Acid Concentrate in Dialysis: Role,Production,Testing Record Keeping

Acid Concentrate in Dialysis: Role,Production,Testing Record Keeping

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You have never sat through an entire movie without having at least one device on your body beep or buzz.. 2. You might be a technician if
Acid Concentrate in Dialysis: Role,Production,Testing Recor...

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2. You have never sat through an entire movie without having at least one device on your body beep or buzz. 2 You might be a technician if?

3. The main function of dialysate is to remove uremic waste material from the blood and to keep useful material from leaving the blood. Electrolytes and water are materials included in dialysate so that their level in the blood can be controlled. Fluid and solutes must be in intravascular (inside the blood vessels) spaces to be removed by dialysis. 3 History

4. The second purpose of hemodialysis is the restoration of normal ion concentrations. As such, the levels of individual ions in the dialysate can be set to their desired plasma levels. Manufacturing of Acid Concentrate for Hemodialysis is regulated by both AAMI and FDA (21CFR 876.5820) 4 History

5. The components of dialysate?or the dialysis 'bath? include: First sodium chloride calcium chloride potassium chloride magnesium chloride acetic acid Dextrose or glucose is generally added Second sodium bicarbonate or sodium acetate (original formula) Third Reverse osmosis water- AAMI standard quality water 5 Composition

6. Major electrolyte of the body?s interstitial (between the cells) fluid and main constituent of acid concentrate. Within the body, sodium (creates osmotic gradient) causes fluid to move across cell membranes between the intra-cellular and interstitial spaces including intravascular spaces and regulates water and fluid balance. Normal sodium concentration in the blood is: 135-145 mEq/L- Concentration in acid concentrate 138-145 mEq/L Goal during dialysis is to achieve normal body sodium levels 6 Sodium Chloride ? NaCl

7. Hyponatremia: This condition causes body water to move out of the patient?s interstitial spaces and into the cells. Loss of water can lead to hypotension, muscle cramping, and hemolysis Too little sodium in dialysate can exacerbate the dialysis disequilibrium syndrome and can affect brain function. Symptoms: headaches, nausea, vomiting, tremors and seizures. Hypernatremia: Excess Na in the blood causes water to move out of the cells and into the interstitial space and can cause tissue swelling (edema). Symptoms: sensation of thirst. In severe cases: headaches, high blood pressure or crenation (shriveling of red blood cells). 7 Complications Related to Sodium

8. Dialysis helps lower serum Potassium level Majority of Potassium is found in the intracellular fluid compartment Potassium level in Blood: 3.5-5.0 mEql/L Potassium level in Acid concentrate 0-4 mEq/L The higher the level of Potassium in the blood, the lower it will be in the dialysate. 8 Potassium ? K

9. Hypokalemia: Interferes with normal heart rhythms causing arrhythmia or even cardiac arrest. Other effects: fatigue, muscle weakness, difficulty walking. Hypercalemia: Can cause muscle weakness including the heart muscle. If potassium levels are too high, the heart will beat irregularly or can even stop. Involved in nerve and muscle function, contraction of the heart muscle Regulates electrical conduction in muscle cells and nerves Potassium ? K

10. Calcium Benefits: Builds bones, promotes normal muscle contractions and transmission of nerve impulse, regulates blood clotting, regulates enzymes, regulates hormone action. Calcium levels in plasma :2.19-2.54mmol Calcium levels in dialysate: 1.25-1.75 mmol/L Hypocalcemia: Symptoms: numbness, muscle spasms, seizures. Can also trigger too much parathyroid hormone and cause bone disease. Affects gastrointestinal tract causing anorexia, nausea, vomiting, but also affects the central nervous system causing confusion, irritability and potentially causing a coma Calcium ? Ca

11. Magnesium assists in the metabolism of proteins, carbohydrates and nucleic acid. Blood levels : 0.6-1.0mmol/L Acid concentrate levels:0-1.5 mmol/l Hypermagnesemia: Caused by medications. Can cause impaired nerve transmission, hypotension, respiratory depression and sleepiness. The treatment is normally dialysis. 11 Magnesium ? Mg

12. K, CA ? available in dry powder form. Can be adjusted by physician?s order. When you use them, add acid to the powder bag to moisten it and make it into a slurry. Add the slurry to the gallon of concentrate and mix. If you spike: label jug with patient?s name, indicate K, Ca amount used, the original lot # of the bath used, record date and time. 12 Additives

13. Bicarbonate dialysis is today?s treatment of choice. Benefits over acetate dialysis include: a lower incidence of hypotension and hypoxemia improved left ventricular stroke work. Dialysate as it is used today was patented by Itoh Nobuo of Nikkiso Japan in 1990. 13 Composition Continued?

14. Body?s main source of cellular energy It is needed by the brain, nervous system, erythrocyte function. Dialysate glucose helps decrease metabolic acid production from protein and fat breakdown, therefore helps maintain blood pH. Dextrose concentration can vary between 0-250 mg/dl. Added to prevent loss of serum glucose. Reduces catabolism (muscle breakdown). Important for diabetic patients or malnourished patients. Dialysate that contains glucose has an osmotic (water-pulling) effect that aids ultrafiltration. 14 Dextrose or Glucose

15. Reduces pH Low pH prevents bacterial growth Balances high pH of Sodium Bicarbonate Acetic Acid

16. Helps regulate acid-base balance (pH) final ph about 7.3 Reduces risk of forming calcium carbonate precipitate which can clog the dialysis machines Normal kidneys regenerate and keep bicarbonate. Patients with Kidney failure cannot. Too much bicarbonate = metabolic alkalosis Too little bicarbonate=metabolic acidosis Sodium bicarbonate used has to be Hemodialysis grade otherwise can be contaminated with Iron or Aluminum Sodium Bicarbonate is mixed with the acid part only at the last minute to prevent precipitate formation. Sodium Bicarbonate

