A Medical Device Daily

FDA has issued a “Dear Colleague” letter to practitioners as a follow-up to a Feb. 7 press statement that Custom Ultrasonics (Warminster, Pennsylvania) had signed a consent decree to an injunction in which the company agreed to stop manufacturing and distributing all devices, including its endoscope washers/disinfectors.

The affected products include the System 83 Plus Washer/Disinfector, the System 83 Plus MiniFlex Washer/Disinfector, and all accessories. FDA recommends that facilities using Custom Ultrasonics endoscope washer/disinfectors discontinue their use if alternative automated endoscope reprocessors (AERs) are available and it is feasible to make the switch.

FDA said it does “not recommend” manual reprocessing as an alternative to using functional AERs. It said, “the risks inherent in manual reprocessing outweigh the benefits.”

It said Custom Ultrasonics “failed to comply with FDA regulations that help ensure that medical devices are safe and effective.” However, it issued no recall of products already in use, and the company has said it disagrees with the conclusion that the products are not safe.

In a letter posted on the company’s web site in February, Frank Weber, owner and president of Custom Ultrasonics, acknowledged the “lack of certain manufacturing procedures and records,” but he disagreed with the FDA’s “assertion” that use of the products should be discontinued.

“We strongly believe that the System 83 Plus Washer/Disinfector, when used and maintained as directed, will continue to provide endoscopes that are safe for your patients as they always have done in the past.”

In its “Dear Colleague” letter, the agency cited various quality deficiencies: failure to establish an adequate quality assurance program for manufacturing the devices; inadequate procedures to prevent and correct problems; inadequate design control; inadequate procedures to process and analyze complaints; lacked of adequate procedures to report problems with these devices; failure to report problems it knew about to the FDA.

The agency said thse problems could result in increased risk of the transmission of pathogenic agents between patients.