Impelled by reported infections spread by contaminated intestinal probes, the U.S. Food and Drug Administration on Friday cracked down on the maker of devices used to clean the instruments between insertions into patients’ bodies. The FDA ordered Custom Ultrasonics to recall all of its automated endoscope re-processors, or AERs, from health care facilities due to regulatory infractions that the agency said in a statement “could result in an increased risk of infection transmission.”
“The agency also issued a safety communication today recommending 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,” according to Friday’s FDA statement.
The timing was noteworthy; for the FDA acted at a time when reports have surfaced in regard to the spread of bacterial infections from improperly cleaned, or “re-processed,” scopes.
“These actions are part of the FDA’s commitment to patient safety and ongoing efforts to minimize the risk of patient infections associated with reprocessed endoscopes, including duodenoscopes and scope accessories,” the agency wrote. “The FDA has been working with federal partners, manufacturers and other stakeholders to better understand the critical factors contributing to bacterial infections associated with duodenoscopes and how to best mitigate them.”
The FDA described duodenoscopes as “flexible, lighted tubes that are threaded through the mouth, throat, stomach, and into the top of the small intestine (the duodenum). They contain a hollow channel that allows the injection of contrast dye or the insertion of other instruments to obtain tissue samples for biopsy or treat certain abnormalities. Unlike most other endoscopes, duodenoscopes also have a movable ‘elevator’ mechanism at the tip. The elevator mechanism changes the angle of the accessory exiting the accessory channel, which allows the instrument to access the ducts to treat problems with fluid drainage.”
Patients have been as active as the FDA, but in a different manner, in holding duodenoscope makers accountable. The FDA’s action came amid the filing of, for lack of a better term, duodenoscope lawsuits that infected patients have been filing.
If you ask an FDA official about the agency’s enforcement action, he or she might suggest that Custom Ultrasonics brought it upon itself.
For instance, the company had a bad spring inspection, and the FDA was not pleased with the aftermath of its examination.
“The FDA’s most recent inspection of Custom Ultrasonics’ facility in April 2015 documented continued violations,” the agency announced Friday. “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.”
And this episode happened after the company and the federal government entered into their 2007 consent decree! Basically, the consequences of violating federal regulations were practically spelled out in 2007.
“We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations,” said Dr. William Maisel, 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.”
Patients who were diagnosed with a bacterial infection after undergoing a duodenoscope procedure can do something about it: Call 1-866-LAW-2400 for a free consultation as to what legal options are available.