Clean Patch

CleanPatch – Product Presentation

Henleys Medical Supply (2014)

First-in-class medical surface repair for hospital

beds and stretchers that restores damaged

mattresses to an intact and hygienic state.

CE Marked Class 1 medical device

Barbara Potter, RN

• ICU Manager, 25 years hospital experience

“Mattresses on patient beds are often

damaged, I also know that it is impossible to

properly clean a surface that was not intact,

and yet it was impractical to replace a mattress

each time a small tear appeared”

ripped mattress pathogens

2014 © Surface Medical Inc. 2

Inspired by a Nurse


How Big of a Problem is It?

Multi-phase research study in a leading Hospital conducted by the Ward of the 21st Century, a third party clinical research organization

Surveyed 20% of mattresses in circulation: 213 patient beds across 33 units

Results

� 101 mattresses, or 47% had damage (rips, tears, cracks)

� 30 damaged mattresses were randomly swabbed:

o 20/30 (65%) tested positive for at least 1 organism

o 2/30 (6%) tested positive for Clostridium difficile

o 1/30 (3%) tested positive for VRE

?


Available Options Today…


What we see…

Lifting Tape + Sticky Mess

Damaged Mattresses cause Infections!

MRSA

VRE

Acinetobacter

Other

Pseudomonas

Reference: Adapted from Creamer and Humphreys(2008)

Journal of Hospital Infections 69.8-23

• Multiple studies have demonstrated that:

� Hospital mattresses harbor dangerous pathogens like MRSA and C.difficile

� Multiple outbreaks have been traced back to contaminated, damaged mattresses

� Mattress intervention, such as improved cleaning and/or returning mattresses to an intact state, have been shown to terminate outbreaks


The Challenge

To address this issue, we spoke to Healthcare

Stakeholders in all departments (Infection Control,

Facilities, Housekeeping) and the product had to;

� Hold up to repetitive cleaning by disinfectants

� Not collect bacteria on the edge

� Be simple to apply

� Be cost-effective

� Last in a real hospital setting

72014 © Surface Medical Inc.

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Introducing… CleanPatch™

3.5 x 3.5 inch Medical Surface Repair Patch

First-in-class medical surface repair for hospital

beds and stretchers that restores damaged

mattresses to an intact and hygienic state.

Designed with Healthcare stakeholders to be

applied in secondsSafe and Simple

Extends the life of mattresses and stretchers

reducing direct and indirect costsCost Savings

Independently tested by a third-party clinical

organization in a real hospital settingClinically Tested


CleanPatch Clinical Assessment

CleanPatch - Clinical Assessment

Primary Study Objectives

1) What is the incidence and severity of microbial growth on the hospital

mattress and CleanPatch before and after terminal cleaning? Is there any

difference?

2) How does CleanPatch perform in a clinical setting over the duration of the

study?

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Project Collaborators: Dr. Thomas Louie (UCalgary, AHS), Craig Pearce (AHS), Linda Ward (UCalgary),

Jill de Grood (UCalgary), Holly Wong (UCalgary), Irene Ma (AHS, UCalgary)


CleanPatch Clinical Assessment

Study Methods

• CleanPatch was applied to 60 mattresses (1 on

top and 1 on side)

• Testing took place between October 2012 and

January 2013

• 12 Microbial swabs were taken per sample

collection, 720 microbial swabs were cultured.

Mattress

LocationBefore Cleaning After Cleaning

TopCleanPatch Surface

CleanPatch Edge

Mattress Surface

CleanPatch Surface

CleanPatch Edge

Mattress Surface

Side CleanPatch Surface

CleanPatch Edge

Mattress Surface

CleanPatch Surface

CleanPatch Edge

Mattress Surface

TOP

SIDE


Primary Study Questions

• Is there any difference between microbial growth between the hospital mattress and

CleanPatch on the Mattress Top Site?

Study Results

• No significant difference in severity of microbial growth between the hospital mattress

and CleanPatch edge or surface, before and after terminal cleaning

• Reduction in pathogenic growth after terminal cleaning on all areas tested

Mattress Location

TOP SITE

Pathogenic Growth

Before Terminal Cleaning

(Mean)

Pathogenic Growth

After Terminal Cleaning

(Mean)

Mattress (n=60) 1.18 0.27

CleanPatch Edge (n=60) 0.83 0.23

CleanPatch Surface (n=60) 1.10 0.13

P-value vs mattress No Significant Difference No Significant Difference

Summary Results - Mattress Top


• 72 CleanPatch applied in October 2012 on mattresses were assessed 1 year

later to determine patch viability and any signs of damage

• 72/72 or 100% looked the same as the day they were applied, CleanPatch

continues to perform well in a hospital environment on mattresses!

