My name is Sevag Demirjian.
I'm the Director of Critical Care Nephrology at the Cleveland Clinic.
The following is a step by step instructional video for making ultra pure continuous dialysis solution.
In the last few months with coronavirus crises there are many medical centers who are running out dialysis supplies.
And unfortunately the companies who make this dialysis solutions have limited solutions in stock.
So we've received many calls from hard hit areas like Chicago, Detroit and New York asking us about the process.
Our experience for many years at Cleveland Clinic it actually started almost 25, 30 years ago with Dr.
Emil Paganini and one of our head techs who still works to this time, Orlandus Robinson who had been the bright minds who put this together way back.
Our Dialysis Manager Tracy Coates and Matthew Layne our CRRT our lead technician will go over the details in the following video.
Thank you and stay safe.
This is the CRRT ultra pure dialysate production SOP.
The solution is prepared using a volumetric single pass dialysis machine Fresenius 2008T and K 2 are used here.
These single patient proportioning dialysis machines use to concentrates; acid and bicarbonate and mixes reverse osmosis product water with the concentrates to create dialysate.
This solution is a replication of the standard dialysate used during intermittent bicarbonate hemodialysis with the correct ionic composition and physiological temperature.
Conductivity is set at a sodium concentration of 140 milli equivalents per liter.
Potassium is two to four milli equivalents per liter.
Bicarbonate it is 30 milli equivalents per liter.
The dialysate feed line is connected to one dialyzer port while the unused dialysate port is capped during the procedure.
The return dialysate line is placed into a container of replenishable water to complete a closed dialysate circuit.
Dialysate is then in flowed at eight hundred milliliters per minute into the dialysate compartment of a high flux, hollow fibre poly cell foam membrane dialyzer Fresenius F 160 here and allowed to transfer by back filtration into the dialyzer blood compartment through sterile lines and splitter from which it is collected into sterile six to eight liter peritoneal dialysis cycler drainage bags.
The non draining side of the dialyzer blood compartment is fed into a sterile line which is clamped during the procedure.
Step 1: Bring the dialysis machine up to conductivity with the desired ionic composition make sure the conductivity limits are plus or minus five of the theoretical conductivity.
If using a portable reverse osmosis system chlorine and chloromine test needs to be done prior to system start up and redone at a maximum of every four hours while in use.
Document readings on dialysate preparation log sheet.
Step 2: Run machine through the standard test by placing the dummy chamber in the air detector.
Step 3: Clamp the F 160 dialyzer into the machine arterial side up.
Mark the date, time and technician initials on the side of the dialyzer Step 4: Fill a jug with wasted dialysate from the drain line of the production machine by placing the drain line in the jug during machine testing.
Step 5: Remove the straight DIN line from packaging.
Step 6: Using aseptic technique remove the cap from the venous blood port of the dialyzer and attach the straight D I N line.
Attach a hemostat to this D I N line.
Uncap and place the distal end of the D I N line in the jug.
Step 7: Remove the other D I N line and splitter from the package.
Step 8: Using aseptic technique uncap and connect the straight D I N line and splitter Step 9: Using aseptic technique remove the cap from the arterial blood port of the dialyzer and attach the straight DIN line with splitter.
Do not remove the caps yet.
Step 10: Placed the dialysis machine into bypass and using aseptic technique remove the dialysate cap and connect the dialysate feed connector blue to the dialysate port closest to the venous bloodline.
Submerge the dialysate return connector, red into a container of replenishable dialysate via the machine drain line to complete a closed dialysate circuit.
Loosen the remaining dialysate cap to vent air do not take off completely.
Step 11: Remove hemostat and then take the machine out of bypass.
Watch the dialysate compartment fill with dialysate.
When the compartment is primed tighten the dialysate port cap on the remaining dialysate port.
Ensure aseptic technique is used the entire time.
Step 12: When all the air bubbles are removed from the flow in the venous D I N line circuit is primed and ready for use.
Step 13: When ready to begin production using aseptic technique attach two four bag Liberty drain bag sets to the two capped ends of the splitter line.
Step 14: Ensure the machine is set to the proper dialysate settings, the proper acid concentrate solution is connected and the machine is operating in the appropriate conductivity range.
Step 15: Then verify conductivity using the Phoenix meter.
Do this by collecting a sample of the fluid coming out of the venous line then sample with the Phoenix meter and ensure the P H and conductivity are in the acceptable range.
Step 16: To start bag production move the hemostat from the arterial D I N line to the venous D I N line.
This will push dialysate into the bags at the flow rate in which the machine is running.
Note the time so as to not overfilled the dialysate bags.
Step 17: Should bag making need to be paused at any time during production simply place the hemostat back on the arterial line.
D I N lines and dialyzer here are only good for 24 hours.
Step 18: Bags should be filled between one hour five minutes and one hour 15 minutes to fill bags to 6.5 liters.
Step 19: When the bags are full place a hemostat on one of the segments on the splitter line.
Then close the clamps on the bags of that line using aseptic technique undo the full bags and then take the cap off the new bags and place it on the full bags.
Then connect the empty bags to the line and undo the hemostat.
Repeat the process for the other line.
Step 20: Cut the lines of the filled bags at the split points on the respective lines.
Then immediately per each bag fold the cut end of the tubing over twice and clamp it off with a plastic tie.
Secure the tie by hand and cut off the extra.
Attach a preprinted label; Green for 4 K, blue for a 3 K, white for a 2 K and red for any special bath.
Write on each label the date, expiration day, five days, production machine number and the initials of the operator.
Step 21: Place the finished bags in the proper storage place.
Make sure to rotate stack to ensure older bags are used first.
Step 22: Spread the newly filled connected bags out so they fill equally.
Step 23: If different potassium bags are needed during production followed this procedure.
Place the hemostat on the arterial line.
Replace the bags currently on the line with new bags.
Put the machine into bypass mode.
Switch the acid concentrate wand to desired acid concentrate.
Place the machine back into normal operation.
Allow to stabilize for a full five minutes to allow the new dialysate flow through the system.
Then verify machine conductivity using the Phoenix meter.
Do this by collecting a sample of the fluid coming out of the venous line then sample with the Phoenix meter and ensure the P H and conductivity are in the proper ranges.
Document on the dialysate preparation log sheet.
Then restart production by switching the hemostat on the arterial line to the venous line.
Step 24: Repeat steps eighteen through twenty two until bag production is finished.
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