Thursday, April 22, 2021

All You Need About Dialysis Machine Preventive Maintenance

How Kidney Failure Occurs? 


There are many reasons for a kidney to stop functioning. Once the kidneys are unable to filter wastes and fluids a fast action needs to take place, as body wastes can quickly accumulate to dangerous levels. There are many reasons for kidney failure the most common are blockages in the urethra, direct damage to the kidney, or due to slow blood flow to the kidney. 

Patients with kidney failure need to alter their diets dramatically, as foods rich in phosphorous are totally prohibited to them as it will accumulate in their bloodstream and then affect their bones as it binds to calcium in the bones. There has been a growing market for foods that are custom made for people on dialysis as it improves their quality of life by keeping renal failure patients away from harmful nutrients to them.  

Why the Dialysis machine is needed?


A dialysis machine is a vital machine that is used for patients with renal failure. Patients with total kidney failure mostly considered end-stage patients or even partial kidney failure might need to apply for several dialysis sessions. Typically 3 sessions per week are needed for renal failure patients to dispose of extra water and other wastes.


Dialysis Patients


Usually, end-stage kidney patients are eligible to get a kidney transplant. However, the numbers of patients that are in need of a kidney transplant are far more than the donors available thus leading to a prolonged need to have dialysis sessions. A patient with end-stage kidney failure is deemed to have 3 dialysis sessions per week for the rest of his life.

In 2017 there were 500,000 people who needed dialysis and more than 200,000 who were living with a kidney transplant, wherein 2019 alone there are 100,000 Americans were waiting for a kidney transplant (1).  

Dialysis in Children

There are many factors that can lead to kidney failure in children when the kidney is not functioning properly then the child will need to have his blood filtered. Usually, the same techniques are used for blood filtration in children. 

Although more care and caution needs to be taken as children are not cooperative to treatment like adults. Many facilities do not provide care for children dialysis as they are not equipped with the needed care for children. 

Searching for hospitals and centers that can treat children in need of dialysis is an important step to have the child accepted to be treated with dialysis. 


Dialysis Machine


Once a patient reaches end-stage dialysis, he will need to have a dialysis machine. Where the dialysis machine takes blood and is filtered through the dialyzer filter and then is returned back to the patient's body. A patient usually needs 2-3 sessions per week and one session will last for around 4 hours.

Can Dialysis Machines replace ALL Kidney Functions? 


Unfortunately, a dialysis machine cannot replace all kidney functions, and will only work on filtering wastes and excessive water. There are various other functions that are currently irreplaceable by having dialysis and this why the lifespan of renal patients is usually lower than usual.  

How a Dialysis Machine Works? 

Dialysis Machine
Diagram Showing Main parts of the Dialysis Machine 

One of the primary jobs of the kidney is to filter wastes or toxins and remove excess water from the blood. So mainly a dialysis machine will try to do just that by having blood taken outside the body and filtered through a filter then returned back to the body. 

Blood passes through a filter or rather a porous membrane that is called the dialyzer or more easily the "Artificial Kidney" where there is a dialysate solution that will help remove unwanted wastes from the blood. There are many alarms and sensors that monitor various things while the dialysis machine is working. Most of the time new dialysis patients will be afraid of the alarms that are beeping. But these alarms are there for their safety as they indicate various things to the operators. 

Dialysis Machines Types

What is the Difference between Hemodialysis and Peritoneal Dialysis?

These are mainly the 2 types of dialysis:

Hemodialysis which uses a dialysis machine like the one shown above to filter the patient's blood  

Peritoneal Dialysis is a dialysate fluid that is injected into the patient's abdominal cavity, so actually, it is another machine type. We will be explaining more about this type of dialysis later.   

Each of the two main types of dialysis has its advantages and disadvantages. But since we will mainly be looking at the machine in this article we will only focus on the hemodialysis part.

How Do Dialysis Machines Filter Blood?


A Hemodialysis machine will withdraw blood from your body this is usually done by placing a fistula surgically that will be arteriovenous where it will enable blood to be withdrawn from the body and then returned back after it is filtered.

The blood will filter though the dialyzer also called the artificial kidney. The Dialyzer is mainly formed of millions of pores where waste materials are drawn from blood to the dialysate through these pores. This process takes several hours to filter all the blood. Typically it takes 4 hours and usually, the sessions are 3 times per week.   

