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Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, Scott Augustine, MD MD CEO, Augustine CEO, Augustine Temperature Management Temperature Management LLC LLC 1

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Page 1: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Patient Warming:

Anesthesia’s Role in

Orthopedic Infection

Reduction

Scott Augustine, Scott Augustine, MDMD

CEO, Augustine CEO, Augustine Temperature Temperature

Management LLCManagement LLC1

Page 2: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Learning Objectives

This presentation will enable participants to:This presentation will enable participants to:

1.1.Recognize the benefits of patient Recognize the benefits of patient warming in preventing soft tissue warming in preventing soft tissue infections. infections.

2.2.Differentiate the etiology of soft-tissue Differentiate the etiology of soft-tissue infections and periprosthetic joint infections and periprosthetic joint infections.infections.

3.3.Examine the purpose of operating room Examine the purpose of operating room ventilation—to prevent bacteria from ventilation—to prevent bacteria from rising from the floor and contaminating rising from the floor and contaminating the surgical field.the surgical field.

2

Page 3: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Learning Objectives

4.4. Analyze the effect of convection Analyze the effect of convection currents formed by waste forced-air currents formed by waste forced-air warming heat on OR ventilation warming heat on OR ventilation airflow.airflow.

5.5. Apply the “Chain of Infection” Apply the “Chain of Infection” methodology to determine methodology to determine disruption of the OR ventilation disruption of the OR ventilation airflow by waste heat is linked to airflow by waste heat is linked to periprosthetic joint infections.periprosthetic joint infections.

3

Page 4: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Conflict of Interest Disclosure

Bair Hugger® Warming

Augustine Medical Inc. Arizant/3M

HotDog® Patient Warming

Augustine Temperature Management LLC.

Page 5: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Importance of Patient Warming

Warm patients do better than cold Warm patients do better than cold patients!patients!

The benefits of patient warming include:The benefits of patient warming include: Reduced wound infections (soft tissue)Reduced wound infections (soft tissue) Reduced blood lossReduced blood loss Reduced cardiac eventsReduced cardiac events Lower mortality ratesLower mortality rates Shortened hospital stays Shortened hospital stays

Active warming is now the standard set Active warming is now the standard set by: Medicare, SCIP, PQRS (US), NICE (UK)by: Medicare, SCIP, PQRS (US), NICE (UK)

Page 6: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Common Patient Warming Methods

Forced-Air Warming (FAW): Bair Forced-Air Warming (FAW): Bair Hugger, WarmTouch, MistralHugger, WarmTouch, Mistral

Resistive electric warming: HotDog Resistive electric warming: HotDog Patient WarmingPatient Warming

Water-based systems: Cincinnati Water-based systems: Cincinnati Subzero, Kimberly ClarkSubzero, Kimberly Clark

Page 7: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Normothermia’s Role in Preventing SSIs (Soft-Tissue Infections)

Kurz et al reported a 66% reduction in Kurz et al reported a 66% reduction in wound infections during colon wound infections during colon surgery, when the patients were surgery, when the patients were warmed to normothermia with FAW warmed to normothermia with FAW (compared to 2(compared to 2C hypothermic, non-C hypothermic, non-warmed control patients). warmed control patients). NEJMNEJM

Warm patients have fewer soft tissue Warm patients have fewer soft tissue infections.infections.

Page 8: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Different Kinds of Infections “SSI” vs. “PJI”

Common mistake: lumping the Common mistake: lumping the varieties of infection together—causes varieties of infection together—causes confusionconfusion

The term The term ““SSISSI”” is reserved for is reserved for soft-soft-tissue infectionstissue infections

SSI are differentiated from SSI are differentiated from Periprosthetic joint infections (Periprosthetic joint infections (““PJIPJI””)* )* that can occur after total joint that can occur after total joint replacement surgery replacement surgery

*Also known as Deep Joint Infections (*Also known as Deep Joint Infections (““DJIDJI””))

Page 9: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

The Infectious Process

Implanted foreign materials Implanted foreign materials fundamentally change the fundamentally change the pathophysiology of the infectious pathophysiology of the infectious processprocess An inoculum of more than An inoculum of more than one million one million

bacteriabacteria are required to cause an are required to cause an SSISSI77

A A singlesingle bacteriumbacterium can cause a can cause a PJIPJI, and it , and it usually enters the wound as usually enters the wound as airborneairborne contamination.contamination.8-108-10

Page 10: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

How can 1 germ cause a PJI?

