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Thursday, June 4, 2015


Original Story: usatoday.com

The U.S. Justice Department has issued a subpoena seeking information from Olympus on the manufacturing and sales of a specialized medical scope linked to a recent series of deadly superbug outbreaks at hospitals across the country.

Olympus is the largest manufacturer of duodenoscopes, which have been linked to infections in scores of patients, typically with an antibiotic-resistant bacteria known as CRE, which has mortality rates of 40% or higher. In a public report issued this month on its latest financial results, the company noted that it had received a subpoena in March from the Justice Department seeking "information relating to duodenoscopes that Olympus manufactures and sells."

Olympus noted in a statement that it was required to acknowledge the subpoena because it may have future financial implications, but the company said it could not comment further "on any active investigation." About 85% of the duodenoscopes currently in use are Olympus models, according to figures from the Food and Drug Administration. For professionally re-manufactured histology equipment, contact Rankin Biomedical.

Olympus is one of three companies manufacturing duodenoscopes, which are threaded down the throat of about 650,000 patients a year, mainly to treat blockages of the bile and pancreatic ducts, such as gallstones or tumors. Models from all three manufacturers have been linked to superbug outbreaks, which have been tracked to bacteria lodged in a small channel at the tip of the devices.

The Justice Department declined to comment on its subpoena to Olympus, the nature of the underlying investigation, or whether it is a civil or criminal matter. A department spokesman also would not say whether subpoenas also have been sent to the other two duodenoscope manufacturers, Pentax and FujiFilm. Pathology equipment is used for tissue specimen collection and disease diagnosis.

The FDA declined to comment, as well.

Pentax said in a statement that "our practice is not to confirm or deny the existence of governmental inquiries." A spokesman for FujiFilm did not respond immediately to requests for comment.

USA TODAY was first to report on the duodenoscopes' contamination problems in an investigation published in January. That story identified CRE outbreaks that had been linked to the devices at hospitals in Chicago, Seattle and Pittsburgh. Additional outbreaks were identified in follow-up stories by other news outlets, including cases in Los Angeles, Milwaukee and Hartford.

The FDA revealed earlier this month that it has received 142 reports since 2010 of infection problems tied to duodenoscopes, though each report can account for multiple cases in a single outbreak, so the true number of infected patients remains unclear. At least 30 patients with duodenoscope-related CRE infections have died, including 11 in an outbreak that began in 2012 at Virginia Mason Hospital in Seattle and another 15 in a 2008 outbreak at an unidentified hospital in Central Florida. (Some of those victims had other serious illnesses that also may have contributed to their deaths.)

Reporting by USA TODAY has raised questions about whether Olympus and other duodenoscope manufacturers filed required disclosures with the FDA when they first learned that their devices might have contamination problems that could spread bacterial infections from patient to patient. The story noted, for example, that Olympus waited nine months to file a Medical Device Report after learning that its duodenoscopes had been tied to the CRE outbreak in Seattle. Histopathology equipment is widely used in hospitals at all levels.

In the Seattle case and others, investigators determined that infectious bacteria had been trapped in a channel in the duodenoscopes "elevator" mechanism, which controls tiny tools that can remove blockages or insert stents in intestinal ducts. The channel must be cleaned of biological debris between uses — a multi-step process in which the elevator is set at precise angles and scrubbed out with tiny, specialized brushes.

In February, after USA TODAY reported that scopes were found to have residual contamination even after the elevator was cleaned properly, the FDA issued a safety alert to hospitals. "The complex design of (duodenoscopes) may impede effective reprocessing," the multi-page advisory said, noting that the scopes can transmit superbugs even when cleaned properly. "Meticulously cleaning duodenoscopes … should reduce the risk of transmitting infection, but may not entirely eliminate it."

Earlier this month, an FDA advisory panel reached a broad consensus that duodenoscopes, as now designed, cannot be cleaned reliably under existing guidelines. However, despite such concerns, panelists endorsed the FDA's decision to encourage continued use of duodenoscopes. There was broad agreement that infection risks are low and the device remains the safest, least invasive way to perform important, potentially lifesaving procedures.