Peritoneal Dialysis, on the other hand, works in a totally different way, where a dialysate solution is injected into the patient belly near the peritoneal membrane. The solution is usually injected daily and removed after several hours usually 8-10 hours and will also filter wastes and restore body electrolytes back to normal ranges.  

Each of these two filtration techniques has its pros and cons and usually, the doctor will make the patient aware of the options available. As not all patients are eligible to do Peritoneal Dialysis as it has many counter-indications and is usually not a preferred method for the doctors due to the high complication rate of such technique. 

New Renal Failure Treatments


There are many promising new treatments for renal failure, although most of them are drug-related treatments, so we will not go through them in detail in this article. Although if you are interested we will provide more information in the references section. 

These treatments are: 

Complement Inhibition

JAK/STAT Inhibition

Monocyte Chemoattractant Protein-1/Chemokine Receptor 2 Inhibition (Paper)

New Dialysis Treatment


Quanta Home Dialysis Device


This device is designed to provide a convenient hemodialysis experience at the comfort of the patient's home. The Quanta device is designed to be user friendly and requires minimal training to use and operate. (Quanta)

Quanta Device

The Implantable Bio-artificial kidney


An implantable artificial kidney is considered a dream for those who have renal failure. Yet this dream might soon come true! A bioartificial kidney might become soon a reality thanks to the efforts of many engineers doctors and health workers. (Bio-Kidney)

Bio-artificial Kidney

There has been good progress in this regards and in November 2019 a small bioreactor with human kidney cells was implanted in a pig and showed no significant complications (Bio-kidney-2019)

These promising findings might be the start of a revolution for patients with End-stage renal disease.
   

AWAK Technologies Portable Peritoneal Device


This is a promising company that is aiming to make peritoneal dialysis a hassle-free procedure by providing a portable device that consumes just 2 liters of peritoneal solution daily and in essence, the device can be working anywhere and everywhere.

AWAK Device

 FDA has granted AWAK a breakthrough device. Yet we need to know more about this new technology and its robustness in providing good quality of life to the patient with wase of use. (AWAK)

Home Dialysis

Next Stage Dialysis Machine

NxStage system
The NxStage System One is the first and only truly portable hemodialysis system cleared for home use in the United States, including solo hemodialysis during waking hours, and nocturnal hemodialysis, while both the patient and care partner sleep. It was specifically designed for patients to use in their homes and is small enough to allow patients to travel and bring their treatment supplies with them.

Traveling with Dialysis

Although it is a challenge, however, it is not impossible to do. It needs diligent planning before making the trip. By either booking to having dialysis sessions in the destination place near the hotel. Shipping the supplied needed before arriving if you are doing peritoneal dialysis or taking the home dialysis device with you to your destination trip. Also, extra precautions are needed to be taken care of if there is any plane delays or trip deviations for any reason. (Kidney travel) 

Dialysis on Cruise Ships


Some cruise ships have already been equipped with hemodialysis machines that will be similar to those that are on the center in your homeland. 

If you are on Peritoneal Dialysis then this means you need to make sure you have enough dialysate solution for the trip. This in many cases can be coordinated with the cruise company. 

The most important thing is to let your caregiver know about your travel plans well before you make any reservations as she can offer advice related to the needed precautions and medications etc. 

If you have a home dialysis device then this might be also a good option to have your device cruising with you. While making sure you have enough supply of solutions and medications. {Dialyis cruise}
 

How Much Do Dialysis Cost?


Dialysis is costly, whatever option you are going to use hemodialysis, peritoneal dialysis, or home dialysis all come at a high price tag. Part of the treatment is covered by insurance companies. But you need to keep in mind all the additional costs that are required. 

If you decide to do home dialysis then you will need a caregiver to be around you. Also, you will need to buy the home dialysis machine and its supplies. In addition to extra costs including providing water and drainage piping, electrical lines to the machines. In addition to repair costs that might be needed occasionally.

In general, dialysis is costly so you need to plan and be financially aware of the options that you have. For more information, you might want to refer to our references related to dialysis costs. (Dialysis cost)

Used or Refurbished Dialysis Machines 


If you are planning to cut costs that should always not be at the cost of safety. You might want to buy a used dialysis machine that is in good condition rather than buying a new one. But always make sure to use the consumables once, reusing any of these one time use supplied might lead to severe consequences either by having infections or line blockages. 

In case you are planning to get a refurbished machine, make sure there is a warranty on the machine for at least 6 months. Or have an accompanied with a service contract. Similar to buying used machines, it is better to buy a higher quality refurbished dialysis machine than buying a lower-priced but lower quality machine.