It’s all about It’s all about biofilm..1111

In the presence of an In the presence of an implanted foreign implanted foreign material, the bacterium material, the bacterium produces a coating of produces a coating of exopolysaccharide exopolysaccharide material.material.

Biofilm effectively Biofilm effectively protects it from protects it from antibodies and antibodies and antibiotics. antibiotics.

Source: www.cell.com

Source: Wyss Institute at Harvard

Page 11: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

No Biofilm in Soft-Tissue

In contrast, bacteria cannot produce In contrast, bacteria cannot produce effective biofilm in soft tissueeffective biofilm in soft tissue

Exposed to both antibodies and Exposed to both antibodies and antibioticsantibiotics

Source: nobelprize.org

Since Since it takes more than a it takes more than a million bacteria to cause million bacteria to cause a soft tissue SSI, the a soft tissue SSI, the airborne contamination in airborne contamination in the operating room is the operating room is virtually irrelevant for virtually irrelevant for soft tissue SSIs. soft tissue SSIs.

Page 12: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

SSI vs PJI

SSI generally an easily treatable SSI generally an easily treatable complicationcomplication

PJI is a catastrophic complicationPJI is a catastrophic complication::• Often requires explantation of the joint and Often requires explantation of the joint and

weeks of antibioticsweeks of antibiotics• Patients never regain full capacity and Patients never regain full capacity and

frequently cannot accomplish the activities of frequently cannot accomplish the activities of daily living. daily living.

• 12% of patients rate their life after surviving a 12% of patients rate their life after surviving a PJI as PJI as ““worse than death.worse than death.””1212

Page 13: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Periprosthetic joint infections (PJI)

PJI after total joint replacement:PJI after total joint replacement:Relatively common complication (1-Relatively common complication (1-

2%) 2%) Medicare says Medicare says 2%2% in primary hips in primary hips

and kneesand knees 10,000 – 20,000 per year in the 10,000 – 20,000 per year in the

USUS

Page 14: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

SSI vs PJI — cost

SSI generally cheap to treatSSI generally cheap to treat

PJI is a very expensive complicationPJI is a very expensive complication:: CostsCosts $100,000 - $150,000 each $100,000 - $150,000 each Not reimbursed by MedicareNot reimbursed by Medicare

Source: sciencedirect.comSource: sciencedirect.com

Page 15: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Rosie Bartell – the “face” of PJI

63 YO grandmother, otherwise 63 YO grandmother, otherwise healthy, s/p R. TKR with MRSA healthy, s/p R. TKR with MRSA PJI PJI 27 surgeries including R. 27 surgeries including R. leg amputation. MRSA biofilm leg amputation. MRSA biofilm on R. hip implant.on R. hip implant.

Patient advocate Patient advocate (RosiesDream.com)(RosiesDream.com)

RosieRosie’’s advice: s advice: ““If your favorite If your favorite hospital uses FAW, go to a hospital uses FAW, go to a different hospital for your hip different hospital for your hip or knee replacement.or knee replacement.””

Page 16: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Periprosthetic joint infections

Why PJI at an anesthesia conference?

Evidence to date: My invention (FAW) used by anesthesia providers worldwide, is linked to 75% or more of PJIs.

I left Bair Hugger more than 12 years ago. Company has been sold twice—now 3M.

My only influence is to teach what I have learned.

Hypothesis: The waste heat from FAW contaminates the sterile surgical field with bacteria, increasing the risk of PJI. Yes or no? If “Yes,” then

PJI is the most common serious anesthetic complication.

