Cleaning & Disinfecting
Hemodialysis Machines & Stations
Revised July 2019
Approved by the BC Hemodialysis Committee
the northern way of caring
Table of Contents
1.0 Scope of Guideline......................................................................................................................................................1
2.0 Definitions.....................................................................................................................................................................1
3.0 Recommendations......................................................................................................................................................1
4.0 References.................................................................................................................................................................. 6
5.0 Sponsors......................................................................................................................................................................7
6.0 Appendices.................................................................................................................................................................7
Appendix 1: Checklist for Dialysis Station Routine Disinfection.................................................................... 8
Appendix 2: Checklist for Disinfecting Small Multi-Use Items ....................................................................10
Appendix 3: National/International Standards (for background).................................................................. 11
IMPORTANT INFORMATION
!
This BC Renal guideline/resource was developed to support equitable, best practice care for patients with chronic
kidney disease living in BC. The guideline/resource promotes standardized practices and is intended to assist renal
programs in providing care that is reflected in quality patient outcome measurements. Based on the best information
available at the time of publication, this guideline/resource relies on evidence and avoids opinion-based statements
where possible; refer to www.bcrenalagency.ca for the most recent version.
For information about the use and referencing of BC Renal guidelines/resources, refer to
http://bit.ly/28SFr4n.
BC Renal
Phone: 604-875-7340 Facebook.com/BCRenalAgency
Email: [email protected] @BCRenalAgency
Web: BCRenalAgency.ca Youtube.com/BCRenalAgency
BC Renal • BCRenalAgency.ca July 2019
1.0 Scope of Guideline (i.e., Minncare, Dialox).
This guideline provides a standardized procedure for Descalent with Heat Disinfection:
cleaning and disinfecting hemodialysis (HD): Combination of descalent and heat disinfection.
(a) machines; and (b) stations (routine cleaning &
disinfection only). Machine Types:
Artis = Baxter Gambro Artis
The guideline applies to the provision of hemodialysis Phoenix = Baxter Gambro Phoenix
(HD) and hemodialfiltration (HDF) in: Fresenius = Fresenius 5008 CorDiax
• In-centre HD units (both adult and pediatric units).
• Community dialysis units (CDUs).
3.0 Recommendations
2.0 Definitions Recommendation #1: Each HD unit develops a
process to identify, update and document the
Rinse: frequency of machine disinfection required for a
Flushing the internal hydraulics of the dialysis specific patient based on the frequency tables in
machine with water that meets CSA dialysis recommendation #2.
standards.
Suggested mechanisms to identify the frequency of
Descalent: machine disinfection include:
Removal of calcification / precipitate from within * Nephrologist/Nurse Practitioner writes an order in
the internal hydraulics of the dialysis machine. i.e., the patient record; or
citric acid or acetic acid-based product or removal of * Nephrologist/Nurse Practitioner provides
calcification. education to the HD RNs/renal techs. HD RNs/
renal techs identify the frequency.
Heat Disinfection:
Destruction of pathogenic and other kinds of Suggested location for documentation of Hepatitis
microorganisms by thermal means. B status and frequency of disinfection: HD log (“run”
NOTE: Disinfection is a less lethal process than sheet).
sterilization. It destroys most recognized pathogenic
microorganisms but does not necessarily destroy all Recommendation #2: Disinfect internal pathways,
microbial forms. the external surface of the HD machine and
peripheral equipment and accessories as per
Chemical Disinfection: Tables 1, 2 and 3.
Destruction of pathogenic and other kinds of
microorganisms by chemical means. Chemicals Standards on Tables 1, 2 and 3 are consistent with the
can include: sodium hypochlorite (bleach), sodium Canadian Standards Association (CSA) standards with
carbonate, peracetic acid / hydrogen peroxide blend one exception noted in the footnote.
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Table 1:
Disinfection of Hemodialysis/HDF Machines & Peripheral Equipment & Accessories1
Internal Pathways2 Blood
External Sur- Peripheral
Recomm- HD with on-line Tubing
HD, no on-line priming face of HD Equipment &
endation priming or HDF sub- Transducer
or substitution fluid Machine Accessories
stitution fluid Protectors
Hep B: Disinfect after each patient Disinfect after each If blood tubing Disinfect after If single-use,
Refer to (even if two consecutive runs patient. transducer each patient & discard.
