Flexible endoscopes already showed up as No. 1 on the ECRI Institute’s Top 10 Health Technology Hazards, and now they are listed as No. 4 on the organization’s Top 10 Patient Safety Concerns.

ECRI officials say the medical technology has been on its radar for years, even before a series of deaths due to carbapenem-resistant Enterobacteriaceae infections that were caused by improperly cleaned endoscopes. ECRI says the complex design of endoscopes — and duodenoscopes in particular — is something of a catch-22. On one hand, the design makes them highly effective and, on the other hand, they are extremely difficult to clean.

“These scopes have been designed to do a special job in the hands of physicians, but they haven’t necessarily been designed to be easily cleaned and disinfected,” says James Davis, MSN, R.N., CCRN, CIC, HEM, senior infection prevention analyst, ECRI.

The Food and Drug Administration (FDA) has been urging duodenoscope manufacturers and reprocessors to rectify the issue with new validated reprocessing instructions. Olympus validated new reprocessing instructions for its model TJF-Q180V duodenoscopes March 2015 and followed suit with its TJF-160F and TJF-160VF models in March. Fujifilm Medical Systems issued new validated instructions for the Model ED-530XT in December, and Pentax followed with new instruction for its ED-3490TK Video duodenoscopes in February.  

In addition to following new recommended steps laid out by manufacturers, ECRI states that organizations should stay on top of medical device alerts and recalls, and review reprocessing procedures for all endoscopes.  

Inadequate antimicrobial stewardship also made this year’s list. Although the latest Health & Human Services report shows that hospital-acquired conditions are down by 17 percent, ECRI emphasizes that overall antibiotic resistance is a “nationwide concern and new, sometimes deadly, drug-resistant infections continue to emerge.”

“Action is needed now to avoid an antibiotic apocalypse,” says Sharon Bradley, R.N., CIC, senior infection prevention analyst, ECRI. “It sounds dramatic, but people need to understand that that’s where we’re headed.”

Rounding out ECRI’s 2016 Top 10 Patient Safety Concerns are:

  • Nonintegrated information technology systems
  • Patient identification errors
  • Inadequate management of behavioral health issues
  • Inadequate test results reporting and follow-up
  • Inadequate monitoring for respiratory depression in patients prescribed opioids
  • Medical errors related to improper measurements
  • Unintentionally retained objects
  • Failure to embrace culture of safety

William Marella, executive director of ECRI’s Patient Safety Organization operations and analytics, says that the list is not meant to dictate which issues an individual health care system or facility should address, “but is an opportunity for organizations to take stock and see whether these issues are things that they are facing and whether they have processes and systems in place to address them.”

Access the full report here.