FDA (FINALLY) warns makers of medical scopes in wake of deadly ‘superbug’ outbreaks:

[Faryn Balyncd]

Nice to know that the FDA has issued a "warning letter", 6 months after a fatal carbapenem-resistant Enterobacteria ("superbug&quot outbreak via duodenoscopes was reported at UCLA's Ronald Reagan Medical Center (which occurred despite knowledge of the problem since at least 2009).

FDA warns makers of medical scopes in wake of deadly ‘superbug’ outbreaks
by Brady Dennis August 17

Investigators believe carbapenem-resistant Enterobacteriaceae (CRE) bacteria acquired from specialized medical devices known as duodenoscopes have infected hundreds of patients and have been linked to numerous deaths. . . .The Food and Drug Administration has sent warning letters to manufacturers of a specialized medical scope that has been associated with outbreaks of a deadly “superbug” virus, saying the companies failed to adequately report problems with the devices and, in some instances, failed to ensure that they could be cleaned properly between uses. . . The warnings come after the devices, known as duodenoscopes, have been linked in recent years to outbreaks of tough-to-fight bacterial infections involving carbapenem-resistant Enterobacteriaceae, or CRE.

A recent outbreak involving contaminated scopes at Ronald Reagan UCLA Medical Center in Los Angeles left at least two people dead, and officials said scores of other patients potentially were exposed to the dangerous bacteria. At Cedars-Sinai Medical Center, also in Los Angeles, officials this year said four patients had been infected by a superbug after undergoing a duodenoscope procedure. A Connecticut hospital said it had contacted nearly 300 patients who might have been exposed to a dangerous type of drug-resistant E. coli after undergoing duodenoscope procedures.

Such incidents prompted the FDA in February to alert doctors and hospitals that duodenoscopes can be difficult to sanitize between uses and “may facilitate the spread of deadly bacteria.” . . . Since 2012, other outbreaks have occurred at Advocate Lutheran General Hospital near Chicago, where 44 people were infected, and at the Virginia Mason Medical Center in Seattle, where at least 32 patients became ill and 11 died. . . .


http://www.washingtonpost.com/news/to-your-health/wp/2015/08/17/fda-warns-makers-of-medical-scopes-in-wake-of-deadly-superbug-outbreaks/

The sad reality is that since these fiberoptic instruments cannot be heat sterilized without destroying the fiberoptics, that consequently whether whether or not a patient gets scoped by an instrument contaminated with resistant bacteria (or, for that matter, with hepatitis C, which has been documented to have been spread via colonoscopes) depends on:
(1) how effective the mechanical cleansing and chemical/gas cleansing protocol is,
(2) how rigorously each facility executes the cleansing protocol between procedures, and
(3) how many $40,000 scopes each facility is willing to purchase.

Culturing protocols devised for duodenoscopes to prevent CRE
An ideal protocol, however, may call for more of the expensive scopes
May 1, 2015


Responding to a series of outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) linked to duodenoscopes, the Centers for Disease Control and Prevention (CDC) has developed an interim protocol for culturing the devices before use to create a greater margin of safety for patients.

But as others have noted, the approach is not foolproof and could be costly if facilities determine that they must purchase more scopes to adopt the protocol. Duodenoscopes are priced in the $40,000 range, according to researchers who came up with a similar protocol at the ECRI Institute in Plymouth Meeting, PA. The CDC protocol provides a plan to determine how scopes may be sampled and how to test the samples in a lab. (To access the protocol, go to http://1.usa.gov/1MwdevG.)

“Like other proposed solutions to the problem of duodenoscope-related CRE infections, we recognize that there are both pros and cons associated with using screening cultures,” Michael Bell, MD, deputy director of the CDC’s Division of Healthcare Quality Promotion, said in a blog post. “There can be concerns about cost, as using this method will mean that the duodenoscopes will not be available for use while waiting for the results of the cultures. This could mean that a facility would need to buy additional scopes in order to be sure they have the equipment available when needed. Additionally, the failure to grow bacteria from the areas sampled may not guarantee that there are no bacteria present anywhere on the scope.”

http://www.ahcmedia.com/articles/135214-culturing-protocols-devised-for-duodenoscopes-to-prevent-cre

Peculiar that in this day and age, we find that decades after the introduction of wonderful high tech diagnostic and therapeutic gadgets, that our faith that these instruments are in fact sterile seems to have possibly been misplaced.

Yet we now have an FDA sending warning letters after 6 years of knowledge of the problem.

(It is a bit disturbing that, some non-bacterial infections which have been documented to have been spread via endoscopes, in particular hepatitis C virus, generally does not manifest itself until years after exposure, making the source of infection less likely to ever be recognized.)





And how might we encourage meticulous compliance with, & execution of, mechanical/chemical cleansing protocols that, having a small margin of error, have been repeatedly shown to be subject to human failure?

How about publicly posting the results of bacterial cultures of each facility's endoscopes?

How about shining a little sunlight on the endoscopic sterilization practices which effect not only the bottom line of healthcare facilities we use, but whether or not our interventions will result in benefit or harm?

[Faryn Balyncd]

1. Study finds biologic contaminants in 15% of colonoscopes, 30% of UGI scopes:

...a study at five hospitals nationwide finds that three out of 20 endoscopes (pictured at right) that are inserted in the rectum to examine the colon for cancer retained bits of “biological dirt” from past patients, putting people at risk for hepatitis and infection. “Three out of 20 is an unexpectedly high number of endoscopes failing a cleanliness criterion,” Marco Bommarito, an investigator with 3M’s infection prevention division, which conducted the study, told the Los Angeles Times. “Clearly, we’d like no endoscopes to fail a cleanliness rating.” The study, presented at the annual conference for the Association for Professionals in Infection Control and Epidemiology, in Fort Lauderdale, Fla., found that rates for colon dirt were as high as 30 percent for reusable endoscopes used for upper gastrointestinal exams, the Times reported.

The instruments are supposed to be cleaned with a detergent or enzymatic cleaner and then soaked in a powerful disinfectant, according to the federal Centers for Disease Control and Prevention (CDC), which issued new sterilization guidelines in 2008. The issue of improperly sanitized equipment was in the news last month after an Atlanta outpatient surgery center sent letters to 456 clients warning them they may have been exposed to HIV as well as hepatitis B and C. The staff had neglected to do the final disinfectant soaking, center officials told the Atlanta Journal-Constitution.

Another 60 clients were tested last year after undergoing the procedure at a hospital in Alamosa, Colo. In 2010, the Palomar Medical Center in San Diego notified 3,400 patients that they could receive free tests for diseases after having had endoscopies with potentially dirty equipment. According to the CDC, about 50 million Americans undergo colonoscopies each year to screen for colon cancer. More outbreaks have been linked to contaminated endoscopes than to any other medical device, the CDC reported.

http://blog.aarp.org/2013/06/12/colonoscopy-instruments-putting-people-at-hepatitis-and-infection-risk/