Medical Scope Infection Probe Expanded by Dept. of Justice

The Department of Justice is widening an investigation into recent infections linked to medical scopes, issuing subpoenas to three manufacturers and one Seattle hospital seeking information relevant to patient injuries and deaths linked to cleaning problems with endoscopy tools. 

A number of recent reports indicate that the subpoenas were sent to Olympus Corp. Fujifilm and Pentax, as well as Virginia Mason Medical Center, although the Justice Department has not confirmed the investigation. Both Olympus and Virginia Mason officials have confirmed receiving the subpoenas.

The investigation, which could lead to criminal charges, comes after a number of duodenoscope hospital infection outbreaks, including an outbreak of carbapenem-resistant enterobacteriaceae (CRE) that was revealed in February at UCLA’s Ronald Reagan Medical Center. The outbreak caused at least seven infections, two deaths, and raised concerns that nearly 200 other patients had been placed at risk by duodenoscopes manufactured by Olympus Corp.

The infections have been linked to problems with medical scope “reprocessing” instructions, which are used to clean the devices before they are used by another patient during an endoscopic retrograde cholangiopancreatography (ERCP) procedures.

The subpoenas appear to be focused on communications between the device manufacturers and Virginia Mason hospital. Attorneys for the hospital have told the media that the probe is centered around potential healthcare offenses.

Virginia Mason, along with a number of patients and loved ones of patients who died due to medical scope infections, have sued Olympus in recent months.

Last week, Olympus filed a countersuit against Virginia Mason, claiming that the hospital failed to properly use and clean the devices and that it damaged the company’s reputation by making claims that the devices could not be properly cleaned according to the company’s instructions.

Despite its claims, Olympus revised the cleaning instructions for the devices in March, after FDA officials echoed Virginia Mason’s claims that the devices could not be cleaned safely according to the company’s instructions.

Last month, an FDA advisory committee determined that manual cleaning is still important and needs to continue, but the panel also recommended that the FDA reclassify duodenoscopes from semi-critical medical devices to critical medical devices and said reprocessing needs to be taken from “high level disinfection” processes to full sterilization.

Despite the concerns, the panel also determined that the benefits provided by ERCP procedures still outweigh the risks associated with the use of duodenoscopes. They called on the FDA to develop a guide of best practices to make sure that manufacturer instructions are followed, in addition to the need for better instructions overall.

Before the meeting, FDA reviewers issued a report which found that the FDA knew for years that the cleaning instructions were inadequate and that the devices were linked to infection outbreaks, but failed to issue a warning until this February.

Several medical scope infection lawsuits have already been filed against Olympus over the duodenoscopes linked to the UCLA outbreak. The complaints allege that design problems that make the scopes especially difficult to clean, placing patients at higher risk of contracting illness.

Exposure to the CRE superbug following an ERCP poses a serious risk of illness, as the bacteria kills 40% to 50% of patients after spreading to the bloodstream.