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Methods for disinfecting dialyzers
| Details |
Inventors: Levin, Nathan; Polaschegg, Hans-Dietrich;
Assignee:
Primary Examiner: Kim; John
Assistant Examiner:
Attorney, Agent or Firm: Klee; Maurice M.
A method for reprocessing dialyzer cartridges used with kidney dialysis machines is provided. The method involves filling the blood and dialysate compartments of the dialyzer with an aqueous solution containing citric acid at a concentration of 1.0-5.0 wt. %, e.g., 1.5 wt. %, and then subjecting the dialyzer to an elevated temperature above 90.degree. C. and below 100.degree. C., e.g., 95.degree. C., for a period of at least 15 hours, e.g., 20 hours. Although citric acid is non-toxic and the temperature used is below the boiling point of water, the process has been found to produce a fully sterilized dialyzer. After reprocessing, the aqueous citric acid solution is preferably left in the dialyzer where it acts as a bacteriostatic agent during storage. Essentially no damage to the dialyzer and, in particular, to its semipermeable membrane results from either the reprocessing or storage procedures. |
|
DETAILED DESCRIPTION In view of the foregoing state of the art, it is an object of this invention to provide an improved method for reprocessing dialyzers.
It is a particular object of the invention to provide a method for reprocessing dialyzers which does not employ toxic chemicals.
It is a further object of the invention to provide a method for reprocessing dialyzers which minimizes the possibility of damage to the dialyzer's semipermeable membrane or structural components.
It is an additional object of the invention to provide an improved method for storing dialyzers prior to use.
To achieve these and other objects, the invention in accordance with certain of its aspects provides a method for reprocessing a dialyzer comprising the steps of: (a) filling the blood and dialysate compartments of the dialyzer with an aqueous solution which comprises citric acid at a concentration of between about 1.
0 and about 5.
0 weight percent per volume; and (b) subjecting the dialyzer containing the aqueous solution to an elevated temperature less than 100.
degree.
C.
for a period of time sufficient to kill pathogenic organisms and viruses contained within the dialyzer.
In certain preferred embodiments of the invention, step (b) is performed for between about 15 hours and about 25 hours at a temperature greater than about 90.
degree.
C.
, e.
g.
, for about 20 hours at a temperature of about 95.
degree.
C.
The preferred concentration of citric acid in the aqueous solution for these times and temperatures is about 1.
5 weight percent by volume.
More generally, it is preferred to perform step (b) for a period of time and at a temperature and citric acid concentration which will achieve sterilization of the dialyzer, i.
e.
, in addition to killing pathogenic organisms and viruses, bacterial spores are also killed.
The citric acid used in the practice of the invention will normally be in its monohydrate form, i.
e.
, it will have the formula HOOCCH.
sub.
2 C(OH)(COOH)CH.
sub.
2 COOH.
H.
sub.
2 O.
A weight percent by volume (hereinafter abbreviated as "wt
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