Health IT malfunctions have been linked to several cases of patient harm and some deaths, according to Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, the Huffington Post Investigative Fund reports.
Shuren is expected to testify about health IT-related adverse events during a government hearing on Thursday.
The testimony indicates that during the past two years, FDA's voluntary notification system recorded 260 reports of health IT malfunctions that had the potential to harm patients, including 44 injuries and six deaths.
Shuren warned that the actual number of health IT-related adverse events could be higher because FDA's reporting system is voluntary.
Reported malfunctions include:
- Loss of important medical information;
- Misplaced test results; and
- Patient mix-ups.
Recommendations for Increased Oversight
In his prepared testimony, Shuren notes that FDA in the past generally refrained from regulating health IT systems. However, he said the recent adverse event reports suggests a need for greater federal scrutiny of the health IT industry.
Shuren suggested that FDA could strengthen its health IT oversight by:
- Requiring health IT manufacturers to register their products, submit reports on safety concerns and fix identified problems;
- Setting minimum quality standards for health IT products;
- Subjecting health IT systems to the regulatory processes that other medical products face before going on the market.
Shuren's testimony does not indicate which approach FDA prefers (Schulte/Schwartz, Huffington Post Investigative Fund, 2/23).