 |
| Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia |
Olympus revealed updated cleaning instructions for duodenoscopes linked to a recent superbug outbreak at UCLA, weeks after the FDA warned that the devices' complex design may contribute to the spread of deadly bacteria and called for label modifications.
As Reuters reports, the company detailed new ways to clean duodenoscopes in an "urgent safety notification," urging providers in a 13-page letter to adopt the procedures "as soon as possible." In the letter, Olympus recommended raising and lowering the elevator mechanism three times while the device is immersed in disinfectant to ensure thorough cleaning. The company also said it would ship a small-bristle brush required for the new cleaning procedures "no later than May 8."
But Olympus did not spell out whether the devices are safe to use until then or if patients should postpone procedures using duodenoscopes until after hospitals have received the brush, Reuters reports. The company recommends cleaning the devices according to the old instructions until the brush arrives, according to the letter.
Updated cleaning instructions come amid backlash for Olympus, as it faces a mounting pile of litigation over its duodenoscope devices. Last week, the company was slapped with two new lawsuits regarding contaminated Q180V duodenoscopes used during endoscopic retrograde cholangiopancreatography (ERCP) procedures at UCLA Ronald Reagan Medical Center. Olympus, the largest manufacturer of the devices, now faces more than 5 suits over duodenoscopes and said it's working with "relevant medical societies and our customers in research of this emerging issue and the development of additional safeguards to prevent infection associated with endoscopic procedures including ERCP."
The FDA is also facing pushback for its role in the recent superbug outbreak, answering to reports that Olympus asked the FDA to water down its guidelines on cleaning procedures for the products. Regulators subsequently issued updated final guidance on cleaning guidelines for the devices, taking a "step toward further reducing the risk of patient infection" by providing manufacturers with recommendations on cleaning instructions. The FDA has signed off on Olympus' latest cleaning instructions and plans to hold an advisory panel meeting on May 14-15 to discuss duodenoscopes' role in spreading infections to patients during certain surgical procedures.
- read Olympus' letter (PDF)
- get the Reuters story
- here's the FDA's safety notice