Table 2 of Hep B+ patients). protector(s) before machine
If using on-line priming comes in is moved from a If can’t discard,
Hep B or using machine for contact with a patient area to dedicate to
status HDF, machine must be patient’s blood, another location. single patient
unknown disinfected before each remove HD where possible
use (i.e., if machine used machine from Refer to (e.g., tape,
on previous patient for clinical care recommendation tourniquet).
conventional HD, machine after treatment #2 for a
must be disinfected is completed description Disinfect
before using on-line for biomedical of routine peripheral
priming or using for HDF). inspection disinfection equipment used
If not possible, do not use & disinfect of the dialysis with HD machine
on-line priming (i.e., use machine PRN. station. (e.g., wands, BP
saline) or for HDF. cuff) after each
patient.
All other Disinfect at end of day3; As per above. As per above. As per above. As per above.
patients
AND If not using on-line
priming or using for
Disinfect after patient if blood HDF, disinfect as per
leak occurs outside the blood instructions in column to
pathway (i.e., membrane is the left (“HD, no on-line
compromised & blood enters priming or substitution
the dialysate pathway). fluid”).
If blood was confirmed in the
dialysate effluent, change the
dialyzer, complete the run with
the same patient, perform a
heat or bleach disinfection,
and pull the machine for
Biomedical Engineering to
inspect.
1
The type of disinfection selected (heat, chemical or heat/descalent combination) will depend on the type of machine and the manu-
facturer’s recommendations for disinfection.
2
Refer to Table 3 for specifics.
3
CSA Standards (CSA Z364.2.1-13, 2013) states “the internal path of the HD machine shall be disinfected between each patient use.”
The rationale deviating from this is:
• Disinfecting at the end of the day (vs after each patient) is standard practice for conventional HD in BC and across Canada. There
is no known evidence to suggest an increased risk of infection as a result of not disinfecting between every patient.
• It may not be feasible in some units to disinfect after every patient (lengthens the time between treatments and could mean
fewer treatments per day).
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Table 2:
Hepatitis B Status & Disinfection of Hemodialysis/HDF Machines
Hepatitis B Status Disinfection Recommendation
HBsAg Negative Susceptible Routine
(as per “all other patients” on Table 1)
Anti-HBc Negative
Anti-HBs Negative
HBsAg Negative Immune due to natural Routine
infection (as per “all other patients” on Table 1)
Anti-HBc Positive
Anti-HBs Positive
HBsAg Negative Immune due to hepatitis B Routine
vaccination (as per “all other patients” on Table 1)
Anti-HBc Negative
Anti-HBs Positive
HBsAg Positive Acutely infected Disinfect after each patient
Anti-HBc Positive
IgM anti-HBc Positive
Anti-HBs Negative
HBsAg Positive Chronically infected Disinfect after each patient
Anti-HBc Positive
IgM anti-HBc Negative
Anti-HBs Negative
HBsAg Negative Interpretation unclear: 4 Disinfect after each patient if:
possibilities: • HBV status unknown
Anti-HBc Positive 1. Resolved infection (most • Confirmed HBV+; and
Anti-HBs Negative common) • Anti-HBS <10 IU/L
2. False-positive-anti-HBc,
thus susceptible
3. “Low level” chronic
infection
4. Resolving acute infection
Source: Columns under “Hepatitis B status”: Centers for Disease Control and Prevention (CDC). http://www.cdc.
gov/hepatitis/hbv/pdfs/serologicchartv8.pdf.
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Table 3:
Specifics re: Disinfection of the Internal Pathways
Item Recommendation
Max time between disinfection and use 24 hours
Max storage time between disinfections, 48 hours
regardless of use
Unless contraindicated by the machine manufacturer, place a low
grade disinfectant into the machine if it is expected to sit for more
than 48 hours.
If a machine has sat for more than 48 hours without a low grade
disinfectant in it, perform 2 consecutive disinfections prior to patient
use.
If a machine has sat for more than 7 days (regardless of whether it
has had a low grade disinfectant in it), follow machine manufacturer’s
recommendation for long-term storage. Before patient use, refer to
Tables 1 & 2 for disinfection requirements if machine used for on-line
priming or HDF.
