61
Antimicrobial Copper Surfaces: Laboratory and Clinical Performance and Impact on Patient Safety James H. Michel Manager, Technical Services Copper Development Association September 14, 2011 Copper Development Association

Antimicrobial Copper Surfaces: Laboratory and Clinical

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Antimicrobial Copper Surfaces: Laboratory and Clinical

Antimicrobial Copper Surfaces:

Laboratory and Clinical Performance and

Impact on Patient Safety

James H. Michel

Manager, Technical Services

Copper Development Association

September 14, 2011

Copper

Development

Association

Page 2: Antimicrobial Copper Surfaces: Laboratory and Clinical

2

Presenter

James H. Michel

M.S. Metallurgical Engineering

Over 38 years experience in non-

ferrous metals in research, sales

and marketing

Metallurgy instructor for the

American Society of Materials

Authored various articles on the

antimicrobial property of copper

Page 3: Antimicrobial Copper Surfaces: Laboratory and Clinical

3

Copper Development Association

Non-profit trade association representing the U.S.

copper industry

Explore new applications for copper and copper

based metals (alloys)

www.copper.org

Page 4: Antimicrobial Copper Surfaces: Laboratory and Clinical

4

US Healthcare-Associated Infection deaths =

One full jumbo jet crashing every day!

Page 5: Antimicrobial Copper Surfaces: Laboratory and Clinical

5

Hospital-acquired infections result in

substantial loss of life, a significant

decrease in the quality of patient care,

and an additional cost to the US

healthcare system of over $45 billion

dollars.

Page 6: Antimicrobial Copper Surfaces: Laboratory and Clinical

6

“The built environment in hospitals

[furnishings, equipment, hardware, and

more] likely accounts for at least 50% of

the HAI’s seen in the Medical Intensive

Care Units.” Dr. Michael G. Schmidt

Medical University of South Carolina WHO 1st International Conference on Prevention & Infection Control

July 1, 2011, Geneva

Page 7: Antimicrobial Copper Surfaces: Laboratory and Clinical

7

Agenda

What is Antimicrobial Copper?

Hospital Surfaces Are Not Adequately Cleaned!

EPA Registration and Other Laboratory Testing

Clinical Testing: Implications to Patient Safety

Applications for Antimicrobial Copper

Page 8: Antimicrobial Copper Surfaces: Laboratory and Clinical

8

What is Antimicrobial Copper?

• Color: copper, metallic

• Properties:

Ductile

Malleable

High thermal conductivity

High electrical conductivity

Easily alloyed

Good corrosion resistance

Readily available

Highly recyclable

Antifouling

Antimicrobial

Page 9: Antimicrobial Copper Surfaces: Laboratory and Clinical

9

Copper alloys = Copper based metals

Copper + other elements (zinc, tin, nickel, and more)

Available in various forms: sheets, strips, plates, foils, rods, bars,

billets, and more

Brasses, bronzes, copper nickels, nickel silvers (copper-nickel-zinc)

Various colors

Page 10: Antimicrobial Copper Surfaces: Laboratory and Clinical

10

Copper

C11000

Commercial Bronze

C22000

Red Brass

C23000

Brass

C24000

Cartridge Brass

C26000

Yellow Brass

C27000

Admiralty Metal

C44300

Phosphor Bronze

C51000

Phosphor Bronze

C52100

Aluminum Bronze

C61400

Aluminum Bronze

C62400

Aluminum Bronze

C62500

Aluminum Bronze

C63000

Silicon Aluminum Bronze

C64200

Silicon Bronze

C65100

Silicon Bronze

C65500

Silicon Manganese

Aluminum Brass

C67400

Manganese Bronze

C67500

Copper Nickel

C70600

Copper Nickel

C71500

Nickel Silver

C75200

Nickel Silver (Coin)

C76500

Tin Bronze

C90700

Aluminum Bronze

C95400

Copper alloys are available in a wide range of

colors

Page 11: Antimicrobial Copper Surfaces: Laboratory and Clinical

11

Antimicrobial Copper is a portfolio of solid,

surface materials that continuously kill bacteria*

Solid, copper-based metal

alloys (e.g. brass, bronze)

