A recent Sunday print edition of the Philadelphia Inquirer (Section G, April 12, 2015) features a detailed article about the challenges, complexities and responsibilities of cleaning and disinfecting – that is, of reprocessing – gastrointestinal GI) endoscopes.

This article focuses on the reprocessing of a specific type of GI endoscope that has become the subject of national concern: side-viewing duodenoscopes, which routinely become contaminated during use and, despite being reprocessed in strict accordance with the manufacturer’s reprocessing instructions, have transmitted dangerous, drug-resistant infections, with associated morbidity and mortality.

Click to read the Philadelphia Inquirer’s article: “Cleanliness is paramount with endoscopes.”

Duodenoscopes, which may also be called ERCP endoscopes, are used by experts to perform a specialized procedure called endoscopic retrograde cholangiopancreatography, or ERCP. This procedure is used to treat certain diseases and ailments of the biliary or pancreatic ductal systems, including obstructed ducts, tumors, and gallstones.

The FDA has concluded that the reason for these instruments transmitting disease is primarily due to their being designed with a complex component called a forceps elevator mechanism that is extremely difficult to clean. This mechanism may be used by physicians to direct accessories into the patient’s ducts as required for treatment.

After a review of the reprocessing instructions provided by all three primary endoscope manufacturers — Olympus, Pentax Medical and FujiFilm — for reprocessing their duodenoscope models, the FDA concluded that these instruction were inadequate, meaning that they had not been validated for effectiveness, although such validation prior to marketing a reusable device in the U.S. is essential.

A superbug outbreak in Philadelphia

Previously, the Philadelphia Inquirer reported in March, 2015, that Thomas Jefferson University Hospital (Philadelphia, PA) had investigated an association between these same types of GI endoscopes between January 2013 and June 1, 2014, to an outbreak of the bacterial “superbug” called carbapenem-resistant Enterobacteriaceae, or CRE.

Eight patients treated with duodenoscopes at this hospital became infected with CRE. Two patients died. But, according to the Inquirer, hospital officials could not prove the endoscopes were the source of the outbreak.

Click here to read the Inquirer’s March article, which is entitled “Jefferson provides data on endoscope, ‘superbugs’.”

Other CRE outbreaks

Investigations have now linked contaminated duodenoscopes to more than half a dozen CRE outbreaks in the U.S. since 2012, with dozens of patients being infected and as many as two dozen dying.

Cities that have also identified such deadly CRE outbreaks following ERCP since 2012 include hospitals in: Pittsburgh (PA), Seattle (WA), Los Angeles (CA), and Park Ridge (IL).

While the majority of outbreaks of CRE in the U.S. have been linked to the TJF-Q180V endoscope model sold by Olympus, whose market share of duodenoscopes and most other types of GI endoscopes in the U.S. is the greatest, superbug outbreaks with associated morbidity and mortality have also been linked to duodenoscopes sold by Pentax Medical and FujiFilm, the other two primary endoscope manufacturers.


Legal Reviews for Consumers, 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.


Certification

Studies have shown that the difficulty associated with reprocessing complex GI endoscopes begets shortcuts and skipped steps.

One proposed solution has been certification of endoscope reprocessing technicians, which New Jersey law currently requires.

According to the Philadelphia Inquirer, Pennsylvania State Rep. Mauree Gingrich (R., Lebanon) has sponsored a bill requiring surgical-processing technicians to be certified. But the measure was opposed by the Hospital and Healthsystem Association of Pennsylvania.

Highlights of the Sunday Inquirer article

The following highlights are from the Philadelphia Inquirer’s article about endoscope reprocessing (April 12, 2015, Sunday edition):

  • A few years ago, researchers from 3M Co. tested 245 GI endoscopes and found that a significant number had not been adequately cleaned.
  • Endoscope reprocessing is a tedious, multistep task performed by workers making as little as $13 an hour
  • Workers reprocessing endoscopes are required to be certified by just two states, New Jersey and New York.
  • A properly trained technician may require as many as two hours to thoroughly clean a GI endoscope, although times may vary if the hospital uses an automated endoscope reprocessor for part or all of the process.
  • Olympus’ instruction manual for reprocessing its TJF-Q180v duodenoscope is 106 pages, which the company supplemented in March, 2015, with an additional 10 pages of instructions to improve the endoscope’s cleaning effectiveness.

Quotes

— Michelle J. Alfa (clinical microbiologist):

  • “Most of the health-care facilities in the U.S. and Canada don’t actually monitor how well the cleaning is done by the staff.”

— Lawrence Muscarella, PhD (an infection-control consultant):

  • “How many (hospital infections) are we not capturing?”

— An endoscope reprocessing technician:

  • “I’m $13 an hour, and I’ve got the surgeon who built the hospital screaming at me. … What am I going to do?”
  • “It’s tedious, but attention to detail needs to be maintained,” he said

Posted 4/16/2015, Rev A.

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