Page 17: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Studies: Joint Sepsis (PJI) vs. OR

Ventilation

1980’s 2000’s 2010’s

0.5

1.0

1.5

0.0

Lidwell, O.M. (UK)

• Multicenter (prospective)• Excellent ventilation• Followed protocol• + Antibiotics

PJI

Rat

e (%

)

Page 18: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Studies: Joint Sepsis (PJI) vs. OR

Ventilation

1980’s 2000’s 2010’s

0.5

1.0

1.5

0.0

Lidwell, O.M. (UK)

• Multicenter (prospective)• Excellent ventilation• Followed protocol• + Antibiotics

Brandt, C. (Ger)Knobben, B. (Hol)• Multicenter (retrospective)• Excellent ventilation• Followed protocol• + Antibiotics

PJI

Rat

e (%

)

Page 19: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Why the increase in infection rates in these ventilation

studies?

The increase in the infection rate is The increase in the infection rate is despite substantial air quality efforts:despite substantial air quality efforts: Laminar flow ventilation: ImprovedLaminar flow ventilation: Improved Body evacuation suits: Regularly usedBody evacuation suits: Regularly used Traffic: Limited number and movement of Traffic: Limited number and movement of

OR personnel. OR personnel.

Something in the standard operating protocols must be disrupting the ventilation.

Page 20: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Causes of ventilation disruption

Blowing air (fans) — noneBlowing air (fans) — none

Ventilation obstructions (e.g.: surgical lights) Ventilation obstructions (e.g.: surgical lights) — same— same

Personnel movement — limitedPersonnel movement — limited

Heat (creates convection currents of rising air) Any new sources of heat introduced to the OR

between the late ’80’s and 2000’s? FAW! 1000 watts of waste heat vented near the

floor since 1989.

Page 21: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1
Page 22: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Research Video evidence supported by 5 published Video evidence supported by 5 published

studiesstudies44-4844-48

Page 23: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Legg, A.J.; Hammer, A.J. Forced-air patient warming blankets disrupt unidirectional airflow.

B&JJ, March 2013 vol. 95-B no. 3 407-410

2,000 times more contaminant 2,000 times more contaminant particles were found in the air over particles were found in the air over the wound with FAW than with air-the wound with FAW than with air-free conductive warming. free conductive warming. 217,300% Increase!217,300% Increase!

Page 24: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Belani, K; et al. Patient Warming Excess Heat: Effects on Orthopedic Operating Room Ventilation Performance. A&A. 2013

Aug;117(2):406-11

““… … exhaust from forced-air warming generated exhaust from forced-air warming generated hot-air convection currents that mobilized hot-air convection currents that mobilized ‘‘bubblesbubbles’’ over the anesthesia drape and into over the anesthesia drape and into the surgical site.the surgical site.””

Page 25: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Ether screen height vs FAW contamination

McGovern P, Reed M et al. Forced Air Warming and Ultra-Clean Ventilation Do Not Mix: An Investigation of McGovern P, Reed M et al. Forced Air Warming and Ultra-Clean Ventilation Do Not Mix: An Investigation of Theatre Ventilation, Patient Warming and Joint Replacement Infection in Orthopaedics. Theatre Ventilation, Patient Warming and Joint Replacement Infection in Orthopaedics. JBJS-Br JBJS-Br 2011;93:1537-2011;93:1537-4444

Page 26: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Increased ventilation velocity increased contamination

0.3 vs 0.5 meters/sec. laminar flow velocity0.3 vs 0.5 meters/sec. laminar flow velocity

Reed M, McGovern P et al. FAW vs. CFW – An evaluation of laminar operating room ventilation disruption. (Unpublished)

Page 27: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Contaminated air = increased infection risk

A.A. Waste FAW heat rises mobilizing infectious Waste FAW heat rises mobilizing infectious contaminates from the floor up into the sterile contaminates from the floor up into the sterile surgical field. surgical field. 44-49, 63, 6444-49, 63, 64

B.B. The concentration of airborne contaminates The concentration of airborne contaminates correlates directly with the concentration of correlates directly with the concentration of contaminates in the wound. contaminates in the wound. 2-4,51-572-4,51-57

C.C. Concentration of contaminates in the wound Concentration of contaminates in the wound correlates with the risk of PJI. (only need one correlates with the risk of PJI. (only need one bacterium) bacterium) 8-10 8-10

