AAMI News November 2017

Citing Infection Danger, Experts Call for Endoscope Sterilization

High-level disinfection (HLD), the most commonly used method of reprocessing endoscopes, is overly complex and leaves patients susceptible to potentially deadly infections, according to experts, who urged the healthcare community to move toward sterilization of the devices.

“HLD is cutting it too close,” when it comes to patient safety, said Cori L. Ofstead, president and CEO of Ofstead & Associates, Inc., a healthcare consulting company based in Saint Paul, MN.

Ofstead was one of 40 experts representing sterile processing professionals, device manufacturers, testing labs, regulators, and others who participated in a meeting held in September at AAMI’s headquarters in Arlington, VA. These stakeholders met to review research into endoscope reprocessing ahead of a revision to a standard that addresses that topic: ANSI/AAMI ST91, Flexible and semi-rigid endoscope reprocessing in health care facilities.

MicrobesThe call to sterilize all endoscopes elicited strong and mixed reactions in the sterile processing community at large, with some calling it a step in the right direction, and others cautioning that it oversimplified a more complex challenge.

At the meeting, William Rutala, director of a statewide program for infection control and epidemiology at the University of North Carolina at Chapel Hill, said more outbreaks are associated with endoscopes than any other reusable medical device. This is partly due to the fact that when endoscopes are reprocessed using HLD there is “no margin of safety.”

“If the margin of safety is so small that perfection is required, then the design is too complex and the process is too unforgiving to be practical in a real-world setting,” Rutala said.

He noted that while HLD removes or inactivates 10 to 100 million spores, sterilization kills 1 trillion spores.

Theoretically, HLD should work, said Ofstead. However, after visiting healthcare facilities throughout the country and collecting real-world data on a large variety of endoscopes, Ofstead and her team have identified a number of barriers to effective reprocessing. These include:

  • Using damaged scopes
  • Cleaning with defoaming agents and lubricants that cannot be removed from scopes and that can harbor biofilm
  • Relying on automated endoscope reprocessors
  • Rinsing scopes with contaminated water
  • Failing to dry endoscopes
  • Storing endoscopes in unventilated storage cabinets
  • Using bare hands and dirty containers to transport endoscopes
  • Neglecting to clean, disinfect, and perform preventive maintenance on reprocessing equipment
  • Insufficient monitoring of reprocessing effectiveness

Many healthcare facilities Ofstead’s team visited placed a high value on efficiency, to the point that patient safety was compromised, she said. This emphasis on efficiency, coupled with human factors barriers, such as complex designs and complicated instructions for use, make it difficult for staff to adhere to all steps required for proper endoscope reprocessing. Everything has to be done perfectly every time, she said, or else “the whole enterprise comes crashing down.”

Switching to sterilization would address all of the identified barriers except the continued use of damaged endoscopes and the use of defoaming agents and lubricants that can’t be removed, Ofstead noted.

To ensure that all endoscopes would be sterilized, Rutala proposed modifying the Spaulding classification system. The Spaulding system describes how a device or instrument should be disinfected based on its intended use. According to the current scheme, devices in the “noncritical” FDA device class (i.e., objects that touch intact skin only, such as oximeters) require cleaning followed by low-level disinfection (in some cases, cleaning alone is acceptable); “semicritical” instruments (i.e., objects that touch mucous membranes or skin that is not intact, such as many endoscopes) require cleaning followed by HLD; and “critical” instruments (i.e., objects that enter normally sterile tissue, the vascular system, or tissue through which blood flows, such as surgical instruments) require cleaning followed by sterilization.

According to Rutala, when the Spaulding scheme was developed 50 years ago, semicritical items, such as endoscopes, rarely—if ever—penetrated sterile tissue, and the healthcare field did not have an adequate appreciation for the infection risk associated with endoscope reprocessing. Therefore, he would like to see the definition of critical items expanded to include those that come in “direct or secondary/indirect contact with sterile tissue,” which would encompass all endoscopes.

The stakeholders in attendance agreed that a move away from HLD to sterilization of endoscopes would be a heavily nuanced issue and something that would need to happen gradually.

Reactions on LinkedIn

Jonathan Wilder “Sterilization as the Band-Aid for incomplete cleaning is not the answer. It is an answer, but you can’t reliably sterilize instruments that are not properly cleaned.”

Donna Swenson “I’m concerned that changing to sterilization will give people a false sense of security. Many times over the years, I’ve heard from people who think sterilization resolves all problems with cleaning. It doesn’t!”

Carmen Ferriero III “While cleaning is the first step, raising the requirement to a more stringent process that yields a higher microbial kill is a huge step forward for these devices. Simply ‘washing them’ with chemicals is an antiquated process. Everything touching the human body should be required to be processed with the highest standard for our patients. This is a huge step forward to making these devices safer for our patients.”

Alison Sonstelie “How can you properly clean something that has been poorly designed for that consideration? As long as these devices are difficult to clean thoroughly, the problem will exist—whether they are sterilized or high-level disinfected.”

Jania Torreblanca “Sterilization alone would not be the answer. Better scope designs and strict assurance of cleaning step compliance would make a huge impact.”

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