The U.S. Food and Drug Administration (FDA) recently ordered the recall
of all automated endoscope reprocessors (AERs) manufactured by Custom
Ultrasonics. According to the agency, the company’s repeat violations
of federal regulations could result in an increased risk of infection
“We are taking action because Custom Ultrasonics failed to meet its
legal and regulatory obligations,” said Dr. William Maisel, chief
scientist in the FDA's Center for Devices and Radiological Health.
The FDA's recall order “is necessary to protect the public health.”
Risks Associated with Reprocessed Scopes
The FDA-ordered recall is the latest development in the agency’s
alarming investigation into the safety of reprocessed endoscopes, including
duodenoscopes and scope accessories. As we have
previously discussed on this San Diego Injury Blog, the scopes must undergo a multi-step cleaning and disinfection procedure
called reprocessing so the medical devices can be reused between patients.
If the complex procedure is not performed properly, the medical devices
can transmit infections, including those that are resistant to antibiotics.
Earlier this year, the inability to thoroughly sterilize the specialty
endoscopes was linked to a drug-resistant “superbug” that
claimed the lives of three California patients.
Custom Ultrasonics’ History of Violations
In news release, the
FDA acknowledged that Custom Ultrasonics has faced scrutiny since 2007, when the agency first charged the company with violations
of the Federal Food, Drug, and Cosmetic Act (FD&C Act), finding that
its corporate practices “posed a potential public health hazard.”
Despite the safety concerns, the FDA did not force a product recall at
that time. In 2012, the FDA ordered Custom Ultrasonics to halt manufacture,
but it later allowed the scope-cleaning machines to remain on the market
after the company made approved changes to the product.
The FDA’s most recent inspection of the Custom Ultrasonics’
facility in April 2015 revealed continued violations. Most concerning,
the company is unable to validate that the AERs can adequately wash and
disinfect endoscopes to mitigate the risk of patient infection.
Approximately 2,800 AERs manufactured by Custom Ultrasonics are currently
in hospitals and outpatient clinics throughout the United States. Given
the risks associated with the recalled medical device, the FDA also issued
a related safety communication. It recommends that health care facilities
currently using Custom Ultrasonics AERs transition away from their use
to alternative reprocessing methods as soon as possible.
If you or someone you care about has suffered serious harm due to a dangerous
or defective medical device, don’t hesitate to contact
a San Diego medical product liability attorney at the Law Offices of Robert
Vaage for a free consultation.