Additional Costs to Dialysis Machine 


Water supply is and water quality will also be an important factor, Dialysis center has large Reverse Osmosis Plants to make sure that water quality is in conformation with manufacturer recommendation. Usually, Hemodialysis machines will need 120 liters per session at a rate of 3 sessions per week.

Having low-quality water not only affects the safety of the dialysis session but also will lead to many problems emerging in the dialysis machine water lines and will thus increase maintenance costs significantly. 

The electricity bill is also expected to increase, in addition to needing a storage area for the supplied needed. If a caregiver is needed than usually they will have a fixed rate per session and that rate varies from where you are? 

It is a good call to buy a high-quality dialysis machine as it will be more robust and can have fewer defects and maintenance needs than lower-priced lower quality machines.
 

Dialysis Machine Rental or Lease

Some dialysis centers provide the services of bringing the portable dialysis device to your home with the machine operator and the supplies. Although this comes at a premium price and is only available in select areas or centers. Some Davita centers provide such a service.

Another option is to lease a dialysis machine, this is in many cases a followed practice by hospitals or dialysis centers. It is almost like leasing a car or a house. Although the total paid capital is more, however, hospitals and dialysis centers don't have to freeze a big portion of their capital on paying for the machines.

Dialysis Machines Manufacturers and Top Brands


Baxter

A US-based company that has been in the medical field for more than 85 years. One of the major manufacturers of various products related to renal failure. With annual sales of around 10 Billion in 2017. Gambro, a prominent dialysis machine manufacturer, has merged with Baxter in September 2013 (BG).

Fresenius Medical care

Fresenius Medical Care is the world-leading provider of dialysis products with 16.55 Billion Euros in revenues in 2018 (AN). They also have around 4000 dialysis centers worldwide serving 333 Thousand patients globally. They have achieved a dialysis market share of 38% in the US market (AN19). In February 2019, Fresenius Medical Care, the world's largest provider of dialysis products and services, completed the acquisition of NxStage Medical, Inc. NxStage is a U.S based maker of in-home dialysis devices. 

B.Braun Melsungen

A Germany based company that in 2018, the company had revenue of 6.908 Billion Euros. However, it is a diversified medical company with more than 5000 different medical products. Producing one of the best dialysis machines and the most reliable ones.  

Asahi Kasei Corporation

A Japan-based company, with 18.5 Billion UD in revenues in 2014, however only 7.5% of that is from healthcare products. Yet they are mainly focused on producing top quality dialyzers, with only one dialysis machine under their belt, the notorious easy to maintain MDS-101

DaVita Inc.

Davita Inc provides kidney dialysis services through a network of 2,753 outpatient dialysis centers in the United States, serving 206,900 patients, and 259 outpatient dialysis centers in 10 other countries serving 28,700 patients. The company primarily treats end-stage renal disease (ESRD), which requires patients to undergo dialysis 3 times per week for the rest of their lives. The company has a 37% market share in the U.S. dialysis market. It is organized in Delaware and based in Denver. (Davita)

Dialysis Machine Disinfection

There are three main pillars to dialysis machine disinfection:

  1. Removal of Calcium Carbonate
  2. Disinfect
  3. Detergency
All are equally important as calcium accumulation can defect some parts inside the dialysis machine. Disinfection also ensures the elimination of infections and diseases and cleaning is good to keep the overall shape of the machine.

There are many techniques to apply these three important procedures we would like to recommend to see on the references a paper approved by BCPRA Hemodialysis Committee on disinfecting a hemodialysis machine {disinfecting}

Some manufacturers recommend their own procedure of disinfection and cleaning. It is best practice to follow manufacturer instructions on cleaning and disinfecting. {fresniusdisinfection}{BBraun}

Dialysis Waste


Peritoneal Dialysis Wastes

The peritoneal fluid that is taken out of the patient needs to be treated as any other body fluids and should be disposed of properly in the toilet. The perineal bag that comes carrying the fluid needs to be sealed in a plastic bag before putting it in the garbage.  