Not a coating or surface treatment! *Laboratory testing shows that, when cleaned regularly, Antimicrobial Copper surfaces kill >99.9% of

MRSA, VRE, Staphylococcus aureus, Enterobacter aerogenes, Pseudomonas aeruginosa, and E. coli

O157:H7 within 2 hours

Page 12: Antimicrobial Copper Surfaces: Laboratory and Clinical

12

Antimicrobial Copper is a portfolio of solid,

surface materials that continuously kill bacteria*

Solid, copper-based metal

alloys (e.g. brass, bronze)

Bent, formed, welded,

cast, stamped, etc.

Not a coating or surface treatment! *Laboratory testing shows that, when cleaned regularly, Antimicrobial Copper surfaces kill >99.9% of

MRSA, VRE, Staphylococcus aureus, Enterobacter aerogenes, Pseudomonas aeruginosa, and E. coli

O157:H7 within 2 hours

Page 13: Antimicrobial Copper Surfaces: Laboratory and Clinical

13

Antimicrobial Copper is a portfolio of solid,

surface materials that continuously kill bacteria*

Solid, copper-based metal

alloys (e.g. brass, bronze)

Bent, formed, welded,

cast, stamped, etc.

Durable, environmental

surfaces

Not a coating or surface treatment! *Laboratory testing shows that, when cleaned regularly, Antimicrobial Copper surfaces kill >99.9% of

MRSA, VRE, Staphylococcus aureus, Enterobacter aerogenes, Pseudomonas aeruginosa, and E. coli

O157:H7 within 2 hours

Page 14: Antimicrobial Copper Surfaces: Laboratory and Clinical

14

Humankind has benefited from the antimicrobial

properties of copper since ancient times

Humankind’s oldest metal: early uses include water transportation,

coins, jewelry, weapons, and more

Long before the germ theory of disease was developed, civilizations

used copper to kill disease-causing organisms

Egypt (2000 BC) – purify drinking water and treat wounds

Hippocrates (400 BC) – Treat leg ulcers related to varicose veins

Aztecs – Copper oxide and malachite for skin conditions

Page 15: Antimicrobial Copper Surfaces: Laboratory and Clinical

15

Agenda

What is Antimicrobial Copper?

Hospital Surfaces Are Not Adequately Cleaned!

EPA Registration and Other Laboratory Testing

Clinical Testing: Implications to Patient Safety

Applications for Antimicrobial Copper

Page 16: Antimicrobial Copper Surfaces: Laboratory and Clinical

16 Kramer A. BMC Infectious Diseases 2006;6:130

Page 17: Antimicrobial Copper Surfaces: Laboratory and Clinical

17 Kramer A. BMC Infectious Diseases 2006;6:130

MRSA 7 days to 7 months

Page 18: Antimicrobial Copper Surfaces: Laboratory and Clinical

18

C. difficile 5 months

Kramer A. BMC Infectious Diseases 2006;6:130

MRSA 7 days to 7 months

Page 19: Antimicrobial Copper Surfaces: Laboratory and Clinical

19

C. difficile 5 months

Kramer A. BMC Infectious Diseases 2006;6:130

MRSA 7 days to 7 months

VRE 5 days to 4 months

Page 20: Antimicrobial Copper Surfaces: Laboratory and Clinical

20

Where are the microbes in hospitals?

Page 21: Antimicrobial Copper Surfaces: Laboratory and Clinical

21

Cleaning has always been taken for granted

Cleaning has never been regarded as an

evidence-based science

Measuring the cleaning process and its impact on

the environment costs money.

Aesthetic considerations make cleaning difficult

to assess

We cannot see the enemy until

Page 22: Antimicrobial Copper Surfaces: Laboratory and Clinical

22

Touch surfaces

Infectious microorganisms can survive in scratches on disinfected surfaces,

but not on Antimicrobial Copper surfaces…

Page 23: Antimicrobial Copper Surfaces: Laboratory and Clinical

23

Agenda

What is Antimicrobial Copper?

