Faulty scope-cleaning machines which are normally used in more than 1,000 hospitals and clinics have been recalled, following an order issued by the Food and Drug Administration (FDA).
The mandatory recall initiated by the FDA on Friday, November 13 concerns 2,800 automated endoscope reprocessors (AERs), which are manufactured by Custom Ultrasonics.
More precisely, the machines are the following: System 83 Plus, System 83 Plus 2 (for cleaning 1-2 flexible endoscopes) and System 83 Plus 9 (for 2-4 flexible endoscopes).
In their place, medical facilities should employ other AERs or alternate sanitizing measures, such as liquid chemical sterilization and manual disinfection.
According to health officials, the company headquartered in Ivyland, Pennsylvania finds itself guilty of breaching several federal regulations on multiple occasions, even after the most recent FDA inspection which took place in April.
Therefore its products, which normally cost between $30,000 and $50,000, can no longer be commercialized or used, since they might pose an infection risk to patients.
Ever since August 10, there have been 21 complaints filed by healthcare centers against the device producer, following several bacterial outbreaks.
Apparently, despite being required to provide proof that its medical equipment can effectively clean and disinfect endoscopes, Custom Ultrasonics has failed to make that information readily available.
Moreover, it was reluctant to present potential limitations associated with using this type of device, thus showing little transparency and accountability.
As a result, according to Dr. William Maisel, chief scientist at FDA’s Center for Devices and Radiological Health, it was decided that the best course of action was to remove scope-cleaning machines from the market, so that public health wouldn’t be endangered.
Currently, the devices whose safety and effectiveness have been called into question are being employed in more than 1,000 outpatient clinics and hospitals across the United States.
Their role is to help sterilize endoscopes, between patient procedures, so as to avoid transmitting infections from one individual to another.
The decision to ban the commercialization of these potentially faulty devices has been in the making for a while now. Ever since 2007, Custom Ultrasonics had been functioning based on a consent decree, following a dispute with the FDA, which had claimed that its equipment might be unfit for use.
In fact, in 2012, the federal agency ordered another recall concerning scope washers, and asked Custom Ultrasonics not to produce such devices anymore. However, this prohibition was lifted shortly afterwards, after the company eventually managed to obtain approval for its new machine software.
Shockingly, the dangers hadn’t been communicated to medical providers, and nothing regarding these negotiations had transpired on the federal authority’s official website, nor through other means of communication. The Times eventually made these events public, sparking fury against the FDA, among consumer safety advocates.
Now, it appears that this recently imposed ban may also be linked to a CRE (carbapenem-resistant Enterobacteriaceae) outbreak, which killed 3 patients, and sickened 5 others, at UCLA’s Ronald Reagan Medical Center.
Duodenoscopes which had been cleaned using Custom Ultrasonic System 83 Plus 2 machines were believed to be the source of the infection, and it seems they might have been involved in several other contaminations with drug-resistant bacteria.
It may be that producers such as Olympus Corporation, Hoya and Fujifilm are also partially to blame, because recently released instruments are extremely complex and can’t be disinfected easily.
Meanwhile, representatives of the controversial Custom Ultrasonics are yet to issue a comment regarding this recall. In theory, they have a period of 7 business days to address this issue and devise a plan to remove the potentially life-threatening devices from hospitals.
Image Source: Custom Ultrasonics