03.20.15

Murray Presses FDA, Calls for Full Review of Practices Surrounding Medical Scopes Linked to Drug-Resistant Infections

Scopes linked to outbreaks of antibiotic-resistant infections at Virginia Mason and facilities across the country

(Washington, D.C.) – Today, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Patty Murray (D-WA), sent a second letter to the Food and Drug Administration (FDA), this time calling for a full review of FDA practices surrounding duodenoscopes, the special medical device linked to outbreaks of an antibiotic-resistant infection at Virginia Mason Medical Center in Seattle, Washington and in health care facilities around the country. 

“…In light of the tragic impact these outbreaks have had on patients and families in my state and nationwide, I write today to seek additional information from the agency,” Murray wrote in the letter. “We must do everything we can to understand how these outbreaks occurred and find out what more can be done to protect patients.”

At a recent HELP Committee hearing, Murray asked FDA Commissioner Dr. Margaret Hamburg to commit to this review. Murray also sent a letter in early February to the FDA following the outbreak of infections at Virginia Mason Medical Center in Seattle and in facilities across the country, urging the agency to provide health care professionals with updated safety guidance and best practices, which the agency has now done.‎

Full text of the letter:

Dear Commissioner Hamburg,

Thank you for your actions in response to my February 3, 2015, letter regarding “superbug” infections at Virginia Mason Hospital in Seattle, Washington, and in other facilities around the country.  In that letter, I urged the Food and Drug Administration (FDA) to take several steps in the wake of these serious outbreaks.  The agency’s actions last week represented important progress.  However, in light of the tragic impact these outbreaks have had on patients and families in my state and nationwide, I write today to seek additional information from the agency.  We must do everything we can to understand how these outbreaks occurred and find out what more can be done to protect patients.

As you know, it appears that these infections were potentially caused by duodenoscopes cleaned according to current protocols, but nonetheless harboring carbapenem-resistant Enterobacteriaceae (CRE) bacteria.  In Washington State, at least 32 patients were infected and, although the cause is not clear, 11 died.

I appreciate that, as requested in my earlier letter, the FDA has issued new guidance to better ensure the safety of all “reprocessed” medical devices.  Specifically, the guidance outlined that manufacturers of certain types of scopes, including duodenoscopes, are expected to demonstrate that testing of cleaning protocols and procedures is sufficiently rigorous and then provide complete testing reports to FDA for review. 

In my earlier letter, I also discussed the importance of FDA providing updated safety information to health care providers and stressed the need to work closely with manufacturers on product labeling.  I appreciate that last Thursday’s guidance also provided updated information for reprocessing of devices in health care settings.  This information will help to ensure that health care professionals are informed about current best practices.

In addition, I appreciate your collaboration with the Centers for Disease Control and Prevention (CDC) on a protocol, released last week, that hospitals can use to culture these devices to detect bacterial contamination – a protocol modeled on the best practices used at Virginia Mason Hospital in Seattle. 

All of these actions are productive steps.  However, since I sent my previous letter, new information has surfaced that heightens my concern about this tragic situation.  For example, I understand that the reprocessing procedures recommended by manufacturers of currently-marketed duodenoscopes may not have been undertaken and validated in a sufficiently rigorous manner.  There are also reports that one manufacturer failed to seek FDA clearance before marketing a specific duodenoscope model, although I understand from FDA that there is no evidence at this time that the lack of clearance is associated with infections.  Finally, some public sources have indicated that FDA received numerous adverse event reports dating back to 2013 related to microbial transmission via reprocessed duodenoscopes.  At least 15 of the patients noted in these adverse event reports may have died from CRE infections.

This additional information raises questions about why updated guidance, including enhanced cleaning protocols, was not released sooner and the rigor of FDA’s examination of post-market data to assess the risks of these devices for patients if not adequately cleaned during reprocessing.

I am glad that you committed to me at the March 10, 2015, Health, Education, Labor and Pensions (HELP) Committee hearing to undertake a full review of this situation.  We must determine the facts, and only then can we formulate additional steps to minimize the risk to patients in the future.  As part of FDA’s efforts, I request that you provide the following information to the HELP Committee:

  1. FDA’s internal review of the adequacy of reprocessing procedures, including review of the validation procedures undertaken by manufacturers of all currently-marketed duodenoscopes, bronchoscopes, endoscopes, and other devices in Appendix E of the new final guidance entitled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.”
  2. Updates regarding FDA’s work with manufacturers of all marketed duodenoscopes on any necessary revisions to product design and labeling, particularly with regard to reprocessing procedures.
  3. A summary of all adverse event reports from 2011 forward for duodenoscopes, bronchoscopes, endoscopes, and other devices in Appendix E of the guidance, including when and how FDA responded to these reports.
  4. An assessment of the adequacy of the 510(k) process regarding revisions to product design and labeling, particularly with regard to reprocessing procedures for duodenoscopes, bronchoscopes, endoscopes, and other devices in Appendix E.

I understand, as you noted at the hearing, that duodenoscopes are important devices that serve a critical role in medical care.  But as we have seen, insufficient cleaning procedures can create huge risks and cost lives.  We cannot afford to be complacent regarding the danger that CRE infections, or other “superbugs,” pose.  I look forward to continuing to work together to improve reusable device cleaning and monitoring recommendations, and I request that you continue briefing my staff regularly.  I appreciate your prompt response to my questions above and all of the steps being taken to protect the public from further infections.

Sincerely,

Patty Murray
Ranking Member

Cc: Lamar Alexander, Chairman 

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