PH12012000328A1 - Dialyzer rinsing machine - Google Patents

Abstract

A DIALYZER RINSING MACHINE (DRM) is used to flush a dialyzer (new and reuse) using an ultrapure water process by dual pass reverse osmosis treated water eliminating the use of expensive 0.9 pcnt normal saline and dialysate to clear debris and other foreign matter during manufacturing of a dialyzer (for new dialyzer) and residual chemical use to disinfect and preserve the dialyzer(for reuse dialyzer). The DRM will also ssure the healthcare team and the patient that the dialyzer will be absolutely free of any chemical residue after flushing without the use of residual test strip. The DRM can also be used to refill the dialyzer with fresh disinfectant/sterilant if the content was expired, evaporated, or the port cover was dislodge. The DRM will standardized dialyzer rinsing procedure monimizing or even eliminating problems of patient infection and chill during dialysis cause by improper rinsing. Therefore, the DRM wil rinse the dialyzer faster, safer, and cheaper.

Description

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Be it known that I, Engr. Apollo M. Arquiza, a citizen of the Philippines and residing at P1

B93 L34 Mabuhay City Subd., Mamatid, Cabuyao, Laguna Philippines have made a new and useful invention for a dialysis ancillary equipment called;

A. TITLE : DIALYZER RINSING MACHINE i ( DIAFLUSH CA-nS)

B. BACKGROUND : :

Since DIALYZER REPROCESSING was introduced in the Philippines, rinsing of a ] dialyzer has became an integral part of dialysis protocol. DIALYZER REPROCESSING is a 4 process of cleaning, testing, and sterilization of hollow fiber dialyzer so that it can be use again by the same patient for his/her dialysis treatment. There are three major benefits of dialyzer reprocessing; 1) increase biocompatibility, 2) decrease biomedical waste, 3) reduce the cost of ; hemodialysis treatment. Since the last procedure of reprocessing is sterilization using a chemical to i kill bacteria, viruses and to preserve the dialyzer during storage. The chemical needs to be flushed out by rinsing the dialyzer before it can be used safely to the patient.

The inventor has been in a dialysis work for 15 years. He has seen different technique of rinsing dialyzer prior for patient use. Some ways are aseptic and safe but expensive and it will take a little ; bit longer to start the dialysis treatment proper. Some ways are fast and cheaper but not aseptic as ; the first . This is done by rinsing the dialyzer with reverse osmosis treated water in a lavatory or ] semi automated reprocessing machine. But unfortunately it is unsafe because the water used to rinse ] the dialyzer is not as sterile as 0.9 sodium chloride plus the fact that the connector used to connect i the sterile dialyzer to the rinsing area is not known to be clean and sterile. The latter rinsing ] procedure flush the dialyzer only but it does not maintain the sterility of the reprocess and/or new dialyzer thus exposing the patient to sepsis infection which is one of the most common problem that cause patient chill during dialysis.

Another factor affecting rinsing is the chemical used to disinfect the dialyzer. There are three f commonly used chemicals, the following are 1) FORMALDEHYDE, 2) PERACETIC ACID, AND 3) CITRIC ACID. Each chemicals have different concentration, dwell time, and procedure to : become effective disinfectant/sterilant. Detecting and removing residual chemical from a dialyzer t being rinsed are different for each chemical. Example ; PERACETIC ACID used peracetic acid 3 residual test strip to detect the level of chemical residue after rinsing a dialyzer. Expire and or 3 improper handling of the test strip may not give an accurate measurement of the residual chemical i in a dialyzer. Unfortunately, rinsing FORMALDEHYDE in a dialyzer has no way to detect the . - level of residue left after rinsing because the test strip is not available here in the Philippines but 4 instead, by experienced, it was being flushed only using an estimated three to four bottle of 0.9 . normal saline assuming that this will clear the chemical residue. The same procedure is apply in rinsing CITRIC ACID. But CITRIC ACID chemical needs to be heated to an oven for at least two 1 hours or more with a temperature range of 85 to 90 degrees Celcius to become an effective i disinfectant. The CITRIC ACID as a disinfectant/sterilant will not be effective if the oven is ] interrupted by a long power failure at night where there are no staff left in the center. 1 1 1

The inventor therefore have found an effective solution to flush the dialyzer (new and reuse) to rinse out particle and any chemical residue.

C. BRIEF STATEMENT OF NATURE AND PURPOSES :

A DIALYZER RINSING MACHINE (DRM) is a dialysis ancillary equipment that aims to : standardize the rinsing procedure of a new and reuse dialyzer in a fast, safe, and cost efficient way. ]

The machine will be used to flush a new or reuse dialyzer prior for hemodialysis treatment. A dual pass reverse osmosis treated water is use in flushing a dialyzer to maintain its sterility thus eliminating the use of 0.9 normal saline and dialysate as a rinsing medium. It also eliminates the use of expensive residual test strip to detect the level of chemical residue in a dialyzer by using an 1 online water quality meter. This water quality meter assure the healthcare team that the dialyzer, after rinsing is free from residual chemical. Chemical residue left in a dialyzer is another common } cause of patient chill during dialysis treatment. The DRM can be used also to refill a dialyzer and ] hemodialysis machine with a fresh sterilant chemical prior for storage. It can be connected also to a J dialysis machine to perform hemodialfiltration.

