AAMI News December 2017

Standards Spotlight: New Standard Tackles Challenge of Device Reprocessing IFUs

Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices

  • Product code: 17664-PDF

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By far, one of the biggest complaints of those tasked with cleaning, disinfecting, and sterilizing medical devices is being able to follow the manufacturer’s instructions for use (IFU). Following these instructions to the letter is essential for patient safety.

“As headlines in recent years unfortunately have highlighted, ineffectively processed devices have led to patient infections, complications, and death,” said Ralph Basile, vice president of marketing and regulatory affairs for Healthmark Industries Company, Inc. “By providing more detail in IFUs and requiring more in terms of performance by the medical device manufacturer, the result will be improved patient outcomes.”

To help manufacturers develop these more detailed processing instructions, an AAMI committee Basile co-chairs has recently adopted ISO 17664, Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices, for use in the United States. This standard has replaced ANSI/AAMI ST81, Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices.

“Along with the Food and Drug Administration’s 2015 reprocessing guidance document, manufacturers selling medical devices into the U.S. market now have richer and more detailed guidance as to the validated processing instructions they need to provide their healthcare facility customers,” Basile said.

The guidance found in ISO 17664 applies to reusable medical devices that must be cleaned, disinfected, and/or sterilized before being used on another patient, as well as nonsterile single-use devices that require processing before use.

The standard outlines the information that needs to be provided to healthcare facilities, including detailed instructions related to pretreatment at the point of use; preparation before cleaning; cleaning; disinfection; drying; inspection, maintenance, and functionality testing; packaging; It also describes the validation testing that needs to be conducted to ensure each process is suitable for processing the device. “Manufacturers of medical devices that are to be processed have a responsibility to ensure that the design of the medical device facilitates achievement of effective processing. This includes consideration of commonly available validated processes,” according to the standard.

Informative annexes provide greater detail about the processes typically employed by healthcare facilities to clean, disinfect, and sterilize medical devices and “can be used as a guide to validate procedures.”

“This richer information should help medical device manufacturers develop instructions for use that are more readily implemented by healthcare facilities,” Basile said. “Overall, by providing more information, more guidance, and more complete requirements, this standard hopefully will mean more effective processes for making devices ready for use on the next patient.”