Hospital Surfaces Are Not Adequately Cleaned!

EPA Registration and Other Laboratory Testing

Clinical Testing: Implications to Patient Safety

Applications for Antimicrobial Copper

Page 24: Antimicrobial Copper Surfaces: Laboratory and Clinical

24

Brass Doorknob

Little bacterial growth

Stainless Steel Doorknob

Heavy bacterial contamination

72 hours after inoculation with E. coli

Doorknobs: A Source of Nosocomial Infection?

by P. J. Kuhn, Diagnostic Medicine, Nov/Dec 1983

Page 25: Antimicrobial Copper Surfaces: Laboratory and Clinical

25

Antimicrobial Copper kills Methicillin-Resistant

Staphylococcus aureus (MRSA)

1

100

10,000

1,000,000

100,000,000

0 60 120 180 240 300 360

Bacte

ria C

ou

nt

(pe

r m

l.)

Time (minutes)

Copper Stainless Steel

*Laboratory testing shows that, when cleaned regularly, Antimicrobial Copper surfaces kill >99.9%

of MRSA, VRE, Staphylococcus aureus, Enterobacter aerogenes, Pseudomonas aeruginosa, and

E. coli O157:H7 within 2 hours

Page 26: Antimicrobial Copper Surfaces: Laboratory and Clinical

26

E. Coli O157:H7 viability

Epifluorescence Images after Staining with Viability Fluorophore CTC

Solid Copper 0 minutes Stainless Steel

31,300,000 CFUs

31,400,000 CFUs

Page 27: Antimicrobial Copper Surfaces: Laboratory and Clinical

27

Epifluorescence Images after Staining with Viability Fluorophore CTC

Solid Copper 30 minutes Stainless Steel

26,899,425 CFUs

1,600,000 CFUs

E. Coli O157:H7 viability

Page 28: Antimicrobial Copper Surfaces: Laboratory and Clinical

28

Epifluorescence Images after Staining with Viability Fluorophore CTC

Solid Copper 60 minutes Stainless Steel

25,933,468 CFUs

2,740 CFUs

E. Coli O157:H7 viability

Page 29: Antimicrobial Copper Surfaces: Laboratory and Clinical

29

E. Coli O157:H7 viability

Epifluorescence Images after Staining with Viability Fluorophore CTC

Solid Copper 120 minutes Stainless Steel

21,066,000 CFUs

<0.01% CFUs

Page 30: Antimicrobial Copper Surfaces: Laboratory and Clinical

30

40+ Peer-reviewed & published papers

Page 31: Antimicrobial Copper Surfaces: Laboratory and Clinical

31

Antimicrobial claims: EPA jurisdiction 6 registrations granted in 2008 with full human health

claims

Page 32: Antimicrobial Copper Surfaces: Laboratory and Clinical

35

Sample approved public health claims for

Antimicrobial Copper

This surface continuously reduces bacterial* contamination, achieving

99.9% reduction within two hours of exposure.

This surface kills greater than 99.9% of Gram-negative and Gram-

positive bacteria* within two hours of exposure.

This surface delivers continuous and ongoing antibacterial* action,

remaining effective in killing greater than 99.9% of bacteria* within

two hours.

*Laboratory testing demonstrates effective antibacterial activity against:

Methicillin-Resistant Staphylococcus aureus (MRSA), Vancomycin-resistant

Enterococcus faecalis (VRE), Staphylococcus aureus, Enterobacter aerogenes,

Pseudomonas aeruginosa, and E. coli O157:H7.

