FALSE CONFIDENCE? Evidence suggests that current IFUs and standards aren't rigorous enough to ensure that endoscopes are adequately reprocessed, say experts.

Has the time come to acknowledge that sterilization, and not just high-level disinfection, is what's called for in endoscope reprocessing? "The evidence suggests that current IFUs and standards aren't rigorous enough," says Cori Ofstead, MSPH, president and CEO of healthcare research company Ofstead & Associates in St. Paul, Minn. "And we now know that they weren't based on real-world evidence of effectiveness."

When we asked a panel of more than 200 Outpatient Surgery Magazine readers how confident they were that their facility will never be the source of an endoscopy-related outbreak, 29% said they were "extremely confident," and 11% admitted they were "not as confident as [they'd] like to be." The other 60% are confident, just not extremely so, perhaps because reprocessing is such a difficult chore.

To wit, one-third of our respondents agreed with this statement: "The large number of tasks involved in high-level disinfection of endoscopes is so complex that it's difficult to be confident that it's being done right every time."

But lack of confidence in the specifics doesn't seem to translate into a lack of confidence overall. "This indicates a misunderstanding of the nature of risk," says Ms. Ofstead, who reviewed our survey results. And the risks, she adds, go well beyond the complexity of the process, no matter how diligent your employees are.

"Human factors and skipped steps are only part of the problem," she adds. "Clinicians often continue to use scopes that have critical defects, and residual contamination is more common when scopes are damaged. Furthermore, outbreaks have occurred even in cases when no breaches were identified."

Cutting it close?
We also asked whether respondents see themselves in this statement: "We place a high value on efficiency and throughput in our facility, which means that we may occasionally be in danger of cutting it a little too close when it comes to endoscope reprocessing."

OVERLY DEPENDENT? What happens if the particularly diligent individual who makes sure all steps are followed to the letter doesn't show up one day?

A huge majority (82%) disagree, insisting, in effect, that the emphasis on speed never compromises safety (14% acknowledge that yes, emphasis on speed is a concern, and 4% say they're not sure).

"Efficiency is never paid for by shortcuts," asserts one respondent.

But, as Ms. Ofstead points out, many also say they rely on 1 or 2 "particularly diligent individuals" to make sure things are done properly. And several suggest that their efforts could be compromised without those key people. "This suggests inadequate systems and vulnerability to breaches any time that person is not at the helm," she adds.

Theadus Stallings, RN, clinical manager of Carolina Gastroenterology Associates in Wilson, N.C., sounds another note of caution: "Even though an employee may have been taught to do all the steps correctly, that doesn't mean they're doing all of the steps when they're not being observed."

Not only is the process "very time consuming with its many steps," notes another respondent. "But they also seem to add requirements that change the processes and make it difficult to keep current."

And if everything isn't done perfectly every time, "the whole enterprise comes crashing down," says Ms. Ofstead.

"We're human," says another respondent. "So one is never safe from the possibility. One missed step could cause an incident."

CAUTION SIGNS
9 Problems That Could Lead to Outbreaks in Your Facility

NOT THEIR JOB Automated endoscope reprocessors won't adequately disinfect if you don't pre-clean dirty endoscopes in the OR.

How can you improve the odds that high-level disinfection will keep your facility outbreak-free, at least until sterilization becomes standard practice? These are the primary areas of concern, says Cori Ofstead, MSPH, president and CEO of healthcare research firm Ofstead & Associates in St. Paul, Minn.:

• unrecognized damaged scopes;
• defoaming agents and lubricants that harbor biofilm and that can't be removed from scope;
• relying on automated endoscope reprocessors to clean dirty endoscopes (scopes not pre-cleaned in the OR);
• rinsing scopes with contaminated water (for example, from poorly maintained or dirty tubing, or from inadequate water-filtration-system maintenance);
• failing to dry endoscopes;
• storing endoscopes in unventilated storage cabinets;
• using bare hands and/or dirty containers to transport endoscopes;
• neglecting to clean, disinfect, and perform preventive maintenance on reprocessing equipment; and
• inadequate monitoring of reprocessing effectiveness.

— Jim Burger

Self audit
Do you frequently audit your endoscope reprocessing practices? What about cleaning verification tests and/or visual inspections to ensure that endoscope reprocessing is being done correctly every time? 89% of our respondents say yes, they frequently audit, and 87% say they test or inspect. That's the good news.

The bad? "We audit at least once a year," says one respondent. "This is done on a quarterly basis, or sooner if needed," says another. "We do weekly culture audits on our scopes," says a third.

In other words, says Ms. Ofstead, audits and inspections aren't being done nearly often enough. Consider that protocols for sterile instruments call for audits to be done with every cycle, for chemical indicators to be put into every tray or peel pouch, or for biological indicators to be used every day or with every load. If audits and verification tests are done less often, can you really be sure that endoscope reprocessing is effective?

"They need to begin doing these quality checks now, and they should be done every day," says Ms. Ofstead.

Moreover, if you perform thorough inspections, you should expect to occasionally see problems with scopes that require re-cleaning, repairs, and more frequent maintenance. But don't blame your reprocessing techs, says Ms. Ofstead. After all, scopes used for messy and bloody procedures are tough to clean, and if they aren't immediately pre-cleaned in the OR, residue becomes virtually impossible to remove.

Critical point
A panel of stakeholders assembled this past fall by the Association for the Advancement of Medical Instrumentation (AAMI) recommended that endoscopes used for therapeutic and diagnostic purposes be reclassified as critical, not semicritical. If that happens, high-level disinfection would no longer be considered adequate.

But the group, which included Ms. Ofstead — in addition to representatives from healthcare organizations, manufacturers, testing labs, research groups, academia, and government, among others — acknowledged that such a transition would be challenging, and would need to happen gradually.

Most of our respondents (60%) agree that a switch to higher standards is needed, despite their confidence that they're currently meeting the challenge nonetheless.

"I have wanted endoscopes to be sterilized for years," says Trish Hebert, RN, BSN, MS, nursing director at the Springfield ASC in Flourtown, Pa. "Even the best high-level disinfection cannot kill spores of certain bacteria. And viruses and bacteria are becoming more virulent."

Help needed
But good intentions can go only so far without cooperation from manufacturers. Nearly half of respondents say they already sterilize their heat-sensitive endoscopes, but among those who don't, lack of guidance from manufacturers ranks high on the list of reasons. Many others point to a lack of equipment and space, or they insist that it's unnecessary if high-level disinfection is performed correctly.

Can you be confident you that your facility will never be the source of an endoscopy-related outbreak?

"I'm confident, but not stupid," says another respondent. "Human error can happen anywhere."

"That's just one reason we need to move toward sterilization," says Ms. Ofstead. "It provides a margin of error we cannot achieve with high-level disinfection." OSM