H sk circuit guard powerpoint presentation

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ARC MedicalThe circuitGuard System

September 2014

ARC Medical

September 2014

How are you protectingyour patients from contamination?

How do you know your filter filters?

Company Background

ARC Medical, Inc. was started in 1990 to serve the filtration and humidification needs of all types of patients.

ARC Medical provides the highest performing devices for filtration and humidification based upon independent, 3rd party testing.

Our manufacturing utilizes state of the art engineering with automated assembly assuring consistently performing devices from one day to the next.

Company Background

ARC Medical is committed to provide Surgery Centers and the Anesthesia Department with innovative and cost saving products, while providing a safe environment for both the patient and the caregiver.

“Always do right. This will gratify some people and astonish the rest.” -- Mark Twain

ARC Medical has five Region Managers and 53 sales reps covering all 50 states

September 2014 8

When was the last time your anesthesia machine was “CLEANED”?

Cleaned Between Patients??

Drager Healthcare Fabius GS Operator’s Manual - page 110

Recommendations for Typical Cleaning and Disinfection After Use

(After each patient)

Breathing bag and hose and Y-piece, Diaphragm, Breathing system,Valve discs, Expiratory port, Absorber and insert, AGS housing,

AGS buffer vol. container, AGS transfer hose, etc

Studies have shown that few if any anesthesia machines are cleaned between patients!

circuitGuard protects the patient from the anesthesia machine and protects the anesthesia machine from the patient.

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But I have a filter on my circuit now?

A question for you…

How do you know your

filter filters?

September 2014

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But I have a filter on my circuit now?

circuitGuard has a story to tell-

why it works!

September 2014

circuitGuard

• On August 10th, 2000, the FDA issued a new ruling on the re-use of single patient devices. “It is not unlawful to reuse single patient devices.”

• Manufacturers, preprocessor and hospitals that choose to reprocess single patient devices must follow GMP – Good Manufacturing Practices.

• Using circuitGuard is not considered to be reprocessing.

circuitGuard

• In July 2009, the FDA issued ARC Medical an additional Indication of Use known as a 510k.

“circuitGuard is used as a hygienic measure alternatively to decontamination of the breathing system and / or breathing gas conveying parts of the

ventilator.”

• Simply stated ……

“Decontamination and subsequent reprocessing of disposable breathing circuits can be avoided by using circuitGuard.”

circuitGuard

• Protects the patient from the machine and the machine from the patient, giving the Surgery Center the choice of re-using the anesthesia breathing circuit of preference.

• Is a highly effective, hydrophobic filter with >99.99+% efficiency – with independent cross-contamination studies showing 100% efficiency against cross-contamination.

• “Unitized Construction” of circuitGuard (the only product with this type of construction) ensures the integrity of the filter media within the housing.

circuitGuard

Independent testing data is available from:

• The 3M Company

• Nelson Labs

• CAMR – the Center for Applied Microbiology and Research located in Porton Down, England

• One of the large independent microbiology laboratories in the world.

• They are also associated with the International Standard Organization (ISO).

“The FilterFlo™ Filter may either be used on the patient side or on the device side of the ventilator / anesthetic device and is used as a hygienic measure alternatively to decontamination of the breathing system and / or breathing gas conveying parts of the ventilator.

The device is intended to protect patients and equipment from contamination.”

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http://www.fda.gov/default.htm

Patient Elbow HCH Media ETCO2

Ridge & Lip Construction Circuit Connection17September 2014

circuitGuard Components

September 2014 18

And circuitGuard…

3M Filtrete Fibers

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3M Filtrete Fibers

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Incorporating a Hydrophobic Barrier

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Unitized Construction

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We have an exclusive advantage in our manufacturing process.

This process is designed so the top and bottom halves of the device will not fit together unless the filter is properly seated, providing 100% inspection for seal and blow by.

Other manufactures depend on glue or ultrasonic welding to seal their halves together.

September 2014


• Pressure testing of other devices only assures that the top and bottom are sealed -- not that their filter media is in it’s correct place.

• Fail points may allow for the passage of gas through the device without filtration.

• Our construction eliminates the possibility of gases bypassing the filter media because circuitGuard has no fail points which ensures filtration efficiencies.

September 2014


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circuitGuard is constructed without fail points -- meaning no glue or ultrasonic

welding is used, only a compression fit.

September 2014

circuitGuard

Our independent cross-contamination study shows 100% efficiency against

cross contamination.

circuitGuard with filter/HME combo circuitGuard filter only combo25September 2014

Better Patient Care

Bottom line, the circuitGuard filter system filters unlike any filter on the market.