Page 33: Antimicrobial Copper Surfaces: Laboratory and Clinical

36

EPA registration - significance

Antimicrobial copper-

only solid surfaces

permitted to make

health claims

Page 34: Antimicrobial Copper Surfaces: Laboratory and Clinical

37

EPA registration - significance

Antimicrobial copper-

only solid surfaces

permitted to make

health claims

Provide continuous

antimicrobial action

Page 35: Antimicrobial Copper Surfaces: Laboratory and Clinical

38

EPA registration - significance

Antimicrobial copper-

only solid surface

permitted to make

health claims

Provide continuous

antimicrobial action

Kill bacteria* between

routine cleanings

*Laboratory testing shows that, when cleaned regularly, Antimicrobial Copper surfaces kill >99.9% of

MRSA, VRE, Staphylococcus aureus, Enterobacter aerogenes, Pseudomonas aeruginosa, and E. coli

O157:H7 within 2 hours

Page 36: Antimicrobial Copper Surfaces: Laboratory and Clinical

39

EPA registration - significance

Antimicrobial copper-

only solid surface

permitted to make

health claims

Provide continuous

antimicrobial action

Kill bacteria* between

routine cleanings

Disinfectants and

sanitizers only work when

applied

*Laboratory testing shows that, when cleaned regularly, Antimicrobial Copper surfaces kill >99.9% of

MRSA, VRE, Staphylococcus aureus, Enterobacter aerogenes, Pseudomonas aeruginosa, and E. coli

O157:H7 within 2 hours

Page 37: Antimicrobial Copper Surfaces: Laboratory and Clinical

40

EPA registration: required language

The EPA requires the following statement to be included when

making public health claims related to the use of Antimicrobial

Copper products:

“The use of an Antimicrobial Copper surface is a supplement to and

not a substitute for standard infection control practices; users must

continue to follow all current infection control practices, including

those practices related to cleaning and disinfection of environmental

surfaces. The Antimicrobial Copper surface material has been shown

to reduce microbial contamination, but it does not necessarily prevent

cross-contamination”

Page 38: Antimicrobial Copper Surfaces: Laboratory and Clinical

41

“[Antimicrobial Copper has] been rigorously tested and [has]

demonstrated antimicrobial activity. After consulting with

independent organizations – the Association for Professionals in

Infection Control and Epidemiology and the American Society for

Healthcare Environmental Services – as well as a leading expert in

the field (Dr. William A. Rutala, Ph.D., M.P.H., University of North

Carolina (UNC) Health Care System and UNC School of Medicine),

the Agency has concluded that the use of these products could

provide a benefit as a supplement to existing infection control

measures. ”

- U.S. Environmental Protection Agency*

*http://www.epa.gov/pesticides/factsheets/copper-alloy-products.htm

Page 39: Antimicrobial Copper Surfaces: Laboratory and Clinical

42

Agenda

What is Antimicrobial Copper?

Hospital Surfaces Are Not Adequately Cleaned!

EPA Registration and Other Laboratory Testing

Clinical Testing: Implications to Patient Safety

Applications for Antimicrobial Copper

Page 40: Antimicrobial Copper Surfaces: Laboratory and Clinical

43

Clinical Trials

Funded by the Department of Defense

Trials at three sites: Memorial Sloan-Kettering Cancer Center

Medical University of South Carolina

Ralph H. Johnson VA Medical Center

CDA provided materials procurement support only

Page 41: Antimicrobial Copper Surfaces: Laboratory and Clinical

44

Antimicrobial Copper touch

surfaces will lower total bacteria

in hospital rooms

Less bacteria = lower risk of

infections

Lower infections = saved lives,

reduced treatment costs

Hypotheses:

Patients

Touch

Surfaces

Health

Care

Workers

Visitors

80% of infectious

diseases are

transmitted by

touch

TIERNO, P. (2001): The Secret Life of Germs. Atria Books: New York, NY, USA.

