FDA recognizes voluntary standards for medical devices

Following several reports, including one from The ECRI Institute, a patient safety organization, the Food & Drug Administration (FDA) has recognized voluntary interoperability standards for medical devices in a notice published in the Federal Register on Aug. 6.

Medical device and health IT interoperability failures are one of the most significant health technology hazards, according to The ECRI Institute's report. And, a study from West Health Institute found that improved medical device interoperability, when combined with the adoption of commonly accepted interoperability standards, could save the U.S. more than $30 billion in healthcare costs annually.

In the Federal Register notice, FDA recognized 25 standards that can be divided into the following three categories:

• IT network risk management applications;

• Point-of-care and personal device communication health informatics; and
• Security systems for industrial communication networks.

The agency's blog, FDA Voice, published comments from Bakul Patel, senior policy adviser to the director of the Center for Devices and Radiological Health at FDA. "As medical devices become increasingly connected to other medical devices, hospital information systems and electronic health records, there is a growing expectation that they will be interoperable--and that the data they transmit will be secure," Patel wrote. "Making sure devices are interoperable requires the creation, validation and recognition of standards that help manufacturers develop products that are harmonious and can 'plug and play.'"

Chuck Parker, executive director of Continua Health Alliance, a global non-profit industry alliance of technology, medical device and healthcare industry leaders and service providers committed to personal connected health, said FDA's recognition of the standards is "a significant step forward for interoperability," in a statement.