IOM: HHS needs to up health IT safety plan; FDA may step in
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The report, “Health IT and Patient Safety: Building Safer Systems for Better Care,” examined the safety of health IT products and their effects on patient safety. The Washington, D.C.-based IOM appointed a study committee to recommend ways to make patient care safer using health IT so that the nation will be in a better position to realize its potential benefits. Overall, the committee found the literature about health IT and patient safety to be inconclusive.
“Some health IT applications are definitively successful at improving medication safety,” the report noted. “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the healthcare system may be limited.”
The proposed plan for the HHS should include a schedule for working with the private sector to assess the impact of health IT on patient safety, the authors asserted. “However, if the secretary determines that progress toward improving safety is insufficient within a year, the FDA should exercise its authority to regulate these technologies. Concurrently, FDA should begin planning the framework needed for potential regulation so that the agency is ready to act if necessary.”
According to the authors, little published evidence exists that quantifies the magnitude of the risk associated with health IT problems, partly because many technology vendors discourage the free exchange of safety-related information in their contracts with healthcare providers. But serious errors involving these technologies--including medication dosing errors, failure to detect fatal illnesses, and treatment delays due to poor human-computer interactions or loss of data--have led to several reported patient deaths and injuries.
HHS should establish a mechanism for both technology vendors and users to report health IT-related deaths, injuries or unsafe conditions, the report said. Reporting events related to patient safety should be mandatory for vendors and voluntary, confidential and non-punitive for care providers. “In addition, Congress should establish an independent federal entity to investigate patient deaths, injuries, or potential unsafe conditions associated with health IT. Based on those investigations, the entity could make nonbinding recommendations, allowing flexibility for HHS, healthcare organizations, vendors and other experts to determine the best course forward.”
The committee urged that a new health IT safety council be funded by HHS to evaluate criteria and develop methods for assessing and monitoring safety and measuring impacts of health IT on safety. The agency should also ensure that health IT vendors support the free exchange of information and not discourage healthcare providers from sharing patient safety concerns, including screen shots, they added.
HHS should establish quality management principles and risk management processes in designing and implementing health IT products, which can be complex and difficult for doctors and nurses to use, the authors added. “Alerts in technology systems should be designed to have lower false-alarm rates and computer interfaces need to be more intuitive for users.
"Creating safer systems begins with user-centered design principles and includes adequate testing and quality assurance assessments conducted in actual or simulated clinical environments, or both," the report concluded. "Designers and users of health IT should work together to develop, implement, optimize and maintain health IT products."
The study was sponsored by HHS.
Read the report in its entirety here.