Standards Spotlight: International Guidance for Minimizing Risk

February 1, 2020

Categories: AAMI News, Government, Medical Device Manufacturers, Medical Device Manufacturing

AAMI has published an update to the international risk management standard. Now in its third iteration, ANSI/AAMI/ISO 14971:2019, Medical devices—Application of risk management to medical devices, provides terminology, principles, and processes for managing risks associated with medical devices, including software as medical devices and in vitro diagnostic medical products.

ANSI/AAMI/ISO 14971 is primarily intended for medical device manufacturers. It covers the risks of injury related to the health of patients, the operator, and others, as well as the potential damage to property, equipment, and the environment. The standard was updated to better align with changes in medical device regulations around the world.

An accompanying draft technical report, AAMI/ISO DTIR 24971:2020, Medical devices—Guidance on the application of ISO 14971, was published in early 2020. It provides guidance on specific areas that are problematic for those implementing a risk management system and more detailed information about the steps manufacturers must take to meet the revised standard’s technical requirements. It also includes new and updated terminology to reflect the current medical device market’s needs.

“The science of risk management hasn’t changed much since the last time the document was revised. What has changed is how the standard and guidance document are structured to present that information,” said Wil Vargas, AAMI director of standards and committee manager for ISO 14971 under the AAMI Secretariat. “The standard and technical report were revised together to ensure maximum efficiency and alignment. Additional time was spent to clarify the 14971/24971 relationship with other connected documents. In this way, risk management for medical devices is now a more integrated part of the interconnected medical device standards universe.”

The Food and Drug Administration (FDA) officially recognized ANSI/AAMI/ISO 14971 in December. The agency recognizes standards developed by organizations such as ISO and AAMI to communicate to manufacturers that such standards are suitable to support a declaration of conformity.

“14971 provides a very high-level approach for any entity using risk management,” said Scott Colburn, director of the standards program for the FDA’s Center for Devices and Radiological Health. “The standard is one of the most popular and highly used by medical device manufacturers and regulators because it covers risk management, which is a lot of what these people do, and communicates the process for risk management in an orderly manner to help identify and mitigate risk.”

“Standards development in general will benefit from the improvements embedded in these documents,” said Colburn, “as well as FDA programs that highlight risk management and mitigation, like the Case for Quality Program and the Medical Device Single Audit Program.”

Available in the AAMI Store

ANSI/AAMI/ISO 14971:2019, Medical devices—Application of risk management to medical devices

AAMI/ISO DTIR 24971:2020, Medical devices—Guidance on the application of ISO 14971