17. Citrate dialysate. Multicenter study to investigate the effect of citric acid on heparin requirements Concentrate with iron-ferric pyrophospate (dissolved into sodium bicarbonate). Concentrate with amino acids. 17 Different Additives in the Concentrate

18. Follow industry standards set by AAMI and FDA. Clearly identify products. Use AAMI set symbols for each proportioning Label acid concentrate storage tanks. Develop a monitoring and control system to prevent errors. 18 Manufacturer?s Responsibility

19. As part of conditions of coverage, staff training for assigned tasks in water and dialysate. Restrict access to storage areas and allow only authorized and specially trained personnel. Follow manufacturer?s specification for the mixing of concentrate: time, water level, and testing. Clean and disinfect mixing tank and mixing equipment and jugs if used. Label all jugs used. Store and dispense acid concentrate as if it were a drug. Check conductivity, pH of product prior to reaching patient. Double check and record concentrate formulas. Assess that the equipment used is compatible with acid concentrate. Use only Stainless steel 316?s or plastic components 19 Customer?s Responsibility

20. 20

21. Inspection by receiving: visual inspection, counted, damage recorded, accounting notified. Quality Control checks CofA of each component. Quality Control releases to production. 21 Raw Material

22. Paperwork generated. Raw materials weighted. Weights checked by Quality Control. Batch assembled. Labels generated. Pump-off. 22 Batch Assembly

23. 23 In Process Testing

24. The most common microbial contaminants in dialysis fluids are: water bacteria gram-negative bacteria nontuberculous mycobacteria Endotoxin /LAL test AAMI RD 61 Product testing: Specific Gravity pH conductivity final concentrations of each component ANSI/AAMI RD 62:2001 24 Testing RO Water

25. Batch moved to quarantine area. Three samples taken from each batch for final release testing. Test results received. Test results reviewed by QC and management rep. Batch released. Labels generated. Batch moved to warehouse. 25 Batch

26. 26 Storage Guidelines

27. Store at or below room temperature: 56? ? 86?F 13? ? 30?C Do not freeze. Short term exposure to warm conditions (104?F or 40?C) will not harm concentrate. Storage of sodium bicarbonate: Do not store in heat or in direct sun. It will decompose. Once opened, sodium bicarbonate must be used within 24 hours. Do not reuse open jugs, do not transfer from one jug to an other. 27 Storage Conditions

28. The FDA does not mandate expiration dates for concentrate. Stability studies have proven that concentrate maintains its composition for 5 years from the manufacturing date with very little variation in the Ca++ ion concentration. Dry powder concentrate can keep indefinitely. Liquid bicarbonate is given an expiration date because of the possibility of bacterial growth. 28 Expiration Dates

29. Color coded to distinguish between formulations. AAMI standard symbol used. Each drum has three labels. Top labels are for put on when pumped off. Initialed, drum number. All labels are issued only for that batch. Exact label number accountability. 29 Labels

30. 30 Labels

31. Customer places order. Order/invoice generated. Order is picked. QA checks, writes lot # on invoice and signs for release. Order is loaded in truck and checked again. Paperwork is put in truck for driver. 31 Orders

32. 32 Staging Area

33. 33 Loading

34. Batch records Lot numbers Test results Sales records 34 Record Keeping - US

35. If you pump concentrate into a tank, label the tank. Keep copies of packing slips and/or a written log of the received product. When you spike, label the product. Record the spike in a long with the date, the initial product, and tests, if any. Label with patients name. Do not keep any unlabeled jugs. 35 Record Keeping - YOU

36. Quality and safety are our main concerns. Qualified and knowledgeable staff monitor the manufacturing process, perform preliminary and final in-house testing and maintain accurate records. Test results reviewed by at least three people. In addition to in-house testing we also have testing performed by an outside laboratory. Follow strict GMP?s 36 Quality Control & Quality Assurance

37. Water testing: RO, colony count, endotoxins. Acid Concentrate testing: specific gravity, conductivity, pH and ion concentration. Sodium Bicarbonate: pH, specific gravity, CO2 content. Electrolytes identified on label must be present within?5% or 0.1 mEq/L with the exception of Na (2%) 37 Testing - US

38. Conductivity in line or with meter. pH strips: easy to use, no calibration, no maintenance. Specific gravity: range provided, hydrometer very easy to use. Lab analysis- per your procedures 38 Testing - YOU

39. Wrong product delivered Wrong product pumped off Conductivity off Solution is not clear 39 What Can Go Wrong?

40. Check pH and conductivity prior to use. If pH or conductivity do not fall within the range, do not use the product. pH of dialysate: 6.5 - 7.5 Conductivity: check chart Check to make sure solution is clear. Check expiration date on liquid bicarbonate. 40 Detecting Problems

41. Patient?s serum K and/or Ca may be too low or too high resulting in patient?s exhibiting signs of hypo- or hyper- kalemia or calcemia. Interchange acid concentrate of different proportionings Use one component of a different proportioning can cause dialysis disequilibrium syndrome 41 Wrong Concentrate

42. Four surgeons were taking a coffee break and were discussing their work: The first said, "I think accountants are the easiest to operate on. You open them up and everything inside is numbered.? The second said, "I think librarians are the easiest to operate on. You open them up and everything inside is in alphabetical order." The third said, "I like to operate on electricians. You open them up and everything inside is color-coded." 42 A technician?

43. The fourth surgeon said, "I like technicians... they always understand when you have a few parts left over at the end..." 43

44. Phone: (800) 838-7077 Fax: (818) 838-7007 E-mail: Website: 44 Contact Us

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