FDA orders recall of 2,800 scope-cleaning machines due to infection risk

The Food and Drug Administration issued a recall order for all automated endoscope reprocessing machines manufactured by Custom Ultrasonics on Friday, citing continued violations on the part of the firm that could result in increased risk of infection.

The recall is being ordered under the terms of a consent decree the FDA entered with the company in 2007. In 2012, after citing violations of the consent decree, the FDA ordered Custom Ultrasonics to stop manufacturing and distributing its devices and ordered a recall. The company then made significant changes to its software operating system and the machines were allowed back on the market. Since that time, the company has not been able to manufacture or distribute new devices, but was allowed to continue servicing existing models.

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"The FDA's most recent inspection of Custom Ultrasonics' facility in April 2015 documented continued violations," an FDA statement reads. "Violations include the inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection. In the months following the inspection, the FDA provided the company with an opportunity to correct inspection violations and requested additional validation data. Following a review of the company's submissions, the agency determined that Custom Ultrasonics has not adequately addressed its continued violations, which could result in an increased risk of infection transmission to patients.
In addition to the recall order, the FDA issued a recommendation that any facilities using the reprocessers begin taking steps to transition to alternative flexible scope reprocessing methods."

There are approximately 2,800 of the machines in use today, according to the FDA. The FDA has recommended facilities still using the machines begin taking steps to transition to other methods of flexible scope reprocessing. The organization also recommends any infections that may be linked to scopes improperly disinfected by Custom Ultrasonics' machines be reported to the FDA via MedWatch.

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