilled 100Cultures processed per week for weekly surveillance

1050.0

Percent of cultures testing positive (based on UVA example)

0.47%

Number of cultures testing positive (based on UVA example) 5 cultures per week $ 9.87 per positive culture $ 49.35

Percent of cultures testing negative 99.53%

Number of cultures testing negative 1045 cultures per week $ 6.57 per negative culture $ 6,869.13

Total weekly cost for 100 patients surveilled weekly

Estimated annual cost for 100 patients surveilled weekly $ 360,000

Estimated annual cost for 500 patients surveilled weekly $ 1,800,000

$6,918

Quantity/Work Estimated Costs of Estimated Costs per Unit

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or it can be embedded in existing devices orequipment.

Because of its always-on capability, SmartSand™provides the equivalent of full-time culturesurveillance—not just daily, or even hourly—butminute-to-minute surveillance that a lab-based processcannot deliver. The impact of the "always-on"capability on patient safety is very significant becausereducing the frequency of surveillance increases thechance that the reservoir of infection represented bycolonized patients will go undetected—anduncontrolled—for longer. As shown in Table 2.2, ina 500 bed hospital with 25,000 admissions per year,monthly surveillance would only have a 1-in-4 chanceof identifying a colonized but asymptomatic patient.Always-on culture surveillance brings 100% coverageand minimizes the chance that an incoming patientwill contract an infection from a reservoir resident inthe hospital.

As was stated earlier, the common point of failureacross the infection control process is the absence ofa control step that assures the quality of the infectioncounter-measure. In other words—short of samplingand culturing every surface, device, and person andsending it to the lab throughout the day—there is noreasonable way to check that a sanitation orsterilization step worked as intended, that hand-hygiene has been observed by everyone at a patient'sbedside, or that visitors entering a hospital are not

carriers of MRSA or some other contagion. A criticalbenefit of the SmartSand™ technology to a healthcarefacility is that it makes the infection controlprocess verifiable, measurable, and therefore,manageable to a degree not otherwise possible. Andthat represents a quantum leap for the field ofinfection control.

V. Analysis

A comparison of infection control process outcomesis summarized in Table 3 below. Overall, the always-on pathogen surveillance capability provided bySmartSand™ increases the chance of detecting apatient colonized with a "super-bug" to100% for afraction of the cost of lab-based culture surveillance.That translates into greatly improved patient safety,and eventually, into growing confidence in thecommunity that hospitals are safe places in their ownright.

Of all the improvement opportunities thatSmartSand™ could be used to address in a healthcarefacility, the biggest may be the chronic under-use ofactive culture surveillance in our hospitals.

The major cost savings that SmartSand™ would bringis in the reduction or elimination of the laboratory-based steps from the infection control process, whichaccount for over 85% of the total process cost. Ofthe estimated $260,000 of residual cost in thisexample, SmartSand™ devices and consumables onlyaccount for 18%. That means that furtheropportunities for efficiency improvement lie morewith the methods of sample collection than with thecost of the SmartSand™ devices, and thoseopportunities may be realizable through products thatembed SmartSand™ detectors in surfaces andequipment—like hospital bed-rails, respirators, andcatheters—in order to provide continuous sampling.

Table 2.2 - Chances of Detecting Contagionfor Annual Admissions of… 10,000 25,000

Number of Hospital Beds 500 500

Patients/Bed per Year 20 50

Chance of Identifying a Colonized Patient w/ Monthly Surveillance

= 1 in 1.7 = 1 in 4.2

Chance of Identifying an Colonized Patient w/ Weekly Surveillance

= 1 in 0.4 = 1 in 1.0

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VI. Conclusion

By removing cost as the key barrier to the adoption ofactive culture surveillance, and by improving theperformance level from weekly or monthlysurveillance (or none) to always-on pathogensurveillance, SmartSand™ has the potential to be thekey innovation allowing our healthcare system tobring nosocomial infection under control and remove

nosocomial infection from the list of top-10 causes ofdeath in America.

Table 3 — Outcome Comparison

TargetedOutcomes

Conventional Lab-based CultureSurveillance SmartSand™-based Surveillance

People

Increased patientsafety (lowerinfection rates)

• Can reduce the failurecosts of infection by afactor of 7 to 12 times.

