Johannes pointed out patient risks in general categories of data-integrity issues, user errors, design/build/workflow issues, system-interface issues, and unplanned system downtime. She stated that Cerner has found that incorporating some requirements that are imposed on medical device manufacturers into the company's design and development of advanced HIT solutions has helped reduce patient safety risks, including good manufacturing practices and quality system requirements.

Regarding approaches to the problems, Jeffrey Shuren, Director of the U.S. Food and Drug Administration's Center for Devices and Radiological Health offered different ideas the FDA could consider in addressing HIT-related safety concerns. These include a focus on post-market safety through a requirement for HIT device establishments to electronically register and list HIT devices, and to submit Medical Device Reports (MDRs) to the FDA. "Under this approach," Shuren said, "HIT device manufacturers would be responsible for correcting identified safety issues." Shuren said the FDA could use its authority to require post-market surveillance or tracking for selected higher-risk devices, and share post-market information with vendors, pre-market certification bodies, and users to help improve the design of future products.


Shuren said a second possible approach would be to require HIT device manufacturers to comply with the previously mentioned requirements and also to adhere to FDA's Quality Systems Regulation (QSR). QSR requires adhering to specific minimum guidelines for the quality and consistency of market products. Shuren explained that QSR requires software devices to comply with appropriate design controls, which he described as an "interrelated set of practices and procedures that are incorporated into the design and development process of a device, in order to check for problems and make corrections in the design of the device before it is put into production." Shuren suggested that based on data collected through post-market safety authority, the FDA could recommend design controls to mitigate the risks that are unique to HIT devices.

A third approach Shuren described would be to apply the agency's traditional regulatory framework to HIT, in which HIT device manufacturers would be required to meet all the same regulatory requirements as other traditional devices, including risk-based pre-market review.

William B. Munier, M.D. Director, Center for Quality Improvement and Patient Safety for the Agency for Healthcare Research and Quality (AHRQ), suggested that the agency's Patient Safety Organization (PSO) program could have significant impact, if its common definitions and reporting formats (Common Formats), are adopted by a large number of institutions and providers. Dr. Munier said AHRQ's PSO Common Formats have the attributes of being scientifically supportable, constructed for use at point-of-care (such as at a hospital), open and transparent, and have technical specifications adhering to emerging Federal HIT conventions.

More Industry Headlines