The February 4, 2015, edition of The Seattle Times newspaper publishes the article: “After Virginia Mason superbug, Patty Murray urges FDA action”
The article’s sub-title states: “U.S. Sen. Patty Murray has called on the federal Food and Drug Administration to finalize guidelines and step up tracking after a deadly superbug outbreak tied to contaminated medical devices at Virginia Mason.”
Notable quotes from the article
U.S. Sen. Patty Murray, D-Washington:
U.S. Sen. Patty Murray, D-Wash., sent a letter on February 2, 2015, to the federal Food and Drug Administration’s (FDA) Commissioner Margaret Hamburg urging stronger action, writing:
- “Due to their complicated and intricate design, duodenoscopes are harder to clean and to disinfect than many reusable medical devices.”
- “Even when providers carefully follow manufacturers’ labeling regarding cleaning and disinfections of duodenoscopes, contamination still poses grave risks to patients.”
Food and Drug Administration (FDA):
- “The FDA has been actively working with federal partners, manufacturers and other stakeholders to better understand the issues that contribute to infections and what can be done to mitigate them.” (Comments by Leslie Wooldridge, an FDA spokeswoman)
Virginia Mason Medical Center’s Dr. Andrew Ross (section chief for gastroenterology):
- “We’re very happy to see that Sen. Murray is taking this up on the national level.”
- “One of the things we really hope to do by disclosing and discussing our experience here has been to elevate this issue to a national level.”
- Hospital officials would like manufacturers to change the design of the scopes to make them easier to sterilize, he added.
Legal Reviews for Patients, Hospitals, Manufacturers: Click here to read about Dr. Muscarella’s expertise and legal assessments of the causes of healthcare-associated infections, including “superbug” outbreaks linked to contaminated GI endoscopes and other reusable medical equipment.
Lawrence F. Muscarella, PhD:
(Not every one of Dr. Muscarella’s quotes appeared in the final printed newspaper article.)
- “Fast action is warranted at this time to prevent further instances of patient morbidity and mortality linked to GI endoscopes contaminated with CRE,” he said, praising Senator Murray’s efforts.
- “Unless there are clinical data in the patient’s medical record demonstrating that the superbug did not play a direct or indirect role in mortality, healthcare-associated CRE would be deemed a contributing factor to (if not a primary cause of) the death of an infected patient. This assessment is likely relevant to the contents and completeness of the infected patient’s death certificate.”
- A misquote: “(Muscarella) urged families … to hold hospitals accountable for the infections.” Actual quote: “Muscarella believes that transparency (for example, the personal notification of impacted patients of a medical error) will necessarily improve accountability, provide more focused funding, and enhance vigilance, resulting in significant reductions in the infection rates of U.S. hospitals.”
- “The risk of CRE outbreaks can be mitigated, if not entirely eliminated, by manufacturers and hospitals working together, with with the FDA’s and CDC’s participation, to improve health care quality and ensure GI endoscopy’s safety.”
- “There are more ways than one to skin a cat. It may be that the guidelines do not have to be changed, but rather disease transmission will be prevented by an enhancement of the design of certain models of GI endoscopes to facilitate their more effective cleaning and disinfection.”
- “I welcome and commend the senator’s involvement and request for prompt action by the FDA. Fast action is warranted at this time to prevent further instances of patient morbidity and mortality linked to GI endoscopes contaminated with CRE. I will work with the senator if she requests my help.”
- “I recommend that the FDA finalize its draft guidance for reusable devices making the revision (not the draft) permanent. I also agree with the senator to advise hospitals and health care providers to educate themselves. More specifically, this draft guidance from 2011 is entitled: “Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.”
- “The publication of this draft guidance document would be a step forward. But it is not up-to-date and does not specifically discuss CRE or the risk of their transmission via ERCP endoscopes. No matter, parts of this draft address some of the current concerns about instrument design and disease transmission.”
- “I provided comments to the FDA in 2011 in response it the posting of the draft guidance document, and I can provide them to the senator upon request. It’s unclear why the project has not been finalized.”
- “CRE and their related superbugs are associated with a mortality rate of as high as 50%. Therefore contribution of this ‘nightmarish’ bacteria to an infected patients death is likely self-evident and significant.”
- “I am considering recommending patients who have undergone ERCP (and endoscopic ultrasound, or EUS) within the past few years to contact their GI physicians and ask whether the hospital where they underwent the procedure has within the past few years linked two or more infections of CRE (i.e., an outbreak) to a contaminated GI endoscope.”
- “This interaction may be necessary because not every hospital and state department of health, or the CDC, is necessarily personally informing the infected patients of an identified CRE outbreak. If the patient is told yes, that the hospital had linked an outbreak of resistant bacteria to GI endoscopy, then the patient may consider asking their GI doctor whether the patient should undergo screening for possible CRE colonization.”
- “I do not favor at this time a change to the guidelines, or hospitals buying a millions dollars of additional endoscopes to mitigate risk. Doing so would be shifting an unnecessary expense onto the hospital. Rather, I recommend that the manufacturers first consider enhancements to the current design of their ERCP endoscopes to facilitate their more effective cleaning and disinfection.”
- “Contact of any high-level disinfectant with a medical device’s cleaned CRE-contaminated surfaces, channels or forceps mechanism will destroy remaining CRE in less than 2 minutes. The solution in my opinion is not likely a change to a guideline or the standard of care, but an enhancement of the instrument’s design and “cleanability.” If an enhancement of the device’s design does not solve the problem, then I might favor a change in the guidelines.”
Legal Reviews for Hospitals, Patients, Manufacturers: Click here to read about Dr. Muscarella’s expertise and legal assessments of the causes of healthcare-associated infections, including “superbug” outbreaks linked to contaminated GI endoscopes and other reusable medical equipment.
Article by: Lawrence F Muscarella, PhD; updated: 2/9/2015, Rev A.