(Reuters) — The largest manufacturer of medical devices at the center of recent superbug outbreaks in the U.S. issued an "urgent safety notification" to health providers today, detailing new procedures for disinfecting the equipment and urging them to adopt the procedures "as soon as possible."
Manufacturer Olympus (TYO:7733) said in a 13-page letter and detailed instructions for cleaning the devices, called duodenoscopes, that a small-bristle brush required for the new cleaning procedures would be shipped "no later than May 8."
Olympus did not directly address whether the devices are safe to use until then and whether patients should, if possible, postpone procedures using the devices until hospitals have received the crucial brush. But until then, the company recommended cleaning the duodenoscope in accordance with the old instructions.
Duodenoscopes are flexible, lighted tubes inserted down the throat in a procedure called endoscopic retrograde cholangiopancreatography. More than 500,000 ERCPs using duodenoscopes are performed in the U.S. annually, usually to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions.
Because the devices are reusable, they are supposed to be thoroughly cleaned after each use so pathogens are not transferred from 1 patient to the next.
After 7 patients at the Ronald Reagan UCLA Medical Center were exposed to antibiotic-resistant bacteria apparently spread by improperly disinfected Olympus duodenoscopes, including 2 who died, federal regulators determined that microbes could spread even when the manufacturer instructions were followed.
The problem was the design of the instruments, regulators determined, in particular a movable part called the elevator that the FDA described as "extremely difficult to access."
In its letter, Olympus now recommends raising and lowering the elevator mechanism three times while the device is immersed in a disinfectant.
In addition, an area around the elevator must be cleaned with 2 different-sized brushes, 1 that hospitals already use and 1 that Olympus will ship by May 8.
The FDA has signed off on Olympus’s instructions. The agency reiterated them in its own safety communication which it issued before the brushes are available "so that facilities can adopt the new high level disinfection steps immediately and begin training" personnel.