Page 42: Antimicrobial Copper Surfaces: Laboratory and Clinical

45

Determine the baseline bio-load on 6 objects in patient rooms

• Bed rails, IV stands, nurse’s call devices, visitor chair arms, over-bed tray tables, data input devices (mice, laptops, touch screen monitor)

Compare bio-load on copper vs. non-copper objects

• 8 rooms with copper objects vs. 8 rooms with non-copper objects

Measure infection rates of patients in copper vs. non-copper rooms

• No changes made to clinical care or handling of environmental surfaces

Testing the performance of antimicrobial copper

in the clinical setting

Medical Intensive Care Units

December 2007 June 2011

Phase 1 Phase 2 Phase 3

Page 43: Antimicrobial Copper Surfaces: Laboratory and Clinical

46

Phase 1: Sampling the built environment

100 cm2 sterile templates placed over tested surfaces

Exposed area wiped in a vigorous side to side motion using five strokes both ways (ten total) applying even pressure

Bacteria liberated from wipe and plated

Page 44: Antimicrobial Copper Surfaces: Laboratory and Clinical

47

Phase 1: Selection of surfaces to sample

Surfaces Selected

Bed rails

IV stands

Over-bed tray tables

Data input devices (mouse, laptop, touch screen monitor bezel)

Visitor’s chair (arms)

Nurses’ call device

Surfaces Screened but not Selected

Laundry hamper

Door hamper

Drawer pulls

Faucet handles

Keyboards

Soap/EtOH dispenser

End table surface

Page 45: Antimicrobial Copper Surfaces: Laboratory and Clinical

48

N = 1113 Rooms

Phase 1 results: Bio-load evaluation

Salgado et al. “Microbial Burden of Objects in ICU rooms.” Poster presentation, Interscience

Conference for Antimicrobial Agents in Chemotherapy (ICAAC), October, 2008.

Page 46: Antimicrobial Copper Surfaces: Laboratory and Clinical

49

Principal Observation Clinical environments carry an average microbial

burden 57 times higher than the levels commonly

accepted as benign (under 250cfu/ 100cm2 - *Dancer,

JHI 2011

N = 1113 Rooms Salgado et al. “Microbial Burden of Objects in ICU rooms.” Poster presentation, Interscience

Conference for Antimicrobial Agents in Chemotherapy (ICAAC), October, 2008.

Phase 1 results: Bio-load evaluation

Page 47: Antimicrobial Copper Surfaces: Laboratory and Clinical

50

Bed rails Nurse’s call device

Data Input Monitor

Mouse

Over-bed tray

table Visitor’s chair Laptop

IV Pole

Phase 2: Antimicrobial Copper products installed

Page 48: Antimicrobial Copper Surfaces: Laboratory and Clinical

51

Page 49: Antimicrobial Copper Surfaces: Laboratory and Clinical

52

Phase 2: Results

Clinical trial results are preliminary and under review; claims related to clinical

trials will be submitted to U.S. EPA for review and approval

Page 50: Antimicrobial Copper Surfaces: Laboratory and Clinical

54

Phase 3 preliminary results*:

Infection-acquisition risk measurement

Study results will be submitted to U.S. EPA for review and

approval. Individual results may vary. Infection reduction claims for

antimicrobial copper surfaces are not permitted at this time.

*Schmidt , Michael G. “Copper Surfaces in the ICU reduced the relative risk of acquiring an infection while hospitalized”,

Slide Session: Innovative Approaches to Infection Controls, WHO 1st International Conference on Prevention & Infection

Control, July 1, 2011, Geneva

Page 51: Antimicrobial Copper Surfaces: Laboratory and Clinical

55

This particular study found:

40% reduction in the risk of acquiring an infection (p=0.039, n=651) for

patients in rooms where some copper objects travelled out

Study results will be submitted to U.S. EPA for review and

approval. Individual results may vary. Infection reduction claims for

antimicrobial copper surfaces are not permitted at this time.

Phase 3 preliminary results*:

Infection-acquisition risk measurement

*Schmidt , Michael G. “Copper Surfaces in the ICU reduced the relative risk of acquiring an infection while hospitalized”,

Slide Session: Innovative Approaches to Infection Controls, WHO 1st International Conference on Prevention & Infection

Control, July 1, 2011, Geneva

Page 52: Antimicrobial Copper Surfaces: Laboratory and Clinical

56

This particular study found:

40% reduction in the risk of acquiring an infection (p=0.039, n=651) for

patients in rooms where some copper objects travelled out

61% reduction in the risk of acquiring an infection (p=0.006, n=541) for

patients in rooms with copper rails and some copper objects travelled out

Study results will be submitted to U.S. EPA for review and

approval. Individual results may vary. Infection reduction claims for

antimicrobial copper surfaces are not permitted at this time.

