Fungal Contamination Case Sheds Light on Serious Risk


Shipping containers may be carrying mold into cleanrooms.

A recent routine surveillance of a health system’s sterile intravenous compounding areas  found mold in two of its facilities.

Information provided to Drug Topics by The Institute for Safe Medication Practices (ISMP) revealed that at one facility, fungus was detected from air sampling in the anteroom. At another location in the same system, fungus was detected in a laminar flow hood. According to ISMP, after the mold was detected, the anteroom was cleaned and the hood was taken out of service.

Management was not able to determine the source of the mold, but process changes were made, and testing was increased to ensure the health system did not have a chronic issue.

At another facility in the same health system, a refrigerated shipment from a drug wholesaler and one of the tote covers had visible fungus growing on it. The fungus on the tote and a sample from a second tote were tested to determine if it was the same species as that found earlier at both facilities.

Contaminated totes

Sterile compounding expert, Eric Kastango, President and CEO of Clinical IQ, said that this latest incident should be a wake-up call that spores and fungi can be found on any packaging, including wholesaler totes. His advice to pharmacies is to always inspect totes and take immediate action.

“The extent of the problem is not really known, but lots of hospitals have been struggling with the presence of highly pathogenic organisms (mold and fungi) in their ISO classified spaces,” Kastango told Drug Topics.

Mold found on containerThe samples were cultured and Cladosporium, Aspergillus, and Penicillium species were found. When the fungus was first detected at the health system, Penicillium was isolated from different areas. The growth on the wholesaler totes may have been the vector, since drugs stored within the totes were used in the compounding area. The extent to which items were wiped down prior to being placed in the anteroom is not known.

ISMP said that the health system contacted its wholesaler to discuss solutions, including cleaning all totes between shipments and discarding refrigeration inserts that cannot be cleaned. It is possible that this type of fungal contamination can occur with other wholesalers, and could potentially harm patients. ISMP strongly advises hospitals to work with wholesalers to find ways to prevent this type of contamination.

What can be done to prevent it?

Sterile isopropyl alcohol is ineffective in eradicating these types of microorganisms, Kastango said. CriticalPoint has developed a best practices newsletter that calls for disinfecting drugs and components with a sporicidal agent before bringing them into the cleanroom.

ISMP’s Cohen said that CrticalPoint’s best practices newsletter is a good start. “The document mentioned wiping items with a sporicidal agent prior to bringing them into the cleanroom. Also, spraying down work areas with isopropyl alcohol when in the cleanroom.”

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