FAW = increased PJI risk: FAW = increased PJI risk: Logic (If A=B and Logic (If A=B and B=C then A=C)B=C then A=C)

Page 28: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Lidwell, O.M. (UK)• Multicenter• Excellent ventilation• Followed protocol• + Antibiotics

Brandt, C. (Ger)Knobben, B. (Hol)• Multicenter• Excellent ventilation• Followed protocol• + Antibiotics• + forced-air warming• No forced-air warming

Studies: Joint Sepsis (PJI) vs. OR

Ventilation

1980’s 2000’s 2010’s

0.5

1.0

1.5

0.0

PJI

Rat

e (%

)

FAW Standard of Care

Page 29: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

CDC: Chain of Infection

The The Chain of InfectionChain of Infection is a well-known is a well-known model used to understand the model used to understand the etiology of infections.etiology of infections.1313

Each link in the chain must be present Each link in the chain must be present to prove the source of an infection.to prove the source of an infection.

PJI: 5 of the 6 links have been proven PJI: 5 of the 6 links have been proven for decadesfor decades

Page 30: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1
Page 31: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

PJI Chain of Infection:

1. Infectious Agent1. Infectious Agent

• “A microbial organism with the ability to cause disease”

• A A singlesingle bacterium can cause a bacterium can cause a PJI, and it usually enters the PJI, and it usually enters the wound as wound as airborneairborne contamination.contamination.8-108-10

Page 32: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

PJI Chain of Infection:

1. Infectious Agent1. Infectious Agent

• PJIs are primarily caused by PJIs are primarily caused by Staphylococcus aureus, Staphylococcus aureus, coagulase-coagulase-negative staphylococci and gram-negative staphylococci and gram-negative bacilli, predominantly skin negative bacilli, predominantly skin bacteria.bacteria.1414

• A person sheds over 1 billion skin A person sheds over 1 billion skin cells a daycells a day

• Up to 10% of these skin cells carry Up to 10% of these skin cells carry pathogenspathogens15-1815-18

Page 33: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

PJI Chain of Infection:

2. Reservoir2. Reservoir

“A place within which microorganisms can thrive and reproduce”

Most bacteria in the operating room Most bacteria in the operating room are shed from the skin of the surgical are shed from the skin of the surgical staff.staff.19-2419-24

Can also originate in the perineal Can also originate in the perineal region of the staff, including vaginal region of the staff, including vaginal and rectal carriage.and rectal carriage.14,25-3214,25-32

Page 34: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

FAW Blowers as a Reservoir

Three studies have found that FAW blowers Three studies have found that FAW blowers are a breeding ground for contaminates.33-are a breeding ground for contaminates.33-3535

Nearly all forced-air blowers are Nearly all forced-air blowers are contaminated with bacteria growing on contaminated with bacteria growing on their internal airflow paths.33-34 their internal airflow paths.33-34

Low efficiency inlet filters fail to block Low efficiency inlet filters fail to block contaminating bacteria from entering the contaminating bacteria from entering the blower where they can stick to the plastic blower where they can stick to the plastic parts and grow.33-34parts and grow.33-34

Page 35: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Forced Air Warming Design: An Evaluation of Intake Filtration, Internal Microbial Build-Up, and

Airborne-Contamination Emissions.

Reed M, McGovern P, Kimberger O et al. JAANA Reed M, McGovern P, Kimberger O et al. JAANA August 2013August 2013

23 Bair Hugger® Model 750 blowers sampled.23 Bair Hugger® Model 750 blowers sampled. 100% cultured positive on the internal air-flow 100% cultured positive on the internal air-flow

paths.paths. Coag-neg StaphCoag-neg Staph MoldMold MicrococciMicrococci

96% emitting 96% emitting ““significant levels of internally significant levels of internally generated airborne contaminantsgenerated airborne contaminants”” out of the hose out of the hose endend, , up to 300 million particles per hour.up to 300 million particles per hour.

Intake filters 63.8% efficient.Intake filters 63.8% efficient.

