Renalin® Cold Sterilant

Q. How much Renalin Cold Sterilant does it take to reprocess a dialyzer using the
Renatron® II Dialyzer Reprocessing System?

A. Approximately 156 ml of Proportioned RENALIN Solution for “OO” and “CH”
mode, and 248 ml for the “HF” mode.

Q. Is it safe to work with RENALIN Cold Sterilant when you are pregnant?

A. Questions are occasionally asked regarding whether pregnant personnel should work with Renalin. We have once again referred this question to a medical consultant specializing in occupational medicine. The findings of the resulting independent toxicology review do not show any studies that indicate a human reproductive hazard from hydrogen peroxide, peracetic acid or acetic acid, which are the active ingredients of Renalin. These results are consistent with the findings of a previous toxicological review.

Before a decision is made regarding the effect of any chemical encountered in the workplace or home environment on fetal development, the informed healthcare worker should first consult with their personal physician. Additionally, all recommended personal protective equipment should be used at all times when working with any chemical and the environmental levels monitored to ensure compliance with applicable standards. Therefore, Minntech advises all healthcare workers to consult with their physician about fetal development and the safety of working with all chemicals including Renalin, if they are pregnant and to take all recommended precautions.

Q. Must a RENALIN indicator test be performed on every dialyzer? How often
and when do dialyzers need to be tested with the PerassayTM 500 Peracetic Acid
Test Strips?

A. Our instructions for use require that each preprocessed or reprocessed dialyzer
be tested for the presence of Proportioned RENALIN Solution with the PerassayTM 500 Peracetic Acid Test Strips after storage and before rinsing.

Q. Is it necessary to store RENALIN solution in the original box once water is added
to the concentrate?

A. In order to avoid deterioration of the RENALIN Solution, Minntech Renal Systems recommends that RENALIN Cold Sterilant, RENALIN Solution, as well as reprocessed and reprocessed dialyzers be stored out of direct sunlight. In many locations this is best accomplished by storing both the RENALIN Cold Sterilant and RENALIN Solution in the original shipping container.

Q. How often do we have to change the clean/dirty cap container solution?

A. If you are using 1% RENALIN Solution, the solution should be mixed fresh once every 24 hours. If using Actril® Cold Sterilant, the solution can be used for up to 14 days, as long as it has been verified with an indicator test strip. The ACTRIL Solution should be checked every morning with an ACTRIL Indicator Test Strip to verify the presence of ACTRIL.

Q. What causes large bubbles within the dialyzer following reprocessing?

A. RENALIN Cold Sterilant will produce oxygen gas when it is exposed to residual blood products remaining in a dialyzer after it has been used. To reduce this phenomenon, you may consider using the pre-clean cycle on the RENATRON II System. You may also wish to analyze the dialyzer handling practices in your dialysis unit that may influence the amount of clotting that may occur during and after a dialysis treatment.

Q. RENALIN vapors – what must be checked and how often?

A. The two components of RENALIN Cold Sterilant, which are subject to OSHA regulation for maximum airborne levels, are hydrogen peroxide and acetic acid. OSHA specifies that their maximum levels, measured as 8-hour time-weighted averages, are 1 and 10 ppm respectively. For an explanation on how to measure TWA, please refer to the Fall/Winter 1994 issue of ReNews®. OSHA has not established a frequency for monitoring, only that these limits be met. We recommend that initial testing be done when exposure appears greatest, such as when diluting RENALIN Cold Sterilant, to establish the maximum expected levels. If these are found to be below the OSHA limits, routine testing can be infrequent. Testing should always be repeated if processes are changed or if personnel experience discomfort.

Q. Is RENALIN Cold Sterilant a known carcinogen?

A. No. Neither RENALIN Cold Sterilant, nor any of its components, are known carcinogens.

Q. Can a dye be added to RENALIN Cold Sterilant?

A. No. The oxidizing nature of RENALIN Cold Sterilant would render any dye colorless in a very short period of time. Many dialysis centers that use Formalin to disinfect dialyzers use a color to verify that the Formalin solution was in the dialyzer. Unfortunately, the presence of colored dye is not an assurance of the proper levels of Formalin in the dialyzer. Our recommended indicator test performed just prior to the use of the dialyzer is a positive assurance of the presence of Proportioned RENALIN Solution at the proper concentration.