Max frequency for bleach or clean cart A Artis: One clean cart A disinfection per week
disinfection Fresenius: Use bleach a maximum of once/week
All other machines: Refer to manufacturer’s recommendations
Min frequency for bleach or clean cart A All machines: once/week
disinfection
Descaling frequency Artis: Daily
Phoenix: After every treatment
Fresenius: 6 times/wk
Residual check post bleach disinfection If use bleach, do residual check post-bleach disinfection (Artis does
not use bleach)
Residual check post citric disinfection Not required
Incoming hoses If possible, conduct integrated heat disinfection of the incoming
water hose weekly or monthly chemical disinfection of the hoses.
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Recommendation #3: Utilize a standardized Selection of disinfectant:
process for routine disinfection of the dialysis • Each manufacturer provides a list of disinfectants
station, including the exterior surface of the tested and validated for use on specific HD
dialysis machine. machines (refer to Table 4). Disinfectants not on
this list have not been tested.
Refer to Appendix 1 for a checklist of the important • HD units may also request approval from the
steps in Dialysis Station Routine Disinfection. manufacturer to utilize a specific disinfectant on a
specific machine.
Disinfectants: • If a disinfectant is used that has not been
• All disinfectants must have a DIN number from approved by the manufacturer, it could damage
Health Canada and be mixed according to the machine and the warranty (if the machine is
manufacturer’s instructions. under warranty) may no longer apply.
• Use of a low level disinfectant is adequate for
cleaning the external surface of HD machines.
Table 4:
Disinfectants Tested & Approved by the Manufacturer
(list only includes disinfectants registered in Canada)
Manufacturer-approved Disinfectants
Machine DO NOT USE Products
Machine Screen
Artis Ethanol 60% or 70% Ethanol 60% or 70% Products containing
benzene, toluene,
Isopropanol 60% Isopropanol 60% xylene, acetone or similar
solvents.
Sodium hypochlorite 1.5%, except on touch
screen, art & ven pumps, air detector, blood
sensor, hemoscan sensor, arterial & venous
line clamps and automatic pinch valves.
Phoenix Ethanol (90%) Ethanol (90%) As above.
Isopropanol 70% Isopropanol 70%
Sodium hypochlorite (active chlorine from Sodium hypochlorite (active
50,000-60,000ppm; bleach/water ratio chlorine from 50,000-60,000ppm;
1:50). Do not use on the blood pump crank. bleach/water ratio 1:50). Rinse after
appropriate contact time.
Fresenius Virox Accel Prevention wipes Virox Accel Prevention wipes As above.
Cavi Wipes, CaviWipes XL Cavi Wipes
Sani-Cloth Plus Sani-Cloth Plus
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Recommendation #4: In the event of a large blood Recommendation #5: Utilize a standardized
spill, utilize a standardized process for disinfecting process for disinfecting small multiple-use items.
the internal pathways of the HD machine and the
dialysis station, including the exterior surface of Refer to Appendix 2 for a checklist of steps for
the dialysis machine. disinfectant solution preparation and disinfection of
small multi-use items.
Notes:
• All hemodialysis machine-associated blood spills
will be thoroughly cleaned and disinfected at the 4.0 References
time of the spill.
• In the event of a hemodialysis machine-related CSA Standards (CSA, 2013)
large blood spill, where components of the
machine may need to be taken apart for cleaning CSA standard CAN/CSA-Z23500:12 (heat disinfection)
and disinfecting: CSA standard CAN/CSA-Z23500:12 (chemical
−− Take the machine out of service. disinfection)
−− Clean the outside surfaces and perform CSA standard CAN/CSA-Z23500:12 (descalent with
internal disinfection per Appendix 1. NOTE: heat disinfection)
Visible contaminant on any surfaces
should be wiped twice using an approved International Standards
disinfectant wipe material.
−− Submit a work request to Biomedical KDIGO, 2018. HCV infections. https://kdigo.org/
Engineering. caring-for-patients-with-hep-c/ (guideline 3; Note:
−− Print the request and tape it to the machine. there was no change from 2008 guideline)
The request must clearly indicate there was a
blood spill. European Renal Best Practice Guidelines, 2009.
