Cause of Device-Related Incident
Device factors

Clinical Specialty or Hospital Department
Dialysis; Nephrology

Device Factors
Device interaction

Document Type
User Experience Network (UEN) reports

External Factors
*Not stated

Mechanism of Injury or Death
Burn (electrical, thermal, chemical); Exposure to hazardous gas

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
*Not stated

UMDNS
Germicides, Liquid [18-161]

Corrosiveness of Renalin Dialyzer Sterilant



User Experience Network™ [Health Devices Oct 1993;22(10):501-2]

Hospital

During an investigation of a leaky drain in our dialysis unit, we discovered that the Renalin sterilant used to reprocess dialyzers had attacked the chrome-plated brass drain. Clinicians had been disposing of excess Renalin by pouring it into the sink. The Renalin had attacked the brass beneath the chrome plating of the drain until just a thin chrome shell was left. While Renalin containers indicate that the material is corrosive, we were not aware that it could attack plumbing fixtures.

Manufacturer

Renalin is an Environmental Protection Agency (EPA) registered sterilant composed of hydrogen peroxide, peracetic acid, acetic acid, and water. While it is rapidly deactivated when mixed with water and can be disposed of safely with water in a sink, it is a corrosive material and an oxidant. (In compliance with federal regulations, the shipping cartons are labeled with warnings about the corrosiveness and oxidizing properties of Renalin.) The materials that are incompatible with Renalin include heavy metals such as iron, copper, copper alloys, brass, and aluminum. Contact with latex rubber, neoprene, and Buna-N (nitrile rubber) should also be avoided. Materials such as acrylonitrile butadiene styrene (ABS), acrylic, Delrin, ethylene-propylene-diene monomer (EP or EPDM), glass, high-density polyethylene, polyvinyl chloride (PVC), polysulfone, silicone rubber, 302 and 316 stainless steels, Teflon, and Viton are compatible. Equipment used in handling Renalin, including drains, sinks, and fume hoods, should be made of these materials.

ECRI

Based on the material safety data sheet (MSDS) provided by Renal Systems, Renalin, as any sterilant, should be handled with care. This material can react with chlorinated cleansers and liberate toxic, corrosive chlorine gas. In addition, it can cause burns and irritation to eyes, skin, and mucous membranes.

Recommendations

  1. Dialysis facilities should request the MSDS information from Renal Systems and inspect areas where Renalin is handled to ensure that materials are compatible. (MSDS information should be on file in hospitals for any stored hazardous materials.)
  2. Renalin can generally be safely disposed of by diluting it with running water in a sanitary sewer, but local and state agencies should be consulted to ensure that this disposal procedure complies with their regulations.
  3. If the plumbing, up to and including the sink trap, used to dispose of excess Renalin is constructed of unidentifiable materials, it should probably be replaced with materials known to be compatible (e.g., PVC, stainless steel). When replacing the plumbing is not practical, new sinks and plumbing constructed of compatible materials should be installed and designated as Renalin disposal sites, while other sinks should be placarded with a warning about incompatibility. Fume hoods installed above handling areas should also be inspected to ensure compatibility.
  4. Alert clinicians to Renalin's incompatibility with the materials listed above, as well as with salts, flammable organics, alkalies, chlorine, and formaldehyde.

UMDNS Term

Germicides, Liquid [18-161]

Cause of Device-Related Incident

Device factor: Device interaction

Mechanism of Injury or Death

Burn (chemical); Exposure to hazardous gas


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