The U.S. Food & Drug Administration has ordered the recall of nearly 3,000 automated endoscope reprocessors (AERs) made by Ivyland, PA-based Custom Ultrasonics over concerns that the devices have not been proven to be effective at preventing the transmission of infections.
FDA Reaffirms Endoscope Washer Recall After Company Tries to Correct Devices
February 25, 2016 – FDA has reiterated its recall of Custom Ultrasonics endoscope washers after the manufacturer tried to correct — rather than recall — the devices, according to the Regulatory Affairs Professional Society (RAPS). Customs Ultrasonics AERs were referenced in a recent Senate investigation into superbug outbreaks linked to duodenoscopes in the U.S. and Europe.
“FDA is so concerned about Custom Ultrasonics AERs’ ability to perform as marketed that the agency deemed a mandatory recall necessary to protect the public’s health,” the Senate report stated, adding that the devices were used to clean duodenoscopes “at least nine out of 16 domestic hospitals that experienced infections … accounting for about 141 patient infections.”
What are AERs?
Automated endoscope reprocessors are free-standing washing machines used to disinfect medical scopes and related accessories, so they can be used in the next procedure. FDA says Custom Ultrasonics’ AERs are used to clean endoscopes that inspect the gastrointestinal (GI) and pulmonary tracts.
Which Models are Affected?
The recall involves approximately 2,800 Custom Ultrasonics automated endoscope reprocessors currently in use in hospitals and outpatient clinics around the country. Affected models include the System 83 Plus, System 83 Plus 2, and System 83 Plus 9. The manufacturer was given a week to submit a written recall proposal.
Manufacturer Cited for Repeated Violations
In 2012, Custom Ultrasonics was ordered to stop manufacturing and recall its AERs after the company failed to obtain approval for software changes it made to one of the devices. That came as a failure to abide by a 2007 consent decree. As part of the decree, Custom Ultrasonics obtained clearance for the AERs, which allowed them to stay on the market.
Superbug Outbreaks Linked to Contaminated Duodenoscope
The actions follow several major outbreaks of the superbug CRE linked to improperly cleaned duodenoscopes, devices used in endoscopic retrograde cholangiopancreatography (ERCP) procedures. Improperly cleaned or reprocessed medical devices may facilitate the spread of infection among patients, increasing the risk of severe injury and death.