Page 36: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

PJI Chain of Infection:

3. Portal of Exit3. Portal of Exit

“A place of exit providing a way for a microorganism to leave the reservoir”

There are multiple portals of exitThere are multiple portals of exit Simple sheddingSimple shedding15-1815-18

““Space suitSpace suit”” exhaust exhaust2222

Rectal and vaginal sheddingRectal and vaginal shedding14,25-3214,25-32

Aerosolized bacteria out the hose of the Aerosolized bacteria out the hose of the forced-air blower forced-air blower

Page 37: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

PJI Chain of Infection:

4. Mode of Transmission4. Mode of Transmission

“Method of transfer by which the organism moves or is carried from one place to another”

Bacteria in the operating room can ride Bacteria in the operating room can ride air currents.air currents.36-3936-39

Since the ventilation airflow is from Since the ventilation airflow is from ceiling to floorceiling to floor, it is not surprising that , it is not surprising that the shed skin particles and bacteria settle the shed skin particles and bacteria settle and concentrate near the floor.and concentrate near the floor.37,38,40,4137,38,40,41

Page 38: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

PJI Chain of Infection:

Mode of TransmissionMode of Transmission

The missing link in the Deep Joint Chain of Infection: How do germs from near the floor get into the wound?

Answer: Riding the Answer: Riding the rising waste FAW rising waste FAW heat. heat.

Page 39: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Mode of Transmission: Waste Heat from Forced-Air Patient

Warming

The nearly 1000 watts of waste heat from The nearly 1000 watts of waste heat from FAW creates massive convection FAW creates massive convection currents.currents.44-4844-48

Waste heat from a FAW blanket:Waste heat from a FAW blanket: Escapes from under the surgical drapes near Escapes from under the surgical drapes near

the floorthe floor Mixes with the floor air that has the highest Mixes with the floor air that has the highest

concentration of airborne contaminantsconcentration of airborne contaminants Forms into convection currents and rises Forms into convection currents and rises

directly into the downward ventilation airflow directly into the downward ventilation airflow and into the sterile surgical field.and into the sterile surgical field.44,46,4844,46,48

Page 40: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

PJI Chain of Infection:

5. Portal of Entry5. Portal of Entry

“An opening allowing the microorganism to enter the host.”

The concentration of airborne The concentration of airborne contaminants in the surgical field is contaminants in the surgical field is directly proportional to the directly proportional to the concentration of contaminants in the concentration of contaminants in the woundwound..2-4,50-572-4,50-57

Page 41: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

PJI Chain of Infection:

6. Susceptible Host6. Susceptible Host

“A person who cannot resist a microorganism invading the body, multiplying and resulting in infection.”

The total joint arthroplasty patient is The total joint arthroplasty patient is susceptible to even small numbers of susceptible to even small numbers of airborne contaminants because of the airborne contaminants because of the implanted foreign materials.implanted foreign materials.8-108-10

The Periprosthetic Joint Chain of Infection The Periprosthetic Joint Chain of Infection is complete. is complete.

Page 42: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

PJI Chain of Infection summary

Rising waste heat from FAW is the Rising waste heat from FAW is the missing link for the PJI Chain of missing link for the PJI Chain of Infection.Infection.

Therefore; Therefore; rising waste heat from rising waste heat from FAW is linked to causing PJIs.FAW is linked to causing PJIs.

Confirm with research…Confirm with research…

Page 43: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Research Results: McGovern et al. Journal of Bone and Joint Surgery-

br 44

Discontinued FAW and switched to HotDog Discontinued FAW and switched to HotDog air-free warming in total joint replacement air-free warming in total joint replacement surgery.surgery.

““[Forced-air] Patient warming ventilation [Forced-air] Patient warming ventilation disruption was associated with a disruption was associated with a significant increase in deep joint infections, as demonstrated by an elevated infection odds ratio (3.8, p=0.028) for the p=0.028) for the forced air versus conductive fabric patient forced air versus conductive fabric patient groups (n=1437 cases, 2.5-year period).groups (n=1437 cases, 2.5-year period).””

Page 44: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Research Results: McGovern et al.

