SCOPES: Murray Continues Oversight of Device Connected to Fatal Outbreak in Washington State, Presses Manufacturers on Safety Following Alarming Food and Drug Administration Findings

FDA found one in twenty closed-channel duodenoscopes remained contaminated even after cleaned

Murray asks three duodenoscope manufacturers how they plan to respond to the findings to ensure patient safety

Murray released a report in 2016 detailing how contaminated duodenoscopes had led to patient deaths, and pushed to strengthen FDA’s ability to address issues related to device safety in 21^st Century Cures

Murray: “It is unacceptable that one in twenty patients who undergo a procedure using a duodenoscope may acquire an infection as a result of that procedure.”

Washington, D.C. – Today, U.S. Senator Patty Murray (D-WA), Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee sent letters to Olympus, Pentax, and Fujifilm asking about the companies’ plans to respond to findings from the Food and Drug Administration (FDA) showing alarmingly high rates of contamination in certain duodenoscopes, even after cleaned, putting patients at risk of infection.

Senator Murray has been fighting for years to provide oversight of these medical devices to ensure patient safety, starting with her work to respond to an outbreak of an antibiotic-resistant infection at Virginia Mason Medical Center in Seattle, Washington in 2015 that was linked to the devices. In 2016, she released a report detailing how certain duodenoscopes had spread life-threatening, antibiotic-resistant infections—including superbug infections—among patients, and worked to strengthen the FDA’s authority to address issues related to device safety in the 21^st Century Cures Act.

“I am writing today to understand how your company plans to respond to these troubling findings and what changes may be necessary going forward to ensure patient safety.  While important steps have been taken to reduce outbreaks, it is unacceptable that one in twenty patients who undergo a procedure using a duodenoscope may acquire an infection as a result of that procedure – even when hospitals have followed cleaning instructions correctly,” wrote Senator Murray.

Read Senator Murray’s letter below and find a PDF of the letter to Olympus HERE.

Find a PDF of the letter to Pentax HERE.

Find a PDF of the letter to Fujifilm HERE.

May 9, 2019

Nacho Abia

President and Chief Executive Officer

Olympus Corporation of the Americas

3500 Corporate Parkway

Center Valley, PA 18034

Dear Mr. Abia:

Last month, the Food and Drug Administration (FDA) released new data revealing alarmingly high rates of contamination in certain duodenoscopes, even after the device is cleaned.  These data raise serious questions about your company’s ability to ensure the health and safety of patients who undergo procedures using Olympus-manufactured closed-channel duodenoscopes.  I am writing today to understand how your company plans to respond to these troubling findings and what changes may be necessary going forward to ensure patient safety.  While important steps have been taken to reduce outbreaks, it is unacceptable that one in twenty patients who undergo a procedure using a duodenoscope may acquire an infection as a result of that procedure – even when hospitals have followed cleaning instructions correctly. 

In October 2015, FDA ordered your company to conduct postmarket surveillance studies to understand how closed-channel duodenoscopes are reprocessed in real-world settings and evaluate the effectiveness of cleaning techniques on duodenoscope contamination.[1]  In March 2018, FDA issued a warning letter to Olympus for failure to conduct the postmarket surveillance studies; Olympus responded to the warning letter with plans to meet FDA’s study milestones.  In December 2018, FDA released interim findings from the sample studies.[2]  These studies revealed 3 percent of samples tested positive for high concern organisms (including antibiotic-resistant bacteria), and 3 percent tested positive for low concern organisms (those unlikely to cause disease but still indicative of cleaning failure).  On April 12, 2019, FDA released an update from the sampling studies showing the rate of contamination is even higher: 5.4 percent of all properly collected samples tested positive for high concern organisms, and up to 3.6 percent of properly collected samples tested positive for low to moderate concern organisms.[3]  These rates far exceed the contamination rate FDA hoped to see: less than 1 percent or as close to zero as possible for duodenoscopes.

Since 2015, I have been conducting oversight of duodenoscopes, and in 2016, I issued a report highlighting serious problems with the ability of regulators and manufacturers to identify and respond to patient safety issues.[4]  I remain concerned about the risk of infection posed by these devices and committed to ensuring rigorous oversight of the safety of Olympus medical devices.  To that end, I request that you provide the following information no later than May 23, 2019:

1. A copy of each Medical Device Report (MDR) that Olympus has submitted to the FDA related to contamination of a closed-channel duodenoscope between January 2017 and today. 

1. The rate of contamination for both high concern organisms and low to moderate concern organisms identified in interim results from the FDA-ordered sampling studies.

1. When does Olympus project it will complete both FDA-ordered postmarket surveillance studies?

1. Has Olympus conducted any analysis of these interim findings?  If so, please provide that analysis.

1. How does Olympus plan to address the findings of its postmarket surveillance studies?  What is Olympus’s position on whether closed-channel duodenoscopes remain safe for patient use?

1. What feedback has Olympus received from users of the Olympus closed-channel duodenoscopes concerning the cleaning and reprocessing instructions or any issues related to device maintenance?

1. Has Olympus engaged in any effort to re-design or modify the closed-channel duodenoscope in order to address concerns about the ability of the device to be properly cleaned?

Thank you in advance for your attention to this matter.  If you have any questions, or would like to further discuss compliance with this request, please contact Carly Rush or Elizabeth Letter with Senator Murray’s HELP Committee Staff at 202-224-0767.

Sincerely,

Patty Murray

United States Senator

Ranking Member, Senate Committee on

Health, Education, Labor, and Pensions

cc:       Lamar Alexander

United States Senator

Chairman, Senate Committee on

Health, Education, Labor, and Pensions

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