FDA recalls medical device used in York Hospital

The Custom Ultrasonics Automated Endoscope Reprocessors, used at York Hospital and Apple Hill Surgical Center, have been linked nationally to infections, but none reported at WellSpan facilities.

David Weissman

WellSpan has identified another device it uses at York Hospital has been linked to infections, though no cases related to this device have been reported at WellSpan facilities.

The Custom Ultrasonics Automated Endoscope Reprocessors, which the U.S. Food and Drug Administration ordered for recall on Nov. 13, is used at York Hospital and Apple Hill Surgical Center, according to WellSpan spokesman Barry Sparks. The recall is due to an increased risk of infection transmission, according to an FDA news release.

A heater-cooler device used at York Hospital has also recently been linked to infections, though that device has not been recalled.

Neither device is not used at Memorial Hospital, Hanover Hospital or OSS Hospital, according to company spokespeople.

Custom Ultrasonics is the manufacturer of the device, which is used to wash and disinfect endoscopes — which are used for internal examinations — between uses.

The FDA estimates approximately 2,800 of the devices are currently in hospitals and outpatient clinics throughout the U.S., according to the release. The FDA ordered Custom Ultrasonics to stop manufacturing and distributing the devices in 2012 after the company failed to obtain FDA clearance, following a significant change to the software operating system.

In an email, FDA spokeswoman Deborah Kotz wrote: "several health care facilities with confirmed or possible duodenoscope-associated infections used the Custom Ultrasonics System 83 Plus for high-level disinfection of duodenoscopes after Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures."

Endoscopic Retrograde Cholangiopancreatography is a technique used to look at the bile ducts, pancreatic duct and gallbladder.

Duodenoscopes are types of endoscopes used only in ERCP procedures.

Local reaction: In an email, Sparks wrote that WellSpan has seen no evidence of contamination with these devices and no reported infections. At both facilities, WellSpan has an up-to-date process for appropriately disinfecting the devices and uses a third-party vendor to maintain and validate the performance of the cleaners, Sparks wrote.

The FDA recommends that all health care facilities currently using the device transition to alternate methods of reprocessing their endoscopes as soon as possible. Kotz wrote that the timing of when hospitals need to remove the recalled devices has not yet been set.

Sparks wrote that WellSpan has finalized a plan to transition away from the devices, and the company is in active discussions with another manufacturer to acquire and install replacement devices as soon as possible.

The units are classified as Class II medical devices, according to the FDA, which are considered medium risk, with Class I being lower risk and Class III being high risk. A devices' classification determines the FDA's degree of regulation over the products.

Also classified as a Class II medical device are the heater-cooler devices, which have been linked to bacterial infections in open-heart surgery patients at York Hospital and Penn State Milton S. Hershey Medical Center.

The hospitals have combined to identify 11 Nontuberculous microbacteria, or NTM, infections among open-heart surgery patients believed to be related to the device. Seven of those patients have died.

Reach David Weissman at dweissman@yorkdispatch.com.