Murray demands records from scope-makers tied to ‘superbug’ infections

U.S. Sen. Patty Murray is demanding records from three medical-device makers tied to reports of “superbug” infections in the nation’s hospitals, including the manufacturer of scopes blamed for an outbreak at Virginia Mason Medical Center in Seattle.

Murray sent letters Tuesday to Olympus Corporation of the Americas, Pentax Medical and Fujifilm Medical Systems detailing continuing concerns about infections allegedly transmitted by specialized devices called duodenoscopes that federal health officials say can’t be properly cleaned, despite following manufacturers’ instructions.

“I have become increasingly concerned by the failure of Olympus to proactively warn patients and providers in the United States of the potential for infections,” Murray wrote.

She demanded that the device makers turn over by June 19 copies of any cleaning guidance, safety alerts or warnings sent to hospitals or regulatory agencies in the U.S. and other countries in the past decade regarding the procedure known as ERCP, or endoscopic retrograde cholangiopancreatography.

In addition, Murray asked for unredacted copies of all medical-device reports related to problems with ERCP during the same time period and copies of all documents regarding certain multidrug-resistant infections linked to endoscopes or duodenoscopes.

ERCP is a procedure performed in about 650,000 patients a year in the U.S. in which a specialized scope is snaked down the throat and into the gut to diagnose and treat problems primarily of the pancreas and bile duct.

The federal Food and Drug Administration (FDA) reported last month that the agency has received 142 reports of infection problems tied to the duodenoscopes since 2010. Each report could include multiple cases of infection.

At Virginia Mason, an outbreak between 2012 and 2014 involved at least 39 people who developed multidrug-resistant infections, including 18 who died, hospital officials have said. It’s not clear what role, if any, the infections played in the deaths.

FDA officials have reported at least nine outbreaks of infections tied to the scopes, including six linked to Olympus devices, two tied to Pentax Medical and one associated with Fujifilm, Murray noted.

Mark Miller, a spokesman for Olympus, said the firm received Murray’s letter and is reviewing it for further action. Pentax Medical and Fujifilm did not immediately respond to requests for comment.

In the letters, Murray also charged that the device makers have known since at least 2013 that the scopes could not be adequately cleaned, even when hospitals such as Virginia Mason meticulously followed the firms’ instructions. In addition, they delayed filing required reports of infection as required with the FDA, she said.

While the device makers warned hospitals and regulatory agencies in Europe of potential problems as early as January 2013, they issued no such warning in the U.S. until this year, Murray noted.