Olympus has issued updated manual reprocessing instructions for duodenoscopes that were linked to a rash of superbug infections, prompting a recall of the medical devices, earlier this year.
The FDA has reviewed the updated reprocessing instructions and validation data and determined that they meet the Agency's expectations.
In February, the FDA reported that the complex design of duodenoscopes may thwart the process to clean and disinfect the reusable devices. If not properly reprocessed, residual body fluids and organic debris may remain in microscopic crevices of the device, despite an attempted cleaning and high-level disinfection.
If these residual fluids contain microbial contamination, patients may be exposed to serious infections. The duodenoscopes made by Olympus, Pentax and Fujifilm Medical Systems were linked to at least 25 incidents of antibiotic-resistant infections that sickened an estimated 250 patients worldwide, according to a Jan. 13 report by the Senate Committee on Health, Education, Labor and Pensions.
At least 32 patients at Virginia Mason Hospital and Medical Center in Seattle were infected and 11 later died, though whether the deaths were a direct result of the infections remains unclear.
The Senate report found that Olympus knew by May 2012 that the duodenoscope model used at Virginia Mason could harbor and spread bacteria even after proper cleaning. In a Jan. 15 letter to healthcare professionals, Olympus America said it was conducting a voluntary removal/corrective action on all of the closed-channel duodenoscopes.
Mark A. Miller, vice president of Corporate and Medical Communications for Olympus Corporation of the Americas, said at the time that Olympus did not agree with all of the report's conclusions, but added that the company would review recommendations to help ensure patient safety.
He said the report demonstrates a shared responsibility with duodenoscope manufacturers, hospitals, manufacturers of automated endoscope reprocessors, and the Food and Drug Administration.
The report found that an estimated 20 U.S. hospitals traced antibiotic-resistant infections directly to the devices, but did not proactively communicate information to federal agencies. Advocate Lutheran General Hospital in Park Ridge, Illinois, with 32 patients infected, was among them; as were Virginia Mason Hospital and Medical Center in Seattle, Washington (32 patients), UMass Memorial Medical Center in Worcester, Massachusetts (20 patients), and and Carolinas Medical Center in Charlotte, North Carolina (18 patients).
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The FDA was also subject to criticism in the Senate report, which said the agency failed to recognize the prevalence of duodenoscope-linked infections and to respond quickly.
For its part, the FDA, following on the heels of Olympus' new reprocessing instructions, issued a recommendation to hospitals that they train staff on the updated instructions and implement them as soon as possible.
Olympus sent a letter dated March 14 to healthcare facilities and other users of the 160 F/VF duodenoscope models outlining the updated, validated reprocessing instructions. An updated reprocessing manual and a box of brushes required for the updated cleaning procedure accompanied the letter.
The FDA has encouraged healthcare professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.