Custom Ultrasonics said yesterday that the FDA inspected and cleared its manufacturing facility in Ivyland, Penn, reinstating the manufacturing, packing and distribution of the company’s System 83 Plus washer and disinfector for use with non-duodenoscope endoscopes.
The Philadelphia-based company said that it was required to perform independent validation testing for its System 83 Plus water filtration system and its inline disc filter, which the FDA approved with no changes to the design.
New validations were also required for processing bronchoscopes and non-GI endoscopes which all met specified performance criteria, the company said.
Custom Ultrasonics said it is still working with the FDA to validate the System 83 Plus for duodenoscopes, after the agency said last August that the system should not be used with the devices in light of a number of “superbug” outbreaks.
“Custom Ultrasonics has undergone many changes in the past several years. The leadership of our new president and CEO has taken Custom Ultrasonics into a new era of progress. Custom Ultrasonics has significantly expanded its quality, regulatory and engineering departments, as evidenced by the company passing a recent inspection of its facility and quality system with no Form 483s, in preparation for Custom Ultrasonics’ re-entry into the automated endoscope reprocessing market and beyond,” the company wrote in a press release.