The U.S. Food and Drug Administration (FDA) cleared the first duodenoscope with a disposable distal cap, improving access for cleaning and reprocessing.
“The new disposable distal cap represents a major step toward lowering the risk of future infections associated with these devices,” says William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
In January 2017, the FDA issued a Safety Communication about a design issue with the ED-3490TK, an earlier version of the Pentax duodenoscope, identifying the potential for cracks and gaps to develop in the adhesive that seals the distal cap onto the scope, potentially allowing fluids and tissue to leak into it.
New features of the Pentax ED34-i10T include a single-use detachable and disposable distal cap, simpler user interface, improved ergonomics, improved image quality, and a reduced length. www.fda.gov; www.pentaxmedical.com
Autocam Medical recertified to ISO 13485:2016
Officials from Autocam Medical announce that their Plymouth, Massachusetts, facility has been recertified to ISO 13485:2016. ISO 13485 requires that the certified organization demonstrate quality systems that are effectively implemented and maintained.
The scope of the certificate is “contract manufacturer of machined non-sterile medical device components and instruments, built to customer specifications.” www.autocam-medical.com