Study – 1 Year Follow-up


The Clinical Study on CleanPatch met its Primary Objectives,

Peer-reviewed publication coming soon!

• CleanPatch does not harbor any more (or less) organisms

than the hospital mattress, and is comparable in

cleanability

• CleanPatch performed well in a clinical setting

Study - Conclusions


Test Protocol Conclusion

180 Degree Peel Test

Accelerated Aging

ASTM D3330 modified

PSTC-9

CleanPatch is stable for at least 2 years under accelerated

aging conditions

Uniaxial Fatigue test Custom designed facility

CleanPatch passed test that included compression,

rotation, urine treatment and cleaning on a ripped

mattress (simulate patient on hospital mattress)

Hospital Disinfectants

testingCustom designed

CleanPatch was stable when exposed to hospital

disinfectants, including Alcohol, Bleach, Quaterniums and

Hydrogen Peroxide (also proven by disinfectant comp)

Laboratory testing performed at a GLP certified facility

CleanPatch – Durability Testing


Mattress (cover + foam)

9.5’’ X 9.5’’ X 3’’

CleanPatch (3.5’’ X 3.5’’)

Mattress Cover Linen

Stainless Steel PlateStainless Steel Plate

1’’ indent

12 to 60 cycles

per hour

90 Degree

Rotation. 45

Degree/sec

A Cut in Mattress (1’’)

Dome Compression

Platen

Uniaxial Fatigue Test - Set-Up


Test Condition Conditions

No. Compression 2,880

No. Rotation 2,880

Urine Treatment 16

Cleaning 16

ResultsNo Change, Passed

Water Leak Test*

Compression = 50% mattress depression

Rotation = (90O CW and CCWW from Zero at 45O per sec).

Urine = Artificial Urine. 10ml/treatment.

Cleaning= Hospital Grade Quaternary Ammonium (516ppm). 10ml/treatment.

*Water Leak Test – NHS (UK) developed method, 10ml of water dispensed on surface + pressure

BEFORE

AFTER

Uniaxial Fatigue Test – Results

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CleanPatch is impermeable, fluid resistant


CleanPatch was designed as a preventative maintenance tool for early signs

of damage on hospital beds, stretchers and other surfaces.

Catch the Damage Early!

Characteristic of Damage site ideally suited for CleanPatch:

� Less than 2 inches

�On the surface or sides

� Polyurethane or Vinyl surface (not Nylon or coated covers)

CleanPatch – Safe & Simple

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EXAMPLES OF DAMAGE

MORE CLEANPATCH

SIZES COMING SOON!

Exam tables, Wheelchairs, Commodes, Chairs may also be possible!


Biocompatible: medical grade, latex-free and non-cytotoxic

Easy to Apply: designed in collaboration with Healthcare Stakeholders, can be

applied successfully with gloves (peel and stick).

CleanPatch – Safe & Simple

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Application video at www.cleanpatch.us


For every 100 mattresses fixed, CleanPatch could save >20,000£* Contact us to develop a specific economic model for your site *

100 damaged hospital mattresses

Cost Savings Example

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Without CleanPatch

Option Quantity Price

per Unit

New Mattress 100 300 £

TOTAL 30,000£

With CleanPatch

Option Quantity Price

per Unit

New Mattress 30 300 £

CleanPatch 70 9-10 £

TOTAL 9,700£


Testimonial

• Over 70 healthcare facilities in North America are purchasing

CleanPatch in the last few months!

"Many studies have shown that healthcare equipment (e.g. mattresses, positioning

pillows, stretchers, wheelchairs, high walkers) that are shared between

patients/residents/clients with rips and tears have resulted in disposal as they

cannot be cleaned nor disinfected properly. We hope to save some money by

using CleanPatch to repair this communal equipment and also provide a safe

environment for our patients. Our facility has been using CleanPatch for the

past eight months and the feedback from our end users is positive,

specifically the product's easy application and durability.We have been

using CleanPatch on our stretchers located in the busy Emergency Department

and it has been able to withstand multiple cleaning and disinfection“

Manager, Infection Prevention and Control in Canada

1000+ bed facility in Toronto, Ontario

Infection Control and User references available upon request


Met the Challenge!

After over 2 years of development and testing,

CleanPatch addresses the issue of damaged

mattresses and stretchers;

�Cleanable by hospital disinfectants

�Does not collect bacteria on the edge

�Simple to apply, Peel and Stick

�Cost-savings possible

�Last in a real hospital setting for 1+ year


Thank You

Manufacturer Contact

Tony Abboud

Surface Medical

[email protected]

403-589-7642

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www.cleanpatch.ca

Clinical whitepapers, instructions and more information can be found at:

UK Distributor Contact

Henleys Medical Supply

www.henleysmed.com


Clean Patch

Healthcare

Transcript of Clean Patch