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Thanks for that Stephen, I am also interested where the sampling should occur for washers disinfectors or re-processors providing a final rinse cycle without a dedicated cycle for specimen collection.
Is there a general consensus and would the manufacturers of these devices be the ones to provide this information?
Kindest Regards
Jo Mayer
Infection Control Manager
Phone:08 9346 6479
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________________________________
Good afternoon all,
The below information relates to AS/NZS 4187 Amendment 2, Table 7.3.
AS/NZS 4187 amendment 2, Table 7.3. The title of table 7.3 is “Final Rinse Water – Washer Disinfectors in accordance with ISO 15883-4 for Thermolabile Endoscopes” See first item on the attached PDF.
This table is stating that all final rinse water analysis for Table 7.3 should be in accordance with ISO 15883-4 methods. Typically the Total Viable Counts (TVCs), Pseudomonas Aeruginosa and Endotoxin methods for analysis are standard methods and comply. The issue nationally in Australia is around Atypical Mycobacterium. See second item on the attached PDF for the method 15883-4 refers to for Atypical Mycobacterium.
This method is a change from the Rapid Growing Atypical Mycobacterium method used as per the GENCA guidelines. The ISO 15883-4 method requires Atypical Mycobacterium samples to be incubated for 28-days. Neither a PCR method or the Rapid Growing Atypical Mycobacterium method used as per the GENCA guidelines are acceptable methods to use. It has to be a 28-day culture grow method.
If the laboratory you have used or are planning to use for your Endoscopy Washer Disinfector Gap Analysis final rinse water samples, are not NATA accredited for all of the Table 7.3 test and are not using methods as per ISO 15883-4, you will not compliant with AS/NZS 4187 amendment 2.
To comply with Table 7.3, the final rinse water sample analysis methods, are required to be NATA accredited under a healthcare scope of work and in accordance with ISO 15883-4.
Simply ask the laboratory you are using, what method they use for each of the Table 7.3 suite of tests? A lot of pathology labs are not NATA accredited for the full suite of tests under the healthcare scope of work. Two laboratories I am aware of are currently waiting for NATA to accredit their 28-day culture grow method.
See item three on the attached PDF, AS/NZS 4187 Amendment 2, here it states that laboratories carrying out the analysis should be ISO 17025. ISO 17025 is NATA accredited. It is between the laboratories and NATA to discuss the scope of work this analysis is carried out under. Technically, as these samples are taken from a medical device, the scope of work should be under healthcare.
I hope you find this information helpful. If you have any questions or would like further clarity, please feel free to ask.
Kind regards,
Stephen Adnams
T 1300 680 898
F +61 (0)3 9533 6193
M +61 (0)403 129 444
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Tristel Pty Ltd.
40/328 Reserve Road | Cheltenham | VIC | Australia | 3192
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