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Biofilm Formation in Cobe C3 Dialysis Machines

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Biofilm is a polymer matrix formed by bacteria. Bacteria produce these extra-cellular ... Biofilms invade nephrology' G. Cappelli B. Purif 2000;18:224-230 ... – PowerPoint PPT presentation

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Title: Biofilm Formation in Cobe C3 Dialysis Machines


1
Biofilm Formation in Cobe C3 Dialysis Machines
  • British Renal Symposium
  • 9th June 2001
  • Gareth Murcutt
  • Royal Free Hospital

2
New Chamber
3
January 2001
4
What Is Biofilm?
  • Biofilm is a polymer matrix formed by bacteria
  • Bacteria produce these extra-cellular polymers
    using nutrients from the surrounding fluid
  • These polymers become fixed to the inside of the
    hydraulic circuit

5
Biofilm Formation
6
Biofilm Up-close
7
Effects of Bacterial Contamination
  • Dialyser membranes are permeable to pyrogens
  • Increased cytokine production occurs in patients
    exposed to contaminated dialysate .
  • Both acute and chronic effects on patients are
    well documented

8
Endotoxin Results 1997
9
Endotoxin Results 98/99
10
Machine Audit
  • Only Cobe C3s affected
  • 9/21 (43) showed evidence of biofilm formation.
  • 6/21 (29) were found to have sever biofilm build
    up around the de-aeration chamber.

11
Audit Image 1
12
Audit Image 2
13
Audit Image 3
14
Response to the Audit
15
Removing Biofilm
  • Chemical cleaning
  • Mechanical cleaning
  • Replacement of heavily contaminated parts
  • Bacterial sampling of cleaned machines

16
Investigation
  • Major water contamination
  • Inadequate disinfection routines
  • Inadequate maintenance

17
Investigation
  • Major water contamination
  • Inadequate disinfection routines
  • Inadequate maintenance

18
Water Analysis
The European Pharmacopoeia sets a limit of 100
cfu/ml
19
Investigation
  • Major water contamination
  • Inadequate disinfection routines
  • Inadequate maintenance

20
Review of Disinfection Policy
  • All Cobe machines left in chemical dwell when not
    in use. Excellent compliance by nursing and ATO
    staff.
  • The brand of peracetic acid/hydrogen peroxide
    used had been changed 6 months previously.

21
Cobe C3 Flow Path
22
Residual Peroxide Levels
High Medium Low
23
Investigation
  • Major water contamination
  • Inadequate disinfection routines
  • Inadequate maintenance

24
Service History
  • Planned maintenance was slightly behind schedule.
  • There was no correlation between last service
    dates and the level of contamination.
  • One badly effected machine had been serviced 3
    months before.

25
Investigation
  • Major water contamination
  • Inadequate disinfection routines
  • Inadequate maintenance

26
Re-occurrence?
  • During the next month a follow up check was done
    on all machines
  • Fluid from a previously contaminated machine
    showed 39 cfu/ml and 0.01 EU/ml endotoxin count.
  • There was no re-occurrence it was a problem
    that came and went

27
The Vital Evidence
28
Other Factors
29
The Cat in the Hat Comes Back
30
The Cat in the Hat Comes Back
31
A Tidemark?
32
A Tidemark?
  • Machines hadnt been properly disinfected in the
    early part of their use
  • The biofilm was found at the top of the chamber.
  • Stronger disinfectant had been introduced
  • Once cleaned away it never reappeared.

33
Conclusions
  • The evidence points to a historical build up of
    low-level biofilm.
  • This was dislodged from its location by the more
    aggressive disinfectant
  • It settled at the top of the de-aeration chamber
    when the dwell phase started
  • What was found in January was a tidemark.

34
Recommendations
  • Technical departments must always be vigilant
  • Any changes, even improvements, to disinfection
    routines should be closely monitored

35
References
  • Should ultrapure dialysate be mandatory
  • G Lonnemann NDT(2000)15 supp 1 5559
  • Biofilms invade nephrology G. Cappelli B.
    Purif 200018224-230
  • Water quality in hemodialysis FMC ISBN
    3-933151-39-2
  • Microbiologic purity of dialysate B Canaud B.
    Purif 200018200-214
  • The cat in the hat comes back - Dr Seuss
  • Email gareth.murcutt_at_royalfree.nhs.uk
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