The U.S. Food and Drug Administration (FDA) has ordered last Friday a recall of all scope-cleaning machines of a Pennsylvania company to prevent infection in patients of over 1,000 hospitals and clinics.

The FDA ordered a recall of Custom Ultrasonics' Automated Endoscope Reprocessors (AERs) based on continued violations from its latest inspection in April, as well as the machines' use in healthcare centers reporting "the transmission of serious bacterial infections."

The agency cited violations such as failing to validate that the AERs can sufficiently wash and disinfect endoscopes to mitigate patient infection risk. "The identified violations could result in an increased risk of infection transmission," the FDA said in its statement.

Since Aug. 10, 21 complaints on Customs Ultrasonics had been received by the FDA, which currently recommended health care facilities using AERs to immediately shift to alternative reprocessing techniques.

The company has had brushes with FDA until they entered a consent decree in 2007, but under the agreement in 2012 and 2013, the FDA ordered it to stop AER device manufacturing and distribution after failing to get cleared for software changes. After obtaining clearance, the affected devices were put back into the market.

AERs are free-standing units for disinfecting flexible endoscopes and accessories in hospitals and clinics, particularly in between the devices' used in gastrointestinal and pulmonary tract procedures.

The FDA also previously issued a warning about duodenoscopes, hard-to-sanitize devices and discovered to spread bacteria that include carbapenem-resistant enterobacteriaceae (CRE).

In August, it warned Olympus for not notifying it of serious injuries or deaths possibly caused by its duodenoscope, including 16 patients who contracted Pseudomonas aeruginosa infection after their endoscopy.

Fujifilm and Hoya were other manufacturers that received FDA warnings for failing to observe related cleaning procedures and report known infection cases.

Sought for comment, a representative for Custom Ultrasonics did not respond. A former Customs Ultrasonics employee, however, spoke about having left the company in 2013 out of his own concerns on product safety.

Hospital-safety consultant Lawrence Muscarella spent 18 years with the endoscope washer manufacturer managing infection control. For him the FDA should have stuck with its 2012 recall and sent alerts to medical providers immediately.

"The failure of the FDA to act more promptly, based on their own words, could have resulted in deaths and injuries," he said, calling it "unacceptable" to recall the products after three years.

At the Ronald Reagan Medical Center in UCLA, a scope-related CRE superbug outbreak affected eight, including three who died. Custom Ultrasonics washers were used for the hospital's duodenoscopes but UCLA, in an investigation in early 2015, found "no functional issue" with the units.

The machines can cost $30,000 to $50,000 and usually take half an hour to wash and disinfect endoscopes after manual cleaning.

Photo: Sam Blackman | Flickr

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