Hemodialysis Machine Wastes

The Dialyzer should be disposed of in a biohazard container and special care should be taken when dealing with dialysis machine waste. Some wastes can be thrown for recycling others needs to be taken care of better. Sharps for example need to be disposed of carefully in a biohazard container to prevent injury. For more information see the references on how to deal with dialysis wastes? {HemoDialWaste}

There was a study performed in 2015 that concluded that many wastes that are generated from the dialysis process are not really recyclable and that manufacturers need to be more aware of this issue and to be more eco-friendly when producing many of their products. {Eco-Dialysis}

Dialysis Machine Lifespan

There is no fixed date when the dialysis machine is expected to be replaced. Usually, the life span is counted in the number of hours not the number of years. Sometimes these two go hand in hand. However, if the dialysis machine is for a single user then this means the number of working hours is going to be far less than the number of years. 

It is safe to say that most good quality dialysis machines will work for 7000 hours without major repairs. Where after 10,000 hours of work real problems start to surface. In some cases and depending on where the dialysis machine is, it can live for as long as 15 years!. This is usually common in countries where labor service is cheap and resources are scarce. Though in the United States and European Countries the average life expectancy is around 5-7 years. 

It is safe to say that machines with 10+ years and over 21,000 hours of work are going to suffer from serious problems and will need serious repairs. 

Dialysis Machine Technical Specifications

In this section, we are going to spotlight the requirements needed by Dialysis machines and the usual specifications of a dialysis machine.

  • The pressure of supplied water 0.1 to 0.3 MPa (1 - 3 bar or 14.5 - 43.5 PSI)
  • The temperature of supplied water 41 - 86 Fahrenheit (5 to 30 Degrees Celsius)
  • Quality of water same or better than ISO13959
  • Range of Dialysate temperature 86 - 104 Fahrenheit (30-40 Celsius) {note this changes from one manufacturer to another, please refer to the technical specifications of that specific make and model}
  • Range of Dialysate flow rate regulation 200-800 mL/min {please refer to the make and model for more accurate numbers}
  • Range of Ultra Filtration rate regulation 0.1 - 5 L/hr.
  • Relative Humidity 30- 85 % (non-precipitative)
  • Power consumption 1.5-2 KVA
  • Voltage 110volts, 220 volts, or 240 volts based on country with 10-15% tolerance.

When to Apply Preventive Maintenance?


Usually, preventive maintenance needs to be performed once every year, most manufacturers will recommend applying preventive maintaining based on the number of hours that a dialysis machine has worked which is more logical as many parts can wear and tear with the increased use of the machine. Typically preventive maintenance is needed every 5000-6000 hours of operation.

Tools needed to Do a Successful Preventive Maintenance 


You will need to have many tools and we will list the most common ones:


  •  Screwdrivers that are Hex, Torx, Flat, Philips, etc 
  •  Pliers longnose or normal 
  •  Laptop or (a Desktop if you are going to work in the workshop) 
  • Calibration Weights (Usually are specific to machine type)
  • One of each of the Disposable sets
  • A calibrated Digital Multimeter 
  • Ground Resistance tester/ Current leakage tester 
  • Calibrated Pressure Meter
  • Luer lock syringe (50 ml recommended) 
  • Stop Watch 
  • Fluid bags (1 liter)
  • Catheters and the machine's disposable set
  • Pressure meter and pressure calibration tube 
  • Some manufacturers have set for preventive maintenance including all spare parts and kits that need to be replaced.  

Visual inspection and Cleaning


One of the most important things to do in any kind of preventive maintenance, especially important in areas that suffer from dusty conditions. Cleaning must be done while the machine is turned off, as you will have to open some covers to inspect and clean from the inside. 

Cleaning any dust or debris from the external or internal control unit surfaces is an important step to be done. including but not limited to any fan outlets, panel inlets, bottom side, and pump rotors.

Make sure to clean any dried up fluids from outside or inside the dialysis unit, using mild detergent.

   

{1}: https://www.kidney.org/news/newsroom/factsheets/KidneyDiseaseBasics
{BG}: https://investor.baxter.com/investors/events-and-news/news/press-release-details/2013/Baxter-Completes-Acquisition-of-Gambro-AB-and-Enhances-Global-Leadership-in-Renal-Therapies/default.aspx
{AN}: FME Annual Report 2018
{AN19}: FME Annual Report 2019
{Davita}: "DaVita Inc. 2019 Form 10-K Annual Report". U.S. Securities and Exchange Commission.
{Eco-Dialysis}:Eco-dialysis: the financial and ecological costs of dialysis waste products: is a ‘cradle-to-cradle’ model feasible for planet-friendly haemodialysis waste management?: AbstractBackground. Approximately 2 million chronic haemodialysis patients produce over 2 000 000 tons of waste per year that includes about 600 000

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