FDA orders Pennsylvania company to recall its scope-cleaning machines used at UCLA and over 1,000 other hospitals and clinics
The US regulators have asked a Pennsylvania company to recall its scope-cleaning machines used at UCLA and over 1,000 other hospitals and clinics, amid the going on investigation into superbug outbreaks across the nation.
On Friday, the Food and Drug Administration (FDA) said that it has ordered the recall because Custom Ultrasonics was continuously violating federal law and such lapses may lead to an increased risk of infection for patients.
The agency has estimated that roughly 2,800 automated endoscope reprocessors created by Custom Ultrasonics have been in use in hospitals and outpatient clinics across the US.
At many hospitals, these sophisticated washing machines play a key role, as they rely on the machines for disinfecting endoscopes at a fast pace for the next patient.
According to the regulators, the company failed to validate that the company’s equipment can satisfactorily wash and disinfect endoscopes. Officials said that the firm also didn't mention the bad events linked to its equipment in a timely manner.
Dr. William Maisel, chief scientist in the FDA's Center for Devices and Radiological Health, said, “We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations. The FDA's recall order is necessary to protect the public health”.
Custom Ultrasonics, based in Ivyland, Pa., representative didn’t revert back to requests for comment.
The action taken by FDA on Friday has sparked renewed criticism of the agency among patient advocates and medical experts, as per whom FDA takes a long time to pull dangerous medical devices off the shelf.
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