Stories of illness and the dangers associated with contaminated duodenoscopes and endoscopes swept through the media recently when CRE infections sickened multiple patients in California hospitals and allegedly killed at least two.
Much of the attention and blame for those deaths and illnesses was focused on a process called reprocessing. Reprocessing is the process of cleaning a duodenoscope or endoscope and making it ready for the next patient. Given that these devices can cost upward of $40,000 each, using a new one for every patient is cost prohibitive.
Because of their shape and flexibility, the devices are notoriously difficult to clean. Even after multiple FDA orders and re-issued cleaning manuals, scopes contaminated with CRE and other bacteria, presumably from biological matter left over from previous patients, were still making their way into hospital operating rooms.
However, in a stunning development, a reprocessing device itself has been recalled by order of the Food and Drug Administration. All 2,800 Custom Ultrasonics automated endoscope reprocessors (AERs) have been ordered recalled from the facilities in which they are used.
The recall stems from company action set in motion three years ago. In 2012, CU significantly changed the software in their AERs. Such a change requires FDA re-approval of the device. When CU failed to re-obtain that clearance they were ordered to stop manufacturing new reprocessors. They were allowed, however, to continue servicing the reprocessors already in use.
Custom Ultrasonics was given the opportunity to restore their standing with the FDA during this time. Instead, the company continued to violate the terms of their agreement and made no effort toward returning the company to FDA compliance.
After an FDA inspection of the CU facility in April of this year, the agency had finally had enough. Found to be in continued violation of FDA regulations, CU lost the last remaining piece of its reprocessing business as all existing AERs were ordered pulled from operating rooms and outpatient care centers across the country.
Reports indicate that CU AERs were in use in at least some of the facilities reported to be part of the recent bacterial outbreaks. If proven true, the allegations against Custom Ultrasonics may take the story of contaminated duodenoscopes and endoscopes from bad to worse.