• If the blood spill was caused by suspected failure HCV infections (response to the 2008 KDIGO
of bloodline or dialyzer component, and the renal guideline)
program / unit has appropriate procedures and http://ndt.oxfordjournals.org/content/
facilities in place to store contaminated supplies, early/2009/02/08/ndt.gfn608.short
the supsplies should be saved for investigation
(lot number must be reported). National Kidney Foundation (KDOQI), 2020. HCV
• If blood spill occurred during the patient management and hemodialysis. https://www.kidney.
treatment and/or before blood was returned to org/professionals/KDOQI/12-10-1601
the patient, a PSLS report must be completed by
the nurse. UK Renal Association, 2019; HCV, HIV and HBV
• If blood spill occurred after the patient treatment infections. https://bmcnephrol.biomedcentral.com/
was completed and blood returned to the patient, articles/10.1186/s12882-019-1529-1 (Guidelines 2.1 -
a PSLS report must be completed by either the 2.4)
nurse or the renal technician/care aide.
BC Renal • BCRenalAgency.ca July 2019
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Canadian Society of Nephrology (CSN), 2005. HCV, Developed by two working groups of renal care
HBV and other blood-borne pathogens. https://www. providers from across BC (biomedical and renal
csnscn.ca/images/Docs_Misc/VAWG/The_Prevention_ educators groups), the guideline was approved
of_Transmission_of_Blood-_Borne_Pathogens_in_ by the BCR Hemodialysis Committee and the BCR
Hemodialysis_Patients.pdf (Recommendations 3,1 Medical Advisory Committee. It has been adopted by
- 3.4) BCR as a provincial guideline.
Other This guideline is based on scientific evidence
available at the time of the effective date; refer to
1. Centers for Disease Control and Prevention www.bcrenalagency.ca for most recent version.
National Center for Emerging and Zoonotic
Infectious Diseases. Checklist: Dialysis Station
Routine Disinfection.http://www.cdc.gov/dialysis/ 6.0 Appendices
PDFs/collaborative/Env_checklist-508.pdf.
Appendix 1: Checklist for Dialysis Station Routine
2. Centers for Disease Control and Prevention. Disinfection
Interpretation of Hepatitis B Serologic Test
Results. http://www.cdc.gov/hepatitis/hbv/pdfs/ Appendix 2: Checklist for Disinfecting Small Multi-Use
serologicchartv8.pdf. Items
3. Fresenius “Cleaning the 5008 CorDiax: General Appendix 3: Recommendations from National/
External Cleaning Instructions.” International Standards
Refer to Appendix 2 for a summary of the standards
from various professional associations.
5.0 Sponsors
This provincial guideline was developed to support
improvements in the quality of hemodialysis care
delivered to patients with chronic kidney disease
in BC. Based on the best information available at
the time it was published, the guideline relies on
evidence and avoids opinion-based statements
where possible. When used in conjunction with
pertinent clinical data, it is a tool health authorities
and health professionals can use to develop local
guidelines.
BC Renal • BCRenalAgency.ca July 2019
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Appendix 1: Checklist for Dialysis Station Routine Disinfection
Preparation for Disinfection of the Dialysis Station
☐☐ Gather necessary supplies including:
• Personal protective equipment (PPE): eye goggles, gown and clean gloves.
• Properly diluted hospital disinfectant (with a DIN number from Health Canada) and wipes/cloths
(separate wipe(s)/cloth(s) per machine).
• Biohazard disposal container(s)
☐☐ Perform hand hygiene.*
☐☐ Don gown, eye goggles and clean gloves.
☐☐ Disconnect and takedown used blood tubing and dialyzer from the dialysis machine.
☐☐ Discard tubing and dialyzers in a leak-proof container (container is brought to the dialyzer station or is
placed as near to the station as is practical as part of the supply set-up in step 1).
☐☐ Check that there is no visible soil or blood on surfaces.
☐☐ If drain bag is still hanging, remove bag and empty in the soiled utility area.
☐☐ Ensure that the patient has left the dialysis station.
• Patients should not be removed from the station until they have completed treatment and are
clinically stable.
• If a patient cannot be moved safely, delay routine disinfection of the dialysis station.
• If patients are moved to a separate seating area prior to removing cannulation needles or while trying
to achieve hemostasis, disinfect the chairs and armrests in those areas in between patients.
