Two Endoscope Cleaners Do Not Meet FDA Standards
THURSDAY, Feb. 8 (HealthDay News) -- Custom Ultrasonics of Buckingham, Pa., has agreed to stop manufacturing two endoscope washer and disinfector systems until the company's manufacturing methods are brought into line with U.S. Food and Drug Administration requirements. The FDA recommends current users of the two devices to contact the manufacturer and use alternative methods where possible due to the risk of patient-to-patient transmission of pathogens.
The decree affects the System 83 Plus Washer/Disinfector and the System Plus 83 Mini-flex Washer/Disinfector, which fail to comply with the FDA's Current Good Manufacturing Practice requirements. As well as bringing its manufacturing methods and controls into line, the company has also committed to develop and implement proper procedures for written device reports.
Although the FDA has not received reports of any adverse events, Custom Ultrasonics' manufacturing methods posed a public health threat because of the risk of transmission of pathogens, with potentially lethal consequences, from one patient to another, according to the federal agency.
"Other options include using an alternative device or following appropriate protocols to manually wash and disinfect the device. If no alternative is available then health care providers should carefully weigh the risks and benefits of using these products," according to the FDA statement.
