Today, November 13, 2015, the FDA ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs), about 2,800 in hospitals and outpatient clinics in the U.S. The FDA’s recall order applies to all Custom Ultrasonics AERs, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9. An FDA safety communication, also issued today, recommends that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.
The violations at the heart of the recall could result in an increased risk of infection transmission, including antibiotic-resistant strains. There are reports that endoscopes reprocessed by Custom Ultrasonics’ AERs were used in health care facilities that reported transmission of serious bacterial infections, according to the FDA recall announcement.
The recall order stated that Custom Ultrasonics violated both federal law and a consent decree entered with the company in 2007.
“We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “The FDA’s recall order stemmed from the company’s continued violations of federal law and the consent decree and is necessary to protect the public health.”
In August of this year, the FDA issued a Safety Communication regarding supplemental measures to enhance duodenoscope reprocessing (cleaning before reuse). These measures were approved after the FDA was informed of instances of outbreaks of bacterial contamination after the use of a duodenoscope, even following strict adherence to manufacturer reprocessing instructions.
The infections involved in these outbreaks were from dangerous antibiotic strains of bacteria, including E. coli. They were resistant even to the last-resort antibiotic Carbapenum, thus the name Carbapenum-Resistant Enterobacteriaceae (CRE) infections. The hospitals involved in three of the outbreaks include:
What are Automated Endoscope Reprocessors?
Automated endoscope reprocessors (AERs) are are used to wash and high-level disinfect endoscopes to decontaminate them between uses, according to the FDA. They are designed to expose outside surfaces as well as interior channels of endoscopes to chemical solutions in order to kill microorganisms and prevent the spread of infection from these reusable medical devices. An endoscope must be thoroughly cleaned to remove any visible debris prior to placing it in an AER, which includes manually scrubbing the elevator mechanism and the recesses surrounding the elevator mechanism.
The Consent Decree and Continued Violations
In 2012, under the terms of the consent decree, the FDA ordered Custom Ultrasonics to stop manufacturing and distributing all AER device models and components and ordered their recall after the company failed to obtain FDA clearance following a significant change to the software operating system for one of its AERs. After Custom Ultrasonics obtained clearance for the significant change to the software operating system, the cleared devices were permitted to remain on the market. Since the 2012 order, the FDA has not authorized Custom Ultrasonics to resume manufacturing or distributing any AERs, though the company has continued to service them.
The FDA’s most recent inspection of Custom Ultrasonics’ facility in April 2015 documented continued violations. 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.
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Attorney Fred Pritzker and his Bad Bug Law Team are helping people sickened in E. coli outbreaks. You can contact Fred and his team with our free consultation form. Our law firm has won millions for clients in personal injury and wrongful death lawsuits against companies responsible for outbreaks of serious infections.