☐☐ Discard all single-use supplies. Move any reusable supplies (e.g., clamps) to an area where they will be
cleaned and disinfected before being stored or returned to a dialysis station. This may occur before or
after the patient has left the station.
☐☐ Remove gloves and perform hand hygiene.
Routine Disinfection of the Dialysis Station
☐☐ Perform hand hygiene* and don clean gloves.
☐☐ Using a wiping motion (with friction), disinfect all surfaces in the dialysis station in contact with the patient
and/or staff. e.g., dialysis chair or bed; tray tables; blood pressure cuffs; countertops; keyboard, etc.
☐☐ Clean dialysis machine from top to bottom.
• If visible contaminant on the machine, wipe off using an absorbent material.
• Clean the machine using wipes/cloths with a disinfectant that is acceptable to the HD machine
manufacturer and the HA renal program/infection control.
• Remove excess fluid from the wipes/cloth(s) prior to using to clean machine.
*Perform hand hygiene at the beginning of this process, at the end and at any point there is a contamination.
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• Clean the monitor.
−− If available on machine, activate the wipe screen option (pauses the screen).
−− If any residue remains after cleaning, wipe down screen with a clean, dry cloth.
• Clean the top of the machine.
• If the machine has a door(s), clean the front first, then the insides of the doors.
• Clean all components of the main interface (screen) and the back of the machine* unless
recommended otherwise by the manufacturer. e.g., sensors and optical detectors.
• Clean exposed surfaces of dialysate, concentrate, and bicarb connectors.
• Clean each side of machine.
• Clean the area between the main interface (screen) and brakes, including the shelf.
• Clean the brakes.
* Frequency of cleaning back of machine is as per HA protocol.
☐☐ Ensure surfaces are visibly wet with disinfectant but not dripping. Allow surfaces to air-dry. Air-drying is
recommended to allow for sufficient contact time with the disinfectant.
☐☐ Remove gloves, eye goggles and gown.
☐☐ Perform hand hygiene.
Special Note on Cleaning the Fresenius 5008 CorDiax Hemodialysis Machine
AVOID wiping the following areas (clean the plastic but NOT the sensor/connector):
☐☐ Venous pressure luer connector (carefully wipe around and do not allow wipe to cover the connector).
☐☐ Single needle pressure luer connector (carefully wipe around and do not allow wipe to cover the
connector).
☐☐ Blood/air detector.
☐☐ Temperature sensors.
☐☐ Blood volume monitor.
Do not bring patient or clean supplies to station until these steps have been completed.
References:
1. Checklist: Dialysis Station Routine Disinfection. Centers for Disease Control and Prevention National
Center for Emerging and Zoonotic Infectious Diseases. www.cdc.gov/dialysis checklist.
2. Fresenius “Cleaning the 5008 CorDiax: General External Cleaning Instructions.”
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Appendix 2: Checklist for Disinfecting Small Multi-Use Items
Preparation for Disinfection of the Dialysis Station
Applies to facilities that do not use external medical device reprocessing (MDR) providers.
☐☐ Gather necessary supplies including:
• Personal protective equipment (PPE): eye goggles, gown and clean gloves.
• Disinfectant wipes.
• Disinfectant concentrate (accelerated hydrogen peroxide).
• Measuring cup.
• 1-4L water (depending on number of items).
• 1-4L container (clean).
• Drying rack or clean absorbent cloths.
☐☐ The schematic process of disinfection is shown on the diagram below:
☐☐ Perform hand hygiene.*
☐☐ Don gown, eye goggles and clean gloves.
☐☐ Discard solutions if containers are not empty.
☐☐ Prepare fresh solutions daily.
☐☐ Fill clean container with 1-4L of water.
☐☐ Add 25 mL of accelerated hydrogen peroxide per 1L of water (100mL of concentrate for 4L of water).
☐☐ Collect dirty small items in soiled utility room until ready to disinfect.
☐☐ Wipe any soiled items with approved disinfectant wipes.
☐☐ Soak small items in solution for 5 minutes.
☐☐ Allow small items to air dry in drying rack or on clean absorbent cloth.
☐☐ Discard solutions at end of day.
*Perform hand hygiene at the beginning of this process, at the end and at any point there is a contamination.
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Appendix 3: National/International Standards (for background)
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