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   HealthMark   Cleaning Verification Kits           

Artificial Test Soil  

 ProCheck II  

HemoCheck

TOSI

   ΰ     

Protein residue on surfaces    

Blood residue on surfaces   

  Washer Celaning Test    

 

   ATS 2015

  Artificial Test Soil  (ΰ )

   Cleaning Efficacy Indicators for Validation and  routine  monitoring. 

   The Individual kits provide objective test of cleaning methods that  are clearly visible and easy to interpret.

   Standardized and verified methods.

   Artificial Test Soil is a test soil comprised of proteins, carbohydrates and hemoglobin.

   It simulates the worst case soiling of medical devices that have been used on patients.

   ATS is used for both testing and validating cleaning procedures of medical devices and cleaning equipment.

 

  Features & Benefits

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REAL

 

 

 

 

 

 Healthmarks Artificial Test Soil is comprised of the organic contaminants remaining on surgical instruments after clinical use,

 including protein (~23mg/ml), hemoglobin (~8mg/ml) and carbohydrates (~6mg/ml).

 These quantities are reflective of the worst case levels found to remain on instruments after patient use, but before reprocessing.

 The FDA and other international regulatory agencies specify that simulated-use testing should approximate as closely as

 possible the actual soiling the instrument is exposed to during clinical use.  

 ATS meets this requirement with extensive research (available upon request) to support it.

SIMPLE

 

 

 

 Our standardized soil is ready-to-mix. You simply add sterile water.

 Medical device manufacturers must employ an organic challenge.

 ATS is easy to use to determine and document the effectiveness of your cleaning protocol to remove organic materials from

 instruments or equipment.

VERSATILE

 

 

 

 

 

 ATS can be inoculated with endotoxin, microorganisms, other biologics to represent the residuals present on devices after patient use.

 Healthmark ATS can be applied to several applications, such as:

   - Testing the cleaning instructions of medical devices

   - Ensuring reprocessing adequacy and assurance

   - Testing microbial load (bioburden) reduction

   - Training personnel 

STABLE

 

 

 Unlike the current organic challenge manufacturers use, ATS offers less variability between batches.

 ATS is described in various AAMI and ISO standards and FDA Guidance Documents and is well documented in peer-reviewed literature.

 Our ATS provides long shelf life and is easily stored at room temperature until rehydrated for use.

COMPLETE

 

 

 

 To provide a complete testing solution, ATS can be used with other Healthmark Proformance products to validate the

 removal of organic soils based on the manufacturers cleaning protocol.

 Further, Proformance products provide a solution for manufacturers to provide their users with a recommended method

 to verify the cleaning process, as indicated by AAMI standards:

 

 WORKFLOW

 

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Lyopholize soil

in bottle. 

Add sterile with.

hard water (400ppm)

Shake well.

  

Mixed ATS ready for

use. 

Draw out ATS

  

Soil instrument

with ATS. 

 

 

    

     Cleaning Validation

   -    Apply to medical device (If bioburden is to be included, suspend the test organism is ATS2015 to desired concentration).

   -    Allow to dry at room temperature for 30-60 minutes.

   -    Post-cleaning, collect a suitable sample from the medical device.

   -    Use sterile RO or DI water for sample collection.

   -    Assess residual soil parameters (e.g. Protein, hemoglobin, LPS, carbohydrates) or perform viable cell count using accepted protocols.

 

      Disinfectant/Sterilant

   -    Resuspend test organism in ATS2015 to desired concentration.

   -    Apply to medical device or test carrier. Allow to dry at room temperature for 30-60 minutes.

   -    Perform cleaning and/or disinfection/sterilization. (Suitable time exposure)

   -    Post-cleaning, collect a suitable sample from the medical device.

   -    Use sterile reverse osmosis water for sample collection.

   -    Assess residual soil parameters (e.g. protein, hemoglobin, LPS, carbohydrate) or perform viable cell count using accepted protocols.

 

  ǰ  

    

            BACTIQUIKTM

    Healthmark offers BactiQuikTM, a new prepackaged 1 ML vial of microbial suspensions that can be quickly and easily mixed with ATS

    to perform validation testing for disinfection and sterilization.

    The vials contain a pure population of approximately 1x108 CFU/ML of viable Geobacillus stearothermophilus or Bacillus atrophaeus.

    G. stearothermophilus has a known resistance for steam sterilization, and B. atrophaeus for ethylene oxide and dry heat sterilizations.

 

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 Shake BactiQuik

 vial well before

 use.

 Add 9ml sterile

 water to the ATS

 vial

 Dissolve by shaking

 or vortexing.

 Let settle ~10 mins.

 Inoculate the ATS

 vial with 100 l

 BactiQuik.

 Mix well by

 shaking

 or vortexing.

 Transfer on

 device to

 innoculate.

 Let soil sit for 2hours  or overnight to

 simulate worst

 case scenario.

 

         BLOOD TEST SOIL (BTS)

    Quick, easy and affordable Blood Test Soil (BTS) is a simple, simulated blood soil that visually mimics blood on the exterior of patient-used instruments.

    The soil is composed of blood proteins: hemoglobin and albumin, and can easily be used to coat surrogate instruments for cleaning  verification with

    Healthmarks Proformance line of products. It has a long, stable shelf life in its lyophilized form. Just rehydrate with sterile water and it is ready to use.

 

      REFERENCES  

  ATS2015 Product Brochure

Data Sheet

  ATS2015 SDS

Data Sheet

  ATS2015 Instructions

Data Sheet

  ATS2015 Mucin/Bone Instructions

Data Sheet

  BTS  (Blood Test Soil)

Data Sheet

  BTS MSDS

Data Sheet

  Inoculating ATS with Bacteria

Data Sheet

  Simulated-Use Testing Flexible Encoscopes

Data Sheet

  Simulated-Use Testing Detergents

Data Sheet

  Simulated-Use Testing Biopsy Forceps

Data Sheet

  Simulated-Use Testing Laparoscopic Instruments

 Data Sheet

  Worst Case Testing of Sterilization

Data Sheet

 

  Physical and Composition Characteristics of Clinical Secretions Compared with Test Soils used for Validation of Flexible Endoscope Cleaning

Data Sheet

  Characterizing Simulated-Use Test Soils Used in Reprocessing Validations, Basile

Data Sheet

  Validation of ATS as an appropriate test soil to assess cleaning and sterilization efficacy in narrow lumened medical

Data Sheet

  A Survey of Reprocessing Methods, Residual Viable Bioburden and Soil Levels in patient-ready ERCP Duodenoscopes used in Canadian centers

Data Sheet

  Artificial Test Soil: United States Patent 6447990

Data Sheet

  Worst-case soiling levels for patient-used flexible endoscopes before and after cleaning. Alfa MJ, DeGagne P

Data Sheet

  Reprocessing Medical Devices in Health Care Settings:Validation Methods & Labeling FDA Final Guidance

Data Sheet

  Monitoring and Improving the Effectiveness of Cleaning Medical and Surgical Devices: Ban the Biofilm!!

 Data Sheet

  Comparison of Two Culture Methods for Use in Assessing Microbial Contamination of Duodenoscopes

Data Sheet

  Decontamination of non-critical vessels used for patients in ward by small dishwasher

Data Sheet

  A.I.M. Clear Flush® Kerrison Cleaning Validation Test

Data Sheet

  Instrument cassettes : Effective & Safe

Data Sheet

  Validation of adenosine triphosphate to audit manual cleaning of flexible endoscope channels

Data Sheet

  BurButler Block Cleaning and Sterilization Study

Data Sheet