September 201426

Prevention of Cross-Contamination Patient to Anesthesia Apparatus to Patient

Using Filters Study

• There is a potential risk of bacterial and viral infection being transmitted through anaesthesia circuits.

• Several studies have shown contamination of parts of anaesthetic equipment with bacteria that colonize the mouth and upper airway.

• Among the recommendations for preventing transmission of infection through anaesthetic circuits are using a bacterial/viral filter for every patient or using disposable circuits.

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Prevention of Cross-ContaminationPatient to Anesthesia Apparatus to Patient

Using Filters Study

Conclusion:• The ideal filter is hydrophobic and does not

increase circuit resistance over the amount specified with the following principles:

1. The filter forms a part of the patient, not the apparatus.

2. Proper placement of the filter is between the patient and the circuits wye piece.

Assoc Physicians India (2001) 49: 454-8

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There are no reported touch contamination incidents between the anesthesia provider

and equipment or patient.

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Lowers Associated Costs

Reduces environmental stress –

An estimated 12 million circuits are disposed of each year.

REDUCE--

RED BAG WASTE !

Value Added Services

ARC has large shipping units per case – less

freight charges.

One dABC box will hold 800

circuitGuards.

ARC currently sells over 450 facilities on a

monthly basis. Since 1990, we have had NO back orders.

Reduces inventory and storage costs

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• Fewer anesthesia circuits are used

• Fewer ETCO2 gas sample lines used

• Eliminates the need for additional filters

• Eliminates the need for additional HMEs

• Reduces red bag disposal costs

• Reduces shipping costs


• Decreases OR turnover times

• Dry, filtered gas sample line protects the ETCO2 monitor from contamination.

• Dry, filtered gas sample lines reduces ETCO2 monitors down time.

• Dry, filtered gas sample lines reduce the replacement of costly water traps and repair costs due to moisture problems.


• ARC has large shipping units for our customers with case quantities of 100 or 300 for larger volume accounts.

• This packaging was established for freight savings considerations.

• Visa and Master Card accepted.

• ARC has not had a back order since 1990.

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Environmental Footprint

• Over 65+ million anesthesia general cases have been performed using circuitGuard…

• Meaning at least 32+ million circuits have been used on multiple patients while using circuitGuard…

• Without a single case of cross-contamination reported to any healthcare monitoring agency in the U.S. or Europe.

September 2014

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Environmental Footprint

Meaning at least 32+ million circuits have been been saved from adding to the environment footprint.

(5,280 feet per mile; 24,901 miles around the earth)

5’ (average length of circuit) times 32,000,000 = 160,000,000’ saved = 30,303 miles

1.22 times around the earth saved

September 2014

Member of Practice GreenhealthGo Green & Reduce Landfill Waste

Manufactured in Sweden

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Questions - Comments

“Directions For Use”(next 5 slides if

requested)

Directions for Use

The circuitGuard is not reusable. It must be changed between patients

• Securely attach the circuitGuard to the patient wye on the breathing circuit.

• Follow the directions for use of the circuitGuard.

• Be sure the elbow is securely attached to the circuitGuard.

• Test the completed breathing circuit assembly prior to use, as directed in breathing circuit directions for use.

• Medicine cannot be delivered through the gas sample port.


• Remove circuitGuard from the flow and use an adapter

• Place circuitGuard back in place after the medicine has been delivered.

• The patient will receive a clean mask and circuitGuard™ at the beginning of each case, but the circuit and bag can be effectively decontaminated in the same manner as other OR equipment surfaces between cases.

• The patient should be monitored continuously while using the circuitGuard system.


• Ventilator alarms should be in use at all times.

• Do not soak, rinse, wash, gas or steam sterilize circuitGuard. Doing so may result in harmful residual gases, dangerously increased resistance, blocked filters or dangerously weaken components.

• The circuit must be discarded if the integrity of the patient-side breathing filter has been breached at any time during use.

• An increase in resistance to flow is one indication that the filter has been breached.


• If there is an increase in resistance, check the circuitGuard to determine if there is an excess of secretions.

• The circuitGuard must not be used with heated humidifiers - active humidification.

• The circuitGuard is not intended for use on patients who produce large amounts of secretions or froth. If a patient produces exudates or blood, which enter the filter, the filter must be removed.


• This accessory device should always be used in accordance with safe hospital policy and sound medical judgment.

• Discard used circuitGuard according to hospital policy.

Questions - Comments

The End

H sk circuit guard powerpoint presentation

Healthcare

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