Medical device reports — or, MDRs, which manufacturers of duodenoscopes and other medical devices are required to submit to the FDA within 30 days of learning that their device might have infected or otherwise harmed a patient — are filed late, and sometimes not at all, according to a recent report in USA TODAY.

Click here to read this USA TODAY article entitled: “Reports to Feds on deadly bacteria outbreaks arrived late” (Peter Eisler, April 15, 2015)

“Pattens of concern”

MDRs filed by manufacturers are important quality records that the FDA uses, among other regulatory tools, to monitor a device’s safety.

These records provide the FDA, analysts, consumers, and researchers with an “early warning system” for identifying safety problems and “patterns of concern” with a device. Based on filed MDRs and the severity of the adverse event, the FDA could initiate a regulatory action, or even recall the device.

The importance of prompt filing of medical device reports (MDRs) to patient safety and improve device quality cannot be overstated. — Lawrence F Muscarella PhD

The public can search the FDA’s database of MDR reports, known as the “MAUDE database,” by clicking here.

Critics have suggested, however, that the MDR process is flawed, adding that prompt filing of several “superbug” infections linked to duodenoscopes in 2008 at two hospitals in Florida might have prodded the FDA to take important safety actions years ago, thereby possibly preventing the more than half dozen outbreaks of the deadly superbug called “CRE” that since 2012 have been linked to multiple patient injuries and deaths.

This system of filing these (MDR) reports is the only thing in place that can tell us that devices are having problems, (and) … it often puts the interests of (device) manufacturers and the hospitals ahead of the public. … It’s a pretty weak system. — Consumers Union, the publisher of Consumer Reports.

A Florida “superbug” outbreak

Providing an initial warning sign if not a red flare, these hospitals in Florida encountered a deadly CRE outbreak in 2008. Seventy patients were colonized or infected during this superbug outbreak, with 15 dying.

Investigators attributed the cause of these infections to faulty manual cleaning of duodenoscopes.

(As a sidebar, it appears that these 70 infected patients may not have been informed of the cause of their infections, either by the hospitals or Florida’s Department of Health. Refer to the April 18, 2015, on-line issue of the Los Angles Times: “A veil of secrecy shields hospitals where outbreaks occur.”)

Duodenoscopes are used more than 500,000 times a year in the U.S. to perform endoscopic retrograde cholangiopancreatography, or ERCP.

This gastrointestinal procedure treats and diagnoses disorders and diseases of the bile and pancreatic ducts. Examples include the use of duodenoscopes to drain fluids, identify cancers, and remove gallstones.

Design concerns

But then, 4 years later beginning in 2012, a number of other investigations similarly linked outbreaks of CRE (and related superbugs) in other states across the U.S. — including Seattle (WA), Pittsburgh (PA), Philadelphia (PA), Los Angeles (CA), and Park Ridge (IL) — to contaminated duodenoscopes, just like those linked to the outbreak in Florida, in 2008.

Suggesting that conclusions about the precise cause of this CRE outbreak in Florida were incomplete or in error, investigations of these other, subsequent superbug outbreaks since 2012 have found that — not faulty manual cleaning — but the designs of the duodenoscope, which hinder thorough cleaning and brushing, might be to blame.

According to these investigations, these complex models of endoscopes feature “difficult-to-clean” crevices and recesses documented to trap infectious materials, resulting in patient-to-patient disease transmission with multiple instances of associated morbidity and mortality.

We are aware that there are reported duodenoscope-associated infections that have occurred for which we have not received MDRs, and we are looking into whether some of those reports should have been submitted. — Food and Drug Administration (FDA)

The FDA agrees with this assessment, stating that the recent spate of CRE outbreaks resulted in patients being with CRE despite hospital staffers cleaning and disinfecting — also known as “reprocessing” — the duodenoscope in strict accordance with the respective endoscope manufacturer’s published reprocessing instructions.

Revised reprocessing instructions

In response, on March, 26, 2015, Olympus (but not, to date, Pentax Medical or FujiFilm, both of whom also sell duodenoscope models used to perform ERCP in the U.S.) released new validated cleaning instructions for its TJV-Q180V duodenoscope — click here to download a copy of these revised instructions, which confirm the inadequacy of the manufacturer’s previous set of reprocessing instructions.

Duodenoscopes manufactured by all three of their primary manufacturers in the U.S. — Olympus, Pentax Medical and FujiFilm — have been implicated in at least one CRE outbreak following ERCP performed in the U.S. since 2012.

The majority of these superbug outbreaks have been linked to the Olympus TJF-Q180V duodenoscope, however, which — in addition to possibly being more complex in design and more difficult to clean than earlier series of Olympus endoscopes and, too, than current models sold by both Pentax Medical and FujiFilm — has been used in the U.S. since 2010 without a legal clearance or approval.

MDR process flawed

Critics also cite what’s one of several “Achilles’ heels” of the FDA’s oversight of medical devices:

that the responsibility for disclosing an injury linked to a medical device rests all but solely in the laps of the manufacturers themselves — not independent regulators or health officials.

Based on the identified causes of the recent outbreaks of CRE in the U.S., and argument can be made that the safety and quality of GI endoscopes and the automated devices used to clean and disinfect them are more self-regulated than is ideal. Lawrence F Muscarella, PhD

Filed MDRs can attract the unwanted attention of federal regulators, providing an incentive, at times, for injuries linked to a device’s shortcomings to be relegated by the manufacturer to user error, with the manufacturer claiming in the filed MDR that a healthcare staff member, not the device, was to blame for an injury or infection.

And, if hospitals have invested in the purchase of an expensive device or technology, they, too, can express a bias towards overlooking the device’s possible contribution to patient injury, all of which can have significant public health implications.

