Olympus Warns That Its EUS Scopes May Pose Infection Risk

Olympus recently issued an Urgent Field Safety Notice regarding the usage of its Endoscopic Ultrasound Endoscopes (EUS). The recall from Olympus comes on the heels of several potential safety issues regarding endoscope reprocessing over the past several years. All of the major endoscope manufacturers had gone through several rounds of notices regarding the usage and disinfection of duodenoscopes. The latest safety issue around endoscopic ultrasound endoscopes will be sure to raise awareness of endoscopic cleaning practices once again.

The latest issue from Olympus stems from the potential risk of contaminated blood and other debris to remain in air/water channels of endoscopic ultrasound endoscopes even after reprocessing. As this article by Nancy Crotti at Mass Device summarizes:

“The global recall covers 8,522 devices distributed in the U.S., according to FDA records.

In an urgent field safety notice, the company listed 23 models of endoscopes that might contain residual blood and foreign matter in the air/water channel. These endoscopes are used in tough-to-diagnose diseases such as pancreatic cancer, according to the company. Olympus is asking medical staff to inspect each of the endoscopes before reprocessing; if they find a blockage, staff should not use the scope but contact the company for a repair.

Contaminated endoscopes have been associated with hospital- and healthcare-acquired infections, including deadly superbugs. In this latest case, Olympus reported to regulators any complaints it received about residual blood and foreign matter in the air/water channel, according to company spokesperson Jennifer Bannan. No patient injuries occurred and the FDA ruled it a Class II recall.

The recall affects 10 models in the U.S., only three of which are currently being sold, Bannan noted. Olympus declined to reveal the total number of endoscopes that might be affected by the recall, but said all were manufactured in Japan.

“Olympus has dedicated field specialists in the U.S. market deployed to help healthcare providers at all customer facilities train on and implement new inspection steps,” Bannan said.”

Read the entire article here: Olympus warns on endoscope infection risk

Hospitals continue to receive notices about the dangers that poorly disinfected endoscopes pose to patients. Hospitals must ensure that they’re doing everything they can to protect themselves and their patients from harm. The article points out that a major risk factor of using endoscopes stems from poorly disinfected air/water channels. Make sure that your staff is following the proper processes and protocols each and every time an endoscope is reprocessed. Endoscope tracking software such as iRIScope can display the proper workflow for reprocessing endoscopes and document the process electronically. Any breaches of protocol can be discovered in real-time to protect patients and identify which staff members need additional training on reprocessing techniques. You owe it to your staff and your patients to offer everyone the peace of mind that flexible endoscopes are being properly reprocessed every single time.