• Always-on SmartSand™ pathogen surveillanceincreases the chance of detecting a colonized patientto100% for a fraction of the cost of lab-based culturesurveillance.

Reduced cost anddrain on staff time

• Increases staff costs,particularly in the lab.

• Substantially reduces or eliminates both staff andmaterials costs in the lab, which account for ~90% ofover all cost.

• May be able to reduce cost of sample collection byembedding SmartSand™ in existing equipment.

Process

Increase patientconfidence inhospital safety

• Would improveconfidence, but may notbe financially feasible

• Visible presence of SmartSand™ always-on pathogensurveillance devices/products demonstrates innovationand reinforces patient and community confidence.

Reduced time-to-detection

• Culturing of samplestakes 1 to 2 days.

• SmartSand™ detection is immediate.

Technology

Reduced time-to-diagnosis andprescription

• Culturing of samplestakes 1 to 2 days.

• SmartSand™ detection is immediate, and its high levelof specificity can accelerate time-to-diagnosis.

Increased patientsafety (lower ratesof infection spread)

• Culturing of samplestakes 1 to 2 days.

• The potential for spreading a contagion over a two dayperiod is eliminated for every colonized patientidentified.

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* * * * *

BioWarn, LLC, is currently selecting corporatepartners to collaborate on the design and testing ofSmartSand™-based products. We are looking forpartners who have a deep understanding of themarkets for pathogen detection, establishedrelationships with key buyers in this field, experiencewith developing medical devices/products and gainingregulatory approvals for them, and a strong reputationfor innovation and customer-focus. Jointly, we candevelop SmartSand™ product prototypes that canbe rapidly integrated with existing marketingchannels to tap the multi-billion dollar marketopportunities for rapid pathogen detectiontechnologies.

This prototype development process will include:

• Choosing pathogens to be detected

• Establishing background contaminant levels andwarning thresholds

• Developing SmartSand™ end-user productdesigns (e.g. handheld devices, HVAC systeminserts, etc.)

• Integrating the network communicationsapproach (wireless, onboard, LAN, etc.)

• Estimating production costs to support businessand marketing strategy development

Please contact Dr. Jeff Riggs, President and COO,BioWarn, LLC, to discuss your needs and to explorethese exciting market opportunities. (Telephonenumber 301-926-9050.)

References:

i N C H S - FASTATS - Deaths/Mortality.www.cdc.gov/nchs/fastats/deaths.htm (AccessedAugust 21, 2005). The list is as follows:

1. Heart disease: 696,9472. Cancer: 557,2713. Stroke: 162,6724. Chronic lower respiratory diseases: 124,8165. Accidents (unintentional injuries): 106,7426. Diabetes: 73,2497. Influenza/Pneumonia: 65,6818. Alzheimer's disease: 58,8669. Nephritis, nephrotic syndrome, and nephrosis:40,97410. Septicemia: 33,865

ii Weinstein RA. Nosocomial Infection Update.Special Issue. Emerging Infectious Diseases. Vol 4No. 3, July Sept 1998.

iii Forth Decennial International Conference onNosocomial and Healthcare-Associated Infections,Morbidity and Mortality Weekly Report (MMWR),February 25, 2000, Vol. 49, No. 7, p. 138.

iv 1. Press Ganey. “Press Ganey KnowledgeSummary: The Cost of Nosocomial Infection.”(2003). www.pressganey.org (Accessed July 8,2005).

v Stone PW, Larson E, Kawar LN. A systematicaudit of economic evidence linking nosocomialinfections and infection control interventions:1990-2000. Am J Infect Control 2002;30:145-52.

vi Infection Control Today - 05/2003: "StricterPrecautions."

vii Ivanhoe's Medical Breakthroughs -"Unnecessary Illness: Four Steps to Save Patients'Lives -- Full-Length Doctor's Interview."http://search.ivanhoe.com/ (Accessed July 18,2005)

viii Karchmer TB, Durbin LJ, Simonton BM, FarrBM. Cost-effectiveness of active surveillancecultures and contact/droplet precautions forcontrol of methicillin-resistant Staphylococcusaureus. J Hosp Infect. 2002 Jun;51(2):126-32.

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