The QMN Weekly Bulletin
Quality / Medical Devices / Inspections and Audits

Australia Urges Caution With Reprocessed Duodenoscopes

July 29, 2016

Two major manufacturers of duodenoscopes marketed in Australia have initiated recalls to address contamination after reprocessing.

Olympus has recalled products in Australia to update its Instructions for Use regarding reprocessing and to modify its device. Similarly, Pentax recalled its video duodenoscope to update its Instructions for Use regarding reprocessing.

As a result of increased cross-contamination between patients due to reprocessed duodenoscopes, the TGA is urging health professionals to be alert of potential changes to some devices’ Instructions for Use labeling.

The TGA received one report this year of a duodenoscope that tested positive to intestinal bacteria despite repeated reprocessing efforts. The agency urges health facilities to report cases of contamination following cleaning and sterilization.

In January, the FDA released a report on safety regulations making a number of recommendations for preventing contamination.

In related news, the TGA is working with manufacturers of heater-cooler devices used in cardiothoracic surgery to ensure that infection risks are mitigated.

Cardiac procedures that use implanted medical devices alongside heater-cooler devices have been reported to cause non-tuberculous mycobacterium infections. These devices include oxygenator heat exchangers, cardioplegia heat exchangers and warming/cooling blankets.

The TGA is advising manufacturers on providing updated cleaning and disinfecting instructions. Manufacturers must keep updated versions of Instruction for Use, provide additional information on recalls and product corrections.

The FDA has a total of 40 medical device reports of infection associated with heater-cooler devices as of April.

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