ECRI Institute Warns of Hazards for Flexible Endoscopes, Ventilators

ECRI Institute is raising safety concerns associated with medical devices ranging from flexible endoscopes to ventilators, calling for awareness of hazards that the products pose to patients.

Duodenoscopes can be problematic because they have a moveable elevator mechanism and a cable — tiny parts that are particularly difficult to clean and disinfect properly.

Flexible endoscopes topped ECRI’s 2016 list of the top 10 health technology hazards, following a series of fatal infections associated with duodenoscopes that were inadequately reprocessed (IDDM, Nov. 13, 2015).

“The poor quality of cleaning was very instrumental in why people were getting infections. It turns out that CDC found the technicians doing this work were in many cases following the manual that was provided by the vendor,” Chris Lavanchy, engineering director of the ECRI health devices group, said during a press briefing in early December at the institute’s office in Plymouth Meeting, Pa.

The technicians were cleaning correctly, yet the devices were still somewhat contaminated before they went on to the disinfection step, he added.

The issue raised questions over how such a well-engineered device could have such a flaw. “The answer is that people felt that as long as they put it in the automated endoscope reprocessor, it would be able to handle whatever might be left behind,” Lavanchy said.

Last year, the FDA issued final guidance strengthening controls on reprocessing in response to the outbreak of antibiotic-resistant bacteria linked to duodenoscopes. The FDA recently gave its blessing to Fujifilm Medical Systems’ updated manual reprocessing instructions for the ED-530XT duodenoscopes to replace those on the original labeling (see related story).

ECRI is urging facilities to emphasize to their reprocessing staff that inattention to the cleaning steps within the reprocessing protocol can lead to deadly infections.

Ventilator Hazards

Ventilators are among other devices that made ECRI’s 2016 list. The devices can be confusing to the user if manufacturers utilize different terminology for the modes of ventilation.

“One issue is that manufacturers make up what they think is a good name, but that name tells you nothing about what the actual mode does,” said Jaime Schlorff, senior project officer of the health devices group at ECRI.

ECRI is encouraging manufacturers to use standardized nomenclature for their modes of ventilation. Under the proposal, the mode would have three basic components:

• The control variable, consisting of pressure or volume;
• The breath sequence, consisting of continuous, intermittent or spontaneous ventilation; and
• The triggering mechanism.

“We are not pushing that they standardize the modes so much as they standardize the naming of the modes. They are coming out with very advanced modes of ventilation that are better, but the problem is they give them such vague names,” said Schlorff.

The dramatic growth in the number of modes has pushed this issue to the forefront. Twenty years ago, there were three modes; today, there are 300.

“The feedback that I am getting from respiratory therapists and clinicians is they don’t use the advanced modes because they don’t know what they do, and they don’t want to risk injuring an already critically ill patient. So, it is unfortunate that these intelligent modes are not even being used,” she added. — Jonathon Shacat