Journal of Bone and Joint Surgery-br

Deep joint infection rates:Deep joint infection rates: 9/9/’’08 – 6/08 – 6/’’10, Forced-air warming: 3.1% 10, Forced-air warming: 3.1%

(1066 cases)(1066 cases) 7/7/’’10 – 1/10 – 1/’’11, HotDog warming : 0.81% 11, HotDog warming : 0.81%

(371 cases)(371 cases)

Discontinuing the use of forced-air Discontinuing the use of forced-air warming resulted in a warming resulted in a 74% reduction in joint implant infections in joint implant infections (p=0.024).(p=0.024).

Retrospective outcome studyRetrospective outcome study

Page 45: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Research Results: Retrospective PJI Outcome

Study (unpublished)

A medium-sized independent regional A medium-sized independent regional healthcare network:healthcare network:

Baseline PJI rate: Baseline PJI rate: FAW (Year 0):1.55% 388 cases

Study PJI rate: air-free HotDog warming (Years 1,2): 0.29% 677 cases

Decrease in PJI rate: 81%

Page 46: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Research Results: Retrospective PJI Outcome

Study (unpublished)

An independent orthopedic and sports institute:

Baseline PJI rate: FAW (Year 0):2.29% 175 cases

Study PJI rate: air-free HotDog warming (Year 1): 0.00% 218 cases

Decrease in PJI rate: 100%

Page 47: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Studies: Joint Sepsis (PJI) vs. OR

Ventilation

1980’s 2000’s 2010’s

0.5

1.0

1.5

0.0

Lidwell, O.M. (UK)

• Multicenter• Excellent ventilation• Followed protocol• + Antibiotics• No forced-air warming

Brandt, C. (Ger)Knobben, B. (Hol)• Multicenter• Excellent ventilation• Followed protocol• + Antibiotics• + forced-air warming

McGovern, P.D. (UK)+2 Customer reports (US)• Multicenter• Excellent ventilation• Followed protocol• + Antibiotics• No forced-air warming

PJI

Rat

e (%

)

FAW Standard of Care D/C FAW

Page 48: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

What are the consequences of PJI besides the patient’s pain

and suffering?

Page 49: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Litigation

Lawsuits have been filed against Lawsuits have been filed against 3M/Bair Hugger forced-air 3M/Bair Hugger forced-air warming. warming.

3M’s response to the Court: the 3M’s response to the Court: the ““learned intermediarylearned intermediary”” defense defense..

Page 50: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

“Learned intermediary” defense

Who is the “Learned Who is the “Learned Intermediary”? Intermediary”? It’s you…and the surgeon and the It’s you…and the surgeon and the

anesthesiologist…and the hospital.anesthesiologist…and the hospital.

The hospital and the providers knew The hospital and the providers knew the risks of using FAW and used it the risks of using FAW and used it anyway so it’s their fault, not the anyway so it’s their fault, not the manufacturer. manufacturer.

Page 51: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

“Wave of New Litigation” 61

Clinical Quality & Infection ControlClinical Quality & Infection Control, a , a publication of publication of BeckerBecker’’s ASC Reviews ASC Review::

““Recent studies published in medical Recent studies published in medical journals questioning the safety of journals questioning the safety of forced-air patient warming in orthopedic forced-air patient warming in orthopedic implant and other ultra-clean surgeries implant and other ultra-clean surgeries could mean a could mean a wave of new litigationwave of new litigation.. ””

Product liability Product liability Medical Medical Malpractice???Malpractice???

Page 52: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

“Wave of New Litigation”

Page 53: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Patient Warming Litigation

With 16,000 PJIs per year; plenty of With 16,000 PJIs per year; plenty of potential plaintiffs…and billions in potential plaintiffs…and billions in potential damages.potential damages.

As the As the ““learned intermediary,learned intermediary,”” you should you should take steps to evaluate the facts and take steps to evaluate the facts and make an informed decision based on your make an informed decision based on your findings. findings.

If you still think this is no big deal, watch If you still think this is no big deal, watch what is on TV these days….what is on TV these days….

Page 54: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

“Wave of New Litigation”

http://www.youtube.com/watch?v=-NBa6RdNuwI

Page 55: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

Thank you!

55

Page 56: Patient Warming: Anesthesia’s Role in Orthopedic Infection Reduction Scott Augustine, MD CEO, Augustine Temperature Management LLC 1

56

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