Poor Reprocessing Instructions Can Harm Patients


Technicians in sterile processing departments (SPDs) at surgical facilities across the country are told to follow manufacturers’ instructions for use (IFUs) while cleaning, disinfecting and sterilizing instruments, tools and other devices.

Failure to do so can lead to the spread of infection, device damage and other harm, say experts at ECRI, one of the county’s largest national patient safety organizations. The techs’ jobs are made harder when the manufacturers’ instructions for use are bad.

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

The issue is the No. 2 concern ECRI says facilities should be on the lookout for in 2024. The group’s Top 10 Health Technology Hazards Webpage ranks the issues and challenges the industry and organizations to make improvements. The full report is accessible to ECRI members and includes practical recommendations and detailed steps to reduce risk and improve patient safety. National Patient Safety Week just ended, but March is still a suitable time to keep safety issues top of mind.

The cause of the IFUs issue and the onus to fix it is clearly on the vendors, says Ms. Sivek. The ECRI report challenges manufacturers of reusable medical devices to provide practical, validated reprocessing instructions for their products. “The instructions should adhere to relevant FDA guidance and should involve the use of common healthcare cleaning products, ” she says.

ECRI recommends that facilities review products in their existing inventory and identify those that have reprocessing-related issues. For any that have been involved with adverse events or near misses that included skipped, incomplete or poorly performed reprocessing, facilities should work with manufacturers to make sure the reprocessing instructions they have are validated, complete and practical to complete. Refresher training courses should be provided to staff if it’s determined the instructions weren’t performed correctly.

For yet-to-be-purchased products, facilities should perform risk assessments that include reprocessing considerations. The assessment should include asking the vendor for validated reprocessing instructions and ask the SPD staff if the steps would be practical to complete. If the vendor can’t provide validated instructions or staff feels they’re overly burdensome, consider a different product.

“The best time to address these issues is before you buy the products,” says Ms. Sivek. OSM

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