The Joint Commission issues advisory on sterile packaging

June 29, 2022

A new Quick Safety advisory from The Joint Commission, “Managing packaged sterile supplies and devices,” provides guidance to keep patients safe from infection and other potential harm from expired or compromised supplies and devices.

Managing commercially prepared sterile supplies and devices can be challenging for healthcare organizations.

“Over the past few years, we have found that many healthcare professionals do not have the proper training to recognize if packaged sterile supplies are appropriate for use,” says Diane Cullen, RN, MSN, MBA, CIC, associate director, Standards Interpretation Group, The Joint Commission. “This is concerning because the packaging includes many symbols which represent critical information about how the item should be used, stored and reprocessed. We hope the new Quick Safety advisory will bring this very relevant patient safety concern to the front of mind.”

The advisory urges healthcare professionals to pay close attention to device labels. Manufacturers of certain medical devices and products must include labeling on or with their devices, according to the U.S. Food and Drug Administration (FDA). The Joint Commission requires that organizations follow the manufacturer’s written instructions for use (IFU) to ensure the end-user understands how to use, clean, disinfect, reprocess and store medical devices.

Additionally, the advisory encourages healthcare professionals to follow a hierarchical approach to infection prevention for packaged sterile supplies and devices. This approach includes following rules and regulations first, followed by the Centers for Medicare & Medicaid (CMS) requirements, manufacturer’s IFU, and evidence-based guidelines and national standards.

Safety actions outlined in the advisory include educating staff to:

·        Recognize the labeling used for supplies and devices, including the stand-alone symbols and their meanings.

·         Follow the hierarchical approach to infection prevention for packaged sterile supplies and devices.

·         Recognize when a commercially prepared sterile medical device would be inappropriate to use.

·         Know where to find information specific to an IFU should a question or concern be identified.

Healthcare organizations may also want to provide posters and other graphic devices as quick references to the meanings of any stand-alone symbols.

The Joint Commission release