Phase 3 preliminary results*:

Infection-acquisition risk measurement

*Schmidt , Michael G. “Copper Surfaces in the ICU reduced the relative risk of acquiring an infection while hospitalized”,

Slide Session: Innovative Approaches to Infection Controls, WHO 1st International Conference on Prevention & Infection

Control, July 1, 2011, Geneva

Page 53: Antimicrobial Copper Surfaces: Laboratory and Clinical

57

This particular study found:

40% reduction in the risk of acquiring an infection (p=0.039, n=651) for

patients in rooms where some copper objects travelled out

61% reduction in the risk of acquiring an infection (p=0.006, n=541) for

patients in rooms with copper rails and some copper objects travelled out

69% reduction in the risk of acquiring an infection for patients in rooms

where copper objects never travelled out (p=0.008, n=462)

Study results will be submitted to U.S. EPA for review and

approval. Individual results may vary. Infection reduction claims for

antimicrobial copper surfaces are not permitted at this time.

Phase 3 preliminary results*:

Infection-acquisition risk measurement

*Schmidt , Michael G. “Copper Surfaces in the ICU reduced the relative risk of acquiring an infection while hospitalized”,

Slide Session: Innovative Approaches to Infection Controls, WHO 1st International Conference on Prevention & Infection

Control, July 1, 2011, Geneva

Page 54: Antimicrobial Copper Surfaces: Laboratory and Clinical

58

Agenda

What is Antimicrobial Copper?

Hospital Surfaces Are Not Adequately Cleaned!

EPA Registration and Other Laboratory Testing

Clinical Testing: Implications to Patient Safety

Applications for Antimicrobial Copper

Page 55: Antimicrobial Copper Surfaces: Laboratory and Clinical

59

EPA Approved Touch Surface Applications

MEDICAL &

HEALTHCARE

FOOD &

HOSPITALITY

PUBLIC

TRANSPORT

SCHOOLS

PUBLIC

BUILDINGS

SPORTS

FACILITIES

Touch Surface Applications

Page 56: Antimicrobial Copper Surfaces: Laboratory and Clinical

60

Portfolio of products available and many more

being developed

Page 57: Antimicrobial Copper Surfaces: Laboratory and Clinical

61

How you can get involved

Introduce the benefits of Antimicrobial Copper

to your colleagues

AntimicrobialCopper.com

Find products

Schedule a presentation for your hospital

Sign up for our newsletter

More background science

See us at:

Association for the Healthcare Environment Annual Conference

September 25-29, Kissimmee, FL

The American Society for Healthcare Risk Management (ASHRM)

Annual Conference, October 16-19, Phoenix

Page 58: Antimicrobial Copper Surfaces: Laboratory and Clinical

62

Summary

Antimicrobial copper is the most effective touch surface

material

Hospital surfaces are not adequately cleaned!

Studies have demonstrated copper’s benefits in real world

settings

Antimicrobial Copper is the only solid surface registered

with EPA to kill disease causing bacteria

Page 59: Antimicrobial Copper Surfaces: Laboratory and Clinical

64

How to control bacteria in hospitals?

Medical Staff Areas Public Areas Patient Rooms

Page 60: Antimicrobial Copper Surfaces: Laboratory and Clinical

65

Use Antimicrobial Copper for contact surfaces

Medical Staff Areas Public Areas Patient Rooms

Page 61: Antimicrobial Copper Surfaces: Laboratory and Clinical

66

Thank you

Jim Michel

[email protected]

(212) 251-7210

Wilton Moran

[email protected]

(212) 251-7212

www.AntimicrobialCopper.com