Quality instructions for medical device reprocessing are so vital that they earned the No. 2 spot on a top patient safety organization’s list of things healthcare facilities should address this year.

The Emergency Care Research Institute (ECRI), one of the country’s largest patient safety authorities, issues its Top 10 Health Technology Hazards annually, identifying key issues and challenges to healthcare organizations.

This year’s ranking placed “inadequate or onerous device cleaning instructions” right below ECRI’s No. 1 concern, medical devices posing “usability challenges for home users, risking misuse and patient harm.”

“Failure to properly clean and disinfect or sterilize reusable medical devices between uses can lead to the spread of infection, device damage, and other forms of harm,” according to ECRI. “Healthcare workers who perform reprocessing may find it difficult or impossible to complete this task effectively — or they may suffer harm in the process.”

Sterile processors at facilities nationwide are instructed to follow manufacturer’s instructions for use (IFUs) when they clean, disinfect and sterilize instruments, including reusable endoscopes, to protect patients from infection.

ECRI recommended that healthcare facilities evaluate the instructions before purchasing any reusable medical devices to ensure that:

• Validated reprocessing instructions will be provided
• The instructions have been shown effective and to ensure safe reuse over the life of the product
• The reprocessing steps are practical to complete in that facility’s setting

The jobs of sterile processors get more difficult when those instructions are unclear or incomplete.

“Our members report issues with various device problems at least weekly,” says Amanda Sivek, a principal project engineer at ECRI, in a post in Outpatient Surgery, published by AORN. “When we look for reprocessing instructions, they can be incomplete, impractical to complete or not even exist.”

Consider reusable flexible endoscopes, which in some cases require sterile processors to perform 100 or more steps to clean. Although the ECRI executive brief does not specifically address cleaning of endoscopes, it has long been recognized that infections can occur when scopes are inadequately cleaned or dried.

In 2022, the ECRI list said poor duodenoscope reprocessing ergonomics and workflows can put healthcare workers and patients at risk.

In fact, flexible endoscopes made the ECRI list every year from 2010 to 2020, with cross-contamination threats topping their list in 2010 and 2016.

Single-use endoscopes, like those manufactured by Ambu, eliminate the need for reprocessing and repairs and the worry of cross-contamination.

Click here to read the 2024 ECRI executive brief.

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