Therefore, because of an inadvertent bias that may cause a manufacturer not to file a MDR after concluding, sometimes in error, that its device was not involved in or to blame for an injury, critics contend that the use of the FDA’s MAUDE database to provide an accurate picture of a device’s potential for injury — and, for example, to draw conclusions about the true incidence of superbug infections caused by duodenoscopes — is flawed.

Moreover, when a manufacturer doesn’t file a MDR, the FDA rarely knows. As a consequence, an unsafe device may remain on the market too long without correction, injuring possibly scores of patients.

Only if the FDA learns of a problem with a device through an inspection of the manufacturer’s facility and operations or by way of a news story, a hospital’s report, or a “tip” might action be taken.

And when manufacturers do file MDRs, the FDA may conclude, correctly or not, that all is in order and no further scrutiny or examination of the device is required.


Legal Reviews and Reports for Hospitals, Manufacturers, Patients:  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.


MDR’s lack of transparency

Furthermore, linking a specific injury or outbreak to a manufacturer’s filed MAUDE report is typically challenging, because of a lack of transparency.

The FDA redacts the originally filed report, removing arguably important identifying information, including the hospital’s name, even the hospital’s state where the injury occurred.

The name of the manufacturer, however, is not redacted and is generally the field or parameter the public uses to search the FDA’s MAUDE database.

An Inspector General audit

Discussed in the USA TODAY article, an audit by the Inspector General (IG) for the Department of Health and Human Services, in 2008, found that the FDA has no reliable system in place to know when — or how frequently — manufacturers fail to file MDRs, noting that the FDA “rarely” takes action when these reports are filed late.

There are exceptions, however.

The USA TODAY investigation that is the subject of this article reports that the FDA filed suit in 2014 to stop a New Jersey company’s production of a medical gel linked by a hospital in Michigan to almost two dozen infections. Notably, the suit includes charges that the company did not file a timely MDR after learning that its gel was contaminated and potentially infected patients.

When did Olympus first learn that its duodenoscope was causing CRE infections and outbreaks? … What did Olympus do with that information?” — Rep. Ted Lieu (D-Calif.)

Rep. Ted Lieu

In March, 2015, Congressman Ted Lieu (D-California) wrote a letter to Olympus (and Pentax Medical) asking it about the circumstances surrounding the more than eight outbreaks of CRE, between 2014 – 2014, that officials have linked primarily to the design of its TJF-Q180V duodenoscope, which the FDA claims hinders thorough cleaning.

Among other questions he posed to the manufacturer, Congressman Lieu asked Olympus: “Why did Olympus not seek FDA approval of the redesign of Olympus’ duodenoscope in 2010?” [A copy of Congressman Lieu’s letter, along with Dr. Muscarella’s review of it, may be read by clicking here.]

Likely prodded by Congressman Lieu’s actions, 10 members of Congress also recently wrote a letter to the FDA both expressing concern and seeking details of the FDA’s progress for preventing additional outbreaks of CRE during ERCP.

And, based on new troubling information, Rep. Lieu is once again calling for congressional hearings to better identify all of the causes and contributing factors of these outbreaks.

According to an article by the Los Angeles Times published on-line on April 20, 2015, nearly two years before the recent superbug outbreak at UCLA’s Ronald Reagan Medical Center, which was first reported on February 19, 2015, Olympus had warned hospitals in Europe about the risk of duodenoscopes transmitting deadly diseases.

After learning about this, Rep. Lieu is quoted in this Los Angeles Times article as saying:

“With every passing week, more information is coming out showing that the manufacturer and regulators had a lot of information about risks of superbug outbreaks from these scopes, and nothing much happened until press stories started coming out.”

Other salient findings

USA TODAY’s investigation provides interesting insight into the filing of MDRs, and, too, into the FDA oversight of this process.

Additional facts presented in USA TODAY‘s article dated April 15, 2015, include:

  • USA TODAY reviewed the FDA’s public database for MDRs on duodenoscope-related infections and did not find enough reports to account for all the CRE outbreaks linked to the devices.
  • At least six of the CRE outbreaks linked to duodenoscopes occurred at hospitals that used models made by Olympus. The company, which dominates the duodenoscope market, declined repeated requests for comment on its MDR filings.
  • Despite duodenoscopes being tied to the transmission of CRE and related drug-resistant bacteria among patients in at least eight U.S. hospitals between 2012-2014, their manufacturers did not always notify the FDA of these outbreaks until months later and, in some cases, no MDRs were ever filed.
  • Although Olympus filed a MDR report with the FDA in response to learning in 2013 of a deadly outbreak of CRE that a hospital in Seattle (WA) had linked to its use of the Olympus TJF-Q180V duodenoscope, it filed the report several months later, in August 2014.  And, Olympus’ account of the circumstances of this hospital’s outbreak, according to USA TODAY, differ “sharply” in some critical aspects from the hospital’s account — for example, contrary to official reports that the manufacturer visited the hospital at the time of the outbreak, Olympus’ filed MDR states that the hospital “declined” Olympus request to visit and evaluate the hospital’s reprocessing practices during the time of the hospital’s superbug outbreak.
  • According to the aforementioned Inspector General (“IG”) report published in 2008: “The inability to obtain complete and usable information in (MDRs) hinders analysts’ review.” The IG report further recommended that the FDA consider tougher enforcement measures to “identify and target manufacturers … with a history of noncompliance with (MDR) submission requirements.”
  • The FDA has stated that it does not intend to recall the Olympus TJF-Q180V duodenoscope, even though the device is without a legal clearance or approval. According to the FDA, these instruments remain the safest, least invasive option for treating certain gastrointestinal ailments.

Article by: Lawrence F Muscarella, PhD; posted 4-21-2015, Rev A.

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