The U.S. Justice Department is seeking thousands of pages of documents from manufacturers of a specialized medical scope linked to a series of deadly outbreaks of the Carbapenem-Resistant Enterobacteriaceae, or CRE superbug.
Update: PENTAX Updates Duodenoscope Cleaning Instructions
February 19, 2016 – Following multiple reports of drug resistant bacteria linked to endoscopes used for Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures, PENTAX Medical has been working with the FDA to validate the reprocessing procedures for the ED-3490TK Video Duodenoscope.
What’s the Problem?
June 9, 2015 – Three manufacturers of duodenoscopes — Olympus, Pentax and FujiFilm — have recently been subpoenaed as part of the probe, according to USA TODAY. A subpoena also was delivered to Virginia Mason Hospital in Seattle, the site of one of the worst outbreaks of antibiotic-resistant bacterial infections associated with contaminated endoscopes.
The subpoenas do not reveal specifically what’s being investigated; however, the document sent to Virginia Mason relates to healthcare violations as defined in federal criminal statutes. Last month, Olympus received a subpoena relating to its duodenoscope manufacturing process, but the broader scope of the investigation has not been made public.
According to the Virginia Mason subpoena, the investigation is being handled by the U.S. attorney’s office in Newark, N.J. The Justice Department has not confirmed or commented on the probe.
The subpoenas were issued in response to growing concerns over the safety of duodenoscopes, which are used in 650,000 medical procedures annually, most often to treat tumor or gallstone blockages in the bile and pancreatic ducts. The devices were first linked to outbreaks of bacterial infection in January, which have since been reported at hospitals in Chicago, LA, Seattle, Pittsburgh, Hartford and other cities. Most cases involved the CRE superbug, a deadly antibiotic-resistant bacteria with mortality rates of 40% or more.
Investigators have found that bacteria can become lodged the duodenoscopes, even after following manufacturing-recommended cleaning protocols, and transmit infections from patient to patient. In May, an FDA advisory panel determined that the instruments cannot be effectively cleaned as currently designed; however, the panel stopped short of advising a recall because infection risks are low and the scopes remain the only option for many important medical procedures.
FDA has received at least 142 reports of infections passed by duodenoscopes since 2010; however, each report can account for multiple cases in a single outbreak, so the actual number of infections is unclear. To date, at least 30 patients have died after developing CRE or other similar bacterial infections that were passed by the scopes, including 11 in the Virginia Mason outbreak and another 15 in a 2008 outbreak at a Florida hospital.
“I’m pleased that the Department of Justice is moving forward with an investigation,” said Senator Patty Murray, (D-WA). “Patients need to be able to trust that the devices used for their treatment are safe and effective.”