D. COMPLETE AND DETAILED SPECIFICATION :

The invention is the first in the Philippines. The objective of the Dialyzer Rinsing Machine ] (DRM) is to standardized the dialyzer rinsing procedure of all dialysis clinics/centers in the country ; in a fast, safe, and cost efficient way. This will guarantee or assure the hemodialysis patients that the E dialyzer they are going to use will be safe from residual chemical and maintain its sterility. The said 1 objective can only be achieved by designing an automatic Dialyzer Rinsing Machine (DRM) i specifically as follows; 1. The feed water that will be use in the DRM must be treated by reverse osmosis and the quality of water must pass the standard set by Department of Health (DOH) and ]

American Advancement for Medical Instrumentation (AAMI). 1 2. That the feed water must be monitor by the DRM using an Online water quality ] meter. ; 3. The feed water must be reprocess by the DRM passing thru a series of redundant ] water treatment equipment such as UV Sterilizer, Ultrafilter, and Revese Osmosis P membrane. ] 4. The Reverse osmosis of the DRM must have a monitoring instrumentation such as ] flow meters, pressure gauges, and online water quality meter. This is to assure the . effectiveness of its filtering function. : 5. The ultrapure water produce by the DRM must be store in a closed, small volume, plastic bladder tank. All fittings, plumbing, and tubings must be food grade plastic, 1 pve, and stainless steel only. This is to maintain its purity and avoid re contamination ! of bacteria, viruses, and pyrogen.

6. All plumbing, tubing lines, and tank of the DRM must be frequently disinfected by incorporating a chemical injector pump. This pump will disinfect the lines and at the ] same time test the function of the online water quality meter. ] 7. DRM use an online water quality meter to act as a real time visual chemical residual : test by comparing the the water reading before the dialyzer being rinse and the 1 effluent water after the dialyzer. 8. DRM incorporate a time controlled solenoid valves to alternately rinse the dialyzer i compartments. This will also shutoff the supply of ultrapure water after the rinse cycle ends. 1 9. The reverse osmosis of the DRM must be designed to effectively recover up to 80% of its feed water. ]

E. SUMMARY OF INVENTION

The inventor relates to a DIALYZER RINSING MACHINE that will produce highest : quality of water that is almost comparable to sterile water which will be use to flush the dialyzer. /

This can be achieved by polishing the reverse osmosis treated water use by the dialysis center/clinic ] by passing thru a series of redundant water treatment process such as U.V. Water sterilization, ; ultrafiltration, and a second Reverse Osmosis filtration. This redundant water treatment process of 1 the DRM will produce a dual pass reverse osmosis treated water. This ultrapure water will be use as the rinsing medium to flushed the dialyzer. The quality of water treated in this process assure to be ; acceptable and safe as a rinsing medium to flush out chemical inside the dialyzer. A multi point : integration of water quality meter is vital to monitor the quality of feed water, the quality of permeate water of the second reverse osmosis, and it will serve as chemical residual test. This multi point water quality meter give a real time visual status of chemical residue present in the dialyzer ] being rinsed by comparing the reading of the water quality before it enters the dialyzer and the : effluent water from the dialyzer. Other monitoring instrumentations were installed such as pressure ] gauges, and flow meters to asses and monitor the effectiveness of the second r.o. membrane. The 4 second R.O. was designed efficiently to recover up to 80% of its feed water. A time controlled ; automatic shutoff rinse valves were used to alternately rinse the dialyzer compartments and automatically stop the flow of ultrapure water after the rinse cycle has ended. To maintain sterility d of the dialyzer being rinsed, a replaceable segment of disinfected silicone tubing are used to connect 1 each dialyzer to the DRM. In addition, the DRM incorporate a chemical injector pump that can be used to 1) Disinfect the machine fluid pathways regularly, 2) Check the function and accuracy of the 1 water quality meter that is used to detect chemical residue from the dialyzer being rinsed. 3) to refill 1 dialyzer and dialysis machine with fresh disinfectant/sterilant prior for storage ;

While the invention has been shown and described in terms of certain preferred 1 embodiments thereof, it should be understood that the invention is by no means limited to these particular embodiments and that many changes and modifications will be obvious to one skilled in : the art without departing from the true spirit and scope of the invention as defined in the appended J claims above. E

Claims (6)

F. CLAIMS :

1. The Dialyzer Rinsing Machine was invented by Apollo M. Arquiza and the first to introduce the procedure in the Philippines/world.

2. The Dialyzer Rinsing Machine was designed for the following useful purposes; a) to rinse and flush chemical from the dialyzer prior for hemodialysis priming procedure using a dual pass reverse osmosis treated water as a flushing medium, b) to refill a dialyzer with a fresh chemical disinfectant/sterilant solution, c) can be } connected to a dialysis machine to perform hemodialfiltration, d) can be use to fill the dialysis machine with disinfectant prior for storage.

3. The Dialyzer Rinsing Machine was designed to produce a dual pass reverse osmosis high purity treated water when connected to a supply of water treated by reverse osmosis in a dialysis center. The water feed in this machine must pass or even exceed the recommended standard for hemodialysis by Department of Health (D.O.H). and American Advancement for Medical Instrumentation (AAMI).

4. The Dialyzer Rinsing Machine was designed to used online water quality meter such as conductivity, or total dissolve solid (ppm), or resitance (megaohm) as a ] method of detecting residual chemical in a dialyzer being rinsed by comparing the 1 water before it enters the dialyzer and the water exiting from the dialyzer. In this ] way it eliminates the use of expensive residual test strip and it can detect any residual : chemical which are commonly used in reprocessing such as Citric acid, Peracetic acid, and Formaldehyde.

5. The Dialyzer Rinsing Machine integrate a chemical injector pump for the following 1 purposes; a) to be able to regularly disinfect the machine fluid pathways, and b) to test the function and accuracy of the online water quality meters, c)to refill dialyzer / and dialysis machine with a fresh disinfectant/sterilant prior for storage. ;

6. It is usually a multi-station machine that can rinse multiple dialyzer. It has a wall i between station that separate a positive patient dialyzer to negative patient dialyzer : to become aseptically safe and decrease or even eliminate the possibility of cross . contamination during rinsing process. 4 4 1