General Reprocessing

Q. Can I use cold AAMI water to process my dialyzers? My heater can’t keep up with water demand, and sometimes my water temperature drops below 60°. Your temperature recommendations are higher.

A. Minntech Renal Systems recommends that water used to dilute RENALIN Cold Sterilant to 21%, and water supplied to the RENATRON II System be at a temperature between 59-75°F. The validation of RENALIN Cold Sterilant as a sterilant was carried out at temperatures between 59-75°F. Storing a dialyzer in temperatures outside of this range goes against the manufacturer’s recommendations for RENALIN Cold Sterilant.

Q. If a cap blows off the reprocessed dialyzer and it is then tested and found positive for Proportioned RENALIN Solution, do we have to reprocess the dialyzer again?

A. Minntech Renal Systems recommends that if a cap blows off of a reprocessed dialyzer, it indicates that the dialyzer may still contain residual blood products or the storage conditions have not been optimal. The dialyzer should be reprocessed and stored a minimum of 11 hours before using.

A. When RENALIN Cold Sterilant and the residual protein in the dialyzer mix, they produce oxygen gas. The ventable caps act as a release for this gas. Always be sure to point the dialyzer port and ventable cap upward and away from eyes, and make sure the clear deflection shield is in the out position. Squeeze the red portion of the ventable cap at the top rounded part of the cap, under the deflection shield. Squeezing the cap twice for 2-3 seconds should vent the pressure properly. For storage, the cap shield is to be fully extended in the “out” position. Repeat these steps after storage and prior to removal of port caps.

Q. Can dialyzers from patients testing positive with hepatitis B or hepatitis C
surface antigens be reprocessed?

A. The 1993 edition of the AAMI guidelines on “Reuse of Hemodialyzers” (which was adopted by HCFA as Final Rule in October of 1995) states in Section 6, “dialyzers
should not be reprocessed from patients who have tested positive with hepatitis B surface antigens.” According to the Federal Register Vol. 60, No. 180, this decision to prohibit the reuse of dialyzers from patients testing positive for hepatitis B was developed by the medical community and reflects the general concern of most professionals that extreme caution is necessary in treating patients with the disease.
The Centers for Disease Control state, in the National Surveillance of Dialysis Associated Diseases in the United States, 1996, that dialysis patients with non-A,
non-B hepatitis should be treated with the same precautions used for all patients, following the 1996 standard precautions. The CDC also noted that patients who are
positive for anti-C HCV or have a diagnosis of non-A, non-B hepatitis do not have to be isolated from other patients or dialyzed separately on dedicated machines, and may participate in a dialyzer reuse program.

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