Decision No. 1338/2004/QĐ-BYT Issuing "Guidelines for the Technical Procedure of Cleaning and Reusing Hemodialyzers"

Pursuant to …;

REGARDING THE ISSUE OF ISSUING THE "GUIDELINES FOR TECHNICAL PROCEDURES FOR WASHING AND REUSING KIDNEY FILTERS"

THE MINISTER OF HEALTH

Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;
Considering the Minutes of the meeting on March 24, 2004, of the Appraisal Board established pursuant to Decision No. 4868/QĐ-BYT dated September 17, 2003, for the acceptance of the Technical Procedure for Washing Blood Membrane Filters for Reuse in Artificial Kidneys;
At the proposal of the Director of the Department of Treatment - Ministry of Health,

Pursuant to …;

Article 1. Now hereby promulgating with this Decision the "Guidelines for Technical Procedures for Washing and Reusing Kidney Filters".

Article 2. The "Guidelines for Technical Procedures for Washing and Reusing Kidney Filters" are professional technical practice guidelines to be applied in all state, semi-state, and private healthcare facilities.

Article 3This Decision shall take effect fifteen days from the date of publication in the Official Gazette.

Article 4. The Heads of the Office, Directors of Treatment Departments, Heads of Inspection, and other Department and Bureau Heads of the Ministry of Health, Directors of Provincial and Central City Health Services, Directors of Institutes and Hospitals under the Ministry of Health, Heads of Health Departments, and Heads of Healthcare Facilities shall be responsible for implementing this Decision.

PROCEDURE

TECHNICAL PROCEDURES FOR WASHING AND REUSING KIDNEY FILTERS

(Issued together with Decision No. 1338/2004/QĐ-BYT dated April 14, 2004)

I. OVERVIEW

Artificial kidney (Hemodialysis) is a necessary treatment method for acute and chronic renal failure, acute poisoning, and certain other conditions when indicated. Hemodialysis involves the exchange of dissolved substances between blood and dialysate through a semipermeable membrane based on diffusion and ultrafiltration principles occurring within the kidney filter. The kidney filter is the most important consumable material for each hemodialysis session. Many countries, including advanced ones, reuse filters. In Vietnam, many artificial kidney units have also researched and reused kidney filters. Reusing filters is necessary but must ensure safety and effectiveness for patients.

II. INDICATIONS

- Filters for reuse are only used for the same patient and can be reused up to 15 times.- Patients with initial filter usage syndrome.

III. CONTRAINDICATIONS

- There are no absolute contraindications- Patients with HIV/AIDS

IV. PREPARATION

1. Specialized Staff:

Personnel performing the technique of washing kidney filters for reuse must be adequately trained in the technique and equipped with protective gear: goggles, masks, clothing, gloves...

2. Equipment:

2. 1. Select reusable membranes:

- Medium or high permeability membranes

- Membranes made from synthetic or semi-synthetic materials

2. 2. Wash water:

Reverse osmosis (RO) water meeting standards

2. 3. Cleaning and sterilizing agents:

- Formaldehyde: 2% - 4% (room temperature)

- Hydrogen Peroxide: 4% - Acetic Acid: 4% (usually combined with hydrogen peroxide)

- Citric Acid: 1.5%, combined with a temperature of 90°C

- Glutaraldehyde: 0.8% - 4%, not combined with sodium hypochlorite

2. 4. Filter processing system:

- Operate correctly.

- Regularly check, maintain, and calibrate.

3. Patients and their families:

Patients and their families are informed, explained, and voluntarily agree to reuse filters.

V. STEPS TO BE FOLLOWED

Step 1: In the hemodialysis room: Observe and mark after the end of hemodialysis.- The outer surface of the filter is cleaned of blood and other substances with 1% Javel water.- Preliminary observation of the condition of the filter and blood lines, accurately record the patient's name, date, and filtration number on the label or adhesive tape with the witness of at least two people: medical staff, patient, or family member, then transfer to the filter washing room.Step 2: In the filter washing room. Mandatory use of sterile reverse osmosis (RO) water.

2. 1. Forward wash: Wash inside the blood circuit and fiber channels.

2. 2. Backwash: Backwash with RO water. Wash the dialysate path with 1 atm pressure - RO water will flow from the dialysate path into the blood path to clear very small pores.

2. 3. Clean all blood lines thoroughly:

Wash time: 5 - 10 minutes

After washing, the kidney filter meets the following requirements:

- All fiber channels are clean and white.

- Both ends of the filter are free of any substance.

- Blood lines are completely clean.

- Both inlet and outlet ports of the blood chamber and dialysate chamber are covered with caps.

- Labels are correctly affixed and do not peel off.

- Sterilization solution concentration should not exceed 4%; concentrated solutions should not be used; sodium hypochlorite and formaldehyde or sodium hypochlorite and peracetic acid should not be combined.

Step 3: Sterilization

- Immerse the filter, including inlet and outlet ports, dialysate chamber, and blood chamber, fully in the sterilization solution.

- Immersion time in the sterilization solution: 24 - 48 hours.

Step 4: Rinse out the sterilization agent before use with RO water:

- Thoroughly rinse all small chambers; rinse both the blood and dialysate paths.

- Rinse time: 10 - 15 minutes.

- After rinsing, the filter is sealed on both the blood and dialysate paths; if not used immediately, it should be stored in a refrigerator at 10°C (cooling compartment) for no more than 4 hours, and should not be kept in the freezer causing freezing of the filter fibers.

Step 5: Before reuse:

5. 1. Rinse the filter with 0.9% NaCl saline solution from 1000 - 2000 ml - Rinse the dialysate path first. - Rinse the blood path.

5. 2. Conduct residual sterilant testing.

5. 3. Connect to the extracorporeal circulation loop as per the blood filtration procedure.

VI. MONITORING AND HANDLING:

1. Closely monitor to detect any abnormal signs during the blood filtration process and any adverse reactions from reused filters, and handle promptly:

1. 1. Membrane tear: Replace the filter.

1. 2. Residual sterilant reaction:

- Stop blood filtration- Return blood to the patient

- Rinse the filter and blood lines again or replace the filter and blood lines if both are reused.

1. 3. Cardiovascular, respiratory complications, and other complications: Handle according to the cause.

2. Monitor and record in the medical chart:

- As per hospital regulations, record comprehensively, especially tests, fever reactions, and chills.

- Reused filters must be clearly labeled with the patient's name, number of uses, and the name of the operator.