Q. Do I need special venting in the reuse area to evacuate RENALIN Cold Sterilant
fumes during reuse?

A. As a result of the closed system design of the RENATRON II System, exhaust fans that provide the reuse room with five room exchanges per hour will meet OSHA requirements and provide a comfortable working atmosphere for staff. When planning ventilation design, the ducts, grills and other air handling equipment should be made of nonmetallic construction to avoid later problems with corrosion. The exhaust vents should not be placed in the ceiling. As RENALIN vapors are heavier than air, preferred placement of vents is at counter-top height just behind the RENATRON II System or immediately adjacent to areas where RENALIN Cold Sterilant is used and mixed.

Q. What reaction takes place when a patient comes into contact with Proportioned
RENALIN Solution remaining in a dialyzer?

A. A patient may respond to a small RENALIN Cold Sterilant exposure just as they would to an exposure to any foreign substance. Some of the symptoms observed in patients that have been exposed to small amounts of RENALIN Cold Sterilant are the
following:

• Burning in extremities
• Dizziness
• Itching
• Nausea
• Sensation or warmth
• Vomiting
• Chest pain or tightness
• Facial flushing
• Hypotension
• Sweating
• Numbness/tingling sensation

Q. What is a RENALIN Certification Agreement?

A. As directed by the US Food and Drug Administration, (FDA) in their 518(a) order, Minntech Renal Systems is required to obtain a signed agreement by all dialysis facilities using RENALIN Cold Sterilant, to ensure that they conform with the 1986 Association for the Advancement of Medical Instrumentation Recommended Practice for Reuse of Hemodialyzers (AAMIROH-1986) and Minntech Renal System’s guidelines. The FDA prohibits the sale of RENALIN Cold Sterilant to dialysis facilities which have not returned a signed copy of this agreement. The agreement covers five different categories of RENALIN Cold Sterilant usage. The customer needs to determine which category or categories accurately describe their RENALIN Cold Sterilant usage. All centers that are RENALIN customers as of April 1, 1993 have a signed Certification Agreement on file. New customers are requested to send a Certification Agreement, signed by their Medical Director
or Administrator.

Q. A 1% RENALIN Solution can be used for port cap disinfection. What is the
formula for making a 1% RENALIN Solution from a 21% RENALIN Solution?

A. 21% RENALIN Cold Sterilant is the concentration of the RENALIN Solution in a 2.5 gallon container with two liters of RENALIN concentrate properly diluted for use with the RENATRON II System. A 1% RENALIN Solution can be made from the 21% RENALIN Solution by using 48mls of the 21% RENALIN Solution and adding 952 mls of AAMI quality water and mixing well. This will deliver one liter of 1% RENALIN Solution for port cap disinfection. (Fresh 1% RENALIN Solution should be made daily.)

Q. What is the rationale for rinsing the blood compartment of a RENALIN sterilant-reprocessed dialyzer with 500 ml of sterile normal saline to drain before initiating dialysate flow to the dialyzer?

A. The RENALIN dialyzer-rinse procedure recommends a 500 ml saline flush to drain through the blood compartment prior to commencing dialysate flow and the ultrafiltration phase of the rinse procedure. The primary recommendation for this saline flush is to prevent formation of gas bubbles within the dialyzer’s hollow fibers.
This can occur when bicarbonate (base) from the dialysate diffuses into RENALIN-filled (peracetic acid) fibers. The resulting acid-base reaction results in liberation of gas within the fibers, which may subsequently obstruct flow through these fibers. Fibers fully or partially obstructed with air are more difficult to rinse and the phenomenon may not be clearly evident from residual test procedures, because the
bulk of saline being recirculated will be from unobstructed, more completely rinsed, fibers. In addition, gas bubbles trapped in the dialyzer fibers may be dislodged later during dialysis, exposing poorly rinsed surfaces to the patient’s blood.
This rinse procedure recommendation for a RENALIN filled dialyzer may differ from the method for rinsing a formaldehyde-filled dialyzer. Often, the dialysate flow is initiated prior to rinsing the blood compartment of a formaldehyde-filled dialyzer.
It must be noted that the saline flush is a critical step to avoid potential gas formation within the dialyzer fibers and should be practiced to prevent air obstructed